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Double blind placebo controlled exposure to molds: exposure system and clinical results
H W Meyer1, K A Jensen, K F Nielsen
1Epidemiological Research Unit, Clinic of Occupational and Environmental Medicine, H:S Copenhagen University Hospital Bispebjerg, Copenhagen NV, Denmark. hmeyer@dadlnet.dk
Unlabelled:
The objective was to develop an experimental setup for human exposure to mold spores, and to study the clinical effect of this exposure in sensitive subjects who had previously experienced potentially building-related symptoms (BRS) at work. From three water-damaged schools eight employees with a positive histamine release test to Penicillium chrysogenum were exposed double- blinded to either placebo, approximately 600,000 spores/m3 air of P. chrysogenum or approximately 350,000 spores/m3 of Trichoderma harzianum for 6 min on three separate days. A statistically significant rise in symptoms from mucous membranes appeared from the 9-graded symptom scale after exposure to T. harzianum or placebo. Dichotomizing the data, whether the participants experienced at least a two-step rise on the symptom scale or not, gave borderline increase in mucous membrane symptoms after exposure to P. chrysogenum. In conclusion this is, to our knowledge, the first study to successfully conduct a human exposure to a highly controlled dose of fungal material aerosolized directly from wet building materials. This short-term exposure to high concentrations of two different molds induced no more reactions than exposure to placebo in eight sensitive school employees. However, a statistical type II error cannot be excluded because of the small sample size.
Practical Implications:
In this double blind, placebo controlled study of mold exposure changes in symptoms, objective measurements and blood samples were small and mostly non-significant, and at the same level as after placebo exposure. The developed exposure system based on the Particle-Field and Laboratory Emission Cell (P-FLEC) makes it possible to deliver a precise and highly controlled dose of mold spores from water-damaged building materials, imitating realistic field exposure conditions. The present experiment is too small to rule out an effect of mold exposure; long-term experimental exposure studies on larger number of subjects are needed.
Insights
This study exposed sensitive individuals to mold spores from water-damaged buildings. Short-term exposure to high mold concentrations did not significantly increase symptoms compared to placebo, but larger studies are needed.
Area of Science:
- Environmental Health
- Mycology
- Occupational Medicine
Background:
- Building-related symptoms (BRS) affect individuals working in water-damaged environments.
- Mold spores are a common indoor air pollutant linked to various health issues.
- Previous studies often lack controlled exposure to realistic mold sources.
Purpose of the Study:
- To develop an experimental setup for controlled human exposure to mold spores.
- To investigate the clinical effects of mold spore exposure in sensitive individuals with a history of BRS.
- To assess reactions to Penicillium chrysogenum and Trichoderma harzianum from wet building materials.
Main Methods:
- Development of a novel exposure system (Particle-Field and Laboratory Emission Cell - P-FLEC).
- Double-blind, placebo-controlled exposure of 8 sensitive employees to mold spores (P. chrysogenum, T. harzianum) or placebo.
- Utilized a 9-graded symptom scale to record mucous membrane and other symptoms.
Main Results:
- A statistically significant increase in mucous membrane symptoms was observed after exposure to T. harzianum and placebo.
- Borderline increase in mucous membrane symptoms noted after P. chrysogenum exposure.
- No significant differences in symptoms, objective measurements, or blood samples were found compared to placebo.
Conclusions:
- The developed P-FLEC system successfully delivered controlled doses of mold spores from building materials.
- Short-term exposure to high concentrations of P. chrysogenum and T. harzianum did not induce significant reactions in sensitive individuals.
- The study's small sample size prevents ruling out a mold exposure effect; larger, long-term studies are recommended.
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