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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

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单位: [1]Department of Dermatology, China-Japan Friendship Hospital, Beijing 100029, China. [2]Department of Dermatology, Beijing Pinggu Hospital, Beijing 101200, China. [3]Beijing Sinocro Pharma Science Co., Ltd., Beijing 100024, China. [4]Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China. [5]Department of Dermatology, Beijing Hospital of Traditional Chinese Medicine, Beijing 100010, China. [6]Department of Dermatology, Dongzhimen Hospital, Beijing 100007, China. [7]Department of Dermatology, Dongfang Hospital, Beijing 100078, China. [8]Department of Dermatology, Guang’anmen Hospital, Beijing 100053, China. [9]Department of Dermatology, Air Force General Hospital, PLA, Beijing 100036, China.
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关键词: Pulian ointment Chinese herbal medicine Blood-heat syndrome Psoriasis vulgaris Efficacy Randomized controlled trial

摘要:
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). However, no significant differences were observed in scores of scaling, erythema and induration/thickness (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.

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出版当年[2016]版:
大类 | 4 区 医学
小类 | 3 区 全科医学与补充医学
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Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
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第一作者单位: [1]Department of Dermatology, China-Japan Friendship Hospital, Beijing 100029, China.
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