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IRCT2013060411763N9 IRCT 2014-04-12 Research Deputy of Isfahan University of Medical Sciences The effect of folic acid and pyridoxine supplementation on symptoms of migraine The effect of folic acid and pyridoxine supplementation on symptoms, severity of headache and inflammatory markers in patients with Migraine with aura (MA) 2013-02-01 anticipated 120 Complete https://irct.ir/trial/11922 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 1 Migraine with aura. Intervention 1: Patients in group 3 received 80 mg/d pyridoxine for 12 weeks. Intervention 2: Patients in group 4 considered as control, received placebo (lactose) for 12 weeks. Intervention 3: patients in group 1 received 5 mg/d folic acid and 80 mg/d pyridoxine for 12 weeks. Intervention 4: Patients in group 2 received 5 mg/d folic acid for 12 weeks. Introduction: Migraine is a neurovascular disease that affects the 10-20% of population worldwide. Studies have shown that migraine is associated with high level of homocysteine and lowering of this level can decrease the migraine symptoms. The aim of this study is to assess the effect of folate and pyridoxine supplementation on migraine symptoms in patients with migraine.<br /> Material and methods: One hundred twenty four migraine patients randomly assigned to four groups (folate+ pyridoxine, pyridoxine, folate and placebo). Migraine symptoms including headache severity, attacks and frequency and duration, and headache diary result (HDR) were assessed at the beginning and end of study. Multivariate analysis of covariance (MANCOVA) was used to determine the effect of supplements intake on migraine symptoms. <br /> Findings: in this study, migraine symptoms including severity, frequency, duration and HDR in pyridoxine +folate group compared with placebo group (p < 0.05). Such reduction was not observed in pyridoxine and folate group compared with placebo (p > 0.05). Although, severity and frequency of attacks reduced significantly in pyridoxine group compared with placebo group (p < 0.05).<br /> Discussion and conclusion: Combined pyridoxine and folate intake can decrease migraine symptoms including severity, frequency, duration and HDR. Further studies are needed to confirm our finding and also to determine the effective doses of vitamins.<br />
public Omid Sadeghi
Iran, Isfahan, Hezargarib street, Isfahan University of Medical Science
Isfahan Iran (Islamic Republic of) +98 31 1792 2658 omidsadeghi69@yahoo.com Isfahan University of Medical Sciences scientific Dr. Gholamreza Askari
Iran, Isfahan, Hezargarib street, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) +98 31 1792 2110 askari@mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Patients suffered from migraine in a long time with current diagnosis of MA and a one-year history of severe; recurrent attacks(1 to 8 attacks per month) were selected; The patients with chronic heart disease; previous stroke incidence; chronic renal failure and also with history of taking vitamin B supplements were excluded from the study. 15 years 65 years Both G43.1 Migraine with aura [classical migraine] Treatment - Drugs Placebo Treatment - Drugs Treatment - Drugs Patients in group 3 received 80 mg/d pyridoxine for 12 weeks. Patients in group 4 considered as control, received placebo (lactose) for 12 weeks. patients in group 1 received 5 mg/d folic acid and 80 mg/d pyridoxine for 12 weeks Patients in group 2 received 5 mg/d folic acid for 12 weeks. Severity of migraine attacks. Timepoint: First and end of intervention (3 month). Method of measurement: VAS scale. Frequency of migraine attacks. Timepoint: First and end of intervention (3 month). Method of measurement: Questionnaire. Duration of migraine attacks. Timepoint: First and end of intervention (3 month). Method of measurement: Questionnaire. Homocysteine level. Timepoint: First and end of intervention (3 month). Method of measurement: Laboratory analysis ( blood test). Crp level. Timepoint: First and end of intervention (3 month). Method of measurement: Laboratory analysis ( blood test). Research Deputy of Isfahan University of Medical Sciences Approved 2013-07-24 Isfahan University of Medical Sciences, Isfahan, Iran Isfahan University of Medical Sciences, Isfahan, Iran, Hezargarib street Isfahan Iran (Islamic Republic of)