Intervention Review

Beclomethasone versus placebo for chronic asthma

  1. Nick P Adams1,*,
  2. Janine C Bestall2,
  3. Reem Malouf3,
  4. Toby J Lasserson4,
  5. Paul Jones5

Editorial Group: Cochrane Airways Group

Published Online: 24 JAN 2005

Assessed as up-to-date: 21 OCT 2004

DOI: 10.1002/14651858.CD002738.pub2

How to Cite

Adams NP, Bestall JC, Malouf R, Lasserson TJ, Jones P. Beclomethasone versus placebo for chronic asthma. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD002738. DOI: 10.1002/14651858.CD002738.pub2.

Author Information

  1. 1

    Worthing & Southlands NHS Trust, Respiratory Medicine, Worthing , UK

  2. 2

    St George's Hospital Medical School, Division of Physiological Medicine, London, UK

  3. 3

    Oxfordshire and Buckinghamshire Mental Health Trust, Department of Psychiatry, Oxford, UK

  4. 4

    St George's, University of London, Community Health Sciences, London, UK

  5. 5

    St George's Hospital Medical School, Cardiovascular Medicine, London, UK

*Nick P Adams, Respiratory Medicine, Worthing & Southlands NHS Trust, Worthing , UK. Nick.Adams@wash.nhs.uk. nadams2002@btinternet.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 24 JAN 2005

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Abstract

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

Background

Inhaled beclomethasone dipropionate (BDP) has been, together with inhaled budesonide, the mainstay of anti-inflammatory therapy for asthma for many years. A range of new prophylactic therapies for asthma is becoming available and BDP has been reformulated using a hydrofluoroalkane-134a (HFA) propellant which is free from chlorofluorocarbon (CFC).

Objectives

The objectives of this review were to:
(1) Compare the efficacy of BDP with placebo with both CFC and HFA propellants in the treatment of chronic asthma.
(2) Explore the possibility that a dose response relationship exists for BDP in the treatment of chronic asthma.
(3) To provide the best estimate of the efficacy of BDP as a benchmark for evaluation of newer asthma therapies.

Search methods

Electronic searches were current as of January 2003.

Selection criteria

Randomised parallel group design trials for a minimum period of four weeks, in children and adults comparing CFC-BDP or HFA-BDP with placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.

Data collection and analysis

One reviewer extracted data; authors were contacted to clarify missing information. We analysed data with RevMan Analyses 1.0.2.

Main results

60 studies recruiting 6542 participants met the inclusion criteria. CFC-BDP (57 studies): In non-oral steroid treated patients, at doses of 400mcg/day or less CFC-BDP produced significant improvements from baseline in a number of efficacy measures compared with placebo, including forced expiratory volume in one second (FEV1) 360 ml (95% CI 260 to 460); FEV1 (% predicted) WMD 12.41% (95% CI 8.18 to 16.64) and morning peak expiratory flow rate (am PEF) WMD 35.95 L/min (95% CI 27.85 to 44.04). BDP also led to reductions in rescue beta-2 agonist use compared with placebo of -2.32 puffs/d (95% CI -2.55 to -2.09) and reduced the relative risk (RR) of trial withdrawal due to an asthma exacerbation 0.25 (95% CI 0.12 to 0.51). Subgroup analyses based on treatment duration provide support to the proposal that a treatment period of greater than four weeks is required to realise a fuller treatment effect. In oral steroid treated patients BDP led to significantly greater reductions in oral prednisolone use WMD -4.91 mg/d (95% CI -5.88 to -3.94 mg/d) and greater likelihood of withdrawing oral steroid treatment RR 8.02 (95% CI 3.23 to 19.92). HFA-BDP (3 studies): In non-oral steroid-treated patients, HFA-BDP was significantly more effective than placebo in improving FEV1, morning and evening PEF, FEF25 to 75%, reduced asthma symptoms and beta2-agonists daily consumption. Significant effects for such outcomes were apparent after six weeks of treatment. In oral steroid treated patients, HFA-BDP improved significantly FEV1 and am PEF. The summary estimates for these outcomes suggested a high level of heterogeneity, and divergent aims of the studies may contribute to the variation we observed. Limited data on adverse events were reported.

Authors' conclusions

This review has quantified the efficacy of CFC-BDP and HFA-BDP in the treatment of chronic asthma and strongly supports its use. Current asthma guidelines recommend titration of dose to individual patient response, but the published data provide little support for dose titration above 400 mcg/d in patients with mild to moderate asthma. There are insufficient data to draw any conclusions concerning dose-response in people with severe asthma.

 

Plain language summary

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

Inhaled beclomethasone compared with placebo for chronic asthma

During an asthma attack, the airways narrow, causing breathing problems, wheezing and coughing. Inhaled corticosteroids (ICS) are used to reduce swelling of the airways. Inhaled beclomethasone dipropionate (BDP) is commonly used. There is now a new formulation of the drug which uses a new propellant (HFA-BDP). This review of trials found that BDP delivered with the old and new propellant is effective in helping people with chronic asthma. BDP at all doses improves airflow, reduces symptoms and the need for rescue bronchodilators. The review only included studies conducted for more than 4 weeks. The drug was well tolerated and the safety profile was comparable with placebo. The findings apply to both children and adults. The effects of the new propellant suggest that it could be more effective than the older version, although a different review will address that particular question.

 

摘要

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

背景

比較beclomethasone和安慰劑在慢性氣喘的治療

多年來,對氣喘患者的處置,併用吸入型beclomethasone dipropionate(BDP)和budesonide一直是抗發炎治療的主流。目前已經有許多新型的氣喘預防性治療可供使用;BDP也經過重新調配,使用不含chlorofluorocarbon(CFC)的hydrofluoroalkane134a (HFA)推進劑。

目標

本回顧的目的在於:(1)比較使用 CFC和HFA為推進劑的BDP和安慰劑對慢性氣喘的療效。(2)探討BDP對慢性氣喘的治療是否有劑量反應關係。(3)提供BDP療效的最佳估計,以作為新的氣喘治療的評估基準。

搜尋策略

電子搜尋到2003年1月為止。

選擇標準

針對兒童和成人,為期至少四週的隨機平行組設計的試驗,,比較CFCBDP或HFABDP 和安慰劑對慢性氣喘的治療。兩位審查員各自評選文章,並評估納入文章的方法學品質。

資料收集與分析

一位審查員擷取數據;缺漏的資料則聯絡作者說明。以Rev Man Analyses1.0.2分析數據。

主要結論

共納入60個研究、6542位參與者。CFCBDP(57個研究):在非口服類固醇治療的病人中,與安慰劑相比,使用CFCBDP每天400mcg或更少者,某些療效測量值(與基準線相比)有顯著的改善,包括:第1秒用力吐氣量(FEV1) 360毫升 (95%信賴區間[CI] 260到460)、FEV1 (%預測值) 加權平均差[WMD] 12.41%(95%信賴區間8.18 到 16.64),和清晨尖峰吐氣流速(AM PEF)加權平均差35.95公升/分鐘(95%信賴區間27.85到44.04)。與安慰劑組相比,BDP組同時減少救急用乙二型作用劑的使用達2.32 puffs/天(95%信賴區間2.55到2.09);同時減少因為氣喘發作而退出試驗的比例-相對風險(RR)0.25(95%信賴區間0.12到0.51)。根據持續治療時間所做的次組分析支持以下建議-為達完整的治療效果,治療時間應超過四週。在口服類固醇治療的患者中,BDP 大大地降低口服prednisolone的使用-加權平均差4.91mg/d (95%信賴區間5.88到3.94 mg/日),也增加患者停止口服類固醇的可能性-相對風險(RR) 8.02(95%信賴區間3.23到19.92)。HFABDP (3項研究):在非口服類固醇治療的患者中,HFABDP比安慰劑更能有效地改善FEV1、清晨及晚間PEF、FEF25 to 75%、減少患者的氣喘症狀、並減少乙型作用劑的每日使用量。這些結果在治療六週後更為顯著。在口服類固醇治療的病患中,HFABDP明顯改善FEV1和AM PEF。這些結果的總體估算值呈現高度的歧異性;各研究的目標分歧可能是造成這項差異的原因。報告中有關副作用的的數據有限。

作者結論

本回顧將CFCBDP和HFABDP治療慢性氣喘的療效加以量化,並且強力支持這類藥物的使用。目前的氣喘指引建議-應針對個別病患反應調整劑量;但是,對於輕度到中度氣喘病患,劑量調整是否應超過400mcg/天?目前已發表的數據僅提供微量支持。至於嚴重氣喘患者的劑量反應,還沒有足夠的數據可以下任何結論。

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

吸入型beclomethasone有助於舒緩兒童和成人的氣喘症狀。當氣喘發作時,呼吸道變狹窄造成呼吸困難、哮喘和咳嗽。吸入型皮質類固醇用來減少呼吸道的腫脹。通常也使用吸入型beclomethasone dipropionate(BDP)。該藥現在有一個使用新推進劑的新劑型(HFABDP)。本回顧發現,無論使用舊和新推進劑的BDP,都能有效幫助慢性氣喘患者。各種不同劑量的BDP可以改善氣流、減少症狀和急救支氣管擴張劑的使用需求。本回顧只納入進行超過四週的研究。本藥物耐受性良好,整體安全性和安慰劑不相上下。這些發現對兒童和成人都適用。新推進劑劑型的效果似乎比舊型的來得好,不過,未來會有另一篇回顧專門討論這個議題。