Peptic ulcers: NSAIDs: omeprazole prevented recurrence and dyspepsia better than ranitidine

Clinical bottom line (level 1b)

  1. Patients on regular NSAIDs with recently-healed peptic ulcer disease who took omeprazole regularly compared with ranitidine were less likely to have treatment failure (recurrent disease, adverse effects or symptoms of dyspepsia) (NNT = 8 at 6 months)
  2. There was no clear difference in the number of patients that stop the medication.
Yeomans et al: New England Journal of Medicine 1998; 338: 719-726
Expires October 2002

The study

Double-blinded ?concealed randomised trial without intention-to-treat
Setting: 73 acute hospitals, Europe, Canada, South Africa, Australia

425 patients (aged 20 to 80; mean 56, 69% female) requiring continuous treatment with NSAIDs and recently-healed peptic ulcer disease.

Excluded if
  • major GI bleeding
  • disorders that might modify drug absorption
  • concurrent erosive or ulcerative oesophagitis
  • pyloric stenosis
  • aged < 18 or > 85
  • on steroids equivalent to > 10 mg prednisolone daily
  • neck instability compromising endoscopy

Control Group: (n = 215, 215 analysed): ranitidine 150 mg po bd
Experimental Group: (n = 210, 210 analysed): omeprazole 20 mg po daily

99% followed for 6 months
Outcome notes:
  • treatment failure : relapse of lesions, dyspeptic symptoms or adverse events leading to discontinuation of therapy

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
treatment failure 6 months 88
(40.9%)		 59
(28.1%)		 31%
(10% to 48%)		 12.8%
(3.88% to 21.8%)		 8
(5 to 26)
discontinued medication 8 weeks 29
(13.5%)		 30
(14.3%)		 -6%
(-70% to 34%)		 -0.80%
(-7.37% to 5.78%)		 -130
(NNT = 17 to infinity;
NNH = 14 to infinity)

Comments

  1. Patients were randomised in blocks of four.
  2. H. pylori status was associated with higher success rates in the healing and the maintenance phase.

Citation

  1. Yeomans ND, Tulassay Z, Juhasz L, et al: a comparison of omeprazole with ranitidine for ulcers associated with non-steroidal anti-inflammatory drugs. New England Journal of Medicine 1998; 338: 719-726
Contributor: Sharon Straus and Chris Ball, October 1999
Reviewer: Zoltan Bodnar

Clinical Question.
Patient NSAID use and recently-healed peptic ulcer disease
Intervention or Exposure omeprazole
Comparison ranitidine
Outcome recurrence of peptic ulcer disease