Department of Medicine, Federal University of São Carlos, São Carlos 13565-905, Brazil.
Department of Medicine, Federal University of São Carlos, São Carlos 13565-905, Brazil.
J Integr Med. 2022 May;20(3):221-229. doi: 10.1016/j.joim.2022.03.003. Epub 2022 Mar 12.
Different homeopathic approaches have been used as supportive care for coronavirus disease 2019 (COVID-19) cases, but none has been tested in a clinical trial.
To investigate the effectiveness and safety of the homeopathic medicine, Natrum muriaticum LM2, for mild cases of COVID-19.
DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: A randomized, double-blind, two-armed, parallel, single-center, placebo-controlled clinical trial was conducted from June 2020 to April 2021 in São-Carlos, Brazil. Participants aged > 18 years, with influenza-like symptoms and positive result from a real-time polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 were recruited and randomized (1:1) into two groups that received different treatments during a period of at-home-isolation. One group received the homeopathic medicine Natrum muriaticum, prepared with the second degree of the fifty-millesimal dynamization (LM2; Natrum muriaticum LM2), while the other group received a placebo.
The primary endpoint was time until recovery from COVID-19 influenza-like symptoms. Secondary measures included a survival analysis of the number and severity of COVID-19 symptoms (influenza-like symptoms plus anosmia and ageusia) from a symptom grading scale that was informed by the participant, hospital admissions, and adverse events. Kaplan-Meier curves were used to estimate time-to-event (survival) measures.
Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between two groups among participants who were reporting influenza-like symptoms at the beginning of monitoring (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least 5 moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04), among the participants with a basal symptom score ≥ 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022). Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group.
Results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19.
UMIN Clinical Trials Registry ID: JPRN-UMIN000040602.
针对 2019 年冠状病毒病（COVID-19）病例，已经使用了不同的顺势疗法方法作为支持性护理，但没有一种方法在临床试验中进行过测试。
研究顺势疗法药物 Natrum muriaticum LM2 对 COVID-19 轻症病例的有效性和安全性。
设计、地点、参与者和干预措施：这是一项 2020 年 6 月至 2021 年 4 月在巴西圣卡洛斯进行的随机、双盲、双臂、平行、单中心、安慰剂对照临床试验。招募了年龄>18 岁、有流感样症状且实时聚合酶链反应检测严重急性呼吸综合征冠状病毒 2 呈阳性的参与者，并随机（1:1）分为两组，在居家隔离期间接受不同的治疗。一组接受顺势疗法药物 Natrum muriaticum，用第二十度五十毫微动态制剂（LM2；Natrum muriaticum LM2）制备，另一组接受安慰剂。
主要终点是 COVID-19 流感样症状恢复的时间。次要结局指标包括从症状分级量表中报告的 COVID-19 症状（流感样症状加上嗅觉丧失和味觉丧失）的生存分析，该量表由参与者提供信息，并包括住院和不良事件。Kaplan-Meier 曲线用于估计时间至事件（生存）的措施。
对 86 名参与者的数据进行了分析（顺势疗法组，n=42；安慰剂组，n=44）。在开始监测时报告有流感样症状的参与者中，两组之间的恢复时间没有差异（顺势疗法组，n=41；安慰剂组，n=41；P=0.56），在开始监测时至少有 5 例中度至重度流感样症状的亚组中也没有差异（顺势疗法组，n=15；安慰剂组，n=17；P=0.06）。次要结局指标表明，在基础症状评分≥5 的患者中，顺势疗法组的症状评分降低 50%的时间明显更早（顺势疗法组，n=24；安慰剂组，n=25；P=0.04）。此外，受限平均生存时间的值表明，接受顺势疗法的患者在随访的前 5 天内可能更快地恢复了 0.9 天（P=0.022）。顺势疗法组的住院率为 2.4%，安慰剂组为 6.8%（P=0.62）。参与者报告在顺势疗法组中有 3 例不良事件，在安慰剂组中有 6 例。
结果表明，Natrum muriaticum LM2 用于 COVID-19 是安全的，但在轻度 COVID-19 病例中，Natrum muriaticum LM2 与安慰剂的主要终点无统计学显著差异。尽管一些次要措施不支持零假设，但较宽的置信区间表明，需要进一步进行更大样本量和更多症状参与者的研究，以测试顺势疗法 Natrum muriaticum LM2 对 COVID-19 的有效性。
UMIN 临床试验注册 ID：JPRN-UMIN000040602。
