A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN Study.
BACKGROUND
The management of Helicobacter pylori negative patients with dyspepsia in primary care has not been studied in placebo-controlled studies.


METHODS
H. pylori negative patients with dyspepsia symptoms of at least moderate severity (> or =4 on a seven-point Likert scale) were recruited from 35 centers. Patients were randomized to a 4-wk treatment of omeprazole 20 mg od, ranitidine 150 mg bid, cisapride 20 mg bid, or placebo, followed by on-demand therapy for an additional 5 months. Treatment success was defined as no or minimal symptoms (score < or = 2 out of 7), and was assessed after 4 wk and at 6 months.


RESULTS
Five hundred and twelve patients were randomized and included in the intention-to-treat (ITT) analysis. At 4 wk, success rates (95% CI) were: omeprazole 51% (69/135; 43-60%), ranitidine 36% (50/139, 28-44%), cisapride 31% (32/105, 22-39%), and placebo 23% (31/133, 16-31%). Omeprazole was significantly better than all other treatments (p < 0.05). The proportion of patients who were responders at 4 wk and at 6 months was significantly greater for those receiving omeprazole 31% (42/135, 23-39%) compared with cisapride 13% (14/105, 7-20%), and placebo 14% (18/133, 8-20%) (p= 0.001), but not ranitidine 21% (29/139, 14-27%) (p= 0.053). The mean number of on-demand study tablets consumed and rescue antacid used was comparable across groups. Economic analysis showed a trade-off between superior efficacy and increased cost between omeprazole and ranitidine.


CONCLUSIONS
Treatment with omeprazole provides superior symptom relief compared to ranitidine, cisapride, and placebo in the treatment of H. pylori negative primary care dyspepsia patients.
Division of Gastroenterology, Dalhousie University, Halifax, Nova Scotia, Canada.
Sander J O
SJ
Veldhuyzen van Zanten
Naoki
N
Chiba
David
D
Armstrong
Alan
A
Barkun
Alan
A
Thomson
Sandra
S
Smyth
Sergio
S
Escobedo
Joanna
J
Lee
Paul
P
Sinclair
D000328:Adult; D000368:Aged; D020117:Cisapride / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004415:Dyspepsia / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D011788:Quality of Life; D011899:Ranitidine / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D011899:Ranitidine; D009853:Omeprazole; D020117:Cisapride