Efficacy and safety of Saccharomyces boulardii in the 14-day triple anti-Helicobacter pylori therapy: a prospective randomized placebo-controlled double-blind study.

BACKGROUND

Recent studies indicate a potential role of Saccharomyces boulardii in the prevention of Helicobacter pylori treatment-related side-effects and also in improvement of eradication rate. Our aim is to investigate the efficacy and safety of S. boulardii in the prevention of side-effects related to H. pylori eradication. The secondary aim of the study was to define the effect of S. boulardii on the eradication success of anti-H. pylori therapy.

MATERIALS AND METHODS

One hundred and twenty-four patients with H. pylori infection (male/female: 44/80, mean age: 48 +/- 14.25 year) receiving 14 days of triple therapy (clarithromycin 500 mg b.i.d., amoxicillin 1000 mg b.i.d., and lansoprazole 30 mg b.i.d.) were randomly assigned to S. boulardii or placebo. Dyspeptic symptoms were recorded by using modified Glasgow Dyspepsia Questionnaire (GDQ). Side-effect profile and tolerability were assessed using a symptom-based questionnaire. H. pylori status was rechecked after 6 weeks after completion of eradication therapy.

RESULTS

H. pylori eradication rate, although higher in the treatment group, was statistically similar in treatment and control groups: 71% (44/62) versus 59.7% (37/62), respectively (p > .05). Nine (14.5%) patients in the treatment group and 19 (30.6%) patients in the placebo group experienced diarrhea (p < .05). Epigastric discomfort was more frequent in the control group [9 (14.5%) versus 27 (43.5%), respectively (p < .01)]. Diffuse abdominal pain, abdominal gas, taste disturbance, urticaria, nausea symptoms were similar in both groups. GDQ scores after treatment were significantly better for treatment group (mean +/- SD, range: 1.38 +/- 1.25 (0-5) vs. 2.22 +/- 1.44 (0-6), respectively; p < .01).

CONCLUSION

S. boulardii improved anti-H. pylori antibiotherapy-associated diarrhea, epigastric discomfort, and treatment tolerability. In addition, S. boulardii supplement decreased post-treatment dyspepsia symptoms independent of H. pylori status. However, S. boulardii had no significant affect on the rate of H. pylori eradication.