A randomized, double-blind study
Magne G. Bøe, MD, Åse Mygland, MD, PhD and Rolf Salvesen, MD, PhD
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.)
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.
NEUROLOGY 2007;69:26-31
© 2007 American Academy of Neurology
http://www.neurology.org
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.)
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.
NEUROLOGY 2007;69:26-31
© 2007 American Academy of Neurology
http://www.neurology.org
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