Skip Navigation LinksHome > September 2008 - Volume 15 - Issue 5 > Measuring symptom relief in studies of vaginal and vulvar at...
Menopause:
doi: 10.1097/gme.0b013e318182f84b
Articles

Measuring symptom relief in studies of vaginal and vulvar atrophy: the most bothersome symptom approach

Ettinger, Bruce MD1; Hait, Howard MS2; Reape, Kathleen Z. MD2; Shu, Haibin MS2

Collapse Box

Abstract

Objective: To assess the importance and usefulness of self-reported symptom data, especially the most bothersome symptom, in the evaluation of treatment for vulvovaginal atrophy.

Design: This was a double-blind, placebo-controlled multicenter study. Women rated symptoms associated with vaginal atrophy (vaginal dryness, vaginal/vulvar irritation/itching, vaginal/vulvar soreness, and dyspareunia) before and during treatment and selected one moderate to severe symptom as the most bothersome.

Results: Among 310 women (n = 156 placebo), vaginal dryness and dyspareunia were most commonly classified as moderate to severe and as most bothersome (44.4% and 30.2%, respectively). For both symptoms, the effect size favoring active treatment consistently increased as the cohort was more narrowly defined (all treated women, women who classified the symptom as moderate or severe, and those who classified the symptom as most bothersome). Compared with the standardized effect sizes for all women, those calculated from the most bothersome symptom were 49% and 62% greater for dyspareunia and dryness, respectively.

Conclusions: The most bothersome symptom approach represents a meaningful new standard for measurement of self-assessed vulvovaginal atrophy symptom change, but evaluation of change in individual symptoms remains an important, unbiased primary analysis of efficacy in vulvovaginal atrophy studies.

©2008The North American Menopause Society

Login

Article Tools

Share

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.