Efficacy of a paracetamol-pseudoephedrine combination for treatment of nasal congestion and pain-related symptoms in upper respiratory tract infection.

OBJECTIVE: This study compared the efficacy of 1000 mg of paracetamol combined with 60 mg of pseudoephedrine, with that of either paracetamol or pseudoephedrine alone and placebo for the treatment of symptomatic URTI. RESEARCH DESIGN AND METHODS: A double-blind, parallel group study was performed on 305 patients with URTI (nasal airflow resistance [NAR] of > 0.25 Pa cm3 s and a global pain score of at least moderate intensity). NAR and pain relief/intensity scores were measured over 4 h after initial dose. Patients then dosed up to three times daily for 3 days and recorded nasal congestion and pain intensity scores. MAIN OUTCOME MEASURES: Nasal airflow conductance (NAC) and pain relief after the initial dose were primary objectives. NAC was calculated from NAR. Pain relief was measured on a 5-point verbal rating scale (VRS) and pain intensity and nasal congestion on a 4-point VRS. Data were analysed using analysis of covariance. Safety was assessed by adverse events.
RESULTS: A single dose of the combination was superior to paracetamol and placebo for NAC (p = 0.0001) and was superior to pseudoephedrine and placebo for pain relief (p < or = 0.048). Multiple doses of the combination were also superior to paracetamol and placebo for decongestion (p < or = 0.021) and were superior to pseudoephedrine and placebo for pain reduction (p < or = 0.0057). All treatments were well tolerated.
CONCLUSIONS: The combination treatment provided a greater decongestant effect than either paracetamol or placebo and better pain relief than either pseudoephedrine or placebo. The additive effect of the combination was apparent for both single and multiple doses.

RCT Entities:   Population Interventions Outcomes