Background: Traditional Chinese medicine (TCM) has a long history in the treatment of psoriasis vulgaris. We\naimed to evaluate the clinical efficacy and safety of Chinese herbal Pulian ointment in treating psoriasis vulgaris of\nblood-heat syndrome.\nMethods: A multicenter, randomized, double-blind, placebo-controlled trial was conducted. Participants with\npsoriasis vulgaris of blood-heat syndrome were blinded and randomized to receive Pulian ointment or\nplacebo ointment twice daily for 4 weeks, with follow-up 8 weeks after treatment. Psoriasis Area Severity\nIndex (PASI) scores, severity of each symptom and area of skin lesion and quality of life were assessed at\nbaseline, 2 weeks, and 4 weeks. Adverse events were recorded during the study. SAS 9.4 software and SPSS\n17.0 software was applied for data analysis.\nResults: A total of 300 participants with psoriasis vulgaris of blood-heat syndrome were assessed for eligibility, and\n294 were randomly assigned to the Pulian ointment and placebo group from six study centers. Full analysis set (FAS):\nafter 4 weeks of treatment, there were significant differences between groups in PASI score and the separate score of\nskin lesion area, favoring Pulian ointment group (P < 0.05). However, no significant differences were observed in scores\nof scaling, erythema and induration/thickness (P > 0.05). Per protocol set (PPS): There was no statistically significant\ndifference in PASI score and separate score of each symptom and area of skin lesion between two groups (P > 0.05).\nQuality of life measured by Hamilton Anxiety Rating Scale (HAMA) and 36-Item Short Form Health Survey (SF-36)\nimproved after treatment in both groups, but there was no significant difference between the two groups (P > 0.05).\nAfter being followed up for 8 weeks, the total relapse rates of the Pulian Ointment group and placebo group were 5.88\nand 8.45%, respectively, and the difference was not statistically significant between the two groups (P > 0.05). No\nadverse event was observed in both groups throughout the study.\nConclusions: Pulian Ointment seems effective and well tolerated in improving the PASI score and separate score of\nskin lesion area for patients with psoriasis vulgaris of blood-heat syndrome. Further research could build on the current\nstudy to explore whether other preparation forms and greater intervention intensity are necessary for better\ntherapeutic effects.
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