Helicobacter pylori eradication from general practice: clinical benefits and health economics
| ISRCTN | ISRCTN57634776 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57634776 |
| Secondary identifying numbers | 00001 RSU447971 |
- 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
Scientific
Gastroenterology Unit
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Other |
| Scientific title | |
| Study objectives | Helicobacter 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) studied | Digestive system diseases: Peptic ulcer disease |
| Intervention | Treatment for H. pylori versus placebo |
| Intervention type | Other |
| Primary outcome measure | 1. Absence of dyspepsia at two years 2. NHS dyspepsia costs for two years after the intervention |
| Secondary outcome measures | 1. Dyspepsia subgroups 2. Quality of life 3. H. pylori eradication rates 4. Adverse events |
| Overall study start date | 07/01/1994 |
| Completion date | 30/06/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients aged 50-59 years from selected General Practice (GP) surgeries (including asymptomatic volunteers as well as patients with dyspepsia) |
| Key exclusion criteria | 1. 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 enrolment | 07/01/1994 |
| Date of final enrolment | 30/06/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Gastroenterology Unit
Birmingham
B18 7QH
United Kingdom
B18 7QH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
