Almitrine-Raubasine combination for dementia

There is currently insufficient evidence on the effects of the combination of almitrine and raubasine (Duxil) for dementia.
Duxil is described as having several properties which may be beneficial for dementia. This review looked for randomized trials comparing Duxil with control in patients with dementia. Three trials were identified. Though there was significant beneficial effect of Duxil on the improvement of cognitive function, due to the low methodological quality of included trials, small number of trials and probable publication bias, this review did not provide sufficient evidence to support the routine use of Duxil for the treatment of patients with dementia. More large, high-quality randomized trials are needed.

Authors' conclusions: 

Due to the low methodological quality of included trials, small number of trials and probable publication bias, this review did not provide sufficient evidence to support the routine use of Duxil for the treatment of patients with dementia. High-quality and large-scale randomised controlled trials are needed to confirm or refute these results.

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Background: 

Almitrine-raubasine combination (brand name Duxil), has been considered as an alternative treatment for dementia.

Objectives: 

To determine the clinical efficacy and safety of Duxil in the treatment of patients with dementia.

Search strategy: 

We searched the Cochrane Dementia and Cognitive Improvement Group Specialised Register (now known as ALOIS) (September 2009), the China Biological Medicine Database (CBM-disc 1979 to December 2009), the Chinese National Knowledge Infrastructure (www.cnki.net 1979 to December 2009), the Stroke Trials Registry at www.strokecentre.org/trials/index.aspx. We searched identified citations for additional trials, contacted the first author of identified trials for additional references and unpublished data. We also contacted the pharmaceutical company manufacturing Duxil (Servier Pharmaceutical Co Ltd) for additional unpublished data.

Selection criteria: 

Randomised controlled trials studying the efficacy and safety of Duxil for dementia were included, irrespective of blinding, publication status, or language. If the trial was cross-over in nature, only data from the first period were included.

Data collection and analysis: 

Two review authors independently selected trials for inclusion, assessed trial quality and extracted the data.

Main results: 

Three trials involving a total of 206 participants were included, all patients with vascular dementia. All three included studies were assessed as being at high risk of bias. When analysing these trials together, there was significant beneficial effect of Duxil on the improvement of cognitive function measured by MMSE (WMD 2.04, 95% CI 1.43 to 2.66). No data on behaviour and death at the end of treatment and follow-up were available from the included trials. Two trials failed to show an improvement of functional performance measured by ADL (WMD -1.68; 95% CI -3.70 to 0.35). Of the three included trials, all described the adverse events in detail, there were no statistically significant differences across the trials (OR 4.84, 95%CI 0.55 to 42.67). Behaviour disturbance, quality of life, caregiver burden were not undertaken in the included trials.

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