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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

Menopause:
doi: 10.1097/gme.0b013e318182f84b
Articles
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.

In Brief

Evaluation of change in self-assessed vulvo-vaginal atrophy symptoms has become an important component of measuring efficacy of treatment

Author Information

From the 1University of California, San Francisco, CA; and 2Duramed Research, Inc., Bala Cynwyd, PA.

Received March 27, 2008; revised and accepted June 11, 2008.

Funding/Support: This work was supported by Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, Inc.

Financial disclosure: None reported.

Address correspondence to: Kathleen Reape, MD, Duramed Research, Inc., One Belmont Avenue, Suite 1100, Bala Cynwyd, PA 19004. E-mail: kreape@barrlabs.com

©2008The North American Menopause Society