Contact information
Type
Scientific
Primary contact
Dr George Lewith
ORCID ID
Contact details
University of Southampton
Complementary Medicine Research Unit
Mailpoint OPH
Royal South Hants Hospital
Britons Terrace
Southampton
SO14 0YG
United Kingdom
+44 023 8082 5246
GL3@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R/35/9.95/Holg
Study information
Scientific title
Acronym
Study hypothesis
The use of homoeopathy in the treatment of allergic disease remains controversial. Two recent reviews concluded that, of the numerous trials investigating homoeopathy, many were methodologically unsound. Numerous calls have been made for better designed and conducted studies in homoeopathy and other complementary therapies. Two such studies investigating the role of homoeopathy in patients with allergic rhinitis and asthma have been performed in Glasgow. Both of these randomised controlled trials reported a significant effect in favour of homoeopathy. This grant proposal aims to replicate the Glasgow findings in their asthma study using an identical treatment in a larger number of patients, and with greater statistical power. The protocol has been developed by extensive consultation within the research homoeopathic community, and will assess two main outcome measures, namely forced expiratory volume in one second FEV1) and the percentage of asthma problem-free days (%PFD). In addition it will employ a number of secondary outcomes to assess well being with respect to asthma. It is anticipated that this trial will provide guidance on whether homoeopathy should be available as a new service provision to purchasers within the NHS, and as such will have significant resource implications for the NHS.
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
Not Specified
Patient information sheet
Condition
Respiratory tract diseases: Asthma
Intervention
Participants were randomised to receive oral homeopathic immunotherapy or identical placebo
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Clinical based assessments: forced expiratory volume in one second (FEV1), quality of life and mood. Diary based assessments: morning and evening peak expiratory flow, visual analogue scale of severity of asthma, quality of life and daily mood
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1996
Overall trial end date
01/01/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Aged 18-55, positive skin prick test to house dust mite, re-diagnosed asthma in response to bronchodilators and activity limited by asthma during pre-treatment baseline period
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Previous drug trial within 30 days, previous treatment with homeopathic immunotherapy, pregnancy, respiratory tract infection within 3 weeks of recruitment or change in asthma medication in the 2 weeks prior to entry
Recruitment start date
01/04/1996
Recruitment end date
01/01/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton
Southampton
SO14 0YG
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South West
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
2002 results in: http://www.ncbi.nlm.nih.gov/pubmed/11872551
Publication citations
-
Results
Lewith GT, Watkins AD, Hyland ME, Shaw S, Broomfield JA, Dolan G, Holgate ST, Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial., BMJ, 2002, 324, 7336, 520.