319 Pizotifen in migraine prevention: A comparison with sodium valproate Ahmad Chitsaz, Mohammad Reza Najafi, Foroud Aghapour Zangeneh, Rasul Norouzi, Mehri Salari Department of Neurology, Isfahan University of Medical Sciences, Isfahan, Iran Abstract Background & Objective: Pizotifen is an alternative option for prophylactic treatment of migraine headache. This study aims to compare the efficacy and safety of pizotifen with sodium valproate; one of the most-widely used drugs in migraine prevention. Methods: This was a single blind, randomized, parallel-group study. After a 4-week baseline evaluation, patients with episodic migraine were randomly assigned to get either sodium valproate or pizotifen for a period of 12 weeks. Patients were asked to fill a headache diary through the study. Headache characteristics and the possible side effects were evaluated throughout and at the end of trial. Results: Forty two patients aged 20 to 49 were recruited to the study. With both drugs, the frequency, intensity and duration of headaches were significantly reduced (p < 0.05). Except for headache duration, pizotifen was significantly superior to sodium valproate in the headache parameters assessed. Total reported side effects were initially higher in patients who received pizotifen (37 vs. 22; P= 0.038); however, persistent side effects were lower for pizotifen (6 vs. 10; P= 0.22). Conclusions: The results of this study suggest that pizotifen is a safe and effective drug in migraine prevention. Neurology Asia 2012; 17(4) : 319 – 324 Address correspondence to: Dr Rasul Norouzi, Isfahan Neurosciences Research Center, Department of Neurology, Alzahra Hospital, Sofeh Blvd, Isfahan 81744-176, Iran. Tel: 0098-311-6291050, Fax: 0098-311-6291050, E-mail: dr.noruzi@gmail.com INTRODUCTION About 15–18% of women and 6% of men suffer from migraine. 1, 2 Nearly 38% of migraineurs need prophylactic treatment; nevertheless, utilization of prophylaxis continues to be low 3 and only 3-13% of patients receive prophylactic treatment. 4 This may be as a result of limited efficacy, a difficult dosage schedule or unpleasant side effects of available options; and so there is a need for an efficient prophylactic treatment with minimal side effects. Sodium valproate is proven to be effective in migraine prevention. 5, 6 However, it may cause several serious adverse events such as liver failure, pancreatitis and teratogenicity which need follow up and laboratory tests. 7 Other common adverse effects which may limit sodium valproate are nausea, vomiting, hair loss, tremor, and especially weight gain. 8,9 Pizotifen is a serotonin antagonist. 10 There are several studies which have shown the usefulness of pizotifen for migraine prevention. 11-17 Nonetheless, because of side effects of drowsiness and weight gain, it is not a first choice prophylactic agent, and is usually used as an alternative option when other medications are ineffective. 18-20 The aim of this trial was to compare the efficacy and safety of pizotifen with sodium valproate. The primary endpoint was a decrease in headache frequency at the end of a 16-week study period. METHODS This randomized single-blind clinical trial without placebo control was carried out on patients with episodic migraine who were referred to the neurology clinic of Alzahra hospital, Isfahan, Iran, 2011. The duration of study was 16 weeks, consisting of a 4-week period for baseline assessment and a subsequent 12-week period in which intervention was given. Patients with episodic migraine who were seeking prophylactic treatment were included in a primary evaluation according to International Headache Society (IHS) criteria. 21 After a comprehensive assessment for inclusion and exclusion criteria, eligible patients who gave informed consent were recruited to the study. A research assistant who was blind to the type of intervention made all evaluations. The exclusion criteria were: (1) Any hypersensitivity to sodium valproate or pizotifen;