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Treatment of secretory otitis media with local instillation of hydroxyzine
T C Theoharides1, S S Manolidis, H Vliagoftis
1Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine, Boston, Mass. 02111.
Insights
Hydroxyzine pamoate significantly reduced relapse rates in children with otitis media with effusion (SOM). This allergy medication also lowered histamine levels in middle ear fluid, suggesting a role in managing SOM.
Area of Science:
- Pediatrics
- Otolaryngology
- Allergy and Immunology
Background:
- Otitis media with effusion (SOM), also known as secretory otitis media, is common in children.
- Understanding the pathophysiology of SOM, including the role of mast cells and histamine, is crucial for effective treatment.
- Current treatment options for SOM may have limitations, necessitating investigation into alternative therapies.
Purpose of the Study:
- To investigate the efficacy of hydroxyzine pamoate in treating children with otitis media with effusion (SOM).
- To evaluate the effect of hydroxyzine pamoate on relapse rates and histamine levels in middle ear effusions.
- To explore the role of mast cells and histamine in the context of SOM pathophysiology.
Main Methods:
- A preliminary single-blind, placebo- and prednisolone-controlled study involving 156 children aged 2-12 years with SOM.
- Surgical insertion of ventilation tubes (grommets) followed by introduction of normal saline (control), prednisolone, or hydroxyzine pamoate solutions.
- Measurement of histamine levels in middle ear effusions and assessment of relapse rates.
Main Results:
- Hydroxyzine pamoate treatment significantly reduced the rate of SOM relapse compared to control and prednisolone groups.
- A significant reduction in histamine levels was observed in the middle ear effusions of children treated with hydroxyzine pamoate.
- The study suggests a potential link between histamine, mast cell activation, and the development or exacerbation of SOM.
Conclusions:
- Hydroxyzine pamoate demonstrates significant efficacy in reducing SOM relapses in children.
- The findings support the hypothesis that histamine plays a role in SOM, potentially mediated by mast cell activation.
- Hydroxyzine pamoate may be a valuable therapeutic option for managing otitis media with effusion, particularly in cases involving allergic mechanisms.
Abstract:
The study is a preliminary single-blind, placebo- and prednisolone-controlled investigation of the treatment of 156 children with otitis media with effusion (secretory otitis media, SOM), ranging from 2 to 12 years. The protocol involved tympanotomy and placement of a ventilation tube (grommet), through which control or drug solutions were introduced. Other parameters and coexisting symptoms which could contribute to SOM were also examined. Patients were divided into 3 groups as follows: group A: control (normal saline, 2 ml); group B: prednisolone (25 mg in 2 ml); group C: hydroxyzine pamoate (10(-5) M in 2 ml). The results indicate that in those children treated with hydroxyzine, the rate of relapse was significantly reduced and so was the amount of histamine present in middle ear effusions. The effectiveness of hydroxyzine is discussed in the context of the pathophysiology of SOM, especially with respect to mast cells and their activation by allergic and nonallergic means.