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ETHICAL ISSUES IN TRADITIONAL MEDICINE

By

R.H.MUCHTAN SUJATNO

BIOETHICS AND HUMANITIES UNIT FKUP/RSHS

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INTRODUCTIONOf the 40.000 species of tropical plants in the world, only an estemated 30.000 grow in Indonesia. Some 7000 cultivated species have been identified. Closed 1000 of these are commonly used in the preparation

Of Indonesia’s traditional medicine, although only 286 plants have been registered in the Materia Medica at the Department of Health.

The use of herbs in a curative or health giving capacity is as old as Javanese civilization itself.

Indonesians believe herbal medicine originated in the ancient palaces of Surakarta (Solo) and Yogyakarta in Central Java.

The culture of the courts also developed as a result of various exotic influences --- Chinese, Indian and Arab --- and these influences are reflected in their herbal medicine.

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EARLY EVIDENCEExpert agree the use of plants for medicinal purpose in Indonesia dates from pre-historic times. The theory is substantiated by the impressive collection of Neolithic stone implements in Jakarta’ museum

Further proof can be found in stone reliefs depicting the human life cycle at the famous Borobudur temple dating from AD 800-900.

In these carving the kalpataruh leaf (from the mythological tree that never dies) and other ingredients are being pounded to make mixtures for women’s health and beauty care

At the end of the first millenium, the influnce of Javanese culture began to spread to the neighbouring island of Bali, whose people had already absorbed influences from as far away as India.

Following the adoption of Islam and subsequent breakup of the Majapahit empire in the late 15 th century, many Javanese fled to Bali, taking their books, culture and custom.

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JAMU IN DAILY LIFESo, what exactly jamu as a traditional medicine of Indonesia ?. The traditional medicine is a substance (mixe or single) derived from plants, animal or mineral which are still unkown the active substances, never ….

been clinical studied and have been used by empirical until now.Can we say that jamu is Indonesian Herbal medicine ? I think: yes.

The Philosophy behind The HealingTo the outsider, Indonesian herbal medicine appears to be an extremely

complex form of healing, combining spiritual, religious, mystical, magical and herbal elements.

Mooryati S: Indonesian who believe in God and his powers understand the mythology of jamu in people’s live. According to ecological concepts, nature is meant to prolong life, and life depends on how people use their senses and instincts. Instincts teach us that if there is darkness there must be light, if ther is disease there must be a cure, if there is poison there must be an antidote.

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HOLISTIC APPROACHjamu is a holistic therapy. The concept of harmony -- balance between a person and their environment, or the balance between the hot and cold

elemnts in the body --> meant that both ilness and medicine are divided

Into hot and cold categories.Who Uses Jamu ?Practically every Javanese woman and many Javanese man use jamu on a reguler

basis.Is jamu safe to use?.Not alwaysJamu developes to FitofarmakaWhat is Fitofarmaka ?Fito farmaka is a medicine have been clinical studied and have kown some active

substances.Ethically the doctor(s) use: FitofarmakaBecause: a. have been clinical studied, this study as responsible to treat the

patient.and b. you know well the farmacology of the medicine.

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Research: Non Pre-clinical research and Clinical researchNon/Preclinical trial: Pharmacology, Toxicology, Pharmakokinetics

PHARMACOLOGY

• Information: studies species, type and number of the experimental animals, Dosage units, dosage intervals, thje administration method, duration of administration, informtion of systemic distribution.

• The follow up• Side effect, toxicity• The procedure of study is must be completely: samples, method,

animal usage, dosage, administration, etc.• Until now there is no committee ethics for animal here in Bandung.

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The condition for clinical study: Have done the preclinical trial.Two conditions preclinical trial: 1. Toxicology study and 2. Pharmacodynamic study. (or safety and efficacy)

• Toxicological test: Acute i.e: LD50 Chronic

• Pharmacodynamic study: Efek of traditional medicine in human being

• If pass the test and than continued the trial by clinical trial• For the ethical clearance, especially in traditional medicine, you have a

sertificate of pre clinical trial.• In the clinic: the study for traditional medicine is the same with the

konventional medicine.

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ORGANIZING COMMITTEE- Medical committee- Research Ethics Committee: protect rights, safety and welfare of all clinical trial subjects. Spec attention: vulnerable subjects.

• The function of REC Clinical trial Ethical clearance Independent

To correct the proposalTo evalutae the procedure of clinical trial.Give the ethical clearance

- Some Departments at RSHS- SP3T FKUP/RSHS: The government has announced that clinical trials maybe

carried out at: Sentra P3T

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SP3T ( the Research Center for The Development and Application Traditional Treatment). The authority to legally authenticate any claims proven during official test.

• SP3T have conducted a number of preliminary clinical trials on selected remedies:

1. Allium sativum: hypertension2. Graptophyllum pictum= handeleum). = hemorrhoid3. Psidium guajava = jambu biji = diare4. Curcuma xanthorrhiza = temu lawak = chronic hepatitis

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Principles of Research of Ethics there is 4 categories:1. Respect for persons (menghormati org) 2. Beneficence ( manfaat) 3. Non- maleficence ( tak membahayakan subjek) 4. Justice (keadilan).

• Risk of study; - Physical risk - Psychological risk - Social riskThis principles and risk not only for Traditional medicine but also for

konvensional medicine.Member of REC:- At least consist of 5 members- Minimum 1 member has major interest in non scientific area.- Minimum 1 member is independent from the institution conducting clinical

trial.Composition: A number of members collectively having qualification and

experience to asses the scientific , medical and ethical aspect of clinical trial.

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References:1. Susan- Jane Beers2001: Jamu.The Ancient indonesian art of herbal Healing.2. Pusat Studi Biomedis dan Reproduksi Manusia BKKBN.1999. ETIKA PENELITIAN. Biomedis dan Reproduksi Manusia. 3. Komite Etik Penelitian FKUP/RSHS