Upper GI bleeds: omeprazole improved outcome at 72 hours.

Clinical bottom line (level 1b)

  1. Patients with bleeding peptic ulcers who took omeprazole, were less likely die or need an operation, additional endoscopic treatment or more than three units of blood transfused, than those given placebo (NNT = 6 at 72 hours) .
  2. There was no clear difference in death at 35 days.
Schaffalitzky de Muckadell et al: Scandinavian Journal of Gastroenterology 1997; 32: 320-327
Expires June 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 34 hospitals, Denmark, Holland and France

274 patients (aged mean 67 years, 93% male) signs of acute upper gastrointestinal bleeding and clinical signs of circulatory stress or blood loss, defined as at least two of:
  • systolic blood pressure <100 mmHg
  • heart rate >100/min
  • blood haemoglobin concentration <7.0 mmol/l for men and <6.5 mmol/l for women
. Endoscopic criteria for inclusion were: peptic ulcer in the stomach or duodenum with
  • spurting bleeding
  • oozing bleeding
  • a visible vessel
  • adherent clot/black base


Excluded if
  • aged <18 years
  • oesophageal varices
  • a Mallory-Weiss lesion
  • deficient haemostasis
  • anticoagulant therapy
  • need for NSAIDs during study
  • upper gastrointestinal malignancy
  • clinically significant abnormalities that might reduce life expectancy to <6 months
  • phenytoin treatment
  • childbearing potential and not using adequate contraception, pregnancy or lactation
  • omeprazole treatment <5 days before inclusion


    • Note:
  • Patients were randomised in blocks of two.


Control Group: (n = 140, 135 analysed): iv placebo
Experimental Group: (n = 134, 130 analysed): iv omeprazole 80 mg as a bolus, followed by continuous infusion of 8 mg/h for 72 hours
Treatments began within 30 minutes of endoscopy. 48 hours from the start of iv treatment, all patients received 20 mg orally omeprazole daily, and this was continued until a follow-up visit on day 21.
97% followed for ?
Outcome notes:
  • treatment failure : died or required an operation, additional endoscopic treatment or >3 units of blood transfused

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
treatment failure 72 hours 50
(37.0%)		 27
(20.8%)		 44%
(16% to 62%)		 16.3%
(5.54% to 27.0%)		 6
(4 to 18)
death 35 days 11
(8.15%)		 10
(7.69%)		 6%
(-115% to 58%)		 0.46%
(-6.05% to 6.96%)		 219
(NNT = 14 to infinity;
NNH = 17 to infinity)

Comments

  1. Small (2 patient) block randomisation may have threatened concealment.

Citation

  1. Schaffalitzky de Muckadell OB, Havelund T, Harling H, et al: Effect of omeprazole on the outcome of endoscopically treated bleeding peptic ulcers. Scandinavian Journal of Gastroenterology 1997; 32: 320-327
Contributor: Clare Wotton and Musab Hayatli, June 2000
Reviewer:

Clinical Question.
    Patient bleeding peptic ulcer
    Intervention or Exposure omeprazole
    Comparison placebo
    Outcome treatment failure