Darling Kathryn A, Eggleston Matthew J F, Retallick-Brown Hannah, Rucklidge Julia J
Department of Psychology, University of Canterbury, Christchurch, New Zealand.
Canterbury District Health Board, Christchurch, New Zealand.
J Child Adolesc Psychopharmacol. 2019 Nov;29(9):688-704. doi: 10.1089/cap.2019.0036. Epub 2019 Jul 25.
This article presents 1-year follow-up of a randomized placebo-controlled trial with open-label extension evaluating the efficacy of a broad-spectrum micronutrient (vitamins and minerals) intervention. The object was to determine if dominant treatment at follow-up was associated with differential psychological outcomes. Ninety percent of the original sample of 93 children with attention-deficit/hyperactivity disorder (ADHD) were followed 52 weeks postbaseline. Assessments included measures of ADHD, mood, anxiety, and general function based on parent/clinician report. Outcome was considered based on dominant therapy at 52 weeks (trial micronutrients [ = 19], medications [ = 21], and no treatment [ = 35]). Nine children were not categorized due to inconsistent therapies. Based on dominant treatment, more of those who stayed on trial micronutrients (84%) were identified as "Much" or "Very Much" improved overall relative to baseline functioning, compared to 50% of those who switched to psychiatric medications and only 21% of those who discontinued treatment [χ(2) = 19.476, < 0.001]. Fifteen (79%) of those still taking micronutrients, 8 (42%) of those using medications, and 7 (23%) of those who discontinued treatment were considered remitters based on parent-reported ADHD [χ(2) = 15.3, < 0.001]. Those who stayed on micronutrients were more likely to have failed medication treatment in the past. The micronutrient group also displayed better outcomes on measures of parent-rated hyperactivity and anxiety, and clinician-rated general function and mood, with moderate to large between-group effect sizes (micronutrients vs. medication: ES = 0.73-1.01; micronutrients vs. no treatment: ES = 0.54-1.01). Most common reasons for stopping trial micronutrients were cost and number of pills to swallow. No continued side effects were associated with micronutrients. Children who benefitted from micronutrients in the short term maintained changes at follow-up, without side effects. While both those who continued micronutrients and those who switched to medication showed improved ADHD symptoms, psychiatric medication use was associated with deterioration in mood and anxiety. Inherent selection bias limits generalizability.
本文介绍了一项随机安慰剂对照试验的1年随访情况，该试验有开放标签扩展阶段，评估了一种广谱微量营养素（维生素和矿物质）干预措施的疗效。目的是确定随访时的主要治疗方法是否与不同的心理结果相关。对93名注意力缺陷多动障碍（ADHD）儿童的原始样本中90%的儿童在基线后52周进行了随访。评估包括基于家长/临床医生报告的ADHD、情绪、焦虑和总体功能的测量。根据52周时的主要治疗方法（试验性微量营养素组[=19]、药物治疗组[=21]和未治疗组[=35]）来考虑结果。9名儿童因治疗方法不一致未被分类。基于主要治疗方法，与改用精神科药物治疗的儿童中的50%以及停止治疗的儿童中的21%相比，继续使用试验性微量营养素的儿童中更多（84%）被认定为相对于基线功能有“很大”或“非常大”的改善[χ(2)=19.476，<0.001]。根据家长报告的ADHD情况，仍在服用微量营养素的儿童中有15名（79%）、使用药物治疗的儿童中有8名（42%）以及停止治疗的儿童中有7名（23%）被视为症状缓解者[χ(2)=15.3，<0.001]。继续服用微量营养素的儿童过去更有可能药物治疗失败。微量营养素组在家长评定的多动和焦虑以及临床医生评定的总体功能和情绪测量方面也显示出更好的结果，组间效应大小为中度至高度（微量营养素组与药物治疗组：ES=0.73 - 1.01；微量营养素组与未治疗组：ES=0.54 - 1.01）。停止试验性微量营养素的最常见原因是费用和吞咽药片数量。微量营养素未出现持续的副作用。短期内从微量营养素中获益的儿童在随访时维持了变化，且无副作用。虽然继续服用微量营养素的儿童和改用药物治疗的儿童ADHD症状均有改善，但使用精神科药物与情绪和焦虑恶化相关。内在的选择偏倚限制了研究结果的普遍性。
