Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled
trial.
Author(s): Foster DC, Kotok MB, Huang LS, Watts A, Oakes D, Howard FM, Poleshuck EL,
Stodgell CJ, Dworkin RH.
Affiliation(s): 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
Publication date & source: 2010, Obstet Gynecol. , 116(3):583-93
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.
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