title: Standard Triple Therapy versus Sequential Therapy in Helicobacter pylori Eradication: A Double-Blind, Randomized, and Controlled Trial.
abstract: Aim. To compare 10-day standard triple therapy versus sequential therapy as first-line treatment in patients infected with H. pylori. Methods. One hundred H. pylori positive patients (diagnosed by rapid urease test and histology), with average age of 47.2, M/F = 28/72, were randomized to receive either standard triple treatment (TT) as follows: lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1 g, b.i.d. for ten days, or sequential treatment (ST) as follows: lansoprazole 30 mg, amoxicillin and placebo 1.0 g b.i.d for the first five days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and tinidazole 500 mg b.i.d, for the remaining five days. Eradication rates were determined 60 days after treatment by urease, histology, or (13)C-urea breath test. Results. In intention to treat (ITT) analysis, the rate of H. pylori eradication in the TT and ST groups was the same for both regimens as follows: 86% (43/50), 95% CI 93,3 to 73.4%. In Per protocol (PP) analysis, the rate of H. pylori eradication in the TT and ST groups was 87.8% (43/49), 95% CI 94,5 to 75.3% and 89.6% (43/48), 95% CI 95,8 to 77.3%, respectively. Conclusions. In Brazil, standard triple therapy is as equally effective as sequential therapy in eradicating Helicobacter pylori patients. This study was registered under Clinical Trials with number ISRCTN62400496.
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Jaime Natan
authors.identifier: 0000-0002-8402-2033
authors.initials: JN
authors.lastname: Eisig
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Tomás
authors.initials: T
authors.lastname: Navarro-Rodriguez
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Ana Cristina Sá
authors.initials: AC
authors.lastname: Teixeira
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Fernando Marcuz
authors.initials: FM
authors.lastname: Silva
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Rejane
authors.initials: R
authors.lastname: Mattar
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Decio
authors.initials: D
authors.lastname: Chinzon
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Christiane
authors.initials: C
authors.lastname: Haro
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Márcio Augusto
authors.identifier: 0000-0002-2427-7843
authors.initials: MA
authors.lastname: Diniz
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Joaquim Prado
authors.initials: JP
authors.lastname: Moraes-Filho
authors.affiliation: Division of Gastroenterology and Hepatology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH 44109, USA.
authors.forename: Ronnie
authors.initials: R
authors.lastname: Fass
authors.affiliation: Division of Gastroenterology and Clinical Hepatology, Hospital das Clínicas da FMUSP, 05493-900 São Paulo, SP, Brazil.
authors.forename: Ricardo Correa
authors.initials: RC
authors.lastname: Barbuti