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Methylphenidate for attention-deficit/hyperactivity disorder in children and adolescents: Cochrane systematic review with meta-analyses and trial sequential analyses of randomised clinical trials
Open accessAbstract
STUDY QUESTION: Is methylphenidate beneficial or harmful for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents? METHODS: Electronic databases were searched up to February 2015 for parallel and crossover randomised clinical trials comparing methylphenidate with placebo or no intervention in children and adolescents with ADHD. Meta-analyses and trial sequential analyses (TSA) were conducted. Quality was assessed using GRADE. Teachers, parents, and observers rated ADHD symptoms and general behaviour. STUDY ANSWER AND LIMITATIONS: The analyses included 38 parallel group trials (n=5111, median treatment duration 49 days) and 147 crossover trials (n=7134, 14 days). The average age across all studies was 9.7 years. The analysis suggested a beneficial effect of methylphenidate on teacher rated symptoms in 19 parallel group trials (standardised mean difference (SMD) -0.77, n=1698), corresponding to a mean difference of -9.6 points on the ADHD rating scale. There was no evidence that methylphenidate was associated with an increase in serious adverse events (risk ratio 0.98, nine trials, n=1532; TSA adjusted intervention effect RR 0.91). Methylphenidate was associated with an increased risk of non-serious adverse events (1.29, 21 trials, n=3132; TSA adjusted RR 1.29). Teacher rated general behaviour seemed to improve with methylphenidate (SMD -0.87, five trials, n=668) A change of 7 points on the child health questionnaire (CHQ) has been deemed a minimal clinically relevant difference. The change reported in a meta-analysis of three trials corresponds to a mean difference of 8.0 points on the CHQ (range 0-100 points), which suggests that methylphenidate may improve parent reported quality of life (SMD 0.61, three trials, n=514). 96.8% of trials were considered high risk of bias trials according to the Cochrane guidelines. All outcomes were assessed very low quality according to GRADE. WHAT THIS STUDY ADDS: The results suggest that among children and adolescents with a diagnosis of ADHD, methylphenidate may improve teacher reported symptoms of ADHD and general behaviour and parent reported quality of life. However, given the risk of bias in the included studies, and the very low quality of outcomes, the magnitude of the effects is uncertain. Methylphenidate is associated with an increased risk of non-serious but not serious adverse events. FUNDING, COMPETING INTERESTS, DATA SHARING: Region Zealand Research Foundation and Copenhagen Trial Unit. Competing interests are given in the full paper on bmj.com. Full data are available in the version of this review published in The Cochrane Library.
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“The most common prescribed drug for treatment of ADHD is methylphenidate (MPH) and it is believed that it can improve cognitive function through a dopaminergic effect (Storebø et al. 2015).”
From Crocus sativus L. Versus Methylphenidate in Treatment of Children with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Pilot Study (2019) · cites this paper as Storebø et al. 2015
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2 retracted
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EEG power spectral slope differs by ADHD status and stimulant medication exposure in early childhood
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“…that were medication naive, we next tested whether our observed electrophysiological group differences were modified by treatment with stimulant medications, which improve behavioral symptoms in children with ADHD and are the most common medicinal treatment for the disorder (Storebø et al. 2015).”
BackgroundCoghill, D., Banaschewski, T., Cortese, S., Asherson, P., Brandeis, D., Buitelaar, J., Daley, D., Danckaerts, M., Dittmann, R. W., Doepfner, M., et al. (2023) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-021-01871-x · Cited by 180
Bellato, A., Arora, I., Hollis, C., & Groom, M. J. (2020) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2019.11.001 · Cited by 179
Attention-Deficit/Hyperactivity Disorder
Banaschewski, T., Becker, K., Döpfner, M., Holtmann, M. H., Rösler, M., & Romanos, M. (2017) · Deutsches Ärzteblatt international · doi:10.3238/arztebl.2017.0149 · Cited by 217
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“Major questions and concerns remain, however, regarding the benefits and risks of ADHD medications (16, 19, 20).”
Real‐time f MRI neurofeedback in adolescents with attention deficit hyperactivity disorder
Alegria, A. A., Wulff, M., Brinson, H., Barker, G. J., Norman, L. J., Brandeis, D., Stahl, D., David, A. S., Taylor, E., Giampietro, V., et al. (2017) · Human Brain Mapping · doi:10.1002/hbm.23584 · Cited by 151
“…control) groups is comparable to typical parent-rated effect size of 0.6 for stimulant medication based on recent meta-analyses [Punja et al., 2016; Storebo et al., 2015], while the effect size for the pre-FU contrast reached almost 1 in the active group but only half of the effect size for the…”
BackgroundInfluentialCoghill, D., Banaschewski, T., Soutullo, C. A., Cottingham, M. G., & Zuddas, A. (2017) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-017-0986-y · Cited by 136
van Lieshout, M., Luman, M., Twisk, J. W. R., van Ewijk, H., Groenman, A. P., Thissen, A. J. A. M., Faraone, S. V., Heslenfeld, D. J., Hartman, C. A., Hoekstra, P. J., et al. (2016) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-016-0820-y · Cited by 128
“sleeping problems, decreased appetite) were evident [37, 38], indicating that, in line with our findings, the long-term effects of pharmacological treatment on functional outcomes of ADHD may need reconsideration [39].”
ResultHuß, M., Duhan, P., Gandhi, P., Chen, C., Spannhuth, C. W., & Kumar, V. (2017) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s130444 · Cited by 104
“69 As with treatment efficacy, the relationship between dose and AEs remains unclear.”
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“Pharmacological treatments can reduce symptoms, but are often unsatisfactory due to side effects, failure to prevent or alter long-term course and discontinuance due to patient and family preferences (Storebø et al., 2015; Swanson et al., 2017).”
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Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)
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Self-citationDoes methylphenidate improve academic performance? A systematic review and meta-analysis
Kortekaas-Rijlaarsdam, A. F., Luman, M., Sonuga-Barke, E., & Oosterlaan, J. (2019) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-018-1106-3 · Cited by 99
“We found no effects of titration method (clinical titration prior to the trial or fixed dosages) which is also in line with findings from [61].”
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“Most patients with ADHD are treated with pharmacological agents for long periods, a treatment directed only against symptoms and frequently associated with negative side effects (Storebø, 2015; Castells et al., 2018).”
BackgroundSocial and Economic Costs of Attention-Deficit/Hyperactivity Disorder Across the Lifespan
Sciberras, E., Streatfeild, J., Ceccato, T., Pezzullo, L., Scott, J. G., Middeldorp, C. M., Hutchins, P., Paterson, R. S., Bellgrove, M. A., & Coghill, D. (2020) · Journal of Attention Disorders · doi:10.1177/1087054720961828 · Cited by 75
“While medication can reduce the symptoms of ADHD, the mental health and broader outcomes remain poorer than for individuals without ADHD (Fazel, 2015; Langberg & Becker 2012; Storebø et al., 2015).”
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“23), and that there is no evidence that MPH increases the risk of serious adverse events [136,137].”
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“The finding of an association between adherence and experienced side effects is reasonable in the light of the high frequency of reported non-serious adverse events secondary to stimulant treatment [27], the high discontinuation rate due to adverse effects [56], and the reported relationship between experiences of adv…”
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“MPH is prescribed for chronic use to a large proportion of ADHD patients, but is linked to possible publication bias in reported efficacy.”
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“In a previous meta-study, medicine was evaluated because it significantly reduced hyperactivity [49].”
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“Moreover, the therapeutic-like MPH-responsiveness observed in DNE mice is consistent with ADHD, since psychostimulants such as MPH exert therapeutic effects in ADHD patients (Franke et al., 2011; Castells et al., 2011; Baird et al., 2012; Storebø et al., 2015; Rezaei et al., 2016; Snitselaar et al., 2017).”
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“Psychostimulant medication has been most extensively studied and has clear efficacy (Chan et al., 2016; Storebø et al., 2015).”
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“, amphetamine, methylphenidate) although questions remain regarding the magnitude of these effects given various methodological problems in the literature [10].”
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“This particular study found that it was underpowered to identify a difference in serious adverse events.(41)”
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“Reviews of pharmacotherapy studies note the inadequate reporting of drug trial methodology, publication bias, limited reliability of results, inadequate data regarding adverse events, and lack of evidence of long term benefit (e.g. Storebø et al., 2015).”
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Combined Modality Intervention for ADHD With Comorbid Reading Disorders: A Proof of Concept Study
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“…children and adolescents with ADHD (i.e., inattentiveness, hyperactivity, impulsivity), particularly in the classroom as reported by teachers, without an increase in serious side effects, at least in the short term (for recent meta-analysis of randomized clinical trials, see Storebø et al., 2015).”
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“Methylphenidate is the drug most often prescribed to treat children with ADHD and is associated with improvements in teacher ratings of general behavior and ADHD symptoms (Storebø et al., 2015).”
BackgroundAttention-Deficit/Hyperactivity Disorder Medication Use in Adolescents: The Patient's Perspective
Kosse, R. C., Bouvy, M. L., Philbert, D., de Vries, T. W., & Koster, E. S. (2017) · Journal of Adolescent Health · doi:10.1016/j.jadohealth.2017.05.027 · Cited by 29
“However, the use of methylphenidate is also associated with adverse effects [8,9].”
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Is there a cluster of high theta-beta ratio patients in attention deficit hyperactivity disorder?
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“A recent review reports adverse effects, like insomnia and decreased appetite, in about 25% of patients using MPH [8].”
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“A Cochrane review published in 2015 examined the literature on the beneficial and harmful effects of methylphenidate on children and adolescents with ADHD [14].”
BackgroundPelsser, L., Frankena, K., Toorman, J., & Rodrigues Pereira, R. (2020) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2020.00096 · Cited by 25
Diagnosis and Treatment Options for Preschoolers with Attention-Deficit/Hyperactivity Disorder
Wigal, S. B., Chappell, P. B., Palumbo, D. R., Lubaczewski, S. L., Ramaker, S., & Abbas, R. (2020) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2019.0116 · Cited by 30
“…patients, despite limited evidence to inform pharmacotherapy choices in this population (Pliszka 2007; Charach et al. 2013) compared with the large volume of evidence from trials conducted in school-aged children and adolescents (Otasowie et al. 2014; Storebo et al. 2015; Punja et al. 2016).”
BackgroundResultCervelló, X. C., Ramon, M., Cunill, R., Olivé, C., & Serrano, D. (2020) · Journal of Attention Disorders · doi:10.1177/1087054720903372 · Cited by 27
Mykletun, A., Widding‐Havneraas, T., Chaulagain, A., Lyhmann, I., Bjelland, I., Halmøy, A., Elwert, F., Butterworth, P., Markussen, S., Zachrisson, H. D., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-041698 · Cited by 26
Methylphenidate HCL for the treatment of ADHD in children and adolescents
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“77 between teacher ratings of MPH and placebo in parallel group trials.[55] Crossover trials showed a large treatment effect with the standardized mean difference”
BackgroundGerlach, M., Banaschewski, T., Coghill, D., Rohde, L. A., & Romanos, M. (2017) · ADHD Attention Deficit and Hyperactivity Disorders · doi:10.1007/s12402-017-0220-2 · Cited by 23
Pittenger, C., Brennan, B. P., Koran, L. M., Mathews, C. A., Nestadt, G., Pato, M. T., Phillips, K. A., Rodríguez, C. I., Simpson, H. B., Skapinakis, P., et al. (2021) · Psychiatry Research · doi:10.1016/j.psychres.2021.113853 · Cited by 22
Boesen, K., Saiz, L. C., Erviti, J., Storebø, O. J., Gluud, C. N., Gøtzsche, P. C., & Jørgensen, K. J. (2017) · BMJ Evidence-Based Medicine · doi:10.1136/ebmed-2017-110716 · Cited by 22
Self-citationBorn which Way? ADHD, Situational Self-Control, and Responsibility
Koi, P. (2020) · Neuroethics · doi:10.1007/s12152-020-09439-3 · Cited by 24
Long-term methylphenidate intake in chronic fatigue syndrome
Blockmans, D., & Persoons, P. (2016) · Acta Clinica Belgica · doi:10.1080/17843286.2016.1200816 · Cited by 21
Lee, C., Chen, T., Gao, Q., Hua, C., Song, R., & Huang, X.-P. (2022) · Child Psychiatry & Human Development · doi:10.1007/s10578-022-01361-4 · Cited by 20
“The benefits of stimulant medications for attention problems in children with ADHD have been well-established [8–10].”
BackgroundMethylphenidate-induced obsessive-compulsive symptoms: A case report and review of literature
Grover, S., Jhanda, S., & Singla, N. (2016) · Journal of Pediatric Neurosciences · doi:10.4103/1817-1745.199461 · Cited by 20
“1 and a positive early response in approximately 70% of cases.[1] The most common side effects associated with methylphenidate are insomnia, headache, irritability, agitation, loss of appetite, nausea, and weight loss.”
BackgroundInfluentialHypertonic Saline in Bronchiolitis and Type I Error: A Trial Sequential Analysis
Harrison, W. N., Angoulvant, F., House, S. A., Gajdos, V., & Ralston, S. L. (2018) · PEDIATRICS · doi:10.1542/peds.2018-1144 · Cited by 22
Mercier, C., Roche, S., Gaillard, S., Kassaï, B., Arzimanoglou, A. A., Herbillon, V., Roy, P., & Rheims, S. (2016) · Epilepsy & Behavior · doi:10.1016/j.yebeh.2016.02.016 · Cited by 20
Darling, K. A., Eggleston, M. J. F., Retallick-Brown, H., & Rucklidge, J. J. (2019) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2019.0036 · Cited by 22
“However, long-term studies of medication for ADHD find that medications do not result in elimination of symptoms or improved academic performance (Advokat 2010; Currie et al. 2014; Storebø et al. 2015).”
Ramstad, E., Storebø, O. J., Gerner, T., Krogh, H. B., Holmskov, M., Magnusson, F. L., Maia, C. R. M., Skoog, M., Groth, C., Gillies, D. M., et al. (2018) · Scandinavian Journal of Child and Adolescent Psychiatry and Psychology · doi:10.21307/sjcapp-2018-003 · Cited by 19
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“The efficacy of stimulants and non-stimulants in reducing ADHD symptoms is well documented in children and adults [4,5].”
BackgroundRefining treatment choices for ADHD
Arnett, A. B., & Stein, M. A. (2018) · The Lancet Psychiatry · doi:10.1016/s2215-0366(18)30295-5 · Cited by 17
Influence of Drugs on Cognitive Functions
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“MPH (Ritalin©) is a psychostimulant approved for the treatment of attention deficit/hyperactivity disorder (ADD/ADHD) [106].”
BackgroundGrassi, G., Albani, G., Terenzi, F., Razzolini, L., & Ramat, S. (2021) · Neurological Sciences · doi:10.1007/s10072-021-05237-8 · Cited by 18
“Methylphenidate acts by inhibiting both the dopamine and the norepinephrine transporters (DAT and NET, despite this latter with a slightly lower affinity) [52].”
BackgroundChu, L., Zhu, P., Ma, C., Pan, L., Shen, L., Wu, D., Wang, Y., & Yu, G. (2022) · Frontiers in Pediatrics · doi:10.3389/fped.2021.813305 · Cited by 21
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“The most effective treatment for inattention is medication (Storebø et al., 2015), which may lead to less room for improvement in MBIs.”
BackgroundBehavioral, Neurochemical and Developmental Effects of Chronic Oral Methylphenidate: A Review
Senior, D., Ahmed, R., Arnavut, E., Carvalho, A. T. P., Lee, W. X., Blum, K., Komatsu, D. E., Hadjiargyrou, M., Badgaiyan, R. D., & Thanos, P. K. (2023) · Journal of Personalized Medicine · doi:10.3390/jpm13040574 · Cited by 15
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“Although medication for ADHD is widely used, it comes with disadvantages: severe side effects such as insomnia, loss of appetite, headache, anxiety, abdominal pain, and nervousness (e.g., Graham et al., 2011; Storebø et al., 2015).”
InfluentialIshizuya, A., Enomoto, M., Tachimori, H., Takahashi, H., Sugihara, G., Kitamura, S., & Mishima, K. (2021) · Scientific Reports · doi:10.1038/s41598-021-81416-z · Cited by 16
Does Methylphenidate Work in Children and Adolescents with Attention Deficit Hyperactivity Disorder?
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“This viewpoint provides an overview of the evidence since the 2015 Cochrane review by Storebø and colleagues [6,7].”
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The Effects of Extended-Release Stimulant Medication on Sleep in Children with ADHD.
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“In fact, the most widely used drugs are psychostimulants, used mainly for childhood treatment of severe ADHD [50], even if the prescription of these therapies is widely extended to late adolescence and adulthood [51,52].”
BackgroundMethylphenidate use and school performance among primary school children: a descriptive study
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“Hundreds of randomized controlled trials demonstrate that MPH treatment is, in general, effective, safe, and well-tolerated [13,14].”
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Attention Deficit Hyperactivity Disorder (ADHD)
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Metadata
- Authors
- Storebø, O. J., Krogh, H. B., Ramstad, E., Moreira-Maia, C. R., Holmskov, M., Skoog, M., Nilausen, T. D., Magnusson, F. L., Zwi, M., Gillies, D., Rosendal, S., Groth, C., Rasmussen, K. B., Gauci, D., Kirubakaran, R., Forsbøl, B., Simonsen, E., & Gluud, C.
- Affiliations
- University of Southern Denmark (DK)
- Region Zealand (DK)
- Copenhagen University Hospital (DK)
- Whittington Hospital (GB)
- Western Sydney Local Health District (AU)
- Capital Region of Denmark (DK)
- Herlev Hospital (DK)
- Ministry for Health (MT)
- Christian Medical College, Vellore (IN)
- University of Copenhagen (DK)
- Corresponding author
- Storebø, Ole Jakob
- ORCID
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2015-11-25
- Volume
- 351
- Pages
- h5203
- ISSN
- 1756-1833 (ISSN-L)
- PMC
- PMC4659414
- OpenAlex
- W2179260900
- Cited by
- 209
- References
- 77
- Citations by year
- 2026: 8 · 2025: 8 · 2024: 11 · 2023: 14 · 2022: 17 · 2021: 24 · 2020: 16 · 2019: 18 · 2018: 25 · 2017: 36 · 2016: 28 · 2015: 4
- FWCI
- 4.27
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- BMJ (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by-nc)
- OAR@UM (University of Malta) (submittedVersion, other-oa)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, cc-by-nc)
- Funders
- Gentofte Hospital
- Syddansk Universitet
- Region Sjælland
- Copenhagen Trial Unit, Centre for Clinical Intervention Research
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- methylphenidate, attention deficit hyperactivity disorder, children, adolescents, ADHD symptoms, quality of life, adverse events, stimulant medication, teacher ratings, parent ratings, trial sequential analysis, risk of bias, quality of evidence, minimal clinically important difference, Child Health Questionnaire
- MeSH terms
- Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Drug Administration Schedule, Humans, Methylphenidate, Quality of Life, Randomized Controlled Trials as Topic, Treatment Outcome, Cross-Over Studies
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