Objective: This study aimed to evaluate the effectiveness of topical amitriptyline 2% in sorbolene (cetomacrogol aqueous) cream in the management of patients with entry dyspareunia caused by provoked vestibulodynia.
Materials and methods: A prospective study of 150 patients presenting with entry dyspareunia to a private gynecologist (R.P.) was undertaken during a 12-month period. Provoked vestibulodynia was diagnosed by the presence of pinpoint tenderness confined to the vulvar vestibule. Most patients (102) had purely provoked vestibulodynia, whereas 48 had both provoked and unprovoked pain. There were 7 patients with grade 1 dyspareunia (intercourse always painful but only occasionally preventing penetration), 83 patients with grade 2 (intercourse always painful preventing penetration on most occasions), and 60 patients with grade 3 (apareunic). Questionnaires were evaluated before and 3 months after commencement of treatment. No control group using placebo was studied because of the private-practice setting.
Results: Duration of symptoms varied from 1 to 30 years, the mean being 4.7 years. There was no response in 66 patients (44%). Of these, 16 patients ceased treatment early because of local skin irritation and hence were regarded as treatment failures. The 84 patients (56%) that responded were divided into 3 groups as follows: (i) 25 with a slight but noticeable improvement; (ii) 44 with a moderate degree of improvement; and (iii) 15 with an excellent response, describing intercourse as comfortable and pain free (10% of the total study group). Most patients in all 3 groups elected to continue application of the cream after completion of the study. The response rate was similar (48%) in the subgroup that also had unprovoked vestibulodynia. There was no difference in the response rate according to parity. The response rate was also similar in patients who had previously taken oral amitriptyline unsuccessfully. In these 44 patients, the overall response rate was 59%.
Conclusions: Topical amitriptyline cream should be considered for first-line treatment in the management of patients with provoked vestibulodynia causing entry dyspareunia. The response rate is reasonable (56%), and it eliminates the problems with systemic administration, namely, drowsiness and the difficulty patients have in accepting antidepressant medication for their condition.