| Abstract | Chronic headaches are difficult to treat and represent the biggest challenge in headache centres. Mirtazapine has a prophylactic and ibuprofen an acute effect in tension-type headache. Combination therapy may increase efficacy and lower side effects. We aimed to evaluate the prophylactic effect of a combination of low-dose mirtazapine and ibuprofen in chronic tension-type headache. Ninety-three patients were included in the double-blind, placebo-controlled, parallel trial. Following a 4-week run-in period they were randomized to four groups for treatment with a combination of mirtazapine 4.5 mg and ibuprofen 400 mg, placebo, mirtazapine 4.5 mg or ibuprofen 400 mg daily for 8 weeks. Eighty-four patients completed the study. The primary efficacy parameter, change in area under the headache curve from run-in to the last 4 weeks of treatment, did not differ between combination therapy (190) and placebo (219), P = 0.85. Explanatory analyses revealed worsening of headache already in the third week of treatment with ibuprofen alone. In conclusion, the combination of low-dose mirtazapine and ibuprofen is not effective for the treatment of chronic tension-type headache. Moreover, the study suggests that daily intake of ibuprofen worsens headache already after few weeks in chronic tension-type headache. |
| Authors | L Bendtsen, L Buchgreitz, S Ashina, R Jensen
(Affiliation: Department of Neurology, Danish Headache Center, Glostrup Hospital, University of Copenhagen, Glostrup, Copenhagen, Denmark. bendtsen at dadlnet.dk)
|
| Journal | European journal of neurology : the official journal of the European Federation of Neurological Societies
(Eur J Neurol)
Vol. 14
Issue 2
Pg. 187-93
(Feb 2007)
ISSN: 1468-1331 England |
| PMID | 17250728
(Publication Type: Journal Article, Randomized Controlled Trial)
|
| Chemical References |
- Adrenergic alpha-Antagonists
- Anti-Inflammatory Agents, Non-Steroidal
- Ibuprofen
- Mianserin
- mirtazapine
|
| Topics |
- Adrenergic alpha-Antagonists
(adverse effects, therapeutic use)
- Adult
- Anti-Inflammatory Agents, Non-Steroidal
(adverse effects, therapeutic use)
- Chronic Disease
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Ibuprofen
(adverse effects, therapeutic use)
- Male
- Mianserin
(adverse effects, analogs & derivatives, therapeutic use)
- Middle Aged
- Tension-Type Headache
(prevention & control)
- Treatment Failure
|
