Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China.
Integr Cancer Ther. 2023 Jan-Dec;22:15347354231188679. doi: 10.1177/15347354231188679.
Aromatase inhibitors (AIs) are recommended as the preferred therapy for postmenopausal women with hormone receptor-positive (HR+) breast cancer. As a result, aromatase inhibitor-associated musculoskeletal symptom (AIMSS) have become a major problem leading to therapy discontinuation and decreased quality of life in patients receiving adjuvant AIs treatment. Multiple therapies have been attempted, but have yielded limited clinical results. This study will be performed to determine whether acupoint thread embedding (ATE) combined with Wenshen Bugu Decoction can effectively treat AIMSS, so as to improve the AIs medication compliance of postmenopausal breast cancer patients.
This study will utilize a randomized, 2 parallel groups controlled trial design. A total of 128 eligible postmenopausal breast cancer women with AIMSS will be randomized to receive a 12-week treatment with Wenshen Bugu Decoction alone (control group) or in combination with ATE (treatment group) in a 1:1 ratio. The primary outcome will be the 12 week Brief Pain Inventory Worst Pain (BPI-WP) score. The secondary outcome measures will include response rate, Brief Pain Inventory-Short Form (BFI-SF), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Functional Assessment of Cancer Therapy-Endocrine Symptom (FACT-ES), Functional Assessment of Cancer Therapy-Breast (FACT-B), bone marrow density (BMD), blood markers of bone metabolite, Morisky medication adherence scale-8 (MMAS-8), credibility and expectancy, and survival outcomes.
This trial may provide clinical evidence that ATE combined with Wenshen Bugu Decoction can be beneficial for treating AIMSS among postmenopausal breast cancer survivors. Our findings will be helpful to enhance the quality of life and reduce the occurrence of AIs withdrawal.
芳香化酶抑制剂（AIs）被推荐为激素受体阳性（HR+）乳腺癌绝经后妇女的首选治疗方法。因此，芳香化酶抑制剂相关的肌肉骨骼症状（AIMSS）已成为导致接受辅助 AI 治疗的患者停药和生活质量下降的主要问题。已经尝试了多种治疗方法，但临床效果有限。本研究旨在确定穴位埋线（ATE）联合温肾补骨汤是否能有效治疗 AIMSS，从而提高绝经后乳腺癌患者 AI 药物的依从性。
本研究将采用随机、2 平行组对照试验设计。共纳入 128 例符合条件的 AIMSS 绝经后乳腺癌女性患者，按 1:1 的比例随机分为温肾补骨汤组（对照组）或 ATE 联合温肾补骨汤组（治疗组），接受 12 周的治疗。主要结局是 12 周简明疼痛量表最差疼痛评分（BPI-WP）。次要结局指标包括缓解率、简明疼痛量表-短表（BFI-SF）、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）、癌症治疗功能评估-内分泌症状（FACT-ES）、癌症治疗功能评估-乳房（FACT-B）、骨密度（BMD）、骨代谢血液标志物、Morisky 用药依从性量表-8（MMAS-8）、可信度和期望以及生存结局。
本试验可能为 ATE 联合温肾补骨汤治疗绝经后乳腺癌幸存者 AIMSS 提供临床证据。我们的研究结果将有助于提高生活质量，减少 AI 停药的发生。
