Topical analgesia for dyspareunia effective in breast cancer survivors

1. In a randomized controlled trial of 46 breast-cancer survivors with dyspareunia, use of topical lidocaine in the vulvar vestibule immediately prior to intercourse demonstrated significantly improved sexual function compared to placebo.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Dyspareunia is common among post-menopausal women, and it is particularly problematic for survivors of breast cancer whose treatment involves a chronically estrogen-deficient state. This complication has a significant impact on quality of life. This study was a randomized, double-blind, placebo-controlled trial to compare the use of topical analgesia versus placebo in the treatment of dyspareunia in breast cancer survivors.

The study randomized 46 breast cancer survivors who reported chronic dyspareunia to topical 4% lidocaine versus normal saline during intercourse. This was followed by an open-label trial where all patients received lidocaine therapy. At the conclusion of this trial, users of lidocaine reported significantly reduced intercourse pain and sexual distress scores as well as significantly improved sexual function scores compared to placebo. Furthermore, during the open-label trial, 90% of all patients reported comfortable sexual function with topical lidocaine. There were no significant side effects associated with use of topical lidocaine and no male partners reported penile numbness. The results of this study support the use of symptomatic management in topical lidocaine in the management of dyspareunia in breast cancer survivors. The study was limited by a small cohort size. Furthermore, the study used subjective pain scores as the primary outcome, which limits the overall generalizability of the results. However, this study provides an interesting proof-of-concept for this topical analgesia therapy in this growing patient population.

Click to read the study in the JCO (Journal of Clinical Oncology)

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In-Depth [randomized controlled trial]: This study was a randomized, double-blinded, placebo-controlled trial comparing 4% aqueous lidocaine versus placebo in breast cancer survivors who experience chronic dyspareunia. Eligible patients were postmenopausal women with a history of >1 year of history breast cancer and moderate to severe dyspareunia for at least 6 months. Patients were excluded if they had a history of pelvic pain, pelvic floor myalgia, or vulvar dermatoses. A total of 46 women were enrolled and randomly assigned to 1 month of self-administered 4% lidocaine or placebo applied directly to the vulvar vestibule, immediately prior to intercourse. The primary outcomes were subjective patient assessment of intercourse pain scale (0 to 10). Secondary outcomes included sexual distress using the Female Sexual Distress Scale, and sexual function assessed by the Sexual Function Questionnaire. Following the randomized trial, all women then received open-label lidocaine for 2 months. At 6 months follow-up, patients in the lidocaine group had significantly decreased intercourse pain scores compared to control (1.0 vs. 5.3; p = 0.007). In assessments of sexual function, women in the lidocaine group had significant improvements in most domains compared to those in the placebo arm. After 2 months of lidocaine use during the open-label trial, 90% of all patients in the trial reported comfortable penetration.

Image: PD

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