Cortese Samuele, Adamo Nicoletta, Mohr-Jensen Christina, Hayes Adrian J, Bhatti Sahar, Carucci Sara, Del Giovane Cinzia, Atkinson Lauren Z, Banaschewski Tobias, Simonoff Emily, Zuddas Alessandro, Barbui Corrado, Purgato Marianna, Steinhausen Hans-Christoph, Shokraneh Farhad, Xia Jun, Cipriani Andrea, Coghill David
Department of Psychology, Developmental Brain-Behaviour Laboratory, Academic Unit of Psychology, Clinical and Experimental Sciences (CNS and Psychiatry), Faculty of Medicine, University of Southampton, and Solent NHS Trust, Southampton, UK.
New York University Child Study Center, New York City, New York, USA.
BMJ Open. 2017 Jan 10;7(1):e013967. doi: 10.1136/bmjopen-2016-013967.
Attention-deficit/hyperactivity disorder (ADHD) is a major public health issue. Pharmacological treatments play an important role in the multimodal treatment of ADHD. Currently, there is a lack of up-to-date and comprehensive evidence on how available ADHD drugs compare and rank in terms of efficacy and tolerability, in children or adolescents as well as in adults. We will conduct a network meta-analysis (NMA), integrating direct and indirect comparisons from randomised controlled trials (RCTs), to rank pharmacological treatments for ADHD according to their efficacy and tolerability profiles.
We will search a broad range of electronic databases, including PubMed, MEDLINE, EMBASE, PsycINFO, ERIC and Web of Science, with no date or language restrictions. We will also search for unpublished studies using international clinical trial registries and contacting relevant drug companies. We will identify and include available parallel-group, cross-over and cluster randomised trials that compare methylphenidate, dexmethylphenidate, amphetamine derivatives (including lisdexamfetamine), atomoxetine, clonidine, guanfacine, bupropion or modafinil (as oral therapy) either with each other or to placebo, in children, adolescents or adults with ADHD. Primary outcomes will be efficacy (indicated by reduction in severity of ADHD core symptoms measured on a standardised scale) and tolerability (the proportion of patients who left a study early due to side effects). Secondary outcomes will be global functioning, acceptability (proportion of patients who left the study early by any cause) and changes in blood pressure and body weight. NMA will be conducted in STATA within a frequentist framework. The quality of RCTs will be evaluated using the Cochrane risk of bias tool, and the quality of the evidence will be assessed using the GRADE approach. Subgroup and sensitivity analyses will be conducted to assess the robustness of the findings.
No ethical issues are foreseen. Results from this study will be published in a peer-reviewed journal and possibly presented at relevant national and international conferences.
CRD42014008976.
注意力缺陷多动障碍（ADHD）是一个重大的公共卫生问题。药物治疗在ADHD的多模式治疗中发挥着重要作用。目前，关于现有ADHD药物在儿童、青少年及成人中的疗效和耐受性如何比较及排序，缺乏最新的全面证据。我们将进行一项网状Meta分析（NMA），整合随机对照试验（RCT）的直接和间接比较，根据疗效和耐受性概况对ADHD的药物治疗进行排序。
我们将检索广泛的电子数据库，包括PubMed、MEDLINE、EMBASE、PsycINFO、ERIC和Web of Science，无日期或语言限制。我们还将使用国际临床试验注册库并联系相关制药公司来检索未发表的研究。我们将识别并纳入可用的平行组、交叉和整群随机试验，这些试验比较哌甲酯、右旋哌甲酯、苯丙胺衍生物（包括赖右苯丙胺）、托莫西汀、可乐定、胍法辛、安非他酮或莫达非尼（作为口服疗法）在患有ADHD的儿童、青少年或成人中彼此之间或与安慰剂的比较。主要结局将是疗效（通过标准化量表测量的ADHD核心症状严重程度降低来表明）和耐受性（因副作用提前退出研究的患者比例）。次要结局将是整体功能、可接受性（因任何原因提前退出研究的患者比例）以及血压和体重的变化。NMA将在STATA中在频率学派框架内进行。RCT的质量将使用Cochrane偏倚风险工具进行评估，证据质量将使用GRADE方法进行评估。将进行亚组和敏感性分析以评估研究结果的稳健性。
预计无伦理问题。本研究结果将发表在同行评审期刊上，并可能在相关的国家和国际会议上展示。
CRD42014008976。
