title: Evaluation of psoriasis severity and inflammatory responses under concomitant treatment with methotrexate plus micronutrients for psoriasis vulgaris: a randomized double blind trial.
abstract: BACKGROUND
  We evaluated the effectiveness of concomitant treatment with methotrexate (MTX) plus micronutrients in comparison with monotherapy with MTX only in psoriasis patients. Plasma levels of interleukin-1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) were also measured and their association with clinical severity was evaluated.
  
  
  METHODS
  Thirty psoriasis patients 20 to 50 years old with a PASI score > 10 were divided randomly into two groups. Both groups were given oral methotrexate (0.2-0.3 mg/kg/week) for 12 weeks. In addition, Group B received one tablet of micronutrient supplement daily. Disease severity was calculated using the psoriasis area and severity index (PASI) score before and after 12 weeks. Levels of IL-1β and TNF-α were measured using enzyme-linked immunosorbent assay (ELISA).
  
  
  RESULTS
  We found that 13 (86.6%) patients in Group B and 8 (53.3%) patients in Group A attained a mild PASI score (≤ 10% body involvement). IL-1β and TNF-α levels were significantly decreased in favor of Group B (p < 0.05). There was a significant correlation between changes in both IL-1β and TNF-α levels and PASI score after the study (p < 0.05).
  
  
  CONCLUSIONS
  The results obtained were positive, and therefore double-blind randomized trials with a larger sample size are highly suggested to confirm or reject these results.
authors.affiliation: Immunology Research Center, BuAli Research Institute, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Hadis
authors.initials: H
authors.lastname: Yousefzadeh
authors.affiliation: Allergy Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Farahzad
authors.initials: F
authors.lastname: Jabbari Azad
authors.affiliation: Cutaneous Leishmaniasis Research Center, Department of Dermatology, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Mahnaz
authors.initials: M
authors.lastname: Banihashemi
authors.affiliation: Immunology Research Center, BuAli Research Institute, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Maryam
authors.initials: M
authors.lastname: Rastin
authors.affiliation: Immunology Research Center, BuAli Research Institute, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Mahmoudi
mesh_terms: D000328:Adult; D000368:Aged; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D053583:Interleukin-1beta / Q000097:blood; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D018977:Micronutrients / Q000627:therapeutic use*; D008875:Middle Aged; D011565:Psoriasis / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000097:blood; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D053583:Interleukin-1beta; D018977:Micronutrients; D014409:Tumor Necrosis Factor-alpha; D008727:Methotrexate