Jacqueline E. Lewis

Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life

OBJECTIVE To use the Menopause-Specific Quality of Life Questionnaire (MENQOL) to assess the impact of menopausal symptoms on health-related quality of life in a large US population-based study. METHODS Participants were recruited from the US population through random-digit-dialing and probability sampling. Analyses included 2703 postmenopausal women 40-65 years old in our Menopause Epidemiology Study. Respondents answered a 30-min questionnaire, including the MENQOL. RESULTS Scores for each domain were: vasomotor: 3.2+/-2.2; psycho-social: 3.3+/-1.8; physical: 3.5+/-1.5; sexual: 2.9+/-2.1. There were significant differences in the MENQOL scores by age, smoking, exercise, education, employment status and BMI. Women aged 60-65 years (p<0.0001), with a bachelors degree or higher level of education (p<0.0001), who exercised at least 3 days a week (p<0.0001), who had never smoked (p<0.0001), with a body mass index < or =25kg/m(2) (p<0.0001), and who had significantly lower scores indicating better quality of life. Hot flashes affected work (46.0%), social activities (44.4%), leisure activities (47.6%), sleep (82.0%), mood (68.6%), concentration (69.0%), sexual activity (40.9%), total energy level (63.3%) and overall quality of life (69.3%). CONCLUSION Symptoms experienced during menopause and socio-demographic characteristics affect the quality of life in postmenopausal women. Hot flashes impact the daily activities of most postmenopausal women, especially those with more frequent/severe symptoms. Treatments that safely and effectively treat these symptoms could improve quality of life among postmenopausal women.

Gabapentin for the treatment of menopausal hot flashes: a randomized controlled trial.

Objective: To compare the effectiveness and tolerability of gabapentin with placebo for the treatment of hot flashes in women who enter menopause naturally. Design: A randomized, double-blind, placebo-controlled trial was conducted across the greater Toronto area between March 2004 and April 2006 in the community and primary care settings. Eligible participants were 200 women in natural menopause, aged 45 to 65 years, having at least 14 hot flashes per week. Study participants were randomized to receive gabapentin 300 mg oral capsules or placebo three times daily for 4 weeks. The primary outcome measure was the mean percentage change from baseline to week 4 in daily hot flash score, determined from participant diaries. Secondary outcome measures included changes in weekly mean hot flash scores and frequencies, quality of life, and adverse events. Results: Of the 197 participants, 193 (98%) completed the study. Analysis was by intention to treat. Hot flash scores decreased by 51% (95% CI: 43%-58%) in the gabapentin group, compared with 26% (95% CI: 18%-35%) on placebo, from baseline to week 4. This twofold improvement was statistically significant (P < 0.001). The Menopause-Specific Quality-of-Life vasomotor score decreased by 1.7 (95% CI: 1.3-2.1; P < 0.001) in the gabapentin group. These women reported greater dizziness (18%), unsteadiness (14%), and drowsiness (12%) at week 1 compared with those taking placebo; however, these symptoms improved by week 2 and returned to baseline levels by week 4. Conclusions: Gabapentin at 900 mg/day is an effective and well-tolerated treatment for hot flashes.

A randomized controlled trial of the effect of dietary soy and flaxseed muffins on quality of life and hot flashes during menopause.

Objective: To compare the effects of daily ingestion of soy flour (S), ground flaxseed (F), or wheat flour (W) muffins, on quality of life and hot flash frequency and severity in postmenopausal women. Design: This was a double-blind, randomized, controlled, intention-to-treat trial. Ninety-nine women, 1 to 8 years after menopause, ingested muffins with 25 g of flaxseed (50 mg of lignans), 25 g of soy (42 mg of isoflavones), or wheat (control) daily for 16 weeks. Subjects completed the Menopause-specific Quality of Life instrument monthly along with daily hot flash frequency and severity diaries. Compliance measures included a 3-day food diary and urinary isoflavone and lignan analyses at weeks 0 and 16 and returned muffin counts monthly. Results: Eighty-seven women (28, ground flaxseed muffins; 31, soy flour muffins; and 28, wheat flour muffins) completed the trial. Multivariate analysis of variance of all quality-of-life domains yielded an insignificant treatment × time interaction (F46,122 = 0.92, P = 0.62) but a significant time main effect (P <.0001). Repeated-measures analyses of covariance controlling for body mass index showed no significant group × time interaction nor time nor group differences on all quality-of-life domains and hot flash measures except severity. Hot flashes were less severe with flaxseed (P = 0.001) compared to placebo; however, the group × by time interaction was not significant. Phytoestrogen excretion analysis showed treatment group exposure as allocated and no contamination. Conclusion: Neither dietary flaxseed nor soy flour significantly affected menopause-specific quality of life or hot flash symptoms in this study.

Minimal decrease in hot flashes desired by postmenopausal women in family practice.

Objective: To determine the minimal important difference in the frequency and severity of hot flashes that postmenopausal women desire from a nonhormonal agent. Design: Women recorded their number of hot flashes daily, along with their degree of severity, using a diary for 1 week and completed the Menopause-Specific Quality of Life Questionnaire. Women were asked to report the percentage reduction in hot flashes that they would find clinically important. Distribution-based estimates were used to estimate the minimal important difference. Results: Approximately 69% of the postmenopausal women who reported their hot flashes as moderate to severe responded that they wanted a nonhormonal agent that provided at least a 50% mean reduction in the frequency of hot flashes (95% CI, 32% to 66%). Median hot flash reduction for all respondents was 50%. Conclusions: The minimal clinically important difference in hot flashes is approximately 50%. This estimate can provide the basis to calculate sample size in clinical trials of anti-hot flash agents and in selecting possible candidates for investigation.

The validity of the Menopause Specific Quality of Life Questionnaire in older women

OBJECTIVES To examine the validity of the Menopause Specific Quality of Life Questionnaire (MENQOL) domains when used with elderly women. We also determined whether MENQOL domain scores were related to depression and cognitive complaints. METHODS 148 post-menopausal women (60-88 years old), not on hormone replacement therapy, were screened for a randomized control trial examining the effectiveness of hormone replacement therapy in the delay of cognitive impairment. Validation of the psychosocial, physical and sexual domains of MENQOL involved linear regression analysis with the mental component and the physical component of the SF-36, and with marital status, respectively. We used logistic regression analysis to examine the relationship between the above MENQOL domain scores and depression, and linear regression analysis to examine the relationship between these MENQOL domain scores and cognitive complaints. All regression analyses were adjusted for age, education, and whether or not a woman had surgical menopause. RESULTS We found 44% of the variation in the MENQOLs physical and psychosocial domain scores could be explained by their respective validation measures, and that 18% of the variation in the sexual domain scores could be explained by marital status. Poor quality of life (QoL) on the physical and psychosocial domains was significantly associated with depressed affect and more cognitive complaints. CONCLUSIONS The results support the validity of the MENQOL physical, psychosocial and sexual domains as QoL measures in elderly women. QoL impairment on the physical and psychosocial MENQOL domains are also related to depression and cognitive complaints.

Use of the Menopause-Specific Quality of Life (MENQOL) questionnaire in research and clinical practice: a comprehensive scoping review.

Objective:The Menopause-Specific Quality of Life (MENQOL) questionnaire was developed as a validated research tool to measure condition-specific QOL in early postmenopausal women. We conducted a comprehensive scoping review to explore the extent of MENQOLs use in research and clinical practice to assess its value in providing effective, adequate, and comparable participant assessment information. Methods:Thirteen biomedical and clinical databases were systematically searched with “menqol” as a search term to find articles using MENQOL or its validated derivative MENQOL-Intervention as investigative or clinical tools from 1996 to November 2014 inclusive. Review articles, conference abstracts, proceedings, dissertations, and incomplete trials were excluded. Additional articles were collected from references within key articles. Three independent reviewers extracted data reflecting study design, intervention, sample characteristics, MENQOL questionnaire version, modifications and language, recall period, and analysis detail. Data analyses included categorization and descriptive statistics. Results:The review included 220 eligible papers of various study designs, covering 39 countries worldwide and using MENQOL translated into more than 25 languages. A variety of modifications to the original questionnaire were identified, including omission or addition of items and alterations to the validated methodological analysis. No papers were found that described MENQOLs use in clinical practice. Conclusions:Our study found an extensive and steadily increasing use of MENQOL in clinical and epidemiological research over 18 years postpublication. Our results stress the importance of proper reporting and validation of translations and variations to ensure outcome comparison and transparency of MENQOLs use. The value of MENQOL in clinical practice remains unknown.

Research and Clinical Application of the Menopause-specific Quality of Life (MENQOL) Questionnaire: a comprehensive systematic review

Conclusions Results and Data Analysis RESEARCH AND CLINICAL APPLICATION OF THE MENOPAUSE-SPECIFIC QUALITY OF LIFE (MENQOL) QUESTIONNAIRE: A COMPREHENSIVE SYSTEMATIC REVIEW Beate C Sydora, PhD; Hilary Fast, MA; Sandy Campbell, MLS; Nese Yuksel, PharmD; Kathleen Hegadoren, PhD; Tami Shandro, MD; Nan Schuurmans, MD; Jacqueline Lewis, MD; Sue J Ross, PhD. Mature Women’s Health Clinic, Royal Alexandra Hospital, and Department of Obstetrics and Gynecology, University of Alberta, Edmonton