Oral Desipramine and Topical Lidocaine for Vulvodynia: A Randomized Controlled Trial

• Published in: Obstetrics and gynecology (New York. 1953) Vol. 116; no. 3; pp. 583 - 593
• Main Authors: Foster, David C., Kotok, Merrill Beth, Huang, Li-Shan, Watts, Arthur, Oakes, David, Howard, Fred M., Poleshuck, Ellen L., Stodgell, Chris J., Dworkin, Robert H.
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved 01.09.2010; Lippincott Williams & Wilkins
• Subjects: Administration, Intravaginal; Administration, Oral; Adult; Anesthetics, Local - administration & dosage; Antiarythmic agents; Antidepressive Agents, Tricyclic - administration & dosage; Biological and medical sciences; Cardiovascular system; Desipramine - administration & dosage; Double-Blind Method; Female; Gynecology. Andrology. Obstetrics; Humans; Lidocaine - administration & dosage; Medical sciences; Neuropharmacology; Pharmacology. Drug treatments; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease); Psychology. Psychoanalysis. Psychiatry; Psychopharmacology; Treatment Outcome; Vulvodynia - drug therapy; Young Adult; Desipramine; Psychotropic; Gynecology; Oral administration; Anticonvulsant; Vulva; Catecholamine; Tricyclic compound; Reuptake inhibitor; Antiarrhythmic agent; Obstetrics; Local anesthetic; Local administration; Randomization; Pain; Neurotransmitter; Antidepressant agent; Clinical trial; Organic amide; Norepinephrine; Lidocaine; Vulvodynia
• ISSN: 0029-7844; 1873-233X
• DOI: 10.1097/AOG.0b013e3181e9e0ab

To estimate the efficacy of common treatments for vulvodynia: topical lidocaine monotherapy, oral desipramine monotherapy, and lidocaine-desipramine combined therapy. 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. 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. 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. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00276068. I.