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

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268 Appendix 12 Study Intervention Participants Outcomes Co-morbid disorders Not reported Diagnostic subtypes Not reported Additional information Previous medication: There was a 1-week placebo wash-out period before study. 64% of children in both groups had been treated previously with medications for ADHD Participants were required to be medication free (amphetamines, PEM or investigational drug) in the 30 days preceding study entry Concurrent medication: Concomitant use of clonidine, anticonvulsant drugs or medications known to affect blood pressure, heart rate or CNS function excluded individuals from the trial
Core symptoms Educational performance Quality of life Adverse events 2 children (MPH) discontinued treatment owing to adverse events. 52% of 155 children in the MPH group and 38% of 161 children in the placebo group spontaneously reported one or more adverse events (p = 0.01) Teacher scores: MPH MPH Parent scores: placebo placebo Appetite loss 42 (27%) 17 (11%) 73 (47%) 33 (20%) Dull, tired, listless 47 (30%) 45 (28%) 48 (31%) 41 (26%) Crabby, irritable 34 (22%) 48 (30%) 70 (45%) 79 (49%) Tearful, sad, depressed 28 (18%) 33 (20%) 44 (28%) 37 (23%) Worried, anxious 41 (26%) 43 (27%) 36 (23%) 39 (24%) Motor tics 20 (13%) 26 (16%) 11 (7%) 8 (5%) Buccal-lingual 17 (11%) 22 (14%) movements 9 (6%) 7 (4%) Picking at finger or 32 (21%) 34 (21%) skin, nail-biting, lip or 37 (24%) 38 (24%) cheek chewing Stomach aches 19 (12%) 8 (5%) 36 (23%) 25 (16%) Headaches 18 (12%) 7 (4%) 33 (21%) 29 (18%) Trouble sleeping Not Not evaluated evaluated 50 (32%) 38 (24%) Not reported Not reported Conners’ Global Index: teacher MPH: baseline 12.7 (7.24); 3 weeks 4.9 (4.7) Placebo: baseline 11.5 (7.35); 3 weeks 10.3 (6.9) MPH > placebo, p < 0.001, 95% CI: 5.26 to 8.09 Conners’ Global Index: parent MPH: baseline 13.6 (6.6); 3 weeks 7.4 (5.9) Placebo: baseline 12.9 (7.6); 3 weeks 10.1 (6.7) MPH > placebo, p < 0.001; 95% CI: 1.7 to 4.9 CGI-Improvement ratings: CGI efficacy scores in the moderately improved range or better: MPH: 64% (98/154) Placebo: 27% (98/154) CGI-I Scores: MPH: 81% (125/154) Placebo: 50% (78/156) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 No differences between treatments were found in physical examinations performed at the end of the treatment period Conclusions Authors’ conclusions: Modified-release MPH administered once daily in the morning is effective and safe in controlling ADHD symptoms throughout the day Reviewer’s comments: No comments noted 269
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366 Appendix 13 Study characteristi
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