PMID: 16504956Mar 1, 2006Paper

Efficacy and tolerability of a spray with Salvia officinalis in the treatment of acute pharyngitis - a randomised, double-blind, placebo-controlled study with adaptive design and interim analysis

European Journal of Medical Research
Michael HubbertW Kehrl

Abstract

This randomised, double-blind, parallel group phase II/III study with adaptive two-stage design and interim analysis compared the efficacy and tolerability of spray (containing a Salvia officinalis fluid extract) against placebo in the treatment of patients with acute viral pharyngitis. - in two study parts, a total of 286 patients with subjective and objective evidence of pharyngitis were randomized. In the first study part 122 patients were enrolled. In the second study part 164 patients were included. The treatment duration per patient was 3 days, including one baseline visit and one final visit. - Area under Curve for change of throat pain intensity (spontaneous pain), documented every 15 minutes within the first 2 hours after the first application as compared to baseline using a visual analog scale (VAS 100 mm). - Following the interim analyses of the first study part the 15 % spray containing 140 microl sage extract per dose was the most promising preparation for the second study part (main study) whereas for the 30% and the 5% preparation results made superiority over placebo unlikely in the final analysis. Overall, the 15 % spray was significantly superior to placebo for the primary efficacy variable with regard to a re...Continue Reading

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