Abstract
IntroductionHepatitis B-related compensated liver cirrhosis is related to a higher risk of hepatocellular carcinoma, and antiviral therapy is the preferred method. As the pathological mechanisms of liver fibrosis are complex, drugs developed for a single target are difficult to be effective in clinical practice, so there are no chemical drugs or biological drugs with clear efficacy available for clinical application at present. Traditional Chinese medicine is a kind of medical science that has been gradually formed during thousands of years and continuously enriched by the people of all ethnic groups in China. Traditional Chinese medicine shows curative effects in the treatment of liver diseases, especially in the field of liver fibrosis prevention and treatment. This study aims to test the integrative medicine (Chinese medicine plus antiviral therapy) effective on lowing hepatocellular carcinoma risk among patients with hepatitis-related compensated liver cirrhosis.Methods and analysisThis is a multi-center randomized controlled trial, and a total of 5 hospitals and 802 patients will be involved in. All the subjects are randomly allocated to the YinQiSanHuang Jiedu decoction (YQSHD) group (n = 401) or the placebo group (n = 401). The YQSHD group receives YQSHD granule with entecavir (ETV), and the placebo group receives YQSHD placebo with ETV. The treatment period will last for 52 weeks, and the follow-up period for 52 ± 2 weeks. The primary outcome measure is the annual incidence of HCC. Outcomes will be assessed at baseline and after treatment. The objective of this trial is “the integrative of YQSHD with ETV reduce the annual incidence of HCC to 1%.”Ethics and disseminationThe protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital, China (No.2019-006-KY), and the other centers in the trial will not begin recruiting until the local ethical approval has been obtained. Trial final results will be disseminated via publication.Trial registrationChinese Clinical Trial Registry ChiCTR1900021532. Registered on February 26, 2019
Highlights
Hepatitis B-related compensated liver cirrhosis is related to a higher risk of hepatocellular carcinoma, and antiviral therapy is the preferred method
Liver fibrosis is involved in most chronic liver diseases, with further development could lead to liver cirrhosis, which affects the health and life of patients seriously [1]
The results showed that the traditional Chinese medicine (TCM) group (intervened by astragalus polysaccharide (AP), which is the main active ingredient of the astragalus medicine in YinQiSanHuang Jiedu decoction (YQSHD)) under the exposure mode of atomic force microscope liver sinusoidal endothelial cells (LSECs) spread more obviously, and Young’s modulus of LSECs after fibrotic serum injury was higher than the control group
Summary
Hepatitis B-related compensated liver cirrhosis is related to a higher risk of hepatocellular carcinoma, and antiviral therapy is the preferred method. The treatment goals for LC patients are to maximize long-term inhibition of HBV replication [7], reducing liver cell inflammation and necrosis and liver fibrous tissue hyperplasia, delaying and reducing the occurrence of liver failure, decompensation of LC, HCC, and other complications, improving the quality of life of patients, and extending their survival time, and for some patients could pursue the clinical cure [8, 9] To achieve those treatment goals, many patients and internal medicine doctors seek supplemental and alternative therapies in addition to the antiviral methods, such as traditional Chinese medicine (TCM)
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