Department of Oncology Diseases, Henan Province Hospital of Traditional Chinese Medicine, Zhengzhou, Henan, China.
Graduate School Department, Beijing University of Chinese Medicine, Beijing, China.
PLoS One. 2024 Sep 6;19(9):e0309144. doi: 10.1371/journal.pone.0309144. eCollection 2024.
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 <0.00001). 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).
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.
本研究旨在评估小檗碱（BBR）联合 5-氨基水杨酸（5-ASA）治疗溃疡性结肠炎（UC）的疗效和安全性。
通过电子数据库（包括 Medline/PubMed、Sinomed、Embase、CNKI、Wanfang 和 VIP）进行全面检索，截至 2024 年 1 月，以识别所有给予 BBR 联合标准治疗（5-ASA）的随机对照试验（RCT），以支持 UC 的治疗。使用 RevMan 5.4.1 进行荟萃分析来综合数据。主要终点是临床疗效率。相比之下，次要终点包括 Baron 评分、疾病活动指数（DAI）评分、症状缓解潜伏期、炎症标志物、免疫指标和不良事件。
在这项分析中，检查了 10 项包含 952 例 UC 患者的 RCT。BBR 显著提高了临床疗效率（RR=1.22，95%CI[1.15，1.30]，P<0.00001），减轻了 Baron 评分（SMD=-1.72，95%CI[-2.30，-1.13]，P<0.00001）和 DAI 评分（SMD=-2.93，95%CI[-4.42，-1.43]，P<0.00001）。此外，它改善了临床症状（SMD=-2.74，95%CI[-3.45，2.02]，P<0.00001），减轻了炎症反应（SMD=-1.59，95%CI[-2.14，1.04]，P<0.00001），并调节了免疫反应（SMD=1.06，95%CI[0.24，1.87]，P<0.00001）。然而，BBR 对减少不良反应的影响在统计学上并不显著（RR=0.75，95%CI[0.42，1.33]，P>0.05）。
BBR 在治疗 UC 方面具有显著疗效，不会引起严重的不良反应，可能是一种可行的辅助治疗方法。然而，其临床应用需要更多高质量、低偏倚 RCT 的证实。
