Acupuncture or ear acupuncture for weight loss in Polycystic Ovary Syndrome

In both interventions, case report forms will be completed at each treatment to assess adherence. Arm 1: Body acupuncture and lifestyle The intervention in this arm is Chinese medicine needle acupuncture delivered in a semi-pragmatic setting (as per usual clinical practice but treating acupuncturists must include acupuncture points from a list provided). Individualisation of treatment Acupuncturists are to perform Chinese medicine diagnosis based on history and examination as per usual clinical practice. The list of points that acupuncturists must select from are based on acupuncture points used in other clinical trials on acupuncture for weight loss in PCOS and also on a textbook and literature review. Extent to which treatment will be varied In choosing the acupuncture prescription, treating acupuncturists are given the following instructions: • Treatment of obesity/overweight is the primary objective of the acupuncture treatment • At least six acupuncture points must be chosen from a list of 17 core acupuncture points that will be provided to the practitioner. These points are chosen from the traditional points that are recommended for treatment of syndromes that are related to obesity and PCOS, and from the points used in previous acupuncture for obesity and PCOS trials. • Points on the chest or back must be avoided to avoid risk of pneumothorax. • De qi must be obtained for each point using thrusting, twirling and rotating, until the participant reports numbness, heaviness, pressure, soreness or tingling. • Needles are manipulated after ten minutes (thrusting, twirling and rotating until De qi is reported) • Needles are withdrawn after 30 minutes Details of needling A minimum of ten acupuncture needles will be inserted per session. The core acupuncture points to be used are ST36, SP6, ST25, ST40, CV12, CV6, LI11, SP9, CV9, CV3, CV4, LI4, KI13, KI7, ST28, LR3, GB34. These points are located on the upper or lower limbs or abdomen. Acupuncture points will be generally needled bilaterally, unless they are midline points, or there are other reasons for unilateral needling for example pain or bruising on one side. Needles will be inserted until de qi is obtained. De qi is defined as numbness, heaviness, pressure, soreness or tingling. A combination of manual and electrical stimulation (electro-acupuncture) will be used. De qi must be obtained for each point using thrusting, twirling and rotating, until the participant reports numbness, heaviness, pressure, soreness or tingling. Electro-acupuncture will be applied to four acupuncture points. Electro-acupuncture is delivered using TGA-approved electro-acupuncture devices that deliver low-frequency electrical pulses to the attached needles. Electroacupuncture will be given to ST28 - SP6 bilaterally, at 0.3ms pulse width, 2Hz, and at a stimulation level that causes a mild muscle contraction but without pain or discomfort. Needles are retained for 30 minutes. Needles are stainless steel, sterile and disposable. Acupuncture needles are standard , 32G thickness and 30mm length. Women allocated to the acupuncture group will receive a total of 11 treatments of acupuncture over 12 weeks (twice a week for the first two weeks, weekly for four weeks, then fortnightly for 3 treatments). This tapering schedule is consistent with usual clinical practice. Needles are retained for 30 minutes. Other components of treatment Treating acupuncturists may provide diet and lifestyle advice according to Chinese medicine principles. This advice usually consists of advice to avoid ingesting foods that are considered too “hot” or “cold” for the patient’s constitution. However, no additional Chinese medicine treatments will be provided including Chinese herbal medicine, or additional physical or stimulation treatments such as moxibustion or cupping. Participants will attend for treatment at private clinics of the treating acupuncturists. Treating acupuncturists are advised that they may proceed according to usual clinical practice with the following limitations: • The acupuncture protocol must be targeted at weight loss as the primary outcome • The acupuncture protocol must adhere to the standardization applied to acupuncture points, manipulation, stimulation, retention time, frequency as described above • Only body acupuncture, diet and lifestyle advice (according to Chinese medicine) may be provided. Practitioners are free to practise as they usually practise. They will be trained to ask about adverse events, and to treat patients warmly and courteously. All efforts will be made to ensure the participants have a comfortable acupuncture experience. Practitioners will record details of each treatment on an individual Case Report Form which will be kept in a locked cupboard in the clinic and returned to the research team at the end of the study. Practitioner background A minimum of six practitioners have been chosen to administer the treatments. They are have a Bachelor degree in Chinese Medicine, have five or more years of clinical experience and are registered with the Chinese Medicine Registration Board. Co-intervention: Lifestyle intervention (health coaching) as provided by GethealthyNSW. All participants will register for the GetHealthy NSW program. All women will receive individually-tailored telephone-based lifestyle coaching for 3 months, consisting of 6 telephone calls from an exercise physiologist with nutrition training, exploring healthy eating, physical activity, and weight management. Lifestyle coaching is provided by Healthways under the GethealthyNSW program, which has been offered to all NSW residents for free by the NSW government since 2009. Medical referral is not required. Information given to participants is consistent with national guidelines on physical activity and nutrition, which are also recommended by national PCOS guidelines. Arm 2: Auricular Electro-acupuncture and lifestyle The intervention in this arm is auricular electro-acupuncture using a fixed protocol that is informed by both Chinese medical and medical acupuncture principles. Reasoning for treatment provided No Chinese medicine diagnosis is required. The acupuncture points are chosen based on a literature review and expert consensus on the traditional and physiological indications of the points. Extent to which treatment will be varied There is to be no variation in treatment. Details of needling Each subject will receive needling at three acupuncture points on the concha of one ear only. The ears are to be alternated between visits unless there is any objection from the participant. The core acupuncture points on the concha of the ear to be used are the Stomach, Appetite Control, and Thalamus points. No de qi sensation is to be sought. Needles are to be inserted superficially and not into the cartilage of the ear. The Neurova device will be attached after insertion of the needles to the ear, according to the manufacturer's instructions. Needles are retained for up to 96 hours. The participant is to remove the Neurova device by gently pulling out the needles and disconnecting the wire. The needles are then placed into a provided sharps container. Gentle pressure is applied with a cotton ball if there is any bleeding. Participants can remove the device before 96 hours if they experience significant discomfort. Participants bring the sharps container back to the post-intervention visit for adequate biological hazard waste disposal through NICM laboratories. Needles are surgical grade titanium, sterile and disposable and approximately 6mm in length. Women allocated to the AEA group will receive a total of 6 treatments of acupuncture over 12 weeks (twice a week for the first two weeks, then fortnightly for four treatments). Other components of treatment No additional Chinese medicine treatments will be provided including body acupuncture, Chinese herbal medicine, or additional physical or stimulation treatments such as moxibustion or cupping. Practitioner background A minimum of six practitioners have been chosen to administer the treatments. They are have a Bachelor degree in Chinese Medicine, have five or more years of clinical experience and are registered with the Chinese Medicine Registration Board. Participants in this arm will also receive the co-intervention of telephone-based health coaching/lifestyle intervention as described in the comparator