Helicobacter pylori eradication from general practice: clinical benefits and health economics

ISRCTN ISRCTN57634776
DOI https://doi.org/10.1186/ISRCTN57634776
Protocol serial number 00001 RSU447971
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive Northern and Yorkshire (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
10/11/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Paul Moayyedi
Scientific

Gastroenterology Unit
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesHelicobacter pylori is responsible for 95% of duodenal ulcers and most gastric ulcers. It may be responsible for some functional dyspepsia and may be a major factor in the aetiology of gastric cancer, the fourth commonest cause of death from malignancy in the UK. Approximately one person in forty of the UK population dies from a H. pylori associated disease. Successful eradication from the community should prevent duodenal ulcer, gastric ulcer and possibly gastric cancer. An average FHSA spends £4,000,000 per annum on acid reducing drugs. The Leeds FHSA expenditure is £5,000,000 per annum. The investigation of dyspepsia is also costly. The General Infirmary at Leeds serving a population of 400,000 spends £800,000 per annum on endoscopy and £90,000 per annum on barium meals. 10% of the population consult their general practitioner for dyspepsia every six months. Patients with dyspepsia have 2.6 times as many sick leave days as the background population matched for age, sex and occupational status. Primary prevention could lead to saving in drug expenditure, general practice consultations and hospital investigation. It should lead to reduction in the costs of sick pay, invalidity benefit and should reduce time lost from work.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDigestive system diseases: Peptic ulcer disease
InterventionTreatment for H. pylori versus placebo
Intervention typeOther
Primary outcome measure(s)

1. Absence of dyspepsia at two years
2. NHS dyspepsia costs for two years after the intervention

Key secondary outcome measure(s)

1. Dyspepsia subgroups
2. Quality of life
3. H. pylori eradication rates
4. Adverse events

Completion date30/06/1998

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Key inclusion criteriaPatients aged 50-59 years from selected General Practice (GP) surgeries (including asymptomatic volunteers as well as patients with dyspepsia)
Key exclusion criteria1. Severe mental illness
2. Severe medical illness that would make the subject unable to survive for two years
3. Allergy to proton inhibitors, clarythromycin or metronizadole
4. Unwillingness to abstain from alcohol whilst taking antibiotics
5. Pregnancy
6. Concomitant prescription of cisapride, warfarin, antihistamines or theophyllines
Date of first enrolment07/01/1994
Date of final enrolment30/06/1998

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Gastroenterology Unit
Birmingham
B18 7QH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 13/05/2000 Yes No
Results article 10 year follow-up results 01/12/2005 Yes No
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