Table A16-40Risperidone versus placebo for the treatment of non-cognitive symptoms of dementia (individual adverse events)

Quality assessmentSummary of findings
No of patientsEffectQualityImportance
No of studiesDesignLimitationsConsistencyDirectnessOther considerationsrisperidoneplaceboRelative (95% CI)Absolute (95% CI)
AE: Hallucinations ( Follow up: )
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyImprecise or sparse data (−1)1,17/196 (8.7%)5/94 (5.3%)RR 1.63 (0.62 to 4.29)30/1 000 (−30 to +90)⊕⊕⊕○
Moderate
9
AE: Somnolence ( Follow up: )
5Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)2237/1175 (20.2%)80/779 (10.3%)RR 2.07 (1.63 to 2.63)110/1 000 (80 to 140)⊕⊕⊕⊕
High
9
AE: Hostility ( Follow up: )
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyImprecise or sparse data (−1)1,13/196 (6.6%)1/94 (1.1%)RR 6.23 (0.83 to 46.95)60/1 000 (20 to 110)⊕⊕⊕○
Moderate
9
AE: Confusion ( Follow up: )
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyImprecise or sparse data (−1)1,20/196 (10.2%)6/94 (6.4%)RR 1.60 (0.66 to 3.85)40/1 000 (−30 to +100)⊕⊕⊕○
Moderate
9
AE: Flu/fever syndrome ( Follow up: )
3Randomised trialsNo limitationsNo important inconsistency3No uncertaintyImprecise or sparse data (−1)1,59/825 (7.2%)19/427 (4.4%)RR 1.34 (0.82 to 2.20)20/1 000 (−10 to +40)⊕⊕⊕○
Moderate
9
AE: Abnormal gait ( Follow up: )
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)2,31/363 (8.5%)5/264 (1.9%)RR 3.93 (1.56 to 9.91)60/1 000 (30 to 90)⊕⊕⊕⊕
High
9
AE: Urinary tract infection ( Follow up: )
3Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone139/864 (16.1%)70/571 (12.3%)RR 1.28 (0.97 to 1.69)30/1 000 (0 to 70)⊕⊕⊕⊕
High
9
AE: Urinary incontinence ( Follow up: )
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone25/196 (12.8%)1/94 (1.1%)RR 11.99 (1.65 to 87.15)120/1 000 (70 to 170)⊕⊕⊕⊕
High
9
AE: Asthenia ( Follow up: )
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone17/196 (8.7%)2/94 (2.1%)RR 4.08 (0.96 to 17.28)70/1 000 (20 to 110)⊕⊕⊕⊕
High
9
AE: Peripheral edema ( Follow up: )
3Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)2,98/864 (11.3%)26/571 (4.6%)RR 2.10 (1.34 to 3.23)50/1 000 (20 to 80)⊕⊕⊕⊕
High
9
AE: Clinically significant weight gain ( Follow up: )
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyImprecise or sparse data (−1)1,6/196 (3.1%)1/94 (1.1%)RR 2.88 (0.35 to 23.56)20/1 000 (−10 to 50)⊕⊕⊕○
Moderate
9
1

Confidence interval compatible with both increased risk and no risk

2

RR > 2, p < .01

3

I-squared = 56.7%

From: APPENDIX 16, EVIDENCE PROFILE TABLES FOR QUANTITATIVE REVIEWS

Cover of Dementia
Dementia: A NICE-SCIE Guideline on Supporting People With Dementia and Their Carers in Health and Social Care.
NICE Clinical Guidelines, No. 42.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2007.
Copyright © 2007, The British Psychological Society & The Royal College of Psychiatrists.

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