Association of a probiotic to a Helicobacter pylorieradication regimen does not increase efficacy or decreases the adverse effects of the treatment: a prospective, randomized, double-blind, placebo-controlled study

BMC Gastroenterology

Research Article

Maricê Nogueira de Oliveira¹  Cristina S Bogsan¹  Jaime Natan Eisig¹  Fernando Marcuz Silva¹  Ricardo Correa Barbuti¹  Rejane Mattar¹  Tomás Navarro-Rodriguez¹  Joaquim Prado Moraes-Filho¹  Décio Chinzon¹ 

[1] Serviço de Gastroenterologia Clínica do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255 – Cerqueira Cezar, São Paulo, SP, Brazil;

关键词: Helicobacter pylori;    Probiotic;    Tetracycline;    Furazolidone;    Peptic ulcer;    Functional dyspepsia;    Treatment efficacy;    Adverse effects;   

DOI  :  10.1186/1471-230X-13-56

 received in 2012-06-26, accepted in 2013-03-19,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundThe treatment for the eradication of Helicobacter pylori (H. pylori) is complex; full effectiveness is rarely achieved and it has many adverse effects. In developing countries, increased resistance to antibiotics and its cost make eradication more difficult. Probiotics can reduce adverse effects and improve the infection treatment efficacy.If the first-line therapy fails a second-line treatment using tetracycline, furazolidone and proton-pump inhibitors has been effective and low cost in Brazil; however it implies in a lot of adverse effects. The aim of this study was to minimize the adverse effects and increase the eradication rate applying the association of a probiotic compound to second-line therapy regimen.MethodsPatients with peptic ulcer or functional dyspepsia infected by H. pylori were randomized to treatment with the furazolidone, tetracycline and lansoprazole regimen, twice a day for 7 days. In a double-blind study, patients received placebo or a probiotic compound (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum and Streptococcus faecium) in capsules, twice a day for 30 days. A symptom questionnaire was administered in day zero, after completion of antibiotic therapy, after the probiotic use and eight weeks after the end of the treatment. Upper digestive endoscopy, histological assessment, rapid urease test and breath test were performed before and eight weeks after eradication treatment.ResultsOne hundred and seven patients were enrolled: 21 men with active probiotic and 19 with placebo plus 34 women with active probiotic and 33 with placebo comprising a total of 55 patients with active probiotic and 52 with placebo. Fifty-one patients had peptic ulcer and 56 were diagnosed as functional dyspepsia. The per-protocol eradication rate with active probiotic was 89.8% and with placebo, 85.1% (p = 0.49); per intention to treat, 81.8% and 79.6%, respectively (p = 0.53). The rate of adverse effects at 7 days with the active probiotic was 59.3% and 71.2% with placebo (p = 0.20). At 30 days, it was 44.9% and 60.4%, respectively (p = 0.08).ConclusionsThe use of this probiotic compound compared to placebo in the proposed regimen in Brazilian patients with peptic ulcer or functional dyspepsia showed no significant difference in efficacy or adverse effects.Trial registrationCurrent Controlled Trials ISRCTN04714018

【 授权许可】

CC BY   
© Navarro-Rodriguez et al.; licensee BioMed Central Ltd. 2013