Peptic ulcer: regular omeprazole led to fewer recurrent bleeds than H. pylori eradication therapy for patients on naproxen but not for those on low-dose aspirin

Clinical bottom line (level 1b)

  1. Patients on low-dose aspirin following an upper GI bleed who received H. pylori eradication therapy compared with omeprazole were not clearly more likely to have a recurrent bleed.
  2. Patients on naproxen following an upper GI bleed who received omeprazole compared with H. pylori eradication therapy were less likely to bleed (NNT = 4 at 6 months) .
Chan et al: N Engl J Med 2001; 344 : 967-973
Expires January 2004

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: university hospital, Hong Kong

400 patients (aged mean 69, 62% male) with
  • a recent upper GI bleed due to endoscopically-confirmed ulcers or erosions
  • histologically-proven H. pylori infection
  • 250 on low-dose aspirin (325 mg or less) and 150 on naproxen


Excluded if
  • concomittant use of non-aspirin NSAID with aspirin, anticoaglants or corticosteroids
  • history of gastric surgery
  • presence of erosive oesophagitis, gastroesophageal varices or gastric-outlet obstruction
  • renal failure (serum creatinine > 200 microg/l)
  • terminal illness
  • cancer

Control Group: (n = 200, 200 analysed): omeprazole 20 mg daily for 6 months
Experimental Group: (n = 200, 200 analysed): H. pylori eradication therapy for 1 week: 120 mg bismuth citrate, 500 mg tetracycline and 400 mg metronidazole, all 4 times a day
All patients received 20 mg omeprazole daily for 8 weeks and follow-up endoscopy to confirm ulcer healing before randomisation.
100% followed for 6 months
Outcome notes:
  • recurrent upper GI bleeding : melaena or haematemesis with ulcers or bleeding erosions on endoscopy; or a fall in Hb of 2 g/dl or more with ulcers or erosions on endoscopy

The evidence

low-dose aspirin
Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
recurrent upper GI bleeding 6 months 1
(0.80%)		 2
(1.60%)		 -100%
(-2100% to 82%)		 -0.80%
(-3.50% to 1.90%)		 -130
(NNT = 29 to infinity;
NNH = 53 to infinity)

naproxen
Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNH
(95% CI)
recurrent upper GI bleeding 6 months 3
(4.00%)		 13
(17.3%)		 -330%
(-1400% to -29%)		 -13.3%
(-23.0% to -3.69%)		 8
(4 to 27)

Comments

  1. Patients were randomised in blocks of ten.

Citation

  1. Chan FK, Chung SC, Suen BY, et al: Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen. N Engl J Med 2001; 344 : 967-973
Search Terms: from ACP Journal Club
Contributor: Chris Ball, January 2002
Reviewer:

Clinical Question.
Patient upper GI bleeding on NSAIDs
Intervention or Exposure H. pylori eradication therapy
Comparison omeprazole
Outcome recurrent GI bleed