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      Nonpharmacologic, nonherbal management of menopause-associated vasomotor symptoms: an umbrella systematic review (protocol)

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          Abstract

          Background

          Vasomotor symptoms such as hot flashes and night sweats are a common concern of perimenopausal and postmenopausal women and are associated with a decreased quality of life. These symptoms can be effectively managed with hormone therapy, but safety concerns limit its use. Thus, understanding the effectiveness of nonpharmacologic therapies such as acupuncture or yoga is critical to managing these common symptoms in older women. Our review seeks to address the following question: In women with menopause-associated vasomotor symptoms, what are the effects on health-related quality of life, vasomotor symptoms, and adverse events of the following nonpharmacologic, nonherbal interventions as compared with any inactive control or active comparator: (a) acupuncture, (b) yoga, tai chi, and qigong, (c) structured exercise, and (d) meditation, mindfulness-based practices, and relaxation?

          Methods

          We describe a protocol for an umbrella review approach, supplemented by evaluating randomized controlled trials (RCTs) published after the most recent good-quality systematic review for each of the eligible interventions. Specific interventions were chosen based on current literature and with input from a technical expert panel and organizational stakeholders. We will conduct a thorough literature search and perform a quality assessment of potentially included systematic reviews and RCTs.

          Discussion

          Our umbrella review, supplemented by an additional search for eligible RCTs, aims to synthesize existing evidence on the use of nonpharmacologic, nonherbal interventions to manage bothersome vasomotor symptoms in perimenopausal and postmenopausal women.

          Systematic review registration

          PROSPERO CRD42016029335

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13643-016-0232-6) contains supplementary material, which is available to authorized users.

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          Most cited references14

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          Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews

          Background Our objective was to develop an instrument to assess the methodological quality of systematic reviews, building upon previous tools, empirical evidence and expert consensus. Methods A 37-item assessment tool was formed by combining 1) the enhanced Overview Quality Assessment Questionnaire (OQAQ), 2) a checklist created by Sacks, and 3) three additional items recently judged to be of methodological importance. This tool was applied to 99 paper-based and 52 electronic systematic reviews. Exploratory factor analysis was used to identify underlying components. The results were considered by methodological experts using a nominal group technique aimed at item reduction and design of an assessment tool with face and content validity. Results The factor analysis identified 11 components. From each component, one item was selected by the nominal group. The resulting instrument was judged to have face and content validity. Conclusion A measurement tool for the 'assessment of multiple systematic reviews' (AMSTAR) was developed. The tool consists of 11 items and has good face and content validity for measuring the methodological quality of systematic reviews. Additional studies are needed with a focus on the reproducibility and construct validity of AMSTAR, before strong recommendations can be made on its use.
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            The 2012 hormone therapy position statement of: The North American Menopause Society.

            (2012)
            This position statement aimed to update the evidence-based position statement published by The North American Menopause Society (NAMS) in 2010 regarding recommendations for hormone therapy (HT) for postmenopausal women. This updated position statement further distinguishes the emerging differences in the therapeutic benefit-risk ratio between estrogen therapy (ET) and combined estrogen-progestogen therapy (EPT) at various ages and time intervals since menopause onset. An Advisory Panel of expert clinicians and researchers in the field of women's health was enlisted to review the 2010 NAMS position statement, evaluate new evidence, and reach consensus on recommendations. The Panel's recommendations were reviewed and approved by the NAMS Board of Trustees as an official NAMS position statement. Current evidence supports the use of HT for perimenopausal and postmenopausal women when the balance of potential benefits and risks is favorable for the individual woman. This position statement reviews the effects of ET and EPT on many aspects of women's health and recognizes the greater safety profile associated with ET. Recent data support the initiation of HT around the time of menopause to treat menopause-related symptoms and to prevent osteoporosis in women at high risk of fracture. The more favorable benefit-risk ratio for ET allows more flexibility in extending the duration of use compared with EPT, where the earlier appearance of increased breast cancer risk precludes a recommendation for use beyond 3 to 5 years.
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              Endometriosis: an overview of Cochrane Reviews.

              This overview reports on interventions for pain relief and for subfertility in pre-menopausal women with clinically diagnosed endometriosis.
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                Author and article information

                Contributors
                919.286.0411 , karen.goldstein@duke.edu
                mcduf.j@dm.duke.edu
                mes86@duke.edu
                deanna.befus@duke.edu
                remy.coeytaux@duke.edu
                megan.van.noord@duke.edu
                adam.goode@duke.edu
                varshavm@gmail.com
                soheir.adam@duke.edu
                avishek.nagi@va.gov
                jw.williams@duke.edu
                Journal
                Syst Rev
                Syst Rev
                Systematic Reviews
                BioMed Central (London )
                2046-4053
                7 April 2016
                7 April 2016
                2016
                : 5
                : 56
                Affiliations
                [ ]Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC USA
                [ ]Department of Medicine, Division of General Internal Medicine, Duke University Medical Center, 411 W. Chapel Hill Street; Suite 500, Durham, NC 27701 USA
                [ ]Duke University School of Nursing, Durham, NC USA
                [ ]Duke Clinical Research Institute, Durham, NC USA
                [ ]Duke University Medical Center Library, Durham, NC USA
                [ ]Department of Physical Therapy, Duke University Medical Center, Durham, NC USA
                [ ]Department of Medicine, Duke University Medical Center, Durham, NC USA
                Article
                232
                10.1186/s13643-016-0232-6
                4823860
                27056180
                929cc761-a451-4817-8777-35351c200a76
                © Goldstein et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 1 February 2016
                : 30 March 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000738, U.S. Department of Veterans Affairs;
                Award ID: Evidence-based Synthesis Program #09-010
                Award Recipient :
                Categories
                Protocol
                Custom metadata
                © The Author(s) 2016

                Public health
                vasomotor symptoms,menopause,nonpharmacologic therapy,umbrella review
                Public health
                vasomotor symptoms, menopause, nonpharmacologic therapy, umbrella review

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