EFFECT OF PENTAERITHRITOL TETRANITRATE, ISOSORBIDE MONONITRATE AND PLACEBO ON THE HEADACHE AND ON THE ABILITY TO WORK OF HEALTHY-VOLUNTEERS

In a randomised, double-blind, four-way crossover study, 24 healthy vo lunteers received 240 mg/d pentaerithritol tetranitrate (PETN: CAS 78- 11-5), 150 mg/d PETN, 60 mg/d isosorbide mononitrate slow release (ISM N, CAS 16051-77-7) or placebo in each study period for two days. Heada che and disability to work were self-rated six times per day; individu al measurements were combined to total scores. ISMN caused headaches m ore frequently (in approx. 90% of volunteers) and more severe (average total score 15.2) and a greater disability (average total score 6.0) than the high or low PETN-dosage (both in approx. 50%, headache score 4.9 or 6.4, disability score 1.1 or 2.1, resp.) and placebo (in approx . 10%, headache 0.8, disability 0), all these differences were statist ically significant (p < 0.01, Wilcoxon). The high PETN-dosage showed a non-significant trend to produce fewer systemic side effects than the low PETN-dosage (not vice versa). With ISMN six volunteers prematurel y terminated the study period and one volunteer who was replaced withd rew from the entire study due to side effects; all volunteers complete d the study periods with the other medications.