OBJECTIVE: Objective of this systematic review is to determine the level of scientific evidence for the use of Donepezil in Alzheimer's Disease. METHODS: Ten randomised controlled double-blind trials testing Donepezil versus Placebo were identified in MEDLINE and EMBASE. All ten trials were included in this systematic review. Following a detailed catalogue of criteria the methodological standard of the ten trials was assessed. RESULTS: The authors of eight trials postulated statistically significant differences in favour of Donepezil. Unfortunately, the methodological standard of all studies was insufficient. The methodological shortcomings are discussed in detail. CONCLUSION: With regard to severe methodological deficiencies the evidence for the use of Donepezil in moderate to severe Alzheimer's Disease is lacking. But even if the trials had been conducted in a methodologically correct way the clinical relevance of the postulated positive results would have to be questioned.
