1

A COMPARISON OF A COMBINATION OF PHYSICAL EXERCISE AND PLACEBO

WITH PHYSICAL EXERCISE AND GINSENG IN THE TREATMENT OF ERECTILE

DYSFUNCTION IN MARRIED MEN ATTENDING GENERAL OUT PATIENT CLINIC

AND UROLOGY CLINIC, JOS UNIVERSITY TEACHING HOSPITAL,

JOS

BY

DR BAKZAK ISAAC BULUS

(MBBS, UNIJOS, JOS, 2006)

A DISSERTATION SUBMITTED TO NATIONAL POSTGRADUATE MEDICAL

COLLEGE OF NIGERIA (NPMCN) IN PARTIAL FULFILMENT OF THE

REQUIREMENTS FOR THE AWARD OF FELLOWSHIP OF THE COLLEGE IN

FAMILY MEDICINE (FMCFM)

DEPARTMENT OF FAMILY MEDICINE,

JOS UNIVERSITY TEACHING HOSPITAL

JOS NIGERIA

MAY, 2017

2

DECLARATION

I hereby declare that this work is original and has not been submitted to any college for award of

fellowship or any university for award of degree. It has not been submitted elsewhere for journal

publication

___________________________________

DR. BAKZAK ISAAC BULUS

DATE _____________________________

3

CERTIFICATION

This research work was carried out by Dr Bakzak Isaac Bulus under our supervision. We also

supervised the writing of the dissertation.

SUPERVISORS:

1. Signature ________________ Date _____________________

Dr Lar N Nimkong (FMCGP)

Consultant family physician

Department of Family Medicine

Jos University Teaching Hospital, Jos Nigeria.

2. Signature ________________ Date ______________________

Dr Longmut Remen (FMCGP)

Consultant Family Physician

Department of Family Medicine

Jos University Teaching Hospital, Jos Nigeria.

HEAD OF DEPARTMENT

Signature __________________ Date ______________________

Dr Patricia Agaba (FWACP, FMCGP)

Consultant Family Physician and Head

Department of Family Medicine

Jos University Teaching Hospital,

Jos Nigeria.

4

DEDICATION

This book is dedicated to my God, my parents and my wife Nanbwet for the inspiration and

encouragement received in the course of this work.

5

ACKNOWLEDGEMENT

I want to acknowledge first and foremost my Lord and Saviour Jesus Christ for giving me the

strength and enablement to pursue this goal. It was because of his love, guidance and protection

that i was able to complete this work.

I am highly indebted to my supervisors Drs Lar and Longmut for guiding me through this part of

my training and their unending support.

I am also grateful to Drs Pitmang, Sule Joshua, Jonathan and professor Dakum for helping me

read through and make corrections in this book.

I want to thank all the consultants and residents of the departments of Family Medicine and

Urology of JUTH for their encouragement and support during this study. I have been encouraged

and blessed with the pleasure of working with each of you.

Thank you Drs Turshak and Abimuku for helping me in the analysis, Nenpalang, Maijida and

Madina Mohammed for helping me print this work.

I am also grateful to my support staff Mrs Chitau and Kyauta for their unrelenting love and

support that encouraged me to complete this work.

I am also grateful to my friends, staff of Sendi Hospital for helping me with stationaries,

encouragement and prayers that helped me to get to this day.

Finally, to my star and beacon of hope, my dear wife Nanbwet and my children Bwetsun,

Pandok and Africa for their unrelenting love, support and understanding through the period of

this research, thanks for the support

6

TABLE OF CONTENTS

Title page --- --- --- --- --- --- --- --- --- --- --- --- --- --- ---- ----- i

Declaration --- --- --- --- --- --- --- --- --- --- --- --- --- -- ii

Dedication --- --- --- --- --- --- --- --- --- --- --- --- --- - ---- ----- iii

Acknowledgement --- --- --- --- --- --- --- --- --- --- --- ---- --- --- iv

Certification --- --- --- --- --- --- --- --- --- --- --- --- --- ---- ----- v

Table of contents --- --- --- --- --- --- --- --- --- --- --- --- ---- ------ vi-ix

List of figures --- --- --- --- --- --- --- --- --- --- --- --- -- ------- x

List of tables --- --- --- --- --- --- --- --- --- --- --- --- -- - ----- xi

List of abbreviations --- --- --- --- --- --- -- ---- ---- --- --- --- xii-xiv

Summary --- --- --- --- --- --- --- --- --- --- ---- --- --- --- ----- 1

CHAPTER ONE

1.1 Introduction - - - - - - - - 3

1.2 Statement of Problem - - - - - - - 9

1.3 Aim and Objectives of Study - - - - - - 10

1.4 Justification/ Relevance of the study to Family Medicine - - 10

CHAPTER TWO: Literature Review

2.1 Overview of erectile dysfunction - - - - - - 13

2.2 Epidemiology of erectile dysfunction - - - - - 16

2.3 Risk factor of erectile dysfunction - - - - 18

7

2.4 Anatomy and Pathophysiology of erectile dysfunction - - - 23

2.5 Classification of erectile dysfunction - - - - - 26

2.6 Assessment of patients with erectile dysfunction - - - - 28

2.7 Erectile dysfunction scores - - - - - 30

2.8 Severity of Erectile Dysfuntion - - - - - 33

2.9 Investigations of erectile dysfunction - - - - - 34

2.10 Treatment of Erectile Dysfunction - - - - 35

2.10.1 Pharmacological treatment - - - - - - - 36

2.10.2 Non pharmacological treatment - - - - - 37

2.10.3 Physical exercise- - - - - - - - - - - 39

2.10.3 Complementary and alternative medicine - - - - - - - 43

2.10.4.1Red Korean Ginseng - - - - - - - 46

2.10.4.2 Side Effects of Ginseng - - - - - - - - - 49

CHAPTER THREE: Methodology

3.1 Study area - - - - - - - - - 53

3.2 Study Population - - - - - - - - 54

3.3 Study period - - - - - - - - 54

3.4 Eligibility - - - - - - - - - 54

8

3.5 Sample size determination - - - - - - 55

3.6 Ethical consideration - - - - - - - 56

3.7 Instrument of data collection - - - - - - 56

3.8 Study designs - - - - - - - - 57

3.9 Statistical Analysis - - - - - - - 62

CHAPTER FOUR: Results

4.1 Baseline characteristics - - - - - - - 65

4.2 Medical characteristics - - - - - - - 67

4.3 Erectile dysfunction scores and side effects - - - - 74

CHAPTER FIVE: Discussion

5.1 Socio-demographic Characteristics - - - - - - - - - 81

5.2 Medical Characteristics - - - - - - - - - 81

5.3 Effectiveness of Ginseng on Erectile Dysfunction - - - - 84

5.4 Severity of Erectile Dysfunction - - - - - - 87

5.5 Ginseng Side Effects - - - - - - - 88

5.6 Relationship Between Clinical Characteristics and ED scores- - 89

5.7 Conclusion - - - - - - - - - 90

5.8 Recommendations - - - - - - - 90

9

5.9 Strength of the Study - - - - - - - 91

5.10 Limitations of the study - - - - - - - 91

5.11 Implication of the Study to Family Medicine - - - - 91

5.12 Suggestion for further studies - - - - - 92

REFERENCES - - - - - - - 93

LIST OFABBREVIATIONS/SYMBOLS

95% CI 95% confidence interval

% Percentage

/ Per

< Less than

≤ Less than or equal to

= Equal to

˃ Greater than

≥ Greater than or equal to

BMI Body Mass Index

CAM Complementary and alternative medicine

CBT Cognitive Behavioral Therapy

CDC Center for Disease Control and prevention

COX-2 Cyclo-Oxygenase enzyme 2

DSM-5 Diagnostic and Statistical manual Version 5

ED Erectile Dysfunction

10

ECG Electrocardiography

cGMP Cyclic Guanosine Monophosphate

ESR Erythrocyte Sedimentation Rate

g/dl gram(s) per deciliter

g/L grams(s) per litre

FBG Fasting Blood Glucose

FITT Frequency, Intensity, Type and Time

GABA Gaba Amino Butyric Acid

GAQ Global Assessment Questionaire

GOPD General Out-patient Department

GOPC General Out-patient Clinic

HA Hyaluronic Acid

HHR Heart Rate Researve

HRQoL Health Related Quality of Life

IIEF International Index of Erectile Function

JUTH Jos University Teaching Hospital

Kca Calcium Activated Potasium Channels

Kg Kilogram

MAOI Mono Amine Oxidase Inhibitors

MHR Maximum Heart Rate

Mm Millimeter (s)

M Meter (s)

MUSE Medicated Urethral System of Erections

No. Number

11

NPT Non-pharmacological Treatment

NICE National Institute for Health and Clinical Excellence

NSAIDs Non-Steroidal Anti-inflammatory Drugs

P P-value

PAIR Psychological And Interpersonal Relationship Scale

PCS Physical Component Summary

PHC Primary Health Care

PDE Phosphodiesterase Inhibitors

PTSD Post Traumatic Stress Disorders

QoL Quality of Life

RCTs Randomized Controlled Trials

RHR Resting Heart Rate

SEAR Self Esteem And Relationship

SEP Sexual Encounter Profile

SD Standard Deviation

SHBG Sex Hormone Binding Globuline

SF-36 Short Form-36

SPSS Statistical Package for Social Sciences

SSRI Selective Serotonine Receptor Inhibitors

T t-value

TCAs Tricyclic Antidepressants

US United States

VEGF Vascular Endothelial Growth Factor

WHO World Health Organization

12

WONCA World Organization of National Colleges, Academies,

and

Academic Associations of General Practioners /Family

Physicians

LIST OF FIGURES

Figure 2.1: The multi-factoral causes of erectile dysfunction --- --- --- --- ---23

Figure 2.2: Mechanism of erectile dysfunction --- --- --- --- --- --- --- --- --- 26

Figure 2.3: Algorithm for diagnosis and treatment of erectile dysfunction – 51

Figure 4.1: Study protocol --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- 62

Figure 4.2: Complain on erectile dysfunction--- --- --- --- --- --- --- --- --- --- -67

Figure 4.3: Spouse presentation--- --- --- --- --- --- --- --- --- --- --- --- --- --- -68

Figure 4.4: Side effect of ginseng after treatment --- --- --- --- --- --- --- --- --79

Figure 4.5: Types of Side effect experience after treatment--- --- --- --- - -- 80

LIST OF TABLES

Table 2.1: classification of erectile dysfunction--- --- --- --- --- --- --- ---27

Table 4.1: Socio – demographic characteristics --- --- --- --- --- --- --- --- 65

Table 4.2 Medication used among the study participants --- --- --- --- --- 69

Table 4.3: Risk factors of erectile dysfunction --- --- --- --- --- --- --- --- 70

Table 4.4: Investigations results and examination findings--- --- --- --- - 72

Table 4.5: Erectile dysfunction scores at best line --- --- --- --- --- --- --- 74

Table 4.6: Erectile dysfunction scores post intervention --- --- --- --- --- 76

Table 4.7 Percentage difference in EF at baseline and post intervention—78

13

APPENDICES

1. JUTH ethical clearance I- - - - - - -- 107

2. Approval from National Postgraduate Medical College of Nigeria. I -- 108

3. Assessment of Synopsis of Desartation III - - - - - - 109

4. Consent form (English ) IV - - - - - - -- 110

5. Consent form (Hausa) V - - - - - - - --111

6. Study Questionnaires (English) VI - - - - - -- 112-114

7. Study questionnaires (Hausa) VII - - - - - - - -- 115-117

8. International index of erectile function questionnaire (English) VIII - --118

9. International index of erectile function questionnaire (Hausa) IX - - --- 119

10. Patient encounter form --- --- - - - - - - - - - - - - --120

11. IIEF Questionnaire - - - - - - - - - - - - 121-124

12. IIEF Q uestionaire - - - - - - - - - - - - ---125-127

13. Follow up Questionaire - - - - - - - - - - - -128

14

SUMMARY

BACKGROUND: Erectile dysfunction (ED) has been in existence for many years with majority

of those affected using complementary and alternative medicine for its treatment. Prevalence of

erective dysfunction has been on the increase due to increase in number of its risk factors such as

increase in number of the aging population, hypertension, diabetes, alcohol consumption and

cigarettes smoking.

ED has resulted to a lot of family problems such as marriage separation, family dysfunction and

even divorce, many of which the causes may not be known because of the difficulty in

expressing these problems. This study compared the effectiveness of exercise and ginseng with

exercise and placebo in the treatment of erectile dysfunction. The severity and pattern of ED

among the study population were determined with side effects of Ginseng.

METHOD: The study was a randomized controlled single blinded comparative study among

190 participants within the ages of 25 and 70 years who presented at GOPC and Urology clinic

of Jos University Teaching Hospital (JUTH). They were recruited consecutively as they came

into the clinic, the IIEF was applied and the patients were randomized using simple random

sampling method. Ninety five (95) participants each were randomly allocated into the control

and the intervention group using sealed opaque envelopes. The intervention group took 50mg of

ginseng extract daily plus exercise while the control group were on placebo daily plus physical

exercise for eight weeks. Ninety three from each group completed the study with two (2)

participants from each group lost to follow up.

RESULTS: The mean age of the subjects who participated in the study was 41.7 years .The

standard deviation was 55.6±12 years. The major risk factors of erectile dysfunction identified

15

among the participants were hypertension, alcohol consumption and medications for diabetes and

hypertension. The ED scores at baseline was 7(3.8%) in the intervention group compared to

10(5.4%) in the control group. After treatment 33(17.7%) of the participants in the intervention

group had mild ED compared to 16(8.6%) in the control group. The participants whose erectile

function became normal was 14(7.5%) in the intervention group compared to 2(1.1%) in the

control group after intervention. Majority 71(38.2%) of the participants in both groups had mild

to moderate ED. The proportion of the participants in the intervention groups who had mild side

effects was 34(5%). The commonest side effects were insomnia (50%), breast pain (25%) and

gum swelling (25%).

Conclusion: Ginseng showed significant improvement in erectile dysfunction with minimal side

effects in participants with mild (p=0.03) and moderate (p=0.04) ED. Majority of the

participants had mild to moderate ED. Therefore Ginseng may be integrated in management

protocol for erectile dysfunction which may in-turn reduce ED prevalence in Nigeria.

CHAPTER ONE

16

1.1 INTRODUCTION

Reproductive health is a state of complete physical, mental and social well-being and not merely

the absence of disease or infirmity in all matters relating to reproductive system, functions and

processes.1This implies that people are able to have a responsible satisfying and safer sex life and

also to have a capability to reproduce and the freedom to decide if, when and how to do so.1,2

Reproductive and sexual health problems account for 14% of global burden of ill health for men

between the ages of 35 and 70 years.2 Erectile dysfunction occurs in about 14% of men at 50

years, 17% at 60 years, and 47% at 75years and above.3 Transient and inadequate erection affect

as many as 50% of men between 40 and 50 years.3

Sex and reproduction have rights that are enshrined in many conventions, agreements, laws and

declarations which produce framework within which sexual and reproductive wellbeing can be

achieved.4

Sexual health is a state of physical, mental and social well-being in relation to sexuality and not

the mere absence of disease and infirmity.2 This requires positive and respectful approach to

sexuality and sexual relationship, as well as possibility of having pleasurable and safe sexual

experience free from coercion, discrimination and violence.3

Many of the patients that family physicians see have sexual problems, majority will not be

comfortable to ask questions about their sexual problems, while some will ask indirectly or

through humour or with great personal discomfort.5

Some patients have physical complaints that have psychological basis which can lead to sexual

problems.1Sexual functions and frequency of sexual intercourse have a tendency to decrease with

age while the prevalence of sexual dysfunction increases.6

17

Erectile dysfunction is a topic of considerable importance to men’s health.7 It is increasingly

being recognized as a comorbid condition in men with some diseases such as cardiovascular

diseases and diabetes mellitus.7

Erectile dysfunction is defined as the persistent inability to achieve or maintain an erection

adequate for satisfactory sexual intercourse for at least three months.8 It is a global problem

affecting all communities though not always talked about. It is the most common sexual

problems in men and affects about one third of men throughout their life time prompting them to

seek medical help they ordinarily would not have since it has been a serious problem and a focus

of attention by the general public in recent times.9,10

The burden of ED is as high as up to 30 million persons in the United State of America despite

the availability of effective oral medications for this condition. It is a form of sexual arousal

disorder which reportedly causes distress to both patients and their spouses.11 Erectile

dysfunction is usually underestimated in many under developed world including Nigeria.12,13

Data on erectile dysfunction in Nigeria is limited, but a study done in south west Nigeria found

that about 46.9% of patients between the ages of 20 and 70 years have erectile dysfunction.14 The

Prevalence showed that 28% of erectile dysfunction was found between the ages of 30 and 49

years, 40% between 40 and 69 years and 54% in those above 70 years.14 This shows that erectile

dysfunction increases with age and a menace to our society, causing negative impact on self-

esteem, relationships and quality of life.10 Erectile dysfunction affects about 100 million men

worldwide especially those with diabetes which also increases with age.15 In Saudi Arabia and

Amman, the incidence is 30% and 60% respectively.16Although about 10% of men within the

ages of 40 and 70 years have severe erectile dysfunction, only few of them seek medical

attention.17

18

Erectile dysfunction, called impotence in the past, is a very common condition and varies with

severity, some men have total inability to achieve erection, some have inconsistent ability to

achieve erection (moderate), while others can sustain only brief erection (mild).18

The severity of erectile dysfunction appeared to be stronger in younger men when adjusted to

only age as risk factors.18 The variation in severity of erectile dysfunction makes estimating its

frequency difficult, even though the frequency of nocturnal erections and intercourse decreases

whereas the prevalence of erectile dysfunction increases with age.6 Majority (60%) of the elderly

people have interest in maintaining their sexual function.19

Many men are reluctant to discuss erectile dysfunction with their doctors, thus the condition is

usually undiagnosed.2,19 Many family physicians see quite a number of sexual problems, many of

which are erectile dysfunction yet physicians are reluctant to address this problem largely due to

time constraints, feeling ill prepared, embarrassments, limited knowledge on the topic, cultural

and religious beliefs and that the topic is not relevant to the chief complaints.2 Majority of the

people with erectile dysfunction will not be able to talk about it due to cultural and religious

reasons therefore our response to it can affect them positively or negatively.2

The economic impact of erectile dysfunction can be classified into direct and indirect cost.10 The

direct cost includes physical evaluation, pharmacotherapy and diagnostic testing while indirect

cost include loss of time at work, lost productivity and effect on the partner, family and

coworkers.10

The first line management of erectile dysfunction involved risk factor reduction and oral

medications. Second line management include; Surgical management such as (i) Alprostidil:

This can be administered either intra-carvernosaly (better) or intra-urethral and titrated to an

adequate erectile response. (ii) Vacuum pump device. (iii) Penile prostheses-usually done with

the help of a urologist.10

19

Cognitive behavioral therapy (CBT) is another form of treatment aimed at improving

relationships with subsequent improvement in erectile dysfunction especially when there are no

obvious causes, then psychosocial factors should be explored.10 The potential clues to these

factors include; the ability to achieve normal erections and subsequently orgasm via

masturbation or sex with a different partner.20

Patients often use complementary and alternative medicine in the treatment of erectile

dysfunction aside orthodox medicines.21 Common methods include acupuncture, ginseng, maca,

yohimbin, Dihydroepiandrosterone, Arginine, Coleus, Damiana, Gingko and alpha lipoic acid

which is particularly suited for the treatment and prevention of diabetic complications including

erectile dysfunctions.21 Sex is a two way relationship, therefore erectile dysfunction affects both

the man and the woman depending on the behaviors and the reactions of the man to the

problem.21 These reactions may vary from negative attitudes, dissatisfaction with the problem,

taking no action or ignoring the problem which may end up with breakdown of the role of the

husband leading to family dysfunction.21

The full acknowledgement of the problem and good discussion of the problem is very vital in

seeking professional help.21Alternative treatment of this condition includes Korean Ginseng

which have been reported to improve erections.10

Ginseng is one of the eleven species of slow growing perennial plants with fleshy roots,

belonging to the genus panax of the family araliaceae.18,22 It is commonly found in cooler

climates such as northern hemisphere (North America and eastern Asia). Ginseng is typically

classified into two namely; (a) Asian ginseng: commonly found in Asia, it is further sub

classified into five types namely: Red ginseng which is usually unpeeled (harvested six years and

above), fresh ginseng (harvested less than four years old), white ginseng (harvested less than six

20

years old) – dried and peeled.21,22 Others are sun ginseng and wild ginseng. (b) American

ginseng (p. quinquefloius).21,22,23

Panax Ginseng is typically promoted for the treatment and protection of the following diseases;

anxiety, asthma, cancer, chronic fatigue syndrome, diabetes mellitus, depression, erectile

dysfunction, fever, fibromyalgia, headache, insomnia and stress.18,21 It is also used to slow down

ageing process, enhance memory, stimulate immune system and improved sports

performance.18,21

Most ginsengs are from roots and rarely from the leaf because the roots are more effective.23

Panax (all healing) Ginseng is available in different forms such as tinctures, liquid extracts,

powder and capsules.23

Ginseng appears to be non-toxic when used in both short and long term and reported side effects

are rare.23 Ginseng is used by many cultures as a remedy for erectile dysfunction,23 the reason for

this study therefore, proper identification and management of erectile dysfunction will

significantly improve their quality of life, the management of which has now moved into the

realm of primary care physician.23

Lifestyle is a way of life or style of living that reflects the attitude and values of a person or

group.24 This tends to affect our lives in about 53%, others are genetic, environmental and health

care.24 Physical activity is one of the seven dimensions of wellness, other dimensions of wellness

include occupational, intellectual, social, emotional, spiritual and environmental dimensions.24

Physical activity and sexology are part of the lifestyle practices relating to health, others are

smoking, nutrition, alcohol intake, stress/sleep, hygiene, health literacy, television over viewing

and spirituality.24 A planned, coordinated and regular physical activity is carried out to improve

one or more components of physical fitness.24

21

The human body is made to be physically active, therefore low physical activity leads to

sedentary lifestyle which results in a number of disease conditions including erectile dysfunction,

obesity, cardiovascular diseases and hypertension.25 This is because physical exercise in itself

improves aerobic capacity, muscular strength, metabolic function and coordination leading to

reduction in risk factors of ED.25

Other components of lifestyle that improves erectile dysfunction are diets especially

Mediterranean style of diet and reduced calorie intake which will lead to improved erectile

function, others are reduction or stoppage of alcohol consumption, cigarette smoking and weight

reduction.26 Therefore, good lifestyle maintenance are associated with maintenance of good

erectile function.27 But physical exercise is chosen because it can easily be adapted and

measured.

Regular physical activity is also found to be beneficial in the treatment of erectile dysfunction,

both in normal patients and patients with disease conditions such as cardiovascular diseases and

obesity.28

1.2 STATEMENT OF THE PROBLEM

Sexuality is a very important part of the total person, integral to health and general wellbeing. It

affects our ego, our sexual partners and the entire family either positively (through bonding) or

negatively.2 In our communities, it is usually difficult to get to the root cause of any family

problem caused by erectile problems because they are not usually talked about even in the face

of a serious family problem.2,3

22

The current prevalence of erectile dysfunction is reported as 25% and expected to rise with time.9

Majority of patients with erectile dysfunction seek help from traditional herbalist and

pharmaceutical stores for their problem, many of such drugs, the efficacies, safety and dosages

are not usually documented, The number of persons with ED consuming Ginsomin for the

treatment of ED in our community is increasing and more pharmaceutical companies are

advertising ginsomin for its treatment. Studies have also claimed the effectiveness of Ginsomin

in the treatment of ED. therefore, the family physician should be able to interact with patients in

a way that will make them feel comfortable and relaxed to talk about their sexual concerns. This

is in consideration of the limited health care facilities and poor services in Nigeria.12 The

problem is usually compounded by the few reports on prevalence and treatment pattern of

erectile dysfunction in our environment.12,29,30

The result of this research will provide information about the severity of erectile dysfunction in

our environment. It will also determine the effectiveness of commonly used Ginseng and its side

effects in the treatment of erectile dysfunction. This will help the Family Physician to better

equip himself with the knowledge and practice of sexual health. This will eventually lead to

more sexual satisfaction and build relationships amongst couples. It will eventually reduce the

rate of divorce, promiscuity and dysfunctional family tendencies in our society.1

1.3 AIM AND OBJECTIVES OF THE STUDY

1.3.1 THE AIM

To compare the effectiveness of a combination of physical exercise and ginseng with physical

exercise and placebo in the treatment of erectile dysfunction among married men attending

GOPD and Urology clinics in JUTH Jos, The finding of which may be used to advocate for the

use of Ginseng and life style modification in the management of erectile dysfunction.

1.3.2 SPECIFIC OBJECTIVES

23

a To compare erectile dysfunction scores between treatment and control groups at base line and

at eight weeks

b To determine the pattern of erectile dysfunction

c To determine the side effects of ginseng

1.4 JUSTIFICATION/RELEVANCE OF THE STUDY TO FAMILY MEDICINE

High prevalence of erectile dysfunction from literatures and the number of ED patients seen

daily in our clinics were becoming alarming in Jos. Erectile dysfunction is not always talked

about by both patients and physicians yet affects patient’s quality of life which had led to

emotional problems to the patients. Erectile dysfunction is a multi-factorial condition that results

from chronic diseases that requires long time follow up which is suitable in primary care.

Erectile dysfunction also affects the entire family resulting in patients withdrawing from their

spouses, to marital discords, family separation or dysfunction and even divorce.11,12 ED increases

with age and coupling with its negative effect on relationship, marriages and the entire family

and the psycho-social issues relating with it, therefore the family physician is in the best position

to manage these patients.

Family medicine is a medical specialty that encourages the use of cost effective and preventive

strategies in the management of erectile dysfunction. Physical exercise and ginseng are probably

one of the most cost effective modes of treatment of erectile dysfunction for now.

The family physician is a specialist who provides comprehensive, continuing and well-

coordinated care to patients irrespective of age, gender, and disease or disorder presented. He is

responsible in preventive health services (risk factors) and managing patients in a holistic

manner within the context of the family.

He is usually the first point of contact and the only physician who provides care from cradle to

grave. He manages both patient and the family which justifies this study. Quite a number of

24

patients seen by the family physicians daily are due to sexual (erectile) dysfunctions which when

corrected with the help of the spouse or the family will go a long way in stabilizing the family.

Many medical conditions such as diabetes, heart failure, hypertension and depression are its risk

factors, their long term management and follow up are commonly done by the primary care

physician.31 He understands that the patient’s knowledge of the disease and its issues are

important because he has interest in the patient’s health, happiness and satisfaction. The family

physician also enhance the patients sexual health, quality of life, self-esteem and relationship in

the family since he provides preventive, promotive, screening, test and treatment to these

patients.32 He is in a better position to manage patients with erectile dysfunction.

This study will significantly alleviate the distress associated with this condition for both patients

and their spouses, the result of which will provide information on the effectiveness of combining

physical exercise with ginseng.

The information gained will be helpful in providing care to all patients irrespective of their socio

economic status with reduction in side effects associated with phosphodiesterase inhibitors.

The study will contribute to family medicine specialty by educating the family physicians on the

scope, risk factors and management modalities of ED. It will also help the family physician

enquire on every encounter with adult men about their sexual life as most patients finds it

difficult to talk about it. This will stimulate the specialty in developing sex clinics and protocol

for the management of ED

25

CHAPTER TWO

2.0 LITERITURE REVIEW

2.1 OVERVIEW OF ERECTILE DYSFUNCTION

Erectile dysfunction is considered important to men’s health considering the vast co-

morbidity associated with it as they aged.7 It is the most common sexual problems in men

affecting about one third of men throughout their lifetime.9 Prompting them to seek medical

help they ordinarily would not have, this is because it is a serious problem and a focus of

attention by the general public in recent times.10

Erectile dysfunction is an important component of emotional and physical intimacy that men

and women experience throughout their life time, this is because adult desire love and they

enjoy sexual activity if the health status and personal circumstances allow them to experience

close relationships within marriage.33

In adulthood the commonest intimacy is the presence of

physical and sexual relationship when there is a partner.34

Erectile dysfunction is the persistent inability to achieve or maintain an erection adequate for

satisfactory sexual intercourse for a minimum of three months.8 This has been found to affect

the quality of life (QOL) of men significantly, hence it need to be address promptly.7 The

diagnostic and the statistical manual of mental disorders (DSM-5) classified erectile

dysfunction as belonging to sexual dysfunction disorders that is clinically a significant

inability to respond sexually or to experience sexual pleasure8. Sexual function involves

interaction between factors such as social, cultural, biological and psychological factors,

making the diagnosis of erectile dysfunction etiological difficulty.

26

The following factors must be considered before the diagnosis of erectile dysfunction is made:

partner factors (health issues and sexual history of the partner), relationship factors (level of

sexual desire, communication problems or partner violence).35 Others are cultural or religions

factors (conflict with sexuality and sex inhibitions), medical factors (chronic medical conditions

and drug side effects) and individual factors such as (psychiatric conditions, sexual and

emotional abuse).35 Erectile dysfunction increases with age and a menace to our society causing

substantial impact that are negative on self-esteem, relationship and quality of life.10 This is

compounded by poverty and ignorance in the region suggesting that men with erectile

dysfunction may not have access to adequate care.11

In a study by Kubin et al in 2003 suggested that 5-20 of men have moderate to severe erectile

dysfunction and about 70 of these patients with erectile dysfunction are not treated.36 because

they rarely seek help10 or they find it difficult to talk about it due to cultural and religious

reasons.10,11,36 Therefore our responses to it can affect these patients either positively or

negatively.1 Erectile dysfunction is also seen to be common in people who are divorced or

separated than the married ones, this is because life events such as marriage separation and

divorce could be a possible cause of erectile dysfunction in them.11,13 These psychological causes

includes loss of self-esteem, low libido, pressure and frustration that may eventually leads to

depression.11,13 Erectile dysfunctions seems to be related to culture and environment since similar

cases of erectile dysfunction seen in primary health care clinics in developing countries are the

same compared to industrialized world.37

The impact created by erectile dysfunction could be devastating since sexual function is one of

the most important indices of quality of life.11 It could affect level of intimacy of these patients

27

such as emotions, social, sexual, recreational and intellectual intimacy with significant affection

of quality of life in these patients.11

These reactions may vary from negative attitudes, dissatisfaction with the problem or taking no

action by ignoring the problem which may end up with breakdown of the role of the husband

leading to family dysfunction.20The importance of sex is that it maintains good relationship and

this can persist even in old age, but can be disrupted by erectile dysfunction which gets worst

with advancing age.34 Normal changes occur in elderly group, therefore more time needed to

achieve a complete erection.34

2.2 EPIDEMIOLOGY OF ERECTILE DYSFUNCTION

ED is one of the most common problems in men worldwide.9 it ranges from partial decrease in

penile rigidity to complete erectile failure.9 The burden of erectile dysfunction is quite high as up

to 30 million of united State of Americans have erectile dysfunction.11It is estimated that world’s

population of erectile dysfunction patients will rise to 322 million by the year 2015.10 This is

usually underestimated in many developing countries because these patients rarely seek help due

to the stigma that is associated with it.10

Erectile dysfunction is about three times commoner in American diabetics compared to non-

diabetic men.38 A study done in Canada, USA and Europe found a prevalence of ED ranging

between 31.6% to 52% in men 40 years and above. in southeast Asia, it was between 36-51%,

18.8% in Iran and 63.2% in Japan.39 Similar study was done in Denmark Europe, 5.4% of men

reported reduction in their erectile function. Erectile dysfunction was 2% in men below 40 years

and about 18% in men between 55 and 88 years.40 Fugal Meyer also reported 29% of mild

erection dysfunction and 5% of severe erectile dysfunction.36

28

The prevalence of severe erectile dysfunction in South African diabetics was estimated at 50%

in patients 50 years and above with 95% of them having some forms of ED.41 There are a few

reports which documented erectile dysfunction in Nigeria. Total prevalence of 86.8% had some

forms of erectile dysfunction. About 2.4% of hypertensive patients had severe erectile

dysfunction while 10.4% had moderate erectile dysfunction.42

Another study in Nigeria showed that up to 46 of patients within the ages of 20 and 70 years

had erectile dysfunction, 28 of these patients are within the ages of 30 and 40 years, 40

between 40 and 69 years and 54 in those over 70 years.14 This shows that erectile dysfunction

increases with age and a menace to our society causing substantial impact that are negative on

self-esteem, relationship and quality of life.10 This is compounded by poverty and ignorance in

the region suggesting that men with erectile dysfunction may not have access to adequate care.11

In South Western Nigeria, the prevalence of 45.7% was found in patients who had some forms of

erectile dysfunction. Thirty four percent of these patients were below 40 years while 72% were

above 40 years.43 The participants who had hypertension, diabetes or both was 17.7% with

majority (60%) of the patients on traditional medication for treatment.43 Only 42.9% of the

patients were able to discuss their problems with their health personnel.43

The severity of erectile dysfunction from the Omisanjo study found 40% of the patients with

mild erectile dysfunction, 40% had mild to moderate erectile dysfunction, 10% had moderate

while another 10% had severe erectile dysfunction.43 The Massachusetts male aging study was a

community based survey of white non institutionalized married men, this study found that 25%

of men within ages of 40-70years had moderate degree of erectile dysfunction, and 10% of the

men had a completely absent erectile response.44

29

Erectile dysfunction is about 60 in married individuals and 45 in the unmarried suggesting it

increases with increased frequency of sexual intercourse. It is also commoner in educated men

than the uneducated because of their status and lifestyle which has a tendency to predispose them

to cardiovascular risk factors and erectile dysfunction.11 Nicolisi et al found an inverse

relationship between level of education and erectile dysfunction45

2.3 RISK FACTORS OF ERECTILE DYSFUNCTION

Common risk factors for developing erectile dysfunction include. (a) Age: This is common as

age advances.42 There are two reasons attributed to this,42 (i) older men are more likely to

develop chronic diseases such as hypertension and diabetes mellitus. These processes alone

cause vascular endothelial damage. (ii) Aging processes cause decrease compliance of tissues

including copora cavernosa. Prevalence studies in Nigeria showed erectile dysfunction is usually

related to age which can be a distressing or embarrassing part of andropause.14,42 About 60% of

these older men still expresses interest in maintaining their erection with ageing.34 Functional

decline may actually be the cause of erectile dysfunction in them when it is diagnosed.34

(b) Diabetes mellitus; Prevalence studies found that erectile dysfunction tends to develop 10 -15

years earlier in diabetic men, it is up to 55% in men between the ages 50 and 60 years who have

had diabetes for about 10 years. These are due to34 (i) Onset and greater severity of

atherosclerosis that narrow the arteries thereby reducing the delivery of blood to the penis. (ii)

Diabetic neuropathy occurs as a result of damage to both the sensory and autonomic nerves

supplying the penis as a result of high blood glucose level. (iii) Myopathy decreases the

compliance of the muscles in the copora cavernosa leading to inability of the penis to initiate and

or maintain erection. Erectile dysfunction is found in about 75 % of diabetic men over 60 years,

predisposing them to higher risk of developing coronary artery disease.34

30

(c) Hypertension and cardiovascular diseases: Studies have shown that those with essential

hypertension have been found to have (i) Low production of nitric oxide by the arteries of the

penises (ii) It accelerates the progression of atherosclerosis which contributes to erectile

dysfunction.18 Men with hypertension are likely to develop severe form of erectile dysfunction

(15%) and this will increase to (20%) if they also smoke.46 Hypertension, age and diabetes and

their drugs have been found to be the major risk factors for erectile dysfunction.11,47 It is seen to

be more severe in hypertensive patients on antihypertensive and about three times greater in

those on diabetic treatment thus making it difficult to differentiate the real cause.11 Olusegun et al

showed that erectile dysfunction is commoner in hypertensives, this is related to endothelial

damage found in hypertensives compared to non-hypertensives.48

(d) Smoking cigarettes: Smoking has been shown to aggravate atherosclerosis thereby increasing

the risk of developing erectile dysfunction.18 It is also seen to decrease nitric oxide synthetase

activity in the penis, this results in nicotine-induced vasoconstrictions of cavernous smooth

muscles, therefore people with erectile dysfunction are likely to be smokers than those who do

not smoke49

(e) Alcohol: A peer review article showed that alcohol consumption is related with erectile

dysfunction negatively. Its contribution is due to nerve damage that leads to testicular atrophy

resulting in decrease erectile function.18 The effect of alcohol on people’s erection largely

depends on the volume and duration of alcohol consumed. Omigbodun et al also showed that ED

occurs as a result of its central effects on the brain which include sedation, depression and loss of

libido. The study also showed that alcohol when taken in smaller quantity, it improves erectile

function.49 Consumption of 7% drinks or more per week increases the risk of erectile dysfunction

significantly while below 7% drinks per week may not affect erection.50 Alcohol is a central

31

nervous system depressant, therefore it increases sexual desire, but reduces sexual

performance.50 Alcohol is a known cause of ED and this is proportionate to the amount of

alcohol and duration consumed, about 33.3% of subjects with alcohol dependence complain of

ED.51 Alcohol in the form of palm wine, local gin and liquor are locally produced substances

with historical and traditional importance which are commonly used in celebrations can also lead

to erectile dysfunction51

(f) Substance abuse such as heroin, marijuana, cocaine and methamphetamines.18

(g) Drugs that have been found to cause erectile dysfunction are as a result of their side effects.10

these includes:

1. Analgesics e.g. opiates, anticholinergic e.g. TCA.

2. Anticonvulsants e.g. phenytoin, phenobarbital.

3. Antidepresants e.g. lithium, mono amine oxidase inhibitors (MAO), Selective serotonine

receptor inhibitors (SSR) I, Trycyclic antidepressants (TCA).

4. Antihistamines e.g. dimnehydranate, deplenhydramin, hydroxyzin (visteryl), Meclizine

(antivert), promethazine (phenergan).

5. Antihypertensives e.g. alpha blockers, B blocks, calcium channel blockers, clonidine (catapres),

methyldopa,( reserpine.)

6. Antiparkinsonian drugs e.g. bromocryptin (perlodel), levodopa, trihexyphenidil.

7. Cardiovascular agents e.g. digoxin, disopyamide (Norpace), gemfibrozil (lopid).

8. Cytotoxic agents e.g. methotrexate.

9. Diuretics e.g. spironolactone (aldactone), thiazides.

10. Hormones e.g. 5 alpha reductase inhibitors, corticosteroids, estrogens, leutinising hormones

releasing hormones agonist, progesterones.

32

(h)Psychogenic causes: psychological causes of erectile dysfunctions include stress, anxiety

disorders, prolong guilt, depression, widower’s syndrome, low self-esteem, post-traumatic stress

disorders and performance anxiety.10

The American Psychiatric Association have observed that depression is likely the commonest

cause of psychogenic erectile dysfunction with both cognitive and behavioral factors as

contributors to erectile dysfunction.35 Another common cause of Erectile dysfunction is

depression.35 Post traumatic stress disorders (PTSD) patients have a higher chance of developing

erectile dysfunction. Therefore, men who develop PTSDs should also be evaluated for erectile

dysfunction.35

(i) Low testosterone: Emily et al observed that testosterone is the primary sex hormone in men. It

is necessary for libido enhancement and maintenance of nitric oxide levels in the penis, thus,

hypogonadism results in both low sex drive and erectile dysfunction.18

Testosterone level in the body reduces with age while erectile dysfunction increases.52 This

occurred in about 45% of men 45 years and above.52 Prevalence studies on ED also showed that

low level of testosterone is associated with sexual dysfunction that includes low libido, poor

erection, reduced spontaneous erection, sexual activity, orgasmic or ejaculatory dysfunction.52,53

It is also responsible in moderating mood, cognition, vitality, muscle, bone and fat

compositions.53 The association between testosterone and erectile dysfunction is still unclear, but

about 35-40% of patients treated with testosterone replacement had significant improvement in

erectile function after six months of treatment similar to phosphodiesterase inhibitors type 5

(PDE-5.)53

(j) Nerve and spinal cord damage especially to the pelvis can cause erectile dysfunction.18 This

damage can be due to multiple sclerosis, trauma, surgical procedures such as pelvic and vertebral

33

cord compression, prostate surgeries and multiple sclerosis even though age and obesity are the

main risk factors.2,18 Others are pelvic irradiation, hyper-prolactinaemia and

hypercholesterolemia.

(k) Obesity: It is a state of chronic oxidative stress and inflammation. Obesity is associated with

increased oxidative stress which increase free radicals that results in deactivation of nitric oxide

within the vasculature with resultant reduction of erectile function.27,54

Prevalence studies showed that obesity is a significant cause of erectile dysfunction.10 Body mass

index (BMI) and lipid profile were found to be predictors of erectile dysfunction about 25 years

later.54 This is associated with higher level of pro-inflammatory cytokines and C-reactive cytokin

proteins that results in erectile dysfunction.55,56 and hypogonadism.34Weight loss may lead to

reduction in oxidative stress, therefore weight loss programs are seen to reduce erectile

dysfunction. Obesity has been positively related to endothelial dysfunction and increased

vascular inflammatory markers.55 A significant association between erectile dysfunction and

obesity due to the effect of inflammatory markers that contribute to vascular endothelial

damage.57 Elevated body fats and vascular response to l-arginine and cytokines exist with such

association resulting in reduction of nitric oxide activity in the vascular endothelium hence ED.57

(k) Chronic liver disease: Olusegun et al showed that erectile dysfunction is higher in caucasians

with chronic liver diseases, this is seen to have improved with liver transplant in cirrhotic

patients independent of alcohol aetiology.48 This occurs as a result of hormone problems such as

decrease in testosterone levels and reactions with other medications used in the treatment of

chronic liver disease.48 Therefore advance liver damage is associated with poor erectile

function.48

FIGURE 2.1 The multifactorial causes of erectile dysfunction.48

34

2.4 ANATOMY AND PATHOPHYSIOLOGY OF ERECTILE DYSFUNCTION

The main organ involved in sexual dysfunction is the penis.58 It is the male sex organ which

contains two chambers called the corpora cavernosa that runs the length of the upper side of the

penis while the corpus spongiosum lies ventral to the two cavernosa muscles.38 The corpus

cavernosa and the bulbo spongiosum originated from the pubic bones and join (terminated) at the

head of penis. The urethra which is the channel of urine and ejaculate runs along the underside of

the copora cavernosa to the tip of the penis.58 Arteries originates from internal pudendal artery

while veins drains blood from the superficial intermediate and deep veins to internal pudendal

veins.58 The corpora cavernosa is a spongy tissue consisting of smooth muscle and arteries.

Tunica albuginea is a membrane that surrounds the corpora cavernosa which drains blood out of

the penis to the internal pudendal veins58

The arterial supply of the penile skin originates from the left and right superficial external

pudendal arteries while the ventral part of the penis is from the arterial supply of deep structures

of the pelvis.59 The arterial supply to the penile muscles originates from the common penile

artery which is a branch of the internal pudedal artery.59 The common penile artery branches into

VASCULO GENIC

Arterial insufficiency

venous leak

Atherosclerosis

Arteriosclerosis

ENDOCRINOLOGIC

Hypogonadism

Psychogenic

ANATOMIC Peyronie’s Disease

NEUROLOGIC

Spinal cord injury

Peripheral neuropathy

Diabetes

35

the dorsal, bulbo urethral and cavernous arteries.59 The dorsal artery is responsible for the

engorgement of the glands during erection while the bulbo-urethral branch supplies the corpus

spongiosiom and the bulb of the penis. The carvenous branch supplies the corpus cavernosal

muscles which affects tumulscence and responsible for erection principally. It also supplies the

trabeculae erectile tissues and the sinusoids.59

The venous drainage originates from the venules of the sinusoids beneath the tunica albuginea,

these veins form the emissary veins of the penis.35 The primary nerve fibres to the penis

originated from the dorsal nerve of the penis which is a branch of the pudendal nerve. The

cavernous nerves of the penis serve both sympathetic and parasympathetic stimulus as part of the

autonomic nervous system. They enter the copora cavernosa and the corpus spongiosum through

the prostate to regulate blood flow in the penis during sexual stimulation.39 The pudendal nerve

also gives a branch (dorsal somatic nerves) which is responsible for penile sensation .35,59

Penile erection is a vascular event primarily which can be impaired in conditions that end with

endothelial dysfunction.13 Therefore physiological alteration related to hormonal changes

together with sedentary lifestyles have been implicated in erectile dysfunction.47

During intercourse, the penis must sustain an erection which is the state of rigidity induced in

erectile tissues of the penis as a result of engorgement of the tissues with blood in response to

sexual arousal or during sleep.60 This results from the combination of neurotransmitters and

vascular smooth muscles response largely due to impulse from the brain which stimulates the

flow of blood from arteries leading to engorgement of the penis.60

Erection occurs with specific sequence of events involving nerve impulse from the brain, spinal

column, muscles, penis, fibrous tissues, arteries and veins.61 The mechanism of erection begins

with sexual stimulation which can either be tactile or mental.61 Sexual stimulation generates

36

electrical impulses along the nerves going to the penis. This causes the nerves to release nitric

oxide which in turn increase the production of cyclic guanosine monophosphate (cGMP) in the

smooth muscle of the copora cavernosa. The cGMP causes the smooth muscle of the copora

cavernosa to relax and allow rapid flow into the penis.61

The incoming blood fills the corpora carvernosa making the penis to expand, the pressure from

the expanding penis compresses the veins in the tunica albugeneae helping to trap the blood in

the corpora carvernosa thereby sustaining the erection.61 Erection is reversed when cGMP levels

in the corpora cavernosa falls.62 This causes the smooth muscle of the corpora carvernosa to

contract stopping inflow of blood and opening veins that drain blood away from the penis.62 The

level of the cGMP in the corpora cavernosa falls because It is destroyed by an enzyme called

phosphodiesterase type 5 (PDE5).62

E n d o lle l ia l

c e l l a n d

n e u ro n e

P D E 5

5 G M T

(in a c tiv e )C G M P

C G M P -d e p e n d e n t

(p ro te in k in a s e )

G u s n ily l

c y la s e

G T P

P ro te in s

P h o s p h o p ro te in s

( in c lu d e s c a rtt p u m p s

R e d u c e c y to p la s m ic

c a tt

R e la x a tio n

- in c re a s e b lo o d flo w

- e re c tio n

S m o o th m u s c le s

N itr ic o x id e

F IG U R E 1

P D S 5 in h ib ito rs

37

Erectile dysfunction is commoner in older men because of hormonal changes which occur as a

result of changes in testicular size, hence a decline in sex hormones.63

2.5 CLASSIFICATION OF ERECTILE DYSFUNCTION

The International Society of Impotence Research has adopted that erectile dysfunction is usually

multifactorial and classified primarily as organic or psychogenic.64 The organic component can

also be sub-classified to either vasculogenic, neurogenic, anatomic, endocrinologic or mixed.64

The psychogenic is further sub-divided to be either generalized which affects all situations,

stimulations and partners or situational which affect some partners situation or stimulations.64

The generalized psychogenic type is divided into type A which is generalized unresponsiveness

and type B which is generalized inhibition.64 The situational is subdivided into type A which is

partner related ,type B which is performance related and type C which is psychological distress

or adjustment related.35,64

38

Category Common disorders Pathopysiology

39

Organic

I

II

III

Iv

Psychogenic

I

Vasculo genic

A

B

C

Neurogenic

Anatomic

Endocrinologic

Generalized

Type

A

B

Situational

Type

A

B

C

Arteriogenic

Cavernosal

Mixed

Generalized unresponsiveness

1. Primary lack of sexual arousability

2. Aging related decline in sexual arousability

Generalized inhibition

1. Chronic disorder of sexual intimacy

Partner related

1. Lack of arousibility in specific relationship

2. Lack of arousability due to sexual preference

3. High central inability due to partner conflict

Performance related

1. Associated with other sexual dysfunction

(ejaculation)

2. Situational performance anxiety (e.g. fear of

failure)

Psychological distress or adjustment related

1. Association with negative mood state (e.g.

depression) or major life stress (e.g. death of

partner

TABLE 2.1: Classification of Erectile Dysfunction

40

Classification of erectile dysfunction is recommended by the nomenclature committee of the

International Society of Impotence Research as follows.64

The American Psychiatric association (DSM-5) classified erectile dysfunction based on the

duration of the disease as lifelong (disorder was present from first sexual experience), or

acquired (disorder occur after some period of normal sexual activity).35It can also be classified

based on its occurrence as generalized which occurred with all stimulations, partners or

situations or situational which occurred with either stimulations, partners involved or situations

of sexual activity.35,65 Lifelong erectile dysfunction is commonly seen in patients with

psychological factors while the acquired type is commonly seen in patients with biological

factors.35,65

Erectile dysfunction has a strong organic component, but can also be psychogenic in nature

especially in younger men who are less than 35 years.11 Psychogenic erectile dysfunction can be

found in about 10% of older men above 50 years.11

2.6 ASSESSMENT OF PATIENTS WITH ERECTILE DYSFUNCTION

The symptoms and signs of erectile dysfunction are difficult to get from patients because they

are not easily discussed like any other disease.66 Diagnosis of erectile dysfunction is usually

made from history and examination while investigations are usually done to determine its risk

factors.10 Sexual history should focus on erection adequacies, altered libido, quality and timing of

orgasms, volume and appearance of ejaculate, presence of sexually induced genital pains or

penile curvature (peyronies disease) and sexual functions.10

Patients usually present with inability to achieve and or maintain erection, poor sexual

satisfaction, symptoms and signs of risk factors and other psychological and psychiatric

41

manifestation.10 The guidance and counseling psychologist have adopted several methods that

can be used to identify patients with erectile dysfunction. These methods include.66

(a) Natural observation: This is done by observing the lifestyle of these individuals concerning

their sexual desires and the way they relate to opposite sex naturally.66 This can be a pointer to

erectile dysfunction.

(b) Case history: This involves taking a complete inquiry of the person sex life and his sexual

behavior. This is the commonest method of diagnosing erectile dysfunction in clinics.

(c) Surveys: This can be done through questionnaires or mails in obtaining ways in which they act

or think concerning erectile dysfunction, this is used to identify people with erectile dysfunction

in the communities.

(d) Correlation studies: This is usually done to make comparison between two categories ofpeople

to determine the level of their relationships. It measures between a person’s sexual desires and

his sexual performance.

(e) Experimental methods: This studies how animals and man behave in order to identify its cause

and effects. It identifies those suffering from erectile dysfunction and all kinds of abilities,

interests and achievements concerning erectile dysfunctions.

Sexual history: In assessing erectile dysfunction, the patient’s level of comfort must be first

assessed. This will avail the physician an opportunity to educate the patient on erectile

dysfunction and its treatment. If erectile dysfunction is suspected, history should be aimed at

determining the sexual response that is affected.65

The following questions should be asked when obtaining sexual history: Difficulty obtaining

erection, if erection is suitable for penetration, rigid erection that can be maintained until

completion of sexual intercourse, presence or absence of ejaculation and sexual satisfaction.65

42

This gives the clinician the avenue to make an objective opinion on relationship between the

patient and his sexual partner.65

2.7: ERECTILE DYSFUNCTION SCORES

The assessment of erectile function in most studies relies primarily on questionnaires which are

self reporting such as the international index of erectile function (IIEF).67 The erectile function

can generally be measured in three categories.67 (a) vascular capacity (neuro-physiological

testing (c) erectile capacity (penile dimensions of tumescence and rigidity). The vascular and

neuro-physiological studies usually diagnose the cause of erectile dysfunction.67 The erectile

function questionnaire measures solely the physiology aspect of erectile dysfunction and its

dimension.67

Other instruments that can be used to assess erectile function includes the Rigscan (commonly

used for nocturnal penile tumescence and rigidity measurements) and penile monitoring (audio

visual during sexual stimulation).67 The commonest instrument in most population studies is the

international index of erectile function which is a self reporting instrument that measures men’s

perception of erectile function with penile measurements that records anatomical changes.67 It is

commonly used because it is easier to use especially for large scale studies, but for smaller

studies, measurement of physiological changes of erectile function, penile measurement may

provide more clue.67

The IIEF has been validated in many languages and used all over the world.67 The limitation is

having sexual intercourse four weeks before assessment may give a wrong perception of his

erectile function.67 The international index of erectile function was introduced in 1997 for

assessment of erectile function.67 It is a brief, reliable and valid self-administered questionnaire

that contains five domains used in assessing erectile dysfunction and its severity.56 It is the gold

43

standard in the assessment, severity and treatment related responses in erectile dysfunction while

measuring the outcome measure in both groups before and after treatment.68

The IIEF questionnaire was developed to assist the clinician in evaluating patients with erectile

dysfunction. Other questionnaires that can be used includes, sexual encounter profile (SEP),

Global assessment Questionnaires (GAQ), Psychological and Interpersonal Relationship Scale

(PAIRS), Self-esteem and Relationship (SEAR).56 The investigation results should be discussed

with both the patient and his sexual partner. This discussion should involve the anatomy and

physiology of sexual response, activity and risk factors identified.68A score is usually awarded

before to measure severity and after to measure improvements. It has a total score that is usually

added up to a maximum of 25. The ratings are; 22-25 as no ED, 17-21 as mild ED, 12-16 as mild

to moderate ED, 8-11 as moderate ED and 5-7 as severe ED.68 This has been widely used in

many countries including Nigeria.68

The specific criteria used in the diagnosis of erectile dysfunction according to DSM-5 includes

one or more of the following: Marked difficulty obtaining erection prior to penetration, marked

difficulty in maintaining the erection until through the period of sexual activity and marked

decrease in rigidity of penis lasting for up to three months.35 These symptoms must cause stress

to both the individual or sexual partner.35 The limitation to using IIEF is its subjective nature and

it cannot be used in men who had sex four weeks before assessment as the score might have

changed over time.67 Interventions in erectile dysfunctions such as lifestyle changes, (diets and

exercise), drugs (phosphodiesterase inhibitors) and surgical interventions have led to significant

changes in IIEF.67 Ginseng has also been shown to improve IIEF in some studies such as.

44

Gaurang et al studied multi herbal supplements ( VxP) which is a polyherbal preparation used in

the treatment of erectile dysfunction, It contains ginseng and other vitamins. Only ginseng had

been proven to aid erectile function by improvement in IIEF scores in the VXP group.69

The study showed that VxP was well tolerated, the most common side effect was fever. It was

mild on the subjects with mild to moderate erectile dysfunction.69 It is an alternative to invasive

approaches with a good penile rigidity, penetration and maintenance of erection.69 There are little

evidences for the recommendation of natural supplements for enhancement of erectile

dysfunction, but there were positive effects of ginseng on erection , hence it can be

recommended as an aphrodisiac in the treatment of erectile dysfunction.70

Korean red ginseng is one of the most widely used herbal remedies.22 A meta-analysis of it

shows a significant effect with improvement in IIEF, a sub group analysis also shows its

beneficial effects on psychogenic erectile dysfunction.22 Erectile dysfunction including orgasmic

dysfunction, sexual desires, sexual satisfaction and overall satisfaction improved significantly

after 12 weeks of treatment with majority of the patients (90%) indicated interest in continuing

with the drug after the study.69

Thuryan et al showed that Red Ginseng is effective in the treatment of erectile dysfunction.71

Although, effort has been made to find the ideal treatment for erectile dysfunction, but this has

not been identified.72 A meta- analysis of seven Randomized control trials in South Korea

compared the therapeutic effect of ginseng and placebo, they found a significant effect in the

treatment of erectile dysfunction.73 A sub-group analysis of same also showed some beneficial

effect of Red Ginseng also in psychogenic erectile dysfunction.73 It is also an antioxidant and

plays a protective role with significant effects in rigidity, libido and patient satisfaction.72

45

Ginseng has both stimulation and inhibitory effect on the central nervous system and act

centrally in the process of erection through multiple mechanisms that have not been elucidated.72

2.8: SEVERITY OF ERECTILE DYSFUNCTION

Erectile dysfunction generally presents as mild, mild to moderate, moderate and severe forms.

The presentations differ with each study before or after ginseng treatment.44 The Massachusetts

study reported majority of subjects (25%) reported with mild to moderate erectile dysfunction.

This was followed by those who presented with mild erectile dysfunction, followed by those

with severe ED.44 Omisango study also showed higher population in patients with mild to

moderate erectile dysfunction.43 Idung et al study in Uyo Nigeria reported higher severity in the

mild ED.11 Panax Ginseng administration was found to reduce the severity of erectile

dysfunction in Gaurang69 et al and Peak studies74.

PHYSICAL EXAMINATION: Particular attention to risk factor, physical examination is an

important aspect of erectile dysfunction management which should assess for blood pressure and

heart rate, body habitus for central obesity, cardiovascular, neurological, genitourinary systems,

digital rectal examination, the testicles and the penis,75 examine the lips for evidence of prolong

cigarettes smoking.2,36 For the genitals, the following should be sought for: (a) characteristic of

the penis e.g. painful bending of the penis leading to peyronies disease, response of the penis to

touch (b) small testicles, lack of hair, Gynaecomastia pointing to hypogonadism. (c) Pedal artery

palpation for low blood flow which may be as a result of atherosclerosis.

There is no preferred first line diagnostic test for erectile dysfunction and routine screening is not

also recommended, but common investigations such as fasting blood glucose and urinalysis can

be done to identify risk factors of ED.10

46

It is necessary to include unsuspected signs such as small testes, prostate cancer, infections, and

penile plagues in the evaluation of erectile dysfunction.65

2.9 INVESTIGATIONS OF ERECTILE DYSFUNCTION

World health organization (WHO) recommend limited diagnosis test in erectile dysfunction

except in refractory case.10 Hence full blood count, urinalysis, blood glucose assay, prolactin

levels, sex hormones binding globulin, free testosterone and lipid profiles are usually the initial

investigations requested to ascertain the risk factors responsible.10 Other specialized diagnostic

testing not commonly done include (a) Neurological testing such as vibrometry, bulbo

cavernosus reflex latency, cavernosal electromyography. (b) Nocturnal penile tumescence and

rigidity assessment. (c) Psychiatric assessment (d) specialized endocrinologic testing such as

hypothalamic-pituitary- gonadal function test. (e) Magnetic resonance imaging of sella tursica

and computed tomography (f) Vascular diagnosis such as doppler ultrasound, penile pharmaco

cavernosography, penile arteriography and nuclear imaging even though doppler ultra-

sonography is not so useful in the diagnosis of erectile dysfunction.76

Diagnosis of erectile dysfunction is made in men who have repeated inability to achieve and or

maintain an erection for satisfactory sexual performance for at least three months.8 A good

communication between patient and doctor is important in establishing a diagnosis, assessing

severity and determining the cause.5

2.10 TREATMENT OF ERECTILE DYSFUNCTION

Considerable effort has been made to unravel the ideal treatment of identified erectile

dysfunction, but this has not been identified.69 Most of these patients do not take any form of

47

treatment for their illness which may be attributed to limited access to health care facility or they

are not bothered about milder forms of erectile dysfunction.77 Those who seek medical care,

majority of them (60%) resort to herbal medication, which is a prominent practice in our

localities.77

Treatment of erectile dysfunction is best when the sexual partners are involved in the

management.78 The first step in managing patients with erectile dysfunction is understanding the

patient’s problem. This helps in identifying the best treatment option for the patients.65

Treatment of erectile dysfunction is divided into:

2.10.1 Pharmacological treatment: Medication for treatment of erectile dysfunction such as

phosphodiesterase inhibitors type 5 are considered the most effective oral drug in the treatment

of erectile dysfunction.10 These includes: sildenafil, vardenafil and tadalafil. The

phosphodiesterase type 5 inhibitors are considered to be relatively similar in effectiveness, but

differences in dosing, onset of action and duration of therapeutic effect. There are no data

suggesting the superiority of one to the other.34 ( but most data suggest equal effectiveness, but

differ in dosing and onset of action, they are not effective in improving libido. 10 This oral

medication selectively inhibits the enzyme phosphodiesterese types 5 and has completely

changed the treatment of erectile dysfunction.79

Each of the three phosphodiesterase types and inhibitors has different pharmacokinetics and their

absorption is affected differently when co-administered with fatty meals. Their onset of action

are 11 minutes with sildenafil and 14 minutes with vardenafil and tadalafil.79 The most

significant difference in the three medications is their serum half life of 4 hours in sildenafil and

vardenafil, while that of tadalafil is 20 hours approximate. This is usually the reason for on

demand dosing for sildenafil and vardenafil while a daily dosing for tadalafil.79 PDE5 inhibitors

48

are generally well tolerated but the adverse effect include headache, facial flushing, dyspepsia,

rhinitis, abnormal vision, dizziness, syncope and rarely non arthritic anterior optic neuropathy.80

Other oral agents that were in use before the advent of PDE5 are Adrenergic receptor antagonist

(e.g phentolamin, yohimbine and delequamine), Dopamine receptor antagonist (e.g

apomorphine and bromocriptin), serotonergic receptor activators (e.g trazodone), xanthine

derivatives (e.g pentoxifyllin) and oxytocinergic receptor stimulators (e.g oxytocin) of which

some are still being reviewed.81 These act on the brain to facilitate or inhibit erection.81

Testosterone is better in primary than secondary hypogonadism. Side effects of testosterone

includes erythrocytosis, increased transaminases, exacerbation of untreated sleep apnea, benign

prostatic hyperplasia and increased risk of prostatic adenocarcinoma.34 It improves erectile

dysfunction and libido, but requires close monitoring of hemoglobin, serum transaminases and

should be considered first line.10

Testosterone replacement has been seen to improve libido, erectile function and overall

wellbeing.82 Testosterone can be administered as oral, injectable, dermal gel. A combination of

different routes of administration at the same time has been found to be more effective in

treatment of erectile dysfunction than single route, but the adverse effects of PDE5 should

considered especially in difficult to treat patients.83

Newer agents that are still undergoing trial for the treatment of erectile dysfunction include

dopamine and melanocortin receptor agents, second generation phosphodieterase inhibitors,

rhokinase inhibitors, soluble quanylate cyclases and maxi-k-channel activators.84

2.10.2: Non-Pharmacological Treatment: Non Pharmacological treatment of erectle

dysfunction includes:

49

(a) Improving life style which is aim at modifying risk factors of erectile dysfunction(ED).

Frequent exercise which help in reducing excess weight and sedentary lifestyle, controlling

hypertension and blood glucose, reduce alcohol consumption, cigarettes smoking and significant

risk factors of obesity thereby maintain good health.76

(b) Cognitive behavioral therapy (CBT) is a form of treatment specifically for psychogenic

erectile dysfunction which also improves relationship problems.10 Cognitive behavioral therapy

or psychogenic therapy such as sensate focus techniques is aimed at improving relationship

difficulties.10 It has equal effectiveness with alprostidyl injections and vacuum devices.10 Stress

management and sexual counseling are the most important part of treatment for patients with

sexual problems. It is usually done by sexual counselors, but the primary care physician, the

urologist and the gynecologist who commonly see these patients also serve in the capacity.

Ideally the patient’s partner should be involved in the counseling, and also discuss the mode of

treatment that is appropriate for him, stress management has been found to be beneficial in

treatment of erectile dysfunction.85

(c) Surgical management of erectile dysfunction includes (i) Intra cavernosal injection of

vasodilators: these are vasolidators that are injected into the corpus cavernosum to produce

erections e.g. Alprostidil which is synthetic prostaglandin (PGE1) and phentolamin which are

effective either as a single agent or when combined.78 They induced formation of nitric oxide

synthetase thereby inducing erections.80,86

Alprostidil is the commonest agent used in achieving rigid erections with enormous benefits.80,86

It is indicated in patients with healthy copora cavernosa and effective within or after 90 minutes

of injection.80,86

50

Intra urethral injection: Medicated urethral system for erections (MUSE) is a system that

involves injecting a vasodilator into the penile urethra to achieve or maintain an erection.65,87

prostaglandin E1 e.g Alprostidil is also commonly used and is effective in about 65% of the

patients. The limitation to this form of treatment are the cost of injection and inability to provide

rigid erection consistently.65,87

Newer agent that is still under study is the vascular endothelial growth factors (VEGF). It

increases nitric oxide which increases vascular blood flow.87 .Adverse effects include urethral

bleeding, dizziness dysuria, penile pain and hematoma.87

(d) Penal implant: This involves placement of a device inside the copora cavernosa with the sole

aim of achieving erection.97 It is effective in more than 90% of the patients that need it, but the

benefit and risk should be explained to the patient and their spouse88,89

Penile prosthesis is usually indicated in patients who did not respond to other forms of

management and in those who had penile reconstruction and those that went through radical

prostatectomy and cannot responding to PDE-5 inhibitors.88 Penile prosthesis are classified into

semi rigid and inflatable types both with similar disadvantages such as risk of infections,

consistent erection at all times, penile injuries etc. Patient reported better satisfaction with penile

implant compared to sildenafil and alprostidic (PGE1).89

(e) Vaccum devices are plastic devices that are placed over the penile skin and a partial pressure

is created to pump out air resulting in erections.89 A constricting band is later applied at the base

of the penis to sustain the erection already achieved. Erection is usually maintained until

constricting band is removed which should not be more than 30 minutes.89 These are non-

invasive and contraindicated in patients with sickle cell disease and patients on anticoagulants.

Penile prostheses are usually inserted with the help of urologist. These forms of management are

51

difficult with more adverse effects, thus, Ginseng will be preferred because of simplicity in

management with few side effects.77

Patients with erectile dysfunction should be educated on the benefits of physical exercise,

reduction of weight and to stop smoking so as to improve or restore erectile function in the

absence of co-morbidities.90 Good glycemic and blood pressure control is also important in

preventing or reducing erectile dysfunction.90

2.10.3: PHYSICAL EXERCISE

Physical inactivity affects erectile function negatively, therefore physical activity has a beneficial

effect on erectile function and has an additive effect when combined with diets especially

Mediterranean diets.91 This occurs due to decrease in metabolic disturbance of inflammatory

markers, insulin resistance, decrease visceral adipose tissue and improvement in vascular

function.92

Physical activity is beneficial in patients with heart diseases, stroke, hypertension, diabetes,

colorectal cancer, prostate disorders and arthritis.93 Studies done by Baccon et al found that men

who ran for an hour and a half or three hours of vigorous outdoor activity a week are found to be

20% less likely to develop erectile dysfunction than those who did not.93

The exercise that is required to reduce the risk of erectile dysfunction has no specification, but 30

minutes or an hour of physical activity in most days of the week has a good health benefit and

can be divided over the days.93

Physical exercise is not devoid of complications which occur as a result of quick movement

during exercise, these include muscle and joint problems, strains, tears or fractures, but too hard

exercise can lead to joint stiffness, tendon and ligament inflammations and sudden death.93

52

Physical activity is one of the seven dimension of wellness.25 It is defined as a planned, co-

ordinated and regular physical activity carried out to improved one or more component of

physical fitness.25 There is a shift from communicable disease to non-communicable disease

worldwide.85 One of the risk factors for non-communicable diseases is physical inactivity which

is now the fourth leading risk factor for global morbidity and mortality.103 Physical inactivity or

low activity contributed about 3.2 million death and 2.8% of disability-adjusted life years

globally in 2010.94

Olufemi et al observed that the prevalence of physical inactivity ranges between 31-61% in adult

Americans and 30.7% among Brazilians.95 Worldwide it is estimated that 31% of adults are

inactive and this level is rising and associated with major public health implication while

prevalence of inactivity in Nigeria and Ghana ranges between 25 and 57%.96,97 Physical activity

has been found to be beneficial to erectile dysfunction patients and obesity and might also be

protective against erectile dysfunction.27,107 This may even have reversal effect on the

development of erectile dysfunction regardless of the intensity and type of exercise done,50

Studies have shown that both interval and continues physical activity have been found to be

beneficial in erectile dysfunction27,98

An inverse relationship exists between physical exercise and biomarkers of inflammation in both

diabetes and cardiovascular disease and their complication which includes erectile dysfunction,

hence the role of exercise in the management of erectile dysfunction.99 Daily physical exercise is

divided into mild, moderate and high intensity based on the rating designed to keep the human

body active as follows ; (a) less than 5000 steps is considered sedentary (b) 5000-7499 steps in

low activity (c) 7500-9999 is somewhat active (d) 10000-12499 steps is active (e) greater than

12500 is highly active, the minimum any person can go to remain healthy is low activity.24

53

The relationship between physical exercise and erectile dysfunction is related to the biochemical,

hormonal and neural changes in the blood vessel walls, this results in blood vessel wall

relaxation with acute or long term exercise because of its local production of nitric oxide and

lactic acid, decrease nerve activity, changes in certain hormones and their receptors together with

the warming effect of exercise.109 As the exercise is increased or repeated, there is prolong effect

, thus regular or long term physical training can decrease basal concentration of inflammatory

markers.100

Exercise meant for improving physical fitness follows the FITT principle which states that

exercising a part of the body or system at intensity above that which it normally works leads to

an improved function of that part or system.26 Therefore prescribing physical exercise in order to

achieve these set goals are as follows; (a) moderate physical exercise done at least 30 minutes

over 5 days a week e.g. fast walking ( 3-4 miles/ hour), watering a garden, skipping, household

chores etc. (b) high intensity physical exercise i.e. 20 minutes for at least 3 times a week e.g.

jugging, running, cycling, farming, swimming and gymnastic based structured activities which

can be done either continuously or at an interval periods, both of which are beneficial in the

management of erectile dysfunction.99,100

An indirect way of assessing exercise intensity is the use of maximum heart rate (MHR), heart

rate reserve (HRR) and resting heart rate (RHR). Where the MHR=220- age in years. To assess

for heart rate reserve, HRR=MHR-RHR.87 An international physical activity questionnaire can

also be used to assess physical activity such as walking, moderate and vigorous intensity

exercise classified as low, moderate an high intensity.95

The five trans-theoretical model of change is used to assess readiness for exercise in humans.23

These are (a) pre contemplation: not considering or not ready to change (b) contemplation-

54

acknowledges the problem and considering taking an action within the next six months, (c)

preparation- planning to change the bad behavior within the coming next months (d) action-

actually carrying out the behavior (e) maintenance- continues to practice it for at least five years

(f) adoption/termination- has fully integrated the new behavior into his/her live.25

Factors or barriers limiting physical exercises in humans are; lack of enough time, not

enjoyable, not convenient, lack of self-motivation, unfavorable weather, ignorance of its benefits,

fear of being injured, no space for exercise, etc.25 Other forms of lifestyle that improve erectile

dysfunction are diets such as the Mediterranean style of diets and reduction in calorie intake

invariably leads to improvements in erectile dysfunction.26 Others are reduction or stoppage of

alcohol consumption, cigarettes smoking and weight reduction.57 Lifestyle changes that result in

weight reduction invariably improve erectile dysfunction in one third of obese patients under 55

years of age.57

Chevrolet-Meason et al postulated that spouses of patients are encouraged to be part of the

management because treatment of erectile dysfunction usually foster positive, realistic

expectations for couples and maintenance of drug use when partners are involved.28

2.10.4: COMPLEMENTARY AND ALTERNATIVE TREATMENT

Complementary and alternative medicines is defined as a group of various medical and health

care systems, practices and products that are not presently considered to be part of conventional

medicines.101 Complimentary interventions are health care approaches used in conjunction with

conventional interventions while alternative practices replace the conventional ones.101 They are

used all over the world and use varies from one country to the other.102 Commonly used

complementary and alternative practices all over the world are herbs, acupuncture, non- vitamins

and minerals, natural products and spirituality.101

55

In Africa and in India, about 38.5% of the population uses complementary and alternative

medicines with spirituality being the commonest,102 while in Saudi Arabia, about 80% of the

general population uses the product and traditional healing modalities for treatment.101 The

commonest aspect of complementary and alternative medicine are spirituality (49.4%) aloe- vera

(23.1%), forever living products (16.3%) and black stone(12.5%).101 It is commonly used by

people with low socio-economic status and low education, but reverse is the case in developed

countries.101

There are evidences to show that people use complementary and alternative medicine because of

the in- effectiveness of the conventional medicine or the adverse effects to them and also having

a holistic health approach and greater control of our health.103 Studies have shown that the

commonly used complementary and alternative medicine used all over the world is the biological

methods with Honey being the commonest, others are spirituality (49.4%) with faith and prayer

being the commonest and physical therapy (22.1%) with massage being the commonest in use

and black stone the most commonly used.101

Patient’s preference of complementary and alternative medicine compared to orthodox medicine

in our environment may be connected to social stigma, cultural perception on the etiology of the

disease and the perceived response to the indigenous herbs.9,11A study done by Ernest et al also

evaluated acupuncture, ginseng, meca and yohimbine for the treatment of erectile dysfunction,

insufficient evidence was found for meca and acupuncture, but positive conclusions were drawn

for ginseng and yohimbine.104

Other commonly used complementary and alternative medicines are Arginine, dihydro

epiandrosterone, coleus, Damina, Gingko and alpha lipoic acid which is particularly suited for

the treatment and prevention of diabetic complications including erectile dysfunction.105 Erectile

56

dysfunction with undiagnosed co-morbidities exist in about 6.8% of general population with

majority of them using complementary and alternative medicines for treatment.11

Herbal medications are usually the common choice therapy for self-care among individuals

taking more active roles in their health care.106 This has been promoted by mass media who have

enhanced widespread use of herbal medicine within the general population especially in

developing countries.106 According to WHO, Herbal medicines are medications prepared from

one or more herbs or plant parts (roots, stem, bark, seeds and or fruits).106,107

Herbs contain chemical compounds, vitamins, plant hormones and minerals which are essential

for plant growth and health in humans.107 Humans need the phyto-chemicals for metabolism and

healthy living which are naturally found in the plant.107 Herbal medicines are found to be better

than conventional medicines because they are natural and have minimal side effects, they are not

only used in the treatment of isolated symptoms, but also maintain general wellbeing.107 About

30-50% of adults in industrialized nations had used natural products in treating diseases and

prevention in one form or the other.107

Herbal medicine is a combination of fruits, vegetables, leaves etc used in the treatment of some

ailments.107 Men and their spouses are interested in using herbal and complementary medicines

in treating their ailments.107 The common herbal medications used in the treatment of erectile

dysfunctions include: red, white and fresh ginseng, ginko biloba, robus coreanus, schisandra

chinensis, epimedium koreanum, lepidum meyenii, male silkworm extract, artenisia capillaris

cuscuta chinensis and plant mixtures.107 The differences between herbal medicines and western

style medicines are that herbal medicines are mixture of all kinds of medicines, they act slowly,

they are natural while western medicines act fast, usually a single agent and artificial.107

57

Common herbal treatments used in erectile dysfunction are ginseng and yohimbine, but

yohimbine has serious side effects compared to gingering, these side effect includes headaches,

insomnia, gastric upset and constipation.18,71 Others are bradycardia, hypoglycaemia,

nervousness, diarrhea, high blood pressure, palpitation and high estrogenic effect.18,108

Ginseng in one of the complementary and alternative drugs used in the treatment of erectile

dysfunction.104 There are evidences to show that the use of herbal medication is not strange

especially in African society as about 80% of Africans and 27 million South Africans used

traditional herbs.109,110 but general use of herbs in Nigeria is not well documented.111

Ezeoma et al observed that the reasons several people use herbs for treatment of erectile

dysfunction are that they are natural and safe.112 Others are for economic reasons, high cost of

health care, poor access to conventional medicines, protracted health issues, religion, traditional

or cultured beliefs as well as dissatisfaction with the efficacy of conventional medications and

the perception that it is much more efficacious than orthodox medicines.113,114 Panax Ginseng is

an important medicinal herb that is widely cultivated in Korea, China and Japan.115 It has been

used for over 200 years in oriental countries and use is rapidly increasing in western countries.115

2.10.4.1: RED KOREAN GINSENG

Korean ginseng also known as panax ginseng is one of the most widely used herbal remedies in

the world and commonly in Asia.116 It is usually steamed before it is dried and ready for use.116 It

is long been used and seen to be effective in the treatment of psychological erectile

dysfunction.116 Panax ginseng had been in use for decades for the treatment of erectile

dysfunctions and other ailments such as nausea, diabetes mellitus.72 A Randomized Controlled

Trial found that Ginseng is effective at the dose of 1000mg when taken over twelve weeks.72

Kim et al study found that Panax Ginseng does not affect the level of cholesterol or prolactin,

58

therefore it is an alternative to invasive procedures for treating erectile dysfunctions. The study

also found that the effect of Korean red ginseng on erectile dysfunction is dose dependent.117 The

higher the dose of ginseng the higher the levels of nitric oxide in corpus cavernosum.117 It all

inhibits penile fibrosis and can be used to improve erectile function in patients with erectile

dysfunction.117 Ginseng is broadly classified into two i.e. Asian and American Ginseng which

are both made up of similar chemicals such as Ginsenosides.118,119 This is considered the active

ingredient in Ginseng. Others are saponins, glycans polysaccharides fractions, peptides, maltol,

vitamin B, flavonoids and volatile oils.118,119 There are more than 30 sub types of ginsenosides

that have been identified and more attempt are being made to increase its production because of

its increased use.119 Ginseng is a perineal plant that grows slowly and has a long production

cycle of 4-6 years, it is a snarled roots that looks like arms and legs.119

The different types of ginsenosides extract exist in the form of Rg1, Rb1,Rb2, and Rb0 depending

on their polarity which is usually graded A-Z. Ginsenoside Rg1 has been found to be more

effective in treatment of sexual dysfunctions.91 The effect of ginsenocides are induction and

activation of large conductance (KCa) channels in human copora carvenosal smooth muscle

relaxation by hyper-polararizing the smooth muscle membrane via the KCa channels which is

one of the mechanism of action of ginsenocides.91

Korean ginseng is commonly used in Korea to treat erectile dysfunction because it relaxes the

penile smooth muscle by ultimately increasing nitric oxide – cyclic guanosin monophosphate

pathway (cGMP) leading to increased erectile and endothelial functions.73 Korean red ginseng is

a mixture of lytium babarium, cuscuta chinese, rubus coreanus, miqi torilis Japanica fruits,

Schisandra fruit concentrate.73

59

Ginsenoside is found in all parts of the ginseng plant that is leaves, roots, barks and berries, but

the roots and the berries produce more ginsenoside of up to 4-6 times more than other parts of

the plants.120 The berries also have anti glycaemic and anti-obesity effects in mice.120 Panex

ginseng also improves glucose metabolism and immune response, maintains vitality and body

restoration in humans.121 Red Korean ginseng derived from the roots of ginseng plant has

stimulating effects on corpus spongiosum smooth muscle, therefore it is being promoted for the

treatment of erectile dysfunction.122 A randomized Controlled Trial observed that drug

interaction with panax ginseng includes theophylline and other asthmatic drugs, metabolism of

monoamine oxidase inhibitors such as phenelzine, tranylcypromine, isocabaxazid and

antipsychotics.18,123

Ginseng is usually available as tincture, liquid extract, powders and capsules.124 Studies have

found out that Ginseng preparation that has been used and found to be more effective in the

treatment of erectile dysfunction are in the form of root that are chewed or taken in the form of

tea as short term for six months and 100 mg to 600 mg capsule daily in divided dose.61,123 Even

though optimal dose of ginseng is unknown but when taken for a long time at high dose can lead

to a phenomenon called ginseng abuse syndrome. This occurs when ginseng is used for a long

period of time presenting with increased blood pressure, nervousness, insomnia, diarrhea and

skin eruptions.124 It is usually non toxic when used for a short time.124

It has also been postulated that uptake of gamma aminobutyric acid (GABA),glutamate,

dopamine, nor-adrenaline and serotonine in rats brains synaptosomes sin a concentration

dependent fashion which competes with the agonist of GABA receptor.72 Studies has also shown

a marked improvement in erectile performance in person including sexual satisfaction after

treatment with Red korean ginseng including moderate to severe forms after taking 900mg three

60

times a day.7,8,.72 An animal study also using red korean ginseng has been shown to significantly

relax the pre-contracted penile corpus cavernosum smooth muscle in rabbits9,10 Ginseng has

been used by many cultures as a remedy for erectile dysfunction. There is a significant

relationship between erectile dysfunction and weight, triglycerides and diabetes, but no

difference between testosterone fractions and sex hormone binding globulin (SHBG) levels.125

There is also a positive correlation between diabetes and hypertension with severity of erectile

dysfunction.125 Ginseng was used to restore and enhance normal wellbeing of the body, the effect

of which acts on the central nervous system, cardiovascular system and metabolism.125 Korean

ginseng is also effective in the treatment of orgasmic disorders and sexual desires.74 There exists

a significant relationship between weight, triglycerides and diabetes mellitus.119,125 There is also

a positive correlation between diabetes mellitus, hypertension and severity of erectile

dysfunction.125

Erectile dysfunction is a medical condition where patients patronize Complementary and

alternative medicine (CAM) heavily since most cannot express their problems to the physician,

2.10.4.2 SIDE EFFECTS OF GINSENG

Panax ginseng has been in used and its among the top 10 selling herbal supplements in the

United State as an adaptogen.126 There has been some few reports of side effects in human

studies. Panax ginseng is also considered a very safe and well tolerated drugs in animal studies

with a few reports of toxicity.126

Nam et al study, a randomized controlled double blinded study done in healthy volunteers

showed mild adverse events after using 1gram and 2grams of Ginseng.126 These adverse events

included dyspepsia, insomnia, hot flushes, constipation, low energy, dizziness and nausea which

were similarly seen in the placebo group.126 There was no significant difference between in

61

adverse events between the placebo and the ginseng group. The study conducted in subjects with

mild ED.126 Similar study conducted by Hyong et al, also a Randomized Controlled study

showed 1% side effect with one participant withdrawing from the study because of the side

effect. (systemic rash and pruritus) after using 1gram of ginseng within seven days of the

study.127

A systematic review of forty four selected studies on safety analysis of panax Ginseng, sixteen

of the studies reported minimal side effects while 23 studies did not report on side effects.128

Panax Ginseng used as a mono preparation in the study showed a safe profile with no significant

difference between Red Korean Ginseng and placebo.128 The side effects recorded were similar

to Nam. Aksam and Thuryan et al found that the optimum dose of red ginseng in the treatment of

erectile dysfunction is not known, but had been found to improve sexual dysfunction which had

been used at different dosages such as 100mg, 500mg and1000mg125,126. Same studies also

showed that the safety profile of red ginseng reported no adverse drug reaction but effective in

the treatment of erectile dysfunction.125,126 Many patients with erectile dysfunction use herbal

medication in addition to conventional medicines.129 Common side effects of ginseng by Fakeye

et al are sleeping problems. Other side effects not commonly seen are menstrual problems in

women, increased blood pressure, tachycardia, headaches, dizziness, diarrhea, skin rash and

gastric upset.129

Ginseng rarely interacts with some conventional medications such as blood thinners, monoamine

oxide inhibitors (MAO), immune system suppressants and insulin for treatment of diabetes

mellitus and the side effect was reported to be mild .129,69 De Adraede and Thuryan et al

reviewed the safety profile of red ginseng. They reported no evidence of adverse drug reaction

with normal dose of red ginseng.71,72

62

Figure 2.3 ALGORITHM FOR DIAGNOSIS AND TREATMENT OF ED10

Obtain a comprehensive medical, sexual, psychosocial history, assess vital signs, perform risk

factor analysis and a detailed examination of the cardiovascular, neurologic and genito-urinary

systems.10

Neurologic and genito- urinary systems.

Complete 5 items version of IIEF Questionnaire to categorize ED severity

Obtain a fasting serum glucose level and lipid panel, TSH, morning total testosterone level

.

63

Definable medical etiology Non definable medical etiology

1. Maximize treatment of coronary artery disease 1. Screening for psychological

2. Diabetes Mellitus causes e.g. anxiety, Depression

Guilt, sexual abuse, marital

2. Referred for behavioral

Therapy

3. Hormones disorder e.g.hypogonadism 3. Removal of negative

Hypothyroidism,psychosocial factors thoughts

4. Hypercholesteronamia

5. Hypertension

6. Metabolic syndrome

7. Neurologic conditions e.g. Alzheimer’s

disease, multiple sclerosis

8. Obesity

9. Vascular disease

10.

FIRST LINE THERAPY

1. Lifestyle and pharmacotherapy modification

(a) Oral therapy with phosphodiesterases inhibitors type 5 (ensure patients is not taking nitrates).

(b) Testosterone supplementation if patients has clinical hypogonadism

SECOND LINE THERAPY

64

Intraurethral and intracavernosalalprostidyl or

Vacuum pump devices

Referral to the urologist for further evaluation

CHAPTER THREE

3.0 METHODOLOGY

3.1 STUDY AREA

The study was carried out in Jos, the Plateau State Capital. Plateau State is located in the North

central zone of Nigeria bounded by Bauchi in the North while Bauchi and Taraba states are in

the north and East respectively, to the South by Nassarawa State while to the West by parts of

Nassarawa and Kaduna States. It is located on latitude 90 55 N and longitude 8053 E at an altitude

of about 1300m (about 4100 ft) above sea level.130

Its landscape is mostly treeless in the North and comprises features like hills and captivating rock

formations ranging from bare rocks, artificial hillocks and deep ponds which emanated from

years of mining. It has a dry season between November and March and a rainy season between

April and October. It covers an area of 7800 sq/km.130

The temperature on the Plateau is generally about 40C lower than that on the coast and annual

rainfall of about 1300mm is considerably higher than the surrounding lowland.

65

The State has an estimated population of over 3.1 million130 as at 2006 census which majority are

farmers, civil servants and traders. The capital city of the State is Jos, comprising of Jos North,

Jos South and part of Jos East. It is a cosmopolitan city where various tribes are represented.

The estimated population of Jos North is 429,300 while that of Jos South is 306,716.91 (2006

census). Plateau State has fairly well distributed health facilities with two teaching hospitals

(JUTH) and Bingham University Teaching hospital), General hospitals and over 500 Primary

health care (PHC) distributed over 17 local government councils130.

Jos University Teaching Hospital is the first and the largest teaching hospital in the whole of

North central Nigeria. It is located in Lamingo (new site).The hospital is a 525 bed hospital that

provides primary, secondary, tertiary health care to people of Plateau State and other adjourning

States.

The General Outpatient Clinic (GOPC) is the first point of contact for all patients including

patients with erectile dysfunction. Many of the patients are managed and followed up in the

GOPC while those who need specialist care are referred to the specialist in the various

departments of the hospital. Both Urology clinic and GOPC are located in the permanent site in

Lamingo.

3.2 STUDY POPULATION

The study population comprises all male patients with ED within the ages of 25 and 70 years

presenting at GOPC and urology clinic in Jos University Teaching Hospital with erectile

dysfunction. An average of 60 (15 Patients per week and 3 patients per clinic day) patients with

erectile dysfunctions are usually seen in GOPC and 30 (8 patients per clinic visit) patients per

month usually seen in Urology clinic.

3.3 STUDY PERIOD

The study was carried out between November 2014 and March 2015 – four months.

66

3.4 ELIGIBILITY

3.4.1 Inclusion Criteria

(1) Married men between the ages of 25 and 70 years who presented with erectile dysfunction for

at least three months (2) Participants who are were willing to participate in the study.(3) Subjects

who were not on Ginseng and other medications for ED and had the ability to come for

stipulated follow up.

3.4.2 Exclusion Criteria (1) Participants who were too ill to participate in the study (2)

participants who had significant cardiovascular diseases such as myocardial infarction, cardiac

failure and stroke because they may not be stable for regular follow up appointment. (3)

Asthmatics and patients on theophylline were also excluded because of rare adverse reactions

associated with ginseng (4) Patients on antipsychotics for instance, phenelzine, tranylcypromine

and isocarbaxazide due to drug interactions with Ginseng.

3.5 SAMPLE SIZE DETERMINATION

The sample size is determined by the following formula.131

N = 2P(1-P) (za + zb)2 where P = PA +PBD D= PB – PA

D2 2

Where N = Sample size (sample size in one study arm i.e group A or B)

PA = proportion of those in group A who have 50% improvement in erectile function using

11EF after 8 weeks of placebo and exercise from Assumption

PB = Proportion of those group B who will have at least 75% of improvement in erectile

function using 11EF after 8 weeks of treatment with Ginseng and exercise i.e. 25%

improvements

D = PB – PA = Smallest clinically significant difference to be detected = 75% - 50%

D = 25% = 0.25

67

P = PA + PB = 50% + 75% = 125% = 63% P=0.63

2 2

The alpha error of 5% = 9 = P value = 0.05, 95% confidence interval (Cl) and power of 80% (B

error = 20%)

Za = value of alpha error = 1.96

Zb = value of B error = 0.842

The sample size is therefore calculated

2x 0.63 (1 – 0.63) (1.96 +0. 842)2

(0.25)2

= 1.26 (0.37) (7.851204)

0.0625

= 3.6602313/0.04= 91.5

= 92 in each arm

This gives a minimum sample size of 184 for both the control and intervention groups for the

study.

Providing for a 10% attrition rate 10100⁄ × 184 = 18.4.

This will give rise to a maximum sample size of 101 on each group giving a total of 202

participants.

3.6 ETHICAL CONSIDERATION

Ethical clearance was obtained from the ethical committee of Jos University Teaching Hospital.

The aims, objectives and benefits were explained to the patients. Confidentiality was ascertained

throughout the study and written consent from each patient was obtained prior to recruitment.

They were told they could opt out of the study any time they wished with no consequences or

penalty.

68

3.7 INSTRUMENTS OF DATA COLLECTION

(i) Consent form written both in English and Hausa

(ii) Questionnaire: International Index of Erectile Function (IIEF) which is validated for the

diagnosis and classification of erectile dysfunction. It was scored before and after the study. The

scores are 22-25 (Normal erectile function), 17-21 (Mild ED), 12-16 (Mild to moderate ED), 8-

11 (Moderate ED), and 5-7 (Severe ED).

(iii) Standard bathroom weighing scale (Hamson) for weight measurement of the participants,

Calibrated from 0 to 120kg and adjusted to zero before each participant weight was measured.

The weight was measured by removing shoes and other heavy objects and standing straight on

the weighing scale.

(iv) Wall-mounted stadiometer was used to measure height of the participants (SECA cooperation.

Maryland USA). The participant stood straight while backing the stediometer. The height was

measured by moving the reader to the head . The readings ranged between 5.5- 78.75 in (14-

200cm) with graduation of 0.125 in 0.1cm

(v) Calculator (TAKSUN TS 568) for calculation of BMI, Sample Size and Statistics. A scientific

calculator with a rigid dual cover and scientific buttons with model size of 101x60x11MM.

(vi) Mercury sphygmomanometer (AccosonDecamet – Essex Cm19, 96p) for blood pressure

measurement. A table top sphygmomanometer containing a bulb, a cuff, tubbing, metal case and

a meter with a mercury measurement ranging from 0 to 220mmH. The cuff was tight to mid

portion of the left arm and inflated to 30mmHg above palpable systolic pressure. The bulb was

released gradually while listening with the stethoscope for systolic and diastolic blood pressures.

(vii) Stethoscope (Littman’s) for blood pressure measurement. It contains the ear piece, head set, the

bell and the diaphragm to complement sphygmomanometer in blood pressure measurement.

69

(viii) Urinalysis strips for urinalysis. It’s a plastic diagnostic chemical reagent strips containing URS-

K for detection of ketones, URS-3 for glucose, protein and ph, and URS-10 for glucose,

billirubin and blood. The urinalysis strip was immersed inside the urine and compares the colour

change with a standared colour chart.

(ix) Glucometer for blood glucose measurement (life scan one touch ultra easy-made in Switzerland).

It has a meter for the readings, tests strips, sterile lancets and a carrying case. It has a storing

capacity of up to 300 test result with dates and time. The tip of the thumb was cleaned and

pricked. The blood was collected on the test strip and the blood glucose read through the meter.

3.8 STUDY DESIGNS

The study was a randomized controlled single blinded comparative study where clients were

randomly allocated through simple random sampling after obtaining informed consent from the

subjects.

3.8.1 SAMPLING METHOD The participants were recruited consecutively as they come into

the clinic and selected at random by picking sealed envelopes randomly containing letter A and

B allocated into control and intervention groups respectively (Each participant had equal chance

of being selected). Sixty (60) patients per month are usually seen in GOPC (from records) ie 180

over three months and thirty (30) patients seen in Urology clinic per month ie 90 patients over

three months. The ratio of patients to be seen in GOPC and Urology making up the sample size

is 180:90 making a total of 270 in three months.

3.8.2: HYPOTHESIS The study was set to test the hypothesis that physical exercise and

Ginseng will reduce the severity and prevalence of erectile dysfunction in Jos.

HO The study was set to test the hypothesis that physical exercise and Ginseng is not effective in

the treatment and reduction of ED severity.

H1 Physical exercise and Ginseng is effective in the treatment and reduction of ED severity

70

3.9 STUDY PROTOCOL

Married men within the ages of 25 and 70 years who attended either GOPC or urology clinic in

JUTH with erectile dysfunction. Subjects who had persistent inability to achieve or maintain

erection for satisfactory sexual intercourse for about three months and who met the inclusion

criteria and consented for the study were recruited. One hundred and sixty two (162) participants

were recruited from GOPC over four months (two patients per day within five clinic days in a

week) and twenty eight (28) were recruited from Urology clinic (Two patients per day within

one clinic day per day) making a total of 190 participants. The duration of the study was

extended by one month because the minimum number of patients seen in the two clinics could

not meet up the minimum sample size in three months (due to security reasons) therefore, the

total number expected in three months was not feasible. Direct interview during history taking

was done by the investigator and also referral from colleagues as notices were placed in all the

consulting rooms to refer all patients who complained of poor erection. They were counseled on

the aim of the study and its implication on the management of erectile dysfunction and randomly

allocated equally to control and treatment groups. The consent form and the international index

of erectile function (IIEF) forms were completed by the interviewer. The nurse assistant in

GOPC arrange the patients after referral from colleagues before calling the researcher for the

interview on Uroiogy clinic days. The IIEF Questionnaires were interviewer administered with

the help of two nursing assistants. Full explanation and information concerning the research

processes was given to the participants. The IIEF questionnaire was used to diagnose and

measure the severity of erectile dysfunction.

The socio-demographic questionnaire included socio demographic data (including phone

numbers of subjects and or their spouses), history of sicknesses, medical and social histories

(hypertension, diabetes mellitus, heart disease, alcohol, cigarettes smoking, substance abuse and

71

drugs they were presently on) (1) exercise monitoring and drug adherence form (2) spouse

presentation form and ED severity (3) drug side effects forms. Results of physical examinations

as weight, height, blood pressure (120-139/80-89mmHg was considered normal), BMI (18-

24.9kg/m2 as normal), and the genitals (presence of both testes in the scrotum, firm and equal

sizes),laboratory results (urinalysis with absence of protein and glucose in urine), FBG (blood

glucose less than 7.1mmol/l as normal) lipid profile (with T chol 200mg/dl and below was

considered normal, LDL 70mg/dl, HDL of 60mg/dl and below was considered normal, and

triglycerides 150-200mg/dl, ECG (with normal rate, rhythm and heart size) and testicular

ultrasound results with testicular volume 12-28cm3 as normal). The IIEF was used to measure

outcome in both groups A and B before interventions. Scores were awarded for each subject

which classified erectile dysfunction into no erectile dysfunction rated from 22-25, mild ED from

17-21, mild to moderate ED from 12-16, moderate ED from 8-11 and severe ED from 5-7.

One hundred and ninety subjects who met the inclusion criteria were recruited for the study.

These subjects were randomly assigned into two study arms using letters A and B written on a

separate sealed opaque envelopes by the researcher in equal numbers of the total of 190

envelops. Ninety five (95) subjects were allocated to group A (control group) while ninety five

(95) were allocated to group B (treatment group) after obtaining informed consent from both

groups. Twenty (20) sealed envelopes from group A and 20 sealed envelopes from group B were

selected and mixed together. The first 40 subjects picked the envelopes at random until the first

40 got exhausted before another set of 40 was made available. This continued until the total 190

envelopes were picked. The envelopes were opened only at the time of allocation. The study arm

B was subjected to treatment using 50mg daily of Ginseng from Mega life sciences in addition to

physical exercise (at least brisk walking 30 minutes daily for at least five days per week), while

the control group A received placebo daily with physical exercise (at least brisk walking 30

72

minutes daily for at least five days per week). Reload multivitamin was used as placebo because

it contained Vit A, C, D3, E, K, B1, B2, B3, B6, B12, Biotin, Pentatonic acid, Ca2 iodine, Zn,

Mg, Chromium and was not a common drug for easy identification by the subjects. These

vitamins were also present in Ginsomin except ginseng. Both study arms were counseled on the

need for physical exercise (brisk walking 30 minutes daily for at least five days) a week while a

self administered physical activity questionnaire was completed each day of exercise (simply

ticking day and duration of exercise) and submitted at next visit for adherence assessment.

They were encouraged to come with their spouses because treatment of erectile dysfunction

usually fosters positive, realistic expectations for couples and maintenance of drug use when

partners are involved.28 Their role was to help their husbands in terms of adherence to

medication and physical exercise.

Both study arms were followed up in two weekly intervals (monitored on the follow up

questionnaire) of a total of five follow up visits (where lab results were reviewed in first follow

up visit, adherence to medication by reviewing the adherence form, exercise and follow up were

assessed at second to fourth visits while IIEF questionnaires were completed in the fifth follow

up visit). Four participants were lost to follow up with two participants losing follow up at six

weeks in the control group while two lost to follow up at the first two weeks in the intervention

group. One participant travelled for a holiday in the intervention group while other participants

who lost to follow up gave no reason. The subjects were contacted through phone calls about a

week to each follow up visit as a reminder.

At the end of the study, 186 participants completed the study and the data was analysed. The

international index of erectile function (IIEF) questionnaire was administered and completed by

the assistants using a separate questionnaire from the one used at recruitment. This was used to

assess the ED scores and the side effects between the two groups.

73

3.10 STATISTICAL ANALYSIS

Excel spread sheet and Statistical Package for Social Sciences (SPSS version 20) were used for

statistical analyses. The data was tested with One-sample Kolmogrorov-Smirnov test and the

Levenne test for equality of variances to satisfy the assumption of test model. Parametric tests

were used on variables that were normally distributed, while equivalent non-parametric tests

were used on variables that were not normally distributed.

Student T-Test was used to analysed any differences between the control and intervention group

in relation to age structure, educational level and the used of medication. Similarly, Student T-

test was used to analysed erectile dysfunction score and severity in the control and the

intervention groups. To compare the statistical difference in side effects of Gingseng

(intervention), Mann-Whitney-U test was carried out.

CHAPTER FOUR

74

4.0 RESULTS

4.1 Subject Flow through the Study

About one hundred and ninety (190) patients who met the inclusion criteria participated in the

study. This comprises of one hundred and sixty two (85.1%) subjects from the GOPC and twenty

eight (14.9%) subjects from the urology clinic. A total of four subjects were lost to follow up,

two from the intervention group and two from the control group. A total of one hundred and

eighty six subjects (97.9%) who completed the study were analyzed. The analysis was done

based on the number of subjects that completed the study. The study protocol through the study

is illustrated in figure 4.1

There were no subjects that were followed up to the end of the study that abandoned the study

and no subject crossed over the group.

Fig 4.1: STUDY PROTOCOL

75

GOPC Urology clinic

At base line

End of study

4.2 Baseline Characteristics of the study groups

Table 4.1: Socio-demographic characteristics

Participants Recruited

N= 162

Participants Recruited

N = 28

Those who Met the Inclusion criteria N= 190

ControL Group

N = 95

Intervention group

N = 95

Measure IIEF at

baseline + Placebo

First FU +Review

drugs + exercise+ lab

re adhirateform

Second Fu+ Review

Third FU +Review loss to Fu N=2

Fouth FU +Review

Fifth FU +IIEF

assessment

N = 93

Measure IIEF at

baseline + Ginseng

First FU+ drugs Rev

+ exercise+ Lab

RREResults

Second FU + Review

Third FU+Review

Loss to fu

N = 2

Fourth FU+Review

Fifth FU+ IIEF

assessment

N = 93

76

Characteristics Control (%) Intervention (%) Total (%) P-Value

AGE GROUP(years)

25-35

18(9.7)

12(6.5)

30(16.1)

0.35

36-45 12(6.5) 20(10.8) 32(17.2)

46-55 23(12.4) 22(11.8) 45(24.2)

56-65 20(10.8) 20(10.8)

40(21.5)

66-75 20(10.8) 19(10.2) 39(21.0)

Total 93(50.0) 93(50.0) 186(100)

EDUCATIONAL LEVEL

No Formal

19(10.2)

22(11.9)

41(22.0)

0.93

Primary 21(11.3) 18(9.7) 39(21.0)

Secondary 25(13.4) 19(10.2) 44(23.7)

Tertiary 28(15.1) 34(18.3) 62(33.3)

Total 93(50.0) 93(50.0) 186(100)

EMPLOYMENT STATUS

Government/Private 31(16.7) 30(16.1) 61(32.8) 0.38

Self-Employed 31(16.7) 28(15.1) 59(31.7)

Retiree 11(5.9) 13(7.0) 24(12.9)

Student

20(10.8) 22(11.2) 42(22.5)

Total 93(50.0) 93(50.0) 186(100)

RELIGION

77

Christianity 64(34.4) 60(32.3) 124(66.7) 0.98

Islam 29(15.6) 33(17.7) 62(13.3)

Traditional 0(0) 0(0) 0(0)

Total 93(50.0) 93(50.0) 186(100)

A total of 186 patients were analyzed. The mean age with standard deviation of the study

population (N = 186) was 41.7±25years. The age ranged range in this study was from 25-70

years. There was no significant difference in age distribution between the intervention and

control group (t=0.097, p=0.35)

The educational level of the 186 participants is shown in table 4.1. Forty-one (22.0%) of the

participants had no formal education, 39(21.0%) had primary education, 44(23.7%) had

secondary education and 62 (33.3%) had tertiary education. The employment status of the

participants indicated 61(32.8%) were government or privately employed, 59(31.7%) were self

employed, 24(12.9) were retirees, and 42(22.5%) were students,.

Among the 186 participants in this study, 124 (66.7%) were Christians, 62 (13.2%) were

Muslims. The overall table 4.1 showed that randomization was effective as there was no

significant difference in the baseline socio- demographic characteristics.

78

4.3 Medical Characteristic of the study Group

Fig 4.2 primary complain of erectile dysfunction

Participants who presented to the clinic with primary complaint of erectile dysfunction were:

29.0% while subjects who came with a different complaint were 71.0%

0

10

20

30

40

50

60

70

80

Self Presentation Physician Motivated

Res

po

nd

ents

79

4.4 SPOUSE PRESENTATION

Fig 4.3 Participants Spouse Presentation at the Clinic

Out of the total of 186 subjects who completed the study, only 13(7%) of the participants

presented at least once with their spouses. About 173(97%) did not come for visit with their

wives even once. All the wives presented only once to the clinic and they were admonished

to encourage their husbands on adherence to medication and physical exercise.

0

10

20

30

40

50

60

70

80

90

100

Spouse No spouse

Res

po

nd

ets

80

4.5 Medication Use

Table 4.2 Medication used among the study participants

Control (%)

N(%)

Intervention (%)

N(%)

Total (%)

N(%)

P-value

MEDICATION USED

Traditional

27(14.5)

22(11.8)

49(26.3)

0.79

Orthodox 19(10.2) 18(9.7) 37(19.9)

None 47(25.3) 53(28.5) 100(53.8)

Total 93(50.0) 93(50.0) 186(100)

Among the 186 participants, 53.8% of the participants had not been treated before for erectile

dysfunction, 19.9% had been treated with orthodox medications and 26.3% had been treated with

traditional medication. There was no significant difference in medication used across the study

groups. (P = 0.79)

81

4.6 Risk Factors

Table 4.3 Risk Factors of Erectile Dysfunction

Intervention

(%) (N=93)

Control (%)

( N=93)

Total (%)

(N= 186)

p-value

RISK

FACTORS

Diabetes mellitus

Yes

No

33(17.7)

60(32.3.3)

32(17.2)

61(32.8)

65(34.9)

121(65.1)

0.16

Hypertension

Yes

No

50(26.9)

43(23.1)

44(23.7)

49(26.3.3)

94(50.5)

92(49.4)

0.64

Heart disease

Yes

No

0(0)

93(50.0)

0(0)

93(50.0)

0(0)

186(100)

Smoking

Yes

No

27(14.5))

66(35.5)

21(11.3)

72(38.7)

48(25.8)

138(74.2)

0.16

Alcohol

Yes

No

41(22.0)

52(28.0)

39(21.0)

54(29.0)

80(43.0)

106(57)

0.34

Substance abuse

Yes

No

0(0)

93(50.0)

0(0)

93(50.0)

0(0)

186(100)

Drugs

Yes

No

46(24.7)

47(25.3)

34(18.3)

59(31.7)

80(43.0)

106(57)

0.37

Classes of BMI Intervention Control Total 0.56

82

The proportion of the study participants with risk factors of erectile dysfunction are as shown in

Table 4.3. A total of 65(34.9%) of the participants had diabetes mellitus, 94(50.5%) had

hypertension and 39(21%) were smoking, 80(43.0%) were taking alcohol and drugs respectively.

There was no statistical significance in risk factors across the study group. The mean BMI and

standard deviation of the study groups was 25+ 17.2.kg/m2. The proportion of underweight

participants was 19(10.2%), 73(39.2%) were of normal weight, 20(10.8%) were over-weight,

27(14.5%) were in obesity class I and 47(25.3%) were in obesity class II. There was no

significant difference across BMI classes (P =0.56)

4.7: INVESTIGATION RESULTS

Underweight 9(4.8) 10(5.4) 19(10.2)

Normal 39(21.0) 34(18.3) 73(39.2)

Overweight 9(4.8) 11(5.9) 20(10.8)

Obesity I 12(6.5) 15(8.1) 27(14.5)

Obesity II 24(13.0) 23(12.4) 47(25.3)

83

Table 4.4: General

Investigation Results

Intervention Control Total P-value

FBG

Normal 80 (43) 75 (40) 155 (83.3) 0.003

Abnormal 13 (7.0) 18 (9.7) 31 (16.7)

Urinalysis 0.001

Normal 89 (47.8) 88 (47.3) 177 (95.2)

Protein 2 (1.01) 3 (1.6) 5 (2.7)

Glucose 2 (1.01) 2 (1.01) 4(2.2)

Lipid Profile

Normal 93 (50) 93(50) 186 (100) -

Abnormal 0 (0) 0 (0) 0(0)

ECG 0.001

Normal 90(48.4) 91(48.9) 181 (97.3)

Cardiomegally 3(1.6) 2(1.01) 5(2.7)

Testicular Ultra Sound

Normal 92(49.5) 93(50) 185(99.5) 0.001

Single Testes 1(0.5) 0(0) 1(0.5)

Genital Examination 0.001

Normal 92(49.5) 93(50) 185(99.5)

Single Testes 1(0.5) 0(0) 1(0.5)

Among the 186 participants that completed the study, 155(83.3%) had their fasting blood

glucose within the normal range while 31(16.7%) had high blood glucose results at baseline. For

urinalysis, 177(95.2%) had normal result while 5(2.7%) had protein and 4(2.2%) had glucose in

84

urine. All the participants had normal lipid profile. About 181(97.3%) of the participants had

normal ECG results while 5(2.7%) had cardiomegaly. On testicular ultrasound results and

examination findings, 185(99.5%) had normal results while only 1(0.5%) had one testis. There

was a significant difference between participants who had normal results and those with

abnormal results in both the control and intervention groups at baseline.

85

4.8: Erectile Dysfunction Scores of the Participant Before and after the Study

Table 4.5 : Erectile dysfunction Scores at baseline

Intervention

(%) (N=93)

Control

(%)

(N=93)

Difference

(%)

Total (%)

(N=186)

p-value

ED Scores

Mild (17-21)

7(3.8) 10(5.4) 3(1.6) 17(9.1) 0.11

Mild to

moderate(12-

16)

33(17.7) 38(20.4) 5(2.7) 71(38.2) 0.08

Moderate (8-

11)

30(16.1) 26(14.0) 4(2.1) 56(30.1) 0.07

Severe (1-7)

23(12.4) 19(10.2) 4(2.2) 42(22.6) 0.06

Total

93(50%) 93(50%) 186 (100%)

The above table indicated that at baseline the proportion of the participants with mild ED was

7(3.8%) in the intervention group compared to 10(5.4%) in the control group (p=0.11),

33(17.7%) with the mild to moderate ED in the intervention group compared to 38(20.4%) in the

control group (p=0.08), 30(16.1) in the intervention compared to 26 (14.0) in the control groups

had moderate ED (p=0.07) and 23(12.4%) in the intervention compared to 19(10.2%) in the

intervention groups had severe ED (p=0.06). There was no significant difference in erectile

dysfunction scores between the control and intervention groups in each of the domains at

baseline.

86

The severity of erectile dysfunction at baseline (Table 4.5) showed majority of the participants

had mild to moderate ED 71(38.2%), 33(17.7%) were in the intervention group and 38(20.4) in

the control groups. Thirty (16.1%) in the intervention group and 26(14.0) in the control groups in

the moderate domain and 23(12.4%) and 19(10.2.7%) in the intervention and control groups in

the severe domain respectively.

Table 4.6: Erectile Dysfunction Scores post intervention

87

Intervention

(%)

Control

(%)

Difference

(%)

Total p-value

ED Scores

Normal (22-

25)

14(7.5) 2(1.5) 12(6.4) 16(8.6) 0.41

Mild (17-21)

33(17.7) 16(8.6) 17(9.1) 49(26.3) 0.21

Mild to

moderate (12-

16)

19(10.2) 32(17.7) 13(7.5) 51(27.4) 0.16

Moderate (8-

11)

17(9.1) 20(10.8) 3(1.7) 37(20.0) 0.05

Severe (1-7)

10(5.4) 21(11.3) 11(6.1) 31(16.7) 0.22

Total

93(50.0) 93(50.0) 186(100)

After intervention, the proportion of the study participants whose erectile function became

normal was 14(7.5%) in the intervention group compared to 2(1.1%) in the control group. Mild

ED improved to 33(17.7%) in the intervention group compared to 16(8.6%) in the control group

after intervention (p=0.21). Mild to moderate ED was 19(10.2%) in the intervention compared to

32(17.7%) in the control group (p=0.16), Moderate ED was 17(9.1) in the intervention group

compared to 21(10.8) in the control group (p=0.05) while in the severe domain 10(5.4) in the

intervention group compared to 21(11.3) in the intervention group (p=0.22). There was a

statistically significant improvement in participants with moderate ED after intervention, but not

statistically significant in the other domains at the end of eight weeks.

After the intervention, the severity of erectile dysfunction improved to thirty three 33(17.7%) in

the intervention group compared to sixteen 16(8.6%) in the control group of the mild domain.

88

Fourteen participants 14(7.5%) had no ED compared to two 2(1.1%) in the control group.

Nineteen 19 (10.2%) in the intervention group compared to thirty two 32(17.7%) in the control

group of the mild to moderate dormain. In the moderate dormain, 17 (9.1%) in the intervention

group compared to 20(10.8) in the control group. In the severe dormain 10 (5.4%) was in the

intervention group compared to 21(11.3%) in the control groups.

Table 4.7 Percentage difference in erectile function between baseline and post intervention

89

ED Scores Baseline

(%)

Post Intervention

(%)

% Difference P-Value

Normal 0 6.4 6.4 0

Mild ED 1.6 9.1 7.5 0.03

Mild to

moderate

2.7 7.5 4.8 0.28

Moderate 2.1 1.7 0.4 0.04

Severe ED 2.2 6.1 3.9 0.21

The table above showed the percentage differences at baseline and post intervention in the

mild (p=0.03) and the moderate (0.04) were statistically significant, while the mild to moderate

(p=0.28) and the severe (p=0.21) domains were not statistically significant. About 6.4% of the

patients had normal erectile function post intervention

4.8 Number of participants who experienced Side Effect of Ginseng

90

Fig 4.4: Side effect of Ginseng after Treatment

Figure 4.4 above showed the side effects of Ginseng after treatment, four participants (4%) out

of 95 (96%) experienced side effects of the drug.

Fig 4.5 Types of Side effects experienced after treatment with Ginseng

0

20

40

60

80

100

120

Side Effects No Side Effects

Res

po

nd

ents

91

Fig 4.5 illustrated the various side effects experienced by four participants with ginseng

treatment. Two participants of four (50%) had insomnia, one of the four participants (25%) had

gingival swelling and one (25%) had bilateral breast pain. There was significantly more

respondence with no side effects compared to those with side effects, (Mann-Whitney U-Test;

Z=12.4, P<0.001)

CHAPTER FIVE

Insomnia50%

Gum Swelling25%

Breast Pain25%

Side Effects

92

5.0. DISCUSSION

5.1 SOCIO DEMOGRAPHIC CHARACTERISTICS

This study was made up of 186 males within the ages of 25 and 70 years. The mean age of the

participant’s was 41.7+25years. The mean age was higher than the mean age (38.8) reported in

Omisanjo study.43 This may be attributed to the wider age range (21-70 years) compared to this

study (25-70 years). This study reported higher proportion of 43(23.1%) participants with

erectile dysfunction within the ages of 46-55 years. The study showed an increase in erectile

dysfunction among participants aged 45-55 and above as shown in table 1.This is comparable to

Oladiji et al’s study in subjects within the ages of 20 and 70 years in Nigeria14 and Cheng et al

within the ages of 26 and 70years.50 These studies are similar in the age ranges of the

participants. However, this study was in contrast to the Massachusetts male aging study in

Tanzania which was carried out in subjects within the ages of 40 and 70 years.44 These studies

demonstrated a consistent increase in erectile dysfunction with age. This could be attributed to

increase in chronic diseases and decrease in compliance of copora cavernosa as they get older.42

This study demonstrated that majority (80%) of participants had formal education. Thirty eight

38(20.4%) had primary level of education, 47(25.3%) had secondary level of education and

64(34.4% ) had tertiary level of education. This showed that erectile dysfunction is higher in men

with higher level of education. Idung etal11 in Uyo, Nigeria reported a similar finding that 99%

of the subjects had at least primary school education and 1% had no formal education.11 45 This

was attributed to the lifestyle associated with higher social class which exposes them to risk

factors of erectile dysfunction such as obesity.11,45 This study was in contrast to a study done by

Nicolisi et al in 2003 which reported that erectile dysfunction is inversely related to higher level

of education.45 He reported (14.0%) of erectile dysfunction among those that completed high

93

school and 9.4% in degree holders. This relationship is attributed to poverty and less access to

medical care.45

Majority (53.8%) of the participants did not seek for help or were treated for erectile dysfunction

in the past. The proportion of participants who used orthodox medication in the past six weeks

was 19.9% while 26.3% had used traditional medication for treatment of ED. Okoli et al77 had

similar finding with 73% of the participants not taking any form of treatment while 60% of the

participants that were treated resorted to herbal medications. This was attributed to limited access

to health care, the culture, and religion of the participants especially in patient with ED38,77,.

Among the 186 subjects who completed the study, majority (93%) came with their wives, while

only 7% came with their wives at least once at either initial visit or as part of follow up. Chevret

et al found that involving their partners in the treatment foster positive, realistic expectation and

also positive drug adherence in the patients.

The study showed 67(36%) of the participants were employed by the government or private

organizations, sixty five (34.9%) were self employed , twenty nine (16.6%) were retirees, twenty

five (13.4%) were students. There was no statistically significant difference (p=0.3) between the

control and the intervention regarding employment status. Idung et al11 study was not in

agreement with his study. He demonstrated that 21.8% of the respondents with ED were

unemployed and 79.2% were employed. Both studies were done in Nigeria but differences may

be attributed to larger sample size and longer duration of study in the Idung study.11 On the

religious domain, The study showed that Christians were 32.3% in the control group and 34.4%

in the intervention group while 17.2% and 16.1% in the control and intervention groups were

Muslims respectively. There was no significant difference across religion in the control and

intervention group

94

5.2 MDDICAL CHARACTERISTICS

This study showed that hypertension (50.5%), DM (34.9%), alcohol and other drugs (43%) are

the commonest risk factors of erectile dysfunction. This study was similar to a study reported by

Chukwunonso in south west Nigeria.42 He reported that hypertension was 16.6% in the study

popoulation.42 Similar studies conducted by Lawrence7 and Idung11 reported that hypertension

was 70% and 92% respectively in their study population. These studies were comparable because

they were done within the same geographical location and in the same age groups.

However, Lawrence7 reported diabetes was 72% in the study population whereas Idung11

reported 7.3% as second commonest risk factors for erectile dysfunction. This study showed that

alcohol (43.0%) and other drugs (43.0%) were next commonest risk factors while DM (34.9%)

was third commonest risk factor.

This study was in contrast with a study done by Fung et al in 2004 which showed that heart

disease was the commonest risk factor for erectile dysfunction.51 Heart disease was reported in

5.8% of the study population. The study also showed that hypertension and higher fasting blood

glucose were not related to erectile dysfunction51. This finding may be attributed to age of the

participants (average72 years) and the study was carried out in patient with heart diseases.

Alcohol was reported in 43% of the study population in this study. This may be attributed to the

high level of alcohol consumption in this environment as alcohol is commonly seen as part of

marriage rites49. Cheng et al in Hong Kong also found negative effects of alcohol (39.1%) on ED

(P<0.007),

The body mass index (BMI) of the participants ranged between 17.5kg/m2 (underweight) to 39.9

9kg/m2 (obesity type II). The mean BMI of the participants at baseline was 25.36±17.5kgm2.

This is significantly lower than Cheng report with mean BMI of 36.6kg/m2. This is sufficient in

95

the fact that Cheng50 study was done in obesed patients. About 39.3% of the study participants

were within normal weight. This study demonstrated that majority of the participants did not

complain to their physicians about their erectile dysfunction similar to Omisanjo study who

demonstrated that majority (57.1%) of patients with erectile dysfunction cannot comfortably

complain or ask questions about their sexual problems.

The laboratory results at baseline showed majority of the participants had normal results with

only few having abnormal results. Five participants had cardiomegaly on ECG and five had

protein in urine all of which were hypertensive patients. The four participants who had glucose in

urine were all diabetic patients while one participant had one absent testis on the right on

examination was confirmed by testicular ultrasound scan. All the participants had normal lipid

profile results. There was a significant difference between participants with normal results and

those with abnormal results in both control and intervention groups.

5.3: EFFECTIVENESS OF GINSENG ON ERECTILE DYSFUNCTION

The present study found an increase in IIEF scores in the intervention group of the mild domain

from 3.8% to 17.7% compared to 5.4% to 8.6% in the control groups. This showed a statistically

significant improvement of red Korean Ginseng in the moderate domain (p=0.05) after

intervention, the mild domain was (p=0.21), mild to moderate domain (p=0.16), and severe

(p=0.22). The proportion of participants whose ED improved to normal erectile function was

encouraging in the intervention groups 7.5% compared to 1.5% in the control group which

suggest that red Korean Ginseng is superior to placebo.

The percentage difference in erectile function at baseline and post intervention (table 4.7)

showed mild ED (p= 0.03) and moderate ED (p=0.04) were statistically significant while the

mild to moderate ED (p=0.28) and severe ED (p=0.21) were not statistically significant. A study

96

done by Jang et al also showed that red ginseng had a significant effect (P<0.00001) on

improvement of erectile function compared to placebo (P=0.96).22 A sub group analysis of the

study also found a significant improvement in psychogenic erectile dysfunction (P=0.001).22

however, the Jang study was a meta analysis that utilizes six RCTs using 600mg, 900mg and

1000mg three times a day as adopted doses for the studies as compared to 50mg of Ginseng daily

for this study. De Andrade et al in their study also found a significant effect (p<0.0001) after

using 1000mg of red ginseng three times a day in the intervention group compared to p>0.05 in

the control group, but the sample size was low (60) and the comparison was between mild with

mild to moderate compared to all the domains of ED in this study.

Peak used a ginseng extract from a tissue red mountain ginseng plant, he also found a significant

improvement in IIEF from 29.78 to 13.14 in the treatment group compared to 39.86 to 15.29 in

the placebo group.84 The improvement in IIEF which was similar to this study showed a

significant improvement in organic function and sexual desire in those subjects.

This study is also similar to Gaurang study who used a poly herbal preparation that contains

ginseng (VXP) as the only ingredient known to improve erectile dysfunction.69 The VXP group

had a significant improvement (P<0.0001) in erectile function with the IIEF improved from

16.08 to 25.08 in the treatment group compared to 15.86 to 16.47 improvement in the placebo

group (P=0.61). The percentage improvement in erectile function with ginseng in this study was

statistically significant only in the mild ED (P=0.03) and moderate ED (p=0.04). This may be

attributed to the lower dose and frequency of ginseng extract (50mg daily) used in the study as

compared to higher dose and frequency (600mg, 900mg and 1000mg three times a day)72 in Jang

studies where all the domains had statistically significant improvement. It may also be attributed

to the duration of study (8 weeks) compared to (12 weeks) in de Andrade and Jang study.22

97

This study showed an increase in IIEF domain scores in eight weeks. However, this study was

conducted in all erectile dysfunction domain (mild, mild to moderate, moderate and severe)

whereas Guarang et al study demonstrated only in patients who had mild to moderate erectile

dysfunction only. This showed that this study had a wider scope of ED assessment compared to

Gaurang study Similarly, De Andrade study demonstrated significant improvement in ginseng

group (P<0.001).72 in patients with mild and mild to moderate ED only. This study showed

significant improvement in the mild ED (p=0.03) and moderate ED (p=0.04) while Kubin etal,36

showed improvement in erectile function (17%) in patients with moderate to severe erectile

dysfunction compared to mild erectile dysfunction and moderate ED. This may also be attributed

to the higher dosages of red Korean ginseng used in these studies.36

Overall, this study in comparison to reports of previous studies indicated that ginseng may be

used in the treatment of mild and moderate erectile dysfunction.

5.4 SEVERITY OF ERECTILE DYSFUNCTION

Significantly, this study showed a total of 71 (38.2%) of the participants with erectile

dysfunction had the mild to moderate form at baseline. This was followed by 56 (30.1%)

participants in the moderate domain, 42(22.6%) in the severe domain and 17(9.1%) in the mild

domain. The control group had more participants with mild to moderate ED while the

intervention had more of the moderate and the severe type before the study. This result support

the findings of Massachusetts study44 which demonstrated that majority (25%) of the participants

98

had mild to moderate erectile dysfunction, 17% had mild ED while 10% had severe ED44 similar

to a study done by Omisanjo also demonstrated higher population with mild to moderate erectile

dysfunction.43 This study showed a significantly lower population with severe ED after the study

in the intervention group. This finding is comparable to Gaurang et al study which IIEF

improved from 16.08 to 25.08 and peak et al study which improved from 29.78-13.14 who also

demonstrated a decrease in population of erectile dysfunction after intervention. This study

showed higher proportion of subjects with mild to moderate erectile dysfunction before (38.2%)

and after (27.4%) the study. however the proportion of subjects with mild to moderate and

moderate ED was lower in the treatment groups (10.2%) compared to the control groups (17.7%)

after the study.

The findings in this study highlighted the severity of erectile dysfunction in the mild to moderate

group. A contrasting reported by Idung etal in Uyo Nigeria reported higher severity (16%) in the

mild domain compared to (8.6%) in the mild to moderate at baseline. Both studies were hospital

based but the differences may be attributed to larger sample size (400 men) and study design

(cross sectional) as compared to this study.

5.5 GINSENG SIDE EFFECTS

This study demonstrated minimal side effects (4.3%) of ginseng across the treatment group

compared to 95.7% without side effects after treatment. The minimal side effects in this study

correspond to De Andrade study (0%) which showed no side effects after 12 weeks of ginseng

treatment in a randomized controlled trial.72 This is expected as ginseng is a natural product

(CAM) commonly seen with minimal or no side effects. There was no adverse reaction recorded

in the study which was similar to De Andrade study.72 The side effects recorded in this study

included poor sleep, gum swelling and bilateral breast pain. However, Young et al in a

99

systematic review of 44 selected Randomized Controlled Studies of the safety profile of ginseng

over 12 weeks.128 They found only 16 studies (36%) reported minimal side effects of Ginseng.

The side effects were similar to this study and there was no significant difference (p=378) in side

effects between the treatment and the placebo group.128

This study was Similar to Hyong et al study in patients with chronic fatique syndrome.127 They

assessed side effects of ginseng in two groups (1g and 2g) and recorded 1% side effects of

Ginseng in each group similar to this study. Their similarities were their study designs, results

and the age of the participants (20-65 years), but the difference is their shorter duration of study

(4 weeks) compared to this study.

In contrast to this study, Nam-Hum et al assessed the safety profile of red ginseng in two groups

of participants using 500mg and 1000mg of ginseng which was matched with placebo.126 They

found higher side effects in all the groups compared to this study. The placebo group recorded

31.6% side effects, 33.9% in the 500mg group and 29.8% in the 1000mg group but there was no

statistical difference (p=0.895) in side effects between the placebo and the treatment group. The

side effects may be attributed to the higher doses of ginseng used in their study compared to this

study, The similarities in the two studies was their sample size (170) but difference was their

duration of treatment (4weeks).

5.6 RELATIONSHIP BETWEEN CLINICAL CHARACTERISTICS AND ERECTILE

DYSFUNCTION SCORES

This study demonstrated a positive relationship between risk factors such as age diabetes

mellitus, alcohol and educational level with erectile dysfunction. Nicolisi did not find any

positive relationship between level of education and erectile dysfunction.45

100

The researcher could not find anything relating age and level of education with erectile

dysfunction scores. A number of studies have found a relationship between increased risk factors

with decrease in erectile function scores.59,72 which is an inverse relationship.

The improvement in erectile dysfunction in this study was lower after using 50mg of ginseng

compared to Jang and De Andrade study that used 1000mg for the study. The results of these

studies corresponds to the finding of De Andrade et al that erectile dysfunction may improve

with increase in dose of ginseng.72 This may suggests that increasing the dosage may improve

scores in mild to moderate and severe erectile dysfunction since improvement in erectile function

is better in studies that used higher dosages of ginseng as seen in Jang study.

There was a U-shaped relationship between BMI and ED in this study. The highest proportion of

participants (39.2%) with ED were with normal BMI followed by obesity type II (25.3%) and I

(14.5%). The lowest ED was found in participants who were underweight (10.2%) or overweight

(10.8%). This relationship is similar to Cheng et al studies which showed similar characteristics,

but Cheng;s study was a cross sectional study.

5.7 CONCLUSION

The purpose of the study was to determine the effects of ginseng and its side effects in the

treatment of unselected erectile dysfunction in JUTH. In line with the first objectives, the study

found some clinical improvement in patients with mild and moderate erectile dysfunction in

groups on ginseng compared to the groups on placebo which were statistically significant. The

pattern of erectile dysfunction showed more patients had mild to moderate ED among the study

population. The severity of erectile dysfunction was markedly reduced in the treatment groups

after the intervention. The side effects of Ginseng were minimal on patients with erectile

101

dysfunction. These side effects include breast pain, gum selling and insomnia which all resolved

within two weeks of treatment.

5.8 RECOMMENDATION

The results of this study showed significant improvement in mild and moderate erectile

dysfunction, (1) Red Korean ginseng should be included in the routine care of patients with mild

and moderate erectile dysfunction. With the minimal side effects (2%) encountered in the

treatment of erectile dysfunction with Ginseng which were observed to be mild, Ginseng is

considered to be safe in the treatment of mild erectile dysfunction.

(2) Family Physicians should be on a watch for patients with ED as majority of the patients have

mild to moderate erectile dysfunction with majority of the patients within the ages of 46-55

years. (3) It is recommended that sexual histories should be included in routine patient encounter

as majority of them may not complain to the physicians of their condition.

(4) A multi-disciplinary approach should also be adopted as Family Physicians, Psychiatrist,

health counselors, psychologist, dieticians, endocrinologist and nurses who are interested in this

discipline in order to significantly reduce the prevalence of erectile dysfunction in Nigeria.

5.9 STRENGTH OF THE STUDY.

The strength of the study was that it was interventional study, where the subjects were

randomized into two groups. The researcher was of the same sex with the subjects thereby

increasing their comfort ability in discussing their problems. There was a good communication

between the researcher and the subjects as researcher understood both English and Hausa spoken

by the subjects. The questionnaires were both in English and Hausa. There was also a good

support between the researcher and his colleagues in GOPC and urology clinic.

102

5.10: LIMITATIONS OF THE STUDY.

Most of the work done on erectile dysfunction in Nigeria and other African countries were not

interventional studies but little observational studies on this topic. This could explain limited

information on this topic from this part of the world. Culture and religion was also a barrier as

some patients found it difficult expressing their concerns. Cost of drugs especially ginseng was a

problem for this study. security was a great concern to patients coming from afar as it was at the

peak of insurgency in Northern Nigeria.

5.11: IMPLICATIONS OF THE STUDY TO FAMILY PHYSICIANS

Family physicians render comprehensive care to all ages, sex and disease at a primary level. He

is the first doctor to be seen, hence he must be equipped in managing all kinds of diseases. The

study is important to family medicine because it demonstrated the effectiveness of ginseng in the

management of erectile dysfunction. The result showed erectile dysfunction is common in our

environment with majority of the patient seen in GOPC of the Jos University Teaching Hospital.

This study further highlighted the risk factors and treatment modalities associated with this

disease. Family physicians should acquire knowledge and skills in managing erectile dysfunction

and sexual problems in general.

5.12: SUGGESTION FOR FURTHER STUDIES

To the best of knowledge, there are no available interventional studies done in this subject in

Nigeria therefore, more interventional studies are required. Further studies with higher dosages

of ginseng with longer duration is required in order to draw more conclusive evidence in the use

of ginseng in management of erectile dysfunction. Robust sponsorship is recommended for

studies in order to encourage larger studies. Sex clinic should be opened in GOPC with adequate

103

privacy considering the larger number of patients with erectile dysfunction drawn from these

studies.

REFERENCE

1. United Nations. Sexual and reproductive health/UNFPA.2015 (Accessed on April 15, 2015).

Available from http.unfpa.org.sexual-reproductive health.html

2. Ojomo F. Sexual Problems Amongst Married Women in the Reproductive Age Group Seeking

Medical Care in Jos, Nigeria. FWACFM Dissertation. West African College of Physicians. 2005;

1-9: 59–62

3. World Health Organization (WHO).Sexual and Reproductive Health. 2015 (Accessed on May

12, 2015). Available from http:www.who.int.reproductivehealthhtml

4. Baryamutuma R, Baingana F. Sexual, Reproductive Health Needs and Rights of Young people

with Perinataly Acquired HIV in Uganda. Afri Health Sci 2011; 2: 211 – 18.

104

5. Theobold I, Sally E. Strengthening the Research to Policy and Practice Interface Exploring

Strategies Used by Research Organizations Working on Sexual and Reproductive Health and

HIV/AIDS, Health Research Policy and Systems 2011; 9 (1):12.

6. Araugo AB, Mohr BA, Mohr BA, Mckinlay JB. Changes in Sexual Function in Middle Aged

and Older Men: Longitudinal Data from the Massachusetts Male Aging Study. J AM Geriatric

Soc. 2004; 9: 1502- 9.

7. Lawrence AA, Olubunmi Z, Olapade O, Modupe M L, Emeto TO, Prevalence and Correlates of

Erectile Dysfunction Among Primary Care Clinic Attendees in Nigeria. Global Health Sci

2012; 4(4):17.

8. Ronald W, Lewis MD, Kersten S ,Fugl M, Bosch R, Axel R.et al. Epidemiology /Risk Factors of

Sexual Dysfunction. Journal of Sexual Medicine 2004; 1(1): 36-9.

9. Ariba AJ, Oladapo OT, Iyaniwura CA. Dada OA. Management of Erectile Dysfunction,

Perception and Practice of Nigerian Primary Care Clinicians. South African Family Practice

2007; 49(9):16-29.

10. Joel JH. Management of Erectile dysfunction. American Family Physician 2010; 81(3): 305-12.

11. Idung AU, Abasiubong F, Ukott A, Udoh SB, Unadike BC Prevalence and Risk Factors of

Erectile Dysfunction in Niger Delta Region Nigeria. Afri Health Sci 2012; 12(2): 160 -5

12. Olarinoye JK, Kuranga SA, Katibi IA, Adeniran OS, Jimoh AA, Sanye EO. Prevalence and

Determinants of Erectile Dysfunction among People with Type 2 Diabetes in Ilorin, Nigeria. The

Nigerian Postgraduate Medical Journal 2006; 13(4):291-6.

13. Quek FK, Sallam AA, Chai Heng NG, Chua CB. Prevalence of Sexual Problems and its

Association with Social, Phychological and Physical Factors Among men in Malaysian

Population, Cross Sectional Study SEJournal of Sexual Medicine 2008;5(1): 70-6.

105

14. OladijiF. Kayode O, Parakoy DB, Influence of Socio-demographic Characteristics on Prevalence

of Erectile Dysfunction in Nigeria. Int J Impot Res 2013; 25: 18-23.

15. Thieti T, Adjaye a, FousekaV. Erectile Dysfunction. Clinical Diabetes 2005; 23:105-13.

16. Khatibi FA, Jarrah NS, Shegem NS, Bateiha A, Abu-Ali RM, Adj louni K. Sexual Dysfunction

Among Jordanian Men with Diabetes. Saudi Medical Journal 2006; 27(3):351-6.

17. Yousef AA. Erectile Dysfunction among Diabetic Patients in Saudi Arabia. Journal of

Community Medicine 2007; 14(1):19-23.

18. Emily B, Joshy G, walter PA, Leonard K, Peters M, Korde RJ, et al. Erectile Dysfunction

Severity as a Risk Marker for Cardiovascular Disease, Hospitalization and all Cause Motility.

Open Access Peer Review Article 2013; 10:101– 7.

19. Sandro LV, Rosita C, Enzo V, Rosario D, Aldo EC. Physical Activity and Erectile Dysfunction

in Middle Aged Men. Journal of Andrology 2012; 33(2):154-61.

20. Giti O, Saeideh Z, Fazlollah A, Mahger A. Transition stages in Adjustment of wives with their

husbands with erectile dysfunction. Iran Red Creascent Med J 2014;16(3):16594

21. Edzard E. Panax Ginseng. An Overview of Clinical Evidence. J Ginseng Res 2010; 34(4): 259-

63.

22. Jang DJ, Lee MS, Shin BC. Lee YC, Ernst E Red Ginseng for treating Erectile Dysfunction. A

Systematic Review Br. J. Clin Pharmacol 2008; 66 (4):444-50.

23. Hoeger WK, Hoeger WK. Behaviour Modification in Lifetime Physical Fitness and Wellness.

Belmonth: Thompson Wadsworth 2009;10:34-60.

24. Philip EM, Capel J, Jonas S. Getting Started as a Regular Exercise In Jonas S and Philip EM

(Ed). EMS, exercise in medicine. A clinicians guide to exercise prescription. Lipincot –Williams

and Wilkins: Philadelphia. 2009; 86-98.

106

25. Hoeger WK, Hoeger SA. Introduction to Physical Fitness and Wellness. 6th edition Wadsworth:

Belmonth 2005;6: 1-22.

26. Sport Fitness Advisor. The FITT Principle of Training. Available at http:// www.sport-fitness

Advisor.com/ fit principle.html. Accessed 19th January 2014.

27. Sikiru L, Agbanusi EC, Richard CN. Effects of Aerobic Exercise in the Management of Erectile

Dysfunction. Ethiop J Health Sci 2011; 21(3): 195-201

28. Chevret – MeassonM, Lavallee E, Troy S, Arnould B Improvement in Quality of Sexual Life in

Female Partners of Men With Erectile Dysfunction Treatment with Sildenafil Citrate. J sex med

2009; 6:225.

29. Masaku E .Erectile Dysfunction in Sample of Patients attending a psychiatric out-patient Clinic.

International Journal of Impotence Research. 2009; 21:235-9.

30. Okeahalam BN. Erectile Dysfunction in Nigerian Hypertensive. African Journal of Medical

Sciences.2007; 36:221-4.

31. Truls Q, Kimberly SH, Yarnal MP, Katrina MK, Kathryn IP, Gradison M. Is there time for

Management of Patients with Chronic Diseases in Primary Care? Annals of Fam Med 2005;

3(3): 2009-14.

32. Richard S, Kevin C. How a Primary Care Clinicians Approaches Erectile Dysfunction. Current

Clinical Urology.2006; 8:77-104.

33. Babaei AR, Safarinejad MR, Kolahi AA. Penile Revascularization for Erectile Dysfunction. A

Systematic Review and Meta Analysis of Effectiveness and Complications. Urol J 2009; 6(1): 1-

7.

34. Camacho ME, Reyes-Ortiz CA. Sexual dysfunction in the Elderly: Age or Disease? Int J Impot

Research.2005;17:52-56

107

35. American psychiatric association diagnostic and statistical manual of mental disorders. Fifth

edition, Arlington VA: American psychiatric Association; 2013; 426-9.

36. Kubin M. Wagner G, Fugl-Mayer AR, Epidemiology of Erectile Dysfunction. Int J Impot Res

2003; 15(1):63-71.

37. Khalaf IM, Levinson IP. Erectile Dysfunction in the Africa/Middle East Regions. Epidemiology

and Experience with Sildenafil Citrate (viagraR). Institutional Journal of Impot Research 2003;

15(1). 51-2

38. Reuben KM, Janeth L, Muhsin A, Bejamin AK. Prevalence of erectile dysfunction and

associated factors among diabetic men attending diabetic clinic at Muhimbili National Hospital

in Dar-es-salam, Tanzania. Pan African Medical Journal 2014;17-:227

39. Peera B, meta P, sarachais. Prevalence of erectile dysfunction among treated hypertensive in

Thailand. J Med association Thai 2006; 89(5): 528-36

40. Campbell MM, stein DJ. Sexual dysfunction. A systematic review of South African research. SA

Med J 2014; 104(6): 440-513.

41. Kempt T, Reeder P. The prevalence and association of erectile dysfunction in South African

male diabetic urban population. Journal of endocrinology, metabolism and diabetes of South

Africa 2015; 20(3): 134-9.

42. Chukwunonso ECC, Kingsley CE, Chinemerem EO. Erectile Dysfunction and Hypertension

Among Adult Males in Umudike, Nigeria: A Study of Prevalence and Relationships. Asian

Journal of Scientific Research 2015; 8(3):315-323.

43. Omisanjo O, Faboya O, Babatunde A, Taiwo A, Ikuerowo S. Aleetan O.Prevalence and

Treatment Pattern of Erectile Dysfunction Amongst Men in South Western Nigeria. Internet

Journal of Sexual Medicine 2014;3(1).38-62

108

44. Jonathan L. Impotence and its Medical and Psychological Correlates, Massachusetts Male Aging

Study. Br J Diabetes and Vascular Diseases 2002; 2:278.

45. Nicolisi A, Glasser DB, Moreira ED, Villa M. Prevalence of Erectile Dysfunction and

Associated Factors among men without Concomitant Disease. A population Study. Int J Impot

Research 2003; 15(4): 253-57.

46. Garko SB, Ogunsina MO, Danbauchi SS. Sexual Dysfunction in Hypertensive Patients.

Implications for Therapy. Ann Afri Med 2005; 4(2): 46-51.

47. Billups KI, Bank AJ, Padma-Nathan H, Katz S, William R. Erectile Dysfunction as a Marker of

Cardiovascular Disease: Results of Minority health institude expert advisory Panel. J sex Med.

2005;2(1) :40-52

48. Olusegun A, Denis AN, Ernest OJ, Oluwasegun I. Assessment of the Sexual Function of Males

with Chronic Liver Disease in South Western Nigeria. Annals of African Med 2014: 13(2): 81-6

49. Omigbodun OO, Babalola O. Psychosocial Dynamics of Psychoactive Substance Mis-use among

Nigerian Adolesents. Annals of African Medicine 2004;3(3):111-5

50. Cheng JYW, Ng EML, Ko JSN,Chen RYL. Physical Activity and Erectile Dysfunction: A Meta-

analysis of Population Based Studies. 2007;19: 245-52

51. Fung MM, Beltencout R, Barret C E. Heart Disease Risk Factors Predict Erectile Dysfunction

25years later: The Rancho Bernardo Study. J AM Cardio 2004;43:1405-11

52. Mulligan T, Frick MF, Zuraw QC, Stemhagen A, Mcwhirter C. Prevalence of Hypogonadism in

Males Aged at least 45 years: the HIM study. Int J clin pract 2006;60(7):762-9.

53. Guay AT. Testosterone and Erectile Physiology- Aging Male 2006;9(4):201-6.

54. Esposito K, Giugliano D. Obesity the Metabolic Syndrome and Sexual Dysfunction. Int J Impot

Research 2005;17(5):391-98

109

55. Giugliano F, Maiorrino MI, Bellastella G, Autorino R, De Sio M, Giugliano D et al. Adherence

to Mediterranean Diet and Erectile Dysfunction in Men with Type 2 Diabetes. J Sex Med. 2010;

7(5):1911-17.

56. James EF, Culley CC. Phosphodiesterase Type 5 Inhibitors as a Treatment for Erectile

Dysfunction: Current Information and New Horizons. Arab Journal of Urology. 2013; 11(3):222-

9.

57. Espositor K, Guiglano F, Dipalo G. Effect of Lifetime changes on Erectile Dysfunction in

Obesed Men, JAMA;2004291(24):2978-84

58. Kerin TM. Erectile Dysfunction, New Engl J Med 2007; 357:2472-81

59. Jordan GH, Mc Cammon KA. Surgery of the Penis and Urethra. In Wein AJ, Kavoussi LR,

Novick AC, Partin AW, Peters CP, ed. Cambell’s Urology, 10th ed. Philadelphia PA: Elsevier

Sounders; 2012.

60. Umeh CS. Erectile Dysfunction. Proceeding of the West African College of Physicians (WACP),

Revision Course, 2012, May 15. Ibadan Nigeria.

61. Andersson KE. Mechanism of Penile Erection and Basis of Pharmacological Treatment of

Erectile Dysfunction. Int. pharmacol Journals 2011; 63(4):813-28.

62. Robert CD, Tom FL. Physiology of Penile Erection and Pathophysiology of Erectile

Dysfunction. Urol Clin North AM 2005;32(4):379.

63. Piores OM, Jimeno CA, Acampado LT. Erectile Dysfunction Among Diabetic Men at UP-OGH

Out- Patient Department: Prevalence and Risk Factors. Phil J Internet Medicine 2004; 42:197-

202

64. Benjamin DS.The First Organic Psychogenic Destruction and Related Problems in the

Classification of Erectile Dysfunction. Int J impot Res 2003; 15:72-8.

110

65. Chou PS, Chou WP, Chen MC, Lai CL, Yeh KC,Wen YC et al. Newly Diagnosed Erectile

dysfunction and Risk of Depression. A population Based five year follow up study in Taiwan. J

Sex Med 2015;12(3):804-12.

66. Nnamdi JO, Ifeoma EO. Counseling Against Sexual Dysfunction in Nigerian Men. Ansu Journal

of Integrated Knowledge 2014;3(1)2315-5857

67. Yang CC, Michael PP, David FP. Comparison of the International Index of Erectile Function,

Domain Scores and Nuctural Penile Tumescence and Rigidity Measurement. Does One Predict

the other? Bju Int 2006; 98 (1): 105 – 9.

68. Unadike BC, Eregie A, Ohwovoriole AE. Prevalence and Types of Sexual Dysfunctions Among

Males with Diabetes in Nigeria. African Journal of Diabetes Medicine 2008;18-20.

69. Gaurang RS, Manoj kumar VC, Suresh BP, Shrikant VP, Vilas PS, Navneet AS. Evaluation of a

multi herb supplements for Erectile Dysfunction: A randomized double blind placebo controlled

study. BMC complementary and alternative med 2012:12:155

70. Shanloul R. Natural Aphrodisiac: J Sex Med 2010;7:39-49.

71. Thuryan P, Gopala-Krishanan G. Erectile Dysfunction. Clin Evid. 2006; 15(57):1227-51.

72. De Andrade E, De Mesquita AA, Claro JA, de Andrade PM, Ortiz V, Paranhos M et al. Study of

the Efficacy of Korean Red Ginseng in the Treatment of erectile dysfunction. Asian J Androl

2007;9(2): 241-44.

73. Sung HH, Chae MR, So I, Jeon JH, Park JK, Lee SW. Effects of Ginsenocids on Large

Conductance K(ca) Channels on Human Corporal Smooth Muscle Cells. Int J Impot Res 2011;

23(5):193-9

74. Peak ky, Park JK, Youn NY. Effects of Tissue Cultured Mountain Ginseng (Panax Ginseng CA

Meyer) Extracts on Male Patients with ED. Asian J androl 2009;11:356-61.

111

75. Erectile Dysfunction Guidelines Panel. The Management of Erectile Dysfunction. An Update

Baltimore, MD. American Urology Association, Education And Research2005.http://www.ngc.

gov/summary.aspx?doc1d=10018&amp.jnbr=00532&AMP;string=erectile+AND+dysfunction.

Assessed August 13 2015

76. Bocchio M, Scarpeli P, Necozoiner OS, Pelticcione F,Spartera C, Francavilla F et al. Penile

Duplex Pharmaco Ultrasonography of Cavernous Arteries in Men with Erectile Dysfunction and

Generalized Atherosclerosis. International Journal of Andrology. 2006; 29(4): 496-501

77. Okoli RI, Aigbo O. Ohaju O, Mensah JK. Medicinal Herbs Use for Managing Common

Ailments Among Esan People of Edo State,Nigeria. Pakistan Journal OF Nutri 2007; 6:490-496

78. Rosen RC, Jackson G, Kostis JB. Erectile dysfunction and cardiac Disease: Recommendation of

the Second Princeton Conference. Curr Urol Rep 2006;7(6):490-6.

79. Jenny HY, Lawrence SB, Penile Embryology and Anatomy. Science world Journal.

2010;10:1174-1179

80. Montague DK, Jarow JP, Broderick GA lue TF, Imochowski RR, Henton JP et al. The

Management of Erectile Dysfunction, an AUA update.2005 J. Urol;174(1): 230-9.

81. Anderson KE, Mechanism of Penile Erection and Basis for Pharmacological Treatment of

Erectile Dysfunction. Pharmacological Reviews 2011; 63(4):811-59.

82. Corona G, Isidori AM, Buvat J, Aversa A, Rastrelli G, Hackett G et al. Testosterone

Supplementation and Sexual Function: A Meta Analysis Study. J Sex Med 2014;11(6):1577-92.

83. Aversa A, Francomano D, Lenzi A. Does Testosterone Supplementation Increase PDE5-

inhibitors Responses in Difficult to Treat Erectile Dysfunction Patients? Expert opin

Pharmacotherapy 2015;16(5):625-8

84. Peak ky, Park JK, Youn NY. Effects of Tissue Cultured Mountain Ginseng (Panax Ginseng CA

Meyer) Extracts on Male Patients with ED. Asian J androl 2009;11:356-61.

112

85. Kalaizidou I, Venetikou MS, Konstadinidis K, Artemiadis AK, Chrousos G, Darviri C. Stress

Management and Erectile Dysfunction. A Pilot Comparative Study. Andrologia 2014; 46(6)698-

702

86. Lin CS, Ho HC, Chen KC, Lin G, Nunes L, Lue TF. Intra Cavernosal Injection of Vascular

Endotheleal Growth Factor Induces Nitric Oxide Synthatase 150 Forms. BJU Int

2002;89(9):955-60.

87. Williams G, Abbou CC, Amar ET, Desvaux P, Flam TA, Lycklama A et al. Efficacy and Safety

of Transurethral Alprostidil Therapy in Men with Erectile Dysfunction. The MUSE Study

Group. Br J urol 1998;81(6):889-94.

88. Burchardt M, Burchardt T. Anastasiadis AG, Buttyan R, De la ta A, ShabsighA et al. Application

of Angiogenic Growth Factors for Therapy of Erectile Dysfunction: Protein and DNA Transfer

of VEGF 65 Into the Penis. J Urology 2005;66(3):665-70.

89. Mulhall JP, Ahmed A, Branch J, Parker M. Sereal Assessment of Efficacy and Satisfaction

Profile Following Penile Prosthesis Surgery. J urology 2003;169(4):1429-33.

90. Glina S, Sharlip ID, Hellstrom WS. Modifying Risk Factors to Prevent and Treat Erectile

Dysfunction. J Sex Med 2013;10(1):115-9.

91. Aksam AY,Joanne EN, Farid S Yousef A, Dany-Jan y, Yousef ED. Is There a Relationship

Between the Severity of Erectile Dysfunction and Comorbidity Profile in Men with Late Onset

Hypoganadism. Arab Journal of Urology 2015;13(3):162-8.

92. La Vignera S, Condorelli R, Vicari E, D’Agata R, CalogEro AE. Physical Activity and Erectile

Dysfunction in Middle Aged Men. J Androl 2012;33(2):154-61.

93. Bacon CG, Mittleman MA, Kawachi I, Giovannucci E, Giovannucci E, Glasser DB, Rimmo E B.

A Prospective Study of Risk Factors for Erectile Dysfunction. J of Urology 2006;176:217-21.

113

94. Lim SS, Vos J, Flaxman AD, Daei G, Shibuya K, Adair-Rohani KG et al. A Comparative Risk

Assessment of Burden of Disease and Injury Attributable to 67 Risk Factors and Risk Factor

Clusters in 21 Regions, Miao-2010 in systematic analysis for the global burden of disease study

2010. Lancet 2012;380:2224-2260

95. Olufemi OO, Olatunde O, Kolawole SO, Akolade OI. Physical Activity Among Type II

Diabetic Adults in Nigerians. Annals of African Medicine 2014;13(4):189-194.

96. Hallal PC, Anderson LB, Bull FC, Guthold R, Haskel W, Ekelund U .Global Physical Activity

Levels: Surveillance Progress, Pitfalls and Prospects. Lancet 2012;380: 247-257.

97. Abubakari AR, Bhopal RS. Systematic Review on the Prevalence of Diabetes, Overweight/

Obesity and Physical inactivity in Ghanaians and Nigerians. Public Health 2008;122:173-182

98. Maio G, Saraed S, Marchiori A. Physical Activity and PDES Inhibitory in the Treatment of

Erectile Dysfunction. Result of a Randomized Controlled study. J Sex Med 2010;7(6): 2201-08

99. Kullo JJ, Khaleghi M, Hensrud DD. Markers of Inflamation are Inversely Associated With VO2

Max in Symptomatic Men. Journal of Applied Physiology 2007;102:1374-79.

100. Lamina S, Okoye CG, Dagogo TT. Therapeutic Effect of an Interval exchange Training Program

in the Management of Erectile Dysfunction in Hypertensive Patients. Journal of Clinical

Hypertension 2009;11(3):125-129.

101. Jane –lovena EO, Okoronkwo IL, Ogowonaya NP. Complementary and alternative medIcine use

among adults in Enugu Nigeria. BMC complementary and alternative med 2011;11:19

102. Singh V, Raidoo DM, Harries CS. The prevalence pattern of usage and peoples attitude towards

complementary and alternative medicine among the CAM Indian community in Chartsworred,

South Africa. Biomed central, Complementary and Alternatuve medicine 2004;4:3.

103. Humpel N, Jones SC. Gaining insight into the what, why and where of complementary and

alternative medicine use by cancer patients and survivors. Euro J cancer care 2006;15(4):362-8.

114

104. Tamler R, Mechanick JI. Dietary supplements and nentroceuticals in the management of

andrologcologic disorder. Endocrinol metab clin north AM 2007;36(2): 533-52.

105. Ernst E, Posadzki P, Lee MS. Complementary and Alternative Medicine (CAM) for Sexual

Dysfunction and Erectile Dysfunction in Older Men and Women: an Over view of Systematic

Reviews. Maturitas. 2011;70(1):37-41.

106. Hurdaq C, Ozkara A, Citci S, Uyaney I, Damirci C. The Effects of Alpha Lipoic Acid on Nitric

oxide Synthetase Dispersion in Penile Function in Steptozotocin induced Diabetic Rats.

International Journal of Tissue Reaction 2005;27(3)145-150.

107. Oshikoya KA, Senbanjo IO, Njokanma OF, Soipe A, Use of Complemetary ans Alternatine

medicine for Children with Chronic Health Condition in Lagos, Nigeria. BMC CAM.2008; 8:66.

108. Yucel S, Baskin LS. Identification of Communicating Branches Among the Dorsal, Perineal and

Cavernous Nerves of the Penis. J urol 2003;170(1):153-8.

109. David k, Traci P. Panax Ginseng AM FAM Physican.2003; 15. 68(8): 1539-42.

110. Afolayan AJ, Sunmonu TO. In vivo Studies on Anti Diabetic Patients use in South Africa Herbal

Med. J Clin Biochem Nutri 2010;47:98-106.

111. Folodun A. Herbal Medicine African Distribution, Standardization and Prospects. Research

Journal of Phyto Chemistry 2010;4:154-61

112. Ezeome ER, Anarado AN. Use of complementary and alternative medicine by Cancer Patients

at University of Nigeria Teaching Hospital Enugu, Nigeria. BMC CAM 2007;7:28.

113. Constable S, Ham A, Pir Mohammed M. Herbal Medicine and Acute Medical Emergency

Admissions to Hospital. Br J Clin Pharmacol 2007; 63:247-8.

114. King AR, Flint SR, Russett FS, Generali JA, Gruer DW. Evaluation and Implications of Natural

Product use in Pre-operative Patients. A Retrospective Review. BMC Complementary and

Alternative Medicine 2009;9:38

115

115. Collins D, Oakey S, Ramakrishnan V. Peri-operative Use of Herbal Complementary and Over

the Counter Medicine in Plastic Surgery Patients. Eplasty 2011;11:e27

116. Jane DJ, Leem S, Shim BC, LeeYC, Einst E. Red Ginseng For Treating Erectile Dysfunction; A

Systematic Review Br J Clin Pharmacol 2008;66(4)444-50

117. Kim SD, Kim JY, Huh JS, Kim SY, Sohn DW. Improvement of Erectile Function by Korean

Red Ginseng (panax ginseng) in Male Rat Model of Metabolic Syndrome. Asian J Androl

2013;15:395-99

118. Collins D, Oakey S, Ramakrishnan V. Peri-operative Use of Herbal Complementary and Over

the Counter Medicine in Plastic Surgery Patients. Eplasty 2011;11:e27

119. Shim M, Lee YJ. Ginseng as a Complementary and Alternative Medicine for Post-Menopausal

Symptoms. J Ginseng Res. 2009; 33:89-92.

120. Kim HS,Woo SH, Jo S, Hahne J, Youn NY, Lee HL, Double Blind Placebo Controlled Multi

Center Study for the Therapeutic Effect of Mountain Panax Ginseng: A Mayer Extracts in men

with erectile dysfunction: a preliminary report.Korean J Androl. 2006; 24(2): 84-8

121. Dey L, Xie JT, Wang A, Wu J, Maleckar SA, Yuan CS. Anti hyperglycemic Effects on Ginseng.

Comparison Between Root and Berry Phyto-medicine 2003;10(6-7):600-5.

122. Ker WL, Alice STW. Ginseng and Male Reproductive Function Asia J Androl 2013; 3 (3)

E26391

123. Yucel S, Baskin LS. Identification of Communicating Branches Among the Dorsal, Perineal and

Cavernous Nerves of the Penis. J urol 2003;170(1):153-8.

124. Ham WS, Kim WT, Lee JS, Ju HJ, Kang SJ. Efficacy and Safety of Red Ginseng Extract Powder

in Patients with Erectile Dysfunction: Multi Center, Randomized, Double-Blind, Placebo-

controlled study). Korean J Urol 2009; 50:159-64.

116

125. Aksam AY,Joanne EN, Farid S Yousef A, Dany-Jan y, Yousef ED. Is There a Relationship

Between the Severity of Erectile Dysfunction and Comorbidity Profile in Men with Late Onset

Hypoganadism. Arab Journal of Urology 2015;13(3):162-8.

126. Nam – HL, Ray S, Hyeong GK, Jung HC, Chang GS. Safety Profile of Panax Ginseng Root

Extracts. A Randomized Controlled Trial in Healthy Korean Volunteers. J CAM Alt Med 2012;

18(11): 1061 – 69.

127. Hyong GK, Jung HC, Sa RY, Jin SL, Jong MH, Yo CA et al. Adverse Effects of Panax Ginseng.

CA Meyer. A Randomized Controlled Double Blinded Trial PLOS one 2013; 8 (4): 61271.

128. Young SK, Jung YW, Chang KH, Moo C. Safety Analysis of Panax Ginseng in a Randomized

Controlled Trial. A Systematic Review. Medicines 2015; 2: 106 – 26.

129. Fakeye TO, Tijani A, Adebisi O. A Survey on Use of Herbs among Patient Attending

Secondarylevel of Health Care Facilities in South Western Nigeria. J Herb Pharmacotherapy

2007;7(3-4): 213-27.

130. Plateau State Government Website [web page].[ Accessed on: September 10,2015].Available

from www.plateau State gorvnment.org/visit.htm.

131. Charab J, Biswas T. How to calculate sample size for different study designs in medical research.

Indian J psychol Med.2013; 35(2):121-6

APPENDIX I

JOS UNIVERSITY TEACHING HOSPITAL

JOS, NIGERIA

117

Phone: 073-450226-9 Cables & Telegram: JUTH

e-mail: juth@infoweb.abs.net P.M.2076

JUTH/DCS/ADM/127/XIX/5865

Dr. Bakzak Isaac Bulus,

Department of Family Medicine,

Jos University Teaching Hospital,

Jos-Nigeria.

RE: ETHICAL CLEARANCE/APPROVAL

I am directed to refer to your application dated 2nd December, 2013 on the research proposal

teed:

“A Comprison of a Combination of Physical Exercise and Placebo with Physical Exercise

and Ginseng in the Treatment of Erectile Dysfunction in Adult Black Men” and your

appearance before the Ethical Committee on 6th December, 2013.

Following recommendation from the Institutional Health Research Ethical Committee, I am to

inform you that Management has given approval for you to proceed on your research topic as

indicated.

You are however required to obtain a separate approval for use of patients and facilities from the

department(s) you intend to use for your research.

The Principal Investigator is required to send a progress report to the Ethical Committee at the

ration of three (3) months after ethical clearance to enable the Committee carry its oversight

function.

Submission of final research work should be made to the Institutional Health Research Ethical

committee through the Secretary in Room 2 Administration Department, please.

On behalf of the Management of this Hospital, I wish you a successful research outing.

20m January, 2014.

Ref: ………………………………… Date:………….…………….………

118

119

120

APPENDIX IV

CONSENT FORM (ENGLISH)

I Dr. Bakzak Isaac Bulus a senior registrar of the Department of Family Medicine Jos

University Teaching Hospital, Jos.

I want to carry out a proposal on the topic A comparison of a combination of physical

exercise and placebo with physical exercise and Ginseng in the treatment of erectile

dysfunction in adult married men in Jos University Teaching Hospital, Jos.

To compare the effectiveness of the combination of physical exercise and ginseng and

comparing it with the effectiveness of physical exercise alone in the treatment of erectile

dysfunction amongst married men attending GODP and urology clinic in JUTH Jos.

This study will involve asking you question to fill in my questionnaire. It will also

involve physical examination and laboratory samples for various investigations related to

the study. you are free to participate in this study but if you decide not to, this study will

in no way affect the outcome of your treatment. All information filled in the

questionnaire will be kept strictly confidential and your identity will not be disclosed.

If you accept to participate in the study, kindly sign in the space below.

I, (initials) …………………………………….have asked questions regarding this

research and have been satisfactorily answered. I therefore wish to participate in the

research.

Thank you.

Signature of the Patient or Parent or Guardian/Date ………………………………….

Signature of witness/Date ……………………………………………………………..

Signature of investigator/Date …………………………………………………………

121

APPENDIX V

CONSENT FORM (HAUSA)

Ni Likita Isaac Bulus,Bakzak, ni likita ne a bangare na Family Medicine a Jos University

Teaching Hospital Jos

Ina son in hada magunguna kashi biyu saboda in gan wane magani da ya fi aiki a kan tashiwan

gaban maza. Ina so in hada mwosa jiki da wadansu magunguna guda biyu in gani ko wacece tafi

aiki a kan karfin tashiwan gaban na miji a JUTH na JOS.

Wannan gwajin zata kumshi cikan wadansu tagarda, a duba jikin ku gaba daya da kuma wadansu

gwaje gwaje a duba lafiyan ku. Zaka iya ka shiga cikin gwajin, amma in baka so ba, ba bu tilas a

ciki, kuma ba zata hana kula da kai ba. Duk abinda muka yi da kai ba mai ji ko ya sani.

In ka yarda, sai ka sa hanu a nan.

Ni ___________, na yi tambayoyi kuma an bani amsa da ta gamshe ni. Na kuma yarda in shiga

cikin gwajin.

Na gode.

Sa hanu da ranan sa hanu______________________________

Sa hanu shaida da ranar sa hanu____________________________

Sa hanun mai gwajin_____________________________

122

APPENDIX VI

QUESTIONNAIRE ON SOCIO- DEMOGRAPHIC CHARACTERISTICS (ENGLISH)

Identification No:………………………………

Date ……………………………

Hospital No:………………………………….Group……………………………

Date ………………………………………….. Phone Number:………………....

Socio- Demographic Date

1. Name (Initial)

2. Age:……………………….(at last birthday)

3. Sex male [ ] Female [ ]

4. Tribe:………………………………

5. Religion : Christianity [ ]

Islam [ ]

Traditional [ ]

Others (specify)…………………………………………………………

6. Contact address:……………………………………………………………………..…

………………………………………………………………………………………….

7. Educational Level:

None [ ]

Primary [ ]

Secondary [ ]

Tertiary [ ]

123

8. Marital Status Married [ ]

Single [ ]

Others (specify) [ ]

9. Occupation Employed [ ]

Government [ ]

Self employed [ ]

House wife [ ]

Student [ ]

Retire [ ]

Other (specify) [ ]

HISTORY OF SICKNESS

Do you have difficulties initiating ormaintaining erections Yes [ ] No [ ]

When did it you start? Below 3months [ ] 3months andabove[ ]

Is it getting worst Yes[ ] No [ ]

Onset of sexual intercourse ……………………………….

Are you on any treatment? Yes [ ] No[ ]

If yes which Medications are you on …………………………….

MEDICAL SOCIAL HISTORY

Hypertension [ ]

Diabetes mellitus [ ]

Heart diseases [ ]

Smoking [ ]

Alcohol [ ]

Substance abuse [ ]

Drugs [ ]

PHYSICAL EXAMINATION

124

a Weight…………………………

b Height ……………………………

c. Blood pressure………………….

d. Body Mass index (BMI)…………………

e. Genitals………………………………….

LABORATORY TEST RESULTS (baseline and fourth month)

a. Urinalysis……………………………..

b. Fasting blood glucose………………….

c. Lipid profile…………………………...

d. ECG…………………………………..

e. Testicular USS………………………...

APPENDIX VII

125

QUESTIONNAIRE ON SOCIO – DEMOGRAPHIC CHARACTERISTICS

(HAUSA)

Lamba: ……………………… Rana: ………………………….

Lamban Asibiti:……………... Sashi:…………………………

Rana:………………………… Lamban waya:…………………

Socio – Demographic Date

1. Suna

2. Shekaru:…………………….(a karshen haifuwa)

3. Na miji [ ] Mace [ ]

4. Yare:……………………………..

5. Adini: Christa [ ]

Musulunci [ ]

Gargajiya [ ]

Sauransu ……………………………

6. Adreshi

……………………………………………………………………………..……………………..

7. Makarantu:

Babu [ ]

Primary: [ ]

Secondiri [ ]

Makarantan gaba [ ]

8. Kana da aure? Ma-auraci [ ]

126

Ba aure [ ]

Sauran [ ]

9. Sana’ a:

Aikin Gobnati [ ]

Aikin Kanka [ ]

mace mai zaman aure [ ]

Dan makaranta [ ]

Mai ritaya [ ]

Da sauran su [ ]

TARIHIN CHIWO

Akwai damuwan tashiwan gaban ka? akwai [ ] babu [ ]

Yaushe ya fara? Kasa da wata uku [ ] sama da wata uku [ ]

Yana karuwa? Ai [ ] a’a [ ]

Yaushe ne ka soma jima’i……………………………...

Kana kan magani? …………………………………….

In haka ne, wace magani……………………………….

TARIHIN JIKI

Akwai hawan jinni? [ ]

Akwai ciwon shuga? [ ]

Akwai ciwon zuciya? [ ]

Kana shan taba? [ ]

Kana shan kwaya? [ ]

127

Sauran magunguna fa [ ]

GWAJIN JIKI GABA DAYA

a. Nauyi ka………………………………………..

b. Tsayi ka ………………………………………..

c. Hawan jinni …………………………………

d. Tsayi da nauyi (BMI)…………………….

e. Gaban ka ……………………………………..

GWAJE GWAJE (na fari da karshe)

a. Gwajin fisari ……………………………………….

b. Gwajin shuga ………………………………………..

c. Gwajin kitse ………………………………………..

d. Gwajin aikin zuciya ………………………………..

e. Gwaji (duban gwaiwa)……………………………..

APPENDIX VIII

128

EXERCISE PRESCRIPTION AND ADHERENCE

TO MEDICATION FORM DAYS EXERCISE DRUGS SIGNATURE DAYS EXERCISE DRUGS SIGNATURE

Day1 Day1

Day2 Day2

Day3 Day3

Day4 Day4

Day5 Day5

Day6 Day6

Day7 Day7

Day8 Day8

Day9 Day9

Day10 Day10

Day11 Day11

Day12 Day12

Day13 Day13

Day14 Day14

Day15 Day15

Day16 Day16

Day17 Day17

Day18 Day18

Day19 Day19

Day20 Day20

Day21 Day21

Day22 Day22

Day23 Day23

Day24 Day24

Day25 Day25

Day26 Day26

Day27 Day27

Day28 Day28

Day29 Day29

Day30 Day30

Day31 Day31

MEDICATION SIDE EFFECTS……………………………………………..

APPENDIX IX

FILE NO: SPOUSE PRESENTATION QUESTIONNAIRE

129

NAME AGE GROUP SPOUSE NAME

DATE VISIT YES NO

SPOUSE TEL________________________

APPENDIX X

PATIENT ENCOUNTER FORM

130

Name, Age, Group, File no.

Primary complain Yes No

Secondary complain Yes No

131

APPENDIX XI

IIEF QUESTIONNAIRE (ENGLISH)

Hospital No………………………..

Date of Birth………………………… Age……………

Address…………………………………………………..

Tel. No……………………………………………………

The International Index of Erectile Function (IIEF-5) Questionnaire for Health Care

Providers

IIEF-5 scoring:

The IIEF-5 score is the sum of the ordinal responses to the 5 items.

22-25: No erectile dysfunction

17-21: Mild erectile dysfunction

12-16: Mild to moderate erectile dysfunction

8-11: Moderate erectile dysfunction

5-7: Severe erectile dysfunction

The international index of erectile function IIEF (Gold standard in the assessment of severity and

treatment related responses in erectile dysfunction) will be used to measure outcome in both

groups before and after treatment. A score will be awarded before (to measure severity) and after

(to measure improvement) in erectile dysfunction.

132

It is a veritable tool because of its wide adoption, strong psychometric properties, highly

sensitive and specific, highly predictive of patient’s ability to achieve satisfactory intercourse

and focus mainly on erectile dysfunction.

Its limitations are that, it focuses only on current sexual functioning, no information on partner

relationship or sexual functioning, it does not identify the course of erectile dysfunction.

The IIEF – 5 Questionnaires (SHIM)

133

Please encircle the response that best describes you for the following five questions:

Over the past 6 months:

1. How do you rate Very low Low Moderate High Very high

your confidence

that you could get

and keep an erection? 1 2 3 4 5

2. When you had Almost never A few Sometimes Most times Almost Always

Erections with or never times or always

sexual stimulation,

how often were your

erections hard enough (much less (about (much

for penetration? than half half the more than

the time) time) half the time)

1 2 3 4 5

3. During sexual Almost never A few Sometimes Most Almost always

Intercourses, how or never times times or always

Often were you (much less (about half (much

Able to maintain than half the time) more than

Your erection after time) half the

You had penetrated time)

Your partner?

1 2 3 4 5

134

4. During sexual Extremely Very Difficult Slightly Not difficult

Intercourses, how difficult difficult difficult

difficult was it to

maintain your

erection to completion

of intercourse?

1 2 3 4 5

5. When you Almost never A few Sometimes Most times Almost always

attempted or never times or always

sexual intercourse

how often was it (much less (about half (much more

satisfactory for than half the time) than half

you? the time) the time)

1 2 3 4 5

Total Score: ________________________

1-7: Severed ED 8-11: Moderate ED 12-16: Mild-Moderate ED 17-21: Mild ED 22-25:

No ED

APPENDIX XII

IIEF QUESTIONNAIRE (HAUSA)

Lamban Asibiti: ……………………………

Ranan Haifuwa:…………………………. Shekaru:…………………

135

Adereshi: …………………………………………………………..

Lamban Waya:………………………………….

The international index of Erectile function (IIEF - 5) questionnaire for Health Care

Provides

IIEF-5 scoring:

The IIEF-5 score is the ordinal responses to the 5 items

22-25: No erectile dysfunction

17-21: Mild erectile dysfunction

12-16: Mild to moderate erectile dysfunction

8-11: Moderate erectile dysfunction

5-7: Severe erectile dysfunction

The international index of erectile function IIEF (Gold standard in the assessment of severity and

treatment related responses in erectile dysfunction) will be used to measure outcome in both

groups before and after treatment. A score will be awarded before (to measure severity) and after

(to measure improvement) in erectile dysfunction.

The IIEF – 5 Questionnaires (SHIM)

Ka zana amsa da ta dace da kai a cikin tamboyi nan guda biyar.

Ka zana amsa da ta dace da kai a cikin tamboyoyi nan guda biyar.

A CIKIN WATA SHIDA DA TA WUCE:

1. Ya ya kake babu karfi ko kadan.. babu karfi.. dadan karfi kadan.. da karfi..da karfi sosai

ganin karfin

tashiwar gaban

ka har ka riketa? 1 2 3 4 5

2. In gabarka ta tashi babu ko kadan dan kadan lokaci kada lokaci son da dama kowace

bayan ka ji ka hadu daba ta kai rabin kamar rahin data fi rahin lokaci

dana mace son nawa lokaci ba. lokaci lokaci

yak e karfi da zai shege

136

2 In gabarka ta tashi Babu ko kadan Dan kadan Kadan lokaci Son da dama kowace

bayan ka ji ka yi jima’i, lokaci da ba ta kamar rabin data fi rabin lokaci

yaya karfin kai rabin lokaci lokace

da zai shige lokaci ba

ta

1 2 3 4 5

3. A lokacin jima’i babu ko dan kadan Kaman son kowane

son nawa kake kadan lokacin da rabin da dama lokaci

iya rike tashin bai kai rabin lokaci da ya fi

gabanka bayan ba rabin

ka shiga matarka? Lokaci

1 2 3 4 5

4. A lokacin jima’i da wuya sosai da wuya dawuya da wuya kadan babu wuya

Ya ya wahalar sosai sosai

rike gabanka a

cikin matarka

har ka gama?

1 2 3 4 5

126

5. In kayi jima’i babu ko wata rana wani yawan cin kowace

da matarka, kadan da ba ta lokaci lokaci da lokaci

kana jin dadin kai rabin kamar ta fi rabin

har ta ishe ka? lokacin ba rabin lokaci

lokaci

1 2 3 4 5

137

Total score; _________________________________1 –7 Severed ED 8- 11: Moderate ED 12-

16: Mild- Moderate ED 17- 21: Mild ED 22- 25: No ED

138

Appendix XIII

FOLLOW UP QUESTIONAIRE

Physical Finding

Laboratory Finding Drugs

First Follow Up

Second Follow Up

Third Follow Up

Fourth Follow Up

Fifth Follow Up

IIEF