Objective: To compare the efficacy of acetaminophen, ibuprofen, and prednisone in the treatment of interferon β-1a (IFNβ-1a) flu like syndrome (FLS). Methods: Patients with relapsing remitting multiple sclerosis initiating treatment with IM IFNβ 1a were randomized in a multicenter, randomized, double blind, controlled trial to receive acetaminophen 500 mg before and 6 and 12 hours after each injection, ibuprofen 400 mg before and 6 and 12 hours after each injection, or prednisone 60 mg daily for 1 week, plus tapering. Patients were instructed to keep a daily diary of fever severity, myalgia, chills, headache, and asthenia for 27 days. The sum of the scores of individual symptoms was used to obtain a daily FLS index. The primary outcome was the FLS index area under the curve (AUC) corrected by the number of measurement days. Results: Eighty four patients were randomized at 11 hospitals: acetaminophen (n = 28), ibuprofen (n = 28), and corticosteroids (n = 28). No differences were detected between treatments in the mean AUC of the FLS index. With limitation of the analysis to the days of IM IFNβ 1a injection, differences favoring ibuprofen were observed in the mean FLS index (p = 0.0007). Conclusions: No prophylactic treatment for flu like syndrome seems to be superior to another in terms of overall well being during the first month of IM IFNβ 1a therapy. However, ibuprofen confers better control of symptoms immediately following IM IFNβ 1a injection.
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