Polycystic Ovary syndrome: A Randomised feasibility and pilot study using Chinese Herbal medicine to explore Impact on Dysfunction (ORCHID)-Study protocol

IntroductionWe aim to evaluate the feasibility of, and pilot procedures for, a randomised study in the UK administering Chinese herbal medicine (CHM) to women with polycystic ovary syndrome (PCOS) related oligo- and/or amenorrhoea. Our primary aim of this feasibility study is to evaluate how appropriate oligo- and amenorrhoea is as the primary outcome of the main study.MethodsA prospective, multi-centre, randomised, patient- and practitioner-blind, feasibility and pilot study will be conducted. 40 women with PCOS-related oligo- and/or amenorrhoea will be randomised to one of two parallel arms comparing standardised CHM treatment against individualised CHM treatment as usual for 6 months. Participants will be prescribed 8 g of CHM granulated extracts twice daily, totalling 16 g per day. Feasibility will be determined by collecting data on menstrual regularity, body mass index, waist hip ratio, weight, Polycystic Ovary Syndrome Questionnaire, Measure Yourself Medical Outcome Profile, Dermatology Life Quality Index, Morisky Medication Adherence Scale, modified Ferriman-Gallwey scale, liver and kidney function, practitioner-blinding questionnaire and participant feedback forms. Process data will also inform feasibility such as recruitment rate, completion rate and reasons for dropout. Statistical analysis will be piloted in this study. We will present descriptive statistics for primary and secondary variables and use analysis of variance and Chi-squared tests where appropriate.Results and conclusionThis study received ethical approval in December 2012. 40 participants were recruited between January 2013 and August 2013 and the study is expected to complete in March 2014.