Effectiveness of Pseudoephedrine Plus Acetaminophen for Treatment of Symptoms Attributed to the Paranasal Sinuses Associated With the Common Cold
Steven J. Sperber, MD;
Ronald B. Turner, MD;
James V. Sorrentino, PhD;
Robert R. O'Connor, BS;
James Rogers, PhD;
Jack M. Gwaltney, Jr, MD
Arch Fam Med. 2000;9:979-985.
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 acetaminophentreated subjects compared with 0.93 ± 0.06 in the placebo-treated subjects (P.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 acetaminophentreated subjects compared with 0.84 ± 0.06 in the placebo-treated subjects (P.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.
From the Department of Internal Medicine, Hackensack University Medical Center, Hackensack, NJ, and the University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Newark (Dr Sperber); Departments of Pediatrics and Laboratory Medicine, Medical University of South Carolina, Charleston (Dr Turner); Healthcare Products Development, Norwalk, Conn (Dr Sorrentino); Novartis Consumer Health Inc, Summit, NJ (Mr O'Connor); SCIREX Corp, Bloomingdale, Ill (Dr Rogers); Department of Internal Medicine, University of Virginia School of Medicine, Charlottesville (Dr Gwaltney).
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