A comparison between placebo, pizotifen and 1-isopropyl-3-hydroxy-5-semicarbazono-6-oxo-2.3.5.6-tetrahydroindol (Divascan) in migraine prophylaxis.

The effects and side-effects in migraine prophylaxis of placebo, Divascan (1-isopropylnoradrenochrome--5--monosemicarbazone) and pizotifen were compared in a double-blind cross-over study. The dosage was for Divascan 15 mg a day and for pizotifen 3 mg a day. Data from the last 6 weeks of each test period of 8 weeks were used to assess the effect of the treatment. Thirty patients entered the trial. Data from 28 patients treated with placebo and Divascan and 27 patients treated with pizotifen were used for final evaluation. Pizotifen significantly reduced the number of migraine attacks, headache index and the consumption of ergotamine. Divascan also seemed to have effect. The consumption of ergotamine was reduced compared with placebo and there was a reduction, although not significant, of headache frequency and headache index. Pizotifen gave significantly larger reduction in headache frequency and headache index than Divascan and signficantly more patients stated a preference for pizotifen compared with Divascan. A good or very good effect was reported by 11 per cent of the patients on placebo, 39 per cent on Divascan and 70 per cent on pizotifen. Pizotifen had frequent side-effects, mainly drowsiness and weight gain, whereas Divascan in this respect did not differ from placebo. Physical examinations and laboratory investigations did not show any significant changes, apart from weight gain.

RCT Entities:   Population Interventions Outcomes