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

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The negative personal impact of PCOS on women’s quality of life and self-esteem is well defined and recognised. Evidence-based medical management emphasises a multidisciplinary approach with lifestyle intervention recommended as first-line treatment in international clinical guidelines. However, the strength of evidence for lifestyle intervention remains limited by high attrition in RCTs and clinical uptake is impeded by the lack of evidence for optimal dietary and exercise practices. Additional forms of management are often sought by women with PCOS and needed to achieve clinical outcomes, including fertility outcomes. Pharmaceuticals and surgery may be used to regulate menstruation, reduce androgens and treat infertility and hyperinsulinaemia, however these have limited capacity to address the range of PCOS symptoms, are often contra-indicated due to increased risk of co-morbidities or have high adverse effect profiles. In addition, women with PCOS have expressed preferences for alternatives.

Naturopathy is a type of complementary medicine with traditional origins in ancient western civilisations. Naturopathy is based on holistic philosophy, six principles of practice and theories with naturopaths provide health care for a wide range of conditions using natural treatment modalities to enhance well-being and support the innate healing capabilities of the body. The case for naturopathy for PCOS is presented here based on three rationales; a clinical gap in medical management; clinical potential for herbal medicine and nutritional supplements in PCOS, and the preferences and acceptability of complementary medicines by women. This thesis examined the role of naturopathy in women with PCOS by answering the following questions.

1. What is the prevalence of use and attitudes towards complementary medicine, self-help and lifestyle interventions by women with PCOS?

2. What is the evidence from randomised controlled trials for naturopathic herbal medicines and nutritional supplements for women with PCOS?

3. What is the pre-clinical and corroborating clinical evidence for the reproductive endocrine effects of herbal medicine for the treatment of oligo/amenorrhoea, hyperandrogenism and PCOS?

4. Does the addition of a Western herbal medicine combination (Tribulus terrestris, Glycyrrhiza glabra, Paeonia lactiflora, Hypericum perforatum and Cinnamomum cassia) to a lifestyle intervention compared with the lifestyle intervention alone improve menstrual regularity in overweight women PCOS?

Methods: These 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.

The evidence base for nutritional supplements and herbal medicine was examined through two literature reviews. The evidence from randomised controlled trials (RCT) for nutritional supplements and herbal medicine for clinical effects in women with PCOS was synthesised following a systematic review of the literature. Consistent pre-clinical and clinical evidence of reproductive endocrine effects in PCOS for herbal medicines used in naturopathic clinical practice explained the mechanisms of five herbal medicines that theoretically could contribute to regulating the menstrual pattern, reducing hyperandrogenism, and improving ovarian morphology in PCOS.

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.

The literature review of the mechanisms of herbal medicines in oligo/amenorrhoea, hyperandrogenism and PCOS revealed consistent pre-clinical and clinical evidence for six herbal medicines (Cimicifuga racemosa, Cinnamomum cassia, Glycyrrhiza spp, Paeonia lactiflora, Tribulus terrestris and Vitex agnus-castus). Reproductive endocrinological effects were reduced LH (Cimicifuga racemosa, Paeonia lactiflora and Cinnamomum cassia), raised FSH (Tribulus terrestris), reduced testosterone (Glycorrhizza spp. and Paeonia lactiflora) and improved fasting insulin (Cinnamomum cassia). The mechanisms of herbal medicines and naturopathic clinical practices informed the development of a new herbal combination for investigation in the RCT.

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. Weaknesses included wide confidence intervals found for the primary outcome.

Conclusion: This thesis provides new evidence for the potential therapeutic role and safety of naturopathy as an adjunct to lifestyle intervention for the management of PCOS. It demonstrates that women with PCOS are frequent users of complementary medicine and the evidence of reproductive endocrine effects of Western herbal medicines includes lowered LH, and glucose and raised FSH and oestradiol. The evidence from published RCTs demonstrated the clinical efficacy of two nutritional supplements, inositol and omega-three fish oils, and two herbal medicines, Cimicifuga racemosa and Mentha spicata for an improved hormone profile, reproduction and reduced risk factors.

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).