Peptic ulcers: NSAIDs: omeprazole healed ulcers better than ranitidine

Clinical bottom line (level 1b)

  1. Patients on regular NSAIDs with peptic ulcer disease who took omeprazole compared with ranitidine were more likely to heal (NNT = 6 at 8 weeks) .
  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

541 patients (aged 20 to 82; mean 57, 67% female) requiring continuous treatment with NSAIDs and peptic ulcers or more than 10 gastric or duodenal erosions on endoscopy.

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 = 174, 174 analysed): ranitidine 150 mg po bd for 4 to 8 weeks
Experimental Group: (n = 174, 174 analysed): omeprazole 20 mg po daily for 4 to 8 weeks
Experimental Group: (n = , 187 analysed): omeprazole 40 mg po od for 4 to 8 weeks

99% followed for 8 weeks
Outcome notes:
  • treatment failure : 20 mg omeprazole v. ranitidine: peptic ulcer or >10 erosions, moderate or severe symptoms of dyspepsia or adverse events leading to treatment discontinuation.
  • discontinued medication : 20 mg omeprazole v. ranitidine
  • treatment failure : 40 mg omeprazole v. ranitidine
  • discontinued medication : 40 mg omeprazole v. ranitidine

The evidence

omeprazole 20 mg v. ranitidine
Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
treatment failure 8 weeks 64
(36.8%)		 34
(19.5%)		 47%
(24% to 63%)		 17.2%
(7.97% to 26.5%)		 6
(4 to 13)
discontinued medication 8 weeks 25
(14.4%)		 18
(10.3%)		 28%
(-27% to 59%)		 4.02%
(-2.88% to 10.9%)		 25
(NNT = 9 to infinity;
NNH = 35 to infinity)

omeprazole 40 mg v. ranitidine
Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
treatment failure 8 weeks 64
(36.8%)		 39
(20.9%)		 43%
(20% to 60%)		 15.9%
(6.69% to 25.2%)		 6
(4 to 15)
discontinued medication 8 weeks 25
(14.4%)		 19
(10.2%)		 29%
(-24% to 60%)		 4.21%
(-2.57% to 11.0%)		 24
(NNT = 9 to infinity;
NNH = 39 to infinity)

Comments

  1. Patients were randomised in blocks of three.
  2. There was no significant difference between the two doses of omeprazole.

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 NSAIDs and peptic ulcers
Intervention or Exposure omeprazole
Comparison ranitidine
Outcome healing