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The Breast Journal
Article . 2019 . Peer-reviewed
License: Wiley Online Library User Agreement
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Oral versus topical tamoxifen in cyclical mastalgia—A randomized controlled trial

Authors: Divya Dhananjay Singh; Kadambari Dharanipragada; Shanmugam D; S. Manikandan;

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 3 months, and in Group 2, the participants received Oral Tab Tamoxifen 10 mg OD and a placebo gel for 3 months. 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 3 months of treatment and once more at the end of 6 months for recurrence. After completion of 1 month 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 1 month, 3 months (P < .001), and 6 months (P < .001). There is a significant difference in the Nodularity found between oral and topical groups at presentation (P = .004), at 1 month (P = .003) and at 6 months (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.

Keywords

Tamoxifen, Humans, Breast Neoplasms, Female, Neoplasm Recurrence, Local, Mastodynia, Pain Measurement

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
9
Top 10%
Average
Average
gold