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226 Appendix 12 Core symptoms Educational performance Quality of life Adverse events Not reported Not reported Frequency (%): MPH, placebo treatment Insomnia 38, 25% Anorexia 24, 25% Incoherent speech 15%, 18 Stomach pain 12, 25 Nausea 16, 17 Tiredness 18, 8 Headache 20, 25 Sedation 8, 8 Anxiety 16, 16 Irritability 29, 27 Moodiness 33, 27 Tics 10, 0 Social isolation 8, 0 Nightmares 8, 8 Hallucinations 4, 0 Paresthesias 0, 0 Severity (%): MPH, placebo treatment No distress: 84, 83 Distress: 12, 17 Considerable distress: 4, 0 Sum (median, range) of 2.0 (0–10), adverse events: 2.5 (0–7) There was poor compliance in two subjects owing to side-effects; they were nonetheless included in the analysis. Adjustment of MPH dosage was necessary in four subjects owing to increased agitation, restlessness and insomnia Data presented in graphs cannot be extracted. The authors stated that no significant difference was detected between MPH and placebo Conclusions Authors’ conclusions: Pindolol was modestly effective in the treatment of ADHD. Safety concerns on troubling side effects clearly limit the use of it Reviewer’s comments: No comments noted
Study Intervention Participants Outcomes Core symptoms Symptom Checklist: inattentiveness and hyperactivity Parent Questionnaire: impulsiveness and hyperactivity Reference Conners et al., 197245 Source AHRQ Report Co-existent problems Symptom Checklist: defiance, sociability Parent Questionnaire: conduct disorder, immaturity, psychosomatic, obsessive and antisocial Arm 1 Cylert 25 mg/day increasing to mean dosage of 82 mg/day (25–125 mg/day); administered before breakfast and a placebo before lunch (from day 4) (Administered by parent and teacher) Setting USA Design Parallel trial Educational performance Teacher global ratings of classroom performance WRAT: reading, spelling and arithmetic Gates Diagnostic Reading Test: comprehension, speed and accuracy Gray Oral Reading Test Illinois Test of Psycholinguistic Abilities (ITPA) Inclusion criteria 1. 6–12 years old 2. IQ 80 3. No severe neurotic, psychotic or neurological symptoms 4. No history of family psychopathology sufficient to account of current behaviour symptoms 5. One or more of the following indications of ‘minimal brain dysfunction’: (a) significant history of complications of pregnancy, parturition, delivery or perinatal complications (b) delayed or otherwise abnormal developmental milestones (c) early onset of severe hypermotility (d) soft neurological signs (e) abnormal EEG of a non-epileptic type (f) visual or auditory perceptual impairment (g) a significant discrepancy between actual school achievement and learning potential Arm 2 Dexedrine 5 mg/day increasing to a mean dosage of 20 mg/day (5–40 mg/day); administered before breakfast and before lunch (from day 4) (Administered by parent and teacher) Duration Total treatment period: 8 weeks Purpose To compare the efficacy, side-effects and safety of magnesium PEM (Cylert) and dextroamphetamine (Dexedrine) compared with placebo © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Diagnostic criteria See inclusion criteria Number Total randomised = 84 (male = 74) Arm 1 = 28 Arm 2 = 28 Arm 3 = 28 Arm 3 Placebo Administered before breakfast and before lunch (from day 4) (Administered by parent and teacher) Health Technology Assessment 2006; Vol. 10: No. 23 Psychological function WISC: full scale, verbal IQ, performance IQ, information, comprehension, arithmetic, similarities, vocabulary, digit span, picture completion, picture arrangement, block design, object assembly and coding Harris Goodenough Draw-a-Man Test Bender Visual Motor Gestalt Test Porteus Mazes: test quotient and qualitative Frostig Test of Developmental Visual Perception: Perceptual Quotient, Eye Motor Coordination, Figure Ground, Constancy of Shape, Position in Space and Spatial Relationships Continuous Performance Test (CPT) Paired Associate Learning (PAL) task Total withdrawals = 3 Arm 1 = 1 Arm 2 = 1 Arm 3 = 1 Age 98.99 months (mean); 6–12 years (range); 17.95 months (SD) IQ Not reported continued 227
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366 Appendix 13 Study characteristi
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