Arman 2013.
Methods | A cohort study measuring heart rate and cardiac abnormalities at the second to fourth week of treatment with methylphenidate | |
Participants | Number of participants screened: not stated Number of participants included: 15 Number of participants followed‐up: 15 Number of withdrawals: 0 Diagnosis of ADHD: not stated (subtype: combined (53%), inattentive (47%)) Age mean: 9.08 years (range: 7‐13 years) IQ: not stated Sex: 11 males, 4 females Methylphenidate‐naïve: not stated Ethnicity: not stated Country: Turkey Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria: None stated Exclusion criteria:
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Interventions | Methylphenidate dosage: 0.25‐1 mg/kg/day Mean methylphenidate dosage: 0.6 mg/kg/day Administration schedule: not stated Duration of intervention: not stated, but the outcome measures were monitored from week 2 to 4 Treatment compliance: not stated |
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Outcomes | Serious adverse events: Cardiac rhythm abnormalities monitored by 12‐lead‐surface electrocardiogram and 24‐hour‐ambulatory Holter monitorisation Non‐serious adverse events: Heart rate variability (HRV) monitored by 12‐lead‐surface electrocardiogram and 24‐hour‐ambulatory Holter monitorisation |
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Notes | Sample calculation: not stated Ethics approval: not stated Funding/vested interest/authors' affiliations: not stated Any withdrawals due to adverse events: not stated Key conclusions of the study authors: our study showed a significantly increased heart rate and decreased heart rate variability due to methylphenidate treatment in children with ADHD, suggesting an increased sympathetic tonus especially at the daytime. Risk of sudden cardiac death and serious arrhythmia has not been demonstrated Comments from the review authors: no full text available, only an abstract. No information on ADHD diagnosis so we are only able to use data on serious adverse events Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated Supplemental information requested through personal email correspondence with the authors in August 2014. They were not able to provide further information |