Emsley Robin, Niehaus Dana J H, Koen Liezl, Oosthuizen Piet P, Turner H Jadri, Carey Paul, van Rensburg Susan Janse, Maritz J Stefan, Murck Harald
Department of Psychiatry, Faculty of Health Sciences, University of Stellenbosch, PO Box 19063, Tygerberg 7505, Cape Town, South Africa.
Schizophr Res. 2006 May;84(1):112-20. doi: 10.1016/j.schres.2006.03.023. Epub 2006 Apr 24.
Worldwide, conventional antipsychotic medication continues to be used extensively, and tardive dyskinesia (TD) remains a serious complication. The primary objective of the present study was to compare the efficacy of EPA versus placebo in reducing symptoms of TD.
This was a 12-week, double-blinded, randomized study of ethyl-EPA 2g/day versus placebo as supplemental medication, in patients with schizophrenia or schizoaffective disorder, with established TD.
Eighty-four subjects were randomized, of whom 77 were included in the analysis. Both the EPA and placebo groups displayed significant baseline to endpoint improvements in Extrapyramidal Symptom Rating Scale dyskinesia scores, but there were no significant between-group differences (p=0.4). Response rates (>or=30% improvement in TD symptoms) also did not differ significantly between EPA-treated subjects (45%) and placebo-treated subjects (32%) (p=0.6). However, a post-hoc linear mixed model repeated measures analysis of variance indicated an effect for treatment group and duration of TD. The EPA-treated patients had significantly greater mean reductions in dyskinesia scores initially, although this was not sustained beyond 6 weeks.
This trial failed to demonstrate an anti-dyskinetic effect for ethyl-EPA 2g/day on the primary efficacy measure. However, a modest and transient benefit is suggested in patients with more recent onset of TD. The lack of clear-cut efficacy could be explained on the basis of the dose of EPA being too low, the study being underpowered, TD being too chronic in the majority of cases, differences in dietary fatty acid intake, or that EPA lacks an anti-dyskinetic action.
在全球范围内，传统抗精神病药物仍被广泛使用，迟发性运动障碍（TD）仍然是一种严重的并发症。本研究的主要目的是比较二十碳五烯酸（EPA）与安慰剂在减轻TD症状方面的疗效。
这是一项为期12周的双盲随机研究，将2克/天的乙基-EPA与安慰剂作为补充药物，用于患有精神分裂症或分裂情感性障碍且已确诊TD的患者。
84名受试者被随机分组，其中77名被纳入分析。EPA组和安慰剂组的锥体外系症状评定量表运动障碍评分从基线到终点均有显著改善，但组间差异无统计学意义（p = 0.4）。EPA治疗组（45%）和安慰剂治疗组（32%）的反应率（TD症状改善≥30%）也无显著差异（p = 0.6）。然而，事后线性混合模型重复测量方差分析表明治疗组和TD病程有影响。最初，EPA治疗的患者运动障碍评分的平均降低幅度显著更大，尽管这种情况在6周后未持续。
该试验未能证明2克/天的乙基-EPA对主要疗效指标有抗运动障碍作用。然而，对于TD发病较晚的患者，提示有适度且短暂的益处。疗效不明确可能是由于EPA剂量过低、研究效能不足、大多数病例中TD病程过长、饮食脂肪酸摄入量不同，或者EPA缺乏抗运动障碍作用。
