Evidence Table 9b. Efficacy of Pharmacologic Intervention for Behavioral Problems Related to Dementia: Randomized Controlled Trials

AuthorNIntervention OutcomesResult Quality and Comments
DrugDosePeriodScaleTreatmentPlaceboP value/ NNT
Teri et al., 2000113 148Haldol0.5–3 mg/day16 weeksBehavioral (BRSD, RMBPC, CMAI, ABID, CGIC)CGIC (% improved)Hal: 32%31% P > 0.5Fair (not all outcomes considered)
Trazedone50–300 mg/dayCaregiver burden (SCB)Traz: 41%Attrition rate 38%
BMT8 weekly + 3 biweekly sessionsCognitive (MMSE)BMT: 32%Significant difference between groups at baseline in caregiver gender; analysis adjusted for this
PlaceboFunctional (ADL)ABID (mean change)NS for allNS
CMAI (mean change)NS for allNS
RMBPC (mean change)NS for allNS
BRSD (mean change)NS for allNS
MMSE (mean change)Hal: -0.6-0.28 P < 0.05
Traz: -1.97
BMT: -0.05
Basic ADL (mean change)Hal: 2.51.3 P <0.05
Traz: 1.6
BMT: -0.3
Instrumental ADL (mean change)Hal: 1.80.9 P < 0.05
Traz: 1.8
BMT: 0.2
SCB-Subjective (mean change)Hal: -1.9-2.6NS
Traz: -1.97
BMT: -2.95
Devanand et al., 199894 66Haldol (standard dose)2–3 mg/day6 weeksBehavioral (BSRS-P, BSSD-A, SADS)BPRS-Psychosis (% clinically responsive patient)SD: 60%30% P < 06 3Fair (not all outcomes considered)
Haldol (low dose)0.5–.75 mg/dayCognitive (MMSE)Low: 30%
Functional (BFAS)BSSD-agitation (% clinically responsive patient)SD: 55%30% P = .11
Low: 25%
SADS (% clinically responsive patient)SD: 55%25% P <.06 3
Low: 35%
MMSE--------NS
BFAS--------NS
Auchus et al., 1997110 15Haldol3 mg/day6 weeksBehavior (CMAI, BEHAVE-AD)CMAI mean changeH: -2.4-1.4 P =.82 NSFair (not all outcomes considered)
Fluoxetine20 mg/dayCaregiver burden (CSI)F: +1.4
BEHAVE-ADH: -2.6+1.0 P =.35 NS
F: +1.8
CSIH: +14+18.6 P =.67 NS
F: -16.8
Petracca et al., 1996111 21Clomipramine25–100 mg/day2–6 weeksDepression (Ham-D)Ham-D (% pt entered remission at 6 weeks)82% lower than placebo30% higher P =.02 2Possibly poor (questionable use of ITT)
crossover designCognitive (MMSE)MMSE mean score---- P <.01
Functional (FIM)FIMfavors placebo NS
Lyketsos et al., 20004 22Sertraline25–150 mg/day13 weeksDepressive (CDDS, HDS, psychiatrist impression)Psychiatrist impression, %75%20% P < 0.05Fair (not all outcomes considered)
PlaceboFunctional (ADL, PDRS) full or partial responders
Cognitive (MMSE)CDDS (mean change)-10.7%-2.1% P = 0.03
HDS (mean change)-11.1%-3.5% P = 0.2
MMSE (mean change)--------NS
ADL /PDRS--------NS

From: Appendix B. Evidence Tables

Cover of Screening for Dementia
Screening for Dementia [Internet].
Systematic Evidence Reviews, No. 20.
Boustani M, Peterson B, Harris R, et al.

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