Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents: assessment of harmful effects in non-randomised studies




Poster session 5


Thursday 27 October 2016 - 10:30 to 11:00


All authors in correct order:

Storebø OJ1, Pedersen N1, Ramstad E2, Krogh HB2, Kielsholm ML2, Nielsen SS2, Moreira-Maia CR3, Magnusson FL2, Holmskov M2, Nilausen TD4, Skoog M5, Rosendal S6, Groth C7, Gillies D8, Rasmussen KB2, Gauci D9, Zwi M10, Kirubakaran R11, Håkonsen SJ12, Aagaard L13, Simonsen E14, Gluud C15
1 Psychiatric Research Unit, University of Southern Denmark, Denmark
2 Psychiatric Research Unit, Denmark
3 Department of Psychiatry, Federal University of Rio Grande do, Brazil
4 Psychiatric Research Unit, Denmark
5 Copenhagen Trial Unit, Denmark
6 Psychiatric Centre North Zealand, Denmark
7 Pediatric Department Herlev University Hospital, Denmark
8 Western Sydney Local Health District – Mental Health, Australia
9 Directorate for Health Information and Research, Department of Health, Malta
10 Islington Child and Adolescent Mental Health Service, Whittington Health, United Kingdom
11 South Asian Cochrane Network & Center, Christian Medical College, India
12 Department of Health Science and Technology, Aalborg University, Denmark
13 Department of Public Health, Faculty of Health Science, University of Southern Denmark, Denmark
14 Psychiatric Research Unit, Institute of Clinical Medicine, Faculty of Health and Medical Science, Copenhagen University, Denmark
15 Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Denmark
Presenting author and contact person

Presenting author:

Ole Jakob Storebø

Contact person:

Abstract text
Introduction: The use of methylphenidate for ADHD in children and adolescents has increased during the past decade. However, in our systematic review of randomised clinical trials (RCTs), we found that the very low quality of the evidence made it uncertain as to whether methylphenidate offers more benefits than harms compared with placebo or no treatment. Because of the limitations of identifying and reporting adverse events in RCTs, a thorough systematic assessment of harms reported in non-randomised studies is needed.

Aim: To assess the harmful effects of methylphenidate for children and adolescents with ADHD in non-randomised studies.

Methods: This review is being conducted according to Cochrane guidelines for systematic reviews and based on a comprehensive search for literature in scientific medical databases, unpublished data from the US Food and Drug Administration and European Medicines Agency, and data received from pharmaceutical companies. The primary outcome is the number of serious adverse events as defined within international guidelines. The secondary outcomes are all other adverse events.
We included 322 studies in total: cohort studies, case-control studies, follow-up periods from RCTs, cross-sectional studies, and single participant studies. Through data obtained from non-randomised studies, the review identifies rare adverse events, as well as long-term harms. Depending on study design, measures of prevalence, incidence and risk ratio are used to estimate harms. Results are interpreted according to the study design, and different subgroup analyses are conducted according to co-occurring conditions, sex, age, and type of ADHD.
This review is one of the first Cochrane Reviews to evaluate bias by using A Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies of Interventions.

Discussion: The study will contribute to a wider knowledge on harms of methylphenidate usage for children and adolescents with ADHD. We will present the results of both primary and secondary outcomes. Furthermore, we will discuss the methodological topic of bias and confounding in studies assessing harms from the use of methylphenidate.