STW 5，一种用于功能性消化不良患者的植物药：一项多中心、安慰剂对照双盲研究的结果。

STW 5, a phytopharmacon for patients with functional dyspepsia: results of a multicenter, placebo-controlled double-blind study.

作者信息

von Arnim Ulrike, Peitz Ulrich, Vinson Bettina, Gundermann Karl-Josef, Malfertheiner Peter

机构信息

Otto-von-Guericke-Universität Magdeburg, Zentrum für Innere Medizin, 39120 Magdeburg, Germany.

出版信息

Am J Gastroenterol. 2007 Jun;102(6):1268-75. doi: 10.1111/j.1572-0241.2006.01183.x.

DOI:10.1111/j.1572-0241.2006.01183.x

PMID:17531013

Abstract

BACKGROUND

Functional dyspepsia (FD) constitutes a complex picture with a variety of epigastric symptoms. No standard therapy is currently available for FD.

OBJECTIVE

This multicenter, placebo-controlled, double-blind study evaluated the efficacy and tolerability of the herbal drug STW 5, mainly comprising a fresh plant extract from Iberis amara.

METHODS

Patients with FD were included. Gastrointestinal endoscopy, H. pylori-status, and a 7-day run-in phase were required. A total of 315 patients were treated with 3 x 20 drops/day of either STW 5 or placebo. Symptom assessment: day 0, 2, 4, and 8 wk of treatment. The principal outcome criterion was the change in a validated Gastrointestinal Symptom Score (GIS). Symptom severity was rated using the Likert scale.

RESULTS

A total of 315 patients remained in the safety population. Of them, 158 were treated with STW 5 and 157 with placebo. The intention-to-treat population comprised 308 patients. Dropout number was similar in both groups. GIS showed improvement during the treatment period. The STW 5 group improved 6.9+/-4.8 points up to day 56, placebo group by 5.9+/-4.3 (P<0.05). H. pylori did not influence the results. Drug tolerability and safety were similar in both groups.

CONCLUSION

This placebo-controlled study with an 8-wk treatment period documents the efficacy of STW 5 in FD.

摘要

背景

功能性消化不良（FD）表现为一系列复杂的上腹部症状。目前尚无针对FD的标准治疗方法。

目的

这项多中心、安慰剂对照、双盲研究评估了草药STW 5（主要由伊比利亚荠菜新鲜植物提取物组成）的疗效和耐受性。

方法

纳入FD患者。需要进行胃肠内镜检查、幽门螺杆菌状态检测以及为期7天的导入期。总共315例患者接受治疗，每天3次，每次20滴，分别给予STW 5或安慰剂。症状评估：治疗第0、2、4和8周。主要结局标准是经过验证的胃肠道症状评分（GIS）的变化。症状严重程度采用李克特量表进行评分。

结果

共有315例患者纳入安全性分析人群。其中，158例接受STW 5治疗，157例接受安慰剂治疗。意向性分析人群包括308例患者。两组的脱落人数相似。治疗期间GIS有所改善。至第56天，STW 5组改善了6.9±4.8分，安慰剂组改善了5.9±4.3分（P<0.05）。幽门螺杆菌感染情况不影响结果。两组的药物耐受性和安全性相似。