• David C Foster, Merrill Beth Kotok, Li-Shan Huang, Arthur Watts, David Oakes, Fred M Howard, Ellen L Poleshuck, Chris J Stodgell, and Robert H Dworkin.
• Departments of Obstetrics and Gynecology, Biostatistics, Anesthesiology and Neurology, and Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York 14642, USA. david_foster@urmc.rochester.edu
• Obstet Gynecol. 2010 Sep 1; 116 (3): 583-93.

ObjectiveTo estimate the efficacy of common treatments for vulvodynia: topical lidocaine monotherapy, oral desipramine monotherapy, and lidocaine-desipramine combined therapy.MethodsA 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.ResultsAll 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.ConclusionOral 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 RegistrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00276068.Level Of EvidenceI.

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