Standard Operating Procedure to Derive Homoeopathic Prophylaxis in COVID-19 through Prophylactic Clinical Trial—A Perspective

Abstract

The pandemic coronavirus disease 2019 (COVID-19) has become a public health emergency of international concern affecting human health and economy across the world. The outbreak in India is accelerating even after enforcement of lockdown as well as promotion of hand hygiene, respiratory etiquettes and social distancing mainly due to nonavailability of specific antiviral medicine and vaccine. Historically, for the purpose of prevention and treatment, homoeopathy has shown its usefulness in recent and past epidemics using carefully selected medicines as genus epidemicus (GE) for each epidemic. In the present era of evidence-based medicine, usefulness of therapeutic agent as prophylaxis is recognised only after obtaining significant result in prophylactic clinical trial. Claims of usefulness of certain homoeopathic medicine as prophylaxis or GE of COVID-19 can be used to generate research hypothesis and can be tested through prophylactic clinical trial. In this article, outbreak investigation procedures are highlighted, necessity of epidemic preparedness with engagement of community is emphasised, several recent developments in clinical trial regulations for an outbreak are pointed out, among which online submission of research protocol, expedition of ethical review procedure, virtual meeting of the ethics committee, Good Participatory Practice Guidelines for Trials of Emerging (and re-emerging) Pathogens are mentioned. Standard operating procedures are discussed to conduct a comparative effectiveness research using cluster randomisation in a multidisciplinary approach to investigate the effectiveness of the homoeopathic medicine as a prophylaxis for COVID-19 which can be used by the policy makers as an effective public health intervention to stop transmission and prevent community spread of this highly infectious disease.

Keywords

COVID-19 - prophylaxis - homoeopathy - standard operating procedure - genus epidemicus - comparative effectiveness research - prophylactic clinical trial

Publikationsverlauf

Artikel online veröffentlicht:
16. September 2020

• References

• 1 Bradford TL. The Life and Letters of Dr. Samuel Hahnemann. Reprint edition. New Delhi: B Jain Publishers; 2004
• 2 Winston J. The Faces of Homeopathy-An Illustrated History of the First 200 Years. Wellington: Great Auk Publishing; 1999
• 3 Dewey W. Homeopathy in influenza – A chorus of fifty in harmony. J Am Inst Homeopath 1921; 13: 1028-1043
• 4 Prompetchara E, Ketloy C, Palaga T. Immune responses in COVID-19 and potential vaccines: lessons learned from SARS and MERS epidemic. Asian Pac J Allergy Immunol 2020; 38 (01) 1-9
• 5 Riley S, Fraser C, Donnelly CA. , et al. Transmission dynamics of the etiological agent of SARS in Hong Kong: impact of public health interventions. Science 2003; 300 (5627): 1961-1966
• 6 Zhu N, Zhang D, Wang W. , et al; China Novel Coronavirus Investigating and Research Team. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med 2020; 382 (08) 727-733
• 7 Huang C, Wang Y, Li X. , et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020; 395 (10223): 497-506
• 8 Li Q, Guan X, Wu P. , et al. Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia. N Engl J Med 2020; 382 (13) 1199-1207
• 9 Chen N, Zhou M, Dong X. , et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet 2020; 395 (10223): 507-513
• 10 MoHFW | Home [Internet]. [cited 2020 Jun 1]. Available from: https://www.mohfw.gov.in/ . Accessed June 19, 2020
• 11 World Health Organisation. Novel Coronavirus( 2019-nCoV) Situation Report-8 [Internet]. [cited 2020 May 18]. Available from: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200128-sitrep-8-ncov-cleared.pdf?sfvrsn=8b671ce5_2
• 12 Jiang F, Deng L, Zhang L, Cai Y, Cheung CW, Xia Z. Review of the clinical characteristics of coronavirus disease 2019 (COVID-19). J Gen Intern Med 2020; 35 (05) 1545-1549
• 13 Arons MM, Hatfield KM, Reddy SC. , et al; Public Health–Seattle and King County and CDC COVID-19 Investigation Team. Presymptomatic SARS-CoV-2 infections and transmission in a skilled nursing facility. N Engl J Med 2020; 382 (22) 2081-2090
• 14 Beigel JH, Tomashek KM, Dodd LE. , et al; ACTT-1 Study Group Members. Remdesivir for the treatment of Covid-19 - preliminary report. [Online ahead of print] N Engl J Med 2020
• 15 Ministry of Health and Family Welfare, National Taskforce for COVID-19. Advisory on the use of hydroxy-chloroquine as prophylaxis for SARS-CoV-2 infection. 2020 . [Internet]. [cited 2020 May 18]. Available from: https://www.mohfw.gov.in/pdf/AdvisoryontheuseofHydroxychloroquinasprophylaxisforSARSCoV2infection.pdf . Accessed June 19, 2020
• 16 Liu J, Cao R, Xu M. , et al. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov 2020; 6 (01) 16
• 17 Wang M, Cao R, Zhang L. , et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res 2020; 30 (03) 269-271
• 18 Ghosh AK. A short history of the development of homeopathy in India. Homeopathy 2010; 99 (02) 130-136
• 19 Hahnemann S. Organon of Medicine. 6th edition. New Delhi: B Jain Publishers; 2004: 267
• 20 Harilal KN, Thyagaraj AP, Thomas MVSA. Development of Homoeopathic Genus Epidemicus for Secondary Level Prevention of Dengue Virus Infection at Kannur, Kerala. [Internet]. Kerala: Research in Homeopathy; 2018 . Available from: https://www.researchgate.net/publication/326742719_DEVELOPMENT_OF_HOMOEOPATHIC_GENUS_EPIDEMICUS_FOR_SECONDARY_LEVEL_PREVENTION_OF_DENGUE_VIRUS_INFECTION_AT_KANNUR_KERALA/link/5b61dfdfaca272a2d67af39e/download . Accessed June 19, 2020
• 21 Teixeira MZ. Homeopathy: a preventive approach to medicine. Int J High Dilution Res 2009; 8 (29) 155-172
• 22 Rastogi DP, Sharma VD. Study of homoeopathic drugs in encephalitis epidemic (1991) in Uttar Pradesh (India). CCRH Quarterly Bull 1992; 14 (3&4): 1-11
• 23 Rejikumar R. A Study on the Prophylactic Efficacy of Homoeopathic Preventive Medicine Against Chikungunya Fever. [Internet]. [cited 2020 May 18]; Available from: www.similima.com . Accessed June 19, 2020
• 24 Prompetchara E, Ketloy C, Palaga T. Immune responses in COVID-19 and potential vaccines: lessons learned from SARS and MERS epidemic. Asian Pac J Allergy Immunol 2020; 38 (01) 1-9
• 25 Nayak D, Nayak C, Oberai P. , et al. Homoeopathic Genus Epidemicus ′Bryonia alba′ as a prophylactic during an outbreak of Chikungunya in India: a cluster -randomised, double -blind, placebo- controlled trial. Indian J Res Homoeopath. 2014; 8 (03) 160
• 26 Ferley JP, Zmirou D, D'Adhemar D, Balducci F. A controlled evaluation of a homoeopathic preparation in the treatment of influenza-like syndromes. Br J Clin Pharmacol 1989; 27 (03) 329-335
• 27 Bracho G, Varela E, Fernández R. , et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy 2010; 99 (03) 156-166
• 28 Jacobs J, Jonas WB, Jiménez-Pérez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediatr Infect Dis J 2003; 22 (03) 229-234
• 29 Bawaskar RS, Shinde VH. A review of homoeopathic research in the prevention and treatment of dengue fever. Homœopathic Links 2019; 32 (01) 10-17
• 30 Mathie RT, Baitson ES, Frye J, Nayak C, Manchanda RK, Fisher P. Homeopathic treatment of patients with influenza-like illness during the 2009 A/H1N1 influenza pandemic in India. Homeopathy 2013; 102 (03) 187-192
• 31 Chakraborty P, Lamba C, Nayak D. , et al. Effect of individualized homoeopathic treatment in influenza like illness: a multicenter, single blind, randomized, placebo controlled study. Indian J Res Homoeopath. 2013; 7 (01) 22
• 32 LMHI. Collecting clinical experience of homeopathic support in COVID-19 [Internet]. 2020 May [cited 2020 Jun 1]. Available from: http://www.lmhi.org/downloads/nvp/CollectingclinicalCOVIDLMHI9May10.2020.pdf Accessed June 19, 2020
• 33 Ministry of AYUSH, Govt of India. ANNEXURE-I advisory from Ministry of Ayush for meeting the challenge arising out of spread of CORONA virus (COVID-19) in India [Internet]. [cited 2020 May 18]. Available from: https://www.ayush.gov.in/docs/125.pdf . Accessed June 19, 2020
• 34 Bellavite P, Signorini A, Marzotto M, Moratti E, Bonafini C, Olioso D. Cell sensitivity, non-linearity and inverse effects. Homeopathy 2015; 104 (02) 139-160
• 35 Saine A. Case management of the influenza and pneumonia patient with homeopathy during the COVID-19 pandemic [Internet]. [cited 2020 May 26]. Available from: https://vimeo.com/402537849?fbclid=IwAR0rjwd25qRBfiIQ-bVWLt7pNnojAvA . Accessed June 19, 2020
• 36 LMHI. LMHI Executive committee communication regarding Corona virus epidemic [Internet]. [cited 2020 May 26]. Available from: http://www.lmhi.org/Home/Corona . Accessed June 19, 2020
• 37 Ministry of AYUSH, Govt. of India. Guidelines for Homoeopathic Practitioners for COVID-19 [Internet]. [cited 2020 Jun 1]. Available from: https://health.ncog.gov.in/ayush-covid-dashbaord/assets/Classified/AYUSHGuidelinesforCOVID-19/1 . Guidelines for practitioners/c. HOMOEOPATHIC Guidelines/HOMEOPATHY Guidelines (1).pdf. Accessed June 19, 2020
• 38 Murhekar M, Moolenaar R, Hutin Y, Broome C. Investigating outbreaks: practical guidance in the Indian scenario. Natl Med J India 2009; 22 (05) 252-256
• 39 Hankins C. Outcome document of the consultative process [Internet]. 2016 [cited 2020 May 26]. Available from: https://www.who.int/blueprint/what/norms-standards/GPP-EPP-December2016.pdf?ua=1 . Accessed June 19, 2020
• 40 ICMR. SOP template for ethics review of biomedical and health research during COVID-19 pandemic [Internet]. Bengaluru; 2020 [cited 2020 May 26]. Available from: http://ethics.ncdirindia.org/ . Accessed June 19, 2020
• 41 Mathur R. , Ed. National guidelines for ethics committees reviewing biomedical & health research during COVID-19 Pandemic. 2020 . Available from: http://www.ncdirindia.org/Downloads/EC_Guidance_COVID19.pdf . Accessed June 19, 2020
• 42 Keusch GT, McAdam K, Cuff PA, Mancher M, Busta ER. Integrating clinical research into epidemic response: The Ebola experience. Integrating Clinical Research into Epidemic Response: The Ebola Experience. National Academies Press; 2017: 1-316
• 43 Williams CM, Skinner EH, James AM, Cook JL, McPhail SM, Haines TP. Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice. Trials 2016; 17 (01) 406
• 44 Alschuler L, Weil A, Horwitz R, Stamets P, Chiasson AM, Crocker R. , et al. Integrative considerations during the COVID-19 pandemic. Explore. 2020 ;S1550–8307(20):30113–0
• 45 Oberai P, Varanasi R, Padmanabhan M. , et al. Effectiveness of homeopathic medicines as add-on to institutional management protocol for acute encephalitis syndrome in children: an open-label randomized placebo-controlled trial. Homeopathy 2018; 107 (03) 161-171
• 46 Nayak D, Chadha V, Jain S. , et al. Effect of adjuvant homeopathy with usual care in management of thrombocytopenia due to dengue: a comparative cohort study. Homeopathy 2019; 108 (03) 150-157
• 47 Frass M, Linkesch M, Banyai S. , et al. Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit. Homeopathy 2005; 94 (02) 75-80
• 48 Frass M, Friehs H, Thallinger C. , et al. Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - a pragmatic randomized controlled trial. Complement Ther Med 2015; 23 (03) 309-317
• 49 ICMR. ICMR policy on research integrity and publication ethics [Internet]. 2020 [cited 2020 May 30]. Available from: http://sts.icmr.org.in/Result/ICMR_Policy_On_RIPE_30.7.19.pdf . Accessed June 19, 2020