Peptic ulcer: triple therapy reduced ulcers in patients on NSAIDs who were infected with H. pylori

Clinical bottom line (level 1b)

Patients with H. pylori infection requiring NSAIDs for musculoskeletal disorders who had triple therapy, compared with nothing, were less likely to develop peptic ulcers (NNT = 5 at 8 weeks) .

Chan et al: Lancet 1997; 350: 975-979

Expires October 2002

The study

Unblinded concealed randomised trial without intention-to-treat
Setting: medical and family clinics, university hospital, Hong Kong

100 patients (aged 33 to 84; median 63, 72% female) with musculoskeletal disorders requiring NSAID therapy, and H. pylori infection (confirmed diagnosis by CLO test and histology).

Excluded if

peptic ulcers on endoscopy
aged < 18
previously exposed to NSAIDs, antiulcer drugs, steroids, anticoagulants or cytotoxic agents in the last 8 weeks
received antihelicobacter therapy
history of peptic ulcer disease or gastric surgery
renal impairment (serum creatinine > 200 ľ mol/l

Control Group: (n = 50, 47 analysed): nothing
Experimental Group: (n = , analysed): one week course of triple therapy- bismuth subcitrate 120 mg, tetracycline 500 mg, metronidazole 400 mg, each given orally four times daily.
All patients took naproxen 250 mg tds for 8 weeks. Patients took paracetamol/propoxyphene 325/50 mg if additional pain relief was required.
92% followed for 8 weeks
Outcome notes:

peptic ulcer : on endoscopy

The evidence

Outcome	Time to outcome	CER	EER	RRR (95% CI)	ARR (95% CI)	NNT (95% CI)
peptic ulcer	8 weeks	12 (25.5%)	3 (6.67%)	74% (14% to 92%)	18.9% (4.42% to 33.3%)	5 (3 to 23)

Comments

The rate of ulcer development, 25% in just 8 weeks, is high - this might tend to exaggerate the true difference. For example, it is higher than the 6.8% risk for gastric lesions after 4 weeks and 4% risk for duodenal lesions after weeks calculated by Bandolier (May 97;39-6)

Citation

Chan FK, Sung JJ, Chung SC, et al: randomised trial of eradication of Helicobacter pylori before non-steroidal anti-inflammatory drug therapy to prevent peptic ulcers. Lancet 1997; 350: 975-979

Contributor: Chris Ball and Clare Wotton, October 1999
Reviewer: Martin Dawes and Kev Hopayian

_{Clinical Question.}

_Patient	_{H. pylori infection and requiring NSAIDs for musculoskeletal disorders}
_{Intervention or Exposure}	_{triple therapy}
_Comparison	_nothing
_Outcome	_{peptic ulcers}