Intervention Review

Drugs versus placebo for dysthymia

  1. Mauricio Silva de Lima1,*,
  2. Joanna Moncrieff2,
  3. Bernardo Soares3

Editorial Group: Cochrane Depression, Anxiety and Neurosis Group

Published Online: 20 APR 2005

Assessed as up-to-date: 17 FEB 2005

DOI: 10.1002/14651858.CD001130


How to Cite

Silva de Lima M, Moncrieff J, Soares B. Drugs versus placebo for dysthymia. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD001130. DOI: 10.1002/14651858.CD001130.

Author Information

  1. 1

    Eli Lilly & Co, Medical, Basingstoke, Hampshire, UK

  2. 2

    Warley Hospital, University College London, Essex, UK

  3. 3

    Brazilian Cochrane Centre, São Paulo, SP, Brazil

*Mauricio Silva de Lima, Medical, Eli Lilly & Co, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, UK. msilvadelima@yahoo.com.br. limama@lilly.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 20 APR 2005

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Abstract

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

Background

Dysthymia is a depressive disorder of chronic nature but of lower severity than major depression. Depressive symptoms are more or less continuous for at least two years. Patients with this disorder experience considerable social dysfunction and disability and are more likely than the general population to use general medical services and to take non-specific psychotropic drugs. Examining the use of pharmacotherapy for this condition is of critical importance.

Objectives

The aim of this review was to conduct a systematic review of all randomised controlled trials comparing drugs and placebo for the treatment of dysthymia.

Search methods

Electronic searches of The Cochrane Library, MEDLINE, EMBASE, PsycLIT, biological abstracts and LILACS; reference searching; personal communication; conference abstracts; unpublished trials from the pharmaceutical industry; book chapters on the treatment of depression.

Selection criteria

All randomised controlled trials that focused on the use of drugs versus placebo for dysthymic patients were included.

Exclusion criteria were: non-randomised controlled trials, a mixture of major depression and dysthymia (trials not providing separate data) and depression secondary to other disorders (e.g. substance abuse).

Data collection and analysis

The reviewers extracted the data independently. In order to achieve an intention-to-treat analysis it was assumed, when not reported in the trial, that people who died or dropped out had no improvement. Authors of relevant trials were contacted for additional and missing data. Absence of treatment response as defined by authors was the main measure of outcome used. Relative risks and 95% confidence intervals (CI) of dichotomous data were calculated with the random-effects model. Where possible, number needed to treat and number needed to harm were estimated, taking the reciprocal of the absolute risk reduction.

Main results

Currently the review includes 29 trials, 17 reporting data for the main outcome measures. Similar results were obtained in terms of efficacy for different groups of drugs, such as tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors and other drugs (sulpiride, amineptine, and ritanserin). The pooled relative risk for absence of treatment response was 0.68 (95% CI 0.59 to 0.78) for tricyclic antidepressants and the number needed to treat was 4.3 (95% CI 3.2 to 6.5). Selective serotonin reuptake inhibitors showed similar relative risk for this outcome: 0.68 (95% CI 0.56 to 0.82), the number needed to treat was 5 (95% CI 3.3 to 9). Concerning monoamine oxidase inhibitors, the relative risk was 0.59 (95% CI 0.48 to 0.71) and the number needed to treat was 2.9 (95% CI 2.2 to 4.3). Other drugs (amisulpiride, amineptine and ritanserin) showed similar results in terms of absence of treatment response. Using more stringent criteria for improvement, i.e. full remission, the results were unchanged. Patients treated on tricyclic antidepressants were more likely to report adverse events, compared with placebo.

Authors' conclusions

Drugs are effective in the treatment of dysthymia with no differences between and within drug classes. Tricyclic antidepressants are more likely to cause adverse events and dropouts. As dysthymia is a chronic condition, there remains little information on quality of life and medium or long-term outcome.

 

Plain language summary

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

Antidepressants drugs compared with placebos for dysthymia

The reviewers found that the quality of the reviewed reports was poor, as some important information had been omitted (design of the studies, analysis and generalisability). However, they concluded that tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, sulpiride, amineptine and ritanserin are effective in the treatment of this disorder. Amisulpiride, amineptine and ritanserin produced similar results; tricyclic antidepressants, on the other hand, are more likely to produce side-effects and dropouts. In general, the drugs examined are effective in the treatment of dysthymia, with no major differences between or within drug classes. Little information was provided on quality of life and medium/long-term outcome, except for tolerability.

 

摘要

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

药物治疗与安慰剂对心境恶劣障碍的疗效比较

研究背景

心境恶劣障碍是一种慢性的抑郁症,严重程度低于重度抑郁症。抑郁症状需至少持续两年左右。患者具有明显的社会功能障碍,与普通人群相比,他们可能需要更多的医疗服务和服用非特定的精神药物。因此评估该疾病药物疗法的使用情况非常重要。

研究目的

本研究旨在对比较药物与安慰剂治疗心境恶劣障碍疗效的随机对照试验进行系统评价。

检索方法

电子检索了Cochrane Library、MEDLINE、EMBASE、PsycLIT、biological abstracts和LILACSC等数据库,并追溯文献的参考文献,与作者联系以获得信息,搜索会议论文摘要,收集药厂未发表的灰色文献以及书上有关抑郁症治疗的章节。

纳入标准

纳入标准: 所有比较药物与安慰剂治疗心境恶劣障碍的随机对照试验。

排除标准: 非随机对照试验,混合了重度抑郁症和心境恶劣障碍(没有单独分组的试验),以及继发性抑郁症(例如药物滥用引起的抑郁)。

数据收集与分析

评价者分别独立地提取数据。进行意向性分析时,如无特殊说明,均假定死亡或退出病例为治疗无效。通过联系相关试验的原作者以获得额外和缺失的信息。由原作者界定的治疗无效是主要的结局指标。采用随机效应模型计算二分类变量数据的相对危险度和95%的可信区间。并在条件允许时,利用绝对风险降低率的倒数分别估计NNT(需治疗例数)以及NNH(造成伤害所需例数)。

主要结果

共纳入29个试验,其中17个试验报告了主要结局指标。不同种类药物的疗效结果相似,如三环类抗抑郁剂、5−羟色胺再摄取抑制剂、单胺氧化酶抑制剂以及其他药物(sulpiride(舒必利),amineptine(安咪奈丁)和ritanserin(利坦色林))。三环类抗抑郁剂治疗无效的合并RR为0.68(95%CI: 0.59~0.78),NNT为4.3(95%CI: 3.2~6.5)。5−羟色胺再摄取抑制剂治疗无效的RR为0.68(95%CI: 0.56~0.82),NNT为5(95%CI: 3.3~9)。单胺氧化酶抑制剂治疗无效的RR为0.59(95%CI: 0.48~0.71),NNT为2.9(95%CI: 2.2 ~4.3)。就治疗无效这一指标,其他药物(amisulpiride, amineptine, ritanserin)也显示出类似的结果。若以更严格的标准界定“有效”,如“完全缓解”,其结果仍然不变。与安慰剂相比,服用三环类抗抑郁剂的病人更易发生不良反应。

作者结论

药物对心境恶劣障碍普遍有效,且不同种类间或同类药物间的疗效无显著差异。三环抗抑郁剂较可能产生不良反应,并导致中断治疗。心境恶劣障碍是一种慢性疾病,目前仍缺乏患者生命质量以及药物中长期疗效的研究资料。

 

概要

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

药物治疗与安慰剂对心境恶劣障碍的疗效比较

抗抑郁剂与安慰剂对心境恶劣障碍的疗效比较

评价者发现纳入文献的质量不高,一些重要信息缺失(如研究设计,资料分析和可推广性)。由这些文献得到的结论是,三环类抗抑郁剂、5−羟色胺再摄取抑制剂、单胺氧化酶抑制剂、sulpiride、amineptine和ritanserin对治疗心境恶劣障碍有效,且amisulpiride,amineptine和ritanserin的疗效相似。另一方面,三环抗抑郁剂更易引起不良反应,并导致中断治疗。总而言之,这些药物对心境恶劣障碍都有效,且不同种类间或同类药物间的疗效无显著差异。除耐受性外,文献对患者生命质量及药物中长期疗效所提供的信息有限。

翻译注解

本摘要由重庆医科大学中国循证卫生保健协作网(China Effective Health Care Network)翻译。

翻译注解":本摘要由重庆医科大学中国循证卫生保健协作网(China Effective Health Care Network)翻译。: China Effective Health Care Network

 

摘要

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

背景

藥物與安慰劑對於輕鬱症(dysthymia)的療效比較

輕鬱症是一慢性的憂鬱症,在嚴重度上低於重鬱症。憂鬱症狀至少需持續兩年。患者的社會功能會有相當的障礙,很有可能比一般人多使用到醫療服務,並服用非特定的精神藥物。所以檢視此種狀況下的藥物治療深具重要性

目標

此篇文獻回顧的目標在系統性地回顧比較藥物與安慰劑治療輕鬱症的隨機對照試驗

搜尋策略

藉由搜尋Cochrane Library, MEDLINE、EMBASE、PsycLIT、biological abstracts和LILACSC等資料庫,文章的參考文獻,私人的溝通,會議摘要,藥廠未發表的試驗,書上有關憂鬱症治療的章節

選擇標準

針對藥物與安慰劑治療輕鬱症的比較的隨機控制試驗都被納入。排除準則為:非隨機控制試驗,混合了重鬱症,輕鬱症,和次發型的憂鬱症(例如物質濫用引起的憂鬱)

資料收集與分析

文獻回顧者各自獨立從試驗中摘取資料。 縱使試驗中沒有提到,為了做intentiontotreat analysis,會去假定病人死亡或是退出試驗時,就視為沒有改善。我們聯繫試驗的相關作者,取得額外及遺失的資料。作者關於沒有治療效果的定義被拿來當成主要的結果計量。使用隨機效應模式(randomeffects model)來計算二元變相數據(dichotomous data)的Relative risks 和95%的confidence intervals (CI)。可以的話,會使用絕對風險比率差異(absolute risk reduction)分別去估計number needed to treat(NNT)以及 number needed to harm(NNH)

主要結論

共找到29個試驗,其中有17個報告資料被拿來做結果統計。就不同種類的藥物的療效而言,得到相似的結果,例如三環抗憂鬱劑,選擇性血清回收抑制劑,單胺氧化?抑制劑,及其他藥物(sulpiride, amineptine, ritanserin)。三環抗憂鬱劑治療沒反應的pooled relative risk為0.68(95% 信賴區間: 0.59 ~0.78),NNT為4.3(95% 信賴區間: 3.2 ~6.5)。選擇性血清回收抑制劑治療沒反應的集合相對風險為0.68(95% 信賴區間: 0.56 ~0.82),NNT為5(95% 信賴區間: 3.3 ~9)。單胺氧化?抑制劑治療沒反應的集合相對風險為0.59(95% 信賴區間: 0.48 ~0.71),NNT為2.9(95% 信賴區間: 2.2 ~4.3)。就缺乏治療反應而言,其他藥物顯示相似的結果。若以更嚴厲的條件來定義有改善  相當於“完全緩解”,結果仍不變。與安慰劑比較的話,服用三環抗憂鬱劑的病人傾向有較多的副作用

作者結論

這些藥物對輕鬱症的治療都具療效,不同種類間或是同種類間皆無明顯差異。三環抗憂鬱劑較可能產生副作用,並導致退出試驗。 輕鬱症是一種慢性疾病,目前關於藥物對於生活品質的影響以及中長期療效的資訊仍然不足

翻譯人

本摘要由彰化基督教醫院李冠瑩翻譯

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

總結

文獻回顧檢驗了不同藥物對成人輕鬱症的治療效果。發現文獻的品質不佳,因為有些重要的資訊被省略了(研究設計,分析,廣泛性)然而,得到的結論是三環抗憂鬱劑,選擇性血清回收抑制劑,單胺氧化?抑制劑 sulpiride, amineptine and ritanserin 對治療是有效的,Amisulpiride, amineptine, ritanserin 有相同的效果,三環抗憂鬱劑較可能產生副作用,並導致退出試驗。一般而言,這些藥物間的療效無明顯差異。除了耐受性外,對生活品質及中長期的結果所提供的資訊有限