Background and Objectives

Concerns exist regarding the rising use of methylphenidate. A double-blind, placebo-controlled methylphenidate titration (PCT) for children with attention-deficit/hyperactivity disorder (ADHD) has shown potential to improve titration (i.e., detection of placebo responders and larger ADHD symptom improvement) in experimental settings. This study aims to determine if these advantages can be transferred to clinical settings.

Method

Children (aged 5–13 years) with an ADHD diagnosis and an indication to start methylphenidate (MPH) treatment were recruited. Participants were randomized to PCT or care as usual (CAU) in a 1:1 ratio followed by a 7-week randomized controlled trial (T1) and 6-month, naturalistic, open-label follow-up (T2). Parents, teachers, and physicians rated ADHD symptoms, ADHD medication use, MPH dosing, and treatment satisfaction using questionnaires.

Results

A total of 100 children were enrolled and randomized to PCT (n = 49) or CAU (n = 51). In the PCT group, we found 8.2% placebo responders, 16.3% non-responders, and 65.3% responders to MPH. With PCT compared with CAU, a significantly larger number of children discontinued MPH (T1: 24.5 vs 5.9%, p = 0.009; T2: 41.7 vs 10.4%, p < 0.001) and refrained from using other pharmacological treatment (T1: 20.4 vs 3.9%, p = 0.013; T2: 20.83 vs 6.25%, p = 0.002). At both timepoints, there were no significant differences between the groups in the average dose of MPH, ADHD symptoms, or treatment satisfaction.

Conclusions

PCT can be used to improve detection of children who do not benefit from MPH, and may therefore potentially reduce overtreatment of ADHD with MPH.

中文翻译：

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改善注意力缺陷/多动障碍 (ADHD) 儿童的哌醋甲酯滴定：在临床实践中实施的一项使用安慰剂对照滴定的随机对照试验

背景和目标

人们对哌醋甲酯的使用不断增加感到担忧。针对注意力缺陷/多动障碍 (ADHD) 儿童的双盲、安慰剂对照哌甲酯滴定 (PCT) 已显示出在实验环境中改善滴定的潜力（即检测安慰剂反应者和更大的 ADHD 症状改善）。本研究旨在确定这些优势是否可以转移到临床环境中。

方法

招募了诊断为 ADHD 且有开始哌醋甲酯 (MPH) 治疗指征的儿童（5-13 岁）。参与者以 1:1 的比例随机接受 PCT 或照常护理 (CAU)，随后进行为期 7 周的随机对照试验 (T1) 和 6 个月的自然开放标签随访 (T2)。家长、教师和医生使用问卷评估 ADHD 症状、ADHD 药物使用、MPH 剂量和治疗满意度。

结果

共有 100 名儿童入组并随机分配至 PCT（n  = 49）或 CAU（n  = 51）。在 PCT 组中，我们发现 8.2% 的安慰剂有反应，16.3% 的无反应，65.3% 的 MPH 有反应。与 CAU 相比，PCT 中止 MPH 的儿童数量显着增加（T1：24.5 vs 5.9%，p  = 0.009；T2：41.7 vs 10.4%，p  < 0.001），并且不再使用其他药物治疗（T1：20.4 vs 3.9） %，p  = 0.013；T2：20.83 与 6.25%，p  = 0.002）。在两个时间点，两组之间的 MPH 平均剂量、ADHD 症状或治疗满意度没有显着差异。

结论

PCT 可用于改善对无法从 MPH 中受益的儿童的检测，因此可能会减少 MPH 对 ADHD 的过度治疗。