Acupuncture or ear acupuncture for weight loss in Polycystic Ovary Syndrome

INTERVENTION: 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 • Needles are manipulated after ten minutes (thrusting, twirling and rotating until De qi is reported) • Needles are withdrawn after 30 minutes Details of needling A minimum of ten acupuncture needles will be inserted per session.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. 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 • 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. Practitioner background CONDITION: Obesity Overweight Polycystic Ovary Syndrome INCLUSION CRITERIA: • women aged 18‐45 years 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: 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. 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 PRIMARY OUTCOME: Acceptability assessed by an exit survey designed specifically for the study Recruitment rate as calculated by number of women enrolled per month of recruitment Retention rate calculated as number of women remaining in study at 3 months post intervention as a proportion of number of women who enrolled in the study SECONDARY OUTCOME: Anxiety and Depression (DASS 21) Blood pressure by digital blood pressure monitor Body Mass Index using digital scale and stadiometer Clinical hirsutism score (Ferriman‐Galwey) Compliance with lifestyle coaching provided by GetHealthyNSW from brief patient survey designed specifically for the study Credibility and expectations of treatment using Credibility and Expectancy Questionnaire (validated, composite outcome) Glucose tolerance using 2 hr OGTT Health related Quality of Life (MPCOS Q) Heart rate variability using piezoelectric ambulatory monitor as well as ECG monitor Insulin resistance (2 hr Oral Glucose Tolerance Test) Menstrual cyclicity using a participant menstrual journal recording first day of each menstrual period modified version of the validated Multidimensional Health Locus of Control Scales Physical activity levels (using an accelerometer) Quality of Life (EQ5D) Testosterone by serum assay Waist measurement by tape measure, collected during clinic visits by research assistant Weight Efficacy Lifestyle Questionnaire Weight using digital scale • physician diagnosis of PCOS according to the 2003 Rotterdam Criteria in previous 5 years • BMI greater than 25 kg/m2; no other endocrine disorders; • not pregnant/no pregnancies in preceding 6 weeks and more than 6 weeks postpartum; • not on the following medications in the 3 months preceding enrolment: metformin or other medications affecting insulin and glucose metabolism, hormonal treatments for PCOS/ART including gonadotrophins and the Oral Contraceptive Pill, pharmaceutical or complementary therapies for weight loss