Effectiveness And Safety Of Chinese Herbal Medicines For Hepatitis B Virus-Related Acute-On-Chronic Liver Failure: Study Protocol For A Multicenter Randomized Controlled Trial

OBJECTIVE: To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines (CHMs) against acute-on-chronic liver failure (ACLF) and provide reproducible and high-level evidence for clinical practice.METHODS: This is a prospective, multicenter, centrally randomized controlled trial. Patients diagnosed with hepatitis B virus-related ACLF (n = 510) will be allocated to the standard medical therapy or CHM group at a 1:1 ratio. Two CHMs will be used on the basis of the traditional Chinese medicine syndrome: Liangxue Jiedu granules for excess syndromes and Yiqi Jiedu granules for deficiency syndromes. The primary outcome is transplant-free survival at week 12. The secondary outcomes are (a) transplant-free survival at week 24, (b) liver function as assessed using the model for end-stage liver disease score at week 12, (c) liver function as assessed using the Child-Pugh score at week 12, and (d) the incidence of complications at week 12.DISCUSSION: The effectiveness and safety of CHM formulations will be assessed following treatment for ACLF. (C) 2020 JTCM. All rights reserved.