Condition category
Signs and Symptoms
Date applied
25/04/2007
Date assigned
09/06/2008
Last edited
16/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
c.relton@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol v8

Study information

Scientific title

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 measures

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

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

http://www.shef.ac.uk

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

Results - basic reporting

Publication summary

1. 2010 study design in http://www.ncbi.nlm.nih.gov/pubmed/20304934
2. 2012 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/22551742

Publication citations

  1. 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.

  2. Pilot study

    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.

Additional files

Editorial Notes