Upper GI bleeding: peptic ulcer: nabumetone reduced recurrent bleeding better than misoprostol and naproxen

Clinical bottom line (level 1b)

  1. Patients with a recent GI haemorrhage due to peptic ulcers who received nabumetone compared with naproxen and misoprostol were less likely to have a recurrent GI haemorrhage (NNT = 7 at 6 months) .
Chan et al: Aliment Pharmacol Ther 2001; 15 : 19-24
Expires January 2004

The study

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

96 patients (aged 42 to 93; mean 75, 65% female) with recent ulcer bleeding (documented on endoscopy) and continuing to need long-term NSAIDs

Excluded if
  • on concomitant acid suppressing durgs, steroids, anticoagulants or low-dose aspirin
  • previous gastric surgery
  • concurrent upper GI disease including erosive oesophagitis, eosophageal or gastric varices, gastric outlet obstruction or gastric cancer
  • received H. pylori eradication therapy in the past
  • renal impairment: serum creatinine > 200 micromol/l
  • moribund, terminally ill or unable to be followed-up
  • H. pylori positive
  • taken NSAIDs > 7 days ago

Note:
  • Patients were not randomised until ulcers had healed completely.

Control Group: (n = 48, 45 analysed): naproxen 500 mg daily and misoprostol 200 microgram twice daily for 24 weeks
Experimental Group: (n = 48, 45 analysed): nambumetone 1000 mg daily for 24 weeks

94% followed for 6 months
Outcome notes:
  • upper GI bleeding : recurrent haematemesis, melena or fall in Hb > 2 g/dl and ulcer confirmed on endsocopy

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
upper GI bleeding 6 months 10
(20.8%)		 3
(6.25%)		 70%
(-2% to 91%)		 14.6%
(1.21% to 28.0%)		 7
(4 to 83)

Comments

  1. The study is very small - this result may be by chance.z
  2. Note that recurrent bleeding occurred frequently in the nabumetone group.

Citation

  1. Chan FK, SUng JJ, Ching JY, et al: randomized trial of low-dose misoprostol and naproxen vs. nabumetone to prevent recurrent upper gastrointestinal haemorrhage in users of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 2001; 15 : 19-24
Search Terms: from ACP Journal Club
Contributor: Chris Ball, January 2002
Reviewer:

Clinical Question.
Patient recent GI haemorrhage from peptic ulcer
Intervention or Exposure nabumetone
Comparison naproxen and misoprostol
Outcome recurrent upper GI haemorrhage