title: STW 5, a phytopharmacon for patients with functional dyspepsia: results of a multicenter, placebo-controlled double-blind study.
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.
  
  
  CONCLUSIONS
  This placebo-controlled study with an 8-wk treatment period documents the efficacy of STW 5 in FD.
authors.affiliation: Otto-von-Guericke-Universität Magdeburg, Zentrum für Innere Medizin, 39120 Magdeburg, Germany.
authors.forename: Ulrike
authors.initials: U
authors.lastname: von Arnim
authors.forename: Ulrich
authors.initials: U
authors.lastname: Peitz
authors.forename: Bettina
authors.initials: B
authors.lastname: Vinson
authors.forename: Karl-Josef
authors.initials: KJ
authors.lastname: Gundermann
authors.forename: Peter
authors.initials: P
authors.lastname: Malfertheiner
mesh_terms: D004311:Double-Blind Method; D004361:Drug Tolerance; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts; C039964:iberogast