Abstract
BackgroundPolycystic 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.MethodsThis 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).DiscussionThis 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 registrationAustralian New Zealand Clinical Trial Registry, 8/6/18 ACTRN12618000975291
Highlights
Polycystic ovary syndrome (PCOS) is a prevalent women’s health condition with reproductive, metabolic, and psychological manifestations
Secondary outcomes include anthropometric, metabolic, reproductive, autonomic, lifestyle, quality of life, and psychological
Weight loss is a key goal in PCOS, and lifestyle management techniques targeted at weight loss are first-line approaches in overweight/obese women as even modest weight loss improves reproductive and metabolic outcomes [4]
Summary
Polycystic ovary syndrome (PCOS) is a prevalent women’s health condition with reproductive, metabolic, and psychological manifestations. In non-PCOS populations, acupuncture, in particular auricular acupuncture and electro-acupuncture, is more efficacious than sham for reducing body mass index (BMI) (mean difference [MD] − 0.47 kg/m2) as well as body fat mass (MD − 0.66 kg), waist circumference (MD − 2.02 cm) and hip circumference (MD − 2.74 cm) [8] These effects are mediated through multiple responses including appetite suppression [9, 10], modulation of leptin and ghrelin [11,12,13], and improved insulin sensitivity [14,15,16,17,18,19]. One study reported a mean difference of 0.97 kg/m2 (95% CI 1.51, 0.43) for acupuncture and metformin compared to metformin alone [24]
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