Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (4): 365-373.doi: 10.3736/jcim20110404

• Study Protocol • Previous Articles     Next Articles

Syndrome distribution among patients with chronic hepatitis C and interventions of integrated traditional Chinese and Western medicine: Study protocol

Hong-ming Nie, Yue-qiu Gao, Jian-jie Chen()   

  1. Department of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
  • Received:2011-01-31 Accepted:2011-02-10 Online:2011-04-20 Published:2011-04-15
  • Contact: Chen Jian-jie E-mail:Jianjie_chen@hotmail.com

Background: Chronic hepatitis C is one of the major causes of end-stage liver disease with a high incidence rate, amounting to a grave and serious problem of public health. Currently, interferon-based (with or without ribavirin) antiviral therapy has limited use due to its stringent indications, possible contraindications and side effects. Traditional Chinese medicine (TCM) may have advantages in the prevention and treatment of chronic hepatitis C and it is of significant value to discover the advantages. Through this research, a safe and effective treatment protocol of TCM or integrated TCM and Western medicine for chronic hepatitis C can be formed. To this end, during China’s Eleventh Five-Year Plan, special research projects on acquired immune deficiency syndrome (AIDS), viral hepatitis and the other major infectious diseases were established. Our studies on chronic hepatitis C constitute one of the major special research topics.
Methods and design: Clinical information of patients with chronic hepatitis C will be first collected in a large, multicenter epidemiological survey. Positive symptoms will be analyzed by rapid cluster analysis, principal constituent analysis and factor analysis, and syndrome types will be diagnosed based on expert advice. Concurrently, a large, multicenter, randomized, parallel-group prospective study will be launched based on evidence-based medical principles to evaluate the effects and safety of the treatment protocol for chronic hepatitis C. The evaluated indexes will include the normalization rate of liver function, virological improvement and quality of life improvement for the short-term efficacy and the incidence of liver cirrhosis and (or) primary liver cancer and mortality for the long-term efficacy.
Discussion: This study will investigate the TCM syndrome differentiation norms and the syndrome distribution rules of chronic hepatitis C and evaluate the efficacy and safety of a treatment protocol for chronic hepatitis C based on TCM theory or combined treatment of TCM and Western medicine. The study results will be helpful to developing a TCM treatment program for chronic hepatitis C.

Key words: hepatitis C,chronic, clinical protocol, interferon, ribavirin, traditional Chinese medicine, multicenter study, prospective study, randomized controlled trial

Figure 1

Technical route of traditional Chinese medicine syndrome study of patients with chronic hepatitis C"

Figure 2

Technical route of this randomized therapeutic protocol"

[1] Strader DB, Wright T, Thomas DL, Seeff LB . American Association For the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C[J]. Hepatology, 2004,39(4):1147-1171
doi: 10.1002/hep.20119
[2] Epidemiology and natural history. In: Schinazi RF, Sommadossi JP, Thomas HC. Therapies for viral hepatitis[M]. London: International Medical Press, 1998
[3] Chinese Society of Hepatology and Chinese Society of Infectious Diseases and Parasitology of Chinese Medical Association. Prevention and treatment program for hepatitis C in China[J]. Zhonghua Gang Zang Bing Za Zhi, 2004,12(4):194-198
中华医学会肝病学分会,中华医学会传染病与寄生虫病学分会. 丙型肝炎防治指南[J]. 中华肝脏病杂志, 2004,12(4):194-198
[4] Lindsay KL . Introduction to therapy of hepatitis C[J]. Hepatology, 2002,36(5 Suppl 1):S114-S120
doi: 10.1002/hep.1840360715 pmid: 1240758412
[5] Seeff LB, Hoofnagle JH . National Institutes of Health Consensus Development Conference: management of hepatitis C: 2002[J]. Hepatology, 2002,36(5 Suppl 1):S3-S20
doi: 10.1310/hct.2003.4.1.008 pmid: 12407571
[6] McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team . Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection[J]. N Engl J Med, 2009,361(6):580-593
doi: 10.1056/NEJMoa0808010 pmid: 19625712
[7] Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J . Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection[J]. N Engl J Med, 2002,347(13):975-982
doi: 10.1056/NEJMoa020047 pmid: 12324553
[8] Chen JJ, Wang LT, Ren JJ, Gao YQ, Le M, Zhuo YH . Clinical study on chronic hepatits C treated with Qinggan Granules[J]. Zhong Xi Yi Jie He Gan Bing Za Zhi, 2001,11(4):195-197
陈建杰, 王灵台, 任进余, 高月求, 乐敏, 卓蕴慧 . 清肝冲剂对慢性丙型肝炎的作用研究[J]. 中西医结合肝病杂志, 2001,11(4):195-197
[9] Chen JJ, Wang LT, Ren JJ, Gao YQ, Zhuo YH, Le M . Clinical study on chronic hepatitis C treated with Kidney-Tonifying Granule[J]. Zhongguo Zhong Xi Yi Jie He Xiao Hua Za Zhi, 2001,9(6):334-336
陈建杰, 王灵台, 任进余, 高月求, 卓蕴慧, 乐敏 . 补肾冲剂治疗慢性丙型肝炎的临床研究[J]. 中国中西医结合消化杂志, 2001,9(6):334-336
[10] Li Y, Chen JJ . Study of HCV genetype distribution to 71 patients with chronic hepatitis C in Shanghai district[J]. Zhong Xi Yi Jie He Gan Bing Za Zhi, 2006,16(6):360-362
李莹, 陈建杰 . 上海地区71例慢性丙型病毒性肝炎患者基因型分布研究[J]. 中西医结合肝病杂志, 2006,16(6):360-362
[11] Li YP, Huang ZJ, Zhang H, Chen C . Feasibility of the MOS 36-item Short Form Health Survey in the assessment of the quality of life in hepatitis B patients[J]. Zhongguo Yu Fang Yi Xue Za Zhi, 2007,8(4):352-355
doi: 10.3969/j.issn.1009-6639.2007.04.007
李跃平, 黄子杰, 张宏, 陈聪 . SF-36量表在乙型肝炎患者生存质量测量中的可行性评价[J]. 中国预防医学杂志, 2007,8(4):352-355
doi: 10.3969/j.issn.1009-6639.2007.04.007
[12] Wu CH, Deng QW, Ji XS, Yan LM . Preliminary use of the CLDQ in chronic hepatitis B patients[J]. Zhongguo Lin Chuang Xin Li Xue Za Zhi, 2003,11(1):60-62
doi: 10.3969/j.issn.1005-3611.2003.01.020
吴创鸿, 邓启文, 纪晓抒, 阎郎明 . 慢性肝病问卷在慢性乙型肝炎患者中的试用[J]. 中国临床心理学杂志, 2003,11(1):60-62
doi: 10.3969/j.issn.1005-3611.2003.01.020
[1] Chiung-Hui Huang, Mei-Ling Yeh, Fang-Pey Chen, Daphne Wu. Low-level laser acupuncture reduces postoperative pain and morphine consumption in older patients with total knee arthroplasty: A randomized placebo-controlled trial. Journal of Integrative Medicine, 2022, 20(4): 321-328.
[2] Wan-jun Guo, Yi Wang, Yu Deng, Lin-yan Cheng, Xin Liu, Ruo-fan Xi, Sheng-jie Zhu, Xin-yi Feng, Liang Hua, Kan Ze, Jian-yong Zhu, Dong-jie Guo, Fu-lun Li. Therapeutic effects of the extract of Sancao Formula, a Chinese herbal compound, on imiquimod-induced psoriasis via cysteine-rich protein 61. Journal of Integrative Medicine, 2022, 20(4): 376-384.
[3] Shang-jin Song, Xuan Liu, Qing Ji, Da-zhi Sun, Li-juan Xiu, Jing-yu Xu, Xiao-qiang Yue. Ziyin Huatan Recipe, a Chinese herbal compound, inhibits migration and invasion of gastric cancer by upregulating RUNX3 expression. Journal of Integrative Medicine, 2022, 20(4): 355-364.
[4] Maryam Azimi, Hanieh Niayesh, Mahboobeh Raeiszadeh, Sedigheh Khodabandeh-shahraki. Efficacy of the herbal formula of Foeniculum vulgare and Rosa damascena on elderly patients with functional constipation: A double-blind randomized controlled tria. Journal of Integrative Medicine, 2022, 20(3): 230-236.
[5] Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Ana Elisa Madureira Padula, Livia Mitchiguian Hotta, Amarilysde Toledo Cesar, José Nelson Martins Diniz, Helen de Freitas Santos, Edson Zangiacomi Martinez. Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study). Journal of Integrative Medicine, 2022, 20(3): 221-229.
[6] Marisa Casal. Improving the health and treatment success rates of in vitro fertilization patients with traditional chinese medicine: need for more robust evidence and innovative approaches. Journal of Integrative Medicine, 2022, 20(3): 187-192.
[7] Ning Guo, Fei Wu, Mei Wu, Yuan Wang, Qing Lang, Xiao Lin, Yi Feng. Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine . Journal of Integrative Medicine, 2022, 20(3): 204-212.
[8] Xin Wang, Wen-juan Song, Yi Ruan, Bing-chu Li, Can Lü, Nian Huang, Fan-fu Fang, Wei Gu. Core muscle functional strength training for reducing the risk of low-back pain in military recruits: An open-label randomized controlled trial. Journal of Integrative Medicine, 2022, 20(2): 145-152.
[9] Yan-jun Lin, Kun-li Jiao, Bo Liu, Lu Fang, Shu Meng. Antiplatelet and myocardial protective effect of shexiang tongxin dropping pill in patients undergoing percutaneous coronary intervention: A randomized controlled trial. Journal of Integrative Medicine, 2022, 20(2): 126-134.
[10] Jia-jia Li, Qing Liang, Guang-chun Sun. Traditional Chinese medicine for prevention and treatment of hepatocellular carcinoma: A focus on epithelial-mesenchymal transition. Journal of Integrative Medicine, 2021, 19(6): 469-477.
[11] Rui-jin Qiu, Min Li, Jia-yuan Hu, Jing Chen, Hong-cai Shang. Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine. Journal of Integrative Medicine, 2021, 19(5): 389-394.
[12] Mao-xing Pan, Chui-yang Zheng, Yuan-jun Deng, Kai-rui Tang, Huan Nie, Ji-qian Xie, Dong-dong Liu, Gui-fang Tu, Qin-he Yang, Yu-pei Zhang. Hepatic protective effects of Shenling Baizhu powder, a herbal compound, against inflammatory damage via TLR4/NLRP3 signalling pathway in rats with nonalcoholic fatty liver disease . Journal of Integrative Medicine, 2021, 19(5): 428-438.
[13] Meng-zhu Zhao, Chen Zhao, Shuang-shuang Tu, Xu-xu Wei, Hong-cai Shang. Evaluating the methodology of studies conducted during the global COVID-19 pandemic: A systematic review of randomized controlled trials. Journal of Integrative Medicine, 2021, 19(4): 317-326.
[14] Ning Zhang, Xiao-he Xiao. Integrative medicine in the era of cancer immunotherapy: Challenges and opportunities. Journal of Integrative Medicine, 2021, 19(4): 291-294.
[15] Thomas Efferth, An-long Xu, Roxana Damiescu, Mita Banerjee, Norbert W. Paul, David Y.W. Lee. Can eastern wisdom resolve western epidemics? Traditional chinese medicine therapies and the opioid crisis. Journal of Integrative Medicine, 2021, 19(4): 295-299.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. An explanation on "guiding principles of clinical research on mild cognitive impairment (protocol)". Journal of Chinese Integrative Medicine, 2008, 6(1): 15-21
[2] Yi-ting He, Qing-lin Zha, Jian-ping Yu, Yong Tan, Cheng Lu, Ai-ping Lv. Principal factor analysis of symptoms of rheumatoid arthritis and their correlations with efficacy of traditional Chinese medicine and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 32-36
[3] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[4] Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[5] A-gao Zhou, Yong Zhang, Gang Kui, De-Yun Kong, Hai-liang Ge, Qiu-hua Ren, Jia-rong Dong, Sheng Hong, Xu-ming Mao, Yin Wang, Hui-zheng Zhang, Shu-jun Wang. Influence of traditional Chinese compound recipes with different efficacy on body weight, tumor weight and immune function in H22 cancer-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 77-82
[6] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[7] Li Zhou, Hong-xing Zhang, Ling-guang Liu, Wen-jun Wan. Effect of electro-acupuncture at Fenglong (GV 16) on nitric oxide and endothelin in rats with hyperlipidemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 89-92
[8] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. Guiding principles of clinical research on mild cognitive impairment (protocol). Journal of Chinese Integrative Medicine, 2008, 6(1): 9-14
[9] Xin-jun Wang, Ling-ling Wang . A mechanism of endogenous opioid peptides for rapid onset of acupuncture effect in treatment of depression. Journal of Chinese Integrative Medicine, 2010, 8(11): 1014-1017
[10] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022