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DOI: 10.1055/s-0042-1755365
Homeopathy as an Adjuvant to Standard Care in Moderate and Severe Cases of COVID-19: A Single-Blind, Randomized, Placebo-Controlled Study
Funding The study was funded by the Central Council for Research in Homoeopathy, Ministry of AYUSH, Government of India. The funder approved the study through its review committees, delegated/recruited staff for conducting the study, and facilitated all collaborative procedures.Abstract
Objectives This study aimed to evaluate whether individualized homeopathic medicines have a greater adjunctive effect than adjunctive placebos in the treatment of moderate and severe cases of coronavirus disease 2019 (COVID-19).
Methods The study was a randomized, single-blind, prospective, placebo-controlled clinical trial set in the clinical context of standard care.
Intervention Patients of either sex, admitted in a tertiary care hospital, suffering from moderate or severe COVID-19 and above 18 years of age were included. In total, 150 patients were recruited and then randomly divided into two groups to receive either individualized homeopathic medicines or placebos, in addition to the standard treatment of COVID-19.
Outcome Measures The primary outcome was time taken to achieve RT-PCR-confirmed virus clearance for COVID-19. Secondary outcomes were changes in the Clinical Ordinal Outcomes Scale (COOS) of the World Health Organization, the patient-reported MYMOP2 scale, and several biochemical parameters. Parametric data were analyzed using unpaired t-test. Non-parametric data were analyzed using the Wilcoxon signed rank test. Categorical data were analyzed using Chi-square test.
Results In total, 72 participants of the add-on homeopathy (AoH) group showed conversion of RT-PCR status to negative, in an average time of 7.53 ± 4.76 days (mean ± SD), as compared with 11.65 ± 9.54 days in the add-on placebo (AoP) group (p = 0.001). The mean COOS score decreased from 4.26 ± 0.44 to 3.64 ± 1.50 and from 4.3 ± 0.46 to 4.07 ± 1.8 in the AoH and AoP groups respectively (p = 0.130). The mortality rate for the AoH group was 9.7% compared with 17.3% in the AoP group. The MYMOP2 scores between the two groups differed significantly (p = 0.001), in favor of AoH. Inter-group differences in the pre- and post- mean values of C-reactive protein, fibrinogen, total leukocyte count, platelet count and alkaline phosphatase were each found to be statistically significant (p <0.05), favoring AoH; six other biochemical parameters showed no statistically significant differences.
Conclusion The study suggests homeopathy may be an effective adjunct to standard care for treating moderate and severe COVID-19 patients. More rigorous, including double-blinded, studies should be performed to confirm or refute these initial findings.
Keywords
moderate to severe COVID-19 - coronavirus infection - homeopathy - integrative care - pandemic - RT-PCRData Sets
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Authors' Contributions
Harleen Kaur conceptualized and designed the study, in consultation with Arvind Dayal, the statistician. She drafted the protocol, sought approvals from the concerned committees, executed the study as the Team Leader, and was involved in final compilation and analysis of the data. There were two teams that alternated for duties, with a period of 15 days home quarantine following 15 days COVID duty. Team A was led by Harleen, and Team B was led by Subhash Kaushik. Besides, Subhash was instrumental in effecting homoeopathic prescriptions in treating moderate and severe COVID-19 cases. Sushma Bhatnagar and Anil Khurana played a pivotal role by mentoring the teams for the study, and guiding them from time to time. Naval Kumar Verma provided his clinical acumen on a case-to-case basis, as and when consulted, and also shared a reference compendium of medical literature for quick reference. Khushbu Gautam, Gurpreet Singh and Shweta Singh, and Maneet Parewa, Tania Chatterjee and Syed Ali were the three assisting homoeopathy doctors in Teams A and B, respectively. Arvind Dayal helped in statistical analysis of the huge data generated from the study, along with Harleen, Gurpreet and Shweta. Suraj Pal Singh and Varun Shekhar were instrumental in all study-related coordination with AIIMS' clinical and paramedical staff for execution of the study. All the authors read the draft manuscript and provided their inputs for its refinement or modification. All authors assure the completeness and accuracy of the data and the adherence of the trial to the protocol.
Publikationsverlauf
Eingereicht: 25. Februar 2022
Angenommen: 13. Juni 2022
Artikel online veröffentlicht:
28. November 2022
© 2022. The Faculty of Homeopathy. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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References
- 1 World Health Organization. Weekly epidemiological update on COVID-19. Accessed January 21, 2022 at https://www.who.int/emergencies/diseases/novel-coronavirus-2019
- 2 Petrilli CM, Jones SA, Yang J. et al. Factors associated with hospital admission and critical illness among 5279 people with coronavirus disease 2019 in New York City: prospective cohort study. BMJ 2020; 369: m1966
- 3 Palacios Cruz M, Santos E, Velázquez Cervantes MA, León Juárez M. COVID-19, a worldwide public health emergency. Rev Clin Esp (Barc) 2021; 221: 55-61
- 4 Cao B, Wang Y, Wen D. et al. A trial of lopinavir–ritonavir in adults hospitalized with severe COVID-19. N Engl J Med 2020; 382: 1787-1799
- 5 Colson P, Rolain J-M, Lagier J-C, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents 2020; 55: 105932
- 6 Yao X, Ye F, Zhang M. et al. In vitro antiviral activity and projection of optimized dosing design of hydroxychloroquine for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clin Infect Dis 2020; 71: 732-739
- 7 Gautret P, Lagier J-C, Parola P. et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents 2020; 56: 105949
- 8 World Health Organization. Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD). WHO, 2016. Accessed February 27, 2021 at: https://www.who.int/news/item/12-08-2014-ethical-considerations-for-use-of-unregistered-interventions-for-ebola-virus-disease-(evd)
- 9 Varanasi R, Nayak D. Homoeopathy in the management of infectious diseases: different facets of its use and implications for the future. Indian J Res Homoeopathy 2020; 14: 110-121
- 10 Teixeira MZ. Homeopathy: a preventive approach to medicine?. Int J High Dilution Res 2009; 8: 155-172
- 11 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: 187-192
- 12 Jacobs J. Homeopathic prevention and management of epidemic diseases. Homeopathy 2018; 107: 157-160
- 13 Manchanda R, Oberai P, Prasad R. et al. Evaluation of homoeopathic medicines as add-on to institutional management protocol in acute encephalitis syndrome: an exploratory observational comparative study. Indian J Res Homoeopath 2015; 9: 34-41
- 14 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: 150-157
- 15 Golden I. Large scale homœoprophylaxis: results of brief and long-term interventions. Am J Homeopath Med 2019; 112: 31-36
- 16 Shinde V. Homoeopathy in pandemic Spanish flu 1918. Indian J Res Homoeopath 2020; 14: 152-159
- 17 Winston J. The Faces of Homeopathy. Wellington, New Zealand: Great Auk Publishing; 1999
- 18 Rajendran ES. Homeopathy seen as personalised nanomedicine. Homeopathy 2019; 108: 66-70
- 19 Tramontana A. COVID-19 pneumonia: a potential role of homeopathy. Homeopathy 2021; 110: 70-71
- 20 Masiello DJ. The COVID-19 pandemic: a view from New York City. Homeopathy 2020; 109: 163-166
- 21 Adler UC, Adler MS, Hotta LM. et al. Homeopathy for Covid-19 in primary care: a structured summary of a study protocol for a randomized controlled trial. Trials 2021; 22: 109
- 22 Govt. of India. Ministry of Health & Family Welfare.. Clinical Management Protocol: COVID-19. 2020 , Version 4; Accessed June 27, 2020 at: https://www.mohfw.gov.in/pdf/ClinicalManagementProtocolforCOVID19dated27062020.pdf
- 23 World Medical Association. WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects. 64th WMA General Assembly. Fortaleza, Brazil: 2013
- 24 Paterson C, Britten N. In pursuit of patient-centred outcomes: a qualitative evaluation of the ‘Measure Yourself Medical Outcome Profile’. J Health Serv Res Policy 2000; 5: 27-36
- 25 World Health Organization. COVID-19 Therapeutic Trial Synopsis. World Health Organization; 2020. Geneva, Switzerland: 1-9 . February 18, 2020. Available at: https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis
- 26 Chu CM, Leung WS, Cheng VCC. et al. Duration of RT-PCR positivity in severe acute respiratory syndrome. Eur Respir J 2005; 25: 12-14
- 27 Jain V, Yuan JM. Predictive symptoms and comorbidities for severe COVID-19 and intensive care unit admission: a systematic review and meta-analysis. Int J Public Health 2020; 65: 533-546
- 28 Khedr EM, Daef E, Mohamed-Hussein A. et al. Impact of Comorbidities on COVID-19 Outcome. medRχiv; 2020
- 29 Fang L, Karakiulakis G, Roth M. Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection?. Lancet Respir Med 2020; 8: e21
- 30 Rutten L, Smedley T, Ives G. et al. Data collection during the COVID-19 pandemic: learning from experience, resulting in a Bayesian repertory. Homeopathy 2021; 110: 94-101
- 31 Mathie RT, Lloyd SM, Legg LA. et al. Randomised placebo-controlled trials of individualized homeopathic treatment: systematic review and meta-analysis. Syst Rev 2014; 3: 142
- 32 Van Halem K, Bruyndonckx R, van der Hilst J. et al. Risk factors for mortality in hospitalized patients with COVID-19 at the start of the pandemic in Belgium: a retrospective cohort study. BMC Infect Dis 2020; 20: 897
- 33 Olivas-Martínez A, Cárdenas-Fragoso JL, Jiménez JV. et al. In-hospital mortality from severe COVID-19 in a tertiary care center in Mexico City; causes of death, risk factors and the impact of hospital saturation. PloS One 2021; 16: e0245772
- 34 Mudd PA, Crawford JC, Turner JS. et al. Targeted Immunosuppression Distinguishes COVID-19 from Influenza in Moderate and Severe Disease. medRχiv; 2020
- 35 Ponti G, Maccaferri M, Ruini C, Tomasi A, Ozben T. Biomarkers associated with COVID-19 disease progression. Crit Rev Clin Lab Sci 2020; 57: 389-399
- 36 Bilgir O, Bilgir F, Calan M, Calan OG, Yuksel A. Comparison of pre- and post-levothyroxine high-sensitivity c-reactive protein and fetuin-a levels in subclinical hypothyroidism. Clinics (São Paulo) 2015; 70: 97-101
- 37 Zhang C, Wu Z, Li JW, Zhao H, Wang GQ. Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality. Int J Antimicrob Agents 2020; 55: 105954-105960
- 38 Del Valle DM, Kim-Schulze S, Huang HH. et al. An inflammatory cytokine signature predicts COVID-19 severity and survival. Nat Med 2020; 26: 1636-1643
- 39 Zhang L, Yan X, Fan Q. et al. D-dimer levels on admission to predict in-hospital mortality in patients with Covid-19. J Thromb Haemost 2020; 18: 1324-1329
- 40 Wool GD, Miller JL. The impact of COVID-19 disease on platelets and coagulation. Pathobiology 2021; 88: 15-27
- 41 Aggarwal M, Dass J, Mahapatra M. Hemostatic abnormalities in COVID-19: an update. Indian J Hematol Blood Transfus 2020; 36: 1-11
- 42 Zhu B, Feng X, Jiang C. et al. Correlation between white blood cell count at admission and mortality in COVID-19 patients: a retrospective study. BMC Infect Dis 2021; 21: 574
- 43 Kumar A, Kumar P, Dungdung A, Gupta AK, Anurag A, Kumar A. Pattern of liver function and clinical profile in COVID-19: a cross-sectional study of 91 patients. Diabetes Metab Syndr 2020; 14: 1951-1954
- 44 Day SJ, Altman DG. Statistics notes: blinding in clinical trials and other studies. BMJ 2000; 321: 504
- 45 Canevelli M, Trebbastoni A, Quarata F. et al. External validity of randomized controlled trials on Alzheimer's disease: the biases of frailty and biological aging. Front Neurol 2017; 8: 628
- 46 The New Indian Express. Delhi records over 8,000 COVID-19 cases for first time, 4.59 lakh cases in capital. November 12, 2020
- 47 Schmacke N, Müller V, Stamer M. What is it about homeopathy that patients value? What can family medicine learn from this?. Qual Prim Care 2014; 22: 17-24