Effect of nasal polivalent bacterial lysate on the clinical course of seasonal allergic rhinitis in children - preliminary study

Background: Seasonal allergic rhinitis (SAR) is an inflammatory condition of the upper airways that occurs in response to exposure to airborne allergens. In Poland SAR is the most often caused by grass pollen. Current research shows the positive effect of polyvalent bacterial lysates (PBL) in their use in the prevention and treatment of asthma and allergic rhinitis. Methods: A randomized, double-blind, placebo-controlled study included 40 children aged 6-17 years with SAR caused by grass pollen. One group (n=18) received nasal PBL (NPBL-Polyvaccinum® mite, IBSS BIOMED S.A.) during the grass pollen season once daily nasal for 6 weeks in addition to typical antihistamine treatment and nasal steroids. The remaining patients (n=22) did not receive NPBL. The severity of SAR symptoms and associated eye symptoms were assessed by: TNSS, TOSS, NPIF, VAS for nasal (nVAS) and eye symptoms (eVAS). The average values of TNSS, TOSS obtained at the beginning and at the end of the grass pollen season and NPIF values, nVAS, eVAS were used for statistical analysis. Study was approved by the Bioethic Committee and patients had to give written informed consent to participate in the study. Results: P-Value (with α=0.05) for all tests are as follow: general test – 0.39, TNSS – 0.11, TOSS – 0.08, NPIF – 0.01, nVAS – 0.03, eVAS – 0.48. It means that NPBL treatment does not improve clinical symptoms. Conclusion: Administration of NPBL in the pollen season does not improve the process of SAR in relation to patients taking placebo, but improves NPIF and nVAS. Further studies with higher number of patient are highly required.