Yu Mingkun, Jin Xuejing, Liang Changhao, Bu Fanlong, Pan Deng, He Qian, Ming Yang, Little Paul, Du Hongbo, Liang Shibing, Hu Ruixue, Li Chengze, Hu Yanhong Jessika, Cao Huijuan, Liu Jianping, Fei Yutong
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
School of Public Health, University of Alberta, Edmonton, AB, Canada.
Therap Adv Gastroenterol. 2020 Oct 23;13:1756284820961299. doi: 10.1177/1756284820961299. eCollection 2020.
Diarrhea is a ubiquitous digestive system disease, leading to loss of fluid and electrolytes, and may be life-threatening, especially in children and adults who are immunosuppressed or malnourished. Berberine has a broad-spectrum antibiotic activity and is very widely used to treat diarrhea in China. No systematic review has been carried out to evaluate the evidence presented in clinical trials. The aim of this study was to assess the effectiveness and safety of berberine in diarrhea treatment among children and adults.
Seven databases and two clinical trial registries were searched on 1 September 2019. Randomized controlled trials were included, where participants were diagnosed (first diagnosed) as having diarrhea according to clear diagnostic criteria. Berberine alone or in combination with Western medication as intervention were included. Subgroup analyses were conducted based on children or adults, acute or persistent diarrhea, infectious or noninfectious and treatment courses. Primary outcomes were clinical cure rate and duration of diarrhea. The GRADE tool was used to assess the quality of evidence.
A total of 38 randomized controlled trials were included involving 3948 participants (including 27 trials on 2702 children) were included. Compared with antibiotics, berberine plus antibiotics showed better results in both adults and in children in general, especially when given for 7 days or 3 days in acute infectious diarrhea of children. Compared with the control groups, using berberine alone or in combination with montmorillonite, probiotics, and vitamin B increased the clinical cure rate of diarrhea. The use of berberine alone or berberine combined with montmorillonite reduced the duration of hospitalization. Using berberine had significantly better laboratory indicators (isoenzyme, inflammatory factors, myocardial enzyme, and fecal trait) and fewer systemic symptoms than the no berberine groups. Overall, 22 of 27 trials on children used berberine as an enema. No deaths and serious adverse events were reported. The quality of evidence of included trials was moderate to low or very low. The impact of different dosages, frequencies and treatment durations on the outcomes was not evaluated due to insufficient number of trials.
This review demonstrated that berberine was generally effective in improving clinical cure rates and shortening the duration of diarrhea compared with control groups. No severe adverse event was reported. However, there is still a lack of high-quality evidence for evaluating the efficacy and safety of berberine.
PROSPERO CRD42020151001 (available from http://www.crd.york.ac.uk/PROSPERO/).
腹泻是一种普遍存在的消化系统疾病，可导致体液和电解质流失，甚至可能危及生命，尤其是在免疫抑制或营养不良的儿童和成人中。黄连素具有广谱抗菌活性，在中国被广泛用于治疗腹泻。目前尚未进行系统评价以评估临床试验中提供的证据。本研究的目的是评估黄连素在儿童和成人腹泻治疗中的有效性和安全性。
于2019年9月1日检索了7个数据库和2个临床试验注册库。纳入随机对照试验，其中参与者根据明确的诊断标准被诊断（首次诊断）为患有腹泻。纳入单独使用黄连素或与西药联合作为干预措施的试验。根据儿童或成人、急性或持续性腹泻、感染性或非感染性以及疗程进行亚组分析。主要结局为临床治愈率和腹泻持续时间。采用GRADE工具评估证据质量。
共纳入38项随机对照试验，涉及3948名参与者（包括27项针对2702名儿童的试验）。与抗生素相比，黄连素联合抗生素在成人和儿童中总体显示出更好的效果，尤其是在儿童急性感染性腹泻中给予7天或3天时。与对照组相比，单独使用黄连素或与蒙脱石、益生菌和维生素B联合使用可提高腹泻的临床治愈率。单独使用黄连素或黄连素与蒙脱石联合使用可缩短住院时间。与未使用黄连素的组相比，使用黄连素具有明显更好的实验室指标（同工酶、炎症因子、心肌酶和粪便性状）和更少的全身症状。总体而言，27项儿童试验中有22项使用黄连素灌肠。未报告死亡和严重不良事件。纳入试验的证据质量为中、低或极低。由于试验数量不足，未评估不同剂量、频率和治疗持续时间对结局的影响。
本综述表明，与对照组相比，黄连素在提高临床治愈率和缩短腹泻持续时间方面总体有效。未报告严重不良事件。然而，评估黄连素疗效和安全性仍缺乏高质量证据。
PROSPERO CRD42020151001（可从http://www.crd.york.ac.uk/PROSPERO/获取）
