Jiuweirougan Granule in the Treatment of Chronic Hepatitis with Hepatic Fibrosis: A Double-Blind Randomized Controlled Trial_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Lichun ¹ , LEI Bingjun ¹ , LIU Li ¹ , LIU Cong ¹ , ZHANG Ruiming ² , LI Tingqian ²

1.Department of Infectious Disease; West China Hospital; Sichuan University; Chengdu 610041; China2.National Center for Drug Clinical Trial（TCM）; West China Hospital; Sichuan University; Chengdu 610041; China;

Corresponding author：

Keywords：

Jiuweirougan granule; Chronic hepatitis with hepatic fibrosis; Double-blind randomized controlled trial

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Objective 　To assess the effectiveness and safety of Jiuweirougan granule in the treatment of chronic hepatitis with hepatic fibrosis.
Methods 　A double-blind, double dummy and randomized controlled method was adopted. Forty-six patients were selected by using the inclusion and exclusion criteria and were randomizedly allocated to the treatment group (n=23, Jiuweirougan 10 g, twice a day) and the control group (n=23, treated with Biejiaruangan 4 pills, three times a day). The duration of treatment for both groups lasted for 6 months.
Results 　Two patients in the treatment group dropped out halfway through the study, while one patient in the control group was withdrawal for irregular treatment. Analysis according to intention-to-treat (ITT) and per-protocol (PP) was conducted. In the treatment group, the effective rates of TCM (Traditional Chinese Medicine) on the syndrome were 82.61% (19/23) (ITT) and 90.48% (19/21) (PP), while in the control group, there were 86.96% (20/23) (ITT) and 86.36% (19/20) (PP). There was no significant difference between the two groups (P＞0.05). The improvement rate of serum parameters in the treatment group such as hyaluronic acid (HA), type Ⅲ procollagen (PCⅢ), type Ⅳ collagewn (CⅣ) and laminin (LN) were 28.57% (6/21), 23.81% (5/21), 28.57% (6/21) and 4.76% (1/21), respectively, while in control group, the rates were 36.37% (8/22),13.64% (3/22), 36.37% (8/22) and 9.09% (2/22), respectively. No significant difference was seen between the two groups (P＞0.05). ITT and PP analysis revealed similar results. No obvious adverse effects were noted.
Conclusion 　Jiuweirougan granule may improve chronic hepatitis with fibrosis, and its effect is equal to that of Biejiaruangan. No obvious toxic-adverse effects were seen.

Citation： WANG Lichun,LEI Bingjun,LIU Li,LIU Cong,ZHANG Ruiming,LI Tingqian. Jiuweirougan Granule in the Treatment of Chronic Hepatitis with Hepatic Fibrosis: A Double-Blind Randomized Controlled Trial. Chinese Journal of Evidence-Based Medicine, 2004, 04(11): 778-782. doi: Copy

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11.	程书权, 张自富, 赵永伟. 血清HA、PLD、PCⅢ、LN、CⅣ联合检测对慢性肝病的诊断价值探讨[J]. 中国实用内科杂志, 1999; 19(1): 28～30.
12.	［7］Liu RC, Liu LX, Zhang DY, etc. Relation of serum content of HA, LN, CⅣ, PCⅢ and grade of inflammation and fibrosis of chronic hepatitis[J]. Chinese Journal of Infectious Disease, 1999; 17(2): 122123.
13.	刘仁才, 刘龙秀, 张德远等. 血清HA、LN、CⅣ、PCⅢ含量与慢性肝炎炎症活动度及纤维化程度的关系[J]. 中国传染病杂志, 1999; 17(2): 122～123.

1. ［1］Yao ZP, Huang WH, Luo XM. Clinical effect of Ruangan pill on hepatitis and cirrhosis[J]. Clinical Journal of Liver and Gall Disease, 1999; 15(3): 187-189.
2. 姚作平, 黄维恒, 罗辛卯. 软肝丸治疗肝炎肝硬化临床观察[J]. 临床肝胆病杂志, 1999; 15(3): 187～189.
3. ［2］Yao ZM, Lu KY, Zhao QY. Experimental study of Biejia fried pill to treat liver fibrosis[J]. Journal of Zhejiang College of traditional medicine, 1997; 21(1): 45-47.
4. 姚真敏, 吕奎源, 赵洽友. 鳖甲煎丸抗肝纤维化作用的实验研究[J]. 浙江中医学院学报, 1997; 21(1): 45～47.
5. ［3］Program of prevention and cure of viral hepatitis[J]. Chinese Journal of Hepatic Disease, 2000; 8(6): 324-329.
6. 病毒性肝炎防治方案[J]. 中华肝脏病杂志, 2000; 8(6): 324～329.
7. ［4］Su BH, Chief-editor. New insights of statistics for clinical trials of new drugs[M]. 2nd editon.Shanghai: Publishing House of Science, Technology and Literrature,1999; 43-44.
8. 苏炳华主编. 新药临床试验统计新进展[M]. 第2版. 上海: 上海科技文献出版社, 1999; 43～44.
9. ［5］Okazaki I, Watanabe, T, Hozawa S. Reversibility of hepatic fibrosis: from the first report of collagenase in the liver to the possibility of gene therapy for recovery [J]. Keio J Med, 2001; 50(2): 58-65.
10. ［6］Cheng SQ, Zhang ZF, Zhao YW. Research of diagnostic value of collaborated examination of HA, PLD, PCⅢ, LN and CⅣ[J].Chinese Journal of Practical Internal Medicine, 1999; 19(1): 2830.
11. 程书权, 张自富, 赵永伟. 血清HA、PLD、PCⅢ、LN、CⅣ联合检测对慢性肝病的诊断价值探讨[J]. 中国实用内科杂志, 1999; 19(1): 28～30.
12. ［7］Liu RC, Liu LX, Zhang DY, etc. Relation of serum content of HA, LN, CⅣ, PCⅢ and grade of inflammation and fibrosis of chronic hepatitis[J]. Chinese Journal of Infectious Disease, 1999; 17(2): 122123.
13. 刘仁才, 刘龙秀, 张德远等. 血清HA、LN、CⅣ、PCⅢ含量与慢性肝炎炎症活动度及纤维化程度的关系[J]. 中国传染病杂志, 1999; 17(2): 122～123.

Chinese Journal of Evidence-Based Medicine

Jiuweirougan Granule in the Treatment of Chronic Hepatitis with Hepatic Fibrosis: A Double-Blind Randomized Controlled Trial

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