Background: Naturalistic trials are needed to evaluate whether the results obtained in randomised trials of cholinesterase inhibitors (CEI) can be generalised to clinical practice. We conducted two studies in Norway to address this issue.
Material and methods: We included patients with dementia from 16 centres in Norway who had received treatment with a CEI until November 2001 (study 1, n = 1,167, retrospective case review) or who came to the first evaluation after onset of treatment (study 2; n = 252; prospective enrollment). Adverse events, global effectiveness, and Mini-Mental State Exam scores were recorded.
Results: In study 1, 56% of the patients were rated as mildly or markedly improved two to four months after onset of treatment. Side effects were recorded in 23%; 8% discontinued treatment due to side effects. In study 2, 49% were rated as mildly or markedly improved on at least one of the items cognition, psychiatric symptoms, activities of daily living or behaviour. Treatment was discontinued due to lack of effectiveness in 12%.
Interpretation: CEI were found to be useful in clinical practice in Norway. The open and uncontrolled design of the study limits the generalisability of the study.