Ghanizadeh 2012.
Methods | Double‐blind, placebo controlled parallel trial
Investigating the efficacy, tolerability, and adverse effects of nortriptyline for treating enuresis in children with ADHD. No control/no‐intervention group |
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Participants | Number of patients screened: 45 Number included in trial: 43 Number included in placebo group: 16 First follow‐up in placebo group: 13 Number of withdrawals in placebo group: 3 Second follow‐up in placebo group: 13 Lost to final evaluation in placebo group: 1 Final evaluation in placebo group: 12 Diagnosis of ADHD: DSM‐IV‐TR (subtype: not stated) Age: mean: 8.9, range: 5‐14 years old IQ: above 70 Sex: 34 males, 9 females Methylphenidate‐naïve: not stated Ethnicity: not stated Country: Iran Comorbidity: primary enuresis (100%) Comedication: not stated Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Methylphenidate type: not stated Methylphenidate dosage: 20 mg/day (< 30 kg), 30 mg/day (> 30 kg) Administration schedule: not stated Duration of intervention: 45 days Treatment compliance: not stated |
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Outcomes | Spontaneously reported adverse events Systematically reported using a checklist, at baseline and 2 weeks and 4 weeks after onset of interventions, and 2 weeks after stopping the interventions Bedwetting, parent rated, daily |
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Notes | Sample calculation: not stated Ethics approval: yes, Shiraz University of Medical Sciences Funding: the author received a grant Vested interest/authors' affiliations: not stated Key conclusions from study authors: nortriptyline decreases the frequency of enuresis in the children with ADHD and its effect disappears after the discontinuation of treatment Comments from the study authors: the sample size was relatively small and may result in type II errors. In addition, all children were diagnosed with ADHD and formed a clinical sample. Therefore, the results of this study cannot be generalised to other settings, such as a community sample. There was a predominantly higher number of boys than girls, and also it is not clear whether these results can be generalised to other age groups. In the literature there are contradictory reports about the relationship between enuresis and sociodemographic factors. Therefore, it is questionable whether the findings of this study can be applied to other cultures. This current trial was short‐term, and the children had not received an enuresis alarm or desmopressin. Therefore, they were not therapy‐resistant children. Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated Supplemental information received through personal email correspondence with the authors in June 2014 (Ghanizadeh 2014 [pers comm]) |