Are the therapeutic effects of homeopathy attributed to the consultation, the homeopathic remedy or both? An exploratory randomised controlled trial in rheumatoid arthritis (RA) patients
| ISRCTN | ISRCTN09712705 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09712705 |
| Protocol serial number | Version 20 |
| Sponsor | University of Southampton (UK) |
| Funders | Samueli Institute (USA), Southampton Complementary Medical Research Trust (UK), Department of Health (UK) |
- Submission date
- 17/10/2005
- Registration date
- 21/11/2005
- Last edited
- 21/12/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sarah Brien
Scientific
Scientific
Complementary Medicine Research Unit
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 (0)2380 241 069 |
|---|---|
| sbb@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Hoorah |
| Study objectives | The aims of this study are based on the following two hypotheses: 1. Those who receive a homeopathic remedy (be it classical single individualised or complex homeopathy) will experience more benefit in RA endpoints compared with the placebo group 2. Those who receive homeopathy with consultation will experience more benefit in RA end points as compared with those who receive homeopathy with no consultation |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Rheumatoid Arthritis |
| Intervention | Arm 1: Consultation + individualised homeopathic treatment Arm 2: Consultation + rheumatoid complex Arm 3: Consultation + placebo Arm 4: No consultation + rheumatoid complex Arm 5: No consultation + placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
1. 20% improvement from baseline to end of treatment in global RA symptoms (ACR20, a binary outcome) based on the Outcome Measures for Arthritis Clinical Trials (OMERACT) |
| Key secondary outcome measure(s) |
1. 15% improvement from baseline to end of treatment in the Measure Yourself Medical Outcome Profile scores (MYMOP, a continuous variable) |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 110 |
| Key inclusion criteria | 1. Aged over 18 2. Formal diagnosis of RA (American College of Rheumatology [ACR] guidelines) for at least two years 3. On stable medication for at least three months 4. Have a minimum Disease Activity Score (DAS) of over 2.6 (based on Fuchs 28 joint count) 5. Have a Patient Global Assessment (visual analogue scale [VAS]) score of 30 mm or above and at least 3 tender joints 6. Ability to comply with the requirements of the study and to give informed consent |
| Key exclusion criteria | 1. Those with severe co-morbidities e.g. cancer that would make their RA symptoms unstable 2. Participation in an investigational trial within 45 days prior to enrolment 3. Those patients having any condition that requires immunosuppressant treatments for the treatment of cancer 4. Those patients taking biological disease-modifying anti-rheumatic drugs (i.e. anti-tumour necrosis factor [TNF]) 5. Those classified as functional status IV based on the Classification of Global Functional Status in Rheumatoid Arthritis 6. Those who are currently using homeopathy, or have used homeopathy within the past 3 months 7. Those who are pregnant or hoping to become pregnant or breastfeed within the duration of the study |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Complementary Medicine Research Unit
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2011 | Yes | No | |
| Protocol article | 1. protocol | 01/06/2004 | Yes | No |
