Polycystic ovary syndrome: a randomised feasibility and pilot study using Chinese Herbal medicine to explore Impact on Dysfunction (ORCHID) - Study Protocol
Polycystic ovary syndrome: a randomised feasibility and pilot study using Chinese Herbal medicine to explore Impact on Dysfunction (ORCHID) - Study Protocol
Introduction
We 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.
Methods
A 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 conclusion
This 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.
chinese herbal medicine, plycystic ovary syndrome, feasibility study, pilot, menstrual disorders, randomised controlled trial
Lai, Lily
4ad55f3d-3e0c-4faa-a981-cbbbb4319811
Flower, A.
5256a2c8-6e74-49be-acc8-463ed3c18c6a
Moore, M.
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Prescott, P.
cf0adfdd-989b-4f15-9e60-ef85eed817b2
Lewith, G.
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Lai, Lily
4ad55f3d-3e0c-4faa-a981-cbbbb4319811
Flower, A.
5256a2c8-6e74-49be-acc8-463ed3c18c6a
Moore, M.
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Prescott, P.
cf0adfdd-989b-4f15-9e60-ef85eed817b2
Lewith, G.
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Lai, Lily, Flower, A., Moore, M., Prescott, P. and Lewith, G.
(2014)
Polycystic ovary syndrome: a randomised feasibility and pilot study using Chinese Herbal medicine to explore Impact on Dysfunction (ORCHID) - Study Protocol.
European Journal of Integrative Medicine.
(doi:10.1016/j.eujim.2014.03.001).
Abstract
Introduction
We 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.
Methods
A 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 conclusion
This 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.
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More information
Accepted/In Press date: 2014
e-pub ahead of print date: 12 March 2014
Keywords:
chinese herbal medicine, plycystic ovary syndrome, feasibility study, pilot, menstrual disorders, randomised controlled trial
Organisations:
Primary Care & Population Sciences
Identifiers
Local EPrints ID: 364995
URI: http://eprints.soton.ac.uk/id/eprint/364995
ISSN: 1876-3820
PURE UUID: b3cc417b-02e6-4202-9f3d-e49c0ed2bfde
Catalogue record
Date deposited: 19 May 2014 11:46
Last modified: 15 Mar 2024 03:22
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Contributors
Author:
A. Flower
Author:
G. Lewith
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