title: Almitrine-Raubasine combination for dementia.
abstract: BACKGROUND
  Almitrine-raubasine combination (brand name Duxil), has been considered as an alternative treatment for dementia.
  
  
  OBJECTIVE
  To determine the clinical efficacy and safety of Duxil in the treatment of patients with dementia.
  
  
  METHODS
  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citations for additional trials, contacted the first author of identified trials for additional references and unpublished data. We also contacted the pharmaceutical company manufacturing Duxil (Servier Pharmaceutical Co Ltd) for additional unpublished data.
  
  
  METHODS
  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.
  
  
  METHODS
  Two review authors independently selected trials for inclusion, assessed trial quality and extracted the data.
  
  
  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.
  
  
  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.
authors.affiliation: Department of Neurology, First Affiliated Hospital, Zhengzhou University, No. 1, Jinshe Road East, Zhengzhou, Henan Province, China, 450052.
authors.forename: Weimin
authors.initials: W
authors.lastname: Yang
authors.forename: Ming
authors.initials: M
authors.lastname: Liu
authors.forename: Junfang
authors.initials: J
authors.lastname: Teng
authors.forename: Zilong
authors.initials: Z
authors.lastname: Hao
authors.forename: Bo
authors.initials: B
authors.lastname: Wu
authors.forename: Taixiang
authors.initials: T
authors.lastname: Wu
authors.forename: Guan J
authors.initials: GJ
authors.lastname: Liu
mesh_terms: D000368:Aged; D015765:Almitrine / Q000627:therapeutic use*; D003704:Dementia / Q000188:drug therapy*; D004338:Drug Combinations; D006801:Humans; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D015016:Yohimbine / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; D018696:Neuroprotective Agents; D015016:Yohimbine; C037558:almitrine, raubasine drug combination; D015765:Almitrine