Efficacy and safety of berberine plus 5-ASA for ulcerative colitis: A systematic review and meta-analysis.

2024-09-06
PloS one 19(9)
- Jilei Li
- Chenchen Zhang
- Yanchao Xu
- Lili Yang

PubMed: 39241013
DOI: 10.1371/journal.pone.0309144

Study Design

Type: Meta-Analysis
Sample size: n = 952
Population: 952 patients with UC
Methods: A comprehensive search was conducted in electronic databases, including Medline/PubMed, Sinomed, Embase, CNKI, Wanfang, and VIP, through January 2024 to identify all randomized controlled trials (RCTs) that administered BBR conjunction in standard therapy (5-ASA) for to support the treatment of UC. The data were synthesized using a meta-analysis approach with RevMan 5.4.1.

Purpose

This study aimed to assess the efficacy and safety of berberine(BBR) plus 5-aminosalicylic acid (5-ASA) for treating ulcerative colitis (UC).

Methods

A comprehensive search was conducted in electronic databases, including Medline/PubMed, Sinomed, Embase, CNKI, Wanfang, and VIP, through January 2024 to identify all randomized controlled trials (RCTs) that administered BBR conjunction in standard therapy(5-ASA) for to support the treatment of UC. The data were synthesized using a meta-analysis approach with RevMan 5.4.1. The primary endpoint was the clinical efficacy rate. In contrast, the secondary endpoints included the Baron score, disease activity index (DAI) score, symptom relief latency, inflammatory markers, immunological indicators, and adverse events.

Results

In this analysis, 10 RCTs comprising 952 patients with UC were examined. BBR considerably improved the clinical efficacy rate (RR = 1.22, 95% CI [1.15, 1.30], P < 0.00001), attenuated the Baron score (SMD = -1.72, 95% CI [-2.30, -1.13], P < 0.00001) and reduced the DAI score (SMD = -2.93, 95% CI [-4.42, -1.43], P < 0.00001). Additionally, it ameliorated clinical symptoms (SMD = -2.74, 95% CI [-3.45, 2.02], P < 0.00001), diminished inflammatory responses (SMD = -1.59, 95% CI [-2.14, 1.04], P < 0.00001), and modulated immune reactions (SMD = 1.06,95% CI [0.24,1.87], P <0.00001). Nonetheless, the impact of BBR on reducing adverse reactions was not statistically significant (RR = 0.75, 95% CI [0.42, 1.33], P > 0.05).

Conclusion

BBR demonstrates substantial efficacy in treating UC without causing severe adverse reactions and may serve as a viable complementary therapy. However, its clinical application warrants confirmation by additional high-quality, low-bias RCTs.

Research Insights

Berberine→Improved Clinical Efficacy Rate
BBR considerably improved the clinical efficacy rate (RR = 1.22, 95% CI [1.15, 1.30], P < 0.00001)
Effect
Beneficial
Effect size
Large
Berberine→Improved Immune Modulation
modulated immune reactions (SMD = 1.06,95% CI [0.24,1.87], P <0.00001)
Effect
Beneficial
Effect size
Large
Berberine→Reduced Baron Score
attenuated the Baron score (SMD = -1.72, 95% CI [-2.30, -1.13], P < 0.00001)
Effect
Beneficial
Effect size
Large
Berberine→Reduced Disease Activity Index Scores
reduced the DAI score (SMD = -2.93, 95% CI [-4.42, -1.43], P < 0.00001)
Effect
Beneficial
Effect size
Large
Berberine→Reduced Inflammatory Markers
diminished inflammatory responses (SMD = -1.59, 95% CI [-2.14, 1.04], P < 0.00001)
Effect
Beneficial
Effect size
Large
Berberine→Reduced Symptom Relief Latency
ameliorated clinical symptoms (SMD = -2.74, 95% CI [-3.45, 2.02], P < 0.00001)
Effect
Beneficial
Effect size
Large

Adverse Events Reported

Berberine→Overall tolerability
the impact of BBR on reducing adverse reactions was not statistically significant (RR = 0.75, 95% CI [0.42, 1.33], P > 0.05)
Finding
No significant difference
Magnitude
RR = 0.75, 95% CI [0.42, 1.33]
Significant
No
Berberine→Overall tolerability
without causing severe adverse reactions
Finding
Reported
Grade
severe