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.

Keywords

multiple sclerosis interferon β side effects naproxen acetaminophen ibuprofen

Get full access to this article

View all access options for this article.

References

Aranson BGW. Treatment of multiple sclerosis with interferon b . Biomed Pharmacotherapy 1999; 53: 344-350 .

Arnason BGW. Immunologic therapy of multiple sclerosis . Ann Rev Med 1999; 50: 291-302 .

Munschauer FE , Kinkel RP. Managing side effects of interferon b in patients with relapsing-remitting multiple sclerosis . Clinical Therapeutics 1997; 19: 883-893 .

McDonald WI , Compston A , Edan G , Goodkin D , Hartung HP , Lublin D et al. Recommended diagnostic criteria for multiple sclerosis: Guidelines from the International Panel on the diagnosis of multiple sclerosis . Ann Neurol 2001; 50: 121-127 .

Fisk JD , Ritvo PG , Ross L , Haase DA , Marrie TJ , Schlich WF. Measuring the functional impact of fatigue: Initial validation of the Fatigue Impact Scale . Clin Infect Diseases 1994; 18 (Suppl J): S79-S83 .

Fisk JD , Pontefract A , Ritvo PG , Archibald CF , Murray TJ. The impact of fatigue on patients with multiple sclerosis . Can J Neurol Sci 1994; 21: 9-14 .

Krupp LB , LaRocca NG , Muir-Nashi J , Steinberg AD. The Fatigue Impact Scale: An application to patients with multiple sclerosis and systemic lupus erythmatosis . Arch Neurol 1989; 46: 1121-1123 .

LaChapelle DL , Finlayson MA. An evaluation of subjective and objective measures of fatigue in patients with brain injury and healthy controls . Brain Inj 1998; 12: 649-659 .

The IFN b Multiple Sclerosis Study Group and The University of British Colombia MS/MRI Analysis Group . Interferon b-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial . Neurology 1995; 45: 1277-1285 .

10.

Rice GPA , Ebers GC , Lubkin FD , Knobler RL. Ibuprofen treatment versus gradual introduction of interferon b in patients with MS . Neurology 1999; 52: 1893-1895 .

11.

Rio J. Ibuprofen treatment versus gradual introduction of interferon b-1b in patients with MS . Neurology 2000; 54: 1710-1710 .

12.

Reese J. Both paracetamol and ibuprofen are equally effective in managing flu-like symptoms in relapsing-remitting multiple sclerosis patients during interferon b-1a (Avonex) therapy . Multiple Sclerosis 2002; 8: 15-18 .

13.

Rio J. Low-dose steroids reduce flu-like symptoms at the initiation of IFN b-1b in relapsing-remitting MS . Neurology 1998; 50: 1910-1912 .

14.

Martinez-Cacenes EM. Amelioration of flu-like symptoms at the onset of interferon b-1b therapy in multiple sclerosis by low dose oral steroids is related to a decrease in interleukin-6 induction . Ann Neurol 1998; 44: 682-685 .

15.

Mora JS , Kao KP , Munsai TL. Indomethacin reduces the side effects of intrathecal interferon . N Engl J Med 1997; 310: 126-127 .