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Effect of esomeprazole triple therapy on eradication rates of Helicobacter pylori , gastric ulcer healing and prevention of relapse in gastric ulcer patients . OBJECTIVES To compare esomeprazole-based triple therapy with esomeprazole alone for the eradication of Helicobacter pylori ( H. pylori ) , healing of ulcer and prevention of relapse in H. pylori-related gastric ulcer ( GU ) diseases . METHODS In this double-blind study , 401 H. pylori-positive patients with more than or equal to two GUs were randomized to : esomeprazole ( 20 mg ) twice daily ( bid ) and amoxicillin ( 1000 mg ) bid and clarithromycin ( 500 mg ) bid ( EAC ) for 1 week , followed by placebo for 3 weeks ( EAC and placebo ) ; EAC for 1 week , followed by esomeprazole ( 20 mg ) once daily ( E20 ) for 3 weeks ( EAC and E20 ) ; or esomeprazole ( 20 mg ) bid and placebo antimicrobials for 1 week , followed by E20 for 3 weeks ( E20 bid and E20 ) . Patients with unhealed GUs at 4 weeks received E20 for an additional 4 weeks . Healed patients were followed up for 12 months . RESULTS Eradication rates at 4 weeks or 8 weeks were 82 % for EAC and E20 , 77 % for EAC and placebo and 9.5 % for E20 bid and E20 ( intention-to-treat analysis ) . Significantly more patients receiving EAC than those receiving esomeprazole alone remained free of GUs during follow-up [ EAC and E20 , 90 % ; EAC and placebo , 87 % ; P=0.0005 for combined group vs. esomeprazole alone [ E20 bid and E20 ( 74 % ) ] . All treatments were well tolerated . CONCLUSION Esomeprazole-based triple therapy is effective for the eradication of H. pylori , healing of GU and prevention of relapse . Esomeprazole monotherapy for 3 weeks after triple therapy may be beneficial in terms of healing .
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Intervention_Physical
esomeprazole triple therapy
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Intervention_Pharmacological
esomeprazole-based
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Intervention_Pharmacological
esomeprazole
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Intervention_Pharmacological
amoxicillin
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Intervention_Pharmacological
clarithromycin
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Intervention_Control
placebo
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Intervention_Pharmacological
esomeprazole
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Intervention_Pharmacological
esomeprazole
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Intervention_Control
placebo antimicrobials
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Intervention_Pharmacological
Esomeprazole-based
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Outcome_Other
eradication rates of Helicobacter pylori ,
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Outcome_Physical
gastric ulcer healing
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Outcome_Other
and prevention of relapse
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Outcome_Other
eradication of Helicobacter pylori ( H.
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Outcome_Other
prevention of relapse
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Outcome_Other
Eradication rates
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Outcome_Physical
remained free of GUs
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Outcome_Other
tolerated
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Outcome_Other
effective
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Outcome_Mental
eradication of H. pylori ,
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Outcome_Physical
healing of GU
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Outcome_Mental
and prevention of relapse .
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Outcome_Other
beneficial
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Participant_Condition
gastric ulcer
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Participant_Sample-size
401
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Participant_Condition
H. pylori-positive patients with more than or equal to two GUs