Reporting of adverse effects in clinical trials should be improved: Lessons from acute postoperative pain
Reporting of adverse effects in clinical trials should be improved: Lessons from acute postoperative pain
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DOI：
10.1016/s0885-3924(99)00093-7
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发表时间：
1999-12-01
影响因子：
4.7
通讯作者：
Collins, SL
中科院分区：
文献类型：
--
作者：
Edwards, JE;McQuay, HJ;Collins, SL
我们评估了单剂量对乙酰氨基酚或布洛芬与安慰剂相比治疗中度至重度术后疼痛的随机、双盲临床试验中不良反应的评估和报告质量。通过系统检索一些书目数据库（例如，MEDLINE）。提取了关于不良反应评估、严重程度和报告、患者退出和所用麻醉剂的信息。注意到遵守了先前的不良反应报告指南。纳入了52项研究，其中2项未提及不良反应。19项研究未提供评估方法。20项试验没有报告所用麻醉剂的类型，8项没有提到患者退出，9项没有说明报告的不良反应的严重程度。只有两项研究描述了不良反应严重程度的评估方法。当汇总所有不良反应数据时，活性药物治疗组报告的不良反应显著多于安慰剂组。对于个体不良反应，活性药物（对乙酰氨基酚1000 mg或布洛芬400 mg）和安慰剂之间没有差异;例外情况是布洛芬400 mg组的嗜睡/困倦显著增加。90%的试验报告了布洛芬400 mg的嗜睡/困倦是牙痛。1994年以后发表的所有研究都符合以前的不良反应报告指南。评估不良反应的不同方法产生不同的报告发生率：患者日记产生的不良反应明显多于其他形式的评估。我们推荐临床试验中报告不良反应信息的指南。(C)美国癌症疼痛缓解委员会，1999年。
We assessed the quality of assessment and reporting of adverse effects in randomized, double-blind clinical trials of single-dose acetaminophen or ibuprofen compared with placebo in moderate to severe postoperative pain. Reports were identified by systematic searching of a number of bibliographic databases (e.g., MEDLINE). Information on adverse effect assessment, severity and reporting, patient withdrawals, and anesthetic used was extracted. Compliance with former guidelines for adverse effect reporting was noted. Fifty-two studies were included; two made no mention of adverse effects. No method of assessment was given in 19 studies. Twenty trials failed to report the type of anesthetic used, eight made no mention of patient withdrawals, and nine did not state the severity of reported adverse effects. Only two studies described the method of assessment of adverse effect severity. When all adverse effect data were pooled, significantly more adverse effects were reported with active treatment than with placebo. For individual adverse effects, there was no difference between active (acetaminophen 1000 mg or ibuprofen 400 mg) and placebo; the exception was significantly more somnolence/drowsiness with ibuprofen 400 mg. Ninety percent of trials reporting somnolence/drowsiness with ibuprofen 400 mg were in dental pain. All studies published after 1994 complied with former guidelines for adverse effect reporting. Different methods of assessing adverse effects produce different reported incidence: patient diaries yielded significantly more adverse effects than other forms of assessment. We recommend guidelines for reporting adverse effect information in clinical trials. (C) U.S. Cancer Pain Relief Committee, 1999.