A double blind, randomised, parallel group study evaluating the efficacy of a homeopathic remedy in asthma
| ISRCTN | ISRCTN56657172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56657172 |
| Protocol serial number | R/35/9.95/Holg |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South West |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 29/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr George Lewith
Scientific
Scientific
University of Southampton
Complementary Medicine Research Unit
Mailpoint OPH
Royal South Hants Hospital
Britons Terrace
Southampton
SO14 0YG
United Kingdom
| Phone | +44 023 8082 5246 |
|---|---|
| GL3@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory tract diseases: Asthma |
| Intervention | Participants were randomised to receive oral homeopathic immunotherapy or identical placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Not Specified |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/1996 |
| Date of final enrolment | 01/01/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Southampton
Southampton
SO14 0YG
United Kingdom
SO14 0YG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/03/2002 | Yes | No |
