A randomized placebo-controlled trial of an omega-3 fatty acid and vitamins E plus C in schizophrenia
A randomized placebo-controlled trial of an omega-3 fatty acid and vitamins E plus C in schizophrenia
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DOI：
10.1038/tp.2013.110
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发表时间：
2013-12-01
影响因子：
6.8
通讯作者：
Bohmer, T.
中科院分区：
文献类型：
--
作者：
Bentsen, H.;Osnes, K.;Bohmer, T.
膜脂代谢和氧化还原调节可能在精神分裂症中受到干扰。我们研究了在抗精神病药物中加入ω-3脂肪酸和/或维生素E+C的临床效果。假设多不饱和脂肪酸（PUFA）的基线水平较低可预测添加治疗的获益更多。该试验采用多中心、随机、双盲、安慰剂对照2 x 2析因设计。在挪威精神科连续纳入了18-39岁的精神分裂症或相关精神病患者。他们接受活性或安慰剂二十碳五烯酸乙酯（EPA）2 g/天（-1）和活性或安慰剂维生素E 364 mg/天（-1）+维生素C 1000 mg/天（-1）（维生素），持续16周。主要观察指标为阳性和阴性症状量表（PANSS）总分和各分量表评分，采用线性混合模型进行分析。共纳入99例患者。在基线时，测量了97名受试者的红细胞PUFA。单独服用EPA和维生素会增加辍学率，而当两者结合时，与安慰剂没有差异。在低PUFA患者中，EPA单独损害总PANSS（Cohen's d = 0.29; P = 0.03）和精神病性症状（d = 0.40; P = 0.003）的过程，特别是迫害妄想（d = 0.48; P = 0.0004）。单独使用维生素D可损害精神病性症状的病程（d = 0.37; P = 0.005），尤其是迫害妄想（d = 0.47; P = 0.0005）。在EPA中添加维生素中和了对精神病的有害影响（相互作用d = 0.31; P = 0.02）。在高PUFA患者中，试验药物对PANSS量表无显著影响。总之，在急性发作期间分别给予EPA和维生素E+C，可诱导PUFA水平低的患者出现精神病症状。综合起来，这些特工看起来很安全。
Membrane lipid metabolism and redox regulation may be disturbed in schizophrenia. We examined the clinical effect of adding an omega-3 fatty acid and/or vitamins E+C to antipsychotics. It was hypothesized that lower baseline levels of polyunsaturated fatty acids (PUFAs) would predict more benefit from the add-on treatment. The trial had a multicenter, randomized, double-blind, placebo-controlled 2 x 2 factorial design. Patients aged 18-39 years with schizophrenia or related psychoses were consecutively included at admission to psychiatric departments in Norway. They received active or placebo ethyl-eicosapentaenoate (EPA) 2 g day(-1) and active or placebo vitamin E 364 mg day(-1)+vitamin C 1000 mg day(-1) (vitamins) for 16 weeks. The main outcome measures were Positive and Negative Syndrome Scale (PANSS) total and subscales scores, analyzed by linear mixed models. Ninety-nine patients were included. At baseline, erythrocyte PUFA were measured in 97 subjects. Given separately, EPA and vitamins increased drop-out rates, whereas when combined they did not differ from placebo. In low PUFA patients, EPA alone impaired the course of total PANSS (Cohen's d = 0.29; P = 0.03) and psychotic symptoms (d = 0.40; P = 0.003), especially persecutory delusions (d = 0.48; P = 0.0004). Vitamins alone impaired the course of psychotic symptoms (d = 0.37; P = 0.005), especially persecutory delusions (d = 0.47; P = 0.0005). Adding vitamins to EPA neutralized the detrimental effect on psychosis (interaction d = 0.31; P = 0.02). In high PUFA patients, there were no significant effects of trial drugs on PANSS scales. In conclusion, given separately during an acute episode, EPA and vitamins E+C induce psychotic symptoms in patients with low levels of PUFA. Combined, these agents seem safe.