Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-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 treatme...
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| Format: | Article |
| Language: | English |
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BMC
2020-06-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04395-y |
| _version_ | 1818308101717098496 |
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| author | Qing-Juan Wu Wen-Liang Lv Juan-Mei Li Ting-Ting Zhang Wen-hui Zhou Qiang Zhang Jiu-Chong Wang Qing-Nan Wang Ruo-Xuan Zhang Xin Zhao Si-Tong Chen Shuang Liu Gao-Hui Li Zheng-Min Cao Lei Xu Jing Chen |
| author_facet | Qing-Juan Wu Wen-Liang Lv Juan-Mei Li Ting-Ting Zhang Wen-hui Zhou Qiang Zhang Jiu-Chong Wang Qing-Nan Wang Ruo-Xuan Zhang Xin Zhao Si-Tong Chen Shuang Liu Gao-Hui Li Zheng-Min Cao Lei Xu Jing Chen |
| author_sort | Qing-Juan Wu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T07:08:55Z |
| format | Article |
| id | doaj.art-4f414478d63147cab8a18bdae20a5927 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T07:08:55Z |
| publishDate | 2020-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4f414478d63147cab8a18bdae20a59272022-12-21T23:55:43ZengBMCTrials1745-62152020-06-0121111010.1186/s13063-020-04395-yEfficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trialQing-Juan Wu0Wen-Liang Lv1Juan-Mei Li2Ting-Ting Zhang3Wen-hui Zhou4Qiang Zhang5Jiu-Chong Wang6Qing-Nan Wang7Ruo-Xuan Zhang8Xin Zhao9Si-Tong Chen10Shuang Liu11Gao-Hui Li12Zheng-Min Cao13Lei Xu14Jing Chen15Guang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesGuang’anmen Hospital of China Academy of Chinese Medical SciencesAbstract 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.http://link.springer.com/article/10.1186/s13063-020-04395-yChronic hepatitis BCirrhosisTraditional Chinese medicineClinical trialEfficacy |
| spellingShingle | Qing-Juan Wu Wen-Liang Lv Juan-Mei Li Ting-Ting Zhang Wen-hui Zhou Qiang Zhang Jiu-Chong Wang Qing-Nan Wang Ruo-Xuan Zhang Xin Zhao Si-Tong Chen Shuang Liu Gao-Hui Li Zheng-Min Cao Lei Xu Jing Chen Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial Trials Chronic hepatitis B Cirrhosis Traditional Chinese medicine Clinical trial Efficacy |
| title | Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial |
| title_full | Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial |
| title_fullStr | Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial |
| title_full_unstemmed | Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial |
| title_short | Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial |
| title_sort | efficacy and safety of yinqisanhuang antiviral decoction in chronic hepatitis b study protocol for a randomized placebo controlled double blinded trial |
| topic | Chronic hepatitis B Cirrhosis Traditional Chinese medicine Clinical trial Efficacy |
| url | http://link.springer.com/article/10.1186/s13063-020-04395-y |
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