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.
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.


RESULTS
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]).


CONCLUSIONS
Community screening and treatment for H. pylori produced only a 5% reduction in dyspepsia. This small benefit had no impact on quality of life.
Moayyedi
P
P
Centre for Digestive Diseases, General Infirmary at Leeds, UK. paulmo@ulth.northg.nhs.uk
Feltbower
R
R
Brown
J
J
Mason
S
S
Mason
J
J
Nathan
J
J
Richards
I D
ID
Dowell
A C
AC
Axon
A T
AT
D000328:Adult; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D018434:Sickness Impact Profile; D014011:Tinidazole / Q000009:adverse effects / Q000627:therapeutic use
D000897:Anti-Ulcer Agents; D014011:Tinidazole; D017291:Clarithromycin; D009853:Omeprazole