Plain language summary
Migraine is considered as an intense unilateral throbbing headache, often accompanied by nausea, vomiting, photophobia and phonophobia, which can be exacerbated by routine physical activity. It has been shown that cytokines levels are altered in migraineurs. Cytokines are inflammatory mediators that can stimulate calcitonin gene-related peptide (CGRP) [amino acid] transcription. The aim of this study was to investigate the effects of soy isoflavones supplementation on migraine headache characteristics, mental status, quality of life and CGRP concentration in adult women with migraine. This study is a double-blind, placebo-controlled clinic trial. Participants (n=88 women) were randomly assigned to one of the two groups: intervention or placebo groups (1:1). Patients in the intervention group received one tablet containing 50 mg isoflavones. Results indicate that consumption of 50 mg/day soy isoflavones supplementation for 8 weeks led to significant reduction in frequency, duration, and clinical indices of migraine and improved quality of life and CGRP levels. However, severity of migraine headache and mental status including depression, stress and anxiety were not affected by supplementation. Authors conclude that even though their findings were promising, further studies focusing on the mental status dimensions including depression, stress and anxiety are needed.
Abstract
BACKGROUND Literature suggests a relationship between estrogen levels and migraine headache pathogenesis. However, the effect of soy isoflavones on migraine characteristic remains unclear. This study aimed to investigate the effect of soy isoflavones on migraine characteristics and calcitonin gene-related peptide (CGRP) levels in women with migraine. METHODS Eighty-three participants completed a randomized double-blind controlled trial, receiving 50 mg per day soy isoflavones or placebo supplementation for 8 weeks. Migraine severity, migraine days per month, frequency and duration of attacks, mental status, quality of life and serum CGRP levels were measured at baseline and the end of the intervention. Bivariate comparison and intention-to-treat (ITT) were used for analysis. RESULTS Soy isoflavones intake resulted in a significant decrease in mean frequency (-2.36 vs -0.43, P < 0.001), duration (-2.50 vs -0.02, P < 0.001) of migraine attacks and CGRP level (-12.18 ng/l vs -8.62, P = 0.002) in compared to placebo group. Also, a significant improvement was found in quality of life (16.76 vs 2.52, P < 0.001). Although, reduction in the migraine severity and mental status did not reach a statistically significant level (P > 0.05). CONCLUSION soy isoflavones supplementation may be considered as a complementary treatment for women with migraine to improve migraine characteristics and reduce the burden of disease.
Methodological quality
Jadad score
:
5
Allocation concealment
:
Yes
