almitrine--raubasine-drug-combination and Dementia

Almitrine-raubasine combination (brand name Duxil), has been considered as an alternative treatment for dementia.. To determine the clinical efficacy and safety of Duxil in the treatment of patients with dementia.. 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citations for additional trials, contacted the first author of identified trials for additional references and unpublished data. We also contacted the pharmaceutical company manufacturing Duxil (Servier Pharmaceutical Co Ltd) for additional unpublished data.. 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.. Two review authors independently selected trials for inclusion, assessed trial quality and extracted the data.. 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.. 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.

Topics: Aged; Almitrine; Dementia; Drug Combinations; Humans; Middle Aged; Neuroprotective Agents; Yohimbine

A controlled double-blind drug versus placebo trial was conducted in a population of mentally impaired hospital patients divided at random into two groups. In the group treated with Duxil the level of intelligence remained stable and the mental and psychomotor performances improved, as demonstrated by the response time to sounds and colours and by the number of correct answers and errors by perseveration in the Benton's test. The improvement observed under Duxil may be ascribed to a better use of the remaining intellectual capabilities.

Topics: Aged; Almitrine; Clinical Trials as Topic; Dementia; Double-Blind Method; Drug Combinations; Humans; Mental Processes; Piperazines; Psychomotor Performance; Reaction Time; Yohimbine

In a double-blind cross-over study, the effects of Duxil on blood gases at rest were compared to those of a placebo in 39 elderly patients (mean age: 74.8 years). The study lasted 6 months divided into two 3-month periods. A mean increase of 2.10 mmHg in PaO2 was observed in patients under Duxil, the difference with the results obtained under placebo being statistically significant (p less than 0.01). At that dosage level, Duxil may therefore be considered an active treatment of hypoxia associated with old age.

Topics: Aged; Almitrine; Brain Diseases; Dementia; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Oxygen; Partial Pressure; Piperazines; Time Factors; Yohimbine