Contact information
Type
Scientific
Primary contact
Dr Sarah Brien
ORCID ID
Contact details
Complementary Medicine Research Unit
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)2380 241 069
sbb@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 20
Study information
Scientific title
Acronym
Hoorah
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
Ethics approval
Not provided at time of registration
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
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/11/2005
Overall trial end date
30/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Participant 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
Recruitment start date
01/11/2005
Recruitment end date
30/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Complementary Medicine Research Unit
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
Building 27
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
+44 (0)2380 598849
J.Roemer@soton.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Samueli Institute (USA)
Alternative name(s)
Samueli Institute for Information Biology
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United States of America
Funder name
Southampton Complementary Medical Research Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department of Health (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
Basic results (scientific)
Publication list
1.2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15253853
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21076131
Publication citations
-
Results
Brien S, Lachance L, Prescott P, McDermott C, Lewith G, Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial., Rheumatology (Oxford), 2011, 50, 6, 1070-1082, doi: 10.1093/rheumatology/keq234.
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Brien S, Lachance L, Lewith GT, Are the therapeutic effects of homeopathy attributed to the consultation, the homeopathic remedy, or both? A protocol for a future exploratory feasibility trial in patients with rheumatoid arthritis., J Altern Complement Med, 2004, 10, 3, 499-502, doi: 10.1089/1075553041323768.