Effect of soy isoflavones supplementation on migraine characteristics, mental status and calcitonin gene-related peptide (CGRP) levels in women with migraine: results of randomised controlled trial
What this study found
Soy isoflavones produced clinically meaningful benefits for several migraine outcomes over 8 weeks. Migraine frequency decreased more than placebo, with mean change -2.36 ± 1.20 versus -0.43 ± 1.35 (P < 0.001), and migraine duration also fell more, -2.50 ± 1.74 versus -0.02 ± 2.15 (P < 0.001). Quality of life improved substantially, with MSQ change 16.76 ± 10.15 versus 2.52 ± 13 (P < 0.001), and CGRP levels decreased, -12.18 ± 35.73 versus -8.62 ± 64.24 (P = 0.002). Migraine severity and DASS depression, anxiety, and stress scores did not differ significantly, although MI, HDR, and MHIS…
- Study & population
- This was a randomized, placebo-controlled trial in adult women with migraine recruited from neurology clinics in Isfahan, Iran.
- Intervention
- Soy isoflavones were given orally as one tablet containing 50 mg/day for 8 weeks.
- Key limitation
- The intervention lasted only 8 weeks and the active arm was small, limiting precision and long-term inference.
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Open PDFOriginal 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.