Cucherat M, Haugh M C, Gooch M, Boissel J P
Department of Clinical Pharmacology, Hospitals of Lyon and University Claude Bernard, France.
Eur J Clin Pharmacol. 2000 Apr;56(1):27-33. doi: 10.1007/s002280050716.
To establish, using a systematic review and meta-analysis, whether there is any evidence from randomised controlled clinical trials of the efficacy of homeopathic treatment in patients with any disease.
Published and unpublished reports of controlled clinical trials available up to June 1998, identified by searching bibliographic databases (Medline, Embase, Biosis, PsychInfo, Cinahl, British Library Stock Alert Service, SIGLE, Amed), references lists of selected papers, hand searching homeopathic journals and conference abstracts, and contacting pharmaceutical companies. TRIALS SELECTION: Trials were selected using an unblinded process by two reviewers. The selection criteria were randomised, controlled trials in which the efficacy of homeopathic treatment was assessed relative to placebo in patients using clinical or surrogate endpoints. Prevention trials or those evaluating only biological effects were excluded. One hundred and eighteen randomised trials were identified and evaluated for inclusion. Sixteen trials, representing 17 comparisons and including a total of 2,617 evaluated patients, fulfilled the inclusion criteria.
Data were extracted by two reviewers independently, using a summary form. Disagreements were resolved by a third person.
The evidence was synthesised by combining the significance levels (P values) for the primary outcomes from the individual trials. The combined P value for the 17 comparisons was highly significant P = 0.000036. However, sensitivity analysis showed that the P value tended towards a non-significant value (P = 0.08) as trials were excluded in a stepwise manner based on their level of quality.
There is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials. Studies of high methodological quality were more likely to be negative than the lower quality studies. Further high quality studies are needed to confirm these results.
通过系统评价和荟萃分析,确定是否有来自随机对照临床试验的证据表明顺势疗法对任何疾病患者有效。
截至1998年6月可获取的已发表和未发表的对照临床试验报告,通过检索书目数据库(医学在线数据库、荷兰医学文摘数据库、生物学文摘数据库、心理学文摘数据库、护理学与健康领域数据库、大英图书馆藏书警报服务、灰色文献数据库、澳大利亚医学文献数据库)、所选论文的参考文献列表、手工检索顺势疗法期刊和会议摘要以及联系制药公司来识别。
由两名评审员采用非盲法进行试验选择。选择标准为随机对照试验,其中使用临床或替代终点评估顺势疗法相对于安慰剂在患者中的疗效。排除预防试验或仅评估生物学效应的试验。共识别并评估了118项随机试验以确定是否纳入。16项试验,代表17组比较,共纳入2617例评估患者,符合纳入标准。
由两名评审员独立使用汇总表提取数据。分歧由第三人解决。
通过合并各个试验主要结局的显著性水平(P值)来综合证据。17组比较的合并P值高度显著,P = 0.000036。然而,敏感性分析表明,随着根据试验质量水平逐步排除试验,P值趋向于无显著性意义的值(P = 0.08)。
有一些证据表明顺势疗法比安慰剂更有效;然而,由于试验的方法学质量较低,该证据的强度较弱。方法学质量高的研究比质量低的研究更有可能得出阴性结果。需要进一步的高质量研究来证实这些结果。