Corticosteroids, ibuprofen, and acetaminophen for IFNbeta-1a flu symptoms in MS: a randomized trial.
OBJECTIVE
To compare the efficacy of acetaminophen, ibuprofen, and prednisone in the treatment of interferon beta-1a (IFNbeta-1a) flu-like syndrome (FLS).


METHODS
Patients with relapsing-remitting multiple sclerosis initiating treatment with IM IFNbeta-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 IFNbeta-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 IFNbeta-1a therapy. However, ibuprofen confers better control of symptoms immediately following IM IFNbeta-1a injection.
Centres H. Vall d'Hebron, Barcelona, Spain. jrio@vhebron.net
J
J
Río
C
C
Nos
I
I
Bonaventura
R
R
Arroyo
D
D
Genis
B
B
Sureda
J R
JR
Ara
L
L
Brieva
J
J
Martín
A
A
Saiz
F
F
Sánchez López
J M
JM
Prieto
J
J
Roquer
J F
JF
Dorado
X
X
Montalban
D000082:Acetaminophen / Q000627:therapeutic use*; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D001247:Asthenia / Q000139:chemically induced / Q000188:drug therapy*; D023341:Chills / Q000139:chemically induced / Q000188:drug therapy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000139:chemically induced / Q000188:drug therapy*; D006261:Headache / Q000139:chemically induced / Q000188:drug therapy; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000139:chemically induced / Q000188:drug therapy*; D011241:Prednisone / Q000627:therapeutic use*; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen; D016899:Interferon-beta; D011241:Prednisone; D007052:Ibuprofen; D000068556:Interferon beta-1a