Evaluation of psoriasis severity and inflammatory responses under concomitant treatment with methotrexate plus micronutrients for psoriasis vulgaris: a randomized double blind trial.

INTRODUCTION 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). CONCLUSION 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.