Intervention Review

Vinpocetine for cognitive impairment and dementia

  1. Szabolcs Szatmári1,*,
  2. Peter Whitehouse2

Editorial Group: Cochrane Dementia and Cognitive Improvement Group

Published Online: 20 JAN 2003

Assessed as up-to-date: 23 JAN 2007

DOI: 10.1002/14651858.CD003119


How to Cite

Szatmári S, Whitehouse P. Vinpocetine for cognitive impairment and dementia. Cochrane Database of Systematic Reviews 2003, Issue 1. Art. No.: CD003119. DOI: 10.1002/14651858.CD003119.

Author Information

  1. 1

    University of Medicine and Pharmacy Tg. Mures, Department of Neurology, Targu Mures, Romania

  2. 2

    Center University Hospitals of Cleveland Room 357C, Fairhill Center, Department of Neurology, Cleveland, Ohio, USA

*Szabolcs Szatmári, Department of Neurology, University of Medicine and Pharmacy Tg. Mures, Ghe Marinescu 38, Targu Mures, 540000, Romania. szabolcs.szatmari@gmail.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 20 JAN 2003

SEARCH

 

Abstract

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

Background

Vinpocetine is a synthetic ethyl ester of apovincamine, a vinca alkaloid obtained from the leaves of the Lesser Periwinkle (Vinca minor) and discovered in the late 1960s. Although used in human treatment for over twenty years, it has not been approved by any regulatory body for the treatment of cognitive impairment. Basic sciences studies have been used to claim a variety of potentially important effects in the brain. However, despite these many proposed mechanisms and targets, the relevance of this basic science to clinical studies is unclear.

Objectives

To assess the efficacy and safety of vinpocetine in the treatment of patients with cognitive impairment due to vascular disease, Alzheimer's disease, mixed (vascular and Alzheimer's disease) and other dementias.

Search methods

The Cochrane Dementia and Cognitive Improvement Group's Specialized Register was searched on 23 March 2009 using the terms vinpocetin*, cavinton, kavinton, Rgh-4405, Tcv-3B, "ethyl apovincaminate", vinRx, periwinkle, "myrtle vincapervinc" and cezayirmeneksesi. This register contains up to date references from major health care databases like MEDLINE and EMBASE as well as records from trials databases in the field of dementia.The manufacturers of vinpocetine were asked for information on trials of vinpocetine for dementia. In addition we tried to collect articles not listed in MEDLINE or other sources on the Internet (e.g. articles in Hungarian and Romanian).

Selection criteria

All human, unconfounded, double-blind, randomized trials in which treatment with vinpocetine was administered for more than a day and compared to control in patients with vascular dementia, Alzheimer's dementia or mixed Alzheimer's and vascular dementia and other dementias. Non-randomized trials were excluded.

Data collection and analysis

Data were independently extracted by the two reviewers (SzSz and PW) and cross-checked. Data from "washout" periods were not used for the analysis. For continuous or ordinal variables, such as cognitive test results, the main outcomes of interest were the change in score from baseline. The categorical outcome of global impression was transformed to binary data (improved or not improved) as was the occurrence of adverse effects; here the endpoint itself was of interest and the Peto method of the "typical odds ratio" was used. A test for heterogeneity of treatment effects between the trials was made if appropriate. Data synthesis and analysis were performed using the Cochrane Review Manager software (RevMan version 4.1).

Main results

All identified studies were performed before and in the early 1990s and used various terms and criteria for cognitive decline and dementia. The three studies included in the review involved a total of 583 people with dementia treated with vinpocetine or placebo. The reports of these studies did not make possible any differentiation of effects for degenerative or vascular dementia. The results show benefit associated with treatment with vinpocetine 30 mg/day and 60 mg/day compared with placebo, but the number of patients treated for six months or more was small. Only one study extended treatment to one year. Adverse effects were inconsistently reported and without regard for relationship to dose. The available data do not demonstrate many problems of adverse effects but intention-to-treat data were not available for any of the trials.

Authors' conclusions

Although the basic science is interesting, the evidence for beneficial effect of vinpocetine on patients with dementia is inconclusive and does not support clinical use. The drug seems to have few adverse effects at the doses used in the studies. Large studies evaluating the use of vinpocetine for people suffering from well defined types of cognitive impairment are needed to explore possible efficacy of this treatment.

 

Plain language summary

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

Insufficient evidence of benefits of vinpocetine for people with dementia

Preclinical data of uneven quality suggest a potential beneficial effect of vinpocetine in chronic cerebrovascular diseases and on cognitive performance in a variety of animal models. Clinical trials to test these hypotheses were performed before currently used criteria for dementia had become generally accepted. The results show improvement after the treatment with vinpocetine versus placebo, but the number of demented patients treated for at least six months was small. The available data does not demonstrate many side effect problems. Although the basic science is interesting, the evidence for beneficial effect of vinpocetine on patients with dementia is inconclusive and does not support clinical use.

 

摘要

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

背景

Vinpocetinem用於治療認知損傷及失智症

Vinpocetine是一種合成的apovincamine乙基酯類,長春花生物鹼類(Vinca alkaloids)是由小長春花(Vinca minor)葉子中取得,在1960年代晚期被發現。 雖然用於人體上治療已超過20年,不過它對於治療認知損傷的功效卻未被任何主管機關認可。 過去的基礎科學研究宣稱它對於大腦可能具有重要的療效, 然而儘管提出了許多機制及指標,但是它的基礎科學與臨床研究的相關性仍不明。

目標

評估vinpocetine治療血管疾病、阿茲海默症、混合型(血管型及阿茲海默症)導致的認知受損及其他失智症的療效及安全性。

搜尋策略

2007年1月24日使用vinpocetin*, cavinton, kavinton, Rgh4405, Tcv3B, "ethyl apovincaminate", vinRx, periwinkle, "myrtle vincapervinc" 及cezayirmeneksesi搜尋Specialized Register of the Cochrane Dementia and Cognitive Improvement Group。 並要求Vinpocetine製造商提供vinpocetine治療癡呆症臨床試驗的資料。 此外我們試著收集未列入MEDLINE的文章或網路上其它的來源(例如在Hungarian and Romanian的文章)。

選擇標準

選擇標準如下: 1.所有以人類為對像、未受干擾、雙盲、隨機分配的對照試驗。 2.採用vinpocetine治療超過一天,並且與對照組病人進行比較。患者為血管型失智症、阿茲海默症或是綜合阿茲海默症及血管型失智症,或是其他種類失智症。 3.排除非隨機對照試驗。

資料收集與分析

由兩位回顧作者(SzSz及PW)獨立地摘取資料且交叉檢查。 ashout時期所得的資料未用於本分析。針對連續或是次序變項(如認知測驗結果),所關注的主要結果是從基準所改變的分數。 整體印象的類別結果被轉換成二項式數據(改善或是沒改善),如不良反應發生;在這裡,我們所關注的及是病人最終結果(endpoint)本身,並且使用Peto方式計算傳統勝算比。 適合的話則會進行試驗間治療結果異質性檢驗。並利用Cochrane Review Manager software (RevMan version 4.1)軟體進行資料的合成及分析。

主要結論

所找到的研究都是以前及1990年代早期進行的,此外對於認知衰退及失智症使用各種不一樣的名詞及標準。 本回顧中所包含的三項研究共包含583位以vinpocetine或安慰劑治療的失智症病人。 這些研究的報告不能區分退化性或血管型失智症功效的差異。這些結果顯示與安慰劑比較下,以30 mg/day及60 mg/day劑量vinpocetine治療的效益。但治療施行6個月或更久的病患數目少。只有一項研究持續治療到一年。不良效果的報導不一致,並且沒有考慮到劑量關係。 可取得的數據不能證明不良效果所帶來的許多問題,但在任何臨床試驗中無法取得治療意向的相關數據。

作者結論

雖然基礎科學的結果令人關注,但vinpocetine對於失智症的療效仍不明確,並且不支持臨床上使用。若採用研究中所使用的劑量,本藥物所帶來的不良反應似乎僅有一點點而己。應該採用大型的研究,評估vinpocetine用於各類因認知損傷所苦的患者,以瞭解這個治療可能的效益。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

沒有足夠的證據指出vinpocetine對於失智患者的助益。品質參差不齊的前臨床數據指出vinpocetine在許多動物身上可能對於慢性腦血管疾病以及認知功能有幫助。檢驗這些假說的臨床試驗是在失智症評估標準普遍被接受以前所進行的。結果顯示相較於安慰劑來說,以vinpocetine治療後具有改善,不過在第六個月所剩下的失智病患很少。所取得的數據並沒有提到關於許多副作用的問題。儘管基礎科學的結果令人感興趣,vinpocetine對於失智患者得助益仍未有結論,並且不建議臨床上使用。