Department of Psychiatry, Arak University of Medical Sciences, Arak, Iran.
Prog Neuropsychopharmacol Biol Psychiatry. 2010 Feb 1;34(1):76-80. doi: 10.1016/j.pnpbp.2009.09.026. Epub 2009 Oct 5.
Although stimulants are highly effective in controlling the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD), some children will not respond to, or are intolerant of stimulants. Thus, the desire for safe and effective nonstimulant medications has risen during the past several years. Ginkgo biloba has been suggested in the treatment of dementia and memory impairment. We hypothesized that G.biloba would be beneficial for treatment of ADHD, and this could be evaluated in a double blind, randomized, parallel group comparison of G.biloba (Ginko T.D. Tolidaru, Iran) and methylphenidate.
Fifty outpatients (39 boys and 11 girls) with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of Ginko T.D. at a dose of 80-120 mg/day depending on weight (80 mg/day for <30 kg and 120 mg/day for >30 kg) (group 1) or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for <30 kg and 30 mg/day for >30 kg (group 2) for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale- IV. Patients were assessed at baseline and at 21 and 42 days after the medication started.
Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -6.52+/-11.43 (mean+/-S.D.) and -15.92+/-11.44 (mean+/-S.D.) for Ginko T.D. and methyphenidate, respectively for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -0.84+/-6.79 (mean+/-S.D.) and -14.04+/-8.67 (mean+/-S.D.) for Ginko T.D. and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the Ginko T.D. and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group.
The results of this study suggest that administration of G.biloba was less effective than methylphenidate in the treatment of ADHD.
尽管兴奋剂在控制注意力缺陷/多动障碍（ADHD）症状方面非常有效，但有些儿童对兴奋剂没有反应或不能耐受。因此，在过去几年中，人们对安全有效的非兴奋剂药物的需求有所增加。银杏叶已被提议用于治疗痴呆症和记忆力减退。我们假设银杏叶对治疗 ADHD 有益，这可以通过银杏叶（伊朗 Tolidaru 的 Ginko T.D.）和哌甲酯的双盲、随机、平行组比较来评估。
本试验的研究人群为 50 名（39 名男孩和 11 名女孩）符合 DSM-IV-TR 诊断的 ADHD 门诊患者。从儿童和青少年门诊招募受试者，进行为期 6 周的双盲、随机临床试验。所有研究对象均随机分为两组，根据体重服用银杏叶片（80-120mg/天，<30kg 服用 80mg/天，>30kg 服用 120mg/天）（第 1 组）或哌甲酯（20-30mg/天，<30kg 服用 20mg/天，>30kg 服用 30mg/天）（第 2 组），进行为期 6 周的双盲、随机临床试验。主要疗效指标为教师和家长 ADHD 评定量表-IV。患者在基线和用药后 21 天和 42 天进行评估。
两组在家长和教师评定量表评分上有显著差异。与基线相比，终点的变化为：银杏叶组分别为-6.52+/-11.43（均值+/-标准差）和-15.92+/-11.44（均值+/-标准差），而哌甲酯组分别为-0.84+/-6.79（均值+/-标准差）和-14.04+/-8.67（均值+/-标准差）。银杏叶组和哌甲酯组在不良反应发生率方面无显著差异，除食欲减退、头痛和失眠外，这些不良反应在哌甲酯组更为常见。
本研究结果表明，银杏叶的疗效不如哌甲酯治疗 ADHD。
