Improvement of Clinical Response in Allergic Rhinitis Patients Treated with an Oral Immunostimulating Bacterial Lysate: In Vivo Immunological Effects

Abstract

Allergic rhinitis is known to be one of the most common chronic diseases in the industrialized world. According to the concept that allergic rhinitis patients generally suffer from an immune deficit, in order to stimulate specifically or aspecifically their immune system, immunomodulating agents from various sources, such as synthetic compounds, tissue extracts or a mixture of bacterial extracts, have been used. The aim of the present trial is to evaluate the efficacy of the treatment with an immunostimulating vaccine consisting of a polyvalent mechanical bacterial lysate (PMBL) in the prophylaxis of allergic rhinitis and subsequently to analyze its in vivo effects on immune responses. 41 allergic rhinitis patients were enrolled: 26 patients were randomly assigned to the group for PMBL sublingual treatment and 15 others to the group for placebo treatment. For all 26 patients blood samples were drawn just before (To) and after 3 months of PMBL treatment (T 3) to evaluate plasma IgE levels (total and allergen-specific) and the cytokine production involved in the allergic response (IL-4, IFN-y). The results of our study indicate that PMBL is effective in vivo in the reduction or in the elimination of the symptoms in rhinitis subjects during the treatment period in comparison to a non-immunostimulating treatment. A significant and clinically relevant improvement was found in 61.5%, a stationary clinical response was registered in 38.4% and no negative side effects associated with the medication or worsening were recorded. At the end of a 3-month follow up period the clinical picture remained the same as that observed at T 3 • PMBL treatment did not affect the serum IgE levels (either total or allergen-specific) and did not induce significant changes in IFN-y concentration. In contrast, PMBL therapy may be accompanied, in some patients, by a potential immunomodulating activity by decreasing IL-4 cytokine expression. In the last 20 years allergies have increased in countries with a relatively high standard of living (I). Residency in urban or industrial areas, changes in lifestyle and the falling incidence of microbial infections may be responsible for this increase to some extent. Prevalence estimates suggest, for example, that seasonal allergic rhinitis occurs in 10% and perennial allergic rhinitis in 10-20% of individuals living in industrialized countries, and for children the prevalence rates may be as high as 40% (2). Poorly controlled allergic rhinitis is also a major risk factor for sinus infections and may contribute to the development of asthma and to exacerbations in those subjects who already have

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