[Influence of different timing of Saccharomyces boulardii combined with bismuth quadruple therapy for Helicobacter pylori eradication].

2019-06-01
Zhonghua yi xue za zhi 99(22)
- C X He
- F T Kong
- F Liang
- K X Wang
- H Li
- Y L Liu
- W Zhao
- P P Zhou
- F L Kong

PubMed: 31216821
DOI: 10.3760/cma.j.issn.0376-2491.2019.22.010

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 300
Population: 300 H. pylori-infected patients
Methods: prospective study, randomized assigned into three groups; quadruple therapy (pantoprazole 40 mg + bismuth potassium citrate capsule 220 mg + amoxicillin 1 000 mg + furazolidone 100 mg, bid, oral for 14 days); simultaneous probiotic group (same quadruple + S. Boulardii Sachets 500 mg, bid, oral for 14 days); there after probiotic group (quadruple group then S. Boulardii Sachets 500 mg, bid, 14 days after end of quadruple)
Duration: 14 days

Large Human Trial

Objective: To assess the efficacy and safety of different opportunity of Saccharomyces boulardii (S. Boulardii) Sachets combined with bismuth quadruple therapy for Helicobacter pylori(H. pylori)eradication. Methods: This experiment was a prospective study. A total of 300 H. pylori-infected patients were enrolled and randomized assigned into three groups. Quadruple therapy group received pantoprazole 40 mg+bismuth potassium citrate capsule 220 mg+amoxicillin 1 000 mg+furazolidone 100 mg, bid, oral for 14 days. The simultaneous probiotic group received pantoprazole 40 mg+bismuth potassium citrate capsule 220 mg+amoxicillin 1 000 mg+furazolidone 100 mg+S. Boulardii Sachets 500 mg,bid,oral for 14 days.There after probiotic group:S.Boulardii Sachets was added on the first day after the end of 14 days in the quadruple group, for 500 mg, bid 14 days. The eradication rates and adverse reactions of the three groups were compared. Results: The eradication rates of H.pylori were 89.0%,90.4% and 91.3% in the quadruple therapy group, the simultaneous probiotic group and the there after probiotic group according to Per-protocol(PP) analysis,respectively,with no statistical difference (P=0.870). According to intention-to-treat(ITT)analysis, 81.0%, 85.0% and 84.0%, respectively, the difference was not statistically significant (P=0.732).The overall incidence of adverse reactions and the incidence of diarrhea and nausea in the simultaneous probiotic group, and the there after probiotic group were lower than those in the quadruple group(P<0.05),and the difference was statistically significant.The overall incidence of adverse reactions and diarrhea in the simultaneous probiotic were lower than those in the there after probiotic group (P=0.021, P=0.007), and the difference was statistically significant. Conclusions:S. Boulardii Sachets combined with quadruple therapy at the same time or after eradication treatment can not improve the H.pylori eradication rate,but can reduce the overall incidence of adverse reactions and the incidence of diarrhea and nausea. It is safer to add S. Boulardii Sachets at the same time than after eradication therapy.

Research Insights

saccharomyces boulardii→Improved H Pylori Eradication Rates
The eradication rates of H. pylori were 89.0%, 90.4% and 91.3% in the quadruple therapy group, the simultaneous probiotic group and the there after probiotic group according to Per-protocol (PP) analysis, respectively, with no statistical difference (P=0.870). According to intention-to-treat (ITT) analysis, 81.0%, 85.0% and 84.0%, respectively, the difference was not statistically significant (P=0.732).
Effect
Neutral
Effect size
Small
Dose
500 mg bid

Adverse Events Reported

saccharomyces boulardii→_overall adverse reactions
The overall incidence of adverse reactions and the incidence of diarrhea and nausea in the simultaneous probiotic group, and the there after probiotic group were lower than those in the quadruple group(P<0.05),and the difference was statistically significant.
Finding
Reported
saccharomyces boulardii→diarrhea
The overall incidence of adverse reactions and the incidence of diarrhea and nausea in the simultaneous probiotic group, and the there after probiotic group were lower than those in the quadruple group(P<0.05),and the difference was statistically significant.
Finding
Reported
Significant
Yes
saccharomyces boulardii→nausea
The overall incidence of adverse reactions and the incidence of diarrhea and nausea in the simultaneous probiotic group, and the there after probiotic group were lower than those in the quadruple group(P<0.05),and the difference was statistically significant.
Finding
Reported
Significant
Yes