Acupuncture for attention deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial.

Acupuncture for attention deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial.
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DOI:
10.1186/1745-6215-12-173
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发表时间:
2011-07-11
期刊:
影响因子:
2.5
通讯作者:
Cho SH
Cho SH
中科院分区:
医学4区
文献类型:
--
作者:
Hong SS;Cho SH

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注意缺陷/多动障碍(ADHD)是一种常见的神经精神问题,影响了7-9%的儿童。药物干预被广泛用于ADHD的行为治疗。然而,ADHD的起源尚不清楚,这限制了药物的有效性,并使不良反应变得普遍。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,如多动症。60-65%的ADHD儿童家长使用CAM来缓解ADHD相关症状并避免常规药物的副作用。针灸已被广泛用于治疗多动症患者,但现有证据表明其有效性不足。我们的目的是评估针灸治疗ADHD(任何亚型)患者(无论是单纯治疗还是常规治疗)的有效性和安全性。这项研究是一项候补对照公开试验。我们使用计算机生成的随机方案。这项随机对照试验有两个平行组(针灸组和候补组)。每组有40名参与者。针刺组每周进行2次针灸治疗,共12次,为期6周。治疗后随访3周,补充12个针灸疗程。候补组的参与者在前六周没有接受针灸治疗,只是被要求进行评估。6周后,针灸组接受同样的治疗。该试验的主要结局包括韩国版adhd评定量表(K-ADHD-RS)在随机化前、随机化后3周和6周以及完成治疗后3周的差异。主观测量,如K-ADHD-RS,通常用于ADHD。虽然这些测量具有足够的信度和效度,但缺乏对ADHD的客观评估可能会导致一些争议,如父母安慰剂效应。在ADHD试验中需要更客观的测量,如本研究中的计算机化神经认知功能测试(CNT)。此外,这项试验将为针灸治疗多动症的有效性提供证据。临床研究信息服务(CRiS) KCT0000019
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. 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
DOI: 10.1089/acm.1997.3.119
发表时间: 1997-01-01
期刊: Journal of alternative and complementary medicine (New York, N.Y.)
影响因子: --
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