Department of Dermatology, China-Japan Friendship Hospital, Beijing, 100029, China.
Macau University of Science and Technology, Macau, 999078, China.
Chin J Integr Med. 2019 Apr;25(4):259-263. doi: 10.1007/s11655-018-2940-8. Epub 2019 Feb 27.
To observe the clinical effectiveness and safety of fire-needle therapy, an external approach of Chinese medicine in treating plaque psoriasis.
This study was a two-parallel-arm randomized controlled trial. A total of 151 participants with plaque psoriasis were randomly assigned to the fire-needle therapy group (treatment group, 76 cases) or the control group (75 cases) at a 1:1 allocation ratio using SAS software. All participants received Oral Huoxue Jiedu Decoction (, HXJDD) and applied externally vaseline cream twice a day. Participants in the treatment group received fire-needle therapy once weekly for 4 weeks plus HXJDD and vaseline cream applied the same as the control group. The primary outcome measure was Psoriasis Area and Severity Index (PASI) score, and the secondary outcomes were Dermatology Life Quality Index (DLQL), and Hamilton Anxiety Rating Scale (HAMA), as well as Chinese medicine (CM) syndrome score and photos of target lesions. The indices were evaluated before and after treatment.
Sixty-eight patients in each group completed the study. The treatment group has not yet achieved significant improvement in PASI score (P>0.05) compared to the control group. However, significant differences were found between the two groups in relieving CM syndrome (P<0.05) and improving quality of life (P<0.05).
Fire-needle appears to be safe and may have benefit for psoriasis, the short-term treatment and small sample size limit the conclusions of this study. Further rigorous randomized controlled trials with longer treatment are recommended.
观察火针疗法这一中医外治法治疗斑块状银屑病的临床疗效和安全性。
本研究采用平行对照、随机分组的临床试验设计。将 151 例斑块状银屑病患者按 1∶1 比例随机分为火针组（治疗组，76 例）和对照组（75 例），采用 SAS 软件产生随机数字表进行分组。所有患者均予口服活血解毒方（HXJDD），每日 2 次，外用凡士林乳膏。治疗组在口服 HXJDD 和外用凡士林乳膏的基础上，每周进行 1 次火针治疗，共 4 周；对照组仅予口服 HXJDD 和外用凡士林乳膏，疗程及用法同治疗组。主要结局指标为银屑病皮损面积严重程度指数（PASI）评分，次要结局指标为皮肤病生活质量指数（DLQI）、汉密尔顿焦虑量表（HAMA）评分及中医证候积分，分别于治疗前后进行评估。
每组各有 68 例患者完成研究。与对照组相比，治疗组 PASI 评分改善情况无明显差异（P>0.05），但中医证候积分及生活质量改善情况均优于对照组（P<0.05）。
火针治疗斑块状银屑病安全有效，能在一定程度上改善患者的中医证候，提高其生活质量，但短期疗效及样本量较小限制了本研究结论的可靠性，建议开展更多严格的、大样本的随机对照试验。
