Department of Psychiatry, The Ohio State University, Columbus, OH, USA.
J Altern Complement Med. 2012 Jul;18(7):678-85. doi: 10.1089/acm.2011.0270. Epub 2012 Jul 2.
Current psychotropic medications for childhood bipolar spectrum disorders (BPSD) are associated with significant adverse events. As nutrients play an important role in physical and mental health, they may be useful in treating mood disorders with few side-effects. This open-label study explored the feasibility of testing therapeutic effects of a multinutrient supplement, EMPowerplus™ (EMP+), for pediatric BPSD.
EMP+ was started at one capsule t.i.d. and escalated to a goal of four capsules t.i.d., which eight children attained. Four (4) of these increased to the maximum dose, five capsules t.i.d. Mood symptoms were assessed seven times over 8 weeks.
Ten (10) children, age 6-12 with BPSD, were enrolled in 6.5 months. Seven (7) participants completed the full trial. Three (3) dropped out due to palatability and/or adherence issues.
Mean medication adherence was 91%. With one-tailed nonparametric Fisher's randomization tests, intent-to-treat analyses demonstrated a 37% decrease in depression scores (p<0.06) and a 45% decrease in mania scores (p<0.01) from the start of treatment through final visit, suggesting improvement and possible treatment response. Study completers demonstrated significant decreasing trends in both depression and mania scores from baseline to final visit (p<0.05). Side-effects were minor and transient, mostly temporary gastric discomfort.
Future randomized, placebo-controlled trials of EMP+ are warranted and feasible.
目前用于儿童双相谱系障碍（BPSD）的精神药物与显著的不良事件相关。由于营养物质在身心健康中起着重要作用，它们可能对治疗副作用少的情绪障碍有用。本开放性标签研究探索了多营养补充剂 EMPowerplus™（EMP+）治疗儿科 BPSD 的疗效的可行性。
EMP+ 从每日三次一次一粒开始，逐渐增加到每日三次四粒的目标，有八个孩子达到了这一目标。其中四个孩子增加到最大剂量，即每日三次五粒。在 8 周内对情绪症状进行了七次评估。
共有 10 名年龄在 6-12 岁之间的 BPSD 儿童入组，试验持续了 6.5 个月。有 7 名参与者完成了完整的试验。由于适口性和/或依从性问题，有 3 名儿童退出。
平均药物依从率为 91%。采用单侧非参数 Fisher 随机化检验，意向治疗分析表明，从治疗开始到最后一次就诊，抑郁评分下降了 37%（p<0.06），躁狂评分下降了 45%（p<0.01），提示病情改善和可能的治疗反应。完成研究的参与者从基线到最后一次就诊，抑郁和躁狂评分均呈现显著下降趋势（p<0.05）。副作用轻微且短暂，主要为暂时性胃部不适。
未来有必要进行 EMP+ 的随机、安慰剂对照试验，且该试验是可行的。
