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

Abbasi 2011.

Methods A 6‐week, parallel group, RCT with 2 arms
  1. Methylphenidate plus Acetyl‐L‐carnitine (ALC)

  2. Methylphenidate plus placebo

Participants Number of participants screened: 68
Number of participants included: 40
Number of participants randomised: ALC + MPH: 20, P + MPH: 20
Number of participants followed‐up: MPH + P: 19
Number of withdrawals: MPH + P: 1
Methylphenidate + placebo
Diagnosis of ADHD: DSM‐IV‐TR (combined type: 100%)
Age: mean 8.36 (1.53), range: 7‐13 years old
Sex: 25 males, 5 females
Methylphenidate‐naïve: 100%
Ethnicity: Persian
Country: Iran
Comorbidity: not stated
Comedication: not stated
IQ: > 70
Sociodemographics: not stated
Inclusion criteria:
  1. DSM‐IV‐TR diagnostic criteria for ADHD

  2. Total and/or subscale scores on Attention‐Deficit/Hyperactivity Disorder Rating Scale‐IV (ADHD‐RS‐IV) School Version being ≥ 1.5 SD above norms for patient's age and gender

  3. Parents and children had to be willing to comply with all requirements of the study


Exclusion criteria:
  1. A history or current diagnosis of pervasive developmental disorders, schizophrenia or other psychiatric disorders (DSM‐IV axis I)

  2. Any current psychiatric comorbidity that required pharmacotherapy

  3. Any evidence of suicide risk

  4. Any evidence of mental retardation (IQ < 70)

  5. A clinically significant chronic medical condition, including organic brain disorder, seizures or current abuse or dependence on drugs in the last 6 months

  6. Hypertension or hypotension

Interventions Participants were randomly assigned to MPH and ACL or MPH and placebo
Methylphenidate type: not stated
Methylphenidate dosage: 20‐30 mg/day depending on weight (20 mg/day for < 30 kg and 30 mg/day for > 30 kg)
Administration schedule: morning and midday
Duration of intervention: 6 weeks
Titration period: 3 weeks after randomisation
Treatment compliance: not stated
Outcomes Non‐serious adverse events:
  1. Side effect checklist administered by a child psychiatrist on days 7, 21 and 42

  2. Haematology tests, baseline and weeks 2, 4 and 6

  3. Serum chemistry, urinalysis, 12‐lead ECG, and physical examinations at baseline and week 6

  4. Body weight and vital signs, baseline and weeks 1, 2, 4, and 6

Notes Sample calculation: yes
Any withdrawals due to adverse events: no
Ethics approval: yes
Funding: this study was supported by a grant from Tehran University of Medical Sciences
Key conclusions of the study authors: the principal measure of outcome was the Teacher and Parent attention deficit/hyperactivity disorder Rating Scale‐ IV. No difference was observed between the 2 groups. Side effects consisting of headache and irritability were observed more frequently in the methylphenidate plus placebo group. The results of this study do not support the application of ALC as an adjunctive therapy to methylphenidate in children and adolescents with ADHD.
Comments from the review authors: patients are randomised to receive MPH plus acetyl‐L‐carnitine (ALC) or MPH plus placebo: no outcome measures regarding effect are relevant, because the study does not include a placebo or no‐intervention group. The co‐intervention (ALC/placebo) is not the same in the 2 groups, and therefore we can only use AE data regarding group 2 (MPH+P group).
Supplemental data has not been possible to receive from the authors through email correspondence in August and October 2013. No reply