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

• Published in: PloS one 2024-09, Vol.19 (9), p.e0309144
• Main Authors: Li, Jilei, Zhang, Chenchen, Xu, Yanchao, Yang, Lili
• Format: Article
• Language: English
• Subjects: Abdomen; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Berberine; Berberine - administration & dosage; Berberine - adverse effects; Bias; Clinical trials; Colitis, Ulcerative - diagnosis; Colitis, Ulcerative - drug therapy; Cytokines; Diagnosis; Diarrhea; Drug therapy; Drug Therapy, Combination - adverse effects; Drug Therapy, Combination - methods; Effectiveness; Handbooks; Humans; Immunology; Inflammatory bowel disease; Inflammatory bowel diseases; Latency; Mesalamine - administration & dosage; Mesalamine - adverse effects; Meta-analysis; Randomized Controlled Trials as Topic; Remission (Medicine); Serology; Side effects; Statistical analysis; Systematic review; Treatment Outcome; Tumor necrosis factor-TNF; Ulcerative colitis
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0309144

This study aimed to assess the efficacy and safety of berberine(BBR) plus 5-aminosalicylic acid (5-ASA) for treating ulcerative colitis (UC). 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. 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 0.05). 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.