To assess the effective and safety of berberine hydrochloride in ulcerative colitis: A protocol for systematic review and meta-analysis.

BACKGROUND: Ulcerative colitis (UC) is an inflammatory bowel disease characterized by a relapsing and remitting course, and the curative medical therapy of UC is not yet available with its precise etiology unknown. Berberine hydrochloride, one of the main alkaloids in rhizomes of Coptis chinensis, has been reported the efficacy in patients with UC. However, there is no systematic review related to berberine hydrochloride for UC published. In this work, we will systematically evaluate the effectiveness and safety of berberine hydrochloride for UC by a meta-analysis method to provide a substantial conclusion for clinical practice. METHODS AND ANALYSIS: In this study, we will search the Chinese and English databases by electronic and manual search to find the related literature of berberine hydrochloride in the treatment of UC published from the inception date of each predefined database up to October 2020. Databases include PubMed, Embase, MEDLINE, Cochrane Library Central Register of Controlled Trials, China National Knowledge Infrastructure (CNKI) database, Wanfang Data Knowledge Service Platform, the VIP information resource integration service platform (cqvip), China Biology Medicine Disc (Sino Med), the Chinese Clinical Trial Registry (ChiCTR), and ClinicalTrials.gov. The 2 professional trained authors will independently select the qualified studies for data extraction and assess the risk of bias in included studies. Then the synthesis and analyses of data will be carried out in RevMan 5.4. The heterogeneity of statistics will be assessed by a heterogeneity X test and I tests. Sensitivity analysis is used to evaluate whether the outcomes of systematic review or meta-analysis are robust and reliable. The funnel plot is the main method to evaluate the bias of reporting. Finally, we will use The Grading of Recommendations Assessment, Development and Evaluation to evaluate the quality of evidence. RESULTS: The results of this study will be published in a peer-reviewed journal. CONCLUSION: Whether berberine hydrochloride is an effectiveness and safety for patients with UC will be judged in the conclusion of this systematic review. OSF REGISTRATION NUMBER: 10.17605/OSF.IO/X57U3.

HLA-DQB1/DRB1 Alleles Associate with Traditional Chinese Medicine Syndrome of Chronic Hepatitis B: A Potential Predictor of Progression.

BACKGROUND AND AIMS: Traditional Chinese medicine (TCM) has been widely applied in chronic hepatitis B (CHB) supplementary treatment in China. Kidney yang deficiency syndrome (KYDS), one of the most common TCM syndromes of CHB, is more likely to progress to liver cirrhosis or hepatocellular carcinoma than other syndromes. Polymorphisms in the human leucocyte antigen- (HLA-) DQB1 and -DRB1 genes were reported to be associated with hepatitis B virus infection outcomes. Here, we investigated whether HLA-DQB1 and HLA-DRB1 are associated with the classification of CHB TCM syndromes. METHODS: We genotyped HLA-DQB1 and HLA-DRB1 alleles in a total of 105 subjects, including 74 CHB patients (28 KYDS and 46 non-KYDS) and 31 healthy individuals from Sichuan Province of Southwest China, by polymerase chain reaction sequence-based typing (PCR-SBT). Moreover, a meta-analysis was carried out for further verification. RESULTS: The proportion of patients with high HBV DNA load (≥2000 IU/ml) in the KYDS group is higher than that in the non-KYDS group (60.70% [17/28] vs. 28.30% [13/46]); P=0.01). The frequencies of HLA-DQB1∗02:01 (P=0.04) and HLA-DRB1∗03:01 (P=0.04) in the KYDS group were significantly increased compared to the non-KYDS group. The gene test and meta-analysis showed that HLA-DRB1∗08:03 confers susceptibility to CHB (odds ratio = 1.57). CONCLUSION: We found an association between HLA-DRB1/DQB1 polymorphisms and KYDS of CHB. Moreover, KYDS patients of CHB are characteristic with high HBV DNA loads. These findings help to reveal the biological mechanism of KYDS in high risk of CHB progression and suggest a potential prognostic value for disease outcome evaluation.