Table A16-27Olanzapine versus placebo for the treatment of non-cognitive symptoms of dementia (efficacy analysis)

Quality assessmentSummary of findings
No of patientsEffectQualityImportance
No of studiesDesignLimitationsConsistencyDirectnessOther considerationsolanzapineplaceboRelative (95% CI)Absolute (95% CI)
Neuropsychiatric symptoms (mean change from baseline at 6–12 weeks (NPI/NH total or BEHAVE-AD total) [LOCF], Range: −0.51 to +0.13. Better indicated by: lower scores)
4Randomised trialsNo limitationsImportant inconsistency (−1)5,6No uncertaintyNone471370-SMD −0.09 (−0.23 to 0.05)⊕⊕⊕○
Moderate
9
Psychotic symptoms - hallucinations & delusions (mean change from baseline at 6–12 weeks (NPI/NH psychosis or BEHAVE-AD psychosis) [LOCF], Range: −0.31 to +0.12. Better indicated by: lower scores)
3Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone371265-SMD −0.05 (−0.21 to 0.11)⊕⊕⊕⊕
High
9
General psychiatric symptoms (BPRS Total - mean change from baseline at 6–10 weeks [LOCF], Range: −0.54 to +0.12. Better indicated by: lower scores)
4Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone424330-SMD 0.00 (−0.15 to 0.14)⊕⊕⊕⊕
High
9
Activities of daily living (PDS at 10 weeks)
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyImprecise or sparse data (−1)217083-SMD −0.20 (−0.46 to 0.07)⊕⊕⊕○
Moderate
6
Aggressive behaviour (CMAI total aggressiveness - mean change from baseline at 10–12 weeks [LOCF])
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyImprecise or sparse data (−1)419390-SMD −0.09 (−0.34 to 0.16)⊕⊕⊕○
Moderate
9
Response to treatment (Defined as at least 30–50% reduction from baseline to endpoint on NPI Psychosis total, Follow up: )
1Randomised trialsNo limitationsImportant inconsistency (−1)6No uncertaintyImprecise or sparse data (−1)4120/193 (62.2%)60/91 (65.9%)RR 0.94 (0.78 to 1.13)40/1 000 (−160 to +80)⊕⊕○○
Low
9
Clinical global improvement (CGI-I at 10–12 weeks [LOCF], Range: −0.38 to +0.08. Better indicated by: lower scores)
3Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyImprecise or sparse data (−1)4428334-SMD −0.03 (−0.18 to 0.11)⊕⊕⊕○
Moderate
9
Leaving the study early for any reason ( Follow up: )
4Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone324/1003 (32.3%)125/388 (32.2%)RR 1.14 (0.96 to 1.36)30/1 000 (0 to 60)⊕⊕⊕⊕
High
6
Leaving the study early due to adverse events ( Follow up: )
4Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)8104/1003 (10.4%)18/388 (4.6%)RR 2.39 (1.43 to 3.99)60/1 000 (30 to 90)⊕⊕⊕⊕
High
9
1

One trial of aripiprazole (10 mg/day)

2

One trial of olanzapine (5.2 mg/day)

3

One trial of risperidone (1 mg/day)

4

Confidence interval compatible with both clinically significant and non-significant benefit

5

Random effects model used due to important heterogeneity

6

I-squared > 50%

7

One trial of olanzapine (IM 5mg)

8

RR > 2, p < .01

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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