Patient-reported questionnaires.

Background
Aromatase inhibitors (AI) reduce hormone receptor-positive breast cancer recurrence risk by about 50%. However, half of AI-treated postmenopausal women report new or worsened musculoskeletal symptoms (AIMSS), and 20% discontinue therapy prematurely. Acupuncture is effective for reducing symptoms, but many women are not able to access acupuncture therapy. We hypothesize that self-administered acupressure will reduce AIMSS.
Materials and methods
Postmenopausal women who have been receiving treatment with an AI for more than 3 weeks but less than 2 years, and who report new or worsened joint pain or myalgias since starting AI therapy with worst pain of at least 4 out of 10 on a numerical rating scale, are eligible. Fifty participants will be enrolled and randomized 1:1 to treatment with true or sham acupressure for 12 weeks. Participants will self-apply pressure for 3 minutes to each of the 9 acupoints daily. All participants will complete a pain assessment weekly, and a battery of symptom questionnaires every 6 weeks. Optional stool samples will be collected after 0 and 12 weeks of acupressure to examine changes in the gut microbiome. The primary endpoint is change in worst pain on the Brief Pain Inventory-Short Form with 12 weeks of the acupressure intervention, evaluated with generalized estimating equations.
Conclusion
Determination that self-administered acupressure reduces AIMSS in this randomized phase 2 pilot trial will lead to a larger randomized phase 3 clinical trial to confirm the efficacy of self-acupressure. Reduction of AI-related arthralgias may improve persistence with breast cancer therapy, breast cancer outcomes, and quality of life for AI-treated patients.
Trial registration
Clinicaltrials.gov NCT06228768.

【背景】芳香化酶抑制剂（Aromatase inhibitors, AI）可将激素受体阳性乳腺癌的复发风险降低约50%。然而，接受AI治疗的绝经后女性中有半数报告出现新发或加重的肌肉骨骼症状（AIMSS），且20%的患者会提前终止治疗。针灸对缓解此类症状有效，但许多女性无法获得针灸治疗。我们提出假说：自行穴位按压可减轻AIMSS。

【材料与方法】符合以下全部条件的绝经后女性可入选本研究：接受AI治疗时长超过3周且不足2年，自开始AI治疗后报告新发或加重的关节痛或肌痛，且数字疼痛评分量表（numerical rating scale）中最差疼痛评分至少为4/10。本研究计划招募50名受试者，按1:1比例随机分配至真穴位按压组与假穴位按压组，干预周期为12周。受试者每日需自行按压9个穴位，每个穴位持续按压3分钟。所有受试者需每周完成一次疼痛评估，每6周完成一套症状调查问卷。受试者可自愿提供粪便样本，采集时间为穴位按压干预第0周和第12周后，用于分析肠道微生物组的变化。本研究的主要终点为：经12周穴位按压干预后，受试者在简明疼痛量表简表（Brief Pain Inventory-Short Form）中记录的最差疼痛评分变化，采用广义估计方程（generalized estimating equations）进行统计评估。

【结论】若本项随机对照2期先导临床试验证实自行穴位按压可减轻AIMSS，后续将开展更大规模的随机对照3期临床试验以验证自行穴位按压的疗效。缓解AI相关关节痛或可改善乳腺癌患者的治疗依从性、乳腺癌预后以及接受AI治疗患者的生活质量。

【试验注册】Clinicaltrials.gov NCT06228768。