Randomized Double-Blind, Placebo-Controlled Feasibility Study, Evaluating the Efficacy of Homeopathic Medicines in the Prevention of COVID-19 in a Quarantined Population

Gitanjali Talele; Shashikant Vaidhya; Abhay Chowdhary; Paul Herscu; Rajesh Shah

doi:10.1055/s-0041-1735235

Homeopathy, Table of Contents

Homeopathy 2022; 111(01): 049-056
DOI: 10.1055/s-0041-1735235

Original Research Article

Randomized Double-Blind, Placebo-Controlled Feasibility Study, Evaluating the Efficacy of Homeopathic Medicines in the Prevention of COVID-19 in a Quarantined Population

Gitanjali Talele

¹Research Department, Life Force Foundation Trust, Mumbai, Maharashtra, India

,

Shashikant Vaidhya

²Haffkine Institute, Microbiology Department, Haffkine Institute for Training Research and Testing, Parel, Mumbai, Maharashtra, India

,

Abhay Chowdhary

³Department of Microbiology, DY Patil University, Navi Mumbai, Maharashtra, India

,

Paul Herscu

⁴Division of Research, Herscu Laboratory, Amherst, Massachusetts, United States

,

Rajesh Shah

¹Research Department, Life Force Foundation Trust, Mumbai, Maharashtra, India

› Author Affiliations

Abstract

Introduction Exploring preventive therapeutic measures has been among the biggest challenges during the coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We explored the feasibility and methods of recruitment, retention, and potential signal of efficacy, of selected homeopathic medicines as preventive measure for developing COVID-19 in a multi-group study.

Methods A six-group, randomized, double-blind, placebo-controlled prophylaxis study was conducted in a COVID-19 exposed population in a quarantine facility in Mumbai, India. Each group received one of the following: Arsenicum album 30c, Bryonia alba 30c, a combination (Arsenicum album 30c, Bryonia alba 30c, Gelsemium sempervirens 30c, and Influenzinum 30c), coronavirus nosode CVN01 30c, Camphora 1M, or placebo. Six pills twice a day were administered for 3 days. The primary outcome measure used was testing recruitment and retention in this quarantined setting. Secondary outcomes were numbers testing positive for COVID-19 after developing symptoms of illness, number of subjects hospitalized, and days to recovery.

Results Good rates of recruitment and retention were achieved. Of 4,497 quarantined individuals, 2,343 sought enrollment, with 2,294 enrolled and 2,233 completing the trial (49.7% recruitment, 97.3% retention). Subjects who were randomized to either Bryonia alba or to the CVN01 nosode signaled (p <0.10) a lower incidence of laboratory-confirmed COVID-19 and a shorter period of illness, with evidence of fewer hospitalizations, than those taking placebo. The three other groups did not show signals of efficacy.

Conclusion This pilot study supports the feasibility of a larger randomized, double-blind, placebo-controlled trial. Bryonia alba 30c and CVN01 30c should both be explored in disease prevention or shortening the course of disease symptomatology in a COVID-19-exposed population.

Keywords

coronavirus - SARS-Cov-2 - preventive - COVID-19 - nosode - potentization - homeopathy

Full Text

References

References
1 WHO Coronavirus Disease (COVID-19) Dashboard. 2021 . Available at: https://covid19.who.int/
2 Bartsch SM, O'Shea KJ, Ferguson MC. et al. Vaccine efficacy needed for a COVID-19 coronavirus vaccine to prevent or stop an epidemic as the sole intervention. Am J Prev Med 2020; 59: 493-503
3 Manchanda RK. Dengue epidemic: what can we offer?. Indian J Res Homoeopathy 2015; 9: 137-140
4 Bracho G, Varela E, Fernández R. et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy 2010; 99: 156-166
5 Siqueira CM, Homsani F, da Veiga VF. et al. Homeopathic medicines for prevention of influenza and acute respiratory tract infections in children: blind, randomized, placebo-controlled clinical trial. Homeopathy 2016; 105: 71-77
6 Joshi S, Munshi R, Talele G. et al. An experimental in vitro study to evaluate the antimalarial activity of select homeopathy preparations. International Journal of Medical and Health Research 2017; 7: 65-68
7 Bagai U, Walter NS. Antiplasmodial potential of homeopathic drugs Chelidonium and nosode against Plasmodium berghei infection. J Complement Integr Med 2014; 11: 195-201
8 Camerlink I, Ellinger L, Bakker EJ, Lantinga EA. Homeopathy as replacement to antibiotics in the case of Escherichia coli diarrhoea in neonatal piglets. Homeopathy 2010; 99: 57-62
9 Shah R. Clinical trial for the evaluation of a human immunodeficiency virus nosode in the treatment for human immunodeficiency virus-infected individuals. Indian J Res Homoeopathy. 2015; 9: 25-33
10 Shah R. Hepatitis C nosode: the preparation and homeopathic pathogenetic trial. Homeopathy 2013; 102: 207-214
11 Press Information Bureau, Government of India. Advisory for coronavirus. Available at: https://pib.gov.in/pressreleasepage.aspx?prid=1600895
12 Herscu P. Thoughts on Epidemics from a Clinical Physician Written March 11, 2020. Accessed March 25, 2021 at: http://nesh.com/thoughts-on-epidemics-from-a-clinical-physician-march-11-2020/
13 Herscu P. Winter 2017-2018 Epidemic Updates. Accessed March 25, 2021 at: https://nesh.com/articles-on-homeopathy/winter-2017-epidemic-updates/
14 Brown MJ, Chuang-Stein C, Kirby S. Designing studies to find early signals of efficacy. J Biopharm Stat 2012; 22: 1097-1108
15 Coronavirus LIVE. Maharashtra reports 328 new positive cases, 3648 total cases. Accessed September 25, 2020 at: https://www.nationalheraldindia.com/india/coronavirus-live-updates-covid-19-india-wuhan-us-italy-who-alert-novel-coronavirus-latest-news-18th-april
16 Kaushal J, Mahajan P. Asia's largest urban slum–Dharavi: a global model for management of COVID-19. Cities 2021; 111: 103097
17 Municipal Corporation of Greater Mumbai (Disaster Management Department). Accessed March 25, 2021 at: https://dm.mcgm.gov.in/ward-maps
18 Mukherjee S, Talele G, Chowdhary A. et al. Preparation of coronavirus nosodes sourced from a clinical sample of SARS-Cov-2 positive patient, inactivated strain, and spike glycoprotein. Int J High Dilution Res. 2020; 19: 2-9
19 Talele G, Vaidya S, Shah R. An open-label, homeopathic pathogenetic trial for safety and evaluation of immune response of Coronavirus nosode in healthy volunteers. ( Manuscript under review )
20 Talele G, Shah R. An open-label, exploratory documentation of proving-symptoms of CVN01 (Coronavirus nosode from the clinical sample) in healthy volunteers. ( Manuscript accepted )
21 Wason JMS, Stecher L, Mander AP. Correcting for multiple-testing in multi-arm trials: is it necessary and is it done?. Trials 2014; 15: 364
22 The COVID-19 candidate vaccine landscape and tracker. Accessed May 2, 2021 at: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
23 COVID-19 Vaccine Tracker. Accessed May 2, 2021 at: https://covid19.trackvaccines.org/vaccines/
24 Voysey M, Costa Clemens SA, Madhi SA. et al; Oxford COVID Vaccine Trial Group. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials. Lancet 2021; 397: 881-891
25 Polack FP, Thomas SJ, Kitchin N. et al; C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med 2020; 383: 2603-2615
26 Rincon-Arevalo H, Choi M, Stefanski AL. Impaired antigen-specific memory B cell and plasma cell responses including lack of specific IgG upon SARS-CoV-2 BNT162b2 vaccination among kidney transplant and dialysis patients. MedRχiv 2021.04.15.21255550; doi: https://doi.org/10.1101/2021.04.15.21255550
27 Boyarsky BJ, Werbel WA, Avery RK. et al. Immunogenicity of a single dose of SARS-CoV-2 messenger RNA vaccine in solid organ transplant recipients. JAMA 2021; 325: 1784-1786
28 Kirkby R, Calabrese C, Kaltman L, Monnier J, Herscu P. Methodological considerations for future controlled influenza treatment trials in complementary and alternative medicine. J Altern Complement Med 2010; 16: 275-283
29 Mathie RT. The research evidence base for homeopathy: a fresh assessment of the literature. Homeopathy 2003; 92: 84-91
30 Kirkby R, Herscu P. Homeopathic trial design in influenza treatment. Homeopathy 2010; 99: 69-75
31 Jonas WB. Do homeopathic nosodes protect against infection? An experimental test. Altern Ther Health Med 1999; 5: 36-40
32 Viner RM, Mytton OT, Bonell C. et al. Susceptibility to SARS-CoV-2 infection among children and adolescents compared with adults: a systematic review and meta-analysis. JAMA Pediatr 2021; 175: 143-156