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维生素 B1 和 B6 作为锂盐辅助治疗双相情感障碍 I 型的疗效:一项双盲、随机、安慰剂对照的临床试验。

Efficacy of vitamins B1 and B6 as an adjunctive therapy to lithium in bipolar-I disorder: A double-blind, randomized, placebo-controlled, clinical trial.

机构信息

Department of Psychiatry, Imam Hossein Hospital, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran; Social Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.

Research Committee, Alborz University of Medical Sciences, Karaj, Alborz, Iran.

出版信息

J Affect Disord. 2024 Jan 15;345:103-111. doi: 10.1016/j.jad.2023.10.121. Epub 2023 Oct 20.

DOI:10.1016/j.jad.2023.10.121
PMID:37866735
Abstract

BACKGROUND

The use of adjunctive therapy for bipolar disorder is increasingly considered to increase the efficacy of standard treatments. In this randomized clinical trial, we evaluated the effect of vitamins B1 and B6 in separate treatment arms on mood symptoms, cognitive status, and sleep quality in hospitalized patients with bipolar disorder in manic episodes.

METHOD

In addition to receiving standard lithium treatment, participants (N = 66) were randomized to one of three conditions: 100 mg of vitamin B1, 40 mg of vitamin B6, or placebo. Outcomes were assessed one and 8 weeks of daily treatment, including the Young Mania Rating Scale (YMRS), Pittsburgh Sleep Quality Scale (PSQI), and Mini-Mental State Examination (MMSE). This study was performed between December 2020 and September 2021 based on the registration code number IRCT20200307046712N1.

RESULTS

Vitamin B6 had a significant effect (P value < 0.025 as significant) on mood improvement compared to placebo (F (1, 27.42) = 30.25, P < 0.001, r = 0.72), but vitamin B1 had no significant effect on mood improvement compared to Placebo (F (1/35.68) = 4.76, P = 0.036, r = 0.34). The contrasts between groups on PSQI showed a significant effect (P value < 0.025 as significant) of vitamin B6 over placebo for sleep status improvement (F (1/32.91) = 16.24, P < 0.001, r = 0.57) and also a significant effect of vitamin B1 over placebo (F (1/41.21) = 13.32, P < 0.001, r = 0.49).

CONCLUSIONS

The use of vitamin B6 as an adjunctive therapy to lithium can be associated with the improvement of mood symptoms in patients with bipolar disorder in the midst of a manic episode.

摘要

背景

辅助治疗双相情感障碍的应用越来越被认为可以提高标准治疗的疗效。在这项随机临床试验中,我们评估了在锂盐治疗的基础上,分别给予维生素 B1 和 B6 治疗对躁狂发作住院的双相情感障碍患者的情绪症状、认知状态和睡眠质量的影响。

方法

除了接受标准锂盐治疗外,参与者(N=66)被随机分为三组:100mg 维生素 B1、40mg 维生素 B6 或安慰剂。在每天治疗的第 1 和 8 周评估结果,包括 Young 躁狂量表(YMRS)、匹兹堡睡眠质量量表(PSQI)和简易精神状态检查(MMSE)。本研究于 2020 年 12 月至 2021 年 9 月进行,注册号为 IRCT20200307046712N1。

结果

与安慰剂相比,维生素 B6 对情绪改善有显著影响(P 值<0.025 为显著)(F(1,27.42)=30.25,P<0.001,r=0.72),而维生素 B1 对情绪改善与安慰剂相比无显著影响(F(1/35.68)=4.76,P=0.036,r=0.34)。PSQI 组间比较显示,维生素 B6 改善睡眠状态的效果显著(P 值<0.025 为显著)(F(1/32.91)=16.24,P<0.001,r=0.57),维生素 B1 也显著优于安慰剂(F(1/41.21)=13.32,P<0.001,r=0.49)。

结论

在锂盐的基础上使用维生素 B6 作为辅助治疗,可以改善躁狂发作期间双相情感障碍患者的情绪症状。

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