一项为期1年的随机双盲、安慰剂对照试验（NoMAD）的自然随访，探索微量营养素改善焦虑和抑郁症状的有效性

Q3 Psychology

Journal of Affective Disorders Reports Pub Date : 2025-04-01 DOI:10.1016/j.jadr.2025.100913

Amy Coët, F. Meredith Blampied, Julia J. Rucklidge

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引用次数: 0

摘要

一项随机对照试验（NoMAD试验）显示，与安慰剂相比，微量营养素可以更快地从抑郁和焦虑中恢复。随机对照试验之后是10周的开放标签部分，然后是一年的自然回顾。目的：对NoMAD进行为期1年的随访，探讨1年随访中优势治疗与精神结局之间的关系。研究设计/方法在最初的150名NoMAD参与者中，有94名（63%）完成了1年的随访。主要结局包括广泛性焦虑障碍-7问卷（GAD-7）、患者健康问卷-9 （PHQ-9）和改良临床整体印象改善（mcgi - 1）。结果基于1年随访的主要治疗：微量营养素（n = 20），精神药物（n = 9）和无治疗（n = 56）。9名受试者因随访时采用混合治疗而无法分组。结果无论采用何种主要治疗方法，与基线相比，参与者在1年后的功能明显更好。从开放标签微量营养素治疗10周结束时开始，几乎没有变化，除了抑郁评分显著降低(d = 0.4；术;措施)。大多数参与者在1年的随访中没有或有轻微的抑郁（78%）和焦虑（85%）得分。那些继续服用微量营养素的人在开放标签结束时比那些停止或改用药物的人有更好的反应。与其他人相比，从开放标签随访结束到1年随访期间，他们的健康焦虑程度也有所降低。停止服用微量营养素的主要原因是成本。局限性包括三分之一的原始样本被随访，不均匀的群体规模限制了结果的普遍性。结论：无论长期补充，参与者在一年时功能良好。

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1-year naturalistic follow-up of a Randomised Double-Blind, Placebo-Controlled Trial (“NoMAD”) Exploring the Effectiveness of Micronutrients in Improving Symptoms of Anxiety and Depression

Background

A randomised controlled trial (NoMAD trial) showed micronutrients led to faster recovery from depression and anxiety compared with placebo. The RCT was followed by a 10 week open-label component and then a one year naturalistic review.

Aims

This 1-year follow-up of NoMAD explored the association between dominant treatment at 1-year follow-up with psychiatric outcomes.

Study design/Methods

Ninety-four (63 %) of the original 150 NoMAD participants completed 1-year follow-up. Primary outcomes included Generalised Anxiety Disorder-7 questionnaire (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and Modified-Clinical Global Impression-Improvements (MCGI-I). Outcomes were explored based on dominant therapy at 1-year follow-up: Micronutrients (n = 20), Psychiatric Medications (n = 9), and No Treatment (n = 56). Nine participants could not be grouped due to mixed treatments at follow-up.

Results

Regardless of dominant therapy, participants were functioning significantly better at 1-year compared to baseline. There was little change from end of 10 weeks of open-label micronutrient treatment, with the exception of depression scores, which were significantly lower (d = 0.4; p<.001). Most participants had either no or mild depression (78 %) and anxiety (85 %) scores at 1-year follow-up. Those who stayed on micronutrients were those who experienced better response at end of open-label compared with those who stopped or switched to medications. They also showed a greater reduction in health anxiety from end of open-label to 1-year follow-up compared with others. The main reason cited for stopping micronutrients was the cost. Limitations include a third of original sample lost to follow-up and uneven group sizes limit generalisability of results.