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J. Clin. Gastroenterol. · Apr 2010
Randomized Controlled Trial Comparative StudyTen and eight-day sequential therapy in comparison to standard triple therapy for eradicating Helicobacter pylori infection: a randomized controlled study on efficacy and tolerability.
- Omero Alessandro Paoluzi, Emanuela Visconti, Fabio Andrei, Claudio Tosti, Raffaella Lionetti, Enrico Grasso, Riccardo Ranaldi, Italo Stroppa, and Francesco Pallone.
- Gastroenterology Unit, Department of Internal Medicine, University of Rome "Tor Vergata," Rome, Italy. omeroalessandro.paoluzi@ptvonline.it
- J. Clin. Gastroenterol. 2010 Apr 1; 44 (4): 261-6.
BackgroundSequential therapy (SQT) is effective in the eradication of Helicobacter pylori and could become an alternative to standard triple therapy (STT).AimTo compare the efficacy and tolerability of SQT, for either 8 or 10 days, with a 7-day STT.MethodsA total of 270 naive H. pylori-positive patients were randomized to receive: SQT for 8 days (SQT-8, n=90) or 10 days (SQT-10, n=90) including esomeprazole 20 mg twice daily (bid) associated with amoxicillin 1000 mg bid (early 4 and 5 d, respectively), followed by esomeprazole 20 mg bid associated with clarithromycin 500 mg bid plus tinidazole 500 mg bid (last 4 and 5 d, respectively); STT (n=90) including esomeprazole 20 mg bid plus amoxicillin 1000 mg bid and clarithromycin 500 mg bid for 7 days. Tolerability was assessed by scoring the severity of symptoms.ResultsEradication rates after SQT-8 and SQT-10 were higher than that of after STT at both intention-to-treat (83% and 86% vs. 66%, P<0.02) and per-protocol analysis (90% and 88% vs. 75%, P<0.05), whereas no difference was found between the 2 SQTs.ConclusionsThis study shows that SQT, for 8 or 10 days, is well tolerated and highly effective in H. pylori eradication and could represent a valid alternative to STT. Further studies, with more power, on larger populations and from other countries are necessary to validate the present findings.
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