Amitriptylinoxide

In a double-blind parallel group study the efficacy and safety of amitriptylinoxide were evaluated vs. doxepine in the treatment of in-patients with severe depression. Two groups of 22 patients each received amitriptylinoxide and doxepine respectively at a daily dosage of 120-360 mg for a period of 4 weeks. The total score on the Hamilton Depression Scale (HAMD) was reduced with amitriptylinoxide on an average from 28 +/- 5 before treatment to 12 +/- 8 at the end of treatment, with doxepine from 29 +/- 8 to 13 +/- 11. Of the amitriptylinoxide-treated patients, 12 showed a more than 50% reduction in this score compared with 15 under doxepine. The difference was not statistically significant. Twenty patients in each group experienced adverse drug reactions, the percentage of anticholinergic side effects being equal in the two groups.

Amitriptyline is the medication of first choice in the treatment of chronic 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 with 50–75 mg amitriptyline (AM) and placebo (PL) in a double-blind, parallel-group trial consisting of a four weeks' baseline phase and 12 weeks of treatment. The primary study endpoint was a reduction of at least 50% of the product of headache duration and frequency and a reduction of at least 50% in headache intensity. Statistics used were Fisher's exact test and analysis of variance. No significant difference emerged between AO, AM and PL with respect to the primary study endpoint. Treatment 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 (PAO-PL = .1384, PAM-PL = 1.000, PAO-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 (PAO-PL = .5657, PAM-PL = 1.000, PAO-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 occurred in 75.8% on AO, 82.1% on AM and 76.6% on PL (PAO-PL = 1.000, PAM-PL =.5188, PAO-AM = .4017). Neither depressive symptoms, measured by the SCL-90-R, nor study drug-related adverse events had any influence on the results.