Upper GI bleed: peptic ulcer: omeprazole prevented more rebleeds than cimetidine

Clinical bottom line (level 1b)

Patients with bleeding peptic ulcers who took omeprazole compared with cimetidine were less likely to rebleed (NNT = 5 at 14 days)
There was no clear effect on mortality.

Lin et al: Archives of Internal Medicine 1998; 158: 54-58

Expires October 2002

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 2 acute hospitals, Taiwan

100 patients (aged 17 to 86; median 66, 89% male) with a bleeding peptic ulcer or a visible vessel on endoscopy who had initial haemostasis

Excluded if

bleeding tendency: platelet count < 50 x 10 ⁹ ml, serum prothrombin <30% normal or on anticoagulants
uremia
bleeding gastric cancer

Control Group: (n = 50, 50 analysed): cimetidine 300 mg iv bolus followed by 1200 mg infusion over 24 hours for 3 days, then 400 mg po bd for 2 months
Experimental Group: (n = 50, 50 analysed): omeprazole 40 mg iv bolus, followed by 150 mg infusion over 24 hours for 3 days, then 20 mg po od for 2 months.

100% followed for 14 days
Outcome notes:

rebleeding : confirmed on endoscopy

The evidence

Outcome	Time to outcome	CER	EER	RRR (95% CI)	ARR (95% CI)	NNT (95% CI)
rebleeding	3 days	8 (16.0%)	0 (0.0%)	100% (% to %)	16.0% (5.84% to 26.2%)	6 (4 to 17)
rebleeding	14 days	12 (24.0%)	2 (4.00%)	83% (29% to 96%)	20.0% (6.98% to 33.0%)	5 (3 to 14)
death	14 weeks	2 (4.00%)	0 (0.00%)	50% (-430% to 95%)	2.00% (-4.68% to 8.68%)	50 (NNT = 12 to infinity; NNH = 21 to infinity)

Comments

No patient underwent surgery.
The study is too small to show any difference for mortality.

Citation

Lin HJ, Lo WC, Lee FY: A prospective randomized comparative trial showing that omeprazole prevents rebleeding in patients with bleeding peptic ulcer after successful endoscopic therapy. Archives of Internal Medicine 1998; 158: 54-58

Contributor: Sharon Straus and Chris Ball, October 1999
Reviewer: .

_{Clinical Question.}

_Patient	_{bleeding peptic ulcer}
_{Intervention or Exposure}	_omeprazole
_Comparison	_cimetidine
_Outcome	_{death, rebleed}