Mathie Robert T, Ramparsad Nitish, Legg Lynn A, Clausen Jürgen, Moss Sian, Davidson Jonathan R T, Messow Claudia-Martina, McConnachie Alex
Homeopathy Research Institute, London, UK.
Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Syst Rev. 2017 Mar 24;6(1):63. doi: 10.1186/s13643-017-0445-3.
A rigorous systematic review and meta-analysis focused on randomised controlled trials (RCTs) of non-individualised homeopathic treatment has not previously been reported. We tested the null hypothesis that the main outcome of treatment using a non-individualised (standardised) homeopathic medicine is indistinguishable from that of placebo. An additional aim was to quantify any condition-specific effects of non-individualised homeopathic treatment.
Literature search strategy, data extraction and statistical analysis all followed the methods described in a pre-published protocol. A trial comprised 'reliable evidence' if its risk of bias was low or it was unclear in one specified domain of assessment. 'Effect size' was reported as standardised mean difference (SMD), with arithmetic transformation for dichotomous data carried out as required; a negative SMD indicated an effect favouring homeopathy.
Forty-eight different clinical conditions were represented in 75 eligible RCTs. Forty-nine trials were classed as 'high risk of bias' and 23 as 'uncertain risk of bias'; the remaining three, clinically heterogeneous, trials displayed sufficiently low risk of bias to be designated reliable evidence. Fifty-four trials had extractable data: pooled SMD was -0.33 (95% confidence interval (CI) -0.44, -0.21), which was attenuated to -0.16 (95% CI -0.31, -0.02) after adjustment for publication bias. The three trials with reliable evidence yielded a non-significant pooled SMD: -0.18 (95% CI -0.46, 0.09). There was no single clinical condition for which meta-analysis included reliable evidence.
The quality of the body of evidence is low. A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions. Better designed and more rigorous RCTs are needed in order to develop an evidence base that can decisively provide reliable effect estimates of non-individualised homeopathic treatment.
此前尚未有针对非个体化顺势疗法治疗的随机对照试验（RCT）进行的严格系统评价和荟萃分析报道。我们检验了以下零假设：使用非个体化（标准化）顺势疗法药物治疗的主要结果与安慰剂治疗的结果无差异。另一个目的是量化非个体化顺势疗法治疗的任何特定病症的效果。
文献检索策略、数据提取和统计分析均遵循预先发表的方案中所述的方法。如果一项试验的偏倚风险较低或在一个特定评估领域不明确，则该试验包含“可靠证据”。“效应量”以标准化均数差（SMD）报告，对二分数据进行必要的算术转换；负的SMD表明顺势疗法更有效。
75项符合条件的RCT涉及48种不同的临床病症。49项试验被归类为“高偏倚风险”，23项为“不确定偏倚风险”；其余三项临床异质性试验显示出足够低的偏倚风险，可被指定为可靠证据。54项试验有可提取的数据：合并SMD为-0.33（95%置信区间（CI）-0.44，-0.21），在调整发表偏倚后降至-0.16（95%CI -0.31，-0.02）。三项具有可靠证据的试验得出的合并SMD无统计学意义：-0.18（95%CI -0.46，0.09）。没有一种临床病症的荟萃分析包含可靠证据。
证据质量较低。对所有可提取数据进行的荟萃分析导致我们拒绝零假设，但对一小部分可靠证据的分析并不支持该拒绝。特定病症的荟萃分析缺乏可靠证据，无法得出相关结论。需要设计更好、更严格的RCT，以便建立一个能决定性地提供非个体化顺势疗法治疗可靠效果估计的证据基础。
