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.

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...

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Publicado en:BMC Gastroenterology Vol. 13; no. 1; pp. 56 - 57
Autores principales: Navarro-Rodriguez, Tomás, Silva, Fernando Marcuz, Barbuti, Ricardo Correa, Mattar, Rejane, Moraes-Filho, Joaquim Prado, de Oliveira, Maricê Nogueira, Bogsan, Cristina S, Chinzon, Décio, Eisig, Jaime Natan
Formato: research randomized controlled trial Journal Article
Publicado: BioMed Central 2013
Acceso en línea:Ver este registro en EBSCOhost
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      pub: BioMed Central
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        NLM23530767
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        10.1186/1471-230X-13-56
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        atl: 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.
      aug:
        au:
          Navarro-Rodriguez, Tomás
          Silva, Fernando Marcuz
          Barbuti, Ricardo Correa
          Mattar, Rejane
          Moraes-Filho, Joaquim Prado
          de Oliveira, Maricê Nogueira
          Bogsan, Cristina S
          Chinzon, Décio
          Eisig, Jaime Natan
        affil: Serviço de Gastroenterologia Clínica do Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo, Av, Dr, Enéas de Carvalho Aguiar, 255 - Cerqueira Cezar, Sao Paulo, SP, Brasil. tomasnavarro@uol.com.br.
      sug:
        subj:
          Antibiotics Adverse Effects
          Antibiotics Therapeutic Use
          Disease Outbreaks Prevention and Control
          Helicobacter Infections Drug Therapy
          Helicobacter Infections Prevention and Control
          Helicobacter Pylori
          Probiotics Therapeutic Use
          Brazil
          Double-Blind Studies
          Dyspepsia Drug Therapy
          Dyspepsia Microbiology
          Female
          Human
          Male
          Middle Age
          Nitrofurans Adverse Effects
          Nitrofurans Therapeutic Use
          Peptic Ulcer Drug Therapy
          Peptic Ulcer Microbiology
          Prospective Studies
          Proton Pump Inhibitors Adverse Effects
          Proton Pump Inhibitors Therapeutic Use
          Sulfur Compounds Adverse Effects
          Sulfur Compounds Therapeutic Use
          Tetracycline Adverse Effects
          Tetracycline Therapeutic Use
          Treatment Outcomes
          Middle Aged: 45-64 years
          Female
          Male
      ab: 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.Trial Registration: Current Controlled Trials ISRCTN04714018.
      pubtype: Academic Journal
      doctype:
        research
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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