title: A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis.
abstract: Multiple sclerosis (MS) patients initiating IFN beta-1a, Avonex, therapy (Group 1, n = 30) or experiencing side effects after 6 months on therapy (Group 2, n = 30) were randomized for 5 weeks open label adjunct therapy to naproxen (Aleve), acetaminophen (Tylenol) or ibuprofen (Advil). Our hypothesis was that non-prescription pain medications are effective in decreasing or alleviating the side effects associated with IFN beta-1a therapy. Contrary to the hypothesis, most patients in both groups continued to report side effects on all pain medications. After 5 weeks, headache, fever, chills and injection site pain were low in < or = 50% of patients. Moderate to significant fatigue, muscle or joint pain continued in most patients. As a quality of life measure, the Modified Fatigue Impact Scale (mFIS) improved for Group 1 on naproxen or ibuprofen with greatest improvement in physical subset (P = 0.002 for naproxen and P<0.01 for ibuprofen). Total mFIS for Group 1 on acetaminophen improved (P = 0.04) due to improved cognitive subset rather than physical subset. Group 2, with side effects initially, reported less significant fatigue (severity 5-10) but more moderate fatigue (severity 2-4) at study end for all three medications. All medications improved cognitive subset (P = 0.05). Physical mFIS subset did not improve for Group 2 on acetaminophen, but did with naproxen (P = 0.05) or ibuprofen (P = 0.03). Naproxen and ibuprofen were more effective than acetaminophen in minimizing physical side effects of IFN beta-1a. None of the three pain medications tested were as effective as hypothesized for minimizing fatigue or muscle and joint pain.
authors.affiliation: Department of Genetics, Cell Biology and Anatomy, University of Nebraska Medical Center, Omaha, NE 68198-6395, USA. pleusche@unmc.edu
authors.forename: M Patricia
authors.initials: MP
authors.lastname: Leuschen
authors.forename: Mary
authors.initials: M
authors.lastname: Filipi
authors.forename: Kathleen
authors.initials: K
authors.lastname: Healey
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage*; D000276:Adjuvants, Immunologic / Q000009:adverse effects*; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005221:Fatigue / Q000188:drug therapy; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D009288:Naproxen / Q000008:administration & dosage*; D010146:Pain / Q000188:drug therapy; D011446:Prospective Studies
chemical_list: D000276:Adjuvants, Immunologic; D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; D009288:Naproxen; D016899:Interferon-beta; D007052:Ibuprofen; D000068556:Interferon beta-1a