ω-3指数低且心率变异性降低的双相情感障碍患者补充ω-3脂肪酸：“BIPO-3”试验

Omega-3 fatty acids in bipolar patients with a low omega-3 index and reduced heart rate variability: the "BIPO-3" trial.

作者信息

Berger Michael, Seemüller Florian, Voggt Alessandra, Obermeier Michael, Kirchberg Franca, Löw Anja, Riedel Michael, von Schacky Clemens, Severus Emanuel

机构信息

Zeughaus Practice, Zurich, Switzerland.

Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität München, Munich, Germany.

出版信息

Int J Bipolar Disord. 2022 Apr 1;10(1):9. doi: 10.1186/s40345-022-00253-9.

DOI:10.1186/s40345-022-00253-9

PMID:35362878

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8975918/

Abstract

BACKGROUND

Research suggests that a low omega-3 index may contribute to the low heart rate variability and the increased risk of cardiovascular morbidity and mortality in bipolar disorders. However, so far, no intervention trial with EPA and DHA has been conducted in bipolar patients attempting to increase their heart rate variability.

METHODS

119 patients with bipolar disorder according to DSM-IV were screened, with 55 euthymic bipolar patients-owing to inclusion criteria (e.g. low omega-3 index (< 6%), SDNN < 60 ms.)-being enrolled in a randomized, double-blind, 12-week parallel study design with omega-3 fatty acids (4 capsules of 530 mg EPA, 150 mg DHA) or corn oil as a placebo, in addition to usual treatment. Heart rate variability as well as the omega-3 index were measured at baseline and at the endpoint of the study.

RESULTS

A total of 42 patients (omega-3: n = 23, corn oil: n = 19) successfully completed the study after 12 weeks. There was a significant increase in the omega-3 index (value at endpoint minus value at baseline) in the omega-3 group compared to the corn oil group (p < 0.0001). However, there was no significant difference in the change of the SDNN (value at endpoint minus value at baseline) between the treatment groups (p = 0.22). In addition, no correlation between changes in SDNN and change in the omega-3 index could be detected in the omega-3 group (correlation coefficient = 0.02, p = 0.94) or the corn oil group (correlation coefficient = - 0.11, p = 0.91). Similarly, no significant differences between corn oil and omega-3 group regarding the change of LF (p = 0.19), HF (p = 0.34) and LF/HF ratio (p = 0.84) could be demonstrated.

CONCLUSIONS

In our randomized, controlled intervention trial in euthymic bipolar patients with a low omega-3 index and reduced heart rate variability no significant effect of omega-3 fatty acids on SDNN or frequency-domain measures HF, LF and LF/HF ratio could be detected. Possible reasons include, among others, the effect of psychotropic medication present in our trial and/or the genetics of bipolar disorder itself. Further research is needed to test these hypotheses. Trial registration ClinicalTrials.gov, NCT00891826. Registered 01 May 2009-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT00891826.

摘要

背景

研究表明，低ω-3指数可能导致双相情感障碍患者心率变异性降低以及心血管疾病发病率和死亡率增加。然而，迄今为止，尚未在试图提高心率变异性的双相情感障碍患者中进行过使用二十碳五烯酸（EPA）和二十二碳六烯酸（DHA）的干预试验。

方法

根据《精神疾病诊断与统计手册第四版》（DSM-IV）对119例双相情感障碍患者进行筛查，其中55例病情稳定的双相情感障碍患者因纳入标准（如低ω-3指数（<6%）、标准差值（SDNN）<60毫秒）而被纳入一项随机、双盲、为期12周的平行研究设计，除常规治疗外，服用ω-3脂肪酸（4粒胶囊，每粒含530毫克EPA、150毫克DHA）或玉米油作为安慰剂。在研究基线和终点测量心率变异性以及ω-3指数。

结果

共有42例患者（ω-3组：n = 23，玉米油组：n = 19）在12周后成功完成研究。与玉米油组相比，ω-3组的ω-3指数（终点值减去基线值）有显著增加（p < 0.0001）。然而，治疗组之间的SDNN变化（终点值减去基线值）无显著差异（p = 0.22）。此外，在ω-3组（相关系数 = 0.02，p = 0.94）或玉米油组（相关系数 = -0.11，p = 0.91）中，均未检测到SDNN变化与ω-3指数变化之间的相关性。同样，在玉米油组和ω-3组之间，关于低频（LF）变化（p = 0.19）、高频（HF）变化（p = 0.34）和低频/高频比值（p = 0.84）也未显示出显著差异。

结论

在我们针对ω-3指数低且心率变异性降低的病情稳定的双相情感障碍患者进行的随机对照干预试验中，未检测到ω-3脂肪酸对SDNN或频域测量指标HF、LF和LF/HF比值有显著影响。可能的原因包括，除其他因素外，我们试验中存在的精神药物的作用和/或双相情感障碍本身的遗传学因素。需要进一步研究来验证这些假设。试验注册ClinicalTrials.gov，NCT00891826。于2009年5月1日注册 - 追溯注册，https://clinicaltrials.gov/ct2/show/NCT00891826。