artículo
14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial
Fecha
2011Registro en:
10.1016/S0140-6736(11)60825-8
0140-6736
MEDLINE:21777974
WOS:000294077200030
Autor
Greenberg, E. Robert
Anderson, Garnet L.
Morgan, Douglas R.
Torres, Javier
Chey, William D.
Eduardo Bravo, Luis
Dominguez, Ricardo L.
Ferreccio, Catterina
Herrero, Rolando
Lazcano Ponce, Eduardo C.
Mercedes Meza Montenegro, Maria
Pena, Rodolfo
Pena, Edgar M.
Salazar Martinez, Eduardo
Correa, Pelayo
Elena Martinez, Maria
Valdivieso, Manuel
Goodman, Gary E.
Crowley, John J.
Baker, Laurence H.
Institución
Resumen
Background Evidence from Europe, Asia, and North America suggests that standard three-drug regimens of a proton-pump inhibitor plus amoxicillin and clarithromycin are significantly less effective for eradication of Helicobacter pylori infection than are 5-day concomitant and 10-day sequential four-drug regimens that include a nitroimidazole. These four-drug regimens also entail fewer antibiotic doses than do three-drug regimens and thus could be suitable for eradication programmes in low-resource settings. Few studies in Latin America have been done, where the burden of H pylori-associated diseases is high. We therefore did a randomised trial in Latin America comparing the effectiveness of four-drug regimens given concomitantly or sequentially with that of a standard 14-day regimen of triple therapy. Methods Between September, 2009, and June, 2010, we did a randomised trial of empiric 14-day triple, 5-day concomitant, and 10-day sequential therapies for H pylori in seven Latin American sites: Chile, Colombia, Costa Rica, Honduras, Nicaragua, and Mexico (two sites). Participants aged 21-65 years who tested positive for H pylori by a urea breath test were randomly assigned by a central computer using a dynamic balancing procedure to: 14 days of lansoprazole, amoxicillin, and clarithromycin (standard therapy); 5 days of lansoprazole, amoxicillin, clarithromycin, and metronidazole (concomitant therapy); or 5 days of lansoprazole and amoxicillin followed by 5 days of lansoprazole, clarithromycin, and metronidazole (sequential therapy). Eradication was assessed by urea breath test 6-8 weeks after randomisation. The trial was not masked. Our primary outcome was probablity of H pylori eradication. Our analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, registration number NCT01061437. Findings 1463 participants aged 21-65 years were randomly allocated a treatment: 488 were treated with 14-day standard therapy, 489 with 5-day concomitant therapy, and 486 with 10-day sequential therapy. The probability of eradication with standard therapy was 82.2% (401 of 488), which was 8.6% higher (95% adjusted CI 2.6-14.5) than with concomitant therapy (73.6% [360 of 489]) and 5.6% higher (-0.04% to 11.6) than with sequential therapy (76.5% [372 of 486]). Neither four-drug regimen was significantly better than standard triple therapy in any of the seven sites. Interpretation Standard 14-day triple-drug therapy is preferable to 5-day concomitant or 10-day sequential four-drug regimens as empiric therapy for H pylori infection in diverse Latin American populations.