Efficacy of cisapride therapy in functional dyspepsia.
OBJECTIVE
To assess the efficacy of cisapride therapy in relieving symptoms of functional dyspepsia.


METHODS
After a 2-week placebo run-in period, 61 out of 74 patients were eligible to enter a 4-week double-blind treatment phase, consisting of treatment with cisapride (10 mg) or placebo tablets t.d.s. Gastric emptying was assessed scintigraphically at entry to the study. Patients were stratified before treatment into those with or without active chronic (Helicobacter pylori) gastritis. Patients were also classified retrospectively into those with 'reflux-like' dyspepsia (n = 29) and those with 'motility-like' dyspepsia (n = 32).


RESULTS
At the end of the active treatment phase, there was a similar significant (P < 0.001) reduction in total symptom score from baseline in both cisapride (8.9 +/- 0.5 to 5.8 +/- 0.6) and placebo (9.7 +/- 0.6 to 5.5 +/- 0.6) groups. Scores for heartburn and continual bloating were significantly reduced in the cisapride but not the placebo group; improvement was attributable to patients with normal, rather than delayed, rates of gastric emptying. For continual bloating, significant improvement also occurred in the cisapride subgroup without gastritis, but not in the subgroup with gastritis (mean symptom score reduction 0.48 +/- 0.18, P = 0.03). For global evaluation by the investigator and by the patient, the overall improvement rates were not statistically different between cisapride and placebo groups. In those with normal gastric emptying, however, there was a significant (P = 0.01) improvement in general well-being in the cisapride but not in the placebo group.


CONCLUSIONS
We were unable to show major differences in the short-term efficacy of cisapride and placebo in functional dyspepsia. There were indications, however, of beneficial effects of cisapride over placebo in those with 'reflux-like' dyspepsia, and in those without gastroparesis.
Kellow
J E
JE
Department of Gastroenterology, Royal North Shore Hospital, Sydney, Australia.
Cowan
H
H
Shuter
B
B
Riley
J W
JW
Lunzer
M R
MR
Eckstein
R P
RP
Höschl
R
R
Lam
S K
SK
D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D020117:Cisapride; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy*; D004884:Eructation; D005260:Female; D005746:Gastric Emptying / Q000187:drug effects; D006356:Heartburn / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010880:Piperidines / Q000627:therapeutic use*; D013997:Time Factors
D000897:Anti-Ulcer Agents; D010880:Piperidines; D020117:Cisapride