![]() Only 165/212 trials included usable data on one or more outcomes from 14,271 participants. Trials compared methylphenidate with placebo (200 trials) and with no intervention (12 trials). Methylphenidate treatment duration ranged from 1 to 425 days, with a mean duration of 28.8 days. Most trials were carried out in high-income countries, and 86/212 included trials (41%) were funded or partly funded by the pharmaceutical industry. The mean age of participants was 9.8 years ranging from 3 to 18 years (two trials from 3 to 21 years). We included 212 trials (16,302 participants randomised) 55 parallel-group trials (8104 participants randomised), and 156 cross-over trials (8033 participants randomised) as well as one trial with a parallel phase (114 participants randomised) and a cross-over phase (165 participants randomised). We used Trial Sequential Analyses (TSA) to control for type I (5%) and type II (20%) errors, and we assessed and downgraded evidence according to the GRADE approach. We undertook separate analyses using end-of-last period data from cross-over trials. Data from parallel-group trials and first-period data from cross-over trials formed the basis of our primary analyses. We used standard Cochrane methodological procedures. Six review authors including two review authors from the original publication participated in the update in 2022. Two review authors independently conducted data extraction and risk of bias assessment for each trial. We assessed two primary outcomes, ADHD symptoms and serious adverse events, and three secondary outcomes, adverse events considered non-serious, general behaviour, and quality of life. The search was not limited by publication year or language, but trial inclusion required that 75% or more of participants had a normal intellectual quotient (IQ > 70). We included all randomised clinical trials (RCTs) comparing methylphenidate versus placebo or no intervention in children and adolescents aged 18 years and younger with a diagnosis of ADHD. In addition, we checked reference lists and requested published and unpublished data from manufacturers of methylphenidate. We searched CENTRAL, MEDLINE, Embase, three other databases and two trials registers up to March 2022. To assess the beneficial and harmful effects of methylphenidate for children and adolescents with ADHD. ![]() This is an update of our comprehensive systematic review on benefits and harms published in 2015. Methylphenidate is the psychostimulant most often prescribed, but the evidence on benefits and harms is uncertain. Typically, children and adolescents with ADHD find it difficult to pay attention and they are hyperactive and impulsive. 11 Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.Īttention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed and treated psychiatric disorders in childhood.10 Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.9 Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.8 Research Unit, Mental Health services, Region Zealand Psychiatry, Roskilde, Denmark.BV Moses Centre for Evidence Informed Healthcare and Health Policy, Christian Medical College, Vellore, India. 7 Cochrane India-CMC Vellore Affiliate, Prof.6 Islington Child and Adolescent Mental Health Service, Whittington Health, London, UK.5 Pediatric Department, Herlev University Hospital, Herlev, Denmark.4 Clinical Study Support, Clinical Studies Sweden - Forum South, Lund, Sweden.3 Department of Psychology, University of Southern Denmark, Odense, Denmark.2 Child and Adolescent Psychiatric Department, Region Zealand, Roskilde, Denmark.1 Psychiatric Research Unit, Region Zealand Psychiatry, Slagelse, Denmark.
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