Akehurst R, Kaltenthaler E
School of Health and Related Research (ScHARR) University of Sheffield, Regent Court, 30 Regent Street Sheffield S1 4DA, UK.
Gut. 2001 Feb;48(2):272-82. doi: 10.1136/gut.48.2.272.
Irritable bowel syndrome (IBS) is a common chronic disorder that is associated with significant disability and health care costs. The purpose of this paper is to review and assess published randomised controlled trials examining the clinical effectiveness of interventions for IBS for 1987-1998. A literature search was conducted to identify randomised controlled trials of IBS treatments: 45 studies were identified that described randomised controlled trials and of these, six fulfilled all three criteria used to assess the quality of randomised controlled trials, as described by Jadad and colleagues.(1) These criteria are: adequate description of randomisation, double blinding, and description of withdrawals and dropouts. It is concluded that there are few studies which offer convincing evidence of effectiveness in treating the IBS symptom complex. This review strongly suggests that future work should include well designed trials that: describe the randomisation method; use internationally approved diagnostic criteria; and are double blinded and placebo controlled. Clear well defined outcome measures are necessary. Inclusion of quality of life measures allows comparison between trials in different therapeutic areas. Conducting such studies will help to overcome some of the difficulties identified in this review.
肠易激综合征(IBS)是一种常见的慢性疾病,与严重的功能障碍和医疗费用相关。本文的目的是回顾和评估1987年至1998年间发表的关于IBS干预措施临床有效性的随机对照试验。进行了文献检索以确定IBS治疗的随机对照试验:共识别出45项描述随机对照试验的研究,其中六项符合Jadad及其同事所描述的用于评估随机对照试验质量的所有三项标准。(1)这些标准是:随机化的充分描述、双盲以及对退出和失访的描述。结论是,很少有研究能提供令人信服的证据证明对IBS症状复合体的治疗有效。本综述强烈建议未来的研究应包括精心设计的试验,这些试验应:描述随机化方法;使用国际认可的诊断标准;采用双盲和安慰剂对照。明确界定的结局指标是必要的。纳入生活质量指标可使不同治疗领域的试验之间进行比较。开展此类研究将有助于克服本综述中确定的一些困难。