Homeopathy for seasonal allergic rhinitis: rationale, design and methods of the three-armed randomized controlled HOMEOSAR trial

J. Siewert; M. Teut; K. Gaertner; S. Binting; C. Eberhardt; M. Ortiz; W. Grabowska; T. Reinhold; S. Roll; B. Stoeckigt; S. N. Willich; H. Cramer; B. Brinkhaus

doi:10.1186/s12906-022-03820-w

BMC Complementary Medicine and Therapies (Dec 2022)

Homeopathy for seasonal allergic rhinitis: rationale, design and methods of the three-armed randomized controlled HOMEOSAR trial

J. Siewert,
M. Teut,
K. Gaertner,
S. Binting,
C. Eberhardt,
M. Ortiz,
W. Grabowska,
T. Reinhold,
S. Roll,
B. Stoeckigt,
S. N. Willich,
H. Cramer,
B. Brinkhaus

Affiliations

J. Siewert: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin
M. Teut: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin
K. Gaertner: Institute for Integrative Medicine, University of Witten/Herdecke
S. Binting: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin
C. Eberhardt: Pharmacy Department, Freie Universität Berlin and Humboldt-Universität zu Berlin
M. Ortiz: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin
W. Grabowska: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin
T. Reinhold: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin
S. Roll: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin
B. Stoeckigt: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin
S. N. Willich: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin
H. Cramer: Department of Internal and Integrative Medicine, Faculty of Medicine, Evang. Kliniken Essen-Mitte, University of Duisburg-Essen
B. Brinkhaus: Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin

DOI: https://doi.org/10.1186/s12906-022-03820-w
Journal volume & issue: Vol. 22, no. 1
pp. 1 – 9

Abstract

Read online

Abstract Background Patients with seasonal allergic rhinitis (SAR) frequently use homeopathic therapy. Although there is some evidence that homeopathy may be effective in treating symptoms of SAR, there is a lack of high-quality clinical trials. Therefore, the aim of the homeopathy for SAR (HOMEOSAR) trial is to determine the efficacy of individualized or standardized homeopathic drug treatment compared to placebo regarding rhinitis-related quality of life in patients with SAR. Methods This randomized, placebo-controlled, double-blind, three-armed intervention study will be conducted at two university hospital outpatient clinics for complementary and integrative medicine in Berlin and in 12 office-based practices specializing in homeopathic treatment in Germany. A total of 270 patients with clinical symptoms of SAR and positive allergy test to birch and grass pollen will receive homeopathic anamnesis and subsequently be randomized into (a) standardized homeopathic drug treatment with Galphimia Glauca (potency D6), (b) individualized homeopathic drug treatment (D6), or (c) placebo. All three groups can receive on-demand rescue medication as needed. Treatment will consist of two consultations and daily intake of the study medication for 4 weeks during the pollen season. The primary outcome is the mean overall score of the Rhinitis Quality of Life Questionnaire (RQLQ) in weeks 3 and 4, analyzed using analysis of covariance (adjusted for baseline RQLQ overall score and study center). A closed testing procedure will be used to control the overall type I error comparing the 3 treatment groups. Secondary outcomes include the overall RQLQ and its seven domain scores, responder status (decrease in RQLQ overall score of at least 0.5 points compared to the baseline value), use of rescue medication, intensity of total and individual SAR symptoms based on visual analog scale, generic health-related quality of life, safety, utilization of health care resources and associated costs. In addition, a qualitative data analysis is planned. Conclusion The results of our study will contribute to clarifying the possible therapeutic effects of homeopathic drug treatment for patients with SAR. Trial registration This study has been registered in the German Clinical Trial Registry with trial ID DRKS00018081 on June 09, 2020.

Published in BMC Complementary Medicine and Therapies

ISSN: 2662-7671 (Online)
Publisher: BMC
Country of publisher: United Kingdom
LCC subjects: Medicine: Other systems of medicine
Website: https://bmccomplementmedtherapies.biomedcentral.com/

About the journal

Abstract

Keywords