title: Demonstration of the analgesic efficacy and dose-response of acetylsalicylic acid with pseudoephedrine.
abstract: To determine acute analgesia by acetylsalicylic acid (ASA) when combined with pseudoephedrine (PSE) in patients with upper respiratory tract infection (URTI), we used the sore throat pain model to measure single-dose effects of ASA 500 mg/PSE 30 mg, ASA 1000 mg/PSE 60 mg, and acetaminophen (APAP) 1000 mg/PSE 60 mg (serving as a positive control). Under double-blind, randomized, placebo-controlled conditions, 640 adult patients with confirmed acute pharyngitis and rhinosinusitis associated with URTI rated throat pain intensity and relief at intervals over 6 hours. Efficacy was demonstrated for both doses of ASA/PSE compared with placebo for all end points, including total pain relief and summed pain intensity differences, beginning at 20 minutes on both scales (all P < .05), and the efficacy of APAP/PSE compared with placebo was confirmed (P < .01). Greater differences in pain relief and intensity were also demonstrated between the higher and lower doses of ASA/PSE (P < .05), in particular, among 329 patients with severe pain, as well as between ASA 1000 mg/PSE 60 mg and APAP 1000 mg/PSE 60 mg (P < .05). No serious adverse events were reported. This study demonstrates that ASA is a well-tolerated and effective analgesic in 500- and 1000-mg doses when combined with pseudoephedrine.
authors.affiliation: Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, Connecticut, USA.bschachtel@SRCresearch.net
authors.forename: Bernard P
authors.initials: BP
authors.lastname: Schachtel
authors.forename: Michael
authors.initials: M
authors.lastname: Voelker
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Sanner
authors.forename: Diana
authors.initials: D
authors.lastname: Gagney
authors.forename: Mary
authors.initials: M
authors.lastname: Bey
authors.forename: Emily J
authors.initials: EJ
authors.lastname: Schachtel
authors.forename: Michael
authors.initials: M
authors.lastname: Becka
mesh_terms: D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003139:Common Cold / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D014663:Nasal Decongestants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010147:Pain Measurement; D010612:Pharyngitis / Q000188:drug therapy; D054199:Pseudoephedrine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000503:physiopathology; D012220:Rhinitis / Q000188:drug therapy; D012720:Severity of Illness Index; D012852:Sinusitis / Q000188:drug therapy; D013566:Sympathomimetics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D018712:Analgesics, Non-Narcotic; D014663:Nasal Decongestants; D013566:Sympathomimetics; D054199:Pseudoephedrine; D001241:Aspirin