Intervention Review

Almitrine-Raubasine combination for dementia

  1. Weimin Yang1,*,
  2. Ming Liu2,
  3. Junfang Teng1,
  4. Zilong Hao2,
  5. Bo Wu2,
  6. Taixiang Wu3,
  7. Guan J Liu4

Editorial Group: Cochrane Dementia and Cognitive Improvement Group

Published Online: 16 MAR 2011

Assessed as up-to-date: 1 MAY 2010

DOI: 10.1002/14651858.CD008068.pub2

Database Title

Additional Information

How to Cite

Yang W, Liu M, Teng J, Hao Z, Wu B, Wu T, Liu GJ. Almitrine-Raubasine combination for dementia. Cochrane Database of Systematic Reviews 2011, Issue 3. Art. No.: CD008068. DOI: 10.1002/14651858.CD008068.pub2.

Author Information

  1. 1

    First Affiliated Hospital, Zhengzhou University, Department of Neurology, Zhengzhou, Henan Province, China

  2. 2

    West China Hospital, Sichuan University, Department of Neurology, Chengdu, Sichuan, China

  3. 3

    West China Hospital, Sichuan University, Chinese Cochrane Centre, Chinese Clinical Trial Registry, Chinese Evidence-Based Medicine Centre, INCLEN Resource and Training Centre, Chengdu, Sichuan, China

  4. 4

    West China Hospital, Sichuan University, Chinese Cochrane Centre, Chinese Evidence-Based Medicine Centre, Chengdu, Sichuan, China

*Weimin Yang, Department of Neurology, First Affiliated Hospital, Zhengzhou University, No. 1, Jinshe Road East, Zhengzhou, Henan Province, 450052, China. weiminyanghn@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 16 MAR 2011

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. Resumen

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 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citations for additional trials, contacted the first author of identified trials for additional references and unpublished data.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.

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.

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.

 

Plain language summary

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  2. Abstract
  3. Plain language summary
  4. Resumen

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.

 

Resumen

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  4. Resumen

Antecedentes

Combinación de almitrinaraubasina para la demencia

La combinación de almitrinaraubasina (nombre comercial Duxil) se ha considerado un tratamiento alternativo para la demencia.

Objetivos

Evaluar la eficacia clínica y la seguridad del Duxil para el tratamiento de los pacientes con demencia.

Estrategia de búsqueda

Se hicieron búsquedas en el Registro Especializado de Ensayos Controlados del Grupo Cochrane de Demencia y Trastornos Cognitivos (Cochrane Dementia and Cognitive Improvement Group) (ahora conocido como ALOIS) (septiembre 2009), en la China Biological Medicine Database (CBMdisc 1979 hasta diciembre 2009), en la Chinese National Knowledge Infrastructure (www.cnki.net 1979 hasta diciembre 2009), y en el Stroke Trials Registry en www.strokecentre.org/trials/index.aspx. Se realizaron búsquedas en las citas identificadas para obtener ensayos adicionales, y se estableció contacto con el primer autor de los ensayos identificados para obtener referencias adicionales y datos no publicados. También se estableció contacto con la compañía farmacéutica que fabrica el Duxil (Servier Pharmaceutical Co Ltd) para obtener datos no publicados adicionales.

Criterios de selección

Se incluyeron los ensayos controlados aleatorios que estudiaban la eficacia y la seguridad del Duxil para la demencia, independientemente del cegamiento, estado de publicación o idioma. Si el ensayo fue un estudio cruzado (crossover) solamente se incluyeron los datos del primer período.

Obtención y análisis de los datos

Dos revisores seleccionaron de forma independiente los ensayos para la inclusión, evaluaron su calidad y extrajeron los datos.

Resultados principales

Se incluyeron tres ensayos con un total de 206 pacientes, todos ellos con demencia vascular. Los tres estudios incluidos se evaluaron como de alto riesgo de sesgo. Cuando se analizaron estos ensayos en conjunto, hubo un efecto beneficioso significativo del Duxil sobre la mejoría de la función cognitiva medida por la MMSE (DMP 2,04; IC del 95%: 1,43 a 2,66). En ninguno de los ensayos incluidos se dispuso de datos sobre la conducta o la muerte al final del tratamiento y el seguimiento. Dos ensayos no lograron mostrar una mejoría del rendimiento funcional medido por el AC (DMP −1,68; IC del 95%: −3,70 a 0,35). De los tres ensayos incluidos, todos describieron detalladamente los eventos adversos, y no hubo diferencias estadísticamente significativas entre los ensayos (OR 4,84; IC del 95%: 0,55 a 42,67). El trastorno de la conducta, la calidad de vida, y la carga para el cuidador no se analizaron en los ensayos incluidos.

Conclusiones de los autores

Debido a la baja calidad metodológica de los ensayos incluidos, al escaso número de ensayos y al probable sesgo de publicación, esta revisión no aportó pruebas suficientes para apoyar el uso sistemático de Duxil para el tratamiento de los pacientes con demencia. Se necesitan ensayos controlados aleatorios de alta calidad y a gran escala para confirmar o refutar estos resultados.

Traducción

Traducción realizada por el Centro Cochrane Iberoamericano

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