OBJECTIVES: The aim of this study was to compare the efficacy and tolerance of Dérinox (D) to Rhinofluimucil (R) and placebo (P) in the treatment of common cold, using an objective measure of nasal obstruction, the Peak Nasal Inspiratory Flow (PNIF--Clement Clarke International, Harlow, Angleterre). PATIENTS AND METHODS: This randomized, double-blind, double-dummy, parallel group study enrolled 354 patients (34 P, 165 D et 155 R) included by 85 general practitioners. The treatment duration was 5 days at usual recommended dosage regimens. PNIF measures were done before drug administration (T0) as well as 15 min and 3 h after each intake. Moreover, nasal obstruction, rhinorrhea and global discomfort were subjectively assessed. RESULTS: The efficacy of D was superior to that of P and R when comparing PNIF from T0 to T3 h after the first intake. At T15 min, rhinorrhea was significantly improved with both active treatments and global discomfort was significantly improved with D only. Treatment tolerance was satisfactory and comparable between the 3 groups. CONCLUSION: Efficacy of Dérinox(R) was superior to that of P and R for the improvement of the nasal obstruction (PNIF) between T0 and T3h (main criteria) after the first intake in patients suffering from common cold.
RCT Entities:
OBJECTIVES: The aim of this study was to compare the efficacy and tolerance of Dérinox (D) to Rhinofluimucil (R) and placebo (P) in the treatment of common cold, using an objective measure of nasal obstruction, the Peak Nasal Inspiratory Flow (PNIF--Clement Clarke International, Harlow, Angleterre). PATIENTS AND METHODS: This randomized, double-blind, double-dummy, parallel group study enrolled 354 patients (34 P, 165 D et 155 R) included by 85 general practitioners. The treatment duration was 5 days at usual recommended dosage regimens. PNIF measures were done before drug administration (T0) as well as 15 min and 3 h after each intake. Moreover, nasal obstruction, rhinorrhea and global discomfort were subjectively assessed. RESULTS: The efficacy of D was superior to that of P and R when comparing PNIF from T0 to T3 h after the first intake. At T15 min, rhinorrhea was significantly improved with both active treatments and global discomfort was significantly improved with D only. Treatment tolerance was satisfactory and comparable between the 3 groups. CONCLUSION: Efficacy of Dérinox(R) was superior to that of P and R for the improvement of the nasal obstruction (PNIF) between T0 and T3h (main criteria) after the first intake in patients suffering from common cold.
Authors: Gail Hayward; Matthew J Thompson; Rafael Perera; Chris B Del Mar; Paul P Glasziou; Carl J Heneghan Journal: Cochrane Database Syst Rev Date: 2015-10-13