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

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214 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Not reported Not reported Not reported Withdrawals: Nervous facial tic, dizziness and headache: n = 1 Dizziness, headache and increased hyperactivity: n = 1 Excessive speech and disjointed thinking: n = 1 Parent reports: % severe side-effects (n = 82): Low dose, high dose, placebo Decreased appetite: 7, 13, 1 (significant difference between high dose and placebo) Insomnia: 18, 18, 7 (significant difference between high dose and placebo) Stomach aches: 1, 6, 0 Headaches: 1, 4, 0 Prone to crying: 16, 10, 10 Tics/nervous movements: 4, 7, 5 Dizziness: 0, 1, 0 Drowsiness: 2, 1, 1 Nail biting: 4, 9, 7 Talks less: 1, 2, 1 Anxiousness: 9, 7, 12 Disinterested in others: 1, 2, 0 Euphoria: 4, 7, 9 Irritable: 15, 13, 18 Nightmares: 0, 3, 0 Sadness: 6, 8, 5 Staring: 4, 1, 2 Parent reports: % side-effects (n = 82): Low dose, high dose, placebo: Decreased appetite: 52, 56, 15 (no significant differences between treatment arms) Insomnia: 62, 68, 40 (no significant differences between treatment arms) Stomach aches: 39. 35, 18 (no significant differences between treatment arms) Headaches: 26, 21, 11 (no significant differences between treatment arms) Prone to crying: 59, 54, 49 (significant difference between low dose and placebo) (p < 0.05) Tics/nervous movements: 18, 28, 18 (significant difference between high dose and placebo) (p < 0.05) Dizziness: 10, 7, 4 (no significant differences between treatment arms) Drowsiness: 23, 20, 18 (no significant differences between treatment arms) Nail biting: 26, 29, 22 (no significant differences between treatment arms) Talks less: 20, 22, 16 (no significant differences between treatment arms) Anxiousness: 58, 52, 58 (no significant differences between treatment arms) Disinterested in others: 18, 15, 18 (no significant differences between treatment arms) continued
Core symptoms Educational performance Quality of life Adverse events Euphoria: 34, 43, 41 (no significant differences between treatment arms) Irritable: 65, 66, 72 (no significant differences between treatment arms) Nightmares: 20, 21, 20 (no significant differences between treatment arms) Sadness: 48, 41, 43 (no significant differences between treatment arms) Staring: 38, 38, 40 (no significant differences between treatment arms) The authors also presented incidence data of side-effects reported by teachers and mean severity ratings reported by both parents and teachers Conclusions Authors’ conclusions: Parent ratings indicated that decreased appetite, insomnia, stomach aches and headaches increased significantly in frequency and severity during the two active medication doses compared with placebo. Stimulant medications, when given in therapeutic doses, are generally safe and produce only minor degrees of side effects in most children with ADHD Reviewer’s comments: No comments noted © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 215
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Appendices A systematic review and
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Clinical effectiveness information
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366 Appendix 13 Study characteristi
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