title: A randomized, double blinded, placebo-controlled clinical trial of silymarin in ulcerative colitis.
abstract: OBJECTIVE
  To evaluate the clinical efficacy of silymarin in ulcerative colitis (UC) patients.
  
  
  METHODS
  A randomized double blinded placebo-controlled clinical trial was conducted in 80 UC patients whose disease had been documented and were in remission state between September 2009 and October 2010. Patients were assigned to silymarin group (42 cases) and placebo group (38 cases) using a random number table. Either silymarin (140 mg) or placebo (lactose mono-hydrate, corn starch magnesium stearate) tablets were given once daily for 6 months along with their standard therapy. The efficacies were assessed by disease activity index (DAI), frequency difference of the disease flare-up, and paraclinical data.
  
  
  RESULTS
  Ten patients (4 in the silymarin group due to nausea and 6 in the placebo group due to disease flare-up and abdominal pain) discontinued the study. An improvement in hemoglobin level (11.8±1.6 g/dL vs. 13.4±1.2 g/dL,P<0.05) and erythrocyte sedimentation rate (23.7±11.5 mm/h vs.10.8±3.2 mm/h,P<0.05) was observed in the silymarin group but not in the placebo group. DAI significantly decreased in the silymarin group and reached from 11.3±3.5 to 10.7±2.8 (P<0.05). Thirty-five out of 38 patients in the silymarin group were in complete remission with no flare-up after 6 months as compared to 21 out of 32 patients in the placebo group (P=0.5000).
  
  
  CONCLUSIONS
  Silymarin as a natural supplement may be used in UC patients to maintain remission.
authors.affiliation: Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.|Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.|Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mansoor
authors.initials: M
authors.lastname: Rastegarpanah
authors.affiliation: Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Reza
authors.initials: R
authors.lastname: Malekzadeh
authors.affiliation: Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Homayoun
authors.initials: H
authors.lastname: Vahedi
authors.affiliation: Pharmaceutical Branch, Islamic Azad University, Tehran, Iran.
authors.forename: Maryam
authors.initials: M
authors.lastname: Mohammadi
authors.affiliation: Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Elham
authors.initials: E
authors.lastname: Elahi
authors.affiliation: Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Meghedi
authors.initials: M
authors.lastname: Chaharmahali
authors.affiliation: Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Tahereh
authors.initials: T
authors.lastname: Safarnavadeh
authors.affiliation: Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. Mohammad@tums.ac.ir.|Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran. Mohammad@tums.ac.ir.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Abdollahi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012838:Silymarin / Q000627:therapeutic use*
chemical_list: D012838:Silymarin