Xu Yonglong, Liu Qingwu, Lv Shuying, Yang Dingquan, Wang Lei
Beijing University of Chinese Medicine, Beijing, China.
Dermatology Department, China-Japan Friendship Hospital, Beijing, China.
BMJ Open. 2025 Aug 3;15(8):e096020. doi: 10.1136/bmjopen-2024-096020.
Androgenetic alopecia (AGA), the most prevalent form of hair loss in clinical practice, affects 21.3% of the male population in China. The condition significantly impacts patients' self-perception, psychological well-being and quality of life. Preliminary evidence suggests that acupoint catgut embedding (ACE) may offer therapeutic benefits for AGA. This randomised controlled trial aims to evaluate the efficacy and safety of ACE combined with topical 5% minoxidil tincture in managing AGA.
This is a single-centre, prospective, double-blind, randomised controlled trial. A total of 70 male patients with AGA will be randomly allocated to either the ACE group (ACE combined with topical minoxidil) or the control group (sham ACE combined with topical minoxidil) at a 1:1 ratio. All participants will receive standardised topical 5% minoxidil therapy during the 24-week intervention period, with concomitant administration of either ACE or sham ACE (needle insertion mimicking ACE protocol without suture implantation) at 4-week intervals. Post-treatment follow-up will extend for 24 weeks. The primary outcome measure will be the change in the number of target area hair count (TAHC) after 24 weeks of treatment compared with the baseline. Secondary outcomes will include hair growth assessment, changes in the number of TAHC, changes in the diameter of target area cumulative non-vellus hair width and changes in sex hormone levels. Statistical significance will be defined as a two-sided p value<0.05.
This study has been approved by the clinical research ethics committee of China-Japan Friendship Hospital (project number: 2023-KY-304) and requires written informed consent from the patients. The results will be published in a peer-reviewed academic journal.
ChiCTR2300078123.
雄激素性脱发（AGA）是临床实践中最常见的脱发形式，在中国影响着21.3%的男性人口。这种情况会显著影响患者的自我认知、心理健康和生活质量。初步证据表明，穴位埋线（ACE）可能对AGA有治疗作用。这项随机对照试验旨在评估ACE联合外用5%米诺地尔酊治疗AGA的疗效和安全性。
这是一项单中心、前瞻性、双盲、随机对照试验。总共70名AGA男性患者将按1:1的比例随机分配到ACE组（ACE联合外用米诺地尔）或对照组（假穴位埋线联合外用米诺地尔）。在24周的干预期内，所有参与者将接受标准化的外用5%米诺地尔治疗，同时每隔4周进行一次ACE或假ACE治疗（模拟ACE操作流程进行针刺但不植入缝线）。治疗后随访将持续24周。主要结局指标将是治疗24周后目标区域毛发计数（TAHC）与基线相比的变化。次要结局将包括头发生长评估、TAHC数量的变化、目标区域累积非毳毛宽度直径的变化以及性激素水平的变化。统计学显著性将定义为双侧p值<0.05。
本研究已获得中日友好医院临床研究伦理委员会批准（项目编号：2023-KY-304），并要求患者签署书面知情同意书。研究结果将发表在同行评审的学术期刊上。
ChiCTR2300078123。
