Shinohara K, Tajika A, Imai H, Takeshima N, Hayasaka Y, Furukawa T A
Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
Acta Psychiatr Scand. 2015 Dec;132(6):489-98. doi: 10.1111/acps.12502. Epub 2015 Sep 14.
The selective reporting of favorable outcomes has a serious influence on our evidence base. However, this problem has not yet been systematically investigated in the field of psychiatry. Our study aimed to evaluate registration and outcome reporting in randomized controlled trials (RCTs) of standard treatments for depression: cognitive behavioural therapy (CBT) or new-generation antidepressants (ADs).
We searched for reports of RCTs examining the efficacy of CBT or AD for depression that were published between 2011 and 2013. We then compared their primary outcomes in the trial registries and those in publications.
We identified 170 trials. Among them, 92 trials (54.1%) were registered, 43 trials (25.3%) were properly registered, and only 32 (18.8%) trials were both properly registered and reported (the primary outcomes as recorded in the registries were reported in publications). There was no statistically significant difference in the proportions of properly registered and reported trials for CBT or AD (relative risk: 0.51, 95% CI: 0.25-1.03). High impact factor journals, commercial funding, publication of protocol, and relatively large sample size were significant predictors of proper registration and reporting.
The prevalence of proper registration and reporting is still very low in depression trials.
选择性报告有利结果对我们的证据基础有严重影响。然而，这一问题在精神病学领域尚未得到系统研究。我们的研究旨在评估抑郁症标准治疗的随机对照试验（RCT）中的注册情况和结果报告：认知行为疗法（CBT）或新一代抗抑郁药（ADs）。
我们检索了2011年至2013年发表的关于CBT或AD治疗抑郁症疗效的RCT报告。然后我们比较了试验注册库和出版物中的主要结果。
我们识别出170项试验。其中，92项试验（54.1%）进行了注册，43项试验（25.3%）进行了正确注册，只有32项试验（18.8%）既进行了正确注册又进行了结果报告（注册库中记录的主要结果在出版物中有所报告）。CBT或AD试验在正确注册和报告的比例上没有统计学上的显著差异（相对风险：0.51，95%置信区间：0.25 - 1.03）。高影响因子期刊、商业资助、方案的发表以及相对较大的样本量是正确注册和报告的显著预测因素。
抑郁症试验中正确注册和报告的发生率仍然很低。
