Candace S Brown1, Jim Wan, Gloria Bachmann, Ray Rosen. 1. Departments of Pharmacy, Obstetrics and Gynecology, and Psychiatry, University of Tennessee Health Science Center, Memphis, Tennessee, USA. csbrown@utmem.edu
Abstract
OBJECTIVE: To conduct a prospective study to determine the efficacy of self-management interventions, amitriptyline, and amitriptyline plus topical triamcinolone in reducing vulvar pain in women with vulvodynia. METHODS: This was a randomized, prospective study of 53 women between the ages of 18 and 72 with vulvodynia. Participants undertook one of three treatment interventions for a period of 12 weeks: self-management, oral amitriptyline (10-20 mg/day), or topical triamcinolone plus oral amitriptyline (10-20 mg/day). The McGill Pain Questionnaire (MPQ) was used to measure changes in qualitative pain using the pain rating index (PRI) and in quantitative pain using the present pain intensity (PPI) scale. RESULTS: Of the 53 randomized subjects, 43 completed the trial. There were no statistically significant differences in PRI or PPI scores among the three treatment groups. Significant within-group differences were observed in the self-management group on the PRI and in the amitriptyline group on the PPI. CONCLUSIONS: This first randomized, prospective trial suggests that self-management has a modest effect and that low-dose amitriptyline (with and without topical triamcinolone) is not effective in reducing pain in women with vulvodynia.
RCT Entities:
OBJECTIVE: To conduct a prospective study to determine the efficacy of self-management interventions, amitriptyline, and amitriptyline plus topical triamcinolone in reducing vulvar pain in women with vulvodynia. METHODS: This was a randomized, prospective study of 53 women between the ages of 18 and 72 with vulvodynia. Participants undertook one of three treatment interventions for a period of 12 weeks: self-management, oral amitriptyline (10-20 mg/day), or topical triamcinolone plus oral amitriptyline (10-20 mg/day). The McGill Pain Questionnaire (MPQ) was used to measure changes in qualitative pain using the pain rating index (PRI) and in quantitative pain using the present pain intensity (PPI) scale. RESULTS: Of the 53 randomized subjects, 43 completed the trial. There were no statistically significant differences in PRI or PPI scores among the three treatment groups. Significant within-group differences were observed in the self-management group on the PRI and in the amitriptyline group on the PPI. CONCLUSIONS: This first randomized, prospective trial suggests that self-management has a modest effect and that low-dose amitriptyline (with and without topical triamcinolone) is not effective in reducing pain in women with vulvodynia.
Authors: W C Weijmar Schultz; W L Gianotten; W I van der Meijden; H B van de Wiel; L Blindeman; S Chadha; A C Drogendijk Journal: J Psychosom Obstet Gynaecol Date: 1996-09 Impact factor: 2.949
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Authors: Ruby H N Nguyen; Rachael M Turner; Sarah A Rydell; Richard F Maclehose; Bernard L Harlow Journal: Pain Med Date: 2013-06-06 Impact factor: 3.750
Authors: Candace S Brown; David C Foster; Jim Y Wan; Leslie A Rawlinson; Gloria A Bachmann Journal: Contemp Clin Trials Date: 2013-06-29 Impact factor: 2.226