Intervention Review

Bromocriptine for levodopa-induced motor complications in Parkinson's disease

  1. C Ramaker2,
  2. d e Beek WJT van2,
  3. M JJ Finken2,
  4. van Hilten1,*

Editorial Group: Cochrane Movement Disorders Group

Published Online: 27 JUL 1998

Assessed as up-to-date: 21 MAY 1998

DOI: 10.1002/14651858.CD001203

How to Cite

Ramaker C, Beek WJT van DE, Finken MJJ, van Hilten. Bromocriptine for levodopa-induced motor complications in Parkinson's disease. Cochrane Database of Systematic Reviews 1998, Issue 3. Art. No.: CD001203. DOI: 10.1002/14651858.CD001203.

Author Information

  1. 1

    Leiden University Medical Center, Department of Neurology, Leiden, Netherlands

  2. 2

    Not specified

*van Hilten, Department of Neurology, Leiden University Medical Center, P.O. Box 9600, Leiden, 2300 RC, Netherlands. J.J.van_Hilten@lumc.nl.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 27 JUL 1998

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. 摘要

Background

Motor Complications are an important issue in the management of patients with Parkinson's disease and dopamine agonists have been introduced to ameliorate this problem.

Objectives

To assess the efficacy and safety of adjunct bromocriptine (BR) therapy compared to placebo in the treatment of Parkinson's disease (PD) patients with motor complications.

Search methods

Sources including the Cochrane Library, a MEDLINE search-strategy, reference lists of the reviews found by the MEDLINE search-strategy, Sandoz (producer of BR), symposia reports, PD handbooks, SCISEARCH, contacts with colleagues who had co-ordinated trials on BR and reference lists of all included studies were used to identify randomized controlled trials (RCTs) of interest.

Selection criteria

Randomized trials were eligible for inclusion if they evaluated the efficacy of BR as adjunctive to LD-therapy compared to placebo in PD patients with motor complications. Outcome measures that were evaluated, included occurrence and severity of motor complications, scores on impairment and disability, and the occurrence of side effects.

Data collection and analysis

Three reviewers independently reviewed the quality of identified trials. To determine the feasibility of a quantitative systematic review each eligible study was evaluated concerning the methodological quality.

Main results

This review identified important shortcomings regarding the methodological quality of eight trials. All studies failed to describe adequately their randomization procedure. Consultation with the trialists revealed that three trials adequately randomized their patients. Contrary to the information of the published report, one placebo-controlled trial appeared to be carried out as an open study and was therefore excluded. The remaining seven trials were reported to be carried out according to a double-blind design, although one was unblinded after five weeks. There was a conspicuous variability in the duration of trials: four to forty weeks (mean 14 weeks). None of the included trials was performed according to the intention-to-treat principle. With regard to the inclusion criteria, it frequently remained unclear if PD patients actually suffered from motor complications. Prominent differences between studies regarding the baseline characteristics and the rate by which BR was introduced during the titration phase were found. Major differences between studies emerged concerning the applied outcomes. The various methods used to evaluate the occurrence and/or severity of motor complications lacked a sound clinimetric basis. A great diversity of scales to evaluate impairment and disability was applied. None of the included trials reported whether scores on impairment and disability level referred to the "on"- or "off"-phase.

Authors' conclusions

This review highlights major methodological problems and sources of heterogeneity that not only hamper the comparability of trials but also preclude a conclusion on the efficacy of BR in the adjunct treatment of PD patients with motor complications.

 

摘要

  1. Top of page
  2. Abstract
  3. 摘要

背景

Bromocriptine使用於因左多巴引起之巴金森病動作合併症

動作合併症在治療巴金森氏病上是一個重要的議題;多巴胺促動劑可以減緩這個問題。

目標

評估在有動作合併症的巴金森病人採用添加bromocriptine(BR)療法與安慰劑的比較。

搜尋策略

針對此隨機分配試驗所使用的資源包括考科藍實證醫學資料庫, MEDLINE搜尋, 從MEDLINE搜尋上找到的review參考文獻, Sandoz (BR的製造者),專題論文集報告, 巴金森手冊, SCISEARCH, 聯絡與BR有共同協調試驗之同僚及所有研究之參考文獻。

選擇標準

若隨機分配試驗評估以BR作為有動作合併症的巴金森病人的左多巴療法之輔助治療,並與安慰劑作比較,則納入收案分析。評估結果項目包括動作合併症之發生率及嚴重性,損傷及失能的分數及發生之併發症。

資料收集與分析

三位審閱者分別獨立審閱指定之試驗。為了確立定量系統性審閱的可行性,每一篇合格之研究都會被評估方法學上的品質。

主要結論

本篇指出8個試驗的方法學上品質的重要缺失。所有研究無法適當描述他們隨機抽樣的步驟。諮詢試驗者後發現其中三個試驗是有適當地隨機抽樣他們的病人。有別於該已發表之報告資料,其中一個安慰劑對照試驗似乎是開放性研究並因此被排除。其他7個試驗是按照雙盲設計,雖然其中一個於在5週後被解除盲化。在試驗的時間上有顯著的差異:4到40週(平均值14週)。沒有試驗是根據治療意圖原則。至於納入條件,巴金森病人是否真的有動作合併症經常受到質疑。各試驗中的基礎特徵及BR在被逐漸加入階段的速率有明顯的差異。試驗的主要差異在結果上呈現。各種用來評估發生率及動作合併症嚴重度的方法缺乏醫學上量度的標準(clinimetric basis)。使用了各式各樣不同的量度單位去評估損傷及失能程度。在所有試驗當中,並沒有一個指出這些損壞及失能是在“on”或是“off”phase發生。

作者結論

本篇分析凸顯了重大的方法學上問題及來源異質性不但阻礙了各試驗的比較,同時亦使對於BR用於有動作合併症的巴金森病人作為補助治療是否有效難以定論。

翻譯人

本摘要由新光醫院李建欣翻譯。

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

總結

本篇分析凸顯了重大的方法學上問題及來源異質性不但阻礙了各試驗的比較,同時亦使對於BR用於有動作合併症的巴金森病人作為補助治療是否有效難以定論。