B 族维生素增强中老年患者抗抑郁药治疗反应的效果：B-VITAGE 随机、双盲、安慰剂对照试验的结果。

B vitamins to enhance treatment response to antidepressants in middle-aged and older adults: results from the B-VITAGE randomised, double-blind, placebo-controlled trial.

机构信息

Osvaldo P. Almeida, MD, PhD, FRANZCP, Andrew H. Ford, MBBS, PhD, FRANZCP, WA Centre for Health & Ageing, Centre for Medical Research, Perth, School of Psychiatry & Clinical Neurosciences, University of Western Australia, Perth and Department of Psychiatry, Royal Perth Hospital, Perth; Varsha Hirani, BSc, WA Centre for Health & Ageing, Centre for Medical Research, Perth, School of Psychiatry & Clinical Neurosciences, University of Western Australia, Perth; Vash Singh, MBBS, FRANZCP, Department of Psychiatry, Royal Perth Hospital, Perth; Frank M. vanBockxmeer, PhD, Department of Clinical Biochemistry, PathWest Laboratory Medicine WA, Royal Perth Hospital, Perth; Kieran McCaul, PhD, WA Centre for Health & Ageing, Centre for Medical Research, Perth; Leon Flicker, MBBS, PhD, FRACP, School of Psychiatry & Clinical Neurosciences, University of Western Australia, Perth, School of Medicine and Pharmacology, University of Western Australia, Perth and Department of Geriatric Medicine, Royal Perth Hospital, Perth, Australia.

出版信息

Br J Psychiatry. 2014 Dec;205(6):450-7. doi: 10.1192/bjp.bp.114.145177. Epub 2014 Sep 25.

DOI:10.1192/bjp.bp.114.145177

PMID:25257064

Abstract

BACKGROUND

Depression is common and the efficacy of antidepressants is suboptimal. High plasma homocysteine has been consistently associated with depression, and treatment with certain B vitamins demonstrably reduces its concentration.

AIMS

To determine whether vitamins B6, B12 and folic acid enhance response to antidepressant treatment over 52 weeks.

METHOD

Randomised, double-blind, placebo-controlled trial of citalopram (20-40 g) together with 0.5 mg of vitamin B12, 2 mg of folic acid and 25 mg of vitamin B6 for 52 weeks (Australian and New Zealand Clinical Trials Registry: 12609000256279). Participants were community-dwelling adults aged 50 years or over with DSM-IV-TR major depression. We measured severity of symptoms with the Montgomery-Åsberg Depression Rating Scale (MADRS). The primary outcome was remission of the depressive episode after 12, 26 and 52 weeks. Secondary outcomes included reduction of MADRS scores over time and relapse of major depression after recovery by week 12. Results In total, 153 people were randomised (76 placebo, 77 vitamins). Remission of symptoms was achieved by 78.1 and 79.4% of participants treated with placebo and vitamins by week 12 (P = 0.840), by 76.5 and 85.3% at week 26 and 75.8 and 85.5% at week 52 (effect of intervention over 52 weeks: odds ratio (OR) = 2.49, 95% CI 1.12-5.51). Group differences in MADRS scores over time were not significant (P = 0.739). The risk of subsequent relapse among those who had achieved remission of symptoms at week 12 was lower in the vitamins than placebo group (OR = 0.33, 95% CI 0.12-0.94).

CONCLUSIONS

B vitamins did not increase the 12-week efficacy of antidepressant treatment, but enhanced and sustained antidepressant response over 1 year. Replication of these findings would mandate that treatment guidelines adopt the adjunctive use of B vitamins as a safe and inexpensive strategy to manage major depression in middle-aged and older adults.

摘要

背景

抑郁症很常见，而抗抑郁药的疗效并不理想。血浆同型半胱氨酸水平升高与抑郁症密切相关，而某些 B 族维生素的治疗可显著降低其浓度。

目的

确定在 52 周内，B 族维生素（维生素 B6、B12 和叶酸）是否能增强抗抑郁药的治疗效果。

方法

这是一项随机、双盲、安慰剂对照试验，共纳入 153 名年龄在 50 岁及以上、符合 DSM-IV-TR 重性抑郁发作诊断标准的社区居住成年人，给予西酞普兰（20-40mg）联合 0.5mg 维生素 B12、2mg 叶酸和 25mg 维生素 B6 治疗 52 周（澳大利亚和新西兰临床试验注册中心：12609000256279）。采用蒙哥马利-阿斯伯格抑郁评定量表（MADRS）评估症状严重程度。主要结局为治疗 12、26 和 52 周后抑郁发作的缓解情况。次要结局包括 MADRS 评分随时间的变化和治疗 12 周后恢复时的重性抑郁复发情况。

结果

共有 76 名参与者接受安慰剂治疗，77 名参与者接受维生素治疗。治疗 12 周时，分别有 78.1%和 79.4%的安慰剂组和维生素组参与者达到症状缓解（P=0.840），治疗 26 周时分别有 76.5%和 85.3%，治疗 52 周时分别有 75.8%和 85.5%（干预治疗 52 周的效果：比值比（OR）=2.49，95%置信区间 1.12-5.51）。两组随时间变化的 MADRS 评分差异无统计学意义（P=0.739）。治疗 12 周时达到症状缓解的参与者随后复发的风险在维生素组低于安慰剂组（OR=0.33，95%置信区间 0.12-0.94）。