The addition of naturopathic herbal medicine to a lifestyle intervention for women with polycystic ovary syndrome (PCOS), a randomised controlled trial.

This was a pragmatic randomized controlled trial (RCT). Pragmatic RCTs are designed to assess clinical effectiveness and safety (as opposed to efficacy), with findings anticipated to translate into real world settings and directly meet the information needs of consumers and clinicians. (1,2) They are characterized by a degree of flexibility for the administration of complex interventions; flexibility of practitioner expertise and by broad participant eligibility criteria (3, 4). In this pragmatic RCT, there were two interventions; lifestyle and naturopathic herbal medicine all delivered over three months. All participants received the same lifestyle intervention based on the recommendations defined in the Evidence Based Guidelines (EBG) for the management of PCOS commissioned by the National Health and Medical Research Council. (5) The lifestyle intervention in the EBG recommends reduced dietary energy (caloric) intake in the setting of healthy food choices, irrespective of diet composition (using tools such as lifescripts:www.health.gov.au/lifescripts) and exercise for at least 150 minutes per week including 90 minutes of aerobic activity (60-90% of maximum heart rate) (5). Two trained lifestyle coaches (a nutritionist and an exercise physiologist) collaboratively introduced diet plans and a structured sequence of aerobic and progressive resistance exercises. The ‘exercise prescription’ was designed by an exercise physiologist at Western Sydney University. It included body postures which applied resistance to large skeletal muscle groups (progressive resistance training) combined with aerobic activity (brisk walking on an incline, jogging, cycling, cross trainer, circuits at the gym, dancing etc.). A degree of flexibility was embedded into the program to accommodate individual ability and exercise preferences. Exercise sessions consisted of two parts, aerobic and resistance each estimated to take 20 to 30 minutes. Participants were advised to exercise for at least 150 minutes per week. This was presented in terms of weekly time allocations for exercise for example one 60 minute session and two 45 minute sessions or three 30 minute sessions or three sessions of 50 minutes each. The first exercise session was supervised by the exercise physiologist. Subsequent sessions were either supervised by the exercise physiologist, a trainer at a gym or self-administered at a location convenient to the participant. The intensity of an individual’s exercise prescription increased at two weekly intervals in response to individual progress. Diets were developed according to personal taste and individual requirements. Participant’s recalled their usual daily food intake over the previous two weeks during the trial entry interview. Key dietary components were identified (daily intake of vegetables and fruit (type and number of servings), overall energy content, type of diet and consumption of unhealthy foods (high energy, nutrient sparse and high glycaemic index). Written information was provided outlining the 'Lifescripts diet' for comparison with individual diets. Additional written information was provided to enable participants to identify foods with a low glycaemic index (GI). Specific diet plans were introduced on an individualized needs basis. Dietary adjustments were collaboratively discussed, based on individual energy requirements and considered with reference to participants existing diet. Women were encouraged to swap high energy, nutrient sparse foods with lower energy, nutrient dense foods and foods with a high GI to foods with a low GI. Dietary adjustments were provided in a supportive, conversational manner. Written information, recipes, menus suggestions and referrals to information based web sites enabled participants to access further information provided by the Human Nutrition Unit at the University of Sydney and the Department of Health in Queensland.. Trial participants had access to the lifestyle coaches throughout the trial, were contacted fortnightly, invited to attend supervised exercise sessions and helped to construct their own personalized lifestyle plan. The lifestyle program and its delivery were allowed to vary between participants with the aim to maximize clinical relevance of the trial findings Participants compliance was assessed fortnightly and during an interview at week twelve. Women self-reported the intensity of exercise (mild, moderate or vigorous) and number of minutes per week. Dietary compliance was assessed through the average number of self-reported servings of vegetables and fruit per day and number of high energy, nutrient sparse and high GI foods consumed per week. Naturopathy was provided in the form of two types of herbal medicine tablets and two 30 minute consultations with a naturopath at weeks four and eight. During the consultations, education regarding self-care and responses to questions about the menstrual cycle were provided, Women were asked about their well-being (tailored questions about general health, sleep quality, energy, pain) and assessed for adverse effects. There were two different herbal tablets. The first was a new formulation that contained a total of 3 grams of dried herbal medicine,, constructed from four different herbal extracts commonly used by trained naturopaths and herbalists (Cinnamomum species, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora). The exact formulation of the novel herbal tablet was subject to confidentiality. Participants took three herbal tablets per day for three months. The second herbal tablet, Mediherb Tribulus forte was taken during the pre-ovulation phase of the menstrual cycle, (days 5 to 14) only (three tablets per day in addition to herbal tablet one ). The Tribulus Forte tablet contains Tribulus terrestris extract equivalent to 13.5 g dried aerial parts. Participant compliance was assessed by tablet count with the return of contents of herbal bottles at week 12. 1. Rothwell, P.M., External validity of randomised controlled trials:“to whom do the results of this trial apply?”. The Lancet, 2005. 365(9453): p. 82-93. 2. Zwarenstein, M., et al., Improving the reporting of pragmatic trials: an extension of the CONSORT statement. Bmj, 2008. 337. 3. Sullivan, P. and D. Goldmann, The promise of comparative effectiveness research. JAMA, 2011. 305(4): p. 400-401. 4. Thorpe, K.E., Zwarenstein, M.,Oxman, A.D.,Treweek, S.,Furberg, C., and D.G. Altman, Tunis, S.,Bergel, E.,Harvey, I.,Magid, D.J., A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of clinical epidemiology, 2009. 62(5): p. 464-475. 5. AAPCOS, Evidence-based guideline for the assessment and management of polycystic ovary syndrome., NHMRC, Editor 2011, Jean Hailes Foundation for Women's Health on behalf of the PCOS Australian Alliance: Melbourne, Australia.