Probiotic and vitamin D co-supplementation not associated with improved outcomes in patients with migraine headache
1. In a randomized triple-blinded controlled trial, probiotic and vitamin D supplementation did not significantly change headache duration or serum levels of hs-CRP.
Evidence Rating Level: 1 (Excellent)
Migraines are primary headaches, often chronic, that affect more than 1 billion people globally. They are defined as recurrent headaches with two of four headache characteristics (unilateral, pulsating, moderate to severe, and aggravated by routine physical activity) with one additional correlated symptoms, such as nausea or vomiting, during the attacks. Probiotics may improve headaches through the gut-brain axis, however, research in this area is limited and there is no consensus. Vitamin D has also been implicated as a way to reduce the severity and frequency of migraine attacks through its effect on the brain-intestinal axis. With these possibilities in mind, this study aimed to evaluate the effect of probiotic and vitamin D co-supplementation on migraine frequency and severity, daily functioning, and serum levels of high sensitivity C-reactive protein (hs-CRP) in migraine patients. To achieve this, eligible participants were enrolled in a parallel randomized, placebo-controlled trial and randomly assigned to the probiotic plus vitamin D group or the placebo group. To be deemed eligible, participants had to be between the ages of 18 and 55 years, have a migraine history with or without aura, and had more than 2 attacks per month in the preceding 3 months. The Headache Impact Test-6 (HIT-6) was administered at baseline and at the end of the intervention to evaluate the ability of normal functioning. While the Depression, Anxiety, and Stress Scale (DASS) questionnaire was used to evaluate psychological characteristics of patients. A total of 72 patients with a mean age of 37.46 ± 8.32 (SD) years were enrolled. The mean values for systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) were found to be lower in the probiotic group compared to the placebo group (109.08 vs 115.08 mmHg; P = 0.030 for SBP, 75.92 vs 79.08 mmHg; P = 0.047 for DBP, and 86.97 vs. 91.08 mmHg; P = 0.021 for MAP). Once again when comparing the groups, the probiotic and vitamin D group led to a significant increase in vitamin D serum levels compared to the placebo group (+ 12.86 ± 1.64 vs. + 1.12 ± 0.80 ng/mL, P < 0.001). Upon further comparison in the between-group analyses, the probiotic and vitamin D group had a significant reduction in migraine frequency (- 3.17 ± 0.84 vs. – 1.25 ± 0.34; P = 0.031) and severity (- 1.55 ± 0.35 vs. + 0.67 ± 0.29; P = 0.017) compared to the placebo group. There was no significant difference in headache duration, hs-CRP serum levels, or DASS and HIT–6 questionnaires (P>0.05). The results show that there may be a beneficial effect of probiotic and vitamin D supplementation, but more research is needed. Despite this, the study showed that these supplements did not change headache duration and serum levels of hs-CRP in adult patients with migraine headaches.
Click to read the study in BMC Medicine
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