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From the Department of Neurology, Sørlandet Hospital, Kristiansand, Norway (M.G.B., Å.M.); Hospital of Rehabilitation, Rikshospitalet University Hospital, Kristiansand, Norway (Å.M.); Institute of Clinical Medicine, University of Bergen, Bergen, Norway (Å.M.); Department of Neurology, Nordland Hospital, Bodø, Norway (R.S.); and Department of Neurology, University of Tromsø, Tromsø, Norway (R.S.).
Address correspondence and reprint requests to Dr. Magne G. Bøe, Sorlandet Hospital, Neurological Department, Kristiansand, Norway 4604; magne.geir.boe{at}sshf.no
Introduction: Medication overuse headache is a condition where abrupt drug withdrawal is considered the treatment of choice.
Objective: To study whether prednisolone given orally the first 6 days after medication withdrawal reduces headache intensity during the same period.
Methods: From August 2003 through November 2005, we included patients aged 18 to 70 years with probable medication overuse headache. The study was randomized, double-blind, and placebo controlled. The patients were hospitalized for 3 days to start medication withdrawal. They were randomly assigned to receive prednisolone 60 mg on days 1 and 2, 40 mg on days 3 and 4, and 20 mg on days 5 and 6 (Group A) or placebo tablets for 6 days (Group B). Headache intensity was recorded in a diary for a month before withdrawal (baseline) and throughout the study period of 28 days. The primary endpoint was a calculated mean headache (MH), based on number of days with headache and mean intensity the first 6 days after withdrawal.
Results: We included 26 men and 74 women. Sixty-five had migraine, 13 had tension-type headache, and 22 had both migraine and tension-type headache. Baseline headache days were 25.4 (CI 24.3 to 26.4). Baseline MH was 1.6 (CI 1.41 to 1.69). Fifty-one received Regimen A, and 49 received Regimen B. Baseline features were similar. During the first 6 days after withdrawal, headache was similar in Groups A and B (MH 1.48 [CI 1.28 to 1.68] vs 1.61 [CI 1.41 to 1.82], p = 0.34).
Conclusion: Prednisolone has no effect on withdrawal headache in unselected patients with chronic daily headache and medication overuse.
Editorial, see page 14
This article was previously published in electronic format as an Expedited E-Pub on May 2, 2007, at www.neurology.org.
Disclosure: The authors report no conflicts of interest.
Received December 15, 2006. Accepted in final form March 5, 2007.
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