Intervention Review

Botulinum toxin type A therapy for hemifacial spasm

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

Editorial Group: Cochrane Movement Disorders Group

Published Online: 24 JAN 2005

Assessed as up-to-date: 24 OCT 2004

DOI: 10.1002/14651858.CD004899.pub2


How to Cite

Costa J, Espírito-Santo CC, Borges AA, Ferreira J, Coelho MM, Moore P, Sampaio C. Botulinum toxin type A therapy for hemifacial spasm. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD004899. DOI: 10.1002/14651858.CD004899.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: 24 JAN 2005

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Abstract

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

Background

Hemifacial spasm is characterised by unilateral involuntary contractions of muscles innervated by the facial nerve. The usual cause is a vessel touching the facial nerve near its origin from the brain stem. Although it is a benign condition it can cause significant cosmetic and functional disability. It is a chronic disease and spontaneous recovery is very rare. The two treatments routinely available are microvascular decompression and Botulinum Toxin type A (BtA) muscular injections.

Objectives

To determine whether botulinum toxin (BtA) is an effective and safe treatment for hemifacial spasm.

Search methods

We searched the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1977 to December 2003), EMBASE (1977 to December 2003), and reference lists of articles. We also contacted drug manufacturers and researchers in the field.

Selection criteria

Randomised studies comparing BtA with placebo in people with hemifacial spasm.

Data collection and analysis

Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials.

Main results

We found only one small randomised, placebo-controlled trial involving 11 people. It was a crossover trial during which patients underwent four sets of injections, comparing placebo with three different doses of BtA - formulation Botox(r) (low dose: one-half of the intermediate dose; intermediate dose; and high dose: twice the intermediate dose), and one of placebo. In this trial BtA was superior to placebo.

Authors' conclusions

The findings of this single eligible trial support the results of large, open, case-control studies showing a benefit rate between 76 and 100%. This effect size probably makes it very difficult to perform new large placebo controlled trials for hemifacial spasm.
Despite the paucity of good quality controlled data, all the studies available suggest that BtA is effective and safe for treating hemifacial spasm. Future trials should explore technical factors such as the optimum treatment intervals, different injection techniques, doses, Bt types and formulations. Other issues include service delivery, quality of life, long-term efficacy, safety, and immunogenicity. BtA should be compared with surgical microvascular decompression.

 

Plain language summary

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

Botulinum Toxin type A (BtA) muscular injections are beneficial in treating hemifacial spasm.

Hemifacial spasm is characterised by unilateral involuntary contractions of muscles innervated by the facial nerve. The usual cause is a vessel touching the facial nerve near its origin from the brain stem. Although it is a benign condition it can cause significant cosmetic and functional disability. It is a chronic disease and spontaneous recovery is very rare. The two treatments routinely available are microvascular decompression and Botulinum Toxin type A (BtA) muscular injections. This review demonstrated that BtA is effective and safe to treat hemifacial spasm.

 

摘要

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

背景

肉毒桿菌毒素A型在面肌痙攣的治療

面肌痙攣的特徵是單側顏面神經支配的肌肉不自主的收縮.通常的原因是血管碰觸到靠近腦幹出來的顏面神經.雖然它是良性的情形,但它造成了嚴重的外觀和功能上的失能.它是慢性的疾病,自動的恢復是很少見的.有2個例行可用的治療方式是顯微血管減壓手術和肉毒桿菌毒素A型的肌肉注射.

目標

為了評估肉毒桿菌毒素A型(BtA)對於面肌痙攣是否為一個有效且安全的治療方式.

搜尋策略

我們收尋了Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1977 到12月2003), EMBASE (1977 到12月2003), 和文章的參考資料清單.我們也連絡了藥品製造商和在這個領域的研究員.

選擇標準

比較BtA和安慰劑在有面肌痙攣的人身上的隨機研究.

資料收集與分析

兩個回顧者獨立的評估試驗的品質和擷取資料.為了取得更多的資料,研究作者有被連絡.副作用的資訊從試驗中被收集.

主要結論

我們發現只有一個小的隨機的,有安慰劑對照組的試驗,包括11個人.這是一個交叉試驗,其中病人接受四組注射,比較安慰劑和3種不同劑量的BtA配方(低劑量:中間劑量的一半,中間劑量,和高劑量:中間劑量的2倍),和一組安慰劑. 在這個試驗, BtA 優於安慰劑.

作者結論

這個唯一合格的試驗支持其他大型,開放的有對照組的研究結果,顯示有效率在76到100%之間.這個效果的大小極可能使得著手新的大型的有安慰劑對照組的面肌痙攣試驗非常困難.儘管缺乏有良好品質的對照組資料,所有可得的研究顯示BtA對於治療面肌痙攣是有效且安全的.未來的試驗應該探討技術上的因素,像最佳治療的間距,不同的注射技術,劑量,肉毒桿菌毒素的類型和配方.其它課題包括服務的給予,生活的品質,長期效果,安全性,和免疫抗原性. BtA應該和顯微血管減壓手術來比較.

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

肉毒桿菌毒素A型肌肉注射在治療面肌痙攣是有效的.面肌痙攣的特徵是單側顏面神經支配的肌肉不自主的收縮.通常原因是血管碰觸到靠近腦幹出來的顏面神經.雖然它是良性的,但它造成了嚴重的外觀和功能上的失能.它是慢性的疾病,自動的恢復是很少見的.有2個例行可用的治療方式是顯微血管減壓手術和肉毒桿菌毒素A型(BtA)的肌肉注射.這個回顧顯示肉毒桿菌毒素A型(BtA)對於治療面肌痙攣是一個有效且安全的治療方式.