Prednisolone does not reduce withdrawal headache: a randomized, double-blind study.
BACKGROUND
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).


CONCLUSIONS
Prednisolone has no effect on withdrawal headache in unselected patients with chronic daily headache and medication overuse.
Bøe
Magne G
MG
Department of Neurology, Sorlandet Hospital, Kristiansand, Norway. magne.geir.boe@sshf.no
Mygland
Ase
A
Salvesen
Rolf
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000009:adverse effects* / Q000627:therapeutic use; D001007:Anxiety / Q000209:etiology; D003131:Combined Modality Therapy; D003863:Depression / Q000188:drug therapy / Q000209:etiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004876:Ergot Alkaloids / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D051271:Headache Disorders, Secondary / Q000139:chemically induced / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D008881:Migraine Disorders / Q000150:complications / Q000188:drug therapy; D009664:Norway / Q000453:epidemiology; D011239:Prednisolone / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy* / Q000209:etiology / Q000628:therapy; D018781:Tension-Type Headache / Q000150:complications / Q000188:drug therapy; D017211:Treatment Failure; D014363:Tryptamines / Q000009:adverse effects* / Q000627:therapeutic use
D000700:Analgesics; D004876:Ergot Alkaloids; D014363:Tryptamines; D011239:Prednisolone