Oral versus topical tamoxifen in cyclical mastalgia-A randomized controlled trial.

Abstract

Mastalgia affects premenopausal in which cyclical mastalgia affects up to 40% of women. In approximately 8% of these women, pain will be severe and interfere with their normal activities. oral tamoxifen widely used in the treatment of mastalgia is associated with a wide range of side effects. Topical tamoxifen has the potential to be a more efficacious and safer alternative with lower blood drug levels hence having lower systemic side effects. To compare reduction in the pain, nodularity and blood drug levels of tamoxifen using topical verus oral tamoxifen in cyclical mastalgia. Patients who presented to the surgery outpatient department with complaints of breast pain were provided with a breast pain evaluation questionnaire. Patients were randomized using a computer generated sequence into two groups with 75 participants in each group. In Group 1, the participants received topical tamoxifen gel and a placebo tablet for 3months, and in Group 2, the participants received Oral Tab Tamoxifen 10mg OD and a placebo gel for 3months. They were provided with a Cardiff Breast Pain assessment chart and asked to mark the severity of their pain and response to treatment in the following month and asked to report to the investigator. Patients were called for review every month, and the pain chart was monitored and documented. The response to therapy (relief of pain) was assessed after 3months of treatment and once more at the end of 6months for recurrence. After completion of 1month of treatment, blood sample was drawn to check for the blood drug levels. There is a significant difference of mean pain score between oral and topical tamoxifen groups (P<.001) at the end of 1month, 3months (P<.001), and 6months (P<.001). There is a significant difference in the Nodularity found between oral and topical groups at presentation (P=.004), at 1month (P=.003) and at 6months (P<.001). There is a significant difference of mean blood tamoxifen level (ng/mL) in oral and topical tamoxifen groups (P<.001). From this study, we conclude that topical tamoxifen is more effective than oral tamoxifen treatment in reducing cyclical breast pain and decreasing breast nodularity with lesser side effects and lower recurrence rates.