Mathie Robert T, Ulbrich-Zürni Susanne, Viksveen Petter, Roberts E Rachel, Baitson Elizabeth S, Legg Lynn A, Davidson Jonathan R T
Homeopathy Research Institute, London, United Kingdom.
Department of Research, Swiss Homeopathy Association, Zürich, Switzerland.
Homeopathy. 2018 Nov;107(4):229-243. doi: 10.1055/s-0038-1667129. Epub 2018 Aug 18.
This study focuses on randomised controlled trials (RCTs) of individualised homeopathic treatment (IHT) in which the control (comparator) group was other than placebo (OTP).
To determine the comparative effectiveness of IHT on health-related outcomes in adults and children for any clinical condition that has been the subject of at least one OTP-controlled trial. For each study, to assess the risk of bias and to determine whether its study attitude was predominantly 'pragmatic' or 'explanatory'.
Systematic review. For each eligible trial, published in the peer-reviewed literature up to the end of 2015, we assessed its risk of bias (internal validity) using the seven-domain Cochrane tool, and its relative pragmatic or explanatory attitude (external validity) using the 10-domain tool. We grouped RCTs by whether they examined IHT as an alternative treatment (study design Ia), adjunctively with another intervention (design Ib), or compared with a no-intervention group (design II). For each RCT, we identified a 'main outcome measure' to use in meta-analysis: 'relative effect size' was reported as odds ratio (OR; values >1 favouring homeopathy) or standardised mean difference (SMD; values < 0 favouring homeopathy).
Eleven RCTs, representing 11 different medical conditions, were eligible for study. Five of the RCTs (four of which in design Ib) were judged to have pragmatic study attitude, two were explanatory, and four were equally pragmatic and explanatory. Ten trials were rated 'high risk of bias' overall: one of these, a pragmatic study with design Ib, had high risk of bias solely regarding participant blinding (a bias that is intrinsic to such trials); the other trial was rated 'uncertain risk of bias' overall. Eight trials had data that were extractable for analysis: for four heterogeneous trials with design Ia, the pooled OR was statistically non-significant; collectively for three clinically heterogeneous trials with design Ib, there was a statistically significant SMD favouring adjunctive IHT; in the remaining trial of design 1a, IHT was non-inferior to fluoxetine in the treatment of depression.
Due to the low quality, the small number and the heterogeneity of studies, the current data preclude a decisive conclusion about the comparative effectiveness of IHT. Generalisability of findings is limited by the variable external validity identified overall; the most pragmatic study attitude was associated with RCTs of adjunctive IHT. Future OTP-controlled trials in homeopathy should aim, as far as possible, to promote both internal validity and external validity.
本研究聚焦于个体化顺势疗法（IHT）的随机对照试验（RCT），其中对照组（比较组）并非安慰剂（OTP）。
确定IHT对于成人和儿童与健康相关结局的比较有效性，针对任何已开展至少一项OTP对照试验的临床病症。对于每项研究，评估偏倚风险并确定其研究态度主要是“实用主义”还是“解释性”。
系统评价。对于截至2015年底发表在同行评审文献中的每项合格试验，我们使用七领域Cochrane工具评估其偏倚风险（内部效度），并使用十领域工具评估其相对实用主义或解释性态度（外部效度）。我们根据RCT是否将IHT作为替代治疗（研究设计Ia）、与另一种干预措施联合使用（设计Ib）或与无干预组进行比较（设计II）进行分组。对于每项RCT，我们确定一个“主要结局指标”用于荟萃分析：“相对效应量”报告为比值比（OR；值>1支持顺势疗法）或标准化均数差（SMD；值<0支持顺势疗法）。
11项RCT符合研究条件，代表11种不同的医学病症。其中5项RCT（4项为设计Ib）被判定具有实用主义研究态度，2项为解释性，4项实用主义和解释性程度相同。总体而言，10项试验被评为“高偏倚风险”：其中一项设计Ib的实用主义研究仅在参与者盲法方面存在高偏倚风险（此类试验固有的偏倚）；另一项试验总体被评为“不确定偏倚风险”。8项试验有可提取用于分析的数据：对于4项设计Ia的异质性试验，汇总OR无统计学意义；对于3项设计Ib的临床异质性试验，总体上存在支持辅助IHT的统计学显著SMD；在其余一项设计Ia的试验中，IHT在治疗抑郁症方面不劣于氟西汀。
由于研究质量低、数量少且存在异质性，当前数据无法就IHT的比较有效性得出决定性结论。研究结果的可推广性受到总体确定的可变外部效度的限制；最实用主义的研究态度与辅助IHT的RCT相关。未来顺势疗法的OTP对照试验应尽可能提高内部效度和外部效度。
