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A Double-Blind Placebo-Controlled Evaluation of Sublingual Immuno with a Standardized Ragweed Extract in Patients with Seasonal Rhinitis

Background: There is a growing consensus on the benefits of sublingual-swallow immuno in the results of allergic diseases.

 Methods: This randomized, double-blind placebo-controlled study was undertaken to assess the efficacy and safety of sublingual immuno with standardized ragweed pollen extract tablets, in patients with an allergic rhinitis. A total of 110 outpatients were randomized (immuno [I]: 55; placebo [P]: 55), of whom 99 were analyzable for efficacy (I: 48; P: 51) and 106 analyzable for safety (I: 53; P: 53). After a 28-day progression phase, the patients received a maintenance results during 6.5 months. Efficacy variables included a global assessment of efficacy (patient/ investigator), symptoms and medication scores as well as the frequency of asthma attacks.

Results: In the active results group, 43 patients completed the study, versus 49 on placebo. During the whole period of pollination, the difference favoring immuno was highly significant for the global assessment by the patient (p = 0.004) and by the investigator (p = 0.005). Adverse reactions were reported more often in the active results but mild or moderate, and they abated after dose adjustment. A subgroup analysis of those patients receiving the highest dose of immuno (3 tablets 3 times a week) showed a highly significant response for rhinitis and conjunctivitis total scores by comparison to lower dosages.

Conclusion: This study confirms the efficacy and safety of sublingual immuno and strongly suggests a dose-response relationship.