Combination of low-dose mirtazapine and ibuprofen for prophylaxis of chronic tension-type headache.

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
• Journal: European journal of neurology (Eur J Neurol) Vol. 14 Issue 2 Pg. 187-93 (Feb 2007) ISSN: 1468-1331 [Electronic] England
• PMID: 17250728 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Adrenergic alpha-Antagonists
• Anti-Inflammatory Agents, Non-Steroidal
• Mianserin
• Mirtazapine
• Ibuprofen

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
• Mirtazapine
• Tension-Type Headache (prevention & control)
• Treatment Failure