针灸改善中重度寻常痤疮患者症状和生活质量的疗效：一项随机对照试验研究方案。

Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: study protocol for a randomized controlled trial.

机构信息

Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, China.

China Academy of Chinese Medical Sciences, Beijing, China.

出版信息

Trials. 2020 Jun 23;21(1):563. doi: 10.1186/s13063-020-04346-7.

DOI:10.1186/s13063-020-04346-7

PMID:32576237

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7310417/

Abstract

BACKGROUND

Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested, owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the present study is to evaluate the effectiveness of acupuncture in treating the symptoms and QoL of patients with moderate or severe AV.

METHODS/DESIGN: One hundred eligible participants with AV will be randomly assigned to an acupuncture or a sham acupuncture group (1:1 allocation). All participants will receive 4-week treatment comprising a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, visual analogue scale scores for assessment of itch and pain, patient expectations of acupuncture, and blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population.

DISCUSSION

We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single-center scope, relatively small sample size, and lack of blinding of the acupuncturists.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR-1900023649. Registered on January 2, 2019.

摘要

背景

寻常痤疮（AV）是一种常见的慢性皮肤病，往往会损害患者的外貌和生活质量（QoL）。尽管几项试验表明针灸对 AV 患者的治疗有效，但由于其设计存在潜在的偏倚，这些试验的结果受到了争议。因此，缺乏评估针灸治疗 AV 患者疗效的有力数据。此外，以前 AV 针灸治疗的临床试验均未将 QoL 作为主要结局指标，也未采用假针灸对照臂。本研究旨在评估针灸治疗中重度 AV 患者症状和 QoL 的疗效。

方法/设计：将 100 名符合条件的 AV 患者随机分配到针灸组或假针灸组（1:1 分配）。所有患者将接受 4 周的治疗，共 12 次（每周 3 次）。主要结局指标为治疗结束时 Skindex-16 量表总分的基线变化。次要结局指标为 Skindex-16 子量表评分、皮肤病生活质量指数量表总分、总皮损计数和炎症性皮损计数、瘙痒和疼痛评估的视觉模拟评分、患者对针灸的期望以及假针灸效果的盲法。随访评估将在第 16 周和第 28 周进行。所有结局分析均将在意向治疗人群中进行。