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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 10.1186/ISRCTN09712705
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym Hoorah
Serial number at source Version 20
Study hypothesis 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
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Rheumatoid Arthritis
Participants - 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 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
Participants - 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
Anticipated start date 01/11/2005
Anticipated end date 30/04/2007
Status of trial Completed
Patient information material
Target number of participants 110
Interventions 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
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)
2. 35% improvement in patient global assessment scores from baseline to the end of treatment
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)
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
Sources of funding 1. Samueli Institute (USA)
2. Southampton Complementary Medical Research Trust (UK)
3. Department of Health (UK)
Trial website
Publications 1.2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15253853
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21076131
Contact name Dr  Sarah  Brien
  Address Complementary Medicine Research Unit
Aldermoor Health Centre
Aldermoor Close
  City/town Southampton
  Zip/Postcode SO16 5ST
  Country United Kingdom
  Tel +44 (0)2380 241 069
  Fax +44 (0)2380 701125
  Email sbb@soton.ac.uk
Sponsor University of Southampton (UK)
  Address Building 27
University of Southampton
Highfield
  City/town Southampton
  Zip/Postcode SO17 1BJ
  Country United Kingdom
  Tel +44 (0)2380 598849
  Fax +44 (0)2380 598671
  Email J.Roemer@soton.ac.uk
Date applied 17/10/2005
Last edited 21/12/2011
Date ISRCTN assigned 21/11/2005
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