Dataset Information

Factors associated with a clinically relevant reduction in menopausal symptoms of a standardized acupuncture approach for women with bothersome menopausal symptoms.

ABSTRACT:

Background

Little is known about factors associated with a clinically relevant reduction in menopausal symptoms through a brief acupuncture approach for women with moderate-to-severe menopausal symptoms.

Methods

Post hoc analysis of a randomized controlled trial where participants were allocated to early versus late standardized acupuncture. Both the early group and the late group are included in this study. The late group got an identical intervention parallel staged by 6?weeks. By means of the relative importance, the effect was evaluated for both early versus late women with a 6-week follow-up. We included four symptom subscales from the validated MenoScores Questionnaire: hot flushes, day and night sweats, general sweating, menopausal-specific sleeping problems, as well as an overall score, which is the sum of the four outcomes in the analysis.

Results

67 women with moderate to severe menopausal symptoms were included of whom 52 (77.6%) experienced a clinically relevant reduction in any of the four surveyed symptom subscales or overall score. 48 (71.6%) women experienced a clinically relevant reduction in any of the vasomotor symptom subscales: hot flushes, day and night sweats, general sweating. Women with vocational education were most likely to experience improvement compared to women with higher education. Beyond education, other factors of some importance for a clinically relevant reduction were no alcohol consumption, two or more births and urinary incontinence.

Conclusions

Level of education was the most consistent factor associated with improvement. Beyond education, other factors of some importance were no alcohol consumption, two or more births and urinary incontinence.

Trial registration

This study was registered in ClinicalTrials.gov at April 21, 2016. The registration number is NCT02746497 .

SUBMITTER: Waldorff FB

PROVIDER: S-EPMC7805030 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Factors associated with a clinically relevant reduction in menopausal symptoms of a standardized acupuncture approach for women with bothersome menopausal symptoms.

Waldorff Frans Boch FB Bang Christine Winther CW Siersma Volkert V Brodersen John J Lund Kamma Sundgaard KS

BMC complementary medicine and therapies 20210113 1

<h4>Background</h4>Little is known about factors associated with a clinically relevant reduction in menopausal symptoms through a brief acupuncture approach for women with moderate-to-severe menopausal symptoms.<h4>Methods</h4>Post hoc analysis of a randomized controlled trial where participants were allocated to early versus late standardized acupuncture. Both the early group and the late group are included in this study. The late group got an identical intervention parallel staged by 6 weeks. ...[more]

PMID: 33441145

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Project description:ObjectiveTo investigate the efficacy of a standardised brief acupuncture approach for women with moderate-to-severe menopausal symptoms.DesignRandomised and controlled, with 1:1 allocation to the intervention group or the control group. The assessor and the statistician were blinded.SettingNine Danish primary care practices.Participants70 women with moderate-to-severe menopausal symptoms and nine general practitioners with accredited education in acupuncture.InterventionThe acupuncture style was western medical with a standardised approach in the predefined acupuncture points CV-3, CV-4, LR-8, SP-6 and SP-9. The intervention group received one treatment for five consecutive weeks. The control group was offered treatment after 6 weeks.Main outcome measuresOutcomes were the differences between the randomisation groups in changes to mean scores using the scales in the MenoScores Questionnaire, measured from baseline to week 6. The primary outcome was the hot flushes scale; the secondary outcomes were the other scales in the questionnaire. All analyses were based on intention-to-treat analysis.Results36 participants received the intervention, and 34 participants were in the control group. Four participants dropped out before week 6. The acupuncture intervention significantly decreased hot flushes: Δ -1.6 (95% CI [-2.3 to -0.8]; p<0.0001), day-and-night sweats: Δ -1.2 (95% CI [-2.0 to -0.4]; p=0.0056), general sweating: Δ -0.9(95% CI [-1.6 to -0.2]; p=0.0086), menopausal-specific sleeping problems: Δ -1.8 (95% CI [-2.7 to -1.0]; p<0.0001), emotional symptoms: Δ -3.4 (95% CI [-5.3 to -1.4]; p=0.0008), physical symptoms: Δ -1.7 (95% CI [-3 to -0.4]; p=0.010) and skin and hair symptoms: Δ -1.5 (95% CI [-2.5 to -0.6]; p=0.0021) compared with the control group at the 6-week follow-up. The pattern of decrease in hot flushes, emotional symptoms, skin and hair symptoms was already apparent 3 weeks into the study. Mild potential adverse effects were reported by four participants, but no severe adverse effects were reported.ConclusionsThe standardised and brief acupuncture treatment produced a fast and clinically relevant reduction in moderate-to-severe menopausal symptoms during the six-week intervention. No severe adverse effects were reported.Trial registration numberNCT02746497; Results.

Project description:BackgroundThe MsFLASH (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) Network recruited into five randomized clinical trials (n = 100-350) through mass mailings. The fifth trial tested two interventions for postmenopausal vulvovaginal symptoms (itching, pain, irritation, dryness, or pain with sex) and thus required a high level of sensitivity to privacy concerns. For this trial, in addition to mass mailings we pilot tested a social media recruitment approach. We aimed to evaluate the feasibility of recruiting healthy midlife women with bothersome vulvovaginal symptoms to participate in the Vaginal Health Trial through Facebook advertising.MethodsAs part of a larger advertising campaign that enrolled 302 postmenopausal women for the 12-week randomized, double-blind, placebo-controlled Vaginal Health Trial from April 2016 to February 2017, Facebook advertising was used to recruit 25 participants. The target population for recruitment by mailings and by Facebook ads included women aged 50-70 years and living within 20 miles of study sites in Minneapolis, MN and Seattle, WA. Design of recruitment letters and Facebook advertisements was informed by focus group feedback. Facebook ads were displayed in the "newsfeed" of targeted users and included a link to the study website. Response rates and costs are described for both online ads and mailing.ResultsFacebook ads ran in Minneapolis for 28 days and in Seattle for 15 days, with ads posted and removed from the site as needed based on clinic flow and a set budget limit. Our estimated Facebook advertising reach was over 200,000 women; 461 women responded and 25 were enrolled at a cost of US$14,813. The response rate per estimated reach was 0.22%; costs were US$32 per response and US$593 per randomized participant. The social media recruitment results varied by site, showing greater effectiveness in Seattle than in Minneapolis. We mailed 277,000 recruitment letters; 2166 women responded and 277 were randomized at a cost of US$98,682. The response rate per letter sent was 0.78%; costs were US$46 per response and US$356 per randomized participant. Results varied little across sites.ConclusionRecruitment to a clinical trial testing interventions for postmenopausal vaginal symptoms is feasible through social media advertising. Variability in observed effectiveness and costs may reflect the small sample sizes and limited budget of the pilot recruitment study.

Project description:BackgroundPhysical activity may be an effective way of preventing or attenuating menopause-related symptoms, and it has been shown to improve quality of life in menopausal women. However, there have been some inconsistencies regarding between exercise and menopausal symptoms, and study investigating this association has been scarce in Korea. In this study, the association between physical activity and menopausal symptoms in perimenopausal women in Korea was assessed.MethodsThis cross-sectional observational study was conducted between November 2012 and March 2013. In total, 2,204 healthy women aged 44-56 years were recruited from a healthcare center at the Kangbuk Samsung hospitals for investigating women's attitudes towards menopause. To investigate the influence of physical activity on perimenopause-associated symptoms, 631 perimenopausal women were selected for this study. Their physical activity levels were assessed using the International Physical Activity Questionnaire (IPAQ) short form. The Menopause-specific Quality of Life (MENQOL) questionnaire was used to assess menopause-related symptoms.ResultsThe study participants were, on average, 48.5?±?2.7 years old and had a mean body mass index of 22.8?±?3.1 kg/m2. The total MENQOL score and the psychosocial and physical subscores exhibited U-shaped trends in relation to the level of physical activity. Multiple linear regression analysis adjusted for confounding variables showed that perimenopausal women who performed moderate physical activity reported significantly lower psychosocial (??=?-0.413, P?=?0.012) and physical symptoms (??=?-0.445, P?=?0.002) than women who performed low physical activity. By contrast, a high level of physical activity did not influence the MENQOL total score and subscores relative to the low activity group. In addition, no associations were observed between physical activity and the vasomotor and sexual symptoms in any group.ConclusionsModerate level of physical activity was associated with reduced psychosocial and physical menopause symptoms in perimenopausal Korean women. Although these findings must be confirmed by prospective longitudinal studies, they suggest that physical activity may improve the symptoms of menopause, thereby increasing quality of life.

Project description:Background and objectivesThe menopause transition is increasingly recognized as a time of importance for women's brain health. A growing body of work indicates that the classic menopausal symptom, vasomotor symptom (VMS), may be associated with poorer cardiovascular health. Other work links VMS to poorer cognition. We investigate whether VMS, when rigorously assessed using physiologic measures, are associated with greater white matter hyperintensity volume (WMHV) among midlife women. We consider a range of potential explanatory factors in these associations and explore whether VMS are associated with the spatial distribution of WMHV.MethodsWomen aged 45-67 years and free of hormone therapy underwent 24 hours of physiologic VMS monitoring (sternal skin conductance), actigraphy assessment of sleep, physical measures, phlebotomy, and 3 Tesla neuroimaging. Associations between VMS (24-hour, wake, and sleep VMS, with wake and sleep intervals defined by actigraphy) and whole brain WMHV were considered in linear regression models adjusted for age, race, education, smoking, body mass index, blood pressure, insulin resistance, and lipids. Secondary models considered WMHV in specific brain regions (deep, periventricular, frontal, temporal, parietal, and occipital) and additional covariates including sleep.ResultsThe study sample included 226 women. Physiologically assessed VMS were associated with greater whole brain WMHV in multivariable models, with the strongest associations observed for sleep VMS (24-hour VMS, B[SE] = 0.095 [0.045], p = 0.032; Wake VMS, B[SE] = 0.078 [0.046], p = 0.089, Sleep VMS, B[SE] = 0.173 [0.060], p = 0.004). Associations were not accounted for by additional covariates including actigraphy-assessed sleep (wake after sleep onset). When considering the spatial distribution of WMHV, sleep VMS were associated with both deep WMHV, periventricular WMHV, and frontal lobe WMHV.DiscussionVMS, particularly VMS occurring during sleep, were associated with greater WMHV. Identification of female-specific midlife markers of poor brain health later in life is critical to identify women who warrant early intervention and prevention. VMS have the potential to serve as female-specific midlife markers of brain health in women.

Project description:ImportanceCardiovascular health may be used for prevention of depressive symptoms. However, data on the association of cardiovascular health across midlife with depressive symptoms are lacking.ObjectiveTo evaluate whether better baseline cardiovascular health and improvement of cardiovascular health over time are associated with a lower risk of both incident depressive symptoms and unfavorable trajectories of depressive symptoms.Design, setting, and participantsParticipants without depressive symptoms were included from a prospective community-based cohort in France (GAZEL cohort). Cardiovascular health examinations occurred in 1990 and 1997 and assessment of depressive symptoms in 1997 and every 3 years thereafter until 2015. Data were analyzed from January to October 2022.ExposuresNumber of cardiovascular health metrics (smoking, body mass index, physical activity, diet, blood pressure, glucose, and cholesterol) at an intermediate or ideal level in 1997 (range, 0-7) and 7-year change in cardiovascular health between 1990 and 1997.Main outcomes and measuresPrimary outcome was incident depressive symptoms (20-item Center for Epidemiologic Studies-Depression Scale [CES-D] score of 17 or greater in men or 23 or greater in women); secondary outcome was trajectories of depressive symptoms scores. Trajectories included consistently low scores, moderately elevated scores, low starting then increasing scores, moderately high starting, increasing, then remitting scores, and moderately high starting then increasing scores.ResultsOf 6980 included patients, 1671 (23.9%) were women, and the mean (SD) age was 53.3 (3.5) years. During a follow-up spanning 19 years after 1997, 1858 individuals (26.5%) had incident depressive symptoms. Higher baseline cardiovascular health in 1997 and improvement in cardiovascular health over 7 years were each associated with lower risk of depressive symptoms (odds ratio [OR] per additional metric at intermediate or ideal level at baseline, 0.87; 95% CI, 0.84-0.91; OR per 1 higher metric at intermediate or ideal level over 7 years, 0.91; 95% CI, 0.86-0.96). Also, better cardiovascular health was associated with lower risk of unfavorable depressive symptoms trajectories. Compared with the consistently low score trajectory, the lowest risks were observed for the low starting then increasing score trajectory (OR per additional metric at intermediate or ideal level at baseline, 0.70; 95% CI, 0.64-0.76; OR per 1 higher metric at intermediate or ideal level over 7 years, 0.73; 95% CI, 0.68-0.79) and the moderately high starting then increasing score trajectory (OR per additional metric at intermediate or ideal level at baseline, 0.71; 95% CI, 0.64-0.79; OR per 1 higher metric at intermediate or ideal level over 7 years, 0.71; 95% CI, 0.64-0.77).Conclusions and relevanceIn this prospective community-based cohort study of adults, higher cardiovascular health was associated with a lower risk of depressive symptoms over time. Elucidating which set of cardiovascular factors may affect depression risk could be important for prevention.

Dataset Information

Factors associated with a clinically relevant reduction in menopausal symptoms of a standardized acupuncture approach for women with bothersome menopausal symptoms.

Background

Methods

Results

Conclusions

Trial registration

Publications

Factors associated with a clinically relevant reduction in menopausal symptoms of a standardized acupuncture approach for women with bothersome menopausal symptoms.

Similar Datasets

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