91692
document
A prospective randomized study of amoxycillin and omeprazole with and without metronidazole in the eradication treatment of Helicobacter pylori . A combination of amoxycillin and omeprazole is often used to treat Helicobacter pylori infection . A three-drug regimen comprising metronidazole , amoxycillin and omeprazole has been proposed as an alternative therapy . In a prospective , randomized , comparative study , we evaluated these two regimens with respect to safety and efficacy in patients with H. pylori infection . Sixty patients with peptic ulcer ( gastric , 32 patients ; duodenal , 28 patients ) who had a history of ulcer recurrence were randomly assigned to dual therapy with amoxycillin ( 500 mg three times daily for 2 weeks ) and omeprazole ( 20 mg once daily for 8 weeks ) or to triple therapy with metronidazole ( 500 mg twice daily for 2 weeks ) plus amoxycillin and omeprazole , given in the same dosages as dual therapy . Forty-eight patients completed the protocol ; treatment was discontinued because of side effects in nine patients , and three patients dropped out of the study . On the basis of all patients treated , the rate of H. pylori eradication was significantly higher for triple therapy 20/23 cases , 87.0 % ; 95 % confidence interval ( CI ) , 0.664-0.972 ) than for dual therapy 13/25 , 52.0 % ; 0.313-0.722 ; P < 0.05 ) . On an intention-to-treat basis , the difference between the groups in the rate of H. pylori eradication was marginally significant ( P = 0.06 [ 0.028-0.512 ] ) . Side effects were reported by five patients receiving triple therapy ( skin rash , one ; nausea , two ; headache , one ; abdominal pain , one ) , and four patients receiving dual therapy ( skin rash , two ; abdominal pain , one ; diarrhoea , one ) . All side effects resolved spontaneously after termination of treatment . There was no significant difference in safety between the two regimens . Triple therapy with metronidazole , amoxycillin , and omeprazole was significantly more effective for the eradication of H. pylori than dual therapy with amoxycillin and omeprazole alone . The safety of these regimens was similar , and triple therapy was found to be clinically acceptable .
91693
Intervention_Pharmacological
amoxycillin and omeprazole
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Intervention_Pharmacological
metronidazole
91695
Intervention_Pharmacological
amoxycillin and omeprazole
91696
Intervention_Pharmacological
metronidazole , amoxycillin and omeprazole
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Intervention_Pharmacological
amoxycillin
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Intervention_Pharmacological
omeprazole
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Intervention_Pharmacological
metronidazole
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Intervention_Pharmacological
plus amoxycillin and omeprazole
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Intervention_Pharmacological
metronidazole , amoxycillin , and omeprazole
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Intervention_Pharmacological
amoxycillin and omeprazole alone
91703
Outcome_Mental
the
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Outcome_Physical
rate of H. pylori eradication
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Outcome_Mental
was significantly higher for triple therapy 20/23 cases
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Outcome_Mental
87.0 % ; 95 % confidence interval ( CI ) , 0.664-0.972 )
91707
Outcome_Mental
the difference between the groups in the
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Outcome_Physical
rate of H. pylori eradication
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Outcome_Mental
was marginally significant
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Outcome_Adverse-effects
skin rash
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Outcome_Adverse-effects
nausea
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Outcome_Adverse-effects
headache
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Outcome_Adverse-effects
abdominal pain
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Outcome_Mental
four patients receiving dual therapy (
91715
Outcome_Adverse-effects
skin rash
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Outcome_Adverse-effects
abdominal pain
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Outcome_Adverse-effects
diarrhoea
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Outcome_Other
safety
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Outcome_Mental
Triple therapy with metronidazole , amoxycillin , and omeprazole was significantly more effective for the
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Outcome_Physical
eradication of H. pylori
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Outcome_Mental
than dual therapy with amoxycillin and omeprazole alone
91722
Participant_Condition
Helicobacter pylori
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Participant_Condition
H. pylori infection
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Participant_Sample-size
Sixty
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Participant_Condition
peptic ulcer
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Participant_Condition
gastric
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Participant_Sample-size
32
91728
Participant_Condition
duodenal
91729
Participant_Sample-size
28
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Participant_Condition
history of ulcer recurrence
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Participant_Sample-size
Forty-eight