Original Contribution
The American Journal of Gastroenterology (2005) 100, 1477–1488; doi:10.1111/j.1572-0241.2005.40280.x
A Randomized Trial Comparing Omeprazole, Ranitidine, Cisapride, or Placebo in Helicobacter pylori Negative, Primary Care Patients with Dyspepsia: The CADET-HN Study
Sander JO Veldhuyzen van Zanten MD1, Naoki Chiba MD1, David Armstrong MD1, Alan Barkun MD1, Alan Thomson MD1, Sandra Smyth1, Sergio Escobedo MSc1, Joanna Lee MMATH1 and Paul Sinclair MSc1
1Division of Gastroenterology, Dalhousie University, Halifax, Nova Scotia, Canada; McMaster University, Hamilton, Ontario, Canada; Surrey GI Research, Guelph, Ontario, Canada; McGill University, Montreal, Québec, Canada; University of Alberta, Edmonton, Alberta, Canada; AstraZeneca Canada Inc, Mississauga, Ontario, Canada; and INSINConsulting Inc, Guelph, Ontario, Canada
Correspondence: Sander JO, Veldhuyzen van Zanten, Department of Medicine, Dalhousie University, QEII Health Sciences Centre, Room 928 Centennial, Victoria General Site, 1278 Tower Road, Halifax, Nova Scotia, Canada B3H 2Y9
Received 16 February 2004; Revised 0000; Accepted 17 January 2005.
Abstract
BACKGROUND:
The management of Helicobactor 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 (
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 
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.
CONCLUSION:
Treatment with omeprazole provides superior symptom relief compared to ranitidine, cisapride, and placebo in the treatment of H. pylori negative primary care dyspepsia patients.
