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

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224 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Not reported SERS (parents), no. of side effects out of list of 17 (mean, SD) Placebo: 12.50 (6.56) MPH (0.15): 8.66 (4.71) MPH (0.30): 10.16 (2.85) MPH (0.50): 12.00 (4.42) 0.50 > 0.15: p < 0.05 Weight (mean, SD) Placebo: 102.16 (4.40) MPH (0.15): 103.33 (3.32) MPH (0.30): 104.40 (4.24) MPH (0.50): 103.66 (4.63) No significant differences CPRS-R: learning problems (mean, SD) Placebo: 7.50 (2.94) MPH (0.15): 5.00 (1.26) MPH (0.30): 4.66 (2.33) MPH (0.50): 6.00 (4.51) 0.15/0.30 > placebo: p < 0.05 Arithmetic task: no. of questions attempted (mean, SD) Placebo: 44.50 (8.09) MPH (0.15): 48.00 (4.00) MPH (0.30): 49.66 (0.81) MPH (0.50): 50.00 (0.00) No significant differences CPRS-R: total score (mean, SD) Placebo: 39.66 (3.61) MPH (0.15): 28.83 (9.82) MPH (0.30): 31.50 (5.85) MPH (0.50): 36.50 (3.20), 0.15/0.30 > placebo: p < 0.05 CPRS-R: hyperactivity index (mean, SD) Placebo: 12.66 (4.13) MPH (0.15): 9.33 (4.32) MPH (0.30): 9.00 (3.16) MPH (0.50): 9.33 (2.06) No significant differences Arithmetic task: no. of questions completed correctly (mean, SD) Placebo: 28.66 (16.26) MPH (0.15): 31.83 (14.35) MPH (0.30): 34.33 (15.78) MPH (0.50): 37.16 (15.76) 0.30/0.50 > placebo: p < 0.05; 0.50 > 0.15: p < 0.05; 0.50 > 0.30: p < 0.05 Arithmetic task: accuracy score (mean, SD) Placebo: 62.33 (28.99) MPH (0.15): 66.00 (28.53) MPH (0.30): 68.83 (31.21) MPH (0.50): 74.33 (31.53) 0.50 > placebo: p < 0.05; 0.50 > 0.15: p < 0.05; 0.50 > 0.30: p < 0.05 CPRS-R: impulsivity (mean, SD) Placebo: 8.33 (3.20) MPH (0.15): 4.83 (0.98) MPH (0.30): 4.83 (0.75) MPH (0.50): 3.00 (2.44) 0.50 > placebo: p < 0.05 Conners’ Teacher Hyperactivity Index (ATR) (mean, SD) Placebo: 24.50 (2.81) MPH (0.15): 22.16 (3.12) MPH (0.30): 18.33 (3.07) MPH (0.50): 17.33 (3.72) 0.30/0.50 > placebo: p < 0.05; 0.30/0.50 > 0.15: p < 0.05 Arithmetic task: time spent (mean, SD) Placebo: 26.00 (6.78) MPH (0.15): 33.33 (16.02) MPH (0.30): 32.66 (11.09) MPH (0.50): 29.33 (3.55) 0.15/0.30 > placebo: p < 0.05; 0.50 > 0.15: p < 0.05 ACTeRS: hyperactivity (mean, SD) Placebo: 8.00 (0.63) MPH (0.15): 13.66 (6.97) MPH (0.30): 9.50 (5.04) MPH (0.50): 10.00 (6.69) 0.30/0.50 > 0.15: p < 0.05 ACTeRS: attention Placebo: 7.16 (0.75) MPH (0.15): 5.83 (0.40) MPH (0.30): 5.83 (1.47) MPH (0.50): 7.32 (3.50) No significant differences Conclusions Authors’ conclusions: The authors conclude that MPH is an effective adjunct to the treatment of ADD in adolescents Reviewer’s comments: No comments noted
Study Intervention Participants Outcomes Core symptoms Abbreviated Conners’ Rating Scale (ACRS); parents, teachers, clinic Reference Buitelaar et al., 1996 44 Co-existent problems Not reported Educational performance Not reported Arm 1 Pindolol During first 3 days, participants received a single dose of 20 mg (a.m.); thereafter they were treated with two doses of 20 mg administered at breakfast and noon (Individual administering medication not reported) Source CCOHTA Report Setting The Netherlands Psychological function Not reported Inclusion criteria 1. Diagnosis according to DSM-III-R criteria 2. Scores in the clinical range on both CBCL and CTRS hyperactivity factors 3. Deficits in attention performance on either a reaction-time task or a continuous performance task in the neuropsychological testing 4. No previous treatment with psychotropic medication 5. Clinical indication for drug treatment 6. No diagnosis or family history of tic disorder 7. No pervasive developmental disorder 8. No contraindications for treatment with beta-blockers Design Parallel trial Depression or anxiety Not reported Diagnostic criteria DSM-III-R Number Total randomised = 32 (male = 30) Arm 1 = 11 Arm 2 = 10 Arm 3 = 11 Arm 2 MPH During first 3 days, participants received a single dose of 10 mg (a.m.); thereafter they were treated with two doses of 10 mg administered at breakfast and noon (Individual administering medication not reported) Duration Referral period: August 1990–June 1993; treatment period: 4 weeks Quality of life Not reported Adverse events Stimulant Drug Side Effects Rating Scale (modified version): frequency and severity (parents, psychiatrist) Additional outcomes Pulse Blood pressure Purpose To compare the efficacy and side-effects of pindolol and MPH in children with attentiondeficit/hyperactivity disorder © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Total withdrawals = 0 Arm 3 Placebo Administered twice daily (breakfast, noon) (Individual administering medication not reported) Health Technology Assessment 2006; Vol. 10: No. 23 Age 109.8 months (mean); 6–13 years (range); 20.2 months (SD) IQ 93.2 (mean) Co-morbid disorders Conduct disorder: n = 20; depressive disorder: n = 8 (15%); anxiety disorder: n = 22 (42%); epilepsy: n = 1 (NB: numbers for whole sample of 52) Diagnostic subtypes Not reported Additional information Previous medication: Participants in the trial were required not to have previously received psychotropic medication 225
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366 Appendix 13 Study characteristi
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