Milnacipran in provoked vestibulodynia: Efficacy and predictors of treatment success

Objective: This study aimed to collect preliminary evidence on the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD) and to identify which patient characteristics predict treatment success. Materials and Methods: A 12-week open-label trial was conducted in 22 women with PVD. The Pain Rating Index of the McGill Pain Questionnaire was the primary outcome measure. Other outcome measures included daily diaries, Beck Depression Inventory, State-Trait Anxiety Inventory, Female Sexual Function Index, Brief Pain Inventory, a personal or family history of fibromyalgia, and PVD subtype. Results: Milnacipran (50Y200 mg/d) significantly reduced pain severity on the Pain Rating Index (p = .001), coital pain (p = .001), tampon pain (p = .003), and mean vulvar pain (p e .001). Scores were also decreased on the Beck Depression Inventory (p = .015), State-Trait Anxiety Inventory (p = .046), and Brief Pain Inventory (p = .019) and increased on the Female Sexual Function Index (p = .004). Fibromyalgia history, PVD subtype, presence of depression or anxiety, and level of impairment did not affect treatment response. By logistic regression analysis, it was noted that the odds of treatment success was 3 times higher among women who, at pretreatment, had a sexually satisfying relationship compared to those who did not (odds ratio = 3.30, confidence interval = 1.04-10.50, p = .043). Conclusions: Milnacipran significantly reduced vestibular pain in women with PVD. Treatment success was predicted by pretreatment sexual satisfaction. A larger randomized controlled trial is necessary to confirm the efficacy of milnacipran in PVD and to identify other possible predictors of treatment outcome.