title: Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial.
abstract: Approximately 20% of patients with ulcerative colitis become steroid dependent. Azathioprine is recommended in steroid-dependent ulcerative colitis, but its side effects limit its use. Chinese herbal medicine has been widely used to treat ulcerative colitis in China. However, its effectiveness in steroid-dependent patients has not been evaluated. This study aims to investigate the efficacy of traditional Chinese medicine combination therapy with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis.
  
  
  
  This is a parallel, multicenter, randomized controlled trial. One hundred and twenty eligible patients will be randomly assigned to a traditional Chinese medicine group or azathioprine group. All patients will be given basic treatment, which includes steroids and 5-aminosalicylic acid. Patients allocated to the traditional Chinese medicine group will receive basic treatment plus Chinese herbal medicine granules, while patients in the azathioprine group will receive basic treatment plus azathioprine. The whole study will last 24 weeks. The primary outcome measure is the steroid-free remission rate. Secondary outcome measures are health-related quality of life, efficacy of endoscopic response, degree of mucosal healing, and inflammation indicators.
  
  
  
  Results from this study may provide evidence for the effectiveness of traditional Chinese medicine combined with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. The findings will provide a basis for further confirmatory studies.
  
  
  
  Chinese Clinical Trial Register, ChiCTR-IPR-15005760 . Registered on 2 January 2015.
authors.affiliation: First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.|Department of Gastroenterology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210029, China.
authors.forename: Kai
authors.initials: K
authors.lastname: Zheng
authors.affiliation: Department of Gastroenterology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210029, China. jiangsutcm@163.com.
authors.forename: Hong
authors.initials: H
authors.lastname: Shen
authors.affiliation: Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
authors.forename: Jia
authors.initials: J
authors.lastname: Jia
authors.affiliation: Department of Gastroenterology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210029, China.
authors.forename: Yuelin
authors.initials: Y
authors.lastname: Lu
authors.affiliation: Division of Scientific Research, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Division of Scientific Research, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
authors.forename: Lu
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Division of Scientific Research, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
authors.forename: Zhaofeng
authors.initials: Z
authors.lastname: Shen
mesh_terms: D001379:Azathioprine / Q000627:therapeutic use; D002985:Clinical Protocols; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000009:adverse effects; D019804:Mesalamine / Q000009:adverse effects / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care
chemical_list: D004365:Drugs, Chinese Herbal; D019804:Mesalamine; D001379:Azathioprine
keywords: 5-aminosalicylic acid; Azathioprine; Chinese herbal medicine; Steroid-dependent ulcerative colitis; Study protocol