Oral vitamin B12 to improve aromatase inhibitors (AI)-associated musculoskeletal symptoms (AIMSS).

Abstract

e21679 Background: Breast cancer patients undergoing Aromatase Inhibitor (AI) therapy often experience many side effects, which include musculoskeletal and joint pain. Vitamin B12 has often been used as a naturopathic supplement to relieve joint pain that is caused by arthritis. The purpose of this study was to evaluate the effect of Vitamin B12 supplements on musculoskeletal pain and arthralgias induced by aromatase inhibitors (AI) therapy. Methods: After approval by Institutional Review Board (IRB), we enrolled consecutive patients treated at the Texas Tech Breast Care Center who had a diagnosis of invasive breast cancer, Stages I-III, and were taking an AI and experiencing significant musculoskeletal symptoms assessed by the Brief Pain Inventory-Short Form (BPI-SF) questionnaire. Participants received 2500 mcg of sublingual vitamin B12 daily for 90 days. Assessments included improvement in BPI-SF pain scores at 3 months, the impact on quality of life determined by the Functional Assessment of Cancer Therapy–Endocrine Symptoms, FACT-ES and correlative serum markers. Results: A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study. Analysis of the data collected indicate a 34% average pain improvement (P-value = 0.0001) as reported by patients at baseline and at the end of treatment in the BPI-SF questionnaire. Additionally, a 23 % worst pain improvement (P-value = 0.0003) was obtained for worst pain scores evaluated similarly, at baseline and at the end of treatment. Analysis of the results for the FACT-ES scoring showed improvement on all scales. No significant adverse events were observed. Additionally, decrease in pain score was correlated with increased serum B12 levels. A paired t-test was used to assess the mean difference between baseline and endpoint. Conclusions: This study suggests that vitamin B12 reduces pain and improves quality of life for patients taking AIs who experienced AI-related musculoskeletal symptoms. If confirmed in large randomized prospective trials, Vitamin B12 would be a safe and cost effective option for the treatment of AI -related musculoskeletal symptoms.