Objective: Acetylsalicylic acid (ASA) has been widely used for over a century to treat pain and fever associated with acute upper respiratory tract infection (URTI), but there is a lack of clinical data to support the efficacy of ASA in this disease state. The objective of this study was to investigate the efficacy and safety of ASA for the treatment of sore throat pain associated with URTI.
Design: A double-blinded, placebo-controlled, parallel group design. Two hundred seventy-two patients (mean age: 25 years) with sore throat pain associated with URTI were recruited at two centers. Pain scores were made during a 2-hour laboratory phase and continued for secondary objectives during a 4-hour home phase. Patients were treated with either two effervescent tablets of ASA 400 mg in water or matched placebo tablets. Patients took medication as required over a 3-day home phase.
Results: ASA was found to be superior to placebo for: The primary efficacy parameter predefined in the protocol, reduction in sore throat pain intensity over 2 hours (P < 0.001), and for secondary efficacy parameters, reduction in sore throat pain intensity over 4 and 6 hours, relief of sore throat pain over 2, 4, and 6 hours, reduction in intensity of pain associated with headache, and reduction in muscle aches and pains over a 2-hour time period (P < 0.01). No safety problems were encountered.
Conclusions: Treatment with ASA was shown to provide relief from sore throat pain, headache, and muscle aches and pains associated with URTI.