A randomized, double-blind, placebo-controlled parallel trial to test the effect of inulin supplementation on migraine headache characteristics, quality of life and mental health symptoms in women with migraine

Abstract

Migraine is a complex neurovascular disorder characterized by recurrent headache attacks that are often accompanied by symptoms such as vomiting, nausea, and sensitivity to sound or light. Preventing migraine attacks is highly important. Recent research has indicated that alterations in gut microbiota may influence the underlying mechanisms of migraines. This study aimed to investigate the effects of inulin supplementation on migraine headache characteristics, quality of life (QOL), and mental health symptoms in women with migraines. In a randomized double-blind placebo-controlled trial, 80 women with migraines aged 20 to 50 years were randomly assigned to receive 10 g day⁻¹ of inulin or a placebo supplement for 12 weeks. Severity, frequency, and duration of migraine attacks, as well as depression, anxiety, stress, QOL, and headache impact test (HIT-6) scores, were examined at the start of the study and after 12 weeks of intervention. In this study, the primary outcome focused on the frequency of headache attacks, while secondary outcomes encompassed the duration and severity of headache attacks, QOL, and mental health. There was a significant reduction in severity (−1.95 vs. −0.84, P = 0.004), duration (−6.95 vs. −2.05, P = 0.023), frequency (−2.09 vs. −0.37, P < 0.001), and HIT-6 score (−10.30 vs. −6.52, P < 0.023) in the inulin group compared with the control. Inulin supplementation improved mental health symptoms, including depression (−4.47 vs. −1.45, P < 0.001), anxiety (−4.37 vs. −0.70, P < 0.001), and stress (−4.40 vs. −1.50, P < 0.001). However, no significant difference was observed between the two groups regarding changes in QOL score. This study provides evidence supporting the beneficial effects of inulin supplement on migraine symptoms and mental health status in women with migraines. Further studies are necessary to confirm these findings. Trial registration: Iranian Registry of Clinical Trials (https://www.irct.ir) (ID: IRCT20121216011763N58).