Treatment of chronic tension-type headache with botulinum toxin: a double-blind, placebo-controlled clinical trial.

Botulinum toxin is increasingly advocated as effective treatment in chronic tension-type headache. We conducted a randomized, placebo-controlled clinical trial to prove efficacy of botulinum toxin in chronic tension-type headache. Patients were randomly assigned to receive botulinum toxin (maximum 100 units) or placebo (saline) in muscles with increased tenderness. After 12 weeks there was no significant difference between the two treatment groups in decrease of headache intensity on VAS (-3.5 mm, 95% confidence interval (CI) - 20 to +13), mean number of headache days (-7%; 95% CI - 20 to +4), headache hours per day (-1.4%; 95% CI - 3.9 to +1.1), days on which symptomatic treatment was taken (-1.9%; 95% CI - 11 to +7) and number of analgesics taken per day (-0.01; 95% CI -0.25-0.22). There was no significant difference in patient's assessment of improvement after week 4, 8 and 12. Botulinum toxin was not proven effective in treatment of chronic tension-type headache. Increased muscle tenderness might not be as important in pathophysiology of chronic tension-type headache as hitherto believed.