Intervention Review

Botulinum toxin type A versus botulinum toxin type B for cervical dystonia

  1. João Costa1,*,
  2. Ana A Borges1,
  3. Cláudia C Espírito-Santo1,
  4. Joaquim Ferreira1,
  5. Miguel M Coelho1,
  6. Peter Moore2,
  7. Cristina Sampaio1

Editorial Group: Cochrane Movement Disorders Group

Published Online: 21 JUL 2003

Assessed as up-to-date: 4 MAY 2003

DOI: 10.1002/14651858.CD004314.pub2


How to Cite

Costa J, Borges AA, Espírito-Santo CC, Ferreira J, Coelho MM, Moore P, Sampaio C. Botulinum toxin type A versus botulinum toxin type B for cervical dystonia. Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No.: CD004314. DOI: 10.1002/14651858.CD004314.pub2.

Author Information

  1. 1

    Faculdade de Medicina de Lisboa, Laboratório de Farmacologia Clínica e Terapêutica, Lisboa, Portugal

  2. 2

    NHS Trust, The Walton Centre for Neurology and Neurosurgery, Liverpool, UK

*João Costa, Laboratório de Farmacologia Clínica e Terapêutica, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz, Lisboa, 1649-028, Portugal. joaoncosta@sapo.pt.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 21 JUL 2003

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Abstract

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

Background

Cervical dystonia is the most common form of focal dystonia. It is characterized by involuntary posturing of the head and frequently is associated with neck pain. Disability and social withdrawal are common. Most cases are idiopathic, and generally it is a life-long disorder. In recent years, botulinum toxin type A (BtA) has become first line therapy for cervical dystonia. However, not all patients respond well to BtA, and 5 to 10% become resistant to it. Botulinum toxin B (BtB) is an alternative to BtA and offers the potential to help patients who do not respond to BtA. At present there is no compelling theoretical reason why it should not be as effective as, or even more effective than, BtA.

Objectives

To compare the clinical efficacy and safety of BtA versus BtB in cervical dystonia.

Search methods

Studies for inclusion in the review were identified using the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, by handsearching the Movement Disorders Journal and abstracts of international congresses on movement disorders and botulinum toxin, by communication with other researchers in the field, by searching reference lists of papers found using the above search strategies, and by contact with authors and drug manufacturer.

Selection criteria

Studies were considered eligible for inclusion in the review if they evaluated the efficacy of BtA versus BtB for the treatment of cervical dystonia. Trials must have been randomised and placebo-controlled.

Data collection and analysis

A paper pro-forma was used to collect data from the included studies using double extraction by two independent reviewers. Each trial was assessed for internal validity by each of the two reviewers. Differences were settled by discussion.
The outcome measures used included improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, changes in pain scores, changes in quality of life assessments, and frequency and severity of adverse events.

Main results

We cannot give any results since we have only identified two ongoing trials and there are no preliminary results or interim analyses available for them. The full results of these trials are expected in late 2004 or 2005.

Authors' conclusions

It is currently not possible to make definitive comparisons between BtA and BtB for the treatment of cervical dystonia; uncontrolled comparisons should be regarded with suspicion.

 

Plain language summary

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

A comparison of botulinum toxin type A versus botulinum toxin type B for involuntary positioning of the head, or cervical dystonia.

Cervical dystonia is the most common form of focal dystonia and is characterized by involuntary posturing of the head. It is frequently associated with neck pain and may lead to physical disability and social withdrawal. Botulinum toxin type A (BtA) has become the first line therapy, however, not all patients respond well to BtA, and 5 to 10% become resistant to it. Botulinum toxin type B (BtB) is a related product that may be an effective alternative to BtA and has the potential to help patients who do not respond to BtA. No completed randomised, controlled trials directly comparing the efficacy and safety of BtA and BtB were identified. Two large trials are underway.

 

摘要

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

背景

比較A型肉毒桿菌毒素和B型肉毒桿菌毒素在頸部肌張力異常的治療

頸部肌張力異常是最常見的局部肌張力異常。它的特點是非自主性的頭部擺位,和常伴有頸部疼痛。失能和社交退縮是常見的。大多數病例是特發性的,而且通常是一種終身的疾病。近年來,A型肉毒桿菌毒素(BTA)已經成為治療頸部肌張力異常第一線的藥物。然而,並不是所有的病人反應都很好,有5至10%的病人變的有抗藥性。B型肉毒桿菌毒素(BtB)可以代替BtA,有潛能提供幫助給那些對BtA沒有反應的病人。目前還沒有令人信服的理論說明為何BtB不是同樣有效,甚至比BtA效果更好。

目標

為了比較BtA和BtB對頸部肌張力異常的臨床療效和安全性。

搜尋策略

這篇審查中的研究包括:Cochrane Movement Disorders Group trials register, Cochrane Central Register of Controlled Trials(CENTRAL),MEDLINE, EMBASE,用手工搜索了運動障礙的期刊和國際會議上運動障礙和肉毒桿菌毒素的摘要,與在這領域的其他研究人員溝通,使用上述搜索策略搜尋了文章的參考文獻目錄,並與作者和藥物製造商聯繫。

選擇標準

如果他們有評估BtA和BtB對頸部肌張力異常的療效,研究才被認為是符合列入審查。試驗必須是隨機的並且有安慰劑對照組。

資料收集與分析

由兩個獨立的審查員使用雙提取方式從研究中收集資料。每個試驗分別由兩個審查員評估內部的有效性。藉由討論來解決差異。結果測量包括症狀改善的評分,患者和臨床醫生的主觀評價,疼痛分數的改變,生活品質的改變評估,副作用的頻率和嚴重程度。

主要結論

我們不能得到任何結果,因為我們只找到兩個正在進行的試驗,也沒有初步的結果或暫時的分析。這些試驗的完整結果預計在2004年底或2005年出來。

作者結論

目前無法明確的比較BtA和BtB治療頸部肌張力異常的差異;沒有對照組的比較應該秉持懷疑的態度。

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A型肉毒桿菌毒素與B型肉毒桿菌毒素對非自主性的頭部擺位,或頸部肌張力異常的治療. 頸部肌張力異常是最常見的局部肌張力異常, 它的特點是非自主性的頭部擺位。它經常與頸部疼痛有關,並可能導致身體失能和社交退縮。A型肉毒桿菌毒素(BTA)已經成為第一線的治療,然而,並不是所有病人反應都很好,有5至10%的病人變的有抗藥性。B型肉毒桿菌毒素(BtB)是一個相關的產品,可以有效的代替BtA,而且有潛能幫助對BtA反應不好的病人。沒有完全隨機的,對照組試驗直接比較BtA和BtB的有效性和安全性。兩個大型的試驗正在進行中。