Levofloxacin+Tetracycline Quadruple Regimen for Eradication of Helicobacter pylori: A Multicenter Multinational Randomized Controlled Trial
Abstract
Background: The ideal combination regimen for Helicobacter pylori (HP) eradication has not yet been determined and the success rate of HP eradication has been extensively reduced worldwide due to increasing antibiotic resistance. So this multinational multi-center randomized controlled trial was designed to evaluate the efficacy of tetracycline +levofloxacin for HP eradication. Methods: During a 6-month period, all of the cases with HP infection in eight referral tertiary centers of three countries were included and randomly allocated to receive either tetracycline + levofloxacin or clarithromycin plus amoxicillin quadruple regimen for two weeks. For all of the participants, pantoprazole was continued for 4 more weeks and after one to two weeks of off-therapy, they underwent urea breath test C13 to prove eradication. Results: Overall 788 patients were included (358 male (45.4%), average age 44.2 years). They were diagnosed as having non-ulcer dyspepsia (516 cases, 65.5%), peptic ulcer disease (PUD) (234 cases, 29.69%), and intestinal metaplasia (38 cases, 4.8%). Racially 63.1% were Caucasian, 14.5% Arab, 15.6% African, and 6.1% Asian. The participants were randomly allocated to groups A and B to receive either tetracycline + levofloxacin or clarithromycin. Among groups A and B in intention to treat (ITT) and per protocol (PP) analysis, 75.2% & 82.1% (285 cases) and 67.5% & 70.1% (276 cases) of participants achieved eradication, respectively (P = 0.0001). The complete…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 788 participants or records.
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