AIM: To compare the eradication rates for Helicobacter pylori (H. pylori) and ulcer recurrence of standard triple therapy (STT) and levofloxacin based therapy (LBT). METHODS:Seventy-four patients with perforated duodenal ulcer treated with simple closure and found to be H. pylori infected on 3 mo follow up were randomized to receive either the STT group comprising of amoxicillin 1 g bid, clarithromycin 500 mg bid and omeprazole 20 mg bid or the LBT group comprising of amoxicillin 1 g bid, levofloxacin 500 mg bid and omeprazole 20 mg bid for 10 d each. The H. pylori eradication rates, side effects, compliance and the recurrence of ulcer were assessed in the two groups at 3 mo follow up. RESULTS:Thirty-four patients in the STT group and 32 patients in thelevofloxacin group presented at 3 mo follow up. H. pylori eradication rates were similar with STT and the LBT groups on intention-to-treat (ITT) analysis (69% vs 80%, P = 0.425) and (79% vs 87%, P = 0.513) by per-protocol (PP) analysis respectively. Ulcer recurrence in the STT and LBT groups on ITT analysis was (20% vs 14%, P = 0.551) and (9% vs 6%, P = 1.00) by PP analysis. Compliance and side effects were also comparable between the groups. A complete course of STT costs Indian Rupees (INR) 1060.00, while LBT costs only INR 360.00. CONCLUSION:H. pylori eradication rates and the rate of ulcer recurrence were similar between the STT and LBT. The LBT is a more economical option compared to STT.
RCT Entities:
AIM: To compare the eradication rates for Helicobacter pylori (H. pylori) and ulcer recurrence of standard triple therapy (STT) and levofloxacin based therapy (LBT). METHODS: Seventy-four patients with perforated duodenal ulcer treated with simple closure and found to be H. pylori infected on 3 mo follow up were randomized to receive either the STT group comprising of amoxicillin 1 g bid, clarithromycin 500 mg bid and omeprazole 20 mg bid or the LBT group comprising of amoxicillin 1 g bid, levofloxacin 500 mg bid and omeprazole 20 mg bid for 10 d each. The H. pylori eradication rates, side effects, compliance and the recurrence of ulcer were assessed in the two groups at 3 mo follow up. RESULTS: Thirty-four patients in the STT group and 32 patients in the levofloxacin group presented at 3 mo follow up. H. pylori eradication rates were similar with STT and the LBT groups on intention-to-treat (ITT) analysis (69% vs 80%, P = 0.425) and (79% vs 87%, P = 0.513) by per-protocol (PP) analysis respectively. Ulcer recurrence in the STT and LBT groups on ITT analysis was (20% vs 14%, P = 0.551) and (9% vs 6%, P = 1.00) by PP analysis. Compliance and side effects were also comparable between the groups. A complete course of STT costs Indian Rupees (INR) 1060.00, while LBT costs only INR 360.00. CONCLUSION:H. pylori eradication rates and the rate of ulcer recurrence were similar between the STT and LBT. The LBT is a more economical option compared to STT.
Entities:
Keywords:
Eradication; Helicobacter pylori; Levofloxacin regime; Peptic perforation; Randomized control trial; Standard triple therapy
Authors: James Y Lau; Joseph Sung; Catherine Hill; Catherine Henderson; Colin W Howden; David C Metz Journal: Digestion Date: 2011-04-14 Impact factor: 3.216
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