Objective: To objectively assess the clinical efficacy and safety of a new Pulian Ointment (, NPLO) in treating psoriasis of blood-heat syndrome of Chinese medicine.
Methods: A total of 108 patients with psoriasis of blood-heat syndrome were equally assigned, using a randomizing digital table, to the test group treated externally with NPLO and the control group treated with placebo; the medication was done using a singleblinded method twice a day. Meanwhile, all patients received by oral intake a conventional Chinese decoction for clearing heat and cooling blood; the therapeutic course was 4 weeks for both groups. The therapeutic efficacy, changes in the Psoriasis Area and Severity Index (PASI) score and various aspects of the lesion, including scaly eruption, erythema, infiltration, size, score of itching as well as adverse reactions were observed.
Results: The trial was completed in 100 patients, 51 in the test group and 49 in the control group. The remarkably effective rate was 45.10% and the total effective rate was 84.31% in the test group, which were significantly higher than those in the control group, 12.24% and 51.02%, respectively, showing a significant difference between groups (P<0.01). The test group also showed better effects in the improvement of the PASI score of the lesions and scores on erythema, infiltration, size of lesion as well as itching. No adverse event was found in either group.
Conclusion: NPLO is a Chinese remedy for the external treatment of psoriasis of the blood-heat syndrome with a reliable therapeutic efficacy and good safety.