OBJECTIVE:
To estimate the efficacy of common treatments for vulvodynia: topical lidocaine monotherapy, oral desipramine monotherapy, and lidocaine-desipramine combined therapy.
METHODS:
A 12-week randomized, double-blinded, placebo-controlled trial was conducted on 133 vulvodynia-afflicted women assigned to four treatment arms: placebo tablets–placebo cream, desipramine tablets–placebo cream, placebo tablets–lidocaine cream, and desipramine tablets–lidocaine cream. The tampon test was selected as primary end point using a modified intention-to-treat analysis. Twelve secondary end points were also examined. At completion of the 12-week randomized phase, women were examined “open label” through 52 weeks postrandomization.
RESULTS:
All treatment arms reported substantial tampon-test pain reduction: 33% reduction placebo cream–placebo tablet, 20% reduction lidocaine cream–placebo tablet, 24% reduction placebo cream–desipramine tablet, and 36% reduction lidocaine cream–desipramine tablet. Compared with placebo, we found no significant difference in tampon-test pain reduction with desipramine (t=0.90; P=.37) or lidocaine (t=1.27; P=.21). Of the remaining 12 outcome measures, only the Index of Sexual Satisfaction, improved with desipramine compared with placebo (t=-2.81; P=.006). During the open-label phase, women undergoing vestibulectomy surgery reported significantly improved pain as measured by cotton swab test and the McGill Pain Scale compared with nonsurgical alternatives.
CONCLUSION:
Oral desipramine and topical lidocaine, as monotherapy or in combination, failed to reduce vulvodynia pain more than placebo. Placebo or placebo-independent effects are behind the substantial pain improvement seen in all treatment allocations.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00276068.
LEVEL OF EVIDENCE:
I
