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Homeopathic medication for seasonal allergic rhinitis-a randomised placebo-controlled trial
J Siewert1, H Cramer2, M Ortiz1
1Institute of Social Medicine, Epidemiology and Health Economics, Charité - University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Background:
The study aim was to evaluate the efficacy of homeopathic medication in SAR patients.
Methods:
In a double-blind, three-arm randomised trial, patients at eleven outpatient clinics and two medical centres were randomised to receive (1) individualised homeopathic case taking (IHCT) and standardised homeopathic medication with Galphimia Glauca (GG), (2) IHCT and individualised homeopathic treatment (IHG), or (3) IHCT and placebo (PG). Primary outcome was disease-specific quality of life, assessed using the Rhinitis Quality of Life Questionnaire (RQLQ) after three and four weeks. Secondary outcomes included response rate (≥0.5-point change in RQLQ), rescue medication use, and total nasal and non-nasal symptom scores (TNSS, TNNSS).
Results:
Sixty-two SAR patients (mean age ± SD: 46.9 ± 14.9; 43.5% female) were recruited, approximately 25% of the planned sample size. After weeks three and four, there were no significant differences in RQLQ (p = 0.244) between GG (adjusted mean, 1.2, 95% CI 0.7-1.7), IHG (1.7, 1.2-2.3), and PG (1.4, 0.8-2.0). High response rates were observed (GG: 86.4%, IHG: 66.7%, PG: 81.3%), while RM use was 21.7%, 55.6%, and 29.4%, respectively. There were no relevant differences in RM score, TNSS and TNNSS between the three groups. Eight adverse events but no serious adverse events were reported.
Conclusion:
Standardised and individualised homeopathic drugs were not superior compared to placebo suggesting that treatment response was not based on study medication. The validity of the study and its conclusions are limited by the fact that the recruitment target was not achieved.
Trial Registration:
This study has been registered in the German Clinical Trial Registry with trial ID DRKS00018081.
