[Investigation of the effect of oxymetazoline on the duration of rhinitis. results of a placebo-controlled double-blind study in patients with acute rhinitis].

AIMS AND
METHOD: A prospective placebo-controlled double-blind study investigated the question whether oxymetazoline has a clinically relevant impact on the duration of acute rhinitis. The study included 247 patients with acute rhinitis who, over a maximum of 10 days, received either oxymetazoline hydrochloride (test substance group) or physiological saline solution applied in the form of a spray (control group). The main target measure was the duration of rhinitis, with time to onset of effect and symptoms as secondary measures. The safety of the treatment was determined on the basis of patient satisfaction, heart rate measurement, and undesired side effects recorded.
RESULTS: The duration of the rhinitis decreased significantly under oxymetazoline in comparison with the control group (4 vs. 6 days). On average, the effect of oxymetazoline set in after 25 seconds, as compared with 90 seconds for physiological saline (difference significant, P < 0.001). From the second day of treatment, the symptoms improved significantly more markedly in the oxymetazoline group, and were identical again in both arms of the study from the 9th day onward. The physicians assessed the efficacy of oxymetazoline to be good orvery good in 85% of the cases as compared with 38% for the physiological saline solution (P <0.001). 84% of the patients in the oxymetazoline group assessed the effect to be good or very good, as compared with 44% in the patients in the physiological saline group (P < 0.001).
CONCLUSION: All the parameters investigated revealed oxymetazoline to be significantly superior to physiological saline solution. Treatment with the former significantly shortened the duration of the rhinitis by one-third (2 days).

RCT Entities:   Population Interventions Outcomes