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Oxcarbazepine in the maintenance treatment of bipolar disorder

  • Review
  • Intervention

Authors


Abstract

Background

Some studies have suggested that oxcarbazepine has a role in preventing episode recurrence in bipolar affective disorder. This review attempted to investigate the existing evidence from randomised controlled trials for its use in the maintenance treatment of this illness.

Objectives

To review the efficacy of oxcarbazepine, relative to placebo and other agents, in the prevention of affective episodes of bipolar affective disorder. The efficacy of oxcarbazepine was considered in terms of episode recurrence, general and social functioning. Adverse effects, overall acceptability to participants and mortality were also considered.

Search methods

CCDANCTR-Studies and CCDANCTR-References were searched on 7/11/2007. Medline, CENTRAL, EMBASE and PsycINFO were searched in March 2007. Specialist journals and conference proceedings were handsearched. Reference lists of relevant papers and major textbooks of affective disorder were checked. Authors, experts in the field and pharmaceutical companies were contacted requesting information on published or unpublished trials.

Selection criteria

Randomised controlled trials comparing oxcarbazepine with placebo or alternative agents, where the stated intent of intervention was the maintenance treatment of bipolar affective disorder were sought. Participants with bipolar disorder, male and female, of all ages, were included.

Data collection and analysis

Data were extracted from the original reports individually by two review authors. The methodological quality of included studies was assessed individually by two review authors. The main outcomes were the efficacy of oxcarbazepine maintenance treatment in preventing or attenuating further episodes of bipolar affective disorder (including its efficacy in rapid cycling disorder), the acceptability of oxcarbazepine treatment to participants, the prevalence of side-effects, and mortality, if any, on oxcarbazepine treatment. Where appropriate, data concerning outcome measures and adverse effects were to be extracted from the studies and analysed using Review Manager software.

Main results

Two randomised controlled trials were found that met the methodological criteria for inclusion in the review. However, they did not report data with sufficient clarity to allow their confident extraction for inclusion in the meta-analysis. Findings from the two studies were presented descriptively.

Authors' conclusions

There is an insufficient methodologically rigorous evidence base to provide guidance on the use of oxcarbazepine in the maintenance treatment of bipolar disorder. Given the need for more efficacious therapeutic agents, there is a need for good quality randomised controlled trials examining the therapeutic potential of this and related agents in bipolar disorder.

摘要

背景

使用oxcarbazepine在雙極性疾患的維持治療

有一些研究建議oxcarbazepine在預防雙相情感障礙症的復發上有一定的角色。此篇回顧企圖想找出目前存在應用在此疾病維持治療的隨機對照試驗(randomised controlled trials;RCTs)。

目標

為要回顧oxcarbazepine與安慰劑或其他的藥物在預防雙相情感障礙症的復發療效上的比較。oxcarbazepine的效果可以從復發的次數、一般及社會功能、副作用、受試者整體的接受度及死亡率去做考量。

搜尋策略

我們在2007年7月11日搜尋CCDANCTRStudies 和 CCDANCTRReferences等資料庫,並於2007年3月收尋Medline,CENTRAL,EMBASE and PsycINFO等資料庫。專科的期刊以及會議的議程是以人工方式搜尋,另外尋找相關參考文獻以及重要的情感疾患的教科書,也接觸這個領域的作者、專家、以及藥廠,請求相關發表或未發表的試驗。

選擇標準

搜尋比較oxcarbazepine與安慰劑或其他藥物的隨機對照試驗,並且是用在雙相情感障礙症的維持治療上的文章。雙相情感障礙症的受試者可以包括男女及各個年齡層。

資料收集與分析

資料由兩位負責回顧的作者個別來摘錄。方法學的品質也由兩位作者來評估,主要的結果是要看oxcarbazepine在雙相情感障礙症的預防及減少再發作(包含對快速循環型的病人的效果)維持治療上的療效,受試者對oxcarbazepine治療的接受度,副作用的盛行率,死亡率與結果評估及副作用相關的資料是從研究中摘錄出來、並使用Review Manager Software來分析。

主要結論

發現有兩個隨機對照試驗符合此次回顧中方法學的標準。然而它們並沒有報告足夠的資料可供作統合分析(metaanalysis)。因此這兩篇研究的發現是以描述性的方式來呈現。

作者結論

在嚴格的方法學之下,關於使用oxcarbazepine在雙相情感障礙症維持治療的證據並不充足。由於需要更有效的治療藥物,因此必須有更高品質的隨機對照試驗來檢驗oxcarbazepine及其它用在雙相情感障礙症相關藥物的潛在治療效果.

翻譯人

本摘要由彰化基督教醫院李謙益翻譯。

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

總結

oxcarbazepine在雙極性疾患的維持治療有一些研究顯示oxcarbazepine這種抗癲癇藥在預防雙極性疾患的復發上有一定的角色. 本篇系統性回顧在於瞭解探查oxcarbazepine與安慰劑及其他藥劑比較其在雙相情感症維持治療上的效果及接受度. 發現兩個隨機對照試驗符合此次回顧中方法學的標準. 然而它們的資料不夠清楚到可以拿來做統合分析. 因此目前還沒有充分的證據支持oxcarbazepine使用在雙極性疾患的維持治療上,不論是單一治療還是輔助治療. 因此未來需要更高品質的隨機對照試驗來檢視oxcarbazepine使用在雙極性疾患維持治療上的效果及接受度.

Plain language summary

Oxcarbazepine in the maintenance treatment of bipolar disorder

Some studies have suggested that oxcarbazepine, an anti-convulsant, may have a role in preventing episode recurrence in bipolar affective disorder. This systematic review investigated the efficacy and acceptability of oxcarbazepine compared to placebo and other agents in the maintenance treatment of bipolar disorder. Two randomised controlled trials were found that met the methodological inclusion criteria. However, in both cases, data were reported with insufficient clarity to be confidently extracted for inclusion in a meta-analysis. Currently, there is insufficient evidence on which to base any recommendations on the use of oxcarbazepine in the maintenance treatment of bipolar illness, either in monotherapy or as an adjunctive treatment. There is need for good quality randomised controlled trials examining the efficacy and acceptability of oxcarbazepine in the maintenance treatment of bipolar disorder.

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