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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

Yang 2012.

Methods A single‐blind (rater blinded) randomised parallel trial comparing:
  1. Osmotic release oral system (OROS) methylphenidate

  2. Atomoxetine

  3. A (non‐diagnosed) control group receiving no intervention

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
  1. ADHD criteria by clinical and structured interview

  2. Unmedicated or successfully medicated with methylphenidate but had not received methylphenidate during the last 6 months


Exclusion criteria
  1. History of no response or intolerance to methylphenidate or atomoxetine

  2. Diagnosis of bipolar I or II, psychosis, anxiety disorder, depression, tic disorder or pervasive developmental disorder

  3. Mental retardation (IQ below 70)

  4. Seizure disorder or abnormal EEG associated with epilepsy

  5. Currently taking anticonvulsive drugs

  6. Some medical conditions not appropriate to receive medications such as narrow‐angle glaucoma, cardiovascular diseases, or any diseases which may deteriorate when pulse or blood pressure is increased, including hypertension or those taking anti‐hypertensive drugs

  7. Taking other psychotropic drugs including health food with CNS activity during the prior 30 days or during the study

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
Outcomes Non‐serious adverse events:
15 dropped out of the methylphenidate group due to adverse events
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