Effects of the Efficacy of the Yi Shen Tiao Gan Formula on Aromatase Inhibitor Associated Musculoskeletal Syndrome: A randomized controlled trial

Yan Zhang^1*Meiling Chu²Meina Ye¹Yiqin Cheng¹Hui Cong¹Yulian Yin¹Hongfeng Chen¹

• ¹Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China
• ²Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, China

Background: Aromatase inhibitor-induced musculoskeletal syndrome (AIMSS) has emerged as a major cause of treatment discontinuation in hormone receptor-positive patients treated with aromatase inhibitors. There are currently no standardized guidelines or universally accepted treatments for AIMSS. Therefore, this exploratory study aimed to preliminarily evaluate the efficacy and safety of Yi Shen Tiao Gan formula in AIMSS patients. Methods: A total of 136 patients with AIMSS were included in this single-center, randomized, controlled, single-blind trial and were randomised into the treatment and control groups at a ratio of 1:1. All patients were routinely given Caltrate D. Patients in the treatment group took Breast surgery formula combined with Yi Shen Tiao Gan formula and control group took Breast surgery formula twice a day. The treatment period of Chinese medicine was three months as one course of treatment. The clinical efficacy of two courses of treatment was observed in this study. The study observed and compared the following indicators between the two groups: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, Traditional Chinese Medicine symptom and sign scores, bone mineral density, bone metabolism biochemical indicators, bone metabolism-related hormones and safety assessments. Results: In total, 108 participants were included in the analysis. Before and after treatment, the total WOMAC score of both groups of patients significantly decreased (p < 0.05), with the pain subscale score of the treatment group being significantly lower than that of the control group (p < 0.05). The TCM symptom and sign score significantly decreased in both groups (p < 0.05), with a more pronounced reduction in the treatment group (p < 0.05). Conclusion: The YSTG formula significantly reduced WOMAC scores, improving pain, stiffness, physical function in patients with AIMSS, and alleviating the traditional Chinese medicine symptoms and signs of liver and kidney deficiency, thereby enhancing the overall quality of life for patients. Clinical Trial Registration: The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) and the registration number was ChiCTR2200057785.