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Minimal effect of cholinesterase for Alzheimer's

 

 

Clinical question
Are cholinesterase inhibitors effective in patients with Alzheimer's disease?

Bottom line
The evidence supporting the effectiveness of cholinesterase inhibitors is based on exceedingly small effects found in poorly analyzed studies. Studies of Alzheimer's drugs need to be carefully scrutinized for methodologic errors that inflate the appearance of benefit.

Reference
Kaduszkiewicz H, Zimmermann T, Beck-Bornholdt HP, van den Bussche H. Cholinesterase inhibitors for patients with Alzheimer's disease: systematic review of randomised trials. BMJ 2005; 331:321-27.

Study design: Meta-analysis (randomized controlled trials)

Setting: Various (meta-analysis)

Synopsis
Three treatments for Alzheimer's disease work by inhibiting cholinesterase: donepezil (Aricept), rivastigmine (Exelon), and galantamine (Razadyne). The authors of this meta-analysis combined the results of 22 randomized controlled trials evaluating the drugs' effects on clinical outcomes. The research was identified by searching 3 databases for research in any language. Three researchers independently selected studies on the basis of predetermined criteria. The quality of the studies was poor for many of these studies; the most common problem was that the results were not analyzed by intention to treat, the lack of which tends to inflate evidence of benefit. Most studies used the standard evaluation tool, the Alzheimer's Disease Assessment Scale--cognitive subscale, which uses scores ranging from 0 (no impairment) to 70 (very severe impairment). For all 3 drugs, the differences between the treatment groups and placebo groups was a minimal 1.5 points to 3.9 points. In 12 trials, effectiveness was also measured using the Clinician's Interview Base on Impression of Change; these scores were not significantly different between treatment and placebo groups. One study that used a measure of cognitive decline showed an average 5 months delay with donepezil compared with placebo before a clinically evident functional decline was seen.

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