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


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:
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 of Chronic Rheumatoid Affections of the Hands, which will be obtained at baseline and at 4, 8, 12 and 24 weeks.DiscussionThe results of this study will provide a new strategy to help relieve AIMSS.Trial registration: ISCTN: ISRCTN06129599 (assigned 14 August 2013).

Author: Nan PengYi ZhangCong MaMing-Wei YuGuo-Wang YangQi FuWei-Ru XuXiao-Min Wang
Credits/Source: Trials 2014, 15:171

Published on: 2014-05-15

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