Observations on 73 Vaccine breakthrough COVID-19 infected ...

International Journal of High Dilution Research 2022; 21(cf):04-17

Available online at www.highdilution.org

Cite as: Int J High Dilution Res. 2022; 21(CF): 04-17 4 https://doi.org/10.51910/ijhdr.v21icf.1127

Original article

Observations on 73 Vaccine breakthrough COVID-19 infected patients and their individualized homeopathic treatment

Gyandas G. Wadhwani *1; Aditi Chadha 2

Homoeopathic Physician & Independent Researcher. Holistic Homoeopathic Clinic & Research Center. M-10®, LGF, Lajpat Nagar II, New Delhi – 110024, India. Former Chief Medical Officer (NFSG) (H), Directorate of AYUSH (Homoeopathic wing), Government of National Capital Territory of Delhi, India. Member of Aude Sapere groups, South Africa and Delhi. Editorial Board member: American Journal of Homeopathic Medicine

* [email protected] - https://orcid.org/0000-0003-1932-645X

Abstract

Background: Since the initiation of vaccine rollout, breakthrough COVID-19 infections have been reported. While conventional therapy is the accepted mode of treatment, there has been little recognition of the role played by complementary therapies like homeopathy. The purposes of this study were to observe retrospectively the clinical-symptomatic profile of the vaccine breakthrough COVID-19 infections and their individualized homoeopathic treatment. Methods: Observations on the data of patients treated with homeopathic medicines who confirmed the breakthrough infection criteria, positive infection ≥14 days after completion of both the recommended doses of an authorized COVID-19 vaccine, were conducted. IBM SPSS Statistics 21.0 was used for descriptive data analysis. WHO Clinical Progression Scale and Outcome about Impact on Daily Living score were used to understand the results of treatment. Results: Out of the 1397 Covid-19 positive patients, a total of 73 cases were identified as vaccine breakthrough infections. The median recovery time reported in the data set was 9 ± 2 days. While 5 patients dropped out, 68 (93.15%) patients responded positively to homeopathic treatment, and 55 (75.34%) recovered completely with normalized serological markers/ nasal swabs/ HRCT Chest. About 29 (39.72%) of these presented with mild clinical manifestations, 26 (35.61%) moderate, 17 (23.28%) severe and 1 (1.36%) was critical. 10 homeopathic remedies were prescribed to these 73 patients. Majority of the patients attained an ORIDL score of 4. Maximum patients reported a WHO clinical Progression score of 3. Conclusion: This report compiles a clinical-symptomatic profile of vaccine breakthrough patients, which occurs in a fraction of vaccinated people, their anamnesis and response to individualized homeopathic treatment. Further exploratory research studies and comparative clinical trials may be encouraged. Keywords: Vaccine Breakthrough COVID-19 infection, Clinical-symptomatic profile, Homeopathy, Anamnesis, Individualized homeopathic treatment.

Introduction

Archiving and circulation of the scientific evidence are critical elements serving as an effective response to the pandemic. Following the global outbreak of COVID-19, results of diverse clinical experiences and research conducted on the polymorphism of this disease have been published. The uncertain disease course of COVID-19 is due to its manifestation as a complex multisystemic disorder which created a challenge for clinical researchers while identify beneficial investigations and interventions. The pandemic has so far resulted in 450,007,993 cases to date and 6,036,366 deaths worldwide [1]. Among the SARS-CoV-2 strains which were identified globally in 2020, the D614G variant was dominant [2]. More recently, the SARS-CoV-2 variants B.1.617.2 (first identified in India) followed by B.1 and B.1.1.7 (first identified in the UK) were associated with increased

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transmissibility, has emerged in several countries [3]. Since the initiation of vaccine rollout, there has been a close monitoring of the scientific literature (including preprint servers) and press coverage to identify its effectiveness against COVID-19. India started the mass vaccination drive for COVID-19 majorly with 2 vaccine candidates viz Covaxin and Covishield, since the 3rd week of January 2021 [4] and as on date, a total of 63,09,17,927 people have been vaccinated [5]. Despite effective vaccination strategy, evidence of breakthrough infections has been suggested. Though the numbers appear fractional their possibility cannot be overlooked [6, 7, 8]. A vaccine “breakthrough” infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after they have completed all recommended doses of an authorized COVID-19 vaccine [9]. A person who tests positive for COVID-19 between their first and second doses of two-dose vaccines, or a person who tests positive before the two weeks after their final dose, is not considered a breakthrough case [10]. There has been little recognition for complementary therapies like homeopathy, which too has helped many diagnosed patients recover in this pandemic [11 - 15]. Numerous published research papers in peer-reviewed journals have highlighted the long-standing history of the role of homeopathy in the management of epidemics [16-23]. This report describes the breakthrough infections that were recorded while treating the COVID-19 positive cases at a single homeopathic clinic and the response to their individualized homeopathic treatment. The purposes of this study were to observe the anamnestic clinical-symptomatic profile of vaccine breakthrough COVID-19 infections, and the response to individualized homeopathic treatment.

Methods

Setting

The present study was conducted at a private homeopathic clinic in New Delhi, India between 20th January and 20th May 2021. The data of 73 patients under homeopathic treatment were retrospectively analyzed to investigate the efficacy of homeopathic medicines in these COVID-19 vaccine breakthrough cases. Patients also signed an informed consent form for subsequent data analysis and publication with anonymity and confidentiality of the patients being maintained. The patients were categorized into asymptomatic, mild, moderate, severe, and critical entities as per the international protocol [24].

Inclusion/ Exclusion criteria

All symptomatic patients who consulted ≥14 days after completion of both the recommended doses of an authorized COVID-19 vaccine with: - laboratory confirmed COVID-19 infection with positive RT-PCR - positive inflammatory markers (S. Interleukin 6, C reactive protein, D Dimer, S. Ferritin, S. Procalcitonin, and S. Lactate dehydrogenase) and/ or radiological evidence (HRCT Chest) but negative RT- PCR All those diagnosed with COVID- 19 infection, before completion of 14 days after the second dose of the vaccine were not included in the final data analysis. Variables

These comprised demographic details and clinical symptoms of Vaccine Breakthrough COVID 19-positive patients. Homeopathic treatment protocol






A thorough clinical evaluation of each patient with corresponding serological and radiological investigations and swab tests was conducted/ reviewed before initiating treatment or at each successive follow-up. The prescriptions were a single homeopathic medicine determined according to their individualized clinico-symptomatic profile or homeopathic characteristic data, which was obtained while recording the observable signs and symptoms of each patient, and the homeopathic anamnestic profiling which includes the possible psycho-emotional & environmental triggers, symptomatic and personal modalities, and altered generalities, thermodynamics, disposition and behavior patterns. A few of those patients who were already on conventional medications (home quarantined or hospitalized) were taken off those medicines under close monitoring. Wherever required, oxygen concentrators or O2 support was advised.

Data analysis

The patient data was anonymized by removing direct identifier variables for the analysis. Epidemiological & demographic data, clinical symptomatology, laboratory data, treatment administered, and its outcome were obtained from the patient’s medical records. The response to homeopathic treatment was also assessed using ORIDL (Outcome about Impact on Daily Living) [25]. WHO clinical progression scale [26] a common outcome measure set for COVID-19 clinical research was used as an assessment post homeopathic intervention. IBM SPSS Statistics 21.0 was used for data analysis. Demographic details and occurrence of clinical symptomatology were expressed using descriptive statistics.

Results

During the reported period of analysis, 1397 COVID-19-positive patients were treated exclusively with single homeopathic medicines. Out of these 1397, a total of 367 patients reported having been vaccinated either with 1st or both doses as per the guidelines provided by the Indian Government [27]. Table 1 describes the common complaints recorded in these patients post vaccination. Table 1: Complaints post vaccination: irrespective of 1st or 2nd dose or kind of vaccine

S.no. Complaints Number %

1. Arm pain/discomfort/stiffness 311 84.74

2. Myalgia 287 78.2

3. Fever 236 64.30

4. Weakness 289 78.75

5. Headache 169 46.05

6. GIT symptoms 122 33.24

7. Urinary symptoms 82 22.34

8. No complaints 49 13.35

9. Anxiety-related adverse events 44 11.99

Among the 367 positive cases post vaccination, a total of 248 tested positives after 1st dose, and 119 tested positive after the 2nd dose of the vaccine. Amongst these, 73 cases were found to be actual Vaccine Breakthrough COVID-19 infections since these fulfilled the breakthrough criteria. The






median age reported for the data set was 44 years [SD ± 14.36]. The demographic details and symptomatic profiles post 14 days of 2nd dose of vaccine of the 73 Vaccine Breakthrough COVID-19 patients are described in Table 2.

These vaccine breakthrough cases also presented other morbidities in their anamnesis (past or family history) (Table 2).

Table 2: Demographic details, Symptomatology and Anamnesis of morbidities among the Vaccine Breakthrough cases

Number Percentage %

Gender

Males 41 56.16

Females 32 43.84

Age groups

18 – 30 years 13 17.8

31- 40 years 17 23.29

41- 50 years 24 32.88

51- 60 years 7 9.59

>60 years 12 16.44

Symptoms post 14 days of 2nd dose of vaccine

Arm pain 62 84.93

Myalgia or arthralgia 57 78.08

Fever 68 93.15

Chills and rigors 41 56.16

Fatigue 73 100

Blood pressure fluctuation (higher

than usual)

14 19.17

Blood glucose (higher than usual) 6 8.21

Confusion 5 6.85

Inability to wake or stay awake 18 24.65

Headache 69 94.52

Conjunctivitis 7 9.59

Nasal blockage 16 21.92

Epistaxis 9 12.33

Sneezing 11 15.06

Loss of smell 34 46.57

Nasal coryza 19 26.02

Dryness of mouth 8 10.95

Loss of taste/ Bad taste 47 64.38

Sore throat 33 45.20

Cough 49 67.12

Chest discomfort / pressure 17 23.28

Shortness of breath 33 45.20

Hemoptysis 17 23.28

Retrosternal burning 15 20.54

Nausea 21 28.76

Vomiting 22 30.13






Abdominal pain 6 8.21

Constipation 32 43.83

Diarrhea 29 39.72

Lower Urinary Tract Symptoms

(LUTS)

35 47.94

Pale, gray, or blue-colored skin,

lips, or nail beds (cyanosis)

0 0

Psychological manifestations 57 78.08

Associated Comorbidities / Family History

Diabetes mellitus/ Prediabetes 23 31.5

Thyroid or other endocrine

disorders

8 10.95

HT or other cardio-vascular

conditions

22 30.13

Rheumatological complaints 11 15.06

Neurological disorders 3 4.1

Cancers 5 6.84

TB 6 8.21

Psychiatric disorders 13 17.8

Recurrent respiratory allergies or

infections (upper and lower)

19 26.02

Dengue/ Thrombocytopenia 6 8.21

Corticosteroids or

Immunosuppressant therapies

24 32.87

Autoimmune disorders (not

classified elsewhere)

3 4.1

About 29 (39.72%) of these vaccine breakthrough cases presented with mild clinical manifestations, 26 (35.61%) moderate, 17 (23.28%) severe and 1 (1.36%) was critical and therefore hospitalized at the time of first consultation. Each patient was prescribed a remedy based on the individualizing characteristics after confirming from the homeopathic textbooks, which are distinct from the routine clinical symptomatology, as per the homeopathic treatment protocol. Potencies used were mother tincture of Aspidosperma (20 drops dissolved in 100 ml water, 5 ml to be taken as one dose) and LM or Centesimal potencies viz 200 CH, 1000CH or 10,000 CH of remaining remedies according to the requirement in the presented case. Both the patients who received Influenzinum nosode, besides usual clinical features also had axillary lymphadenopathy. All the patients who received Typhoidinum nosode, besides the usual clinical features and serology, also presented with Typhi dot IgM positive. The following 10 homeopathic remedies were prescribed to these 73 patients (Figure 1).

4 patients (mild category) did not follow up after the initial consultation and prescription. The critical category patient [HRCT Chest score: 24/25, (COVID-19 Reporting and Data System) CO-RADS: 5, and D Dimer value: >50 mg FEU/L (<0.5)] was the only one who could not survive (only one dose of Thuja occidentalis 200 CH could be administered). The response to the homeopathic treatment of the patients can be seen below (Figure 2) through the improvement elaborated by the ORIDL score where a score of 4 showed a recovery back to normal; 3 shows major improvement. A score of 2 shows moderate improvement whereas a score of 1 shows mild improvement. The 5 patients who dropped out were kept in the category of no response hence listed with an ORIDL score of 0.






Figure 1: The prescribed Homeopathic remedies in Vaccine Breakthrough cases*

[* 57 PATIENTS RECEIVED AND RECOVERED ONLY WITH A SINGLE REMEDY. 16 PATIENTS REQUIRED A SECOND REMEDY, AFTER THE FIRST PRESCRIPTION HAD ACTED, TO RECOVER COMPLETELY.]

Figure 2: Response to homeopathic treatment (ORIDL scores)

The median recovery time reported in the data set was 9 days [SD ± 2]. The majority of the patients responded positively following the administration of the homeopathic remedy. The duration of this response varied with the individual reaction to the remedy following its administration (Figure 3).

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5

10

15

20

25

30

35

NU

MB

ER O

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ATI

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HOMEOPATHIC REMEDIES

Number of patients with their respective Homeopathic remedies

0 5 10 15 20 25 30

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3

2

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29

26

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39,70%

35,60%

12,32%

5,47%

6,80%

FREQUENCY OF PATIENTS

OR

IDL

SCO

RES

ORIDL Sore

No. Of Patients Percentage






Figure 3: Response time following administration of Homeopathic remedies

WHO Clinical Progression Scale was measured daily throughout the study. The scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead) with data elements that are rapidly obtainable from clinical records. The outcome post homeopathic intervention is shown in Figure 4.

Figure 4: Outcome of Homeopathic Intervention using WHO Clinical Progression Scale

Discussion

The response to vaccination varies and so does the percentage of breakthrough infections. This can be ascertained from the published studies from different countries [28-30]. The variable number of

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70

Responsewithin 24

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Responsewithin 48

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Responsewithin 72

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Noresponse

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Duration of response

Response within 24hours



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Series 1 66 1 1 5

0 5 10 15 20 25 30 35

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breakthrough infections can be influenced by the severity of the epidemic and the infective viral variant. Although the vaccines have demonstrated high protection levels yet apprehension exists that several variants of concerns (VOCs) can surmount the immune defenses generated by the vaccines [31]. A recent report shows that the population after being vaccinated with the Pfizer-BioNTech vaccine is likely to have > five times lower levels of neutralizing antibodies against the new Delta variant [32]. Sequential studies among healthcare workers in Delhi reported high incidences of positive COVID-19 infection even after a successful 2nd dose of vaccination, and most were found to have been infected with the B1.617.2 variant [33, 34]. Though the worldwide data shows a reduction in the number of new infections, some countries show a paradoxical surge in positive cases posts vaccination suggesting the possibility of breakthrough COVID-19 infection among the susceptible population groups. Seychelles has a vaccinated population against COVID-19 more than any other country, and saw active cases more than double in the 1st week of May, raising the concerns of inoculation not being able to turn the tide in some places. A similar finding was reported in the Maldives. And recently spike in COVID-19 cases were incidental in the U.K despite 82% vaccinated population [35 - 37].

In our retrospective analysis, we found 73 breakthrough infections. 68 (93.15%) of these showed a positive response to homeopathic treatment. While 55 (75.34%) patients displayed complete clinical recovery with normalized serological markers/ nasal swabs, 29 of these (39.73%) patients also repeated their HRCT Chest which showed complete resolution of their pulmonary lesions. In the study group, 13 (17.8%) patients were already hospitalized at the time of the first consultation and another 19 (26.03%) were already on conventional medication of some sort before or during the time of the first consultation. The remaining 41 (56.16%) patients chose homeopathy as their first choice of treatment. The 12 hospitalized patients (7 severe and 5 moderate) also displayed a marked improvement after adjunct homeopathic treatment and were gradually weaned off the conventional medication or steroids. Less than 30% of the patients displayed a past/ family/ associated history of Diabetes mellitus, Hypertension, other cardiovascular disorders, or corticosteroids/ immune-suppressant drugs in their anamnesis. The efficiency of the homeopathic mode of therapeutics has been demonstrated in the treatment of various respiratory complaints, with success rates equivalent to conventional treatment. [38,39] The homeopathic literature also illustrates several remedies that were found to be clinically effective in countering the ill- effects following vaccination such as Sulphur, Mezereum, Antimonium tartaricum, Silicea, Malandrinum, Thuja occidentalis, Vaccininum, etc [40]. Acidum phosphoricum, Antim tartaricum and Thuja occidentalis were the most prescribed remedies in the study group.

The indications (or characteristics) governing the selection of the prescribed remedies were as under [42]:

• Acidum phosphoricum: Best suited to persons of originally strong constitutions, who have become debilitated by violent acute diseases; profound weakness- patient trembles; increased lethargy and apathy; poor thirst; cravings for refreshing things, juicy fruits, and fresh juices; night-sweats towards later part of night or daybreak; heavy dreams of dead people or being pursued, etc.

• Thuja occidentalis: Bad effects of vaccination viz. persisting pains at the site of vaccination; the appearance of perspiration around the neck or only on uncovered parts, even during sleep, or perspiration all over the body except the head; the tip of the tongue sore to touch; 3 am or 3 pm aggravation; marked chills during which even the warm air (draught) feels cold and sunlight also does not help, etc.






• Antimonium tartaricum: When the patient coughs there appears to be a large collection of mucus in the bronchi (death rattle); it seems as if much would be expectorated, but nothing comes up; face cold, blue, pale, covered with cold sweat; great sleepiness or irresistible inclination to sleep, with nearly all complaints; fan like the motion of alae nasi; antidotes bad effects of vaccination; inability to lie down due to coughing, dyspnoea, and vomitings, needs to sit upright; tongue coated pasty, thick, white, with reddened papillae and red edges; red in streaks; very red, dry in the middle; cravings for apples, etc.

• Typhoidinum: Typhoid infections in their convalescent stage present with profound weakness, which is pathognomonic of Covid-19 infection too. A few published case reports of patients initially misdiagnosed and treated for typhoid and were later diagnosed with Covid-19.[41] In the absence of any indicated remedy, Typhoidinum was therefore prescribed (in the absence of indications of another polychrest) when we found in the history that the patient had never been well since an earlier episode of typhoid or when s/he had suffered from recurring typhoid infections. [43,44]

• Pulsatilla nigricans: Thirstless with nearly all complaints; desires open air even during chills; weepiness most of the time; tongue coated white; loss of appetite; bitter taste in mouth; desires company; loss of sense of taste and smell etc.

• Aspidosperma (Quebracho): It has a marked affinity for the lungs and is considered an effective remedy for many cases of bronchial asthma. It is also known to stimulate the respiratory centers. It was therefore prescribed in two patients in whom “Want of breath during exertion” was the only guiding symptom, corroborated with dipping SPO2 levels.

• Influenzinum: The viral infection requiring Influenzinum starts insidiously with marked chilliness and irritability but the symptomatology points neither to Bryonia, Dulcamara, Gelsemium, or Ferrum phos; appetite decreases with slightly increased thirst; body ache that accompanies fever causes restlessness, weakness and a desire to stretch; digestive symptoms viz. nausea, diarrhea and flatulence may also be present; desires warm drinks which do not relieve.

• Sulphur: The febrile affections are accompanied by heat on top of the head, palms and soles, even when afebrile; uncovers soles and looks for a cool spot on the bed; a weak empty gone sensation occurs especially around 11 am; desires sweets, fats and sweet & sour, beer or brandy; aversion to meat and milk disagrees; some parts appear redder than others viz. ears or cheeks or palms, etc. etc.

• Acidum aceticum: Slow fever with night sweats or profuse perspiration; profound weakness; completely thirstless during fever; body ache/ backache > lying on abdomen etc.

• Vaccininum: Increased chilliness after vaccination; fainting episodes; desires to stretch with excessive tiredness; loss of appetite with disgusting taste and smell; shortness of breath with pressure in precordium.

The study indicates the observations on the anamnestic clinico-symptomatic profile of vaccine breakthrough Covid-19 patients and the responses of their individualized homeopathic treatment, which was corroborated by improvement in serological markers and radiological investigations and confirmed by ORIDL. The WHO Clinical Progression scale further verified the disease regression and a shortened clinical course post homeopathic intervention. Survivors of the illness and suffering patients evaluate their recovery in the resumption of the activities for daily living, improved






psychological well-b,eing and regained a sense of control. The COVID-19 recovery outcomes used here elaborated an overall assessment of the recovery including all such parameters.

It may also be inferred through these case observations that the variants of concern could be more transmissible than the original SARS-CoV-2 and may also escape vaccine protection more frequently. The findings of this study may provide evidence for clinically repurposing homeopathic medicines enabling their use in COVID-19 as an adjuvant or stand-alone therapy to help reduce treatment costs and improve patient recovery.

Conclusion

In conclusion, this up-to-date report gathers a clinico-symptomatic profile of vaccine breakthrough patients, their homeopathic anamnesis, and response to individualized homeopathic treatment. Despite the limited number of study subjects, homeopathy showed some promising results in the present setup. Further exploratory research studies and comparative clinical trials may be encouraged to ascertain and confirm the role of individualized homeopathic treatment in the current pandemic and provide more conclusive results. More detailed measures for recovery may be required for trials that assess recovery as a primary outcome.

Study limitations

The limitation of this study was that our study findings are only representative of a group of patients who opted and consulted for homeopathic treatment at one clinic and cannot be generalized for the entire population set due to the limited sample size. Another limitation was the lack of uniformity of resources due to which the follow-up CT scans / RT PCR or other serological markers were not performed by every patient. Also, the comparison of the efficacy of homeopathic medicines between different categories of disease severity is not possible with this retrospective epidemiological model due to the lack of a control group.

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Accepted: 03-20-2022. Published: 20-06-2022

© International Journal of High Dilution Research.

Not for commercial purposes.



https://indianexpress.com/article/india/typhoid-confusion-delays-covid-treatment-bokaro-deaths-double-in-one-month-7308806/

https://indianexpress.com/article/india/typhoid-confusion-delays-covid-treatment-bokaro-deaths-double-in-one-month-7308806/

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