Clinical trial NCT00744510: Reflexology's Effect on Polycystic Ovary Syndrome (PCOS)
Official title: Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Reflexology
Complementary and Alternative Medicine
Endocrinopathy
Oligo
Amenorrhoea
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2008-09-01
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic Ovary Syndrome (PCOS) is very common, affecting approximately 5% of women of reproductive age, and impacts not only on quality of life, but also has long-term health consequences for many sufferers, such as increased risks of developing Type II diabetes, cardiovascular disease and cancer of the womb. The symptoms that may occur such as irregular periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to poor self-esteem. Whilst treatments can help fertility, other treatments to correct the other symptoms are less successful. Alternative methods to regulate periods would be helpful, especially ones which avoid the long-term use of steroids in patients who may already be overweight. Reflexology is poorly represented in scientific papers, with nothing published regarding reflexology and its effect upon PCOS. However patients who use reflexology report more regular periods, thicker hair on scalp and greater wellbeing. Therefore we aim to investigate the effect of reflexology on:

1. The menstruation cycle (normal being every 21-35 days).
2. Imbalances in hormone, insulin and blood sugar levels associated with PCOS.
3. Other problems associated with PCOS such as thinning hair on scalp, excessive body hair, and obesity.
4. Quality of life. Government and NHS agendas agree that if there's evidence of an effective complimentary therapy the NHS should provide it. Therefore the results may have an influence on the care pathways of patients with PCOS towards a more holistic, patient centred and empowered approach. It is also non invasive and liable to result in higher patient satisfaction regarding their treatment. This research may also inform policy makers so that complementary medicine provision is provided on a wider basis within the NHS, which at the moment is dictated by the individual Trust's budget allocation. However this research could save money overall as in America, the yearly cost of treating PCOS is $4.36 billion.


Eligibility criteria: Inclusion Criteria:

* Women with PCOS

Exclusion Criteria:

* Use of complimentary therapies within 6/12 prior to recruitment
* BMI \>35
* Taken combined oral contraceptives, metformin, or cyclical progestogens within 3/12 prior to recruitment

Primary outcomes:
measure: To identify the most appropriate primary outcome measure for the ensuing RCT
timeFrame: Week 30
Secondary outcomes:
measure: Attainment of normal menstrual cycle length (i.e. 21-35 days)
timeFrame: 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
measure: Hormonal imbalances and irregular menses (commonly regarded at 6 cycles per annum or less)
timeFrame: 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
measure: Weight, body mass index (BMI), hirsutism, thinning hair
timeFrame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
measure: Fasting Insulin and blood sugar levels
timeFrame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
measure: Quality of Life
timeFrame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham Hospitals
Study officials:
affiliation: University of Nottingham
name: Dawn-Marie Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References: