Efficacy and Safety of Sterols/Sterolins in Allergic Rhinitis: A Randomised Double Blind placebo-controlled Clinical Trial

Abstract

Objective: Sterols/sterolins (Moducare®) have demonstrated immunomodulation and anti-inflammatory effects in preclinical studies, but no clinical trial of patients with allergic rhinitis has yet been published. Thus, our aim was to investigate the safety and efficacy of sterols/sterolins in patients with allergic rhinitis. Methods: The framework was a pilot double-blind randomized controlled clinical trial. Forty patients were randomized to receive Moducare® capsules or placebos for 12 weeks. Patients were evaluated at weeks 4, 8 and 12 with symptom severity questionnaires and immunological assays, including: serum total immunoglobulin E (IgE), eosinophil, and eosinophil cationic protein (ECP). The primary efficacy endpoint indicated the mean change of the allergic rhinitis symptoms score in the therapeutic period at week 12; the secondary efficacy endpoints represented the changes of the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) monthly score and the immunological assays of IgE, eosinophil and ECP at week 12. Results: A total of 28 patients (70%) completed the 12-week study, with eight patients dropping out of the Moducare® group and four patients dropping out of the placebo group. The results showed no significant adverse events of sterols/sterolins in this 12-week study. The results of the allergic rhinitis symptoms score, Mini-RQLQ, total IgE, eosinophil count and ECP value had no statistically significant changes in either group. Conclusions: While sterols/sterolins were well tolerated and safe in patients with allergic rhinitis, no significant clinical and immunological benefits were demonstrated in this 12-week pilot study.