Topical amitriptyline-baclofen cream for the treatment of provoked vestibulodynia

OBJECTIVE. To evaluate the effectiveness of amitriptyline 2%/baclofen 2% cream (ABC) in treating provoked vestibulodynia (PV). MATERIALS AND METHODS. In this retrospective evaluation of patients with PV who received ABC, women who had PV and met entry criteria were identified from a database of women with chronic vulvovaginal disorders. Treatment consisted of a cream containing 2% amitriptyline and 2% baclofen. Response was assessed using verbal report, visual analog scales of discomfort with daily and sexual activities, and 5-point numerical scales rating extent of interference with social activities, intercourse frequency, sexual desire, difficulty in lubrication, frequency and overall level of discomfort during sex, and satisfaction with overall sexual life. RESULTS. Data were available for 38 patients, with a median follow-up of 33 weeks. Overall, 29% patients reported no or little (<30%) improvement, 18% reported moderate (30-60%) improvement, and 53% reported much (>60%) improvement. On self-administered questionnaires, patients reported a decrease in the extent to which the condition interfered with social activities (p =.017), easier lubrication (p =.022), and lower level of pain with intercourse (p =.05). No change was noted in the reported frequency of sexual intercourse, sexual desire, or satisfaction with sexual life. No patients had systemic side effects. CONCLUSIONS. Our data are limited by the retrospective study design and the lack of a control group. Nevertheless, given a response rate of 71% in women with refractory symptoms and the overall tolerability of this treatment, we suggest that ABC therapy warrants further investigation as a therapy for PV.