Department of Neuropsychiatry, College of Korean medicine, Kyung Hee University, Hoegi-dong Dongdaemun-gu, Seoul, Korea.
Trials. 2011 Jul 11;12:173. doi: 10.1186/1745-6215-12-173.
Attention-deficit/hyperactivity disorder (ADHD) is a common neuro-psychiatric problem, affecting 7-9% of children. Pharmacological interventions are widely used with behavioral treatments in ADHD. Still, the origin of ADHD is unclear, limiting pharmacological effectiveness and making adverse effects common. The use of complementary and alternative medicine (CAM) has increased, especially for developmental and behavioral disorders, such as ADHD. CAM is used by 60-65% of parents of children with ADHD to relieve ADHD-associated symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with ADHD, but the available evidence of its effectiveness is insufficient. Our aim was to evaluate the effectiveness and safety of acupuncture in patients (both and each treatment naive and conventional therapy children) with ADHD (any subtype) compared to the waitlist control.
METHODS/DESIGN: This study is a waitlist controlled open trial. We used a computer generated randomization scheme. This randomised, controlled trial had two parallel arms (acupuncture, and waitlist group). Each arm consisted of 40 participants. The acupuncture group received acupuncture treatment two times per week for a total of 12 sessions over 6 weeks. Post-treatment follow-up was performed 3 weeks later to complement the 12 acupuncture sessions. Participants in the waitlist group did not receive acupuncture treatments during the first six weeks but were only required to be assessed. After 6 weeks, the same treatments given to the acupuncture group were provided to the waitlist group. The primary outcome of this trial included differences in Korean version of ADHD-Rating Scale (K-ADHD-RS) before randomization, 3 weeks and 6 weeks after randomization, and 3 weeks after completing the treatment.
Subjective measurements, like K-ADHD-RS, are commonly used in ADHD. Although these measurements have adequate reliability and validity, lack of objective assessment in ADHD may lead to some disputes, like parental placebo effects. More objective measurements, like Computerized Neurocognitive function Test (CNT) in this study, are needed in ADHD trials. Furthermore, this trial will provide evidence for the effectiveness of acupuncture as a treatment for ADHD.
Clinical Research Information Service (CRiS) KCT0000019.
注意缺陷多动障碍（ADHD）是一种常见的神经精神问题，影响 7-9%的儿童。药物干预与行为治疗广泛用于 ADHD。然而，ADHD 的起源尚不清楚，这限制了药物的有效性，并使不良反应变得常见。补充和替代医学（CAM）的使用有所增加，特别是对于发育和行为障碍，如 ADHD。60-65%的 ADHD 儿童的父母使用 CAM 来缓解与 ADHD 相关的症状，并避免常规药物的副作用。针灸已被广泛用于治疗 ADHD 患者，但现有证据表明其疗效不足。我们的目的是评估针灸在 ADHD 患者（包括治疗初治和常规治疗的儿童）中的有效性和安全性，与等待名单对照。
方法/设计：这是一项等待名单对照的开放性试验。我们使用计算机生成的随机分组方案。这项随机对照试验有两个平行组（针灸组和等待名单组）。每个组有 40 名参与者。针灸组每周接受两次针灸治疗，共 12 次，持续 6 周。治疗后 3 周进行随访，以补充 12 次针灸治疗。等待名单组在最初的 6 周内没有接受针灸治疗，但只需要进行评估。6 周后，对等待名单组提供与针灸组相同的治疗。本试验的主要结局包括随机分组前、随机分组后 3 周和 6 周以及完成治疗后 3 周的韩国版 ADHD 评定量表（K-ADHD-RS）差异。
像 K-ADHD-RS 这样的主观测量常用于 ADHD。虽然这些测量具有足够的可靠性和有效性，但 ADHD 缺乏客观评估可能会导致一些争议，如父母的安慰剂效应。在 ADHD 试验中需要更客观的测量，如本研究中的计算机神经认知功能测试（CNT）。此外，这项试验将为针灸作为 ADHD 治疗方法的有效性提供证据。
临床研究信息服务（CRiS）KCT0000019。
