EFFICACY AND TOLERABILITY OF AMITRIPTYLINOXIDE IN THE TREATMENT OF CHRONIC TENSION-TYPE HEADACHE - A MULTICENTER CONTROLLED-STUDY

Amitriptyline is the medication of first choice in the treatment of ch ronic tension-type headache. In 197 patients with chronic tension-type headache (87M and 110F with a mean age of 38 +/- 13 (18-68)) efficacy and tolerability of 60-90 mg amitriptylinoxide (AO) were compared wit h 50-75 mg amitriptyline (AM) and placebo (PL) in a double-blind, para llel-group trial consisting of a four weeks' baseline phase and 12 wee ks of treatment. The primary study endpoint was a reduction of at leas t .50% of the product of headache duration and frequency and a reducti on of at least 50% in headache intensity. Statistics used were Fisher' s exact test and analysis of variance. No significant difference emerg ed between AO, AM and PL with respect to the primary study endpoint. T reatment response occurred in 30.3% of the AO, 22.4% of the AM and 21. 9% of the PL group. A reduction in headache duration and frequency of at least 50% was found in 39.4% on AO, in 25.4% on AM and in 26.6% on PL (p(AO-PL) = .1384, p(AM-FL) = 1-000, p(AO-AM) = .0973). A reduction in headache intensity of at least 50% was found in 31.8% on AO, in 26 .9% on AM and in 26.6% on PL (p(AO-PL) = .5657, p(AM-PL) = 1.000, p(AO -AM) = .5715). Trend analysis with respect to a significant reduction of headache intensity (p < 0.05) and the product of headache duration and frequency revealed a superior effect of AO. Adverse events occurre d in 75.8% on AO, 82.1% on AM and 76.6% on PL (p(AO-PL) = 1.000, P(AM- PL) = .5188, p(AO-AM) = .4017). Neither depressive symptoms, measured by the SCL-90-R, nor study drug-related adverse events had any influen ce on the results.