Background. Psoriasis is a common and chronic immune-mediated skin disorder, for which there is currently no cure. To our knowledge, this is the first randomized placebo-controlled trial comparing methotrexate and traditional Chinese medicine (TCM) in terms of efficacy, safety, and quality of life for the treatment of psoriasis.
Methods. In total, 61 patients with moderate to severe plaque psoriasis were randomized to receive treatment with methotrexate, TCM or placebo for 6 months. The primary outcome measure was the Psoriasis Area and Severity Index (PASI), and secondary outcome measures were the Physician’s Global Assessment (PGA) and the Psoriasis Disability Index (PDI).
Results. In all, 50 patients completed the study and were included in the analysis. Dropout rates were highest in the TCM group. Mean PASI change from baseline at 6 months revealed an improvement of 73.9% of the methotrexate group, 15.1% of the TCM group and 32.0% of the placebo group. There was a significant difference between the three groups, with methotrexate showing greater effectiveness than the other two groups. No significant difference was found between the TCM and placebo groups. The methotrexate group also had greater improvement when assessed using the PGA and PDI.
Conclusions. Our results verify the therapeutic effect of methotrexate for the management of psoriasis. Despite widespread belief and use of TCM in Asia for the treatment of psoriasis, we were unable to confirm the efficacy of TCM in this study.