Long-term effects of a placebo-controlled trial of enoxaparin for treatment of severe provoked vulvodynia

Objective: Provoked vulvodynia (PV) is the main cause of dyspareunia, affecting millions of women worldwide. Its cause is yet unknown, and treatment is empirical in most cases. Our purpose was to assess the long-term beneficial effects of enoxaparin on PV. Materials and Methods: Women who previously participated in a three-month trial comparing enoxaparin to placebo for the treatment of severe PV were evaluated regarding their current pain levels using Numeric Rating Scale with various activities, whether they sought additional treatment for their condition and their satisfaction with their treatment. For pain levels, we compared time-time points within groups using a paired-sample t-test or Wilcoxon signed rank test, and we compared groups at any given time point using an independentsamples t-test or a Wilcoxon rank-sum test. Results: Thirty-one of the 39 original participants completed the follow-up survey, 17 had been treated with enoxaparin, and 14 had received saline. Compared to their pain at the end of the prior trial, at the time of the present study, those treated with enoxaparin experienced greater decreases in pain during intercourse (34% decrease, p=0.012) than those who received placebo (22.5% decrease, p=0.064), this was also true for other activities. Conclusion: Enoxaparin exhibited continuing benefits three years after daily treatment for 90 days for severe PV and may have an implication for women suffering from PV.