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2015-03-02 陈波 编制 Acupuncture  Abstract: Background: Outcome reporting bias has received widespread recognition and been considered to pose two threats to the validity of clinical decision making because they overestimate the effect of treatments or distort the results of trials. However, the problem of outcome-reporting bias has not been systematically studied among randomized clinical trials of *acupuncture*. Our objectives were to evaluate the consistency between the registered records and subsequent publications评估注册数据与后来发表论文的一致性 with respectto outcomes and other data as well as to determine whether outcome-reporting bias favors significant primary outcomes.决定结果和报道是否存在偏倚。 Methods: A systematic search of 15 registries was conducted from their inception to January 2014 to identify randomized clinical trials on *acupuncture* for which the status was listed as 'completed.' The subsequent publications were retrieved by searching PubMed and three Chinese databases. Basic characteristics and the registration information were extracted from the registered records and publications.We performed comparisons regarding primary outcomes and other data between the registered records and subsequent publications to assess the consistency and selective outcome reporting. Results: Eighty-eight trials on *acupuncture* with 96 published reports were identified.纳入96篇报道，88个试验。 Only 19.3% (17/88) were registered before the start of the trial,只有19.3%在试验开始前进行了临床注册 suggesting prospective registration. The trial registration number was unavailable in 36 published reports (37.5%). A comparison of registered and published primary outcomes 注册与公开发表的数据进行比较could be conducted in 71 publications (74.0%), and the inconsistency of the primary outcomes was identified in 45.1% (32 of 71)45.1% 存在不一致性; 71.4% (15 of 21) had a discrepancy that favored statistically significant primary outcomes有利显著意义主要结局71.4%存在前后矛盾, while 28.6% (6 of 21) favored nonsignificant primary outcomes. Furthermore, the other inconsistencies between the registry records and subsequent publications involved the inclusion criteria (54.7%), exclusion criteria (47.9%) and controls (22.9%).54.7%纳入标准、47.9%排除标准，22.9%的对照 在注册记录和后来发表论文中存在不一致性。 Conclusions: We find that prospective registration for randomized clinical trials on *acupuncture* is insufficient, selective outcome reporting is prevalent, 选择性结果报道偏移目前较为严重and the change of primary outcomes is intended to favor statistical significance主要指标偏向关注利于有统计学意义的指标. These discrepancies in outcome reporting may lead to biased and misleading results of randomized clinical trials on *acupuncture*. 这些结果报道偏倚可以导致针灸随机对照试验结果错误或偏差 pian'chaTo ensure publication of reliable and unbiased results, further promotion and implementation of trial registration are still needed. |
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