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Table A16-49Acetylcholinesterase inhibitors (maximum dose) versus placebo for the treatment of non-cognitive symptoms of vascular dementia

Quality assessmentSummary of findings
No of patientsEffectQualityImportance
No of studiesDesignLimitationsConsistencyDirectnessOther considerationscholinesterase inhibitors (maximum dose)placeboRelative (95% CI)Absolute (95% CI)
Neuropsychiatric symptoms (Observed case) (NPI9)
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyImprecise or sparse data (−1)1
High probability of reporting bias (− 1)3,
279154-WMD −2.20 (−4.32 to −0.08)[plus sign in circle][plus sign in circle]○○
Low
6
Any adverse event ( Follow up: at end of treatment (24 – 28 wks))
3Randomised trialsNo limitationsImportant inconsistency (−1)2No uncertaintyImprecise or sparse data (−1)8722/817 (88.4%)476/588 (81%)RR 1.116 (1.02 to 1.20)90/1 000 (20 to 150)[plus sign in circle][plus sign in circle]○○
Low
6
Mortality ( Follow up: at end of treatment (24 – 28 wks))
3Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyImprecise or sparse data (−1)112/817 (1.5%)10/588 (1.7%)RR 0.88 (0.40 to 1.97)0/1 000 (−20 to 10)[plus sign in circle][plus sign in circle][plus sign in circle]
Moderate
9
AE: Digestive system - Anorexia (donepezil vs. placebo) ( Follow up: at end of treatment (24 wks))
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)13,36/421 (8.6%)14/392 (3.6%)RR 2.37 (1.30 to 4.31)50/1 000 (20 to 80)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
AE: Digestive system - Diarrhea (donepezil vs. placebo) ( Follow up: at end of treatment (24 wks))
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone70/421 (16.6%)40/392 (10.2%)RR 1.63 (1.13 to 2.34)60/1 000 (20 to 110)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
AE: Digestive system - Nausea (donepezil vs. placebo) ( Follow up: at end of treatment (24 wks))
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)13,69/421 (16.4%)29/392 (7.4%)RR 2.21 (1.47 to 3.34)90/1 000 (50 to 130)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
AE: Digestive system - Nausea (galantamine vs. placebo) ( Follow up: at end of treatment (28 wks))
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone93/396 (23.5%)14/196 (7.1%)RR 3.29 (1.93 to 5.61)160/1 000 (110 to 220)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
AE: Digestive system - Vomiting (galantamine vs. placebo) ( Follow up: at end of treatment (28 wks))
1Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone51/396 (12.9%)11/196 (5.6%)RR 2.29 (1.22 to 4.30)70/1 000 (30 to 120)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
AE: Nervous system - Abnormal dreams (donepezil vs. placebo) ( Follow up: at end of treatment (24 wks))
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone24/421 (5.7%)5/392 (1.3%)RR 4.53 (1.74 to 11.79)40/1 000 (20 to 70)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
AE: Other - Cramps/leg cramps (donepezil vs. placebo) ( Follow up: at end of treatment (24 wks))
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone41/421 (9.7%)4/392 (1%)RR 9.70 (3.51 to 26.81)90/1 000 (60 to 120)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
AE: Other - Rhinitisa (donepezil vs. placebo) ( Follow up: at end of treatment (24 wks))
2Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)13,27/421 (6.4%)7/392 (1.8%)RR 3.64 (1.60 to 8.30)50/1 000 (20 to 70)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
Leaving the study early for any reason ( Follow up: at end of treatment (24 – 28 wks))
3Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyNone213/817 (26.1%)95/588 (16.2%)RR 1.61 (1.29 to 2.01)100/1 000 (60 to 140)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
Leaving the study early due to adverse events ( Follow up: at end of treatment (24 – 28 wks))
3Randomised trialsNo limitationsNo important inconsistencyNo uncertaintyStrong association (+1)13,159/817 (19.5%)55/588 (9.4%)RR 2.10 (1.57 to 2.82)100/1 000 (70 to 140)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]
High
9
1

CI compatible with both benefit and no benefit

2

Random effects model used due to heterogeneity

3

Observed case analysis with higher attrition in the active treatment group

4

One relatively small study

5

ADFACS = Alzheimer's Disease Functional Assessment and Change Scale

6

Calculated using a random effects model

7

Unless otherwise indicated, negative effect sizes favour active treatment

8

CI compatible with both harm and no harm

9

Neuropsychiatric Inventory

10

ADAS-cog = Alzheimer's Disease Assessment Scale-cognitive subscale

11

CIBIC-plus = Clinician's Interview-Based Impression of Change-Plus version

12

DAD = Disability Assessment in Dementia

13

RR > 2, p < .01

CI compatible with both benefit and no benefit

Random effects model used due to heterogeneity

Observed case analysis with higher attrition in the active treatment group

Calculated using a random effects model

CI compatible with both harm and no harm

Neuropsychiatric Inventory

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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