Randomised double-blind comparison of simethicone with cisapride in functional dyspepsia.
OBJECTIVE
To compare the efficacy of simethicone with cisapride in patients with functional (non-ulcer) dyspepsia.


METHODS
After standardized diagnostic work-up and at least 6-days wash-out of medication, 177 patients with functional dyspepsia were enrolled; 173 of them (age 19-71 years) were randomized and treated using a double-dummy technique with simethicone (84 mg t.d.s.) or cisapride (10 mg t.d.s.). At baseline and after 2 and 4 weeks, the intensity of the symptoms was scored from 0 (absent) to 3 (severe) using a standardized symptom questionnaire. Efficacy of the treatment was judged by the patients as 'very good', 'good', 'moderate' or 'no effect'.


RESULTS
A total of 166 patients completed the trial. After 2 and 4 weeks, 34% and 46% (respectively), of the patients treated with simethicone judged the improvement in symptoms to be excellent compared to 13% and 22% (respectively) of patients treated with cisapride (P < 0.01). After 2 weeks the difference in the improvement in the global symptom score was significantly better (Delta30.7%, P < 0.001) for simethicone than for cisapride, while this difference failed statistical significance after 4 weeks (Delta10.2%, P=0.11).


CONCLUSIONS
In patients with functional dyspepsia, simethicone relieves symptoms during the first 2 weeks of treatment significantly better than cisapride.
Holtmann
G
G
Division of Gastroenterology, University of Essen, Germany. g.holtmann@uni-essen.de
Gschossmann
J
J
Karaus
M
M
Fischer
T
T
Becker
B
B
Mayr
P
P
Gerken
G
G
D020117:Cisapride / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D012841:Simethicone / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors
D005765:Gastrointestinal Agents; D012841:Simethicone; D020117:Cisapride