Vulvar vestibular effects of ospemifene: a pilot study

Abstract

The study aimed to assess the effects of ospemifene on vulvar vestibule in postmenopausal women with vulvar pain and dyspareunia. Fifty-five postmenopausal women used oral ospemifene 60 mg/d for 60 d. Symptoms of dryness, burning, and dyspareunia were evaluated on a 10 cm visual analog scale. Visual examination of the vulvar vestibule was also conducted. Patients also underwent current perception threshold (CPT) testing obtained from the vulvar vestibule. Fifty-five patients (94.6%) completed the treatment. Hot flashes were the most frequent adverse effects, but this led to a discontinuation of therapy in three patients (5.4%). After therapy, there was a statistically significant decrease from the baseline in the mean scores for dryness, burning, and dyspareunia and reduction of vestibular trophic score (baseline value of 11.2–4.2 after the therapy, p ≤ 002) and cotton swab test scores (2.81 compared with 1.25, p = .001). There was a difference in CPT values for all nerve fibers and more consistent for C fibers (−38% of sensitivity). These results confirm the efficacy of ospemifene on postmenopausal vestibular symptoms and signs; moreover, the drug was effective in normalizing vestibular innervation sensitivity.

Chinese abstract

本研究旨在探讨奥培米芬对外阴疼痛及性交困难的绝经女性外阴前庭的作用。55例绝经女性连续口服奥培米芬60日, 60 mg/日。应用10cm视觉模拟量表评估干燥、灼热和性交痛的症状。并且对外阴前庭进行专科检查。同时也对患者进行了外阴前庭当前感知阈值（CPT）检测。55例患者（94.6%）完成治疗。潮热是最常见的不良反应, 导致3例患者终止治疗（5.4%）。治疗后, 干燥、灼热和性交痛的平均得分较基线水平显著降低, 前庭营养得分（基线值11.2 —4.2治疗后, P ≤ 002）和棉签检查得分（2.81比1.25, p=.001）都有所下降。所有神经纤维的CPT值存在差异, C类神经纤维的CPT更具有一致性（敏感性38%）。这些结果证实了奥培米芬对绝经女性外阴前庭的症状和体征的疗效；此外, 该药物对前庭神经敏感性正常化有效。

Keywords:

• Dyspareunia
• ospemifene
• postmenopausal
• vulvodynia
• vulvar vestibule

Disclosure statement

The authors reported no conflicts of interest relevant to the study.