Therapy Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers
This review may be edited
Summary
Posted By:	Caroline Padget
E-Mail:	c_padget@yahoo.com
Posted Date:	19/09/2002
Title:	Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers
Authors:	James Y. W. Lau, M.B., B.s., Joseph J.Y. Sung, M.D., Kenneth K.C. Lee, PhD., Man-Yee Yung, B.N., Simon K.H. Wong, M.B., ChB., Justin C.Y. Wu, M.B., Ch.B., Francis K.L. Chan, M.D., Enders K.W. Ng, M.B., Ch.B., Joyce H.S. You, Pharm.D., C.W. Lee, M.Phil., Angus C.W. Chan, M.B., Ch.B., S.C. Sydney Chung, M.D.
Reference:	N Engl J Med 2000 Aug; 343(5): 310-6.
Link:	Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract:	Background: After endoscopic treatment of bleeding peptic ulcers, bleeding recurs in 15 to 20 percent of patients. Methods: We assessed whether the use of a high dose of a proton-pump inhibitor would reduce the frequency of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. Patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels were treated with an epinephrine injection followed by thermocoagulation. After hemostasis had been achieved, they were randomly assigned in a double-blind fashion to receive omeprazole (given as a bolus intravenous injection of 80 mg followed by an infusion of 8 mg per hour for 72 hours) or placebo. After the infusion, all patients were given 20 mg of omeprazole orally per day for eight weeks. The primary end point was recurrent bleeding within 30 days after endoscopy. Results: We enrolled 240 patients, 120 in each group. Bleeding recurred within 30 days in 8 patients (6.7 percent) in the omeprazole group, as compared with 27 (22.5 percent) in the placebo group (hazard ratio, 3.9; 95 percent confidence interval, 1.7 to 9.0). Most episodes of recurrent bleeding occurred during the first three days, which made up the infusion period (5 in the omeprazole group and 24 in the placebo group, P<0.001). Three patients in the omeprazole group and nine in the placebo group underwent surgery (P=0.14). Five patients (4.2 percent) in the omeprazole group and 12 (10 percent) in the placebo group died within 30 days after endoscopy (P=0.13). Conclusions: After endoscopic treatment of bleeding peptic ulcers, a high-dose infusion of omeprazole substantially reduces the risk of recurrent bleeding.
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
	Yes - the authors state that identically appearing vials of omeprazole and placebo were prepared by pharmacy and sealed in packages according to a computer generated list of random numbers. When a patient was enrolled in the study a nurse opened the lowest numbered treatment package.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
	Yes - the patients were monitored until discharge and then followed up at 8 weeks in an outpatient clinic.
2b. Were patients analyzed in the groups to which they were randomized?
	Yes- the analysis was done on an intention to treat basis.
3. Were patients, health workers, and study personnel blind to treatment?
	Yes - pharmacy prepared identical appearing vials of omeprazole and placebo. Omeprazole does not have a distinctive odour. All investigators remained unaware of patients treatment assignment until the study was completed.
4. Were the groups similar at the start of the trial?
	The groups appeared similar, but there are no figures given for whether there was any statistically significant differences in the two groups at baseline. For example 40 patients in the placebo group had co-existing disease, compared with 30 in the treatment group, but we are not told whether this is significant.
5. Aside from the experimental intervention, were the groups treated equally?
	Yes - at the end of the omeprazole or placebo infusion, all patients were given 20mg omeprazole oraly per day for 8 weeks. Patients with a positive urease test received 20mg omeprazole bd and approriate antibiotic treatment.
What are the Results?
1. How large was the treatment effect?
	The end point was rebleeding at 30 days. This occurred in 8 patients in the treatment group (6.7%), compared with 27 in the placebo group (22.5%). This gives a relative risk reduction of 70%, an absolute risk reduction of 15.8& and the NNT would be 6.
2. How precise was the estimate of the treatment effect?
	The 95% CI for the ARR range from 7.1% - 24.5% ans so the number needed to treat would be from 4 to 14 to prevent one episode of rebleeding.
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
	Yes - can be applied to patients who have had endoscopic treatment of a peptic ulcer.
2. Were all clinically important outcomes considered?
	Yes - there was a reduced rate of recurrent bleeding, decreased need for endoscopic treatment and blood transfusions, and shortened length of hospitalisation in the omeprazole group. There was also a reduction in mortality in the treatment group 4.2% compared with 10% in the placebo group (p = 0.13). None of the deaths in the omeprazole groups were related to bleeding. However, 6 of the patients in the placebo group died from rebleeding or complications of surgery.
3. Are the likely treatment benefits worth the potential harms and costs?
	Yes. There were no adverse effects reported with the omeprazole infusion and the cost would be offset by reduced rate of repeat endoscopies, blood transfusions, time in hospital and surgery.
What other people had to say about: Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers Add Your Comment
[ Back ] Any questions or comments please contact Gordon S. Doig Implemented and designed by John Soer and Gordon Doig Page last modified on Friday August 10, 2001 www.EvidenceBased.net
	THIS IS A SPACE MESSAGE. THIS IS STILL THE BEST METHOD TO SPACE A TABLE FOR NETSCAPE AND INTERNET EXPLORER. IF YOU SEE THIS MESSAGE CONTACT WEBADMIN@EvidenceBased.net