Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/11/2013
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 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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2002 results in: http://www.ncbi.nlm.nih.gov/pubmed/11872551

Publication citations

  1. 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.

Additional files

Editorial Notes