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2005年顺势疗法的荟萃分析:发表后数据的重要性。

The 2005 meta-analysis of homeopathy: the importance of post-publication data.

作者信息

Rutten A L B, Stolper C F

出版信息

Homeopathy. 2008 Oct;97(4):169-77. doi: 10.1016/j.homp.2008.09.008.

Abstract

BACKGROUND

There is a discrepancy between the outcome of a meta-analysis published in 1997 of 89 trials of homeopathy by Linde et al and an analysis of 110 trials by Shang et al published in 2005, these reached opposite conclusions. Important data were not mentioned in Shang et al's paper, but only provided subsequently.

QUESTIONS

What was the outcome of Shang et al's predefined hypotheses? Were the homeopathic and conventional trials comparable? Was subgroup selection justified? The possible role of ineffective treatments. Was the conclusion about effect justified? Were essential data missing in the original article?

METHODS

Analysis of post-publication data. Re-extraction and analysis of 21 higher quality trials selected by Shang et al with sensitivity analysis for the influence of single indications. Analysis of comparability. Sensitivity analysis of influence of subjective choices, like quality of single indications and of cut-off values for 'larger samples'.

RESULTS

The quality of trials of homeopathy was better than of conventional trials. Regarding smaller trials, homeopathy accounted for 14 out of 83 and conventional medicine 2 out of 78 good quality trials with n<100. There was selective inclusion of unpublished trials only for homeopathy. Quality was assessed differently from previous analyses. Selecting subgroups on sample size and quality caused incomplete matching of homeopathy and conventional trials. Cut-off values for larger trials differed between homeopathy and conventional medicine without plausible reason. Sensitivity analyses for the influence of heterogeneity and the cut-off value for 'larger higher quality studies' were missing. Homeopathy is not effective for muscle soreness after long distance running, OR=1.30 (95% CI 0.96-1.76). The subset of homeopathy trials on which the conclusion was based was heterogeneous, comprising 8 trials on 8 different indications, and was not matched on indication with those of conventional medicine. Essential data were missing in the original paper.

CONCLUSION

Re-analysis of Shang's post-publication data did not support the conclusion that homeopathy is a placebo effect. The conclusion that homeopathy is and that conventional is not a placebo effect was not based on comparative analysis and not justified because of heterogeneity and lack of sensitivity analysis. If we confine ourselves to the predefined hypotheses and the part of the analysis that is indeed comparative, the conclusion should be that quality of homeopathic trials is better than of conventional trials, for all trials (p=0.03) as well as for smaller trials (p=0.003).

摘要

背景

1997年林德等人发表的对89项顺势疗法试验的荟萃分析结果与2005年尚等人发表的对110项试验的分析结果存在差异,二者得出了相反的结论。尚等人的论文中未提及重要数据,而是后来才提供。

问题

尚等人预先设定的假设结果如何?顺势疗法试验与传统试验是否具有可比性?亚组选择是否合理?无效治疗的可能作用是什么?关于疗效的结论是否合理?原始文章中是否缺少关键数据?

方法

分析发表后的数据。对尚等人选择的21项质量较高的试验进行重新提取和分析,并对单一适应症的影响进行敏感性分析。分析可比性。对主观选择的影响进行敏感性分析,如单一适应症的质量和“较大样本”的临界值。

结果

顺势疗法试验的质量优于传统试验。对于规模较小的试验,在样本量小于100的高质量试验中,顺势疗法占83项中的14项,传统医学占78项中的2项。仅顺势疗法选择性纳入了未发表的试验。质量评估与之前的分析不同。根据样本量和质量选择亚组导致顺势疗法试验与传统试验不完全匹配。顺势疗法和传统医学中较大试验的临界值不同,且没有合理的理由。缺少对异质性影响和“质量较高的较大研究”临界值的敏感性分析。顺势疗法对长跑后的肌肉酸痛无效,比值比=1.30(95%可信区间0.96 - 1.76)。得出该结论所依据的顺势疗法试验子集具有异质性,包括针对8种不同适应症的8项试验,且在适应症方面与传统医学试验不匹配。原始论文中缺少关键数据。

结论

对尚发表后的数据进行重新分析并不支持顺势疗法是安慰剂效应的结论。顺势疗法是安慰剂效应而传统医学不是这一结论并非基于比较分析,且由于异质性和缺乏敏感性分析而不合理。如果我们局限于预先设定的假设以及确实具有可比性的分析部分,结论应该是,对于所有试验(p = 0.03)以及规模较小的试验(p = 0.003),顺势疗法试验的质量优于传统试验。

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