62004
document
Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication : a randomized study . BACKGROUND Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide . A sequential treatment schedule has been reported to be effective , but studies published to date were performed in Italy . We undertook this study to determine whether these results could be replicated in India . METHODS A randomized , open-labeled , prospective controlled trial comparing sequential vs. standard triple-drug therapy was carried out at Lokmanya Tilak Municipal General Hospital , Mumbai . Two hundred and thirty-one patients with dyspepsia were randomized to a 10-day sequential regimen ( 40 mg of pantoprazole , 1 g of amoxicillin , each administered twice daily for the first 5 days , followed by 40 mg of pantoprazole , 500 mg of clarithromycin , and 500 mg of tinidazole , each administered twice daily for the remaining 5 days ) or to standard 14-day therapy ( 40 mg of pantoprazole , 500 mg of clarithromycin , and 1 g of amoxicillin , each administered twice daily ) . RESULTS The eradication rate achieved with the sequential regimen was significantly greater than that obtained with the triple therapy . Per-protocol eradication rate of sequential therapy was 92.4 % ( 95 % CI 85.8-96.1 % ) vs. 81.8 % ( 95 % CI 73.9-87.8 % ) ( p = 0.027 ) for standard drug therapy . Intention-to-treat eradication rates were 88.2 % ( 95 % CI 80.9-93.0 % ) vs. 79.1 % ( 95 % CI 71.1-85.4 % ) , p = 0.029 , respectively . The incidence of major and minor side effects between therapy groups was not significantly different ( 14.6 % in the triple therapy group vs. 23.5 % in sequential group , p = 0.12 ) . Follow up was incomplete in 3.3 % and 4.7 % patients in standard and sequential therapy groups , respectively . Sequential therapy includes one additional antibiotic ( tinidazole ) that is not contained in standard therapy . CONCLUSIONS Sequential therapy was significantly better than standard therapy for eradicating H. pylori infection .
62005
Intervention_Pharmacological
Sequential therapy
62006
Intervention_Pharmacological
standard triple-drug therapy
62007
Intervention_Pharmacological
sequential
62008
Intervention_Pharmacological
standard triple-drug therapy
62009
Intervention_Pharmacological
10-day sequential regimen
62010
Intervention_Pharmacological
40 mg of pantoprazole
62011
Intervention_Pharmacological
1 g of amoxicillin
62012
Intervention_Pharmacological
40 mg of pantoprazole
62013
Intervention_Pharmacological
500 mg of clarithromycin
62014
Intervention_Pharmacological
500 mg of tinidazole
62015
Intervention_Pharmacological
sequential regimen
62016
Intervention_Pharmacological
triple therapy
62017
Intervention_Pharmacological
sequential therapy
62018
Outcome_Other
eradication rate
62019
Outcome_Other
Per-protocol eradication rate
62020
Participant_Condition
Helicobacter pylori infection