title: [Syndrome distribution among patients with chronic hepatitis C and interventions of integrated traditional Chinese and Western medicine: study protocol].
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The research program was registered in the Chinese Clinical Trial Registry in English and Chinese in January 2010.
  
  
  BACKGROUND
  ChiCTR-TRC-10000770.
authors.affiliation: Department of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
authors.forename: Hong-ming
authors.initials: HM
authors.lastname: Nie
authors.forename: Yue-qiu
authors.initials: YQ
authors.lastname: Gao
authors.forename: Jian-jie
authors.initials: JJ
authors.lastname: Chen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D002681:China; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012254:Ribavirin / Q000627:therapeutic use; D012939:Social Planning; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004365:Drugs, Chinese Herbal; D012254:Ribavirin; D007372:Interferons