BACKGROUND AND AIM: This prospective randomized study was designed to assess the efficacy of 10-day and 14-day rifabutin-based triple therapy as a third- or fourth-line rescue therapy. METHODS:Patients who failed first- and second-line eradication therapy were enrolled. H. pylori was isolated from gastric biopsy specimens and the rpoB mutation status, a factor of resistance to rifamycins, and minimum inhibitory concentrations (MICs) of rifabutin and amoxicillin were determined. Enrolled patients were randomly assigned to receive 10-day or 14-day eradication therapy with esomeprazole (20 mg, 4 times a day (q.i.d.)), amoxicillin (500 mg, q.i.d.), and rifabutin (300 mg, once a day (q.d.s.)). Poor compliance was defined as intake of <80% of study drugs. Successful H. pylori eradication was confirmed using a [13C] urea breath test or a stool antigen test, 12 weeks after the end of therapy. RESULTS: Twelve patients were assigned to the 10-day group, and 17, to the 14-day group. Intention-to-treat and per-protocol analyses of eradication rates were 83.3% and 81.8% for the 10-day group and 94.1% and 91.7% for the 14-day group, respectively. All patients with rpoB mutation-positive strains (n = 3) showed successful eradication, irrespective of the regimen received. Therapy was stopped due to adverse events in 8.3% and 29.3% of patients in the 10-day and 14-day groups, respectively. CONCLUSION: Both the 10-day and 14-day therapies were effective as rescue regimens. In particular, the 14-day therapy resulted in successful eradication in over 90% of patients, but the 10-day treatment may be enough to obtain a successful eradication rate, considering the tolerability of therapy.
RCT Entities:
BACKGROUND AND AIM: This prospective randomized study was designed to assess the efficacy of 10-day and 14-day rifabutin-based triple therapy as a third- or fourth-line rescue therapy. METHODS:Patients who failed first- and second-line eradication therapy were enrolled. H. pylori was isolated from gastric biopsy specimens and the rpoB mutation status, a factor of resistance to rifamycins, and minimum inhibitory concentrations (MICs) of rifabutin and amoxicillin were determined. Enrolled patients were randomly assigned to receive 10-day or 14-day eradication therapy with esomeprazole (20 mg, 4 times a day (q.i.d.)), amoxicillin (500 mg, q.i.d.), and rifabutin (300 mg, once a day (q.d.s.)). Poor compliance was defined as intake of <80% of study drugs. Successful H. pylori eradication was confirmed using a [13C] urea breath test or a stool antigen test, 12 weeks after the end of therapy. RESULTS: Twelve patients were assigned to the 10-day group, and 17, to the 14-day group. Intention-to-treat and per-protocol analyses of eradication rates were 83.3% and 81.8% for the 10-day group and 94.1% and 91.7% for the 14-day group, respectively. All patients with rpoB mutation-positive strains (n = 3) showed successful eradication, irrespective of the regimen received. Therapy was stopped due to adverse events in 8.3% and 29.3% of patients in the 10-day and 14-day groups, respectively. CONCLUSION: Both the 10-day and 14-day therapies were effective as rescue regimens. In particular, the 14-day therapy resulted in successful eradication in over 90% of patients, but the 10-day treatment may be enough to obtain a successful eradication rate, considering the tolerability of therapy.
Authors: M Asaka; T Sugiyama; M Kato; K Satoh; H Kuwayama; Y Fukuda; T Fujioka; T Takemoto; K Kimura; T Shimoyama; K Shimizu; S Kobayashi Journal: Helicobacter Date: 2001-09 Impact factor: 5.753
Authors: D Vaira; P Malfertheiner; F Mégraud; A T Axon; M Deltenre; A M Hirschl; G Gasbarrini; C O'Morain; J M Garcia; M Quina; G N Tytgat Journal: Lancet Date: 1999-07-03 Impact factor: 79.321
Authors: J P Gisbert; J-L Gisbert; S Marcos; I Jimenez-Alonso; R Moreno-Otero; J M Pajares Journal: Aliment Pharmacol Ther Date: 2007-11-12 Impact factor: 8.171
Authors: Jae Ho Choi; Young Joo Yang; Chang Seok Bang; Jae Jun Lee; Gwang Ho Baik Journal: Gastroenterol Res Pract Date: 2018-05-02 Impact factor: 2.260
Authors: Muhammad Miftahussurur; Modesto Cruz; Dalla Doohan; Phawinee Subsomwong; José A Jiménez Abreu; Celso Hosking; Langgeng Agung Waskito; Yoshio Yamaoka Journal: PLoS One Date: 2019-03-27 Impact factor: 3.240