Assessment procedures and time-points. (DOCX 14Â kb

Fei Shi (290778)

Guangzhong Zhang (4026665)

Jianmin Xing (2383822)

Jianping Liu (182740)

Nuo Li (521186)

Wali Liu (4026662)

Wenbin Zhao (4026677)

Yanping Bai (4026668)

Yuanwen Li (4026671)

Yunbi Zhang (4026674)

BMC Complementary and Alternative Medicine

Changes of SF-36 scores from baseline in Pulian ointment and placebo group. Table S3. Changes of HAMA scores from baseline in the Pulian ointment and placebo group. (DOCX 17Â kb

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Additional file 2: Table S2. of Chinese herbal Pulian ointment in treating psoriasis vulgaris of blood-heat syndrome: a multi-center, double-blind, randomized, placebo-controlled trial

Abstract Background Traditional Chinese medicine (TCM) has a long history in the treatment of psoriasis vulgaris. We aimed to evaluate the clinical efficacy and safety of Chinese herbal Pulian ointment in treating psoriasis vulgaris of blood-heat syndrome. Methods A multicenter, randomized, double-blind, placebo-controlled trial was conducted. Participants with psoriasis vulgaris of blood-heat syndrome were blinded and randomized to receive Pulian ointment or placebo ointment twice daily for 4 weeks, with follow-up 8 weeks after treatment. Psoriasis Area Severity Index (PASI) scores, severity of each symptom and area of skin lesion and quality of life were assessed at baseline, 2 weeks, and 4 weeks. Adverse events were recorded during the study. SAS 9.4 software and SPSS 17.0 software was applied for data analysis. Results A total of 300 participants with psoriasis vulgaris of blood-heat syndrome were assessed for eligibility, and 294 were randomly assigned to the Pulian ointment and placebo group from six study centers. Full analysis set (FAS): after 4 weeks of treatment, there were significant differences between groups in PASI score and the separate score of skin lesion area, favoring Pulian ointment group (P  0.05). Per protocol set (PPS): There was no statistically significant difference in PASI score and separate score of each symptom and area of skin lesion between two groups (P > 0.05). Quality of life measured by Hamilton Anxiety Rating Scale (HAMA) and 36-Item Short Form Health Survey (SF-36) improved after treatment in both groups, but there was no significant difference between the two groups (P > 0.05). After being followed up for 8 weeks, the total relapse rates of the Pulian Ointment group and placebo group were 5.88 and 8.45%, respectively, and the difference was not statistically significant between the two groups (P > 0.05). No adverse event was observed in both groups throughout the study. Conclusions Pulian Ointment seems effective and well tolerated in improving the PASI score and separate score of skin lesion area for patients with psoriasis vulgaris of blood-heat syndrome. Further research could build on the current study to explore whether other preparation forms and greater intervention intensity are necessary for better therapeutic effects. Trial registration Chictr.org.cn Identifier ChiCTR-TRC-12002054 

Nuo Li

Wenbin Zhao

Jianmin Xing

Jianping Liu

Guangzhong Zhang

Yunbi Zhang

Yuanwen Li

Wali Liu

Fei Shi

Yanping Bai

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Chinese herbal Pulian ointment in treating psoriasis vulgaris of blood-heat syndrome: a multi-center, double-blind, randomized, placebo-controlled trial