Efficacy of a food supplement Lertal® as an adjuvant therapy of patients with moderate-to-severe seasonal allergic rhinoconjunctivitis

Abstract

Abstract Background Lertal® is an oral food supplement containing 80 mg of dry extract of Perilla frutescens, 150 mg of bioflavonoid quercetin, and 5 μg of vitamin D3. The aim of this study was to evaluate the efficacy of Lertal® as a complementary therapy to topical therapy of patients with moderate-to-severe seasonal allergic rhinoconjunctivitis (SAR). Results Seventy (n=70) adult patients with moderate-to-severe SAR were included in this prospective study and treated by four different procedures: (1) 21 patients received azelastine intranasal spray for 30 days and, after that, azelastine spray and Lertal® tablets for the next 30 days; (2) 19 patients received combined azelastine with fluticasone intranasal spray for 30 days and azelastine with fluticasone spray and Lertal® tablets for the next 30 days; (3) 15 patients received azelastine spray only for 60 days; (4) 15 patients received combined azelastine with fluticasone spray only for 60 days. Levels of SAR symptoms (sneezing, tearing, ocular itching, rhinorrhea, nasal obstruction, hyposmia, and cough), as well as Total Symptom Scores (TSS), were evaluated at the start of this investigation (visit 0), after 30 days of treatment (visit 1), and after 60 days of treatment (visit 2) using a visual analog scale. After 30 days of treatment, better effects were achieved in groups in which patients were treated with combined (antihistamine with corticosteroid) spray. After 60 days of therapy, we found the best effects in procedure 2 and slightly worse effects in procedure 1. The high differences in the reduction of TSS between the 60th and 30th day were found for procedure 2 (p<0.001) and procedure 1 (p<0.001). The worse improvement of symptoms we found was in procedure 4 (p<0.01), and, for the procedure 3, we found no significant difference (p=0.140). None of the patients reported adverse effects during the therapy. Conclusion Our results suggest that addition of food supplement Lertal® to the standard topical therapy of patients with moderate-to-severe SAR increases the effects of intranasal therapy in reducing nasal and ocular symptoms.