Abbasi 2011.
Methods | A 6‐week, parallel group, RCT with 2 arms
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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:
Exclusion criteria:
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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 |
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Outcomes | Non‐serious adverse events:
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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 |