| Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial. | |
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MedLine Citation:
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PMID: 20733439 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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David C Foster; Merrill Beth Kotok; Li-Shan Huang; Arthur Watts; David Oakes; Fred M Howard; Ellen L Poleshuck; Chris J Stodgell; Robert H Dworkin |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: Obstetrics and gynecology Volume: 116 ISSN: 1873-233X ISO Abbreviation: Obstet Gynecol Publication Date: 2010 Sep |
Date Detail:
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Created Date: 2010-08-24 Completed Date: 2010-09-28 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0401101 Medline TA: Obstet Gynecol Country: United States |
Other Details:
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Languages: eng Pagination: 583-93 Citation Subset: AIM; IM |
Affiliation:
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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 |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00276068 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Intravaginal Administration, Oral Adult Anesthetics, Local / administration & dosage* Antidepressive Agents, Tricyclic / administration & dosage* Desipramine / administration & dosage* Double-Blind Method Female Humans Lidocaine / administration & dosage* Treatment Outcome Vulvodynia / drug therapy* Young Adult |
| Grant Support | |
ID/Acronym/Agency:
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R0-1 HD040123-05/HD/NICHD NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Anesthetics, Local; 0/Antidepressive Agents, Tricyclic; 137-58-6/Lidocaine; 50-47-5/Desipramine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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