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

Trials

Volumn 15, Issue 1, 2014, Pages

  Qu, Jianhui ^a   Yu, Zujiang ^d   Li, Qin ^e   Chen, Yongping ^f   Xiang, Dedong ^g   Tan, Lin ^b   Lei, Chunliang ^h   Bai, Wenlin ^a   Li, Hongyan ^a   Shang, Qinghua ^c   Chen, Liang ⁱ   Hu, Xiaoyu ^j   Lu, Wei ^k   Li, Zhiqin ^d   Chen, Da ^e   Wang, Xiaodong ^f   Zhang, Changjiang ^g   Xiao, Guangming ^h   Qi, Xun ⁱ   Chen, Jing ^j   Zhou, Li ^k   Chen, Guofeng ^a   Li, Yonggang ^a   Zeng, Zhen ^a   Rong, Guanghua ^a   Dong, Zheng ^a   Chen, Yan ^a   Lou, Min ^a   Wang, Chunping ^a   Lu, Yinying ^a   Zhang, Cuihong ^a   Yang, Yongping ^a   more..

^a BEIJING 302 HOSPITAL   (China)

^b Fuyang No 2 People's Hospital Liver Disease Department   (China)

^c Department of Orthopaedics   (China)

^d THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY   (China)

^e Fuzhou Infectious Diseases Hospital   (China)

^f THE FIRST AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY   (China)

^g THIRD MILITARY MEDICAL UNIVERSITY   (China)

^h Guangzhou Eighth People's Hospital   (China)

ⁱ SHANGHAI PUBLIC HEALTH CLINICAL CENTER   (China)

^j CHENGDU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

^k Tianjin Second People s Hospital   (China)

more..

Author keywords

chronic hepatitis B; Compound biejia ruangan tablet; hepatic fibrosis; hepatocellular carcinoma; multicenter randomized controlled trial

Indexed keywords

BIEJIA RUANGAN; ENTECAVIR; LIVER PROTECTIVE AGENT; PLACEBO; UNCLASSIFIED DRUG; ANTIVIRUS AGENT; GUANINE; HERBACEOUS AGENT; TABLET;

ADULT; AGED; ARTICLE; CANCER RISK; CHINESE MEDICINE; CHRONIC HEPATITIS B; CLINICAL PROTOCOL; COMPENSATED LIVER CIRRHOSIS; CONTROLLED STUDY; DEATH; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; LIVER CELL CARCINOMA; LIVER FIBROSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OVERALL SURVIVAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TABLET; ADOLESCENT; ADVERSE EFFECTS; ANALOGS AND DERIVATIVES; CHINA; COMPLICATION; DRUG COMBINATION; HEPATITIS B, CHRONIC; LIVER CIRRHOSIS; METHODOLOGY; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PROCEDURES; TIME; TREATMENT OUTCOME; VIROLOGY; YOUNG ADULT;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTIVIRAL AGENTS; CHINA; CLINICAL PROTOCOLS; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; DRUGS, CHINESE HERBAL; FEMALE; GUANINE; HEPATITIS B, CHRONIC; HUMANS; LIVER CIRRHOSIS; MALE; MEDICINE, CHINESE TRADITIONAL; MIDDLE AGED; PROSPECTIVE STUDIES; RESEARCH DESIGN; TABLETS; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84920825175     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-438     Document Type: Article

References (34)

1. Lavanchy D: Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepatitis 2004, 11:97-107.
2. Zhao H, Si CW: Chinese epidemic status of viral hepatitis B. Chin J Front Med Sci 2008, 1:1-3.
3. Zhang C, Zhong Y, Guo L: Strategies to prevent hepatitis B virus infection in China: immunization, screening, and standard medical practices. Biosci Trends 2013, 7:7-12.
4. Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, Huang GT, Iloeje UH, REVEAL-HBV Study Group: Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006, 295:65-73.
5. Fink SA, Jacobson IM: Managing patients with hepatitis-B related or hepatitis-C-related decompensated cirrhosis. Nat Rev Gastroenterol Hepatol 2011, 8:285-295.
6. Chen LP, Zhao J, Du Y, Han YF, Su T, Zhang HW, Cao GW: Antiviral treatment to prevent chronic hepatitis B or C-related hepatocellular carcinoma. World J Virol 2012, 1:174-183.
7. Papatheodoridis GV, Manolakopoulos S, Touloumi G, Vourli G, Raptopoulou-Gigi M, Vafiadis-Zoumbouli I, Vasiliadis T, Mimidis K, Gogos C, Ketikoglou I: Virological suppression does not prevent the development of hepatocellular carcinoma in HBeAg-negative chronic hepatitis B patients with cirrhosis receiving oral antiviral(s) starting with lamivudine monotherapy: results of the nationwide HEPNET. Greece cohort study. Gut 2011, 60:1109-1116.
8. Cho JY, Paik YH, Sohn W, Cho HC, Gwak GY, Choi MS, Lee JH, Koh KC, Paik SW, Yoo BC: Patients with chronic hepatitis B treated with oral antiviral therapy retain a higher risk for HCC compared with patients with inactive stage disease. Gut in press
9. Chen Q, Wu ZL, Zhong H: Study of treatment of anti-fibrosis compound prescription of Traditional Chinese Medicine. Chin J Integrated Traditional Western Med Liver Diseases 2004, 14:252-254.
10. Miao WH: Compound Biejia Ruangan tablet treatment clinical observation of 40 patients with liver cirrhosis. Mod Med 2009, 15:140.
11. Chen JM, Yang YP, Chen DY: Compound Biejia Ruangan tablet clinical study on the treatment of chronic hepatitis B with hepatic fibrosis. Chin J Exper Clin Virol 2007, 21:358-360.
12. Yang YP, Song XX, Chen DY, Chen JM, Zhang B: The regulation function of γ-IFN, IL-2, IL-6 and tocopherol for proliferation of hepatic stellate-cells and synthesizing collagen on primary cultured hepatic stellate-cells. Chin Clin Hepatol 1995, 11:72-75.
13. 4 induced cirrhotic rats. Western Traditional Med Integration J Hepatol 1994, 4:22-24.
14. Yang YP, Chen DY, Song XX, Zhu AJ, Zhou YX: Effects of Traditional Chinese Medicine compound Biejia Ruangan tablet on the proliferation of hepatic stellate-cells and expression of collagen type I or Sh{cyrillic} mRNA. Western Traditional Med Integration J Hepatol 1995, 5:26-28.
15. Zhao JM: Anti-hepatic fibrosis mechanisms of compound Biejia Ruangan tablet. Med J Chin People's Liberation Army 2004, 29:560-562.
16. Hao HS, Li G: Early clinical application and observation of Fufang Biejia Ruangan tablet on the treatment of liver fibrosis. Med Innovation Chin 2009, 6:36.
17. Geng YM: Fufang Biejia Ruangan tablet on cirrhosis treatments: clinical observation of 60 cases. Chin Healthcare Innovation 2009, 4:31.
18. Xu QH: Observations on anti-hepatic fibrosis effect of compound Biejia Ruangan tablet. Chin J Ethnomed Ethnopharm 2009, 18:72.
19. Chen MS, Chen MH, Ye SL, Qin SQ: Expert consensus on the ablative therapies for hepatocellular carcinoma. Chin Clin Oncol 2011, 16:70-73.
20. Chang TT, Gish RG, Man RD, Gadano A, Sollano J, Chao YC, Lok AS, Han KH, Goodman Z, Zhu J, Cross A, DeHertogh D, Wilber R, Colonno R, Apelian D: A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006, 354:1001-1010.
21. Dienstag JL, Goldin RD, Heathcote EJ, Hann HWL, Woessner M, Stephenson SL, Stephen G, Gray DF, SCHIFF E: Histological outcome during long-term lamivudine therapy. Gastroenterology 2003, 124:105-117.
22. Poynard T, Bedossa P, Opolon P: Natural history of liver fibrosis progression in patients with chronic hepatitis C. Lancet 1997, 349:825-832.
23. Poynard T, McHutchison J, Manns M, Trepo C, Lindsay K, Goodman Z, Ling MH, Albrecht J: Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C. Gastroenterology 2002, 122:1303-1313.
24. Rockey DC, Bissell DM: Noninvasive measures of liver fibrosis. Hepatology 2006,43(Suppl 1):S113-S120.
25. Martinez SM, Crespo G, Navasa M, Forns X: Noninvasive assessment of liver fibrosis. Hepatology 2011, 53:325-335.
26. Chang TT, Lai CL, Yoon SK, Lee SS, Coelho HSM, Carrilho FJ, Poordad F, Halota W, Horsmans Y, Tsai N, Zhang H, Tenney DJ, Tamez R, Iloeje U: Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology 2010, 51:422-430.
27. Jeng WJ, Sheen IS, Chen YC, Hsu CW, Chien RN, Chu CM, Liaw YF: Off-therapy durability of response to entecavir therapy in hepatitis B e antigen-negative chronic hepatitis B patients. Hepatology 2013, 58:1888-1896.
28. Aspinall EJ, Hawkins G, Fraser A, Hutchinson SJ, Goldberg D: Hepatitis B prevention, diagnosis, treatment and care: a review. Occup Med 2011, 61:531-540.
29. Park NH, Song IH, Chung YH: Chronic hepatitis B in hepatocarcinogenesis. Postgrad Med J 2006, 82:507-515.
30. Lok ASF, McMahon BJ: Chronic hepatitis B. Hepatology 2007, 45:507-539.
31. Papatheodoridis GV, Manolakopoulos S, Dusheiko G: Therapeutic strategies in the management of patients with chronic hepatitis B. Lancet Infect Dis 2008, 8:167-178.
32. European Association for the Study of the Liver: EASL clinical practice guidelines: management of chronic hepatitis B. J Hepatol 2009, 50:227-242.
33. El-Serag HB, Rudolph KL: Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. Gastroenterology 2007, 132:2557-2576.
34. Schafer DF, Sorrell MF: Hepatocellular carcinoma. Lancet 1999, 353:1253-1257.