Moore R Andrew, Derry Sheena
Pain Research, Nuffield Division of Anaesthetics, University of Oxford, The Churchill, OX3 7LE Oxford, UK.
Pain Res Manag. 2018 Jan 17;2018:9493413. doi: 10.1155/2018/9493413. eCollection 2018.
We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs) and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, =519), gynaecological surgery (3 trials, =679), and dysmenorrhoea (2 trials, =711) conducted in 1988-1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal. Greater methodological information in CSRs contributed to lesser risk of bias than published trials. Numbers needed to treat (NNT) from CSRs for all six postoperative trials for at least 50% of maximum pain relief over 6 h were 2.2 (95% confidence interval, 1.9-2.6) and 2.1 (1.8-2.4) for 50 and 100 mg diclofenac potassium, respectively. A Cochrane review of published trial data reported NNTs of 2.1 and 1.9, and one comprehensive analysis reported NNTs of 2.2 and 2.1, respectively. All analyses had similar results for patients remedicating within 8 h. No data from dysmenorrhoea CSRs appeared in a Cochrane review. CSRs provide useful information and increase confidence. Stable efficacy estimates with standard study designs reduce the need for updating reviews.
我们比较了双氯芬酸钾在未发表的临床研究报告（CSR）和已发表报告中的疗效，以检验发表偏倚、行业偏倚和全面性。诺华公司提供了1988 - 1990年进行的双氯芬酸钾随机双盲试验的CSR，这些试验涉及第三磨牙拔除术后患者（3项试验，n = 519）、妇科手术（3项试验，n = 679）和痛经（2项试验，n = 711）。检索发现了6项试验的已发表报告。1909例患者中有599例的信息未发表；846/1909例患者的试验发表在一本已停刊的杂志上。与已发表的试验相比，CSR中更多的方法学信息有助于降低偏倚风险。对于所有六项术后试验，在6小时内至少实现最大疼痛缓解50%时，双氯芬酸钾50毫克和100毫克的CSR所需治疗人数（NNT）分别为2.2（95%置信区间，1.9 - 2.6）和2.1（1.8 - 2.4）。对已发表试验数据的Cochrane综述报告的NNT分别为2.1和1.9，一项综合分析报告的NNT分别为2.2和2.1。对于在8小时内重新用药的患者，所有分析结果相似。痛经CSR的数据未出现在Cochrane综述中。CSR提供了有用的信息并增加了可信度。采用标准研究设计得出的稳定疗效估计值减少了更新综述的必要性。
