Pizotifen for the treatment of migraine. A systematic review and meta-analysis

Abstract

Introduction
 Pizotifen is an oral drug developed many years ago for the prophylaxis of migraine. Trials on pizotifen are decades old, and there has never been a systematic review and meta-analyses of data from these clinical studies.
 Methods
 This is a systematic review and meta-analyses on pizotifen's efficacy and safety for prophylactic migraine treatment. We considered for inclusion only randomized clinical trials (RCTs). A comprehensive electronic search was performed without language, date or publication status restrictions in the formal electronic databases, clinical trial registration platforms and grey literature.
 Results
 There were eight RCTs of pizotifen compared either to placebo or to other drugs. Very low certainty of evidence showed that pizotifen seems to be superior to placebo regarding clinical symptoms improvement (Relative risk [RR] 6.00; 95% Confidence interval [CI] 1.63 to 22.03; p = 0.007), but not inferior to naproxen, flunarizine, valproate or clonidine. Weight gain was the most frequent adverse event of pizotifen but there was no difference with placebo (RR 1.92; 95% CI 0.30 to 12.38; 2 RCTs; 142 participants; I2 = 67%; p = 0.49).
 Conclusion
 The RCTs of pizotifen were decades old. It is a safe and potentially efficacious inexpensive drug that deserves a better designed, modern clinical trial before being dismissed as an option for migraine therapy. PROSPERO Register: CRD42020194347.