title: Clinical efficacy of Rong-Yang-Jyh-Gan-Tang on patients with chronic hepatitis C: A double-blinded randomized placebo-controlled crossover study.
abstract: BACKGROUND
  Traditional Chinese medicine (TCM) has been widely used by the Chinese population for treatment of chronic hepatitis. However, the efficacy of TCM for patients with chronic hepatitis has not been confirmed, mostly due to the lack of available scientific parameters such as serum viral load to evaluate treatment response.
  
  
  OBJECTIVE
  We evaluated the efficacy of Rong-Yang-Jyh-Gan-Tang (RYJGT, composed of Long-Dan-Xie-Gan-Tang, Jia-Wei-Xia-Yao-San, Dan-Shen, and Hou-Po) on patients with chronic hepatitis C.
  
  
  METHODS
  Thirty-six patients with chronic hepatitis C who had no response to or had contraindications to interferon-ribavirin therapy were randomly allocated to receive RYJGT 15g/day or placebo for 12 weeks. After a 2-week washout period, patients were crossed over to receive placebo or RYJGT for another 12 weeks. Evaluation parameters included liver biochemistries, serum HCVRNA, side effects of RYJGT/placebo, and TCM symptoms.
  
  
  RESULTS
  Of the patients who had 12-week RYJGT treatment, 51.7% had decreased serum HCVRNA levels, whereas only 25.8% patients had decreased levels in the placebo group (p=0.036). TCM patterns of "Damp-Heat" and "Liver Qi Depression" had significantly improved after RYJGT treatment in comparison with the placebo. Logistic analyses showed that RYJGT treatment, and pre-treatment values of TCM symptoms of "Damp-Heat" and "Liver Qi Depression", were statistically significant factors in predicting the decrease in serum HCVRNA.
  
  
  CONCLUSIONS
  Chronic hepatitis C patients who received a 12-week RYJGT treatment had significantly higher HCVRNA decrease ratio, and improved TCM symptoms of "Damp-Heat" and "Liver Qi Depression", than those who received the placebo. Our results require further larger scale clinical trials.
authors.affiliation: Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Traditional Medicine, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Fang-Pey
authors.initials: FP
authors.lastname: Chen
authors.affiliation: Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Ching-Mao
authors.initials: CM
authors.lastname: Chang
authors.affiliation: Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Ta-Peng
authors.initials: TP
authors.lastname: Wu
authors.affiliation: Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Jen-Lin
authors.initials: JL
authors.lastname: Yang
authors.affiliation: Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Traditional Medicine, National Yang-Ming University, Taipei, Taiwan; Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Yen-Ying
authors.initials: YY
authors.lastname: Kung
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Yi-Hsiang
authors.initials: YH
authors.lastname: Huang
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Chien-Wei
authors.initials: CW
authors.lastname: Su
authors.affiliation: Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Keng-Hsin
authors.initials: KH
authors.lastname: Lan
authors.affiliation: Institute of Hospital and Health Care Administration, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Shu-Chiung
authors.initials: SC
authors.lastname: Chiang
authors.affiliation: Department of Family Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. Electronic address: sjhwang@vghtpe.gov.tw.
authors.forename: Shinn-Jang
authors.initials: SJ
authors.lastname: Hwang
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004365:Drugs, Chinese Herbal; D012367:RNA, Viral; C000621166:rong-yang-jyh-gan-tang; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase
keywords: Chronic hepatitis C; Fatigue severity score; Hepatitis C viral RNA; Quality of life; Rong-Yang-Jyh-Gan-Tang; Serum liver transaminase