Ardic 2014.
Methods | A retrospective chart review of osmotic release oral system methylphenidate and immediate release methylphenidate use for 8 weeks | |
Participants | Number of participants screened: not stated Number of participants included: 122 (68 in the OROS‐MPH group and 54 in the IR‐MPH group) Diagnosis of ADHD: DSM‐IV (subtype: combined (89.00%), hyperactive‐impulsive (0%), inattentive (11%)) Age: mean 9.1 (1.7), range: 7‐15 years old IQ: OROS‐MPH: 98.2 (SD 16.5). IR‐MPH: 99.4 (SD 12.8) Sex: 98 males, 24 females (OROS‐MPH: 58 males, 10 females; IR‐MPH: 40 males, 14 females) Methylphenidate naïve: not stated Ethnicity: not stated Country: Turkey Comorbidity: none Comedication: none Sociodemographics: not stated Inclusion criteria:
Exclusion criteria:
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Interventions | Methylphenidate type: osmotic release oral system (OROS) and immediate release Mean methylphenidate dosage: OROS‐MPH 30.8 (SD 11.5) mg/day; IR‐MPH 27.5 (SD 6.1) mg/day Administration schedule: OROS‐MPH once daily, IR‐MPH twice daily Duration of intervention: 8 weeks Treatment compliance: not stated |
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Outcomes |
Serious adverse events: No severe or life‐threatening adverse effects were reported in either group Non‐serious adverse events: ≥ 1 adverse effect in 76% of the OROS‐MPH group and in 79.6% of the IR‐MPH group. 88% adverse events disappeared/decreased over time. Emotional changes were more frequent in IR‐MPH than OROS‐MPH group (51.9% and 32.4%, respectively; P = 0.03) |
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Notes | Sample calculation: not stated
Ethics approval: local approval was obtained from hospital administration for using the data on the Hospital Information System retrospectively
Funding/vested interest/authors' affiliations: while making the study no support has been taken. Eyup Sabri Ercan is in charge in the advisory board of Lilly and Janssen‐Cilag, and the other authors declare no competing financial interests
Key conclusions of the study authors: OROS‐MPH was effective and safe for Turkish children and adolescents, compared to MPH‐IR Comments from the study authors: an important limitation of our study is our inability to assess treatment adherence in both medication groups. 88% of the adverse effects in the OROS‐MPH group and 86% of those in the IR‐MPH group decreased or disappeared over time Comments from the review authors: adverse events rating scale was created by study authors, but it seems to be very similar to Barkley rating scale. According to the Methods section, heart rate, blood pressure, and weight were measured but are not reported in the paper Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not explicitly stated, but it seems that only methylphenidate‐responders were included Supplemental information regarding heart rate, blood pressure and weight has not been possible to receive from the authors. We have written twice in June 2016 without reply |