Data

The role of naturopathy in the management of women with polycystic ovary syndrome (PCOS) dataset

Western Sydney University
Arentz, Susan ; Smith, Caroline ; Abbott, Jason ; Bensoussan, Alan
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ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Adc&rfr_id=info%3Asid%2FANDS&rft_id=info:doi10.26183/79br-7c50&rft.title=The role of naturopathy in the management of women with polycystic ovary syndrome (PCOS) dataset&rft.identifier=10.26183/79br-7c50&rft.publisher=Western Sydney University&rft.description=Polycystic ovary syndrome or PCOS was first described in 1935 by Irving F. Stein and Michael L. Leventhal as Stein Leventhal Syndrome; ‘women with ovarian hyperthecosis presenting with persistent anovulation, obesity and hirsutism.’ Today, PCOS is the most common reproductive endocrinopathy of women, the most common cause of ovarian infertility and the cause of psychological and emotional distress. PCOS is associated with serious health risks in the short and long term including significantly increased risks for diabetes, cancer and cardiovascular disease, independent to body weight. For the health care system, the annual cost of PCOS in Australia was conservatively estimated as AU$400 million. Methods: Questions were addressed following the survey of women with PCOS, two separate literature reviews and through a randomised controlled trial examining the effectiveness of a naturopathic herbal formula plus lifestyle intervention on a broad range of outcomes in overweight women with polycystic ovary syndrome. An electronic survey of 493 women with PCOS assessed women’s use and attitudes toward complementary medicine and self-care (diet and exercise). Women were recruited from the Polycystic Ovary Syndrome Association of Australia (POSAA) and through social media PCOS support groups on social media. A randomised controlled trial (RCT) compared the clinical effectiveness and safety of the addition of a new herbal combination to lifestyle intervention against lifestyle intervention alone in 122 overweight women with medically diagnosed PCOS. The primary outcome was menstrual regularity. Secondary outcomes included pregnancy rates, serum hormone and blood glucose concentrations, anthropometry, and psychological health outcomes at three months and live birth rates at nine months after the intervention period. Results: Over two-thirds of women surveyed reported regular use of nutritional and herbal supplements to manage their PCOS. Although most respondents reported regular engagement with lifestyle interventions (diet and exercise) few reported satisfaction, and most expressed a desire for transparent information about complementary medicines. The systematic review of the literature revealed evidence from 18 RCTs (1109 women) for six types of nutritional supplements (vitamin D, Omega 3, calcium, chromium, vitamins and inositol) and four herbal medicines (Camellia sinensis, Cimicifuga racemosa Cinnamon cassia and Mentha spicata) for the management of symptoms associated with PCOS. The quality of studies was low to moderate, 11 meta-analyses were applied to 11 outcomes. The strongest evidence was found for inositol for the treatment of a hyperandrogenism, infertility, normalising metabolic hormones and for omega three fish oils for treatment of high cholesterol in women with PCOS. Findings highlighted the lack of robust evidence for many natural health supplements and that outcomes for inositol and omega three may contribute lower grade evidence to the evidence-based guidelines for the management of women with PCOS. One hundred and twenty-two women with PCOS were randomised to receive herbal medicine plus lifestyle intervention or lifestyle intervention alone. At three months there was a significant improvement in menstrual regularity for women taking the additional herbal medicine compared to women using lifestyle intervention alone with a moderate to large treatment effect. Significant improvements for secondary outcomes included fasting insulin, anthropometric characteristics (BMI, body weight, and waist circumference), quality of life (PCOSQ), depression, anxiety and stress (DASS 21) and pregnancy rates. Overall, the herbal medicine was well tolerated however two women were withdrawn due to non-serious side effects. Methodological strengths included sufficient power, low attrition and intention to treat analyses. This thesis presents preliminary evidence for the enhanced effectiveness of lifestyle intervention following the addition of a new herbal formulation for overweight women with PCOS. Significantly improved outcomes included menstrual regularity, metabolic hormones, anthropometry, blood pressure, pregnancy rates, psychological profile and quality of life. This entry includes 2 data-sets that were published in 3 papers. 1. Data collected from a randomised control trial that compared the effectiveness of a naturopathic herbal medicine supplement in addition to lifestyle intervention, compared to lifestyle alone for menstrual regularity in 122 overweight women with polycystic ovarian syndrome. 2. A survey of 496 women with PCOS describing their prevalence and patterns of complementary medicine use 3. A survey of 496 women with PCOS describing their experiences of lifestyle intervention. The survey data-set could be used to further describe women with PCOS who are living in the community, and associated physical and psychological health characteristic ot other associations. It is a reasonably sized sample of 493 responses. The RCT dataset could be used to generate a power calculation for a placebo-controlled efficacy RCT. The IP was commercialised by an Australian company Mediherb Pty Ltd, who manufactured a product called PCOSupport that is registered (listed) with the TGA https://www.tga.gov.au/resources/artg/395997 The ANZCTR entry: Trial Id: ACTRN12612000122853 https://www.anzctr.org.au/trial/MyTrial.aspx The effectiveness of naturopathic herbal medicine and a lifestyle intervention, compared to lifestyle intervention alone for oligomenorrhoea, serum hormones, anthropometric, reproductive, blood pressure, quality of life and adverse outcomes in overweight women with polycystic ovary syndrome (PCOS). &rft.creator=Arentz, Susan &rft.creator=Smith, Caroline &rft.creator=Abbott, Jason &rft.creator=Bensoussan, Alan &rft.date=2024&rft.relation=http://hdl.handle.net/1959.7/uws:42202&rft.relation=http://hdl.handle.net/1959.7/uws:29068&rft.relation=http://hdl.handle.net/1959.7/uws:28897&rft.relation=https://hdl.handle.net/1959.7/uws:59214&rft.relation=http://hdl.handle.net/1959.7/uws:44345&rft.relation=http://handle.westernsydney.edu.au:8081/1959.7/uws:40385&rft.coverage=138.890598,-39.276916 138.890598,-9.939093 154.970287,-9.939093 154.970287,-39.276916 138.890598,-39.276916&rft.coverage=&rft_rights=Copyright Western Sydney University&rft_rights=CC BY 4.0: Attribution 4.0 International http://creativecommons.org/licenses/by/4.0&rft_subject=PCOS&rft_subject=Naturopathy&rft_subject=Traditional, complementary and integrative medicine&rft_subject=HEALTH SCIENCES&rft_subject=Reproduction&rft_subject=Reproductive medicine&rft_subject=BIOMEDICAL AND CLINICAL SCIENCES&rft_subject=Clinical pharmacology and therapeutics&rft_subject=Pharmacology and pharmaceutical sciences&rft_subject=Efficacy of medications&rft_subject=Clinical health&rft_subject=HEALTH&rft_subject=Treatment of human diseases and conditions&rft_subject=Evaluation of health outcomes&rft_subject=Evaluation of health and support services&rft_subject=Women's and maternal health&rft_subject=Specific population health (excl. Indigenous health)&rft.type=dataset&rft.language=English Access the data

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Polycystic ovary syndrome or PCOS was first described in 1935 by Irving F. Stein and Michael L. Leventhal as Stein Leventhal Syndrome; ‘women with ovarian hyperthecosis presenting with persistent anovulation, obesity and hirsutism.’ Today, PCOS is the most common reproductive endocrinopathy of women, the most common cause of ovarian infertility and the cause of psychological and emotional distress. PCOS is associated with serious health risks in the short and long term including significantly increased risks for diabetes, cancer and cardiovascular disease, independent to body weight. For the health care system, the annual cost of PCOS in Australia was conservatively estimated as AU$400 million.

Methods: Questions were addressed following the survey of women with PCOS, two separate literature reviews and through a randomised controlled trial examining the effectiveness of a naturopathic herbal formula plus lifestyle intervention on a broad range of outcomes in overweight women with polycystic ovary syndrome.

An electronic survey of 493 women with PCOS assessed women’s use and attitudes toward complementary medicine and self-care (diet and exercise). Women were recruited from the Polycystic Ovary Syndrome Association of Australia (POSAA) and through social media PCOS support groups on social media.

A randomised controlled trial (RCT) compared the clinical effectiveness and safety of the addition of a new herbal combination to lifestyle intervention against lifestyle intervention alone in 122 overweight women with medically diagnosed PCOS. The primary outcome was menstrual regularity. Secondary outcomes included pregnancy rates, serum hormone and blood glucose concentrations, anthropometry, and psychological health outcomes at three months and live birth rates at nine months after the intervention period.

Results: Over two-thirds of women surveyed reported regular use of nutritional and herbal supplements to manage their PCOS. Although most respondents reported regular engagement with lifestyle interventions (diet and exercise) few reported satisfaction, and most expressed a desire for transparent information about complementary medicines.

The systematic review of the literature revealed evidence from 18 RCTs (1109 women) for six types of nutritional supplements (vitamin D, Omega 3, calcium, chromium, vitamins and inositol) and four herbal medicines (Camellia sinensis, Cimicifuga racemosa Cinnamon cassia and Mentha spicata) for the management of symptoms associated with PCOS. The quality of studies was low to moderate, 11 meta-analyses were applied to 11 outcomes. The strongest evidence was found for inositol for the treatment of a hyperandrogenism, infertility, normalising metabolic hormones and for omega three fish oils for treatment of high cholesterol in women with PCOS. Findings highlighted the lack of robust evidence for many natural health supplements and that outcomes for inositol and omega three may contribute lower grade evidence to the evidence-based guidelines for the management of women with PCOS.

One hundred and twenty-two women with PCOS were randomised to receive herbal medicine plus lifestyle intervention or lifestyle intervention alone. At three months there was a significant improvement in menstrual regularity for women taking the additional herbal medicine compared to women using lifestyle intervention alone with a moderate to large treatment effect. Significant improvements for secondary outcomes included fasting insulin, anthropometric characteristics (BMI, body weight, and waist circumference), quality of life (PCOSQ), depression, anxiety and stress (DASS 21) and pregnancy rates. Overall, the herbal medicine was well tolerated however two women were withdrawn due to non-serious side effects. Methodological strengths included sufficient power, low attrition and intention to treat analyses. This thesis presents preliminary evidence for the enhanced effectiveness of lifestyle intervention following the addition of a new herbal formulation for overweight women with PCOS. Significantly improved outcomes included menstrual regularity, metabolic hormones, anthropometry, blood pressure, pregnancy rates, psychological profile and quality of life.

This entry includes 2 data-sets that were published in 3 papers.

1. Data collected from a randomised control trial that compared the effectiveness of a naturopathic herbal medicine supplement in addition to lifestyle intervention, compared to lifestyle alone for menstrual regularity in 122 overweight women with polycystic ovarian syndrome.

2. A survey of 496 women with PCOS describing their prevalence and patterns of complementary medicine use

3. A survey of 496 women with PCOS describing their experiences of lifestyle intervention.

The survey data-set could be used to further describe women with PCOS who are living in the community, and associated physical and psychological health characteristic ot other associations. It is a reasonably sized sample of 493 responses.

The RCT dataset could be used to generate a power calculation for a placebo-controlled efficacy RCT. The IP was commercialised by an Australian company Mediherb Pty Ltd, who manufactured a product called PCOSupport that is registered (listed) with the TGA

https://www.tga.gov.au/resources/artg/395997

The ANZCTR entry: Trial Id: ACTRN12612000122853 https://www.anzctr.org.au/trial/MyTrial.aspx The effectiveness of naturopathic herbal medicine and a lifestyle intervention, compared to lifestyle intervention alone for oligomenorrhoea, serum hormones, anthropometric, reproductive, blood pressure, quality of life and adverse outcomes in overweight women with polycystic ovary syndrome (PCOS).

Created: 2024-02-20

Data time period: 2012 to 31 12 2014

This dataset is part of a larger collection

Click to explore relationships graph

138.8906,-39.27692 138.8906,-9.93909 154.97029,-9.93909 154.97029,-39.27692 138.8906,-39.27692

146.9304425,-24.6080045

Identifiers
  • DOI : 10.26183/79BR-7C50
  • Local : research-data.westernsydney.edu.au/published/91356760cf7a11eea1d643e149c78efd