Intervention Review
Antidepressant drugs for narcolepsy
Editorial Group: Cochrane Epilepsy Group
Published Online: 16 JUN 2010
Assessed as up-to-date: 11 MAY 2010
DOI: 10.1002/14651858.CD003724.pub3
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Database Title
Additional Information
How to Cite
Vignatelli L, D'Alessandro R, Candelise L. Antidepressant drugs for narcolepsy. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD003724. DOI: 10.1002/14651858.CD003724.pub3.
Publication History
- Publication Status: New search for studies and content updated (no change to conclusions)
- Published Online: 16 JUN 2010
Abstract
Background
This is an updated version of the original Cochrane review published in Issue 1, 2008.
Narcolepsy is a disorder of the central nervous system, the main symptoms of which are excessive daytime sleepiness (EDS) and cataplexy (an abrupt and reversible decrease in or loss of muscle tone, affecting the limbs or trunk or both, elicited by emotional stimuli). Narcolepsy has an adverse impact on people's quality of life. Together with stimulant drugs (used to control EDS), antidepressants are usually recommended to counteract cataplexy. In addition, some antidepressants are also reported to improve EDS.
Objectives
To evaluate the effects of antidepressant drugs on EDS, cataplexy, quality of life, and their side effects in people with narcolepsy.
Search methods
We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library February issue, 2010), MEDLINE (1950 to March 2010), EMBASE (1980 to April 2010), PsycINFO (1872 to March 2010), and CINAHL (1981 to March 2010). Bibliographies of identified articles were reviewed to find additional references. Unpublished randomised trials were searched for by consulting governmental and non-governmental clinical trial registers, disease-specific websites, investigators and experts in the field, pharmaceutical companies/manufacturers.
Selection criteria
Parallel or cross-over randomised or quasi-randomised controlled trials testing the treatment of narcolepsy with any type of antidepressant drug versus no treatment, placebo, or another antidepressant drug.
Data collection and analysis
Two review authors independently assessed trial quality and extracted data.
Main results
Three cross-over and two parallel trials were included with a total of 246 participants. The methodological quality of all studies was unclear. As the trials tested different comparisons, or had a different design or dealt with different outcome measures, meta-analysis was not performed. In one cross-over trial (10 participants) femoxetine had no significant effect in eliminating or reducing EDS but significantly reduced cataplexy. Mild and transient side effects were reported in the femoxetine treatment period by two participants. In a second cross-over trial (56 participants) viloxazine significantly reduced EDS and cataplexy. In a third cross-over trial the authors inappropriately treated the trial design as a parallel study and no conclusions can be reached in favour of either drug. Two more trials with parallel design tested ritanserin versus placebo without finding differences of effectiveness in reducing EDS or cataplexy.
Authors' conclusions
Since the last version of this review no new studies were found.
There was no good quality evidence that antidepressants are effective for narcolepsy or improve quality of life. Despite the clinical consensus recommending antidepressants for cataplexy there is scarce evidence that antidepressants have a positive effect on this symptom. There is a clear need for well-designed randomised controlled trials to assess the effect of antidepressants on narcolepsy.
Plain language summary
Antidepressant drugs for narcolepsy
Narcolepsy is a disorder of the central nervous system, the main symptoms of which are excessive daytime sleepiness (EDS) and cataplexy (an abrupt and reversible decrease in or loss of muscle tone, affecting the limbs and/or trunk, elicited by emotional stimuli). Narcolepsy has an adverse impact on people's quality of life. Together with stimulant drugs (used to control EDS), antidepressants are usually recommended to counteract cataplexy. In addition, some antidepressants are also reported to improve EDS. Five trials with 246 participants were included. There is no evidence that antidepressants have a beneficial effect on narcolepsy. Moreover, despite the clinical consensus recommending their use for cataplexy, there is scarce evidence to support the use of antidepressant drugs to treat this symptom.
摘要
背景
使用抗憂鬱藥物治療猝睡症
猝睡症是指中樞神經系統發生的紊亂，主要症狀表現為： 白天極度嗜睡(excessive daytime sleepiness ，EDS)， 猝倒(肌肉張力突然發生可逆減少或損失，影響四肢、軀幹、四肢和軀幹的活動，因情緒刺激誘發)。猝睡症對患者的生活品質會產生不良影響。通常建議患者服用興奮藥物(用於控制EDS)和抗憂鬱藥來阻止猝倒的發生。 另外，記錄顯示某些抗憂鬱藥可以改善EDS。
目標
這裏將評估抗憂鬱藥對於患有猝睡症患者之EDS、猝倒、生活品質的影響，及其副作用。
搜尋策略
搜尋Cochrane Central Register of Controlled Trials (The Cochrane Library， 2007第2期)、MEDLINE (1966年 −2007年)、EMBASE (1980年 −2007年)患者PsycINFO (1872年 �2007年)以及CINAHL (1981年 −2007年)等資料。 我們回顧了已確認出的文章目錄，尋找其他的參考文獻。我們透過諮詢政府機關和非政府臨床試驗資料庫，特定疾病網站，該領域的研究家和專家，醫藥公司/廠商，尋找還未公開的隨機試驗資料。
選擇標準
使用任意一種抗憂鬱藥治療猝睡症對比無治療方法、安慰劑或其他抗憂鬱藥治療發作性睡病的療效等平行或交叉隨機或半隨機對照試驗。
資料收集與分析
兩位評論作者單獨評估了試驗品質，並摘錄資料。
主要結論
一共包括3個交叉和2個平行試驗，共有246名受試者參加。所有研究的方法學品質不明。各個試驗比較組有所不同，或是結果測量的設計或是處理方式有差異，因此無法進行統合分析(metaanalysis)。在一次交叉試驗中 (10位受試者)， femoxetine對於消除或減少EDS沒有顯著作用，但是明顯減少猝倒。 記錄顯示，兩位受試者在femoxetine治療期間分別出現輕微而短暫的副作用。在第2個交叉試驗中 (56位受試者)， viloxazine顯著減少EDS 和猝倒。第3個交叉試驗中，作者錯把試驗設計以平行研究處理，並且沒有作出有利於任何藥物的結論。超過2個試驗採用平行設計檢驗ritanserin V.S 安慰劑，並沒找到兩者對於減少EDS或是猝倒 方面具有差異。
作者結論
沒有品質良好的證據顯示抗憂鬱藥對猝睡症有效或能夠改善生活品質。儘管臨床一致建議採用抗憂鬱藥於猝倒，但是少有證據顯示抗憂鬱藥對該症狀具有療效。很明顯的，我們需要一個設計更加周全的隨機對照試驗，來評估抗憂鬱藥對猝睡症的療效。
翻譯人
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。
總結
發作性睡病的抗憂鬱藥： 猝睡症是中樞神經系統發生紊亂，主要症狀表現為：白天極度嗜睡(EDS)、猝倒(肌肉張力突然發生可逆減少或損失，影響四肢、軀幹、四肢和軀幹的活動，因情緒刺激誘發)。猝睡症對患者的生活品質產生不良影響。通常建議患者服用興奮藥物(用於控制EDS)和抗憂鬱藥來抵制猝倒的發生。另外，報告顯示，某些憂鬱藥可以改善EDS。 本回顧納入5個試驗，246位受試者，沒有證據顯示抗憂鬱藥對猝睡症產生有利的療效。 而且，儘管臨床一致建議採用抗憂鬱藥來治療猝倒，但是少有證據支持抗憂鬱藥用於治療該症狀。