title: Efficacy and safety of Fufangkushen colon-coated capsule in the treatment of ulcerative colitis compared with mesalazine: a double-blinded and randomized study.
abstract: BACKGROUND
  Fufangkushen colon-coated capsule (FCC) was a newly developed herbal drug for treating ulcerative colitis (UC) patients with traditional Chinese medicine (TCM) pattern of damp-heat accumulating in the interior.
  
  
  OBJECTIVE
  To explore the efficacy and safety of FCC in the treatment of active UC compared with Huidi (HD, mesalazine enteric-coated tablets) were evaluated in a double-blinded and randomized clinical trial.
  
  
  METHODS
  In the double-blind, double-dummy, multicenter, randomized and controlled study, 320 active UC patients with TCM pattern of damp-heat accumulating in the interior were assigned to two groups: 240 treated with FCC plus HD placebo treatment, 80 with HD plus FCC placebo. The drugs and their corresponding placebos were administrated at advised dosage for 8 weeks. The primary endpoint was a positive clinical response at week 8, and Mayo scoring system was employed for assessment of UC activity.
  
  
  RESULTS
  At the 8th week, 72.50% of patients in FCC group (170 of 234) and 65.00% of patients in HD group (52 of 80) had achieved a clinical response. There was no statistically significance between the 2 groups (P>0.05). The proportions of patients who had a clinical remission was similar in 2 groups (41.50% in FCC group, 41.25% in HD group, P>0.05), mucosal healing rate at week 8 in the two groups were also without significant difference (55.13% in FCC group, 55.00% in HD group, P>0.05). Mayo scores at week 8 showed no statistically difference in the two groups. No significant differences were observed between the safety profiles of the 2 groups (P>0.05). No severe AEs were reported in either group. The latent class analysis indicated that FCC was superior applicable for the left hemicolon involved patients than HD.
  
  
  CONCLUSIONS
  Compared with HD, a mesalamine enteric-coated tablet, FCC is similarly effective and safe in the treatment of active UC with TCM pattern of damp-heat accumulation interior pattern. In addition, FCC indicates superior effect in the treatment of UC with inflamed area of the left hemicolon than HD.
authors.affiliation: The General Hospital of Shenyang Military Region, Liaoning, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Gong
authors.forename: Qinglin
authors.initials: Q
authors.lastname: Zha
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.forename: Bo
authors.initials: B
authors.lastname: Yang
authors.forename: Liang
authors.initials: L
authors.lastname: Liu
authors.forename: Aiping
authors.initials: A
authors.lastname: Lu
authors.forename: Yifan
authors.initials: Y
authors.lastname: Lin
authors.forename: Miao
authors.initials: M
authors.lastname: Jiang
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002214:Capsules; D016009:Chi-Square Distribution; D002681:China; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects / Q000473:pathology; D008297:Male; D008516:Medicine, Chinese Traditional; D019804:Mesalamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010946:Plants, Medicinal; D013608:Tablets, Enteric-Coated; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
chemical_list: D000893:Anti-Inflammatory Agents; D002214:Capsules; D004365:Drugs, Chinese Herbal; D005765:Gastrointestinal Agents; D013608:Tablets, Enteric-Coated; C574916:fufangkushen; D019804:Mesalamine