Acupuncture or auricular electro-acupuncture as adjuncts to lifestyle interventions for weight management in PCOS: Protocol for a randomised controlled feasibility study

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dc.contributor.authorEe, C.
dc.contributor.authorSmith, C.A.
dc.contributor.authorCostello, M.
dc.contributor.authorMoran, L.
dc.contributor.authorSteiner, G.Z.
dc.contributor.authorStepto, N.
dc.contributor.authorCave, A.
dc.contributor.authorAlbrehee, A.
dc.contributor.authorTeede, H.
dc.date.issued2020
dc.descriptionPublished online: 25 April 2020
dc.description.abstractBackground: Polycystic ovary syndrome (PCOS) is a prevalent women’s health condition with reproductive, metabolic, and psychological manifestations. Weight loss can improve these symptoms and is a key goal; however, many women find this difficult to achieve. Acupuncture is a Chinese medical treatment that involves insertion of very fine metal needles into specific areas of the body and has been shown to be efficacious for weight loss in non-PCOS populations. However, few studies have been conducted in women with PCOS. A variant of acupuncture, auricular electro-acupuncture (AEA), may have beneficial effects on sympathetic tone, which is associated with insulin resistance, obesity and PCOS. Methods: This prospective three-arm open label parallel randomised controlled trial will assess feasibility and acceptability of acupuncture and/or AEA for weight loss in women with PCOS. We will enrol 39 women from the community aged between 18 and 45 years, with physician diagnosis of PCOS according to the Rotterdam criteria: body mass index (BMI) between 25 and 40 kg/m2. Women will be randomly allocated to receive one of three treatments for 12 weeks duration: body electro-acupuncture + lifestyle interventions, AEA + lifestyle interventions, or lifestyle interventions alone. The lifestyle intervention in this study is telephone-based health coaching (between 4 and 13 phone calls, depending on individual need), provided by the Get Healthy Service. Primary outcomes of the study are feasibility and acceptability of trial methods as determined by recruitment and retention rates, adherence, acceptability, credibility, and safety. Secondary outcomes include anthropometric (body weight, BMI, waist and hip circumference), metabolic (glucose tolerance and insulin sensitivity obtained from a 2-h 75 g oral glucose tolerance test with area under the curve insulin calculated using the trapezoid rule), reproductive (androgen levels, menstrual cyclicity, clinical hyperandrogenism using the Ferriman-Gallwey scoring system), autonomic (heart rate variability, blood pressure), lifestyle (physical activity levels, diet quality, weight self-efficacy), quality of life, and psychological (depression and anxiety symptoms, internal health locus of control). Discussion: This study addresses the feasibility and acceptability of novel interventions to treat overweight/obesity in PCOS. Study findings have the potential to generate a new understanding of the role of acupuncture and auricular acupuncture in weight management. Trial registration: Australian New Zealand Clinical Trial Registry, 8/6/18 ACTRN12618000975291
dc.description.statementofresponsibilityCarolyn Ee, Caroline A. Smith, Michael Costello, Lisa Moran, Genevieve Z. Steiner, Nigel Stepto, ˆ, Adele Cave, Atekah Albrehee and Helena Teede
dc.identifier.citationPilot and Feasibility Studies, 2020; 6(1):53-1-53-12
dc.identifier.doi10.1186/s40814-020-00591-4
dc.identifier.issn2055-5784
dc.identifier.issn2055-5784
dc.identifier.orcidMoran, L. [0000-0001-5772-6484]
dc.identifier.orcidTeede, H. [0000-0001-7609-577X]
dc.identifier.urihttps://hdl.handle.net/2440/139974
dc.language.isoen
dc.publisherBMC
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1102532
dc.rights© The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.
dc.source.urihttps://doi.org/10.1186/s40814-020-00591-4
dc.subjectPolycystic ovary syndrome; PCOS; Obesity; Weight management; Acupuncture; Auricular electroacupuncture, Heart rate variability; Insulin resistance
dc.titleAcupuncture or auricular electro-acupuncture as adjuncts to lifestyle interventions for weight management in PCOS: Protocol for a randomised controlled feasibility study
dc.typeJournal article
pubs.publication-statusPublished

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