Klein K B
Division of Digestive Diseases and Nutrition, University of North Carolina School of Medicine, Chapel Hill.
Gastroenterology. 1988 Jul;95(1):232-41. doi: 10.1016/0016-5085(88)90319-8.
The irritable bowel syndrome (IBS) is a common and poorly understood chronic condition that is treated with a great variety of drugs and other therapies without notable enduring success. As there are no objective markers of improvement, and because there may be a very large placebo response, potential treatments for IBS are difficult to assess. Probably the only method that can reliably evaluate IBS therapies is the randomized, double-blind, placebo-controlled treatment trial. The purpose of this review is to critically examine issues central to establishing the efficacy of treatments for IBS in such trials. These include the definition of IBS, measures of efficacy, the placebo response, trial length, maintaining blindedness, the crossover design, ability to generalize, and statistical considerations. With this background, all published IBS treatment trials are examined. It is concluded that not a single study offers convincing evidence that any therapy is effective in treating the IBS symptom complex. Well-designed and executed IBS treatment trials are urgently needed; suggestions are given for essential features of such trials.
肠易激综合征（IBS）是一种常见但了解甚少的慢性疾病，目前使用了各种各样的药物和其他疗法进行治疗，但均未取得显著的持久疗效。由于缺乏改善的客观指标，并且可能存在非常大的安慰剂反应，因此IBS的潜在治疗方法难以评估。可能唯一能够可靠评估IBS疗法的方法是随机、双盲、安慰剂对照治疗试验。本综述的目的是严格审查在此类试验中确立IBS治疗疗效的核心问题。这些问题包括IBS的定义、疗效衡量指标、安慰剂反应、试验时长、保持盲法、交叉设计、推广能力以及统计学考量。基于此背景，对所有已发表的IBS治疗试验进行了审查。得出的结论是，没有一项研究能提供令人信服的证据表明任何疗法对治疗IBS症状复合体有效。迫切需要精心设计和执行的IBS治疗试验；文中给出了此类试验基本特征的建议。
