A randomized open label study of pain medications (naproxen,acetaminophen and ibuprofen) for controlling side effects during initiation of IFN β-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis

Abstract

Multiple sclerosis (MS) patients initiating IFN b-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 b-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 in5-50% 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 PB-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 b-1a. None of the three pain medications tested were as effective as hypothesized for minimizing fatigue or muscle and joint pain.