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
Secondary identifying numbers Version 20
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

Complementary Medicine Research Unit
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone +44 (0)2380 241 069
Email sbb@soton.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymHoorah
Study objectivesThe 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) studiedRheumatoid Arthritis
InterventionArm 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 typeOther
Primary outcome measure1. 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)
2. 35% improvement in patient global assessment scores from baseline to the end of treatment
Secondary outcome measures1. 15% improvement from baseline to end of treatment in the Measure Yourself Medical Outcome Profile scores (MYMOP, a continuous variable)
2. Time to flare
3. Four weekly Disease Activity Score
4. Weekly analgesic use, and changes in conventional medication
5. Weekly pain scores
6. Weekly global assessment of symptoms
7. Adverse event monitoring
Overall study start date01/11/2005
Completion date30/04/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants110
Key inclusion criteria1. 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 Fuch’s 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 criteria1. 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 enrolment01/11/2005
Date of final enrolment30/04/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Complementary Medicine Research Unit
Southampton
SO16 5ST
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

Building 27
University of Southampton
Highfield
Southampton
SO17 1BJ
England
United Kingdom

Phone +44 (0)2380 598849
Email J.Roemer@soton.ac.uk
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

Government

Samueli Institute (USA)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Samueli Institute for Information Biology
Location
United States of America
Southampton Complementary Medical Research Trust (UK)

No information available

Department of Health (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 1. protocol 01/06/2004 Yes No
Results article results 01/06/2011 Yes No