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Aspirin plus Vitamin C Provides Better Relief than Placebo in Managing the Symptoms of the Common Cold

Aurelio Sessa and Michael Voelker

Background and objective: Acetylsalicylic acid (ASA) has demonstrated efficacy in reducing fever and sore throat pain in patients with common cold symptoms caused by acute upper respiratory tract infection. The purpose of the present study was to evaluate the efficacy and tolerability of a formulation of ASA plus vitamin C in the treatment of common cold symptoms using the Wisconsin Upper Respiratory Symptom Survey (WURSS) questionnaire, a validated measure for evaluating common cold symptom severity and quality of life.
Methods: We compared ASA 800 mg plus vitamin C 480 mg (2 tablets of ASA 400 mg plus vitamin C 240 mg) versus placebo in a randomized, double-blind, multicenter study of adult patients whose onset of cold symptoms occurred ≤ 48 h prior to screening. The primary endpoint was the change in Cold Symptoms (WURSS domain 2) from baseline (0 min, directly before the first dose of study drug on Day 1) to the 2 h assessment on Day 1.
Results and discussion: A total of 388 patients were randomized, 189 to ASA plus C and 199 to placebo. Prior to randomization, the median cold duration was 1 day in both treatment groups and both groups had mild to moderate symptom severity at baseline. Two hours after treatment on Day 1, there was significantly greater improvement in Cold Symptoms in the ASA plus C group compared with placebo (score change (LS means) -19.6 vs. -15.2, P=0.012). At the evening of Day 1, a significant difference in Cold Symptoms remained between the groups (P=0.016). Also by the evening of Day 1, there was a significantly (P=0.015) greater overall relief in the severity, symptoms and functional impairments as measured by the Common Cold Profile (sum of WURSS domains 1-3) associated with the common cold in the ASA plus C group compared with placebo.
Conclusion: ASA plus C was shown to be more effective than placebo in providing early relief of the symptoms of the common cold.