Multimodal self-management has a “modest effect” in reducing vulvodynia, but low-dose amitriptyline, with or without topical triamcinolone, has no significant benefit, according to the first prospective, randomized trial to compare these treatment approaches. The non-blinded pilot study is reported in the February issue of the Journal of Women’s Health.
The self-management approach included components of education and cognitive-behavioral, physical and sex therapy. Over a 12-week period, women in this study arm attended weekly 2-hour sessions variously led by a nurse practitioner, a psychologist/sex therapist and a physical therapist who regularly treats vulvodynia patients.
Conducted at a single center, the study recruited participants who reported vulval pain, itching, burning or tenderness of at least 6 months’ duration. To mimic the range of symptoms reported to physicians, the pain could be localized or generalized and with or without provocation. Exclusion criteria included active vulvovaginal infection.
The average participant was about 47 years old, Caucasian and married, with above-average education and income. Participants were randomized 2:1:1 to the self-management group, an oral amitriptyline group (10-20 mg/day) or a group receiving both oral amitriptyline and topical triamcinolone (approximately 5 mg/day of 0.1% triamcinolone acetonide). Overall, 43 participants completed the study.
In their intent-to-treat analysis, the researchers found no differences among the three groups in scores on the McGill Pain Questionnaire’s Pain Rating Index or Present Pain Index.
When they compared baseline and post-treatment scores within groups, the researchers found significant decreases in the Pain Rating Index total score and the sensory subscore in the self-management group.
The amitriptyline group showed a decrease from baseline on the questionnaire’s quantitative Present Pain Index, and a trend was observed in the self-management group.
The report noted that the study’s statistical power was somewhat compromised. Lead author Dr. Candace S. Brown of the University of Tennessee Health Science Center, Memphis, explained to Reuters Health that higher-than-expected attrition (from refusal to participate) among the 76 patients originally randomized for the study was a factor, as was the 2:1:1 randomization scheme.
The authors suggest that the efficacy of the self-management approach might derive from its multimodal strategy, which combined behavioral and physical techniques to address both the emotional and physiological aspects of pain.
sourse: http://www.medscape.com/viewarticle/590281
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