TO EVALUATE THE EFFICACY AND SAFETY OF VITAMIN D3 AS AN ADD ON THERAPY TO DICLOFENAC FOR TREATMENT OF MASTALGIA: A RANDOMISED CONTROLLED TRIAL

Background:Mastalgia is a medical term used for breast pain. Approximately 66% to 80% of women experience some type of breast pain at least sometime in their lives, and in 10 to 20% of the cases, it is severe. Objective:This study aimed to evaluate the efficacy of vitamin D3 as an add on therapy to diclofenac for decreasing the breast pain of mastalgia patients attending the surgery OPD of a rural tertiary care hospital in Haryana. Material and Methods: A total of 123 treatment naive female patients of age group 15-45 years who presented with mastalgia 5 days in the prior month and with pain intensity 3 on VAS scale were enrolled in the study based on inclusion and exclusion criteria. Patients were divided into three groups- group A, B and C based on serum vitamin D levels.VitaminD insufficient patients were randomly divided into Group A and Group B. Vitamin D sufficient patients were put in Group C. All the patients were given Tab. Diclofenac 100 mg SR SOS for 12 weeks.Patients in group A were additionally supplemented with Vitamin D360,000 IU once a week for 8 weeks. Patients were evaluated for breast pain at baseline and at 3, 6, 9 and 12 weeks by breast pain questionnaire (BPQ). Serum vitamin D levels were done at baseline and 12 weeks. Results: Maximum reduction in the severity of pain was observed in group A.Highly significantcorrelation was found between vitamin D insufficiency and severity of mastalgia. Conclusion: Vitamin D as an add on therapy to diclofenac has a significant role in improvement of mastalgia.