Epidemic Cell, Central Council for Research in Homoeopathy, New Delhi, India.
Clinical Research, Homoeopathy Research Institute for Disabilities, Chennai, India.
Complement Med Res. 2023;30(5):375-385. doi: 10.1159/000526897. Epub 2022 Oct 4.
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.
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.
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.
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.
在 COVID-19 大流行的早期阶段，非药物干预措施是预防严重急性呼吸系统综合征冠状病毒 2 的策略。印度 Ayush 部建议将三氧化二砷 30C 作为预防 COVID-19 的药物。本研究旨在评估三氧化二砷 30C 的保护效果和安全性。
我们开展了一项前瞻性、多中心、集群随机、平行分组、基于社区的开放性研究，纳入了印度 7 个城市中居住在隔离区的明显健康个体。集群被定义为居住在限制行动的隔离区的人群。将 42 个集群按 2:1 的比例随机分配至三氧化二砷 30C 组（30 个集群）或对照组（12 个集群，未接受特定治疗）。药物每日两次给药，共 7 天。主要结局是根据印度国家疾病控制中心通知的病例定义，在 3 周随访期间 COVID-19 的发病情况。
分析纳入了 42 个集群（隔离区）中的 32186 名个体。30 个集群中的 22693 人接受了三氧化二砷 30C 治疗，12 个集群中的 9493 人作为对照组进行观察。三氧化二砷 30C 的总体保护作用为 80.22%（95%置信区间[CI]：71.16-86.44；每 10000 人-周出现 40 例病例[每 10000 人-周 6.04 例]，三氧化二砷 30C 组 vs. 每 10000 人-周 84 例病例[每 10000 人-周 29.78 例]，对照组）。三氧化二砷 30C 对实验室确诊 COVID-19 的保护作用为 68.22%（95%CI：49.64-80；每 10000 人-周出现 32 例病例[每 10000 人-周 4.83 例]，三氧化二砷 30C 组 vs. 每 10000 人-周出现 42 例病例[每 10000 人-周 14.93 例]，对照组）。两组均观察到的不良反应轻微，无需药物治疗即可缓解且无后遗症。
与未治疗相比，顺势疗法药物三氧化二砷 30C 可降低 COVID-19 的发病率并提供一定程度的保护。可能需要进一步开展随机、双盲、安慰剂对照试验来验证本研究的结果。
