Acupoint Thread Embedding Combined With Wenshen Bugu Decoction for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptom Among Postmenopausal Breast Cancer Patients: Study Protocol of a Randomized Controlled Trial

Xuan Zou MD; Zi-Yi Chen MM; Yu-Han Yang MM; Yu Qiao MD; Shu-Jin He MM; Qiong Li MD; Wei-Li Chen PhD, MD; Xin-Yue Zhang MM; Si-Yu Li MM; Shan-Yan Sha MM; Min-Hao Hu MM; Xi-Yin Zhang MM; Ming-Ju Yang MM; Rui-Ping Wang PhD; Huan-Gan Wu PhD, MD; Yin Shi PhD, MD; Xiao-Hong Xue PhD, MD; Ya-Jie Ji PhD, MD

doi:10.1177/15347354231188679

Integrative Cancer Therapies (Aug 2023)

Acupoint Thread Embedding Combined With Wenshen Bugu Decoction for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptom Among Postmenopausal Breast Cancer Patients: Study Protocol of a Randomized Controlled Trial

Xuan Zou MD,
Zi-Yi Chen MM,
Yu-Han Yang MM,
Yu Qiao MD,
Shu-Jin He MM,
Qiong Li MD,
Wei-Li Chen PhD, MD,
Xin-Yue Zhang MM,
Si-Yu Li MM,
Shan-Yan Sha MM,
Min-Hao Hu MM,
Xi-Yin Zhang MM,
Ming-Ju Yang MM,
Rui-Ping Wang PhD,
Huan-Gan Wu PhD, MD,
Yin Shi PhD, MD,
Xiao-Hong Xue PhD, MD,
Ya-Jie Ji PhD, MD

Affiliations

Xuan Zou MD: Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China
Zi-Yi Chen MM: Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China
Yu-Han Yang MM: Shanghai University of Traditional Chinese Medicine, Shanghai, China
Yu Qiao MD: Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China
Shu-Jin He MM: Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China
Qiong Li MD: Shanghai University of Traditional Chinese Medicine, Shanghai, China
Wei-Li Chen PhD, MD: Shanghai University of Traditional Chinese Medicine, Shanghai, China
Xin-Yue Zhang MM: Shanghai University of Traditional Chinese Medicine, Shanghai, China
Si-Yu Li MM: Shanghai University of Traditional Chinese Medicine, Shanghai, China
Shan-Yan Sha MM: Shanghai University of Traditional Chinese Medicine, Shanghai, China
Min-Hao Hu MM: Shanghai University of Traditional Chinese Medicine, Shanghai, China
Xi-Yin Zhang MM: Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China
Ming-Ju Yang MM: Shanghai University of Traditional Chinese Medicine, Shanghai, China
Rui-Ping Wang PhD: Tongji University, Shanghai, China
Huan-Gan Wu PhD, MD: Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China
Yin Shi PhD, MD: Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China
Xiao-Hong Xue PhD, MD: Shanghai University of Traditional Chinese Medicine, Shanghai, China
Ya-Jie Ji PhD, MD: Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China

DOI: https://doi.org/10.1177/15347354231188679
Journal volume & issue: Vol. 22

Abstract

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Background: 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. Methods: 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. Discussion: 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.

Published in Integrative Cancer Therapies

ISSN: 1534-7354 (Print); 1552-695X (Online)
Publisher: SAGE Publishing
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://journals.sagepub.com/home/ict

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