益生菌和维生素 D 联合补充对偏头痛成年患者临床症状、心理健康和炎症的影响：一项随机、三盲、安慰剂对照试验。

Effects of probiotic and vitamin D co-supplementation on clinical symptoms, mental health, and inflammation in adult patients with migraine headache: a randomized, triple-blinded, placebo-controlled trial.

机构信息

Department of Community Nutrition, School of Nutrition and Food Science, Nutrition and Food Security Research Center, Isfahan University of Medical Sciences, PO Box 81745-151, Isfahan, Iran.

Students' Research Committee, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

BMC Med. 2024 Oct 11;22(1):457. doi: 10.1186/s12916-024-03684-6.

DOI:10.1186/s12916-024-03684-6

PMID:39394141

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11470646/

Abstract

BACKGROUND

Migraine headache is a major public health problem. Routine medications for migraine treatment are not useful in treating all patients and may have some side effects. The present study aimed to investigate the effect of vitamin D and probiotic co-supplementation on clinical characteristics of migraine, daily functioning, mental health outcomes, and serum levels of high-sensitivity C-reactive protein (hs-CRP).

METHODS

In this randomized, triple-blinded, placebo-controlled trial, patients aged 18 to 55 years diagnosed with migraine based on the International Classification of Headache Disorders-3 (ICHD-3) were randomized to either vitamin D (50,000 IU every 2 weeks) plus probiotic (4.5 × 10 CFU per day) or placebo for 12 weeks. The Headache Impact Test (HIT-6) and Depression, Anxiety, and Stress Scale (DASS) questionnaires were administered to patients at baseline and after 12 weeks. In addition, the frequency, duration, and severity of migraine headaches per month were assessed using a self-administered 30-day headache diary at baseline and the end of the intervention. Anthropometric indices, blood pressure, and serum levels of 25-hydroxy vitamin D and hs-CRP were also examined at first and the end of the study.

RESULTS

Seventy-two migraine patients with a mean age of 37.46 8.32 years were included in this trial. Probiotic and vitamin D co-supplementation compared to placebo resulted in a significant increase in serum levels of vitamin D (+ 12.86 1.64 vs. + 1.12 0.80 ng/mL, P < 0.001). The between-group analysis in the adjusted model showed a significantly greater reduction in migraine headache 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) in the probiotic and vitamin D group than the placebo group. No significant difference was found between the two arms of the intervention regarding the change in headache duration, hs-CRP, scores of DASS, and HIT-6 questionnaires (P > 0.05).

CONCLUSIONS

This trial showed that probiotic and vitamin D co-supplementation for 12 weeks has beneficial effects on migraine headache characteristics. Further research is needed to confirm this finding.

摘要

背景

偏头痛是一个主要的公共卫生问题。偏头痛的常规治疗药物对所有患者并不都有效，且可能有一些副作用。本研究旨在探讨维生素 D 和益生菌联合补充对偏头痛临床特征、日常功能、心理健康结果和血清高敏 C 反应蛋白（hs-CRP）水平的影响。

方法

在这项随机、三盲、安慰剂对照试验中，根据国际头痛疾病分类-3（ICHD-3）诊断为偏头痛的 18 至 55 岁患者被随机分为维生素 D（50000IU 每 2 周）加益生菌（每天 4.5×10 CFU）或安慰剂组，治疗 12 周。在基线和 12 周后，患者使用头痛影响测试（HIT-6）和抑郁、焦虑和压力量表（DASS）进行评估。此外，在基线和干预结束时，使用自我管理的 30 天头痛日记评估每月偏头痛发作的频率、持续时间和严重程度。在研究开始时和结束时，还检查了体重指数、血压以及血清 25-羟维生素 D 和 hs-CRP 水平。

结果

这项试验纳入了 72 名偏头痛患者，平均年龄为 37.46±8.32 岁。与安慰剂相比，益生菌和维生素 D 联合补充可显著增加血清维生素 D 水平（+12.86±1.64 与+1.12±0.80ng/mL，P<0.001）。调整模型的组间分析显示，偏头痛发作频率（-3.17±0.84 与-1.25±0.34；P=0.031）和严重程度（-1.55±0.35 与+0.67±0.29；P=0.017）显著降低。在益生菌和维生素 D 组和安慰剂组之间，头痛持续时间、hs-CRP、DASS 和 HIT-6 评分的变化没有显著差异（P>0.05）。