title: Protocol of a prospective study for the combination treatment of Shu-Gan-jian-Pi decoction and steroid standard therapy in autoimmune hepatitis patients.
abstract: BACKGROUND
  Prednisone plus azathioprine is considered the mainstay of therapy in the current recommendations for autoimmune hepatitis (AIH). However, it does not provide good benefits for AIH patients because of its serious side effects. Therefore, more and more AIH patients prefer to seek for traditional Chinese medicine (TCM) to manage their symptoms and reduce the side effects of steroids in China. Shu-Gan-Jian-Pi Decoction is a popular used Chinese herbal formula in Guangdong province of China, which has demonstrated the effect of improving efficacy and reducing side effects of corticosteroids in AIH patients. The aim of this study is to evaluate the effects of Shu-Gan-Jian-Pi Decoction combined with steroid in AIH patients. So, this study aims to explore whether the combination treatment of Shu-Gan-Jian-Pi Decoction and steroid standard therapy could improve the clinical management of AIH.
  
  
  METHODS
  A prospective non-randomized study on AIH will be conducted between October 2015 and June 2017 in Guangdong Provincial hospital of Chinese medicine. Eligible AIH patients will be classified as the case group (n = 66) and the control group (n = 66) based on the interventions. Patients taking Shu-Gan-Jian-Pi Decoction combined with prednisone and azathioprine will be in the case group and those taking prednisone and azathioprine will be in the control group. The whole study will last 48 weeks, including a 24-week observation period and a 24-week follow-up period. The primary outcome was complete response to therapy, defined as complete biochemical remission at the patient's last visit of observation period and the absence of predefined steroid-specific side effects throughout treatment.
  
  
  CONCLUSIONS
  This trial will evaluate the efficacy and safety of Shu-Gan-Jian-Pi Decoction combined with prednisone and azathioprine on AIH patients. The achievement of this trial will provide evidence-based data for Shu-Gan-Jian-Pi Decoction, which could provide good benefits for AIH patients.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry: ChiCTR-OOC-15006155 . Registration date: 28 March 2015.
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. chixiaolingqh@163.com.
authors.forename: Xiao-Ling
authors.initials: XL
authors.lastname: Chi
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Huan-Ming
authors.initials: HM
authors.lastname: Xiao
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Yu-Bao
authors.initials: YB
authors.lastname: Xie
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Gao-Shu
authors.initials: GS
authors.lastname: Cai
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Jun-Min
authors.initials: JM
authors.lastname: Jiang
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Guang-Jun
authors.initials: GJ
authors.lastname: Tian
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Mei-Jie
authors.initials: MJ
authors.lastname: Shi
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Shu-Duo
authors.initials: SD
authors.lastname: Wu
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Peng-Tao
authors.initials: PT
authors.lastname: Zhao
authors.affiliation: Department of Hepatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Hui-Jun
authors.initials: HJ
authors.lastname: Chen
mesh_terms: D001379:Azathioprine / Q000627:therapeutic use; D002985:Clinical Protocols; D004365:Drugs, Chinese Herbal / Q000494:pharmacology / Q000627:therapeutic use*; D005938:Glucocorticoids / Q000627:therapeutic use; D019693:Hepatitis, Autoimmune / Q000188:drug therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D011241:Prednisone / Q000627:therapeutic use; D011446:Prospective Studies
chemical_list: D004365:Drugs, Chinese Herbal; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; C534230:shugan jianpi; D001379:Azathioprine; D011241:Prednisone
keywords: Autoimmune Hepatitis; Shu-Gan-Jian-Pi Decoction; Side effects; Steroid