Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold

Background: Little data exist on the cause and treatment of subfacial pain and pressure and other discomfort attributed to the paranasal sinuses that develop early during the course of the common cold. The purpose of this study was to determine the efficacy of the combination of pseudoephedrine hydrochloride with acetaminophen for the treatment of early symptoms during colds, which are attributed by the patient to the sinuses. Methods: Four hundred thirty subjects (216, pseudoephedrine and acetaminophen recipients; 214, placebo recipients) with cold symptoms of 48 hours or less who reported overall sinus symptoms of at least moderate severity were enrolled in this randomized double-blind placebo-controlled 2-dose study. Self-reported symptoms were scored (0 to 4, absent to severe) before and at 2 hours after the first and second doses. The 2 primary were measured 2 hours after the second dose were the overall sinus symptom assessment and a weighted composite assessment of sinus pressure, pain, and congestion (sinus symptoms). Results: Compared with baseline, 2 hours after the second dose, the mean+/-SEM overall sinus symptom assessment score had decreased by 1.30+/-0.06 in the pseudoephedrine and acetaminophen-treated subjects compared with 0.93+/-0.06 in the placebo-treated subjects (P less than or equal to .029). The mean+/-SEM weighted average of sinus symptoms 2 hours after the second dose of study medication had decreased by 1.14+/-0.06 in the pseudoephedrine and acetaminophen-treated subjects compared with 0.84+/-0.06 in the placebo-treated subjects (P less than or equal to .029). Reductions in similar magnitude were also observed for each of the individual sinus symptoms, and headache and rhinorrhea. Nervousness occurred in 4% of the pseudoephedrine and acetaminophen recipients compared with 0% of placebo recipients (P=.007). Conclusion: Our results suggest that pseudoephedrine plus acetaminophen is effective for relief of symptoms attributable to the paranasal sinuses that may develop early in the course of a cold.