Dyspepsia Clinical Trial
Official title:
Long-term Effect of Screening and Eradication of Helicobacter Pylori in the General Population - HEP-FYN 12-years Follow-up
Aims:
1. Evaluate the long-term effect of screening and eradication of Helicobacter Pylori on
the prevalence of dyspepsia, and, as secondary outcomes, to assess the effect on
dyspepsia related health-care consumption and quality of life.
2. To investigate symptoms of gastroesophageal reflux (GER), dyspepsia and the combination
of these conditions and the effect on quality of life, prognosis and dyspepsia-related
health care expenditure.
Methods:
In 1998-99 20.000 individuals, age 40-65 years, identified by their civil registration
number, were allocated by a computerized randomized procedure to HP-screening group and
control group. All participants received a questionnaire at inclusion, 1-year and 5-year and
now again at 12 year follow-up assessing the prevalence of dyspepsia and quality of life. In
addition we will obtain information from registers on, comorbidity, use of endoscopies and
prescription medication. An economic evaluation is done alongside the randomized trial.
The primary unscreened group is invited to HP test (13C-urea breath-test) in order to
analyze the effect of HP-screening according to HP-status
Expected results:
The study will provide information on the long-term effect of HP-screening and eradication
in a population. The study will provide information about the long-term effect on incidence
of peptic ulcer in an aging population that is likely to have an increased consumption of
ASA and NSAID. Furthermore the study will generate knowledge about the long-term prognosis
of dyspepsia and reflux in the population (dyspepsia and reflux. Preliminary results from
the 5-yr follow-up (13) showed that is has a great influence on quality of life and the
dyspepsia-related health care consumption, whether the individual has solely reflux, solely
dyspepsia or a combination of both symptoms.
Long-term follow-up and further analyses of these findings could have great impact on
management and treatment of individuals with symptoms. It is important to focus on groups;
in which the symptoms have the greatest influence on quality of life of the individual. This
finding has not been displayed in other studies.
Questionnaire:
Information on abdominal symptoms (GRSR: Gastrointestinal symptom rating scale, rate of
symptoms, quality of life (SF-36, EQ-5D-5L), consumption of ulcer drugs including over the
counter drugs, hospital admissions, dyspepsia-related sick leave days, consultations and
comorbidity). A reminder is sent out 2 weeks after the first contact.
Register data:
OPED (Odense Pharmaca-epidemiological Database): Information on reimbursable ulcer drugs,
ASA, NSAID and HP-eradication therapy. The Regional Hospital discharge Register: Information
based on International Classification of Diseases (ICD). Information on ulcer-related
admissions, out-patient ulcer diagnosis and comorbidity, use of upper gastrointestinal
endoscopy.
HP-test unscreened group:
Invitation of the primary unscreened group to HP test (13C-urea breath-test) in order to
analyze the effect of HP-screening according to HP-status. Instruments: automated breath
13Co2 analyser- Isotope ratio mass spectrometer.
Almost all persons are infected with HP during childhood. Infection with the bacteria in
adulthood is rare. Only few persons spontaneously turn HP-negative. From OPED we will know
which individuals who have been prescribed HP-eradication treatment. Thus the participants
in the control group, who are HP-positive at 12-yr follow-up, have had the infection the
whole period. Provided they have not received HP-eradication treatment, those who are tested
HP-negative have been so the whole period.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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