Supplementary Material for: Individualized homeopathic medicines in the treatment of post-COVID-19 fatigue in adults: A single-blind, randomized, placebo-controlled trial

Introduction: The coronavirus disease (COVID-19) is leading to unknown and unusual health conditions that are challenging to manage. Post-COVID-19 fatigue is one of those challenges, becoming increasingly common as the pandemic evolves, as it impairs the quality of life of an individual. This trial attempts to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults.
Methods: A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences.
Results: Group differences in both the primary (FAS total: F1, 58 = 14.356, P < 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, P < 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), Sulphur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups.
Conclusion: IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive, robust trials may be undertaken to confirm the findings.
Trial registration: CTRI/2022/03/041316

引言：新型冠状病毒病（COVID-19）引发了诸多难以管控的未知异常健康状况，新冠后疲劳综合征便是其中之一。随着疫情演变，该病症愈发普遍，严重损害患者的生活质量。本试验旨在探寻个体化顺势疗法药物（IHMs）对比安慰剂治疗成人新冠后疲劳综合征的初步疗效证据。
方法：本试验为为期3个月的单盲随机安慰剂对照平行组试验，于印度加尔各答顺势疗法医学院附属医院门诊开展。按1:1比例将60名受试者随机分为两组，分别接受个体化顺势疗法药物（IHMs，n=30）或外观一致的安慰剂（n=30）治疗。主要结局指标为疲劳评估量表（FAS），次要结局指标为日常生活影响结局量表（ORIDL），每3个月内每月测量一次。采用意向治疗样本进行比较分析，以检测组间差异。
结果：3个月随访后，主要结局指标（疲劳评估量表总分：F(1,58)=14.356，P<0.001）与次要结局指标（日常生活影响结局量表：F(1,58)=210.986，P<0.001）均显示个体化顺势疗法药物组优于安慰剂组。最常使用的药物为棒状石松（Lycopodium clavatum，11.7%）、硫（Sulphur，11.7%）、白砷（Arsenicum album，10%）与崖柏（Thuja occidentalis，10%）。两组均未报告任何损害、非预期效应、顺势疗法加重反应或严重不良事件。
结论：在成人新冠后疲劳综合征的治疗中，个体化顺势疗法药物的疗效显著优于安慰剂。未来可开展大规模严谨的确定性试验以验证本研究结果。
试验注册编号：CTRI/2022/03/041316