scholarly journals Efficacy and safety of YinQiSanHuang-antiviral decoction on chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial

2020 ◽  
Author(s):  
qing-juan wu ◽  
Wen-Liang Lv ◽  
Juan-Mei Li ◽  
Ting-Ting Zhang ◽  
Wen-hui Zhou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Hepatitis ◽  
Placebo Group ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Efficacy And Safety ◽  
Double Blinded ◽  
Blinded Trial

Abstract Background: Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better clinical efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation used for over thirty years, and has shown its effect on anti-hepatitis B virus and slowing progression of hepatitis B-related liver diseases in a small-scale clinical observation. Until now there is no convincing evidence demonstrating the clinical effectiveness of YQSH in anti-liver cirrhosis and anti-liver cancer. To evaluate the efficacy and safety of YQSH and its preventive effect on hepatitis B cirrhosis, a rigorously designed randomized, double-blind, placebo-controlled clinical trial is needed. Methods: This is a multicenter, randomized, placebo-controlled, double-blinded trial, 5 hospitals involved in. Totally 802 patients are randomly allocated to two groups: the YQSH group (n=401) or the placebo group (n=401). The YQSH group receives YQSH with Entecavir, the placebo group receives granule of placebo with Entecavir. Patients receive treatment for 52 weeks, and then are followed up for 52±2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are HBV-DNA negative rate, HBsAg negative rate, HBeAg seroconversion rate, liver function (Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), serum albumin (ALB) and total bilirubin (TBIL)), spleen thickness, evaluation scores of patients’ clinical symptoms and safety assessment. Outcomes will be assessed at baseline and after treatment. Discussion: Combination therapy could become a trendy of treatment of CHB, this trial expecting to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB. Trial registration: ChiCTR1900021521, this protocol was registered in the Chinese Clinical Trial Registry (URL: http://www.chictr.org.cn) on February 25th, 2019. Keywords: chronic hepatitis B, cirrhosis, traditional Chinese medicine, clinical trial, efficacy

scholarly journals Efficacy and safety of YinQiSanHuang-antiviral decoction on chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial

2020 ◽  
Author(s):  
qing-juan wu ◽  
Wen-Liang Lv ◽  
Juan-Mei Li ◽  
Ting-Ting Zhang ◽  
Wen-hui Zhou ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Placebo Group ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Antiviral Drugs ◽  
Annual Incidence ◽  
Efficacy And Safety ◽  
Negative Rate ◽  
Double Blinded ◽  
Blinded Trial

Abstract Introduction: Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies shown that combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation, and has shown its effect on anti-hepatitis B virus and slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial, which objective is “the combination of YinQiSanHuang-antiviral decoction with entecavir reduce the annual incidence of liver fibrosis / cirrhosis to 1%”.Methods: This is a multicenter, randomized, placebo-controlled, double-blinded trial, 5 hospitals involved in. Totally 802 patients are randomly allocated to two groups: the YQSH group (n=401) or the placebo group (n=401). The YQSH group receives YQSH with Entecavir, the placebo group receives granule of placebo with Entecavir. Patients receive treatment for 52 weeks, and then are followed up for 52±2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are HBV-DNA negative rate, HBsAg negative rate, HBeAg seroconversion rate, liver function (Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), serum albumin (ALB) and total bilirubin (TBIL)), spleen thickness, evaluation scores of patients’ clinical symptoms and safety assessment. Outcomes will be assessed at baseline and after treatment.Discussion: Combination therapy could become a trendy of treatment of CHB, this trial expecting to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB.Trial registration: ChiCTR1900021521, this protocol was registered in the Chinese Clinical Trial Registry (URL: http://www.chictr.org.cn) on February 25th, 2019.

scholarly journals Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Qing-Juan Wu ◽  
Wen-Liang Lv ◽  
Juan-Mei Li ◽  
Ting-Ting Zhang ◽  
Wen-hui Zhou ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Placebo Group ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Antiviral Drugs ◽  
Efficacy And Safety ◽  
B Virus ◽  
Double Blinded ◽  
Blinded Trial

Abstract Introduction Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation that has shown an effect on anti-hepatitis B virus and on slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial. The objective is that the combination of YinQiSanHuang-antiviral decoction with entecavir will reduce the annual incidence of liver fibrosis/cirrhosis to 1%. Methods This is a multicenter, randomized, placebo-controlled, double-blinded trial involving five hospitals. A total of 802 patients are randomly allocated to two groups: the YQSH group (n = 401) or the placebo group (n = 401). The YQSH group receives YQSH with entecavir; the placebo group receives granules of placebo with entecavir. Patients receive treatment for 52 weeks and then are followed up for 52 ± 2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients’ clinical symptoms, and safety assessment. Outcomes will be assessed at baseline and after treatment. Discussion Combination therapy could become a trend for treatment of CHB, and this trial expects to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB. Trial registration Chinese Clinical Trial Registry: ChiCTR1900021521. Registered on 25 February 2019.

scholarly journals Long-Term Traditional Chinese Medicine Combined with NA Antiviral Therapy on Cirrhosis Incidence in Chronic Hepatitis B Patients in the Real-World Setting: A Retrospective Study

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Zhi-Jun Hou ◽  
Jing-Hao Zhang ◽  
Xin Zhang ◽  
Qi-Hua Ling ◽  
Chao Zheng ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Chronic Hepatitis ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Hepatitis B ◽  
Antiviral Therapy ◽  
Chronic Hepatitis B ◽  
Cumulative Incidence ◽  
Histological Evaluation

Objective. To evaluate the impact of long-term Traditional Chinese Medicine (TCM) syndrome differentiation combined with antiviral therapy with Nucleos (t) ide analogues (NAs) on the incidence of cirrhosis in patients with chronic hepatitis B. Methods. This retrospective cohort study included 521 patients with chronic hepatitis B who underwent a treatment course of ≥3 years from 1998–2019. Of the 521 patients, 261 were defined as TCM users while 260 were TCM nonusers (control group). All the enrolled subjects were followed up until February 2019 to measure the incidence and hazard ratio (HR) of cirrhosis, and the Cox proportional hazards regression model was used to analyze the independent factors affecting the occurrence of cirrhosis. Results. The cumulative incidence of TCM users and nonusers was 6.9% and 13.5%, respectively (P=0.013). Results of the Kaplan–Meier analysis demonstrated that TCM users had a significantly lower cumulative incidence of cirrhosis than TCM nonusers (P=0.011), and TCM users had a significantly lower liver cirrhosis risk than TCM nonusers (adjusted HR = 0.416, 95% CI, 0.231–0.749). The histological evaluation revealed improved fibrosis in 45.0% of TCM users and 11.1% of TCM nonusers (P=0.033). The analysation of the prescriptions including total 119 single Chinese herbs medicinal demonstrated that “replenish qi and fortify the spleen,” “clear heat and dispel dampness,” and “soothe the liver and regulate qi” are the main treatment methods of TCM for CHB. Conclusions. Our study demonstrated that long-term TCM use may attenuate liver cirrhosis risk in patients with chronic hepatitis B (CHB).

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