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| [ Print-friendly version ] |
| A pilot patient cohort randomised controlled trial (RCT) of the effectiveness of an offer of treatment by a homeopath |
| ISRCTN | ISRCTN02875421 |
| ClinicalTrials.gov identifier | |
| Public title | A pilot patient cohort randomised controlled trial (RCT) of the effectiveness of an offer of treatment by a homeopath |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | Protocol v8 |
| 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. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Hot flushes |
| Participants - 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 |
| Participants - exclusion criteria |
1. Taking Hormone replacement therapy (HRT) and not intending to stop
2. On immunosuppressant drugs 3. Currently undergoing chemotherapy |
| Anticipated start date | 01/02/2007 |
| Anticipated end date | 01/11/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 50 |
| Interventions |
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 |
| Primary outcome measure(s) | Hot flush frequency and severity score at baseline and 36 weeks. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Department of Health Training fellowship (UK) |
| Trial website | |
| Publications | |
| Contact name | Mrs Clare Relton |
| Address |
University of Sheffield
Health Services Research (HSR) School of Health and Related Research (ScHARR) 3rd floor Regents Court 30 Regent Street |
| City/town | Sheffield |
| Zip/Postcode | S1 4DA |
| Country | United Kingdom |
| c.relton@sheffield.ac.uk | |
| Sponsor | University of Sheffield (UK) |
| Address |
University of Sheffield Research Office
New Spring House 231 Glossop Road |
| City/town | Sheffield |
| Zip/Postcode | S10 3GW |
| Country | United Kingdom |
| g.pearman@sheffield.ac.uk | |
| Sponsor website: | http://www.shef.ac.uk |
| Date applied | 25/04/2007 |
| Last edited | 09/06/2008 |
| Date ISRCTN assigned | 09/06/2008 |
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