Botulinum toxin type A therapy for blepharospasm

  • Review
  • Intervention




Blepharospasm is a focal dystonia characterized by chronic intermittent or persistent involuntary eyelid closure due to spasmodic contractions of the orbicularis oculi muscles. Other facial and neck muscles are also frequently involved. Most cases are idiopathic and blepharospasm is generally a life-long disorder. Its severity can range from repeated frequent blinking to persistent forceful closure of the eyelids with functional blindness. Botulinum toxin type A (BtA) is the current first line therapy.


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

Search methods

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

Selection criteria

Studies were eligible for inclusion in the review if they evaluated the efficacy of BtA for the treatment of blepharospasm. They must have been randomised and placebo-controlled.

Data collection and analysis

We used a paper pro-forma to collect data from the included studies using double extraction by two independent reviewers. The two reviewers separately assessed each trial for internal validity and they settled differences between them by discussion.
The outcome measures used included adverse events, improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, and changes in quality of life assessments.

Main results

We found few controlled trials. They were of short duration and enrolled small numbers of patients. Because of their poor internal validity, the characteristics of the populations studied, and the types of interventions and outcomes, none of the trials fitted our criteria for inclusion. However, all these trials found BtA to be superior to placebo as did large case-control and cohort studies, which reported that around 90% of patients benefited.

Authors' conclusions

There are no high quality, randomised, controlled efficacy data to support the use of Bt for blepharospasm. Despite this, other studies suggest that BtA is highly effective and safe for treating blepharospasm and support its use.
The effect size (90% of patients benefit) seen in open studies makes it very difficult and probably unethical to perform new placebo-controlled trials of efficacy of BtA for blepharospasm.
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.



以Botulinum toxin type A治療眼瞼痙攣

眼瞼痙攣是一種局部性肌張力障礙,主要病徵是由眼輪匝肌的痙攣性收縮造成的慢性間歇或持續性非自主眼瞼閉合。其它臉部或頸部肌肉也經常會受到牽連。大部分的案例都是原發性的,且眼瞼痙攣通常是終身的障礙。它的嚴重度從反覆頻繁的眨眼到伴隨功能性失明的永久強迫闔眼都有可能。Botulinum toxin type A (BtA)是目前的第一線治療。


評估botulinum toxin (BtA)作為眼瞼痙攣的治療是否有效且安全。


我們利用the Cochrane Movement Disorders Group trials register、 the Cochrane Central Register of Controlled Trials (CENTRAL)、MEDLINE、EMBASE搜尋欲收錄的研究,手動搜尋the Movement Disorders Journal及關於運動障礙和botulinum toxin的國際研討會摘要、和其他這個領域的研究者溝通、搜尋找到論文中的參考資料,以及和這些論文的作者和藥商連絡。











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


以Botulinum toxin type A局部注射作為眼瞼痙攣或非自主性眼瞼閉合的治療。眼瞼痙攣是眼瞼的功能異常,是由眼部肌肉痙攣性收縮造成的非自主性眼瞼閉合。其它臉部及頸部肌肉也時常受到牽連。它通常在晚年發病,嚴重度從反覆性頻繁的眨眼到永久強迫闔眼及功能性失明都有可能。治療方式有手術、心理治療、生物回饋療法及藥物。Botulinum toxin type A (BtA)是目前常用的治療方式。目前沒有有足夠病患數目的隨機對照試驗符合本評論的收錄標準。我們找到的試驗顯示BtA比安慰劑有效,案例對照及世代研究也有想同的結果,其中大約有90%的病人受惠。最常見的不良反應是對於眼睛的影響且很短暫。

Plain language summary

Botulinum toxin type A local injection therapy for blepharospasm or involuntary eyelid closure

Blepharospasm is a dysfunction of the eyelids showing as involuntary eyelid closure due to spasmodic contractions of eye muscles. Other facial and neck muscles are also frequently involved. It often begins late in life with the severity ranging from repeated frequent blinking of both eyelids to persistent forceful closure and functional blindness. Treatment has included surgery, psychological approaches, biofeedback and drugs. Botulinum toxin type A (BtA) is the current treatment. No randomised controlled trials with sufficient numbers of patients fitted the review criteria. Trials identified found BtA to be superior to placebo as did large case-control and cohort studies, with around 90% of patients benefiting. The most common adverse effects affected the eyes and were short lived.