title: Association of a probiotic to a Helicobacter pylori eradication regimen does not increase efficacy or decreases the adverse effects of the treatment: a prospective, randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  The 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.
  
  
  METHODS
  Patients 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.
  
  
  RESULTS
  One 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).
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN04714018.
authors.affiliation: 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. tomasnavarro@uol.com.br
authors.forename: Tomás
authors.initials: T
authors.lastname: Navarro-Rodriguez
authors.forename: Fernando Marcuz
authors.initials: FM
authors.lastname: Silva
authors.forename: Ricardo Correa
authors.initials: RC
authors.lastname: Barbuti
authors.forename: Rejane
authors.initials: R
authors.lastname: Mattar
authors.forename: Joaquim Prado
authors.initials: JP
authors.lastname: Moraes-Filho
authors.forename: Maricê Nogueira
authors.initials: MN
authors.lastname: de Oliveira
authors.forename: Cristina S
authors.initials: CS
authors.lastname: Bogsan
authors.forename: Décio
authors.initials: D
authors.lastname: Chinzon
authors.forename: Jaime Natan
authors.initials: JN
authors.lastname: Eisig
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D001938:Brazil; D060740:Disease Eradication; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy / Q000382:microbiology; D005260:Female; D005664:Furazolidone / Q000009:adverse effects / Q000627:therapeutic use; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000517:prevention & control*; D016480:Helicobacter pylori; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D010437:Peptic Ulcer / Q000188:drug therapy / Q000382:microbiology; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D013752:Tetracycline / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D005664:Furazolidone; D013752:Tetracycline