Cochrane协作撤回了一篇关于哌甲酯治疗成人注意缺陷多动障碍的综述。

Evidence-Based Medicine Pub Date : 2017-08-01 Epub Date: 2017-07-13 DOI:10.1136/ebmed-2017-110716
Kim Boesen, Luis Carlos Saiz, Juan Erviti, Ole Jakob Storebø, Christian Gluud, Peter C Gøtzsche, Karsten Juhl Jørgensen
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引用次数: 19

摘要

2016年5月26日,一篇关于哌醋甲酯即刻释放治疗成人注意力缺陷多动障碍(ADHD)的Cochrane系统综述在其方法和有缺陷的结论遭到大量批评后从Cochrane图书馆撤回。在此基础上撤回科学论文是不寻常的,但可能是必要的。我们对导致撤军的批评进行了总结。我们详细介绍了撤回的Cochrane系统综述的方法学缺陷,以及纳入的ADHD试验的偏倚和缺点的一般问题:与平行组设计比较的交叉设计,排除有精神合并症的参与者,缺乏“功能结果”和使用相关性有限的临床结果,试验持续时间短,试验人群小,由容易识别的副作用引起的破碎盲法,结合试验研究者和参与者的结果评估,结果报告偏倚,对心血管和精神危害的不良评价以及试验人员和系统审稿人的利益冲突。Cochrane系统综述的退出标志着对先前不可靠的ADHD临床研究的认可。我们的结论是,哌醋甲酯即刻释放治疗成人ADHD的临床试验质量很低。我们迫切需要进行良好的、无偏见的长期试验,以评估中枢兴奋剂治疗成人多动症的利与弊。
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The Cochrane Collaboration withdraws a review on methylphenidate for adults with attention deficit hyperactivity disorder.

A Cochrane systematic review on immediate-release methylphenidate for adults with attention deficit hyperactivity disorder (ADHD) was withdrawn from the Cochrane Library on 26 May 2016 after substantial criticism of its methods and flawed conclusions. Retraction of scientific papers on this basis is unusual but can be necessary. We provide a summary of the criticism that led to the withdrawal. We detail the methodological flaws of the withdrawn Cochrane systematic review and general issues of bias and shortcomings of the included ADHD trials: cross-over designs compared with parallel-group designs, exclusion of participants with psychiatric comorbidity, absence of 'functional outcomes' and use of clinical outcomes with limited relevance, short trial duration and small trial populations, broken blinding caused by easily recognisable side effects, combining outcome assessments by trial investigators and participants, outcome reporting bias, poor evaluation of cardiovascular and psychiatric harms and conflicts of interest of trialists and systematic reviewers. The withdrawal of the Cochrane systematic review signals recognition of previous unreliable clinical ADHD research. We conclude that clinical trials of immediate-release methylphenidate in adults with ADHD are of very low quality. We urgently need well-conducted long-term trials free of bias to assess the benefits and harms of central stimulant treatment in adult ADHD.

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