Summary of findings 2. Summary of findings ‐ Atypical antipsychotics compared to placebo in people with Alzheimer's disease and vascular dementia.

Outcomes	Absolute mean change from baseline or absolute risk in each group		Comparison of mean changes or risks between groups (treatment effect)		Certainty of the evidence (GRADE)	Comments
	Placebo group	Antipsychotics group (95%CI)	Relative effect, RR (95% CI)	Absolute effect, MD or RD (95% CI)
Agitation ‐ presented in units on CMAI (higher is worse)a ‐ 1971 persons in 9 RCTs of 3 to 12 weeks	15.0 decrease	18.0 decrease (19.3 to 16.7)b	NA	3.0 greater decrease (4.3 to 1.7)	⊕⊕⊕⊝ Moderatec	Baseline mean on CMAI was 58.8; SMD 0.21 less (0.30 to 0.12 )a
Response for agitation ‐ as defined by authors of RCTs ‐ 1303 persons in 4 RCTs of 3 to 12 weeks	36 per 100	48 per 100 (42 to 54)	1.31 (1.16 to 1.48)	12 more per 100 (6 to 18 more)	⊕⊕⊕⊝ Moderatec	Example of response: improvement on CGIS
Psychosis ‐ presented in units of NPI‐NH P (higher is worse)d ‐ 3364 persons in 12 RCTs of 3 to 12 weeks	4.7 decrease	5.3 decrease (5.7 to 4.9)e	NA	0.6 greater decrease (1.0 to 0.2)	⊕⊕⊕⊝ Moderatec	Baseline mean on NPH‐NH P was 11.2; SMD 0.11 less (0.18 to 0.03)
Response for psychosis ‐ as defined by authors of RCTs ‐ 1958 persons in 7 RCTs of 3 to 12 weeks	49 per 100	56 per 100 (51 to 61)	1.13 (1.03 to 1.23)	7 more per 100 (2 to 12 more)	⊕⊕⊝⊝ Lowc,f	Example of response: improvement on CGI
Extrapyramidal symptoms ‐ assessed with different instruments ‐ 4180 persons in 15 RCTs of 3 to 12 weeks	8 per 100	11 per 100 (9 to 14)	1.39 (1.14 to 1.68)	3 more per 100 (1 to 6 more)	⊕⊕⊕⊝ Moderatec	‐
Somnolence ‐ assessed with different instruments ‐ 3878 persons in 13 RCTs of 3 to 12 weeks	7 per 100	14 per 100 (11 to 17)	1.93 (1.57 to 2.39)	7 more per 100 (4 to 10 more)	⊕⊕⊕⊕ High	‐
Death ‐ 5032 persons in 17 RCTs of 3 to 12 weeks ___________________________________________	19 per 1000 ______________	26 per 1000 (17 to 39) ____________________	1.36 (0.90 to 2.05) ________________	7 more per 1000 (2 less to 20 more) __________________	⊕⊕⊕⊝ Moderateg _______________	‐ ______________________________

CGIS: Clinical Global Impression scale; CI: confidence interval; CMAI: Cohen‐Mansfield Agitation Inventory; MD: mean difference; NA: not applicable (to changes from baseline); NPH‐NH P: NPH‐NH psychosis subscale; RR: risk ratio; RD: risk difference; RCT: randomised controlled trial; SMD: standardised mean difference

GRADE Working Group grades of evidence

High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.

Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.

Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

^a The CMAI is a well‐known and much used scale for agitation (possible range 29‐203)

^b The weighted average SD of change from baseline on the CMAI was 14.4 in intervention the groups

^c Downgraded one level for risk of bias: all studies were rated at high risk of bias in at least one of the following domains: selection bias (comparability of study groups), attrition bias (incomplete outcome data), and other bias (use of a run‐in period)

d NPH‐NH Psychosis subscale was the most frequently used scale (possible range 0‐24)

e The weighted average SD of change from baseline on the NPI‐NH psychosis subscale was 5.4 in the intervention groups

f Downgraded one level for inconsistency: pronounced statistical heterogeneity (I² > 50%)

g Downgraded one level for imprecision: confidence interval encompasses a harmful effect as well as a protective effect