The University of Southampton
Medicine

Research project: ORCHID 2 - Standardised Chinese Herbal Medicine for Menstrual Irregularity in Polycystic Ovary Syndrome: Nominal Group Technique and Prospective Observational Study

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The aim of this project is to improve quality of life for people with PCOS (polycystic ovary syndrome) by exploring new treatments for related oligo- and amenorrhoea (i.e. irregular or absent menstrual periods due to PCOS).

Project Overview

Firstly, we will derive a standardised four-herb remedy for polycystic ovary syndrome using nominal group technique, exploring the feasibility of this approach to seek consensus amongst herbalists. Secondly, we will assess the feasibility of evaluating the clinical effects, safety and adverse events relating to this remedy.

For the first phase of the study, registered Chinese herbal medicine (CHM) practitioners with at least 5 years’ experience in PCOS or gynaecology will be invited to the study. A narrative synthesis of the current literature regarding CHM-prescribing in PCOS will be sent to eligible practitioners. They will then be allowed independent thinking time before being invited to complete an online questionnaire. Analysis of the questionnaire responses will inform development of a group topic guide. During the semi-structured group discussion, contents of herbal prescriptions will be amended in real time as a direct result of comments from practitioners.  At the end of the group discussion, individual voting will take place for each of the herbal prescriptions. The highest-ranking four-herb prescription will be considered the most appropriate to evaluate in the subsequent observational study. Group discussion will be analysed using the framework analysis approach.

The second phase is a prospective observational feasibility study, with before and after outcome assessments for a single group of participants. Women aged 18 to 44 years with oligomenorrhoea or amenorrhoea will be given the four-herb standardised remedy that was finalised in phase 1. The key outcomes of interest include menstrual cyclicity, health-related quality of life, hirsutism and safety by evaluating liver and kidney function. These outcomes will be collected over 24 weeks.

Based on the previous studies, it is estimated that 15 women would provide sufficient data to explore the variability in the key outcome measures to help inform a future sample size calculation for a larger main study.  Allowing for up to 30% drop out in this study would require at least 22 participants. Given that this will be a non-randomised observational study, the recruitment target of up to 25 participants is considered feasible.

INVESTIGATORS: Lily Lai, Andrew Flower, Xiao-Yang Hu, Dawn Dobson, Miriam Santer, Merlin Willcox

FUNDER: NIHR SPCR

Duration: April 2017 to June 2018

Contact: X.Hu@soton.ac.uk    

 

 

 

Related research groups

Primary Care & Population Sciences Academic Units
Primary care Research group

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