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Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial seriesCommentary: Larger trials are needed

BMJ 2000; 321 doi: http://dx.doi.org/10.1136/bmj.321.7259.471 (Published 19 August 2000) Cite this as: BMJ 2000;321:471

Abstract

Objective: To test the hypothesis that homoeopathy is a placebo by examining its effect in patients with allergic rhinitis and so contest the evidence from three previous trials in this series.

Design: Randomised, double blind, placebo controlled, parallel group, multicentre study.

Setting: Four general practices and a hospital ear, nose, and throat outpatient department.

Participants: 51 patients with perennial allergic rhinitis.

Intervention: Random assignment to an oral 30c homoeopathic preparation of principal inhalant allergen or to placebo.

Main outcome measures: Changes from baseline in nasal inspiratory peak flow and symptom visual analogue scale score over third and fourth weeks after randomisation.

Results: Fifty patients completed the study. The homoeopathy group had a significant objective improvement in nasal airflow compared with the placebo group (mean difference 19.8 l/min, 95% confidence interval 10.4 to 29.1, P=0.0001). Both groups reported improvement in symptoms, with patients taking homoeopathy reporting more improvement in all but one of the centres, which had more patients with aggravations. On average no significant difference between the groups was seen on visual analogue scale scores. Initial aggravations of rhinitis symptoms were more common with homoeopathy than placebo (7 (30%) v 2 (7%), P=0.04). Addition of these results to those of three previous trials (n=253) showed a mean symptom reduction on visual analogue scores of 28% (10.9 mm) for homoeopathy compared with 3% (1.1 mm) for placebo (95% confidence interval 4.2 to 15.4, P=0.0007).

Conclusion: The objective results reinforce earlier evidence that homoeopathic dilutions differ from placebo.

Footnotes

    • Accepted 25 April 2000

    Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series

    1. Morag A Taylora, research associate,
    2. David Reilly (davidreilly1{at}compuserve.com)a, honorary senior lecturer in medicine,
    3. Robert H Llewellyn-Jonesb, lecturer,
    4. Charles McSharryc, principal immunologist,
    5. Tom C Aitchisond, senior lecturer in statistics
    1. a University Department of Medicine, Glasgow Royal Infirmary, Glasgow G31 2ER
    2. b Department of Psychological Medicine, University of Sydney, New South Wales 2006, Australia
    3. c University Department of Immunology, Western Infirmary, Glasgow G11 6NT
    4. d Department of Statistics, University of Glasgow, Glasgow G12 8QQ
    5. a Department of Primary Health Care, Institute of Health Sciences, Oxford OX3 7LF
    6. b Integrative Medicine Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA
    1. Correspondence to: D Reilly, Academic Departments, Glasgow Homoeopathic Hospital, Glasgow G12 0XQ
    • Accepted 25 April 2000

    Abstract

    Objective: To test the hypothesis that homoeopathy is a placebo by examining its effect in patients with allergic rhinitis and so contest the evidence from three previous trials in this series.

    Design: Randomised, double blind, placebo controlled, parallel group, multicentre study.

    Setting: Four general practices and a hospital ear, nose, and throat outpatient department.

    Participants: 51 patients with perennial allergic rhinitis.

    Intervention: Random assignment to an oral 30c homoeopathic preparation of principal inhalant allergen or to placebo.

    Main outcome measures: Changes from baseline in nasal inspiratory peak flow and symptom visual analogue scale score over third and fourth weeks after randomisation.

    Results: Fifty patients completed the study. The homoeopathy group had a significant objective improvement in nasal airflow compared with the placebo group (mean difference 19.8 l/min, 95% confidence interval 10.4 to 29.1, P=0.0001). Both groups reported improvement in symptoms, with patients taking homoeopathy reporting more improvement in all but one of the centres, which had more patients with aggravations. On average no significant difference between the groups was seen on visual analogue scale scores. Initial aggravations of rhinitis symptoms were more common with homoeopathy than placebo (7 (30%) v 2 (7%), P=0.04). Addition of these results to those of three previous trials (n=253) showed a mean symptom reduction on visual analogue scores of 28% (10.9 mm) for homoeopathy compared with 3% (1.1 mm) for placebo (95% confidence interval 4.2 to 15.4, P=0.0007).

    Conclusion: The objective results reinforce earlier evidence that homoeopathic dilutions differ from placebo.

    Footnotes

    • Funding Fondation Française pour la Recherche en Homeopathie, Blackie Foundation Trust, British Homoeopathic Association, and Scottish Homoeopathic Research and Education Trust. The project was initially part of a research fellowship created by the Research Council for Complementary Medicine in partnership with the Medical Research Council and the King's Fund.

    • Competing interests MAT's salary was partly paid by the Blackie Foundation Trust, British Homoeopathic Association, and Scottish Homoeopathic Research and Education Trust administered by Glasgow University. She was reimbursed for attending a symposium organised by the Blackie Foundation Trust. DR began this research programme before using homoeopathy or developing education. He uses homoeopathy in clinical care. He accepts occasional lecture and teaching fees but has no consultancy work. He has declined all direct industry grants for research and has used intermediary regulatory organisations to ensure independence.

    • Accepted 25 April 2000

    Commentary: Larger trials are needed

    1. Tim Lancaster, clinical reader in general practice (tim.Lancaster{at}public-health.oxford.ac.uk)a,
    2. Andrew Vickers, assistant attending research methodologistb
    1. a University Department of Medicine, Glasgow Royal Infirmary, Glasgow G31 2ER
    2. b Department of Psychological Medicine, University of Sydney, New South Wales 2006, Australia
    3. c University Department of Immunology, Western Infirmary, Glasgow G11 6NT
    4. d Department of Statistics, University of Glasgow, Glasgow G12 8QQ
    5. a Department of Primary Health Care, Institute of Health Sciences, Oxford OX3 7LF
    6. b Integrative Medicine Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA
    1. Correspondence to: T Lancaster

      Footnotes

      • Competing interests None declared.

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