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QUESTION: In patients with a cold, is a combination of pseudoephedrine hydrochloride and acetaminophen (PHA) more effective than placebo in relieving sinus symptoms?
Design
Randomised {allocation concealed *}†, blinded (clinicians and patients),* placebo controlled trial.
Setting
3 university medical centres in the eastern US.
Patients
430 patients who were 18–65 years of age (mean age 28 y, 66% women), had cold symptoms of ≤48 hours in duration, and reported sinus symptoms of at least moderate severity. Exclusion criteria were diastolic blood pressure >90 mm Hg, underlying illness that might be affected by the study drugs, use of medication that might interact with the study drugs, pregnancy, or potential for pregnancy. 412 patients (96%) completed the study.
Intervention
Patients were allocated to …
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