The use of pizotifen as migraine prophylaxis
| Citation | Study group | Study type (level of evidence) | Outcome | Key results | Comments |
|---|---|---|---|---|---|
| Gillies et al (1986), UK | 47 children (aged 7–14 years) Two patient groups: A (16 patients, pizotifen 0.5 mg 3/12 then placebo 3/12); B (23 patients, placebo 3/12 then pizotifen 0.25 mg 3/12). Dosing in each 3/12 block split into 6/52 b.d. then 6/52 t.d.s. | Double-blind, crossover RCT (level 2c) | No benefit of pizotifen over placebo in reducing number of attacks, total duration of attacks, duration of longest attack or mean duration of attack | Group A: Pizotifen vs. placebo: b.d. dosing: Number of attacks 3.0 vs. 2.5, NS; total duration of attacks 11.25 h vs. 7.8 h, NS; longest attack 6 h vs. 3.4 h, NS; mean duration of attacks 3.6 h vs. 2.0h, NS. t.d.s. dosing: Number of attacks 1.5 vs. 2, NS; total duration of attacks 7 h vs. 7.0 h, NS; longest attack 5.8 h vs. 3.8 h, NS; mean duration of attacks 3.7 h vs 3.0 h, NS. Group B: Placebo vs. pizotifen b.d. dosing: Number of attacks 3 vs. 2, NS; total duration of attacks 9 h vs. 7.5 h, NS; longest attack 4 h vs. 3.5 h, NS; mean duration 2.4 h vs. 2.5 h, NS. t.d.s. dosing: Number of attacks 3 vs. 2, NS; total duration of attacks 8 h vs. 10 h, NS; longest attack 4 h vs 4.5 h, NS; mean duration of attacks 3 h vs 3.5 h, NS. | Study predated the IHS diagnostic criteria for migraine, and participants would not all fulfil the current IHS definition Reliability limited as 17% of children did not complete the study |
| Salmon (1985), UK | 40 children (aged 6–15) | Double-blind, placebo controlled, parallel group (level 2c) | Not reliable | No numerical results data published | Study published in abstract form only, so methodology not open to scrutiny Mixed patient group who would not all fulfil the IHS diagnostic criteria for migraine |