Rochon P A, Gurwitz J H, Simms R W, Fortin P R, Felson D T, Minaker K L, Chalmers T C
Geriatric Research Education and Clinical Center, Brockton/West Roxbury Veterans Affairs Medical Center, Boston, Mass.
Arch Intern Med. 1994 Jan 24;154(2):157-63.
To study the relation between reported drug performance in published trials and support of the trials by the manufacturer of the drug under evaluation, we studied a sample of trials of nonsteroidal anti-inflammatory drugs (NSAIDs) used in the treatment of arthritis.
All randomized control trials of NSAIDs published between September 1987 and May 1990 identified by MEDLINE were reviewed. If an article met the following criteria (n = 61), it was selected: trials involving adult patients with osteoarthritis or rheumatoid arthritis (n = 180), use of nonsalicylate NSAIDs marketed in the United States (n = 101), randomized control trial (n = 81), duration of the trial 4 or more days (n = 78), and use of an efficacy outcome measure (n = 61). Reviewers, "blinded" to manufacturer status, evaluated the narrative interpretation of results and extracted numeric data on efficacy and toxicity. Manufacturer-associated trials were defined as those that acknowledged an association with a pharmaceutical manufacturer. Because of the scarcity of non-manufacturer-associated trials (n = 9), we report only on the manufacturer-associated articles.
Fifty-two publications (85.2%) representing 56 trials were associated with a manufacturer. The manufacturer-associated drug was reported as comparable with (71.4%) or superior to (28.6%) the comparison drug in all 56 trials. These narrative claims of superiority were usually justified with trial data. Of the trials identifying one drug as less toxic (n = 22), the manufacturer-associated drug's safety was reported as superior to the comparison drug in 86.4% of cases. Justification for the narrative interpretation of the trial findings regarding less toxicity was provided in only 12 (54.5%) of 22 trials.
The manufacturer-associated NSAID is almost always reported as being equal or superior in efficacy and toxicity to the comparison drug. These claims of superiority, especially in regard to side effect profiles, are often not supported by trial data. These data raise concerns about selective publication or biased interpretation of results in manufacturer-associated trials.
为研究已发表试验中所报告的药物疗效与所评估药物制造商对试验的支持之间的关系，我们对用于治疗关节炎的非甾体抗炎药（NSAIDs）试验样本进行了研究。
回顾了MEDLINE在1987年9月至1990年5月期间收录的所有NSAIDs随机对照试验。若一篇文章符合以下标准（n = 61），则被选中：涉及成年骨关节炎或类风湿关节炎患者的试验（n = 180）、使用美国市场上销售的非水杨酸盐类NSAIDs（n = 101）、随机对照试验（n = 81）、试验持续时间为4天或更长（n = 78）以及使用疗效结局指标（n = 61）。对制造商情况“不知情”的评审人员评估了结果的叙述性解读，并提取了有关疗效和毒性的数值数据。与制造商相关的试验被定义为那些承认与制药商有关联的试验。由于非制造商关联试验数量稀少（n = 9），我们仅报告与制造商相关的文章。
代表56项试验的52篇出版物（85.2%）与制造商有关联。在所有56项试验中，与制造商相关的药物被报告为与对照药物相当（71.4%）或优于对照药物（28.6%）。这些关于优越性的叙述性声明通常有试验数据支持。在确定一种药物毒性较小的试验（n = 22）中，86.4%的病例报告与制造商相关的药物安全性优于对照药物。在22项试验中，只有12项（54.5%）为关于毒性较小的试验结果的叙述性解读提供了依据。
与制造商相关的NSAID几乎总是被报告为在疗效和毒性方面等同于或优于对照药物。这些关于优越性的声明，尤其是在副作用方面，往往没有试验数据支持。这些数据引发了对与制造商相关试验中选择性发表或结果偏倚解读的担忧。
