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Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial

BACKGROUND: Chronic hepatitis B (CHB) can progress to cirrhosis, hepatocellular carcinoma (HCC) and ultimately liver-related death. Although oral antiviral therapy for patients with CHB reduces the risk of such complications, once cirrhosis is established, the benefits of antiviral therapy are not r...

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Autores principales: Qu, Jianhui, Yu, Zujiang, Li, Qin, Chen, Yongping, Xiang, Dedong, Tan, Lin, Lei, Chunliang, Bai, Wenlin, Li, Hongyan, Shang, Qinghua, Chen, Liang, Hu, Xiaoyu, Lu, Wei, Li, Zhiqin, Chen, Da, Wang, Xiaodong, Zhang, Changjiang, Xiao, Guangming, Qi, Xun, Chen, Jing, Zhou, Li, Chen, Guofeng, Li, Yonggang, Zeng, Zhen, Rong, Guanghua, Dong, Zheng, Chen, Yan, Lou, Min, Wang, Chunping, Lu, Yinying, Zhang, Cuihong, Yang, Yongping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4234899/
https://www.ncbi.nlm.nih.gov/pubmed/25381721
http://dx.doi.org/10.1186/1745-6215-15-438
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author Qu, Jianhui
Yu, Zujiang
Li, Qin
Chen, Yongping
Xiang, Dedong
Tan, Lin
Lei, Chunliang
Bai, Wenlin
Li, Hongyan
Shang, Qinghua
Chen, Liang
Hu, Xiaoyu
Lu, Wei
Li, Zhiqin
Chen, Da
Wang, Xiaodong
Zhang, Changjiang
Xiao, Guangming
Qi, Xun
Chen, Jing
Zhou, Li
Chen, Guofeng
Li, Yonggang
Zeng, Zhen
Rong, Guanghua
Dong, Zheng
Chen, Yan
Lou, Min
Wang, Chunping
Lu, Yinying
Zhang, Cuihong
Yang, Yongping
author_facet Qu, Jianhui
Yu, Zujiang
Li, Qin
Chen, Yongping
Xiang, Dedong
Tan, Lin
Lei, Chunliang
Bai, Wenlin
Li, Hongyan
Shang, Qinghua
Chen, Liang
Hu, Xiaoyu
Lu, Wei
Li, Zhiqin
Chen, Da
Wang, Xiaodong
Zhang, Changjiang
Xiao, Guangming
Qi, Xun
Chen, Jing
Zhou, Li
Chen, Guofeng
Li, Yonggang
Zeng, Zhen
Rong, Guanghua
Dong, Zheng
Chen, Yan
Lou, Min
Wang, Chunping
Lu, Yinying
Zhang, Cuihong
Yang, Yongping
author_sort Qu, Jianhui
collection PubMed
description BACKGROUND: Chronic hepatitis B (CHB) can progress to cirrhosis, hepatocellular carcinoma (HCC) and ultimately liver-related death. Although oral antiviral therapy for patients with CHB reduces the risk of such complications, once cirrhosis is established, the benefits of antiviral therapy are not robustly demonstrated. According to traditional Chinese medicine (TCM), some Chinese herbal medicines promote blood circulation and soften hard masses, and therefore they may block and reverse hepatic fibrosis. The aim of this study is to evaluate the effects of TCM tablets of the compound biejia ruangan (RGT) administered for fibrosis, and entecavir (ETV), on the development of HCC in patients with CHB or hepatitis B virus (HBV)-related compensated cirrhosis. METHODS/DESIGN: This multicenter, centrally randomized, double-blind, placebo-controlled, parallel-group study is planned to complete within 5 years. For the study, 1,000 with CHB or HBV-related compensated cirrhosis are randomly assigned in a 1:1 ratio to a treatment group (0.5 mg ETV once daily; 2 g RGT three times daily) or a control group (0.5 mg ETV once daily; 2 g RGT dummy agent three times daily). The primary end points are the development of HCC and liver-related death. Secondary end points include disease progression and overall survival. DISCUSSION: Although antiviral therapy can achieve sustained suppression of HBV replication, thereby preventing cirrhosis, patients with CHB treated with nucleos(t)ide analogs (NUCs) retain a higher risk for HCC compared with patients with inactive disease. Although previous clinical trials with RGT have confirmed the efficacy of blocking and reversing hepatic fibrosis in patients with CHB or compensated cirrhosis, the long-term risk for HCC or disease progression in these patients treated with combination of RGT and NUCs compared with NUCs alone is unclear. Therefore, it is necessary to investigate the effects of the RGT blockade and reversal of hepatic fibrosis on the development of HCC in patients with CHB or HBV-related compensated cirrhosis in large, prospective, multicenter, double-blind, randomized, controlled trials in China. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01965418. Date registered: 17 October 2013
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spelling pubmed-42348992014-11-19 Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial Qu, Jianhui Yu, Zujiang Li, Qin Chen, Yongping Xiang, Dedong Tan, Lin Lei, Chunliang Bai, Wenlin Li, Hongyan Shang, Qinghua Chen, Liang Hu, Xiaoyu Lu, Wei Li, Zhiqin Chen, Da Wang, Xiaodong Zhang, Changjiang Xiao, Guangming Qi, Xun Chen, Jing Zhou, Li Chen, Guofeng Li, Yonggang Zeng, Zhen Rong, Guanghua Dong, Zheng Chen, Yan Lou, Min Wang, Chunping Lu, Yinying Zhang, Cuihong Yang, Yongping Trials Study Protocol BACKGROUND: Chronic hepatitis B (CHB) can progress to cirrhosis, hepatocellular carcinoma (HCC) and ultimately liver-related death. Although oral antiviral therapy for patients with CHB reduces the risk of such complications, once cirrhosis is established, the benefits of antiviral therapy are not robustly demonstrated. According to traditional Chinese medicine (TCM), some Chinese herbal medicines promote blood circulation and soften hard masses, and therefore they may block and reverse hepatic fibrosis. The aim of this study is to evaluate the effects of TCM tablets of the compound biejia ruangan (RGT) administered for fibrosis, and entecavir (ETV), on the development of HCC in patients with CHB or hepatitis B virus (HBV)-related compensated cirrhosis. METHODS/DESIGN: This multicenter, centrally randomized, double-blind, placebo-controlled, parallel-group study is planned to complete within 5 years. For the study, 1,000 with CHB or HBV-related compensated cirrhosis are randomly assigned in a 1:1 ratio to a treatment group (0.5 mg ETV once daily; 2 g RGT three times daily) or a control group (0.5 mg ETV once daily; 2 g RGT dummy agent three times daily). The primary end points are the development of HCC and liver-related death. Secondary end points include disease progression and overall survival. DISCUSSION: Although antiviral therapy can achieve sustained suppression of HBV replication, thereby preventing cirrhosis, patients with CHB treated with nucleos(t)ide analogs (NUCs) retain a higher risk for HCC compared with patients with inactive disease. Although previous clinical trials with RGT have confirmed the efficacy of blocking and reversing hepatic fibrosis in patients with CHB or compensated cirrhosis, the long-term risk for HCC or disease progression in these patients treated with combination of RGT and NUCs compared with NUCs alone is unclear. Therefore, it is necessary to investigate the effects of the RGT blockade and reversal of hepatic fibrosis on the development of HCC in patients with CHB or HBV-related compensated cirrhosis in large, prospective, multicenter, double-blind, randomized, controlled trials in China. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01965418. Date registered: 17 October 2013 BioMed Central 2014-11-10 /pmc/articles/PMC4234899/ /pubmed/25381721 http://dx.doi.org/10.1186/1745-6215-15-438 Text en © Qu et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Qu, Jianhui
Yu, Zujiang
Li, Qin
Chen, Yongping
Xiang, Dedong
Tan, Lin
Lei, Chunliang
Bai, Wenlin
Li, Hongyan
Shang, Qinghua
Chen, Liang
Hu, Xiaoyu
Lu, Wei
Li, Zhiqin
Chen, Da
Wang, Xiaodong
Zhang, Changjiang
Xiao, Guangming
Qi, Xun
Chen, Jing
Zhou, Li
Chen, Guofeng
Li, Yonggang
Zeng, Zhen
Rong, Guanghua
Dong, Zheng
Chen, Yan
Lou, Min
Wang, Chunping
Lu, Yinying
Zhang, Cuihong
Yang, Yongping
Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial
title Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial
title_full Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial
title_fullStr Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial
title_full_unstemmed Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial
title_short Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial
title_sort blocking and reversing hepatic fibrosis in patients with chronic hepatitis b treated by traditional chinese medicine (tablets of biejia ruangan or rgt): study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4234899/
https://www.ncbi.nlm.nih.gov/pubmed/25381721
http://dx.doi.org/10.1186/1745-6215-15-438
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