Efficacy of Biejiajian Pill on Intestinal Microbiota in Patients with Hepatitis B Cirrhosis/Liver Fibrosis: A Randomized Double-Blind Controlled Trial.
10.1007/s11655-023-3542-2
- Author:
Xin CHI
1
;
Dan-Ying CHENG
2
;
Xiu SUN
1
;
Shun-Ai LIU
3
;
Rong-Bing WANG
4
;
Qin CHEN
5
;
Hui-Chun XING
1
Author Information
1. Center of Liver Diseases Division 3, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
2. Center of Liver Diseases Division 3, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China. cdanying@126.com.
3. Beijing Key Laboratory of Emerging Infectious Diseases, Institute of Infectious Disease, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
4. National Center for Infectious Diseases, Beijing, 100015, China.
5. China Traditional Chinese Medicine Holdings Co. Limited, Guangzhou, 528303, China.
- Publication Type:Journal Article
- Keywords:
Biejiajian Pill;
Chinese medicine;
chronic hepatitis B;
intestinal microbiota;
liver cirrhosis;
liver fibrosis;
randomized controlled trial
- MeSH:
Humans;
Gastrointestinal Microbiome;
Prospective Studies;
Liver Cirrhosis/drug therapy*;
Hepatitis B/drug therapy*
- From:
Chinese journal of integrative medicine
2023;29(9):771-781
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To analyze the efficacy of Biejiajian Pill (BJJP) on intestinal microbiota in patients with hepatitis B cirrhosis/liver fibrosis, and explore its relationship with liver fibrosis.
METHODS:This was a prospective, randomized double-blind controlled trial. Using the stratified block randomization method, 35 patients with hepatitis B liver cirrhosis/liver fibrosis were randomly assigned (1:1) to receive entecavir (0.5 mg/d) combined with BJJP (3 g/time, 3 times a day) or placebo (simulator as control, SC group, simulator 3 g/time, 3 times a day) for 48 weeks. Blood and stool samples were collected from patients at baseline and week 48 of treatment, respectively. Liver and renal functions as well as hematological indices were detected. Fecal samples were analyzed by 16S rDNA V3-V4 high-throughput sequencing, and intestinal microbiota changes in both groups before and after treatment were compared, and their correlations with liver fibrosis were analyzed.
RESULTS:Compared with the SC group, there was no significant difference in liver function, renal function and hematology indices in the BJJP group, however, the improvement rate of liver fibrosis was higher in the BJJP group (94.4% vs. 64.7%, P=0.041). Principal coordinate analysis (PCoA) based on weighted Unifrac distance showed significant differences in intestinal microbiota community diversity before and after BJJP treatment (P<0.01 and P=0.003), respectively. After 48 weeks' treatment, the abundance levels of beneficial bacteria (Bifidobacteria, Lactobacillus, Faecalibacterium and Blautia) increased, whereas the abundance levels of potential pathogenic bacteria, including Escherichia coli, Bacteroides, Ruminococcus, Parabacteroides and Prevotella decreased, among which Ruminococcus and Parabacteroides were significantly positively correlated with degree of liver fibrosis (r=0.34, P=0.04; r=0.38, P=0.02), respectively. The microbiota in the SC group did not change significantly throughout the whole process of treatment.
CONCLUSION:BJJP had a certain regulatory effect on intestinal microbiota of patients with hepatitis B cirrhosis/liver fibrosis (ChiCTR1800016801).
