APPENDICES. A systematic review and economic model of the ...

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322 Appendix 12 Core symptoms Educational performance Quality of life Adverse events The proportion of participants reporting appetite loss differed significantly between Arms 1 and 2, p = 0.001, and between Arms 1 and 3, p = 0.13, but not between Arms 2 and 3 Natural setting: Abbreviated Conners’ Scale (teacher): mean (SD) Arm 1: 16.40 (7.74); Arm 2: 7.94 (5.83); Arm 3: 7.82 (5.92) Significant differences between Arms 1 and 2, and between Arms 1 and 3 (p < 0.001) Natural setting: Abbreviated Conners’ Scale (parent): mean (SD) Arm 1: 19.91 (6.02); Arm 2: 11.41 (6.23); Arm 3: 9.49 (6.50) Significant differences between Arms 1 and 2 (p < 0.001), Arms 1 and 3 (p < 0.001), Arms 2 and 3 (p < 0.05) Laboratory setting: Abbreviated Conners’ Scale (teacher): mean (SD) Arm 1: 7.03 (7.07); Arm 2: 4.03 (6.31); Arm 3: 3.75 (6.66) Significant differences between Arms 1 and 2, and between Arms 1 and 3 (p < 0.001) Laboratory setting: Abbreviated Conners’ Scale (counsellor): mean (SD) Arm 1: 12.70 (7.15); Arm 2: 9.91 (6.15); Arm 3: 9.26 (5.73) Significant differences between Arms 1 and 2 and between Arms 1 and 3 (p < 0.001) SKAMP Teacher ratings: graphical presentation only Conclusions Authors’ conclusions: This investigation supports the efficacy of Concerta long-acting formulation of MPH for parents who desire to have medication benefits for their child throughout the day and early evening Reviewer’s comments: No comments noted
Study Intervention Participants Outcomes Core symptoms IOWA CTRS Inattention–overactivity References Pliszka et al., 1999; 319 Pliszka et al., 2000; 83 Faraone et al., 2001320 and Pliszka, 2003100 Co-existent problems IOWA CTRS Aggression/defiance factor Source NICE Report Educational performance Not reported Arm 1 MPH Dosage and number of administrations were adjusted at the end of weeks 1 and 2 via an algorithm based on teacher and parent ratings. Final dose: 25.2 ± 13.6 mg/day; (0.39 mg/kg per dose); administered one to three times daily (morning, noon or after school) (Individual administering medication not reported) Setting USA Psychological function Not reported Design Parallel trial Depression or anxiety Not reported Inclusion criteria 1. Diagnosis of ADHD 2. School grades 1–5 3. No other medical illness 4. No current treatment with other non-stimulant psychotropic medication 5. No major depression episode, manic episode, or tic disorder. (Children with other co-morbid conditions, e.g. CD, ODD or mild anxiety were included) 6. No history of psychosis or signs of psychosis or significantly depressed mood 7. At least 1.5 SD above the mean for age and sex on the IOWA CTRS inattention–overactivity factor and elevated Conners’ Global Index 8. IQ not lower than 75 (KBIT composite) Arm 2 Adderall Dosage and number of administrations were adjusted at the end of weeks 1 and 2 via an algorithm based on teacher and parent ratings. Final dose: 12.5 ± 4.1 mg/day (0.31 mg/kg per dose); administered once or twice daily (morning or after school) (Individual administering medication not reported) Duration Treatment period: 3 weeks Quality of life Conners’ Global Index (parents) CGI-I (psychiatrist) Diagnostic criteria Diagnostic Interview Schedule for Children Number Total randomised = 58 (male/female split not reported) Arm 1 = 20 Arm 2 = 20 Arm 3 = 18 Purpose To compare Adderall with MPH for the treatment of ADHD © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Adverse events Multi-Modality Treatment of ADHD Side Effects Scale Health Technology Assessment 2006; Vol. 10: No. 23 Additional outcomes Weight 58 participants are reported on in this paper, but is ambiguous whether more were initially randomised (up to 62?) Arm 3 Placebo One to three times daily (Individual administering medication not reported) Total withdrawals = 5 Arm 1 = 1 Arm 2 = 2 Arm 3 = 2 Reasons for withdrawals: Arm 1: No response and adverse effects (n = 11) Arm 2: Adverse events (n = 2) Arm 3: No response (n = 2) Age 8.1 years (mean); 1.4 years (SD) continued 323
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Appendices A systematic review and
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