Association between Usage of Prophylactic AYUSH Medicines and Disease Severity in COVID-19 Patients: A Retrospective Cohort Study.

BACKGROUND: Prior vaccination is often studied for its impact on individuals' post-infection prognosis. Ayurveda, Yoga, Unani, Siddha and Homeopathy (AYUSH) medicines, advised by the Government of India as prophylaxis during the first wave of the coronavirus disease 2019 (COVID-19) pandemic, were consumed by the masses in 2020. A study was therefore undertaken to observe any association between the prior usage of AYUSH prophylactic medicines and post-infection severity as reported by recovered COVID-19 individuals. METHODS: This was a retrospective, multi-centre, cohort study conducted in 21 cities of India from 5th August to 30th November 2020. Data from recovered COVID-19 patients, of either sex or any age, captured information about AYUSH prophylactic medicines intake prior to infection, disease severity, symptomatology, duration of complaints, etc. The study participants were grouped into AYUSH intake and non-intake. Primary composite outcome was the disease clinical course. Secondary clinical outcomes were the rate of and time to clinical recovery. RESULTS: Data of 5,023 persons were analysed. Ayurveda or homeopathic prophylactic medicines were consumed by more than half of the study participants: that is, 56.85% (n = 1,556) and 56.81% (n = 1,555) respectively. The overall adjusted protective effect (PE) of AYUSH prophylactic intake against moderate/severe forms of COVID-19 disease was 56.7% (95% confidence interval [CI], 48.7 to 63.50; p < 0.001). Adjusted PE for homeopathy and Siddha was 52.9% (95% CI, 42.30 to 61.50; p < 0.001) and 59.8% (95% CI, 37.80 to 74.10; p < 0.001), respectively. A statistically significant association was found between AYUSH prophylactic medicine intake and clinical recovery more frequently by the 3rd day of illness (χ2 = 9.01; p = 0.002). Time to resolution of symptoms in the AYUSH intake group was on average 0.3 days earlier than in the non-intake group (p = 0.002). CONCLUSION: AYUSH prophylactics were associated with statistically significant levels of protection against COVID-19 disease severity. Amongst these, previous intake of homeopathy or Siddha medicines was associated with some protection against moderate/severe illness and with a somewhat quicker clinical recovery. Prospective studies with experimental research design are needed to validate the findings of this study. STUDY REGISTRATION: Clinical Trials Registry-India (CTRI/2020/08/027000).

Efficacy of Arsenicum album 30C in the Prevention of COVID-19 in Individuals Residing in Containment Areas: A Prospective, Multicenter, Cluster-Randomized, Parallel-Arm, Community-Based, Open-Label Study.

OBJECTIVE: During the early part of the COVID-19 pandemic, non-pharmacologic interventions were the strategies for the prevention of severe acute respiratory syndrome coronavirus 2. The Ministry of Ayush, Govt. of India, had advised Arsenicum album 30C as a prophylactic to prevent COVID-19. This study was undertaken to evaluate the protective efficacy and safety of the Arsenicum album 30C. METHODS: We conducted a prospective, multicenter, cluster-randomized, parallel-arm, community-based, open-label study involving apparently healthy individuals residing in containment areas of 7 cities in India. Clusters are defined as the population residing in the containment areas, who are under restriction for movement. Forty-two clusters were randomly assigned at 2:1 to the Arsenicum album 30C group (30 clusters) or to the control group (12 clusters, which received no specific therapy). The medicine was given twice daily for 7 days. The primary outcome was the incidence of COVID-19, as per the case definition notified by the National Centre for Disease Control, Government of India, during 3-week follow-up period. RESULTS: The analysis included 32,186 individuals residing in 42 clusters (containment areas). A total of 22,693 individuals from 30 clusters received Arsenicum album 30C, and 9,493 individuals from 12 clusters were observed in the control group. The overall protective effect of the Arsenicum album 30C was 80.22% (95% confidence interval [CI], 71.16-86.44; 40 cases per 22,693 [6.04 per 10,000 person-weeks] in the Arsenicum album 30C group vs. 84 cases per 9,493 [29.78 per 10,000 person-weeks] in the control group). The protective effect of the Arsenicum album 30C against laboratory-confirmed COVID-19 was 68.22% (95% [CI], 49.64-80; 32 cases per 22,693 [4.83 per 10,000 person-weeks] in the Arsenicum album 30C group vs. 42 cases per 9,493 [14.93 per 10,000 person-weeks] in the control group). Adverse effects observed in both groups were mild and resolved without medication and sequelae. CONCLUSION: Homeopathic medicine Arsenicum album 30C was associated with a decrease in the incidence and provided some protection against COVID-19 as compared to nontreatment. Further randomized, double-blind, placebo-controlled trials may be conducted to validate the results of this study.In der Anfangszeit der COVID-19-Pandemie setzte man auf nicht-medikamentöse Massnahmen zur Prävention von Infektionen mit SARS-CoV-2 (Schweres-Akutes-Respiratorisches-Syndrom-Coronavirus 2). Das Ayush-Ministerium der indischen Regierung empfahl Arsenicum album 30C als Prophylaxe zur COVID-19-Prävention. Das Ziel dieser Studie war die Beurteilung der Schutzwirkung und Sicherheit von Arsenicum album 30C.An unserer prospektiven, multizentrischen, Cluster-randomisierten, unverblindeten Parallelgruppen-Bevölkerungs-Studie nahmen gesund erscheinende Bewohner von Sperrzonen in sieben indischen Städten teil. Die Cluster waren definiert als die Bewohnerpopulation je einer Sperrzone, für welche Mobilitätsbeschränkungen galten. 42 Cluster wurden per Randomisierung im Verhältnis 2:1 dem Arsenicum-album-30C-Arm (30 Cluster) oder dem Kontrollarm (12 Cluster, die keine spezifische Behandlung erhielten) zugeteilt. Das Medikament wurde sieben Tage lang zweimal täglich angewendet. Die primäre Zielgröße war die COVID-19-Inzidenz laut der vom National Centre for Disease Control der indischen Regierung bekannt gegebenen Falldefinition in einem Nachbeobachtungszeitraum von drei Wochen.Die Analyse umfasste 32.186 Personen in 42 Clustern (Sperrzonen). Insgesamt 22.693 Personen in 30 Clustern erhielten Arsenicum album 30C, und 9.493 Personen in 12 Clustern wurden als Kontrollarm beobachtet. Die Ergebnisse für Alter, Geschlecht und Komorbidität waren im Behandlungs- und Kontrollarm vergleichbar. Die Gesamt-Schutzwirkung von Arsenicum album 30C betrug 80,22 % (95-%-Konfidenzintervall [KI]: 71,16­86,44; 40 Fälle unter 22.693 [6,04 pro 10.000 Personen-Wochen] im Arsenicum-album-30C-Arm vs. 84 Fälle unter 9.493 [29,78 pro 10.000 Personen-Wochen] im Kontrollarm). Die Schutzwirkung von Arsenicum album 30C gegen laboranalytisch bestätigte COVID-19-Erkrankung betrug 68,22 % (95-%-KI: 49,64­80; 32 Fälle unter 22.693 [4,83 pro 10.000 Personen-Wochen] im Arsenicum-album-30C-Arm vs. 42 Fälle unter 9.493 [14,93 pro 10.000 Personen-Wochen] im Kontrollarm). Die beobachteten unerwünschten Wirkungen waren in beiden Gruppen von geringer Schwere und klangen ohne Medikation folgenlos ab.Das Homöopathikum Arsenicum album 30C war im Vergleich zur Nichtbehandlung mit einer Verringerung der Inzidenz assoziiert und bot gewissen Schutz vor COVID-19. Weitere randomisierte, doppelblinde, placebokontrollierte Studien könnten durchgeführt werden, um die Ergebnisse dieser Studie zu validieren.