Contact information
Type
Scientific
Primary contact
Mrs Clare Relton
ORCID ID
Contact details
University of Sheffield
Health Services Research (HSR)
School of Health and Related Research (ScHARR)
3rd floor Regents Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
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c.relton@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol v8
Study information
Scientific title
A pilot patient cohort randomised controlled trial (RCT) of the effectiveness of an offer of treatment by a homeopath
Acronym
Study hypothesis
The objectives of the pilot study were to assess the following:
1. Willingness of patients to fill in questionnaires, consent to further questionnaires and consent to have data used
2. Willingness of participants to accept the intervention
3. Rate of compliance with the intervention
4. Suitability of the outcome measures chosen
5. Variance of the outcome variable
6. Changes in the health condition in the control group
Estimates of these parameters, especially the variance, will be used to recalculate the sample size to ensure that any main trial has sufficient power.
Ethics approval
South Sheffield NHS Research Ethics Committee. Date of approval: 30/01/2007 (ref: 06/Q2305/181)
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hot flushes
Intervention
Intervention group: Offer of a course of treatment by a homeopath. A series of between one to five appointments with a homeopath, the first consultation being around one hour and subsequent appointments being 20 - 30 minutes in duration.
Control group: No treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Hot flush frequency and severity score at baseline and 36 weeks.
Secondary outcome measures
The following outcomes were measured at baseline and 36 weeks:
1. Euro Quality of Life questionnaire (EQ-5D)
2. Measure yourself Medical Outcome profile (MYMOP2; a quality of life measure)
3. Medication Change questionnaire
4. Health economics information regarding the following:
4.1. Number of hospital admissions
4.2. GP visits
4.3. Time taken off work
4.4. Loss of earnings
4.5. Impact of hot flushes on household activities
4.6. Special diets
Overall trial start date
01/02/2007
Overall trial end date
01/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants for this trial were recruited from those participating in an observational study entitled "Women's Midlife Health Survey" conducted in Sheffield in 2005. The study was funded by a Research Capacity Development Award from the Department of Health.
Inclusion criteria:
1. Female, aged 45-65
2. Fourteen or more hot flushes or night sweats per week, or self rating of hot flushes or night sweats as severe or very severe
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50
Participant exclusion criteria
1. Taking Hormone replacement therapy (HRT) and not intending to stop
2. On immunosuppressant drugs
3. Currently undergoing chemotherapy
Recruitment start date
01/02/2007
Recruitment end date
01/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Sheffield
Sheffield
S1 4DA
United Kingdom
Sponsor information
Organisation
University of Sheffield (UK)
Sponsor details
University of Sheffield Research Office
New Spring House
231 Glossop Road
Sheffield
S10 3GW
United Kingdom
-
g.pearman@sheffield.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Health Training fellowship (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 study design in https://www.ncbi.nlm.nih.gov/pubmed/20304934
2. 2012 results of pilot study in https://www.ncbi.nlm.nih.gov/pubmed/22551742
Publication citations
-
Study design
Relton C, Torgerson D, O'Cathain A, Nicholl J, Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design., BMJ, 2010, 340, c1066.
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Results
Relton C, O'Cathain A, Nicholl J, A pilot 'cohort multiple randomised controlled trial' of treatment by a homeopath for women with menopausal hot flushes., Contemp Clin Trials, 2012, 33, 5, 853-859, doi: 10.1016/j.cct.2012.04.003.