The effect of supplementing with Saccharomyces boulardii on bismuth quadruple therapy for eradicating Helicobacter pylori: a systematic review and meta-analysis of randomized controlled trials.

2024-04-17
Frontiers in medicine 11
- Yin Chen
- Tao Teng
- Yu Su
- Wen-Zhong Chen

PubMed: 38695028
DOI: 10.3389/fmed.2024.1344702

Study Design

Type: Systematic Review
Sample size: n = 404
Population: 1,404 patients
Methods: meta-analysis of randomized controlled trials; comprehensive searches in PubMed, Embase, Web of Science, and Cochrane library databases from inception through November 1, 2023; random-effects model; revised Cochrane Risk of Bias Tool

Background and objective

It remains uncertain if the addition of Saccharomyces boulardii (S. boulardii) to bismuth quadruple therapy (BQT) recommended in the current guidelines can enhance the Helicobacter pylori (H. pylori) eradication rate and decrease the incidence of adverse events. We therefore conducted a meta-analysis of randomized controlled trials (RCTs) to address this issue.

Methods

We performed comprehensive searches in PubMed, Embase, Web of Science, and Cochrane library databases from the inception of the databases through to November 1, 2023. A meta-analysis was conducted to determine the pooled relative risk (RR) with 95% confidence intervals (CI) using a random-effects model. We utilized the revised Cochrane Risk of Bias Tool to assess the risk of bias of included studies.

Results

A total of six RCTs (1,404 patients) included in this meta-analysis. The results of the intention-to-treat analysis showed that the combination of S. boulardii with BQT had a higher eradication rate than BQT alone (87.0% versus 83.3%), with a pooled RR of 1.05 (95% CI: 1.00-1.10, p = 0.03). In the per-protocol analysis, however, there was no statistical significance between the two groups in the eradication rate (93.7% versus 91.0%, RR = 1.03, 95% CI: 1.00-1.06, p = 0.07). The combination of S. boulardii and BQT had a significantly lower rate of overall adverse events (22% vs. 39%, RR = 0.56, 95% CI: 0.44-0.70, p < 0.00001), diarrhea (7.9% vs. 25.7%, RR = 0.29, 95% CI: 0.17-0.48, p < 0.00001), constipation (2.9% vs. 8.4%, RR = 0.35, 95% CI: 0.14-0.88, p = 0.03) and abdominal distention (4.9% vs. 12.7%, RR = 0.41, 95% CI: 0.23-0.72, p = 0.002) than BQT alone. For the assessment of risk of bias, five studies were deemed to have some concerns, while one study was judged to have a low risk.

Conclusion

Current evidence suggests that supplementation with S. boulardii in BQT may not have a major effect on the H. pylori eradication rate, but significantly reduces the incidence of overall adverse events, diarrhea, abdominal distention and constipation. Combining S. Boulardii with BQT can help alleviate symptoms, potentially improving patient adherence.

Systematic review registration

https://osf.io/n9z7c.

Research Insights

saccharomyces boulardii→Improved H Pylori Eradication Rates
The results of the intention-to-treat analysis showed that the combination of S. boulardii with BQT had a higher eradication rate than BQT alone (87.0% versus 83.3%), with a pooled RR of 1.05 (95% CI: 1.00-1.10, p = 0.03). In the per-protocol analysis, however, there was no statistical significance between the two groups in the eradication rate (93.7% versus 91.0%, RR = 1.03, 95% CI: 1.00-1.06, p = 0.07).
Effect
Neutral
Effect size
Small
Dose
not stated
saccharomyces boulardii→Reduced Constipation
The combination of S. boulardii and BQT had a significantly lower rate of ... constipation (2.9% vs. 8.4%, RR = 0.35, 95% CI: 0.14-0.88, p = 0.03)
Effect
Beneficial
Effect size
Large
Dose
not stated
saccharomyces boulardii→Reduced Diarrhea
The combination of S. boulardii and BQT had a significantly lower rate of ... diarrhea (7.9% vs. 25.7%, RR = 0.29, 95% CI: 0.17-0.48, p < 0.00001)
Effect
Beneficial
Effect size
Large
Dose
not stated
saccharomyces boulardii→Reduced Flatulence
The combination of S. boulardii and BQT had a significantly lower rate of ... abdominal distention (4.9% vs. 12.7%, RR = 0.41, 95% CI: 0.23-0.72, p = 0.002)
Effect
Beneficial
Effect size
Large
Dose
not stated

Adverse Events Reported

saccharomyces boulardii→abdominal distention
abdominal distention (4.9% vs. 12.7%, RR = 0.41, 95% CI: 0.23-0.72, p = 0.002)
Finding
Reported
Magnitude
4.9% vs. 12.7%, RR = 0.41, 95% CI: 0.23-0.72, p = 0.002
Significant
Yes
saccharomyces boulardii→constipation
constipation (2.9% vs. 8.4%, RR = 0.35, 95% CI: 0.14-0.88, p = 0.03)
Finding
Reported
Magnitude
2.9% vs. 8.4%, RR = 0.35, 95% CI: 0.14-0.88, p = 0.03
Significant
Yes
saccharomyces boulardii→diarrhea
diarrhea (7.9% vs. 25.7%, RR = 0.29, 95% CI: 0.17-0.48, p < 0.00001)
Finding
Reported
Magnitude
7.9% vs. 25.7%, RR = 0.29, 95% CI: 0.17-0.48, p < 0.00001
Significant
Yes
saccharomyces boulardii→overall adverse events
The combination of S. boulardii and BQT had a significantly lower rate of overall adverse events (22% vs. 39%, RR = 0.56, 95% CI: 0.44-0.70, p < 0.00001)
Finding
Reported
Magnitude
22% vs. 39%, RR = 0.56, 95% CI: 0.44-0.70, p < 0.00001
Significant
Yes