Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence

 

Abstract

Background

Buprenorphine has been reported as an alternative to methadone for maintenance treatment of opioid dependence, but differing results are reported concerning its relative effectiveness indicating the need for an integrative review.

Objectives

To evaluate the effects of buprenorphine maintenance against placebo and methadone maintenance in retaining patients in treatment and in suppressing illicit drug use.

Search methods

We searched the following databases up to October 2006: Cochrane Drugs and Alcohol Review Group Register, the Cochrane Controlled Trials Register, MEDLINE, EMBASE, Current Contents, Psychlit, CORK , Alcohol and Drug Council of Australia, Australian Drug Foundation, Centre for Education and Information on Drugs and Alcohol, Library of Congress databases, reference lists of identified studies and reviews, authors were asked about any other published or unpublished relevant RCT.

Selection criteria

Randomised clinical trials of buprenorphine maintenance versus placebo or methadone maintenance.

Data collection and analysis

Authors separately and independently evaluated the papers and extracted data for meta-analysis.

Main results

Twenty four studies met the inclusion criteria (4497 participants), all were randomised clinical trials, all but six were double-blind. The method of allocation concealment was not clearly described in the majority (20) of the studies, but where it was reported the methodological quality was good.
Buprenorphine was statistically significantly superior to placebo medication in retention of patients in treatment at low doses (RR=1.50; 95% CI: 1.19 - 1.88), medium (RR=1.74; 95% CI: 1.06 - 2.87), and high doses (RR=1.74; 95% CI: 1.02 - 2.96). The high statisitical heterogenity prevented the calculation of a cumulative estimate. However, only medium and high dose buprenorphine suppressed heroin use significantly above placebo.
Buprenorphine given in flexible doses was statistically significantly less effective than methadone in retaining patients in treatment (RR= 0.80; 95% CI: 0.68 - 0.95), but no different in suppression of opioid use for those who remained in treatment.
Low dose methadone is more likely to retain patients than low dose buprenorphine (RR= 0.67; 95% CI: 0.52 - 0.87). Medium dose buprenorphine does not retain more patients than low dose methadone, but may suppress heroin use better. There was no advantage for medium dose buprenorphine over medium dose methadone in retention (RR=0.79; 95% CI:0.64 - 0.99) and medium dose buprenorphine was inferior in suppression of heroin use.

Authors' conclusions

Buprenorphine is an effective intervention for use in the maintenance treatment of heroin dependence, but it is less effective than methadone delivererd at adequate dosages.

 

Plain language summary

Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence

Buprenorphine can reduce heroin use compared with placebo, although it is less effective than methadone. Methadone is widely used as a replacement for heroin in medically-supported maintenance or detoxification programs. Two other drugs are sometimes used to try and help lower use of heroin, specifically buprenorphine and LAAM (levo-alpha-acetylmethadol). Buprenorphine is an opioid drug that is not as powerful as heroin and methadone, although the effects of buprenorphine may last longer. Buprenorphine can be taken once every two days. The review of trials found that buprenorphine at medium (8mg -15mg) and high doses (16mg) can reduce heroin use effectively compared with placebo, although it is less effective than methadone, especially if methadone is prescribed at adequate dose levels of between 60mg and 120mg per day.

 

摘要

背景

Buprenorphine維持療法對照安慰劑或methadone維持療法用於治療鴉片依賴

Buprenorphine已經被報告作為一種替代methadone及LAAM對於鴉片依賴的維持治療方法，關於它的相對效果有不同的結果被報告出來，因此需要一個整合性的回顧。

目標

評估buprenorphine維持療法相對安慰劑與methadone維持療法對於保留病人於治療中並抑制違法藥物使用的效果。

搜尋策略

我們檢索以下的資料庫至2001年，包括：Cochrane Drugs and Alcohol Review Group Register，the Cochrane Controlled Trials Register，MEDLINE，EMBASE，Current Contents，Psychlit，CORK [www. state.vt.su/adap/cork]，Alcohol and Drug Council of Australia (ADCA) [www.adca.org.au]，Australian Drug Foundation (ADF VIC) [www.adf.org.au]，Centre for Education and Information on Drugs and Alcohol (CEIDA) [www.ceida.net.au]，Australian Bibliographic Network (ABN)，Library of Congress資料庫，現有的NIDA專刊，the College on Problems of Drug Dependence Inc.會議記錄，所有已確定的研究的參考文獻及已發表的回顧。已確定的RCT的作者被詢問有關任何其他已發表或未發表的相關RCT。

選擇標準

Buprenorphine維持療法對照安慰劑或methadone維持療法用於鴉片依賴的隨機臨床試驗。

資料收集與分析

回顧者個別分開評估文章並獨立地評價分組隱匿的方法學品質；獨立地摘錄資料用於統合分析並雙重登錄。

主要結論

13篇研究符合納入標準，全部為隨機臨床試驗，除了一篇其餘皆為雙盲試驗。其中11篇研究沒有清楚地描述分組隱匿的方法，否則方法學品質是良好的。給予彈性劑量的buprenorphine比methadone對於保留病患在治療中統計上顯著較沒效果(RR = 0.82；95% CI：0.69 – 0.96)。低劑量buprenorphine並不會比低劑量methadone好。高劑量buprenorphine不會比低劑量methadone保留更多的病患，但也許其抑制海洛因使用的效果較好。對於保留病患上，高劑量buprenorphine沒有優於高劑量methadon(RR = 0.79；95% CI：0.62 – 1.01)，且高劑量buprenorphine對於抑制海洛因使用的效果比高劑量methadon差。對於保留病患在治療中的效果，Buprenorphine在統計上顯著比安慰劑好:低劑量(RR = 1.24；95% CI：1.06 – 1.45))，高劑量(RR = 1.21；95% CI：1.02 – 1.44)，及相當高劑量(RR = 1.52；95% CI：1.23 – 1.88)。然而，只有高劑量與相當高劑量的buprenorphine其抑制海洛因使用的效果顯著比安慰劑好。

作者結論

Buprenorphine是一種用於海洛因依賴之維持治療的有效介入措施，但在適當的劑量下它不比methadone有效。

翻譯人

本摘要由高雄榮民總醫院金沁琳翻譯。

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

總結

Buprenorphine可以減少海洛因的使用，雖然它不如methadone一樣有效。在醫療支持或戒毒計畫中，methadone是最廣泛用於代替海洛因的藥物。兩種其他藥物buprenorphine與LAAM (levoalphaacetylmethadol)有時被用來嘗試並幫助減少海洛因的使用。Buprenorphine是一種鴉片藥物，雖然其效果也許持續較長的時間，但不像海洛因及methadone強。退出buprenorphine治療比methadone容易，且可以每兩天服用一次藥物。試驗的回顧發現buprehnorphine可以有效減少海洛因的使用，雖然它可能不如methadone一樣有效。