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Volume 42 Issue 2
Feb.  2026
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Article Navigation >  Journal of Clinical Hepatology  > 2026  >  42(2): 304-311

Efficacy and safety of Babaodan Capsule in patients with chronic hepatitis B virus infection comorbid with gallbladder polyps

DOI: 10.12449/JCH260210
  • 1.

    Center of Integrated Traditional Chinese and Western Medicine，Beijing YouAn Hospital，Capital Medical University，Beijing 100069，China

  • 2.

    Department of Ultrasound，Beijing YouAn Hospital，Capital Medical University，Beijing 100069，China

  • 3.

    Department of Pathology，Beijing YouAn Hospital，Capital Medical University，Beijing 100069，China

  • 4.

    Center for Evidence-Based Chinese Medicine，Beijing University of Chinese Medicine，Beijing 100029，China

Research funding:

Project of Beijing Municipal Administration of Traditional Chinese Medicine (YJ-2021-01)

More Information
  • Corresponding author: LI Xiuhui， lixiuhui@sohu.com （ORCID： 0000-0002-6707-2693）
  • Received Date: 2025-09-22
  • Accepted Date: 2025-11-28
  • Published Date: 2026-02-25
    Abstract
  •   Objective  To investigate the efficacy and safety of Babaodan Capsule （BBD） in the treatment of patients with chronic hepatitis B virus （HBV） infection with damp-heat in the liver and gallbladder comorbid with gallbladder polyps.  Methods  A randomized， double-blinded， placebo-controlled single-center trial was conducted among 120 patients with chronic HBV infection who were admitted to Beijing YouAn Hospital， Capital Medical University， from August 2020 to April 2023， and they were divided into treatment group （BBD） and control group （placebo）， with 60 patients in each group. The course of treatment was 24 weeks， and follow-up assessments were conducted every 4 weeks. The primary outcome measures were the number and maximum diameter of gallbladder polyps （assessed by ultrasound）， and the secondary outcome measures included traditional Chinese medicine （TCM） syndrome score， blood lipid levels， and liver function parameters. The independent-samples t test or the Wilcoxon rank-sum test was used for comparison of continuous data between two groups， and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups； the Wilcoxon rank-sum test was used for comparison of ranked data between two groups； the generalized estimating equation was used to analyze repeated measures data.  Results  After 8 weeks of treatment， the treatment group had a significantly smaller diameter of polyps and a significantly lower number of polyps than the control group （Z=-1.76 and -1.80， both P<0.05）， and after 24 weeks of treatment， the treatment group had a significantly higher polyp reduction rate than the control group （30.51% vs 10.91%， P<0.05）. The subgroup analysis showed that patients receiving combined antiviral therapy， male patients， patients with a diameter of polyps of <5 mm， and patients with multiple polyps tended to achieve significantly greater benefits. At week 8 of treatment， the treatment group had a significantly better TCM syndrome score than the control group （Z=-2.35， P<0.05）； after treatment， compared with the control group， the treatment group had a significantly greater increase in high-density lipoprotein （Z=-1.85， P<0.05） and significantly lower levels of alanine aminotransferase （Z=-2.06， P <0.05）， aspartate aminotransferase （Z=-2.13， P<0.05）， total bilirubin （Z=-2.12， P<0.05）， and direct bilirubin （Z=-3.09， P<0.05）. No serious adverse events were reported in either group.  Conclusion  BBD can effectively reduce the size of gallbladder polyps， improve TCM syndrome score， and reduce the level of bilirubin in patients with chronic HBV infection with damp-heat in the liver and gallbladder， with a favorable safety profile， and it may be more suitable for patients receiving combined antiviral therapy and specific subgroups （male patients， patients with a diameter of polyps of <5 mm， and patients with multiple polyps.

     

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