IngentaConnect STW 5, a Phytopharmacon for Patients With Functional Dyspepsia: R...

Authors: von Arnim, Ulrike¹; Peitz, Ulrich¹; Vinson, Bettina²; Gundermann, Karl-Josef³; Malfertheiner, Peter¹

Source: The American Journal of Gastroenterology, Volume 102, Number 6, June 2007 , pp. 1268-1275(8)

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 × 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.

(Am J Gastroenterol 2007;102:1268-1275)

Document Type: Research article

DOI: 10.1111/j.1572-0241.2006.01183.x

Affiliations: 1: Otto-von-Guericke-Universität Magdeburg, Zentrum für Innere Medizin, 39120 Magdeburg, Germany 2: Steigerwald Arzneimittelwerk GmbH, 64295 Darmstadt, Germany 3: GMC, 50933 Köln, Germany

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STW 5, a Phytopharmacon for Patients With Functional Dyspepsia: Results of a Multicenter, Placebo-Controlled Double-Blind Study