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顺势疗法的临床效果是安慰剂效应吗?顺势疗法与对抗疗法的安慰剂对照试验比较研究。

Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.

作者信息

Shang Aijing, Huwiler-Müntener Karin, Nartey Linda, Jüni Peter, Dörig Stephan, Sterne Jonathan A C, Pewsner Daniel, Egger Matthias

机构信息

Department of Social and Preventive Medicine, University of Berne, Berne, Switzerland.

出版信息

Lancet. 2005;366(9487):726-32. doi: 10.1016/S0140-6736(05)67177-2.

Abstract

BACKGROUND

Homoeopathy is widely used, but specific effects of homoeopathic remedies seem implausible. Bias in the conduct and reporting of trials is a possible explanation for positive findings of trials of both homoeopathy and conventional medicine. We analysed trials of homoeopathy and conventional medicine and estimated treatment effects in trials least likely to be affected by bias.

METHODS

Placebo-controlled trials of homoeopathy were identified by a comprehensive literature search, which covered 19 electronic databases, reference lists of relevant papers, and contacts with experts. Trials in conventional medicine matched to homoeopathy trials for disorder and type of outcome were randomly selected from the Cochrane Controlled Trials Register (issue 1, 2003). Data were extracted in duplicate and outcomes coded so that odds ratios below 1 indicated benefit. Trials described as double-blind, with adequate randomisation, were assumed to be of higher methodological quality. Bias effects were examined in funnel plots and meta-regression models.

FINDINGS

110 homoeopathy trials and 110 matched conventional-medicine trials were analysed. The median study size was 65 participants (range ten to 1573). 21 homoeopathy trials (19%) and nine (8%) conventional-medicine trials were of higher quality. In both groups, smaller trials and those of lower quality showed more beneficial treatment effects than larger and higher-quality trials. When the analysis was restricted to large trials of higher quality, the odds ratio was 0.88 (95% CI 0.65-1.19) for homoeopathy (eight trials) and 0.58 (0.39-0.85) for conventional medicine (six trials).

INTERPRETATION

Biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.

摘要

背景

顺势疗法被广泛应用,但其药物的特定疗效似乎难以置信。试验实施和报告过程中的偏倚可能是顺势疗法和传统医学试验得出阳性结果的原因。我们分析了顺势疗法和传统医学的试验,并估计了在最不可能受偏倚影响的试验中的治疗效果。

方法

通过全面的文献检索确定顺势疗法的安慰剂对照试验,检索涵盖19个电子数据库、相关论文的参考文献列表并与专家联系。从Cochrane对照试验注册库(2003年第1期)中随机选取与顺势疗法试验的疾病和结局类型相匹配的传统医学试验。数据进行了双人提取,结局进行编码,使得比值比低于1表示有益。被描述为双盲且随机化充分的试验被认为方法学质量较高。在漏斗图和meta回归模型中检查偏倚效应。

结果

分析了110项顺势疗法试验和110项匹配的传统医学试验。研究规模的中位数为65名参与者(范围为10至1573)。21项顺势疗法试验(19%)和9项(8%)传统医学试验质量较高。在两组中,规模较小和质量较低的试验显示出比规模较大和质量较高的试验更有益的治疗效果。当分析仅限于高质量的大型试验时,顺势疗法(8项试验)的比值比为0.88(95%可信区间0.65 - 1.19),传统医学(6项试验)的比值比为0.58(0.39 - 0.85)。

解读

顺势疗法和传统医学的安慰剂对照试验中均存在偏倚。在分析中考虑这些偏倚后,有微弱证据表明顺势疗法药物有特定疗效,但有强有力的证据表明传统干预措施有特定疗效。这一发现与顺势疗法的临床效果是安慰剂效应的观点相符。

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