Effects of the traditional Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: a study protocol for a multicenter, randomized, controlled clinical trial

Trials

Xiao-Min Wang¹  Wei-Ru Xu¹  Qi Fu¹  Guo-Wang Yang¹  Ming-Wei Yu¹  Cong Ma¹  Yi Zhang¹  Nan Peng¹ 

[1] Oncology Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing 100010, China

关键词: Breast cancer;    Aromatase inhibitor-associated musculoskeletal symptoms;    Traditional Chinese medicine;   

Others  :  806173
DOI  :  10.1186/1745-6215-15-171

 received in 2014-03-06, accepted in 2014-04-29,  发布年份 2014

【 摘 要 】

Background

Aromatase inhibitors (AIs) are widely used as an adjuvant endocrine treatment in postmenopausal women with early-stage breast cancer. One of the main adverse effects of AIs is musculoskeletal symptoms, which leads to a lower quality of life and poor adherence to AI treatment. To date, no effective management of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) has been developed.

Methods/design

To determine whether the traditional Chinese medicine Yi Shen Jian Gu granules could effectively manage AIMSS we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients experiencing musculoskeletal symptoms after taking AIs will be enrolled and treated with traditional Chinese medicine or placebo for 12 weeks. The primary outcome measures include Brief Pain Inventory-Short Form, Western Ontario and McMaster Universities Osteoarthritis Index, and Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, which will be obtained at baseline and at 4, 8, 12 and 24 weeks.

Discussion

The results of this study will provide a new strategy to help relieve AIMSS.

Trial registration

ISCTN: ISRCTN06129599 (assigned 14 August 2013).

【 授权许可】

   
2014 Peng et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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