Condition category
Musculoskeletal Diseases
Date applied
17/10/2005
Date assigned
21/11/2005
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 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

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)

SI

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes