Miller Larry E
Ann Gastroenterol. 2014;27(4):338-345.
Clinical trials of therapies intended to alleviate symptoms of irritable bowel syndrome (IBS) are prevalent. However, the ideal study design remains elusive since there is no obvious pathophysiological target and no universally accepted endpoint to assess symptom improvement in IBS. The purpose of this paper is to identify and discuss the most problematic issues in the design of clinical trials intended to evaluate the effectiveness of treatments for IBS symptoms. Lack of standardized diagnostic criteria, symptom variability, heterogeneous subject characteristics, large placebo effects, lack of statistical power, inappropriate endpoint selection, and poorly selected study design are the most critical issues that may confound study outcomes in IBS clinical trials.
旨在缓解肠易激综合征（IBS）症状的治疗方法的临床试验很普遍。然而，理想的研究设计仍然难以捉摸，因为没有明显的病理生理靶点，也没有普遍接受的终点来评估IBS症状的改善情况。本文的目的是识别并讨论旨在评估IBS症状治疗效果的临床试验设计中最具问题的问题。缺乏标准化诊断标准、症状变异性、受试者特征异质性、安慰剂效应大、统计效力不足、终点选择不当以及研究设计选择不佳是可能混淆IBS临床试验研究结果的最关键问题。
