3731
document
The effectiveness of omeprazole , clarithromycin and tinidazole in eradicating Helicobacter pylori in a community screen and treat programme . Leeds Help Study Group . INTRODUCTION Helicobacter pylori screening and treatment has been proposed as a cost-effective method of preventing gastric cancer . AIM To assess , in a randomized controlled trial , the efficacy of therapy in eradicating H. pylori as part of a screening programme , and to report the adverse events associated with this strategy . METHODS Subjects between the ages of 40-49 years were randomly selected from the lists of 36 primary care centres . Participants attended their local practice and H. pylori status was determined by 13C-urea breath test . Infected subjects were randomized to receive omeprazole 20 mg b.d. , clarithromycin 250 mg b.d . and tinidazole 500 mg b.d . for 7 days ( OCT ) or identical placebos . Eradication was determined by a 13C-urea breath test 6 months and 2 years after the first visit . Successful eradication was defined as two negative 13C-urea breath tests or one negative and one missing test . Adverse events and compliance were assessed at the 6-month visit . RESULTS A total of 32 929 subjects were invited to attend , 8407 were evaluable , and 2329 ( 28 % ) of these were H. pylori-positive . A total of 1161 subjects were randomized to OCT and 1163 to placebo ; over 80 % returned for a repeat 13C-urea breath test on at least one occasion . The eradication rates in those allocated to OCT were as follows : intention-to-treat , 710 out of 1161 ( 61 % ; 95 % confidence interval : 58-64 % ) ; evaluable 710 out of 967 ( 73 % ; 95 % CI : 71-76 % ) ; took all medication 645 out of 769 ( 84 % ; 95 % CI : 81-87 % ) . Adverse events occurred in 45 % of the treatment group and in 18 % of the placebo group ( relative risk 2.5 ; 95 % CI : 2.1-2.9 ) . Compliance , male gender , no antibiotic prescription in the subsequent 2 years and experiencing a bitter taste with the medication were independently associated with treatment success . CONCLUSIONS The OCT regimen has an eradication rate of 61 % in intention-to-treat analysis and is therefore less successful in treating H. pylori as part of a screening programme compared with hospital studies in dyspeptic patients .
3732
Intervention_Pharmacological
omeprazole
3733
Intervention_Pharmacological
clarithromycin
3734
Intervention_Pharmacological
tinidazole
3735
Intervention_Pharmacological
omeprazole 20 mg b.d.
3736
Intervention_Pharmacological
clarithromycin 250 mg b.d
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Intervention_Pharmacological
and tinidazole 500 mg b.d .
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Intervention_Control
placebos
3739
Outcome_Other
eradicating Helicobacter pylori
3740
Outcome_Other
Eradication
3741
Outcome_Physical
Successful eradication
3742
Outcome_Other
negative 13C-urea breath tests
3743
Outcome_Other
one negative and one missing test
3744
Outcome_Adverse-effects
Adverse events
3745
Outcome_Mental
compliance
3746
Outcome_Physical
pylori-positive
3747
Outcome_Other
eradication rates
3748
Outcome_Adverse-effects
Adverse events
3749
Outcome_Other
experiencing a bitter taste
3750
Outcome_Other
eradication rate
3751
Participant_Age
between the ages of 40-49 years
3752
Participant_Sample-size
32 929
3753
Participant_Sample-size
8407
3754
Participant_Sample-size
2329
3755
Participant_Condition
H. pylori-positive
3756
Participant_Sample-size
1161
3757
Participant_Condition
dyspeptic