Supplementary Material for: Efficacy of individualized homeopathic medicines in treatment of cervical spondylosis: Double-blind, randomized, placebo-controlled trial

Introduction: Cervical spondylosis (CS) is a degenerative condition of the cervical spine, with approximately 80-90% of people suffering from disc degeneration by the age of 50 years. This trial attempts at evaluating the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of CS. Methods: A 3-months, double-blind, randomized, placebo-controlled trial was conducted at the Organon of Medicine outpatient department of the National Institute of Homoeopathy, India. Patients were randomized to receive either IHMs (n=70) or identical-looking placebos (n=70) in the mutual context of concomitant conservative and standard physiotherapeutic care. Primary outcome measures were 0-10 Numeric Rating Scales (NRSs) for pain, stiffness, numbness, tingling, weakness, and vertigo, and the secondary outcome was Neck Disability Index (NDI); measured at baseline and every month, until 3 months. The intention-to-treat sample was analyzed to detect group differences and effect sizes. Results: Overall, improvements were clinically significant and higher in the IHMs group than placebo, but group differences were statistically non-significant with small effect sizes (all P>0.05, two-way repeated measure analysis of variance). After 2 months of time points, improvements observed in the IHMs group were significantly higher than placebo on a few occasions (e.g., pain NRS: P<0.001; stiffness NRS: P=0.024; weakness NRS: P=0.003). Sulfur (n=21; 15%) was the most frequently prescribed medication. No harm, unintended effects, or any serious adverse events were reported from either group. Conclusions: An encouraging, but non-significant direction of effect was elicited favoring IHMs against placebos in the treatment of CS. Trial registration: CTRI/2018/10/016156; UTN: U1111-1221-8064引言：颈椎病（Cervical spondylosis, CS）是一种颈椎退行性疾病，约80%~90%的人群在50岁时会出现椎间盘退变。本试验旨在评估个体化顺势疗法药物（Individualized Homeopathic Medicines, IHMs）对比安慰剂治疗颈椎病的临床疗效。 方法：本研究于印度国家顺势疗法研究院医学门诊开展一项为期3个月的双盲、随机、安慰剂对照试验。受试者被随机分配至个体化顺势疗法药物组（n=70）或外观一致的安慰剂组（n=70），两组均同步接受常规保守治疗与标准物理治疗。主要结局指标为针对疼痛、僵硬、麻木、刺痛、乏力及眩晕的0~10分数字评分量表（Numeric Rating Scales, NRSs），次要结局指标为颈部残疾指数（Neck Disability Index, NDI）；评估分别于基线及每月进行一次，直至3个月随访结束。本研究采用意向治疗样本进行组间差异与效应量分析。 结果：总体而言，个体化顺势疗法药物组的临床改善程度更高且具有临床意义，但组间差异未达到统计学显著性，效应量较小（所有P>0.05，双向重复测量方差分析）。在随访2个月后的时间节点中，个体化顺势疗法药物组在部分指标上的改善程度显著优于安慰剂组（例如疼痛NRS：P<0.001；僵硬NRS：P=0.024；乏力NRS：P=0.003）。最常开具的处方药物为硫磺（n=21，占比15%）。两组均未报告任何有害事件、非预期效应或严重不良事件。 结论：本研究结果显示，在颈椎病的治疗中，个体化顺势疗法药物的效应方向令人鼓舞，但未达到统计学显著性，其疗效仍优于安慰剂。 试验注册：CTRI/2018/10/016156；UTN: U1111-1221-8064