Yang 2012.
Methods | A single‐blind (rater blinded) randomised parallel trial comparing:
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Participants | Number of participants screened: not stated Number of participants included: 262 Number of participants randomised to methylphenidate: 130 Number of participants followed up: 85 Number of withdrawals: 39 Diagnosis of ADHD: DSM‐IV (subtype: inattentive (42%), combined (56.5%), hyperactive/impulsive (1.2%) Age: mean 9.64 (SD 1.95), range 7‐14 years old IQ: above 70, mean 102.99 (15.01) Sex: 129 males, 23 females Methylphenidate‐naïve: not stated Ethnicity: not stated Country: China Comorbidity: oppositional defiant disorder (n = 44), conduct disorder (n = 2) Comedication: not stated Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Methylphenidate type: osmotic release oral system (OROS) Methylphenidate dosage: started at 18 mg/daily and could be increased each week to 36 mg/daily and then 54 mg/daily according to the patients response Mean methylphenidate dosage: not stated Administration schedule: not stated Duration of intervention: titration + 4‐6 weeks Treatment compliance: not stated |
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Outcomes |
Non‐serious adverse events: 15 dropped out of the methylphenidate group due to adverse events |
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Notes | Sample calculation: yes Ethics approval: yes Funding: Xian‐Janssen Pharmaceutical Ltd. Vested interests/authors' affiliations: Xian‐Janssen, Eli Lilly Key conclusions of the study authors: the results imply that both OROS‐methylphenidate and atomoxetine could improve EF in ADHD children Comments from the study authors: there are a number of methodological limitations in the current study. First, we did not include a group that received placebo; therefore, there might have been a bias in the results for the potential placebo effect when we estimated the effect of each medication. The relatively small sample size in the atomoxetine group may have underestimated its therapeutic effect. Further, the slight differential effect between OROS‐methylphenidate and atomoxetine treatment groups might also have been a type I error. We excluded youths with significant current psychiatric co‐morbidity, restricting the generalisation the findings to more co‐morbid, clinically relevant populations Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes Supplemental information requested from the study authors in May 2014. No reply |