Effect of Population Screening and Treatment for Helicobacter Pylori on Dyspepsia and Quality of Life in the Community: A Randomised Controlled Trial. Leeds HELP Study Group

Lancet. 2000 May 13;355(9216):1665-9. doi: 10.1016/s0140-6736(00)02236-4.

Abstract

Background: Infection with Helicobacter pylori is the main cause of peptic-ulcer disease. Treatment of this infection might lower the prevalence of dyspepsia in the community and improve quality of life. We investigated this possibility in a double-blind randomised controlled trial.

Methods: Individuals aged 40-49 years were randomly selected from the lists of 36 primary-care centres. A researcher interviewed participants with a validated dyspepsia questionnaire and the psychological general wellbeing index (PGWB). H. pylori status was assessed by the carbon-13-labelled urea breath test. Infected participants were randomly assigned active treatment (omeprazole 20 mg, clarithromycin 250 mg, and tinidazole 500 mg, each twice daily for 7 days) or identical placebo. Participants were followed up at 6 months and 2 years.

Findings: Of 32,929 individuals invited, 8455 attended and were eligible; 2324 were positive for H. pylori and were assigned active treatment (1161) or placebo (1163). 1773 (76%) returned at 2 years. Dyspepsia or symptoms of gastro-oesophageal reflux were reported in 247 (28%) of 880 in the treatment group and 291 (33%) of 871 in the placebo group (absolute-risk reduction 5% [95% CI 1-10]). H. pylori treatment had no significant effect on quality of life (mean difference in PGWB score between groups 0.86 [-0.33 to 2.05]).

Interpretation: Community screening and treatment for H. pylori produced only a 5% reduction in dyspepsia. This small benefit had no impact on quality of life.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Ulcer Agents / adverse effects
  • Anti-Ulcer Agents / therapeutic use*
  • Clarithromycin / adverse effects
  • Clarithromycin / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination
  • Dyspepsia / diagnosis
  • Dyspepsia / drug therapy*
  • Dyspepsia / psychology
  • Female
  • Follow-Up Studies
  • Helicobacter Infections / diagnosis
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / psychology
  • Helicobacter pylori*
  • Humans
  • Male
  • Mass Screening*
  • Middle Aged
  • Omeprazole / adverse effects
  • Omeprazole / therapeutic use
  • Peptic Ulcer / diagnosis
  • Peptic Ulcer / drug therapy*
  • Peptic Ulcer / psychology
  • Quality of Life*
  • Sickness Impact Profile
  • Tinidazole / adverse effects
  • Tinidazole / therapeutic use

Substances

  • Anti-Ulcer Agents
  • Tinidazole
  • Clarithromycin
  • Omeprazole