Polycystic ovary syndrome (PCOS) is a common women's health problem affecting at least 10 per cent of Australian girls and women. It often results in irregular periods, infertility, acne, excess facial and body hair, and an increased risk of developing serious and chronic health conditions like diabetes and heart disease.
Women with PCOS are more prone to having excess weight, and excess weight makes the symptoms of PCOS worse. Weight loss will improve the symptoms and complications of PCOS. A healthy diet, reducing calories, and increasing exercise can help women with PCOS lose weight, however many women find it difficult to lose weight even with changing their lifestyle habits, and there is a need for additional weight loss treatments. Metformin is a medicine that can help women with PCOS lose weight, but currently it is not indicated on the Pharmaceutical Benefits Scheme for treatment of PCOS. Also, the combination of lifestyle and Metformin may still not be enough to help women achieve their desired weight loss.
There has been interest in the role of acupuncture as an additional treatment for weight loss. Acupuncture (including ear acupuncture, which involves applying acupuncture needles to points around the ear) has been shown to be more effective for weight loss than sham or "fake" acupuncture in adults without PCOS, and also shows promising results in women with PCOS. However, the current research on acupuncture for weight loss in PCOS is insufficient in telling us whether or not it is an effective weight loss treatment.
Researchers at NICM Health Research Institute are conducting a three month feasibility study to investigate acupuncture and ear acupuncture stimulation as possible weight loss treatments, together with telephone-delivered health coaching for women diagnosed with PCOS.
Recuritment for this study is underway in Sydney from January 2019.
Who can join?
- Women aged 18-45 years.
- Women who:
- Are diagnosed with PCOS by a medical doctor.
- Have a Body Mass Index (BMI) between 25 and 40.
- Are not planning on falling pregnant within the next three months, and not pregnant in the past six weeks.
- Are not on any medication for PCOS (including the oral contraceptive pill).
- Telephone interview to confirm PCOS diagnosis.
- Before and after the three month treatment:
- Attend two clinic visits at Western Sydney University, Campbelltown campus and have weight, height, waist measurement, blood pressure and heart rate recorded.
- Complete surveys about your health.
- Have blood taken, including a two-hour oral glucose tolerance test.
- Wear an accelerometer (pedometer worn at the waist). Register and complete the GetHealthy program (free telephone-based health coaching).
- Participants will be randomly allocated into a treatment group-body acupuncture, ear acupuncture or the GetHealthy program only. Over the three month study:
- Body acupuncture participants will attend 11 acupuncture treatments.
- Ear acupuncture participants will attend six acupuncture treatments and wear an ear acupuncture stimulation device for up to 96 hours after each acupuncture treatment.
What are the benefits of participating?
- Participants health will be monitored for the 12-weeks, including glucose, insulin and hormone levels, and heart rate variability.
- If allocated to the acupuncture or ear acupuncture groups, participants will receive this treatment for free.
- Participants will be reimbursed up to $40 in total for travel costs to the study clinic.
- The benefits to the broader community will not be realised for some time yet, but if acupuncture is shown to be effective for weight loss, it could be a valuable additional treatment because it is readily available in the community and is a generally low-risk treatment.
For more details about the study please read the information sheet below before deciding on whether to participate or not in this study.
Interested in participating?
For further information, please contact:
Clinical Trial Officer
p. +61 487 472 273
Dr Carolyn Ee
Clinical Trial Chief Investigator
p. +61 49 043 5100
Human Research Ethics Committee Approval: This clinical trial has been approved by Western Sydney University Human Research Ethics Committee (Approval Number: H11973).
This study is supported by an NHMRC Centre for Research Excellence in PCOS Project Grant and a Partnership Grant between Neural Ear Stimulation International and NICM Health Research Institute.
NICM Chief Investigator: Dr Carolyn Ee.