Publication and outcome reporting of homeopathy trials registered in ClinicalTrials.gov

Elizabeth T Thomas, Justin Clark BA, LibTech, Paul Glasziou FRACGP, PhD
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引用次数: 6

Abstract

Background

Homeopathy is gaining popularity globally, despite a lack of convincing evidence of its efficacy. For example, a 2015 review by the Australian National Health and Medical Research Council (NHMRC) found no discernible convincing effects beyond placebo. However, a concern was that publication bias and outcome reporting bias could have influenced the results of the included systematic reviews.

Objectives

To study (i) the rates of non-publication and (ii) rates and types of alteration of planned outcomes of homeopathy studies registered in ClinicalTrials.gov.

Methods

We searched ClinicalTrials.gov for all homeopathy trials completed more than 2 years ago. We then checked the trial's publication status by examining the publication field in ClinicalTrials.gov, searching PubMed and finally Google Scholar. We also checked whether the registered primary outcome matched the published primary outcome.

Results

We found 35 registered homeopathy trials, from 11 countries, completed at least 2 years ago. Of these 35, we found 16 (46%) publications in MEDLINE and Google Scholar. In four (of 16), the primary outcome measures had been switched or modified.

Conclusions

Of all homeopathy trials registered in ClinicalTrials.gov, only 46% appear to have published within 2 years of completion, of which a quarter altered their primary endpoint. Further research is warranted on the nature and reasons for non-publication.

在ClinicalTrials.gov上注册的顺势疗法试验的发表和结果报告
顺势疗法在全球越来越受欢迎,尽管缺乏令人信服的证据证明其疗效。例如,2015年澳大利亚国家健康和医学研究委员会(NHMRC)的一项审查发现,除了安慰剂之外,没有明显的令人信服的效果。然而,值得关注的是,发表偏倚和结果报告偏倚可能会影响纳入系统评价的结果。目的研究(i)在ClinicalTrials.gov上注册的顺势疗法研究的未发表率和(ii)计划结果改变的率和类型。方法:我们在ClinicalTrials.gov网站上搜索所有2年前完成的顺势疗法试验。然后,我们通过检查ClinicalTrials.gov的发表字段,搜索PubMed,最后搜索Google Scholar来检查试验的发表状态。我们还检查了登记的主要结局是否与发表的主要结局相符。结果我们发现来自11个国家的35项注册顺势疗法试验至少在2年前完成。在这35篇论文中,我们在MEDLINE和Google Scholar上发现了16篇(46%)论文。在4个(16个中的4个)中,主要结果测量已经改变或修改。在ClinicalTrials.gov上注册的所有顺势疗法试验中,只有46%的试验在完成后两年内发表,其中四分之一的试验改变了其主要终点。有必要对未发表的性质和原因进行进一步的研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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