Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IIS-IP), and Universidad Autónoma de Madrid, Madrid, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Helicobacter. 2018 Oct;23(5):e12529. doi: 10.1111/hel.12529. Epub 2018 Aug 23.
To evaluate the safety, tolerability and efficacy of a probiotic supplementation for Helicobacter pylori (H. pylori) eradication therapy.
Consecutive adult naive patients with a diagnosis of H. pylori infection who were prescribed eradication therapy according to clinical practice (10-day triple or nonbismuth quadruple concomitant therapy) randomly received probiotics (1 × 10 colony-forming units each strain, Lactobacillus plantarum and Pediococcus acidilactici) or matching placebo. Side effects at the end of the treatment, measured through a modified De Boer Scale, were the primary outcome. Secondary outcomes were compliance with therapy and eradication rates.
A total of 209 patients (33% triple therapy, 66% non-bismuth quadruple therapy) were included [placebo (n = 106) or probiotic (n = 103)]. No differences were observed regarding side effects at the end of the treatment between groups (β -0.023, P 0.738). Female gender (P < 0.001) and quadruple therapy (P 0.007) were independent predictors of side effects. No differences in compliance were observed, regardless of the study group or eradication therapy. Eradication rates were similar between groups [placebo 95% (95% confidence interval (CI), 89% to 98%) vs probiotic 97% (95% CI, 92% to 99%), P 0.721]. There were no relevant differences in cure rates (>90% in all cases) between triple and quadruple concomitant therapy.
Probiotic supplementation containing Lactobacillus Plantarum and Pediococcus acidilactici to H. pylori treatment neither decreased side effects nor improved compliance with therapy or eradication rates.
评估益生菌补充剂用于幽门螺杆菌（H. pylori）根除治疗的安全性、耐受性和疗效。
连续入组的、未经治疗的、成年初治的 H. pylori 感染患者，根据临床实践（10 天三联或非铋四联伴随治疗）处方根除治疗，患者随机接受益生菌（每种菌株 1×10 个菌落形成单位，植物乳杆菌和戊糖片球菌）或匹配的安慰剂。通过改良的 De Boer 量表在治疗结束时测量不良反应，这是主要结局。次要结局是治疗依从性和根除率。
共纳入 209 例患者（三联治疗占 33%，非铋四联治疗占 66%）[安慰剂（n=106）或益生菌（n=103）]。两组在治疗结束时的不良反应无差异（β-0.023，P=0.738）。女性（P<0.001）和四联治疗（P=0.007）是不良反应的独立预测因素。无论研究组或根除治疗如何，均未观察到依从性差异。根除率在两组间无差异[安慰剂 95%（95%可信区间（CI），89%至 98%）vs 益生菌 97%（95%CI，92%至 99%），P=0.721]。三联和四联伴随治疗的治愈率（>90%）无显著差异。
含植物乳杆菌和戊糖片球菌的益生菌补充剂用于 H. pylori 治疗，既不能减少不良反应，也不能提高治疗依从性或根除率。
