Talley N J
Department of Medicine, University of Sydney, Nepean Hospital, Australia.
Gastroenterology. 1994 May;106(5):1174-83. doi: 10.1016/0016-5085(94)90007-8.
BACKGROUND/AIMS: Approximately 50% of patients with functional dyspepsia have Helicobacter pylori infection; it remains controversial whether this infection causes chronic symptoms, but rigorously conducted therapeutic trials should establish whether H. pylori plays a role in functional dyspepsia. The aim here was to determine whether the trials published over the past 10 years were methodologically adequate to establish a role for this infection in functional dyspepsia.
A broad-based Medline search to identify all treatment trials published between 1984 and 1993 was performed. All functional dyspepsia trials were systematically analyzed for potential design strengths and weaknesses.
Sixteen trials were included; 8 reported that anti-H. pylori therapy was efficacious and 8 failed to detect a statistically significant benefit. However, in all studies one or more serious methodological weakness was identified, including nonrandomized, non-placebo-controlled designs, lack of maintenance of blindness, application of inadequate outcome measures, failure to eradicate infection and follow up patients after therapy, and inadequate study power.
There is a pressing need for well-designed trials in H. pylori-positive dyspepsia, and practical suggestions are provided based on a review of the published literature.
背景/目的：约50%的功能性消化不良患者感染幽门螺杆菌；这种感染是否会导致慢性症状仍存在争议，但严格开展的治疗试验应能确定幽门螺杆菌在功能性消化不良中是否起作用。本文的目的是确定过去10年发表的试验在方法学上是否足以确定这种感染在功能性消化不良中的作用。
进行广泛的医学文献数据库检索，以识别1984年至1993年间发表的所有治疗试验。对所有功能性消化不良试验进行系统分析，以找出潜在的设计优点和缺点。
纳入了16项试验；8项报告抗幽门螺杆菌治疗有效，8项未检测到统计学上的显著益处。然而，在所有研究中都发现了一个或多个严重的方法学缺陷，包括非随机、非安慰剂对照设计、缺乏盲法维持、采用不充分的结局指标、未能根除感染以及治疗后未对患者进行随访，以及研究效能不足。
迫切需要针对幽门螺杆菌阳性消化不良进行设计良好的试验，并基于对已发表文献的综述提供了实用建议。
