Pilot Study Of Traditional Chinese Medicine Yi Shen Jian Gu Granules For Treatment Of Aromatase Inhibitor-Associated Musculoskeletal Symptoms

Background:Aromatase inhibitors(AIs),that are widely used in postmenopausal women with hormone receptor-positive breast cancer,replacing tamoxifen become the first-line treatment.The main advantages are improvement of disease-free survival,decreased rates of contralateral breast cancer and a more favorable toxicity profile,with lower rates of thromboembolic phenomena and endometrial malignancy.Aromatase inhibitor-associated musculoskeletal symptoms(AIMSS)is one of the most common side effects of the thirdgeneration AIs.Preliminary study has showed a high incidence of AIMSS(47%).AIMSS seriously weakens the quality of life of patients with breast cancer as the unbearable symptoms and the higher incidence.Moreover,patients discontinued therapy because of intolerable musculoskeletal symptoms.Although there are a number of randomized controlled trials,the standard treatments are uncertain.Clinical trails of traditional Chinese medicine to treat the disease are few.Most doctor of traditional Chinese medicine take AIMSS as one of endocrine therapy adverse reactions.Subject:To evaluate the clinical efficacy of traditional Chinese medicine Yi Shen Jian Gu Granules(YSJG)for treatment of aromatase inhibitor-associated musculoskeletal symptoms.Method:This trial is a single-arm study.30 participants who meet the inclusion criteria will receive a 12-week treatment(Calclium Carbonate and Vitamin D3+YSJG).The primary outcome measure is Brief Pain Inventory-Short Form(BPI-SF).The second outcome measures consist of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands(M-SACRAH),the Functional Assessment of Cancer Therapy Breast CancerSpecific(FACT-B),traditional Chinese medicine syndrome scale(TCM scale),bone mineral density(BMD).The primary and second outcome measures will be evaluated at baseline,4,8,12 weeks(except BMD).The examination of BMD and safety assessments will take place at baseline and 12 weeks.Result:Participants have a significant improvement in the BPI-SF worst pain score after a 12-week treatment than baseline(2.24,P=0.001),as well as the secondary outcome measures(P<0.05).However,no significant modulation was observed in BMD.Conclusion:Patients with AIMSS have an improvement in musculoskeletal symptoms,not only in arthralgia and stiffness,but also in the quality of life.