Peptic ulcer: H. pylori: eradication therapy helped gastric ulcer healing.

Clinical bottom line (level 1b)

  1. Patients who used NSAIDs long-term with past or current ulcers or severe dyspepsia and had H. pylori infection who were given eradication therapy, were more likely to have infection eradication than those given control treatment (NNT = 2 at 6 months) .
  2. There is no clear difference in treatment failure.
Hawkey et al: Lancet 1998; 352: 1016-1021
Expires October 2002

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: multicentre, Hungary, Poland, South Africa, Spain and the UK

285 patients (aged mean 55 years, 68% female) Gastric or duodenal ulcer at the start of the study, had an ulcer in the previous 5 years or had moderate or severe NSAID-associated dyspepsia alone or in combination with ulcers. Patients also had a requirement of continuous non-steroidal anti-inflammatory drugs (NSAIDs), and also had Helicobacter pylori infection of the gastric mucosa. An ulcer was defined as at least 3 mm diameter with definite depth, and a minimum dose of NSAID was required (diclofenac 50 mg; ibuprofen 1200 mg; naproxen 500 mg; indomethacin 50 mg) on at least 5 days per week for any musculoskeletal disease.

Excluded if
  • previous attempt at H. pylori eradication
  • treatment in the month before enrolment with antibiotics, bismuth compounds or steroids in a dose equivalent to >10 mg prednisolone daily
  • use of drugs, including methotrexate, that could interact with trial drugs
  • current erosive gastro-oesophageal reflux disease
  • pyloric stenosis
  • substantial bleeding in the upper gastrointestinal tract

Control Group: (n = 143, 141 analysed): control therapy- omeprazole 20 mg twice daily and placebo antibiotics twice daily
Experimental Group: (n = 142, 138 analysed): H. pylori eradication treatment- omeprazole 20 mg, amoxacillin 1000 mg and clarithromycin 500 mg, twice daily for 1 week

98% followed for ?
Outcome notes:
  • H. pylori eradication : negative 13C-urea breath test at 3 months and negative Helicobacter urease at 6 months
  • Gastric ulcer eradication : in patients with ulcers at initial endoscopy (eradication group, n=44; control group, n=37)

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
H. pylori eradication 6 months 31
(22.0%)		 119
(86.2%)		 -292%
(-439% to -185%)		 -64.3%
(-73.2% to -55.3%)		 2
(1 to 2)
treatment failure unknown 58
(41.1%)		 52
(37.7%)		 8.00%
(-23.0% to 32.0%)		 3.45%
(-8.01% to 14.9%)		 29
(NNT = 12 to infinity;
NNH = 7 to infinity)

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNH
(95% CI)
Gastric ulcer eradication 8 weeks 37
(100%)		 39
(88.6%)		 -11.0%
(-20.0% to -1.00%)		 -11.4%
(-20.7% to -1.99%)		 9
(5 to 50)

Comments

  1. It is becoming reasonable to assess high-risk patients for prescribing COX-2 inhibitors, depending on the health provision model in situ.

Citation

  1. Hawkey CJ, Tulassay Z, Szczepanski L, et al: Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study. Lancet 1998; 352: 1016-1021
Contributor: Clare Wotton and Martin Dawes, October 1999
Reviewer: Zoltan Bodnar

Clinical Question.
Patient gastric or duodenal ulcer and NSAID use
Intervention or Exposure H. pylori eradication treatment
Comparison control treatment
Outcome eradication of H pylori