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 Volume 63, Number 3, August 10, 2004
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NEUROLOGY 2004;63:525-528
© 2004 American Academy of Neurology

Corticosteroids, ibuprofen, and acetaminophen for IFNß-1a flu symptoms in MS

A randomized trial

J. Río, MD, C. Nos, MD, I. Bonaventura, MD, R. Arroyo, MD, D. Genis, MD, B. Sureda, MD, J. R. Ara, MD, L. Brieva, MD, J. Martín, MD, A. Saiz, MD, F. Sánchez López, MD, J. M. Prieto, MD, J. Roquer, MD, J. F. Dorado, MD and X. Montalban, MD

From the Centres H. Vall d’Hebron (Drs. Río, Nos, and Montalban), H. Clínic i Provincial (Dr. Saiz), and H. Del Mar (Dr. Roquer), Barcelona, H. Mutua de Terrasa (Dr. Bonaventura), H. Clínico San Carlos (Dr. Arroyo) and CIBEST (Dr. Dorado), Madrid, H. Josep Trueta (Dr. Genis), Girona, H. Son Dureta (Dr. Sureda), Mallorca, H. Miguel Servet (Dr. Ara), Zaragoza, H. Arnau de Vilanova (Dr. Brieva), Lleida, H. Reina Sofía (Dr. Sánchez López), Córdoba, and H. Xeral de Galicia (Dr. Prieto), Santiago de Compostela, Spain.

Address correspondence and reprint requests to Dr. J. Río, 2 planta EUI, Unitat de Neuroimmunología Clínica, Hospital Universitario Vall d’Hebron, Psg. Vall d’Hebron 119-120, 08035 Barcelona, Spain; e-mail: jrio{at}vhebron.net

Objective: To compare the efficacy of acetaminophen, ibuprofen, and prednisone in the treatment of interferon ß-1a (IFNß-1a) flu-like syndrome (FLS).

Methods: Patients with relapsing-remitting multiple sclerosis initiating treatment with IM IFNß-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 IFNß-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 IFNß-1a therapy. However, ibuprofen confers better control of symptoms immediately following IM IFNß-1a injection.

Received January 21, 2004. Accepted in final form April 21, 2004.


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