A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial).
A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial).
复制标题
对重度抑郁症的成年人（“微笑”试验）饮食改善的随机对照试验。
DOI：
10.1186/s12916-017-0791-y
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发表时间：
2017-01-30
期刊：
影响因子：
9.3
通讯作者：
Berk M
中科院分区：
文献类型：
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作者：
Jacka FN;O'Neil A;Opie R;Itsiopoulos C;Cotton S;Mohebbi M;Castle D;Dash S;Mihalopoulos C;Chatterton ML;Brazionis L;Dean OM;Hodge AM;Berk M
饮食改变对现有精神疾病的可能治疗影响在很大程度上是未知的。采用随机对照试验设计，我们的目的是调查饮食改善计划治疗重度抑郁发作的疗效。“SMILES”是一项为期12周、平行组、单盲、随机对照试验，旨在研究饮食干预对治疗中度至重度抑郁症的影响。干预包括由临床营养师提供的七个人的营养咨询会议。控制条件包括社会支持协议相同的访问时间表和长度。抑郁障碍是主要终点，在第12周时使用蒙哥马利-阿斯伯格抑郁评定量表（MADRS）进行评估。次要结局包括症状、情绪和焦虑的缓解和变化。分析采用基于似然的混合效应模型重复测量（MMRM）方法。通过敏感性分析研究了估计值的稳健性。我们评估了166名受试者的合格性，其中67人入选（饮食干预组，n = 33;对照组，n = 34）。其中，55人正在使用某种形式的治疗：21人使用心理治疗和药物治疗相结合; 9人只使用心理治疗; 25人只使用药物治疗。饮食支持组有31人，社会支持对照组有25人，他们在12周时有完整的数据。饮食支持组在基线和12周之间的MADRS改善显著大于社会支持对照组，t（60.7）= 4.38，p < 0.001，Cohen's d =-1.16。缓解定义为MADRS评分<10分，干预组和对照组分别有32.3%（n = 10）和8.0%（n = 2）达到缓解（χ 2（1）= 4.84，p = 0.028）;基于缓解评分的需要治疗人数（NNT）为4.1（NNT的95% CI为2.3-27.8）。一项敏感性分析，测试偏离随机缺失（MAR）假设的辍学，表明干预措施的影响是强大的违反MAR假设。这些结果表明，饮食改善可以提供一个有效的和可访问的治疗策略，这种高度流行的精神疾病的管理，其好处可以扩展到常见的合并症的管理。澳大利亚和新西兰临床试验注册中心（ANZCTR）：ACTRN 12612000251820。2012年2月29日登记。
The possible therapeutic impact of dietary changes on existing mental illness is largely unknown. Using a randomised controlled trial design, we aimed to investigate the efficacy of a dietary improvement program for the treatment of major depressive episodes. ‘SMILES’ was a 12-week, parallel-group, single blind, randomised controlled trial of an adjunctive dietary intervention in the treatment of moderate to severe depression. The intervention consisted of seven individual nutritional consulting sessions delivered by a clinical dietician. The control condition comprised a social support protocol to the same visit schedule and length. Depression symptomatology was the primary endpoint, assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) at 12 weeks. Secondary outcomes included remission and change of symptoms, mood and anxiety. Analyses utilised a likelihood-based mixed-effects model repeated measures (MMRM) approach. The robustness of estimates was investigated through sensitivity analyses. We assessed 166 individuals for eligibility, of whom 67 were enrolled (diet intervention, n = 33; control, n = 34). Of these, 55 were utilising some form of therapy: 21 were using psychotherapy and pharmacotherapy combined; 9 were using exclusively psychotherapy; and 25 were using only pharmacotherapy. There were 31 in the diet support group and 25 in the social support control group who had complete data at 12 weeks. The dietary support group demonstrated significantly greater improvement between baseline and 12 weeks on the MADRS than the social support control group, t(60.7) = 4.38, p < 0.001, Cohen’s d = –1.16. Remission, defined as a MADRS score <10, was achieved for 32.3% (n = 10) and 8.0% (n = 2) of the intervention and control groups, respectively (χ 2 (1) = 4.84, p = 0.028); number needed to treat (NNT) based on remission scores was 4.1 (95% CI of NNT 2.3–27.8). A sensitivity analysis, testing departures from the missing at random (MAR) assumption for dropouts, indicated that the impact of the intervention was robust to violations of MAR assumptions. These results indicate that dietary improvement may provide an efficacious and accessible treatment strategy for the management of this highly prevalent mental disorder, the benefits of which could extend to the management of common co-morbidities. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820. Registered on 29 February 2012.