A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia.
OBJECTIVE
To compare the efficacy of simethicone with placebo and the prokinetic cisapride in patients with functional dyspepsia.


METHODS
One hundred and eighty-five patients with functional dyspepsia were randomized and treated in a double-dummy technique with simethicone (105 mg t.d.s.), cisapride (10 mg t.d.s.) or placebo (t.d.s.). The primary outcome measure was the O'Brien global measure of the patients' rating of 10 upper gastrointestinal symptoms (graded as absent = 0, moderate = 1, severe = 2 or very severe = 3). Outcome measures were assessed at baseline and after 2, 4 and 8 weeks of treatment (intention-to-treat).


RESULTS
At 2, 4 and 8 weeks, treatment with simethicone and cisapride yielded significantly (all P values < 0.0001) better improvement of symptoms compared to placebo. Simethicone was significantly better than cisapride after 2 weeks (P = 0.0007), but the differences were not statistically significant after 4 and 8 weeks. Patients treated with simethicone judged the efficacy of their treatment as very good in 46% of cases, compared to 15% and 16% receiving cisapride and placebo, respectively.


CONCLUSIONS
Simethicone and cisapride were significantly better than placebo for symptom control in patients with functional dyspepsia after 2, 4 and 8 weeks of treatment. Simethicone was also superior to the prokinetic cisapride in the first 2 weeks of treatment.
Division of Gastroenterology and Hepatology, University of Essen, Germany. g.holtmann@uni-essen.de
G
G
Holtmann
J
J
Gschossmann
P
P
Mayr
N J
NJ
Talley
D000328:Adult; D000368:Aged; D020117:Cisapride / Q000627:therapeutic use*; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006305:Health Status Indicators; D016481:Helicobacter Infections / Q000150:complications; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D017060:Patient Satisfaction; D012841:Simethicone / Q000627:therapeutic use*; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D012841:Simethicone; D020117:Cisapride