Intervention Review

Bromocriptine/levodopa combined versus levodopa alone for early Parkinson's disease

  1. van Hilten1,*,
  2. Claudia C Ramaker1,
  3. Rebecca Stowe2,
  4. Natalie Ives2

Editorial Group: Cochrane Movement Disorders Group

Published Online: 17 OCT 2007

Assessed as up-to-date: 19 AUG 2007

DOI: 10.1002/14651858.CD003634.pub2


How to Cite

van Hilten, Ramaker CC, Stowe R, Ives N. Bromocriptine/levodopa combined versus levodopa alone for early Parkinson's disease. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD003634. DOI: 10.1002/14651858.CD003634.pub2.

Author Information

  1. 1

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

  2. 2

    University of Birmingham, University of Birmingham Clinical Trials Unit, Birmingham, UK

*van Hilten, Department of Neurology, Leiden University of Medical Center, Albinusdreef 2, Leiden, 2333 ZA, Netherlands. j.j.van_Hilten@lumc.nl.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 17 OCT 2007

SEARCH

 

Abstract

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

Background

Drugs that mimic dopamine, such as bromocriptine (BR), were introduced as monotherapy or in combination with levodopa (LD) in the hope that this approach would prevent or delay the onset of motor complications in patients with Parkinson's disease (PD). However, hitherto, the role of BR has remained controversial. We present a systematic review of all randomised controlled trials (RCTs) of BR/LD combination therapy compared with LD monotherapy in PD.

Objectives

To assess the efficacy and safety of BR/LD combination therapy in delaying the onset of motor complications associated with LD monotherapy in patients with PD.

Search methods

We searched the Movement Disorders Group trials register which includes MEDLINE and EMBASE; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); handsearched appropriate neurology journals, symposia reports, PD handbooks and reference lists of reviews found by the search-strategy. We also contacted Sandoz -now Novartis- (manufacturer of BR) and PPD Pharmaco and contacted colleagues who had co-ordinated trials on BR.

Selection criteria

RCTs were eligible for inclusion if they evaluated the efficacy of BR/LD combination therapy for delaying the onset of motor complications compared with LD monotherapy in patients with PD. Outcome measures evaluated included the occurrence and severity of motor complications, impairment and disability scores, side effects and dropouts.

Data collection and analysis

To determine the feasibility of a quantitative systematic review two independent reviewers evaluated the methodological quality of identified trials and extracted data from the trials.

Main results

The methodological quality of seven trials showed important shortcomings. All studies failed adequately to describe randomisation procedures. Only three were carried out according to a double-blind design. Differences were found between studies concerning the mean age of the participants, the BR titration phase, the maximum achieved daily dose of LD (62.5 to 1000 mg) and BR (5 to 50 mg), and the applied outcomes. Our results show no evidence of consistent differences between treatment groups concerning the occurrence and severity of motor complications, scores of impairment and disability, or the occurrence of side effects.

Authors' conclusions

This systematic review revealed no evidence to support the use of early BR/LD combination therapy as a strategy to prevent or delay the onset of motor complications in the treatment of PD.

 

Plain language summary

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

Bromocriptine/levodopa combined versus levodopa alone for early Parkinson's disease

Parkinson's disease is a disabling condition characterised by slowness of movement, trembling (tremors) and stiffness. Currently, the best treatment is levodopa. However, according to the number of levodopa treatment years, new disabling fluctuations of movement occur. To overcome this problem, bromocriptine has been tried in combination with levodopa. This review of relevant published trials found no evidence that early use of combined bromocriptine/levodopa prevents or delays such fluctuations of movement in patients with Parkinson's disease.

 

摘要

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

背景

Bromocriptine/levodopa合併治療和levodopa單獨治療在早期巴金森氏病的比較

類似多巴胺的藥物,如bromocriptine(BR),被作為單一療法或合併左多巴(LD)治療,希望這樣的方式可以預防或延遲巴金森病人的運動併發症.然而,迄今為止,BR的作用一直存在爭議。我們呈現了一個系統性的回顧比較BR/LD合併治療和LD單一治療在巴金森病的所有隨機對照試驗(RCTs).

目標

評估BR /LD合併治療對於延緩單獨使用LD治療帕金森患者所引起的肌肉運動併發症之有效性及安全性

搜尋策略

我們搜尋了the Movement Disorders Group trials register包括MEDLINE and EMBASE; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library);手動收尋了適當的神經學期刊, 專題討論會的報告,帕金森疾病手冊和以搜索策略發現的回顧的參考文獻目錄。我們也連絡了Sandoznow Novartis(BR的製造商)和PPD藥商和聯絡了在BR協同試驗上的同事.

選擇標準

隨機對照試驗納入探討的標準為:評估BR/LD合併治療和LD單一治療在延遲帕金森患者的運動併發症的出現之比較。結果分析評估包括運動併發症的發生率和嚴重程度,殘障和失能的分數,副作用及離開試驗的人數。

資料收集與分析

為了確定定量系統性回顧的可行性,2個獨立的審查員分別評估所找到試驗的方法學的品質和從試驗中提取資料。

主要結論

7個試驗的方法學品質顯示有重大缺點。所有的研究不能有效地描述隨機程序。只有3個試驗根據雙盲設計來進行。發展研究之間有以下方面的差異,在受試者的平均年齡,BR劑量增加期,可到達最高的每日劑量LD (62.5 to 1000 mg) 和BR (5 to 50 mg),和所使用的結果.我們的結果顯示沒有證據表明治療組之間在運動併發症的發生率和嚴重度,殘障和失能分數,或發生的副作用有一致性的差異。

作者結論

這個系統性的回顧表明沒有證據支持早期使用BR/LD合併治療,可用來當作預防或延緩發生在治療帕金森氏病的運動併發症。

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

比較早期巴金森病使用Bromocriptine/ levodopa合併治療和levodopa單獨治療之效果.巴金森氏病是一種失能的情況,特徵是緩慢的運動,顫抖(震顫)和僵硬。目前,最好的治療是左多巴。然而,根據左多巴治療數年的數量,新的波動性的動作障礙失能會產生。為了克服這個問題,bromocriptine已經被嘗試用來和左多巴合併使用。這篇回顧相關出版的試驗發現,沒有證據表明在帕金森氏病患者身上早期合併使用BR/LD可以預防或延遲這種動作障礙的波動。