Intervention Review

Budesonide versus placebo for chronic asthma in children and adults

  1. Nick P Adams1,*,
  2. Janine C Bestall2,
  3. Paul Jones3

Editorial Group: Cochrane Airways Group

Published Online: 25 OCT 1999

Assessed as up-to-date: 28 JUN 1999

DOI: 10.1002/14651858.CD003274

How to Cite

Adams NP, Bestall JC, Jones P. Budesonide versus placebo for chronic asthma in children and adults. Cochrane Database of Systematic Reviews 1999, Issue 4. Art. No.: CD003274. DOI: 10.1002/14651858.CD003274.

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

    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: 25 OCT 1999

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Abstract

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

Background

Inhaled budesonide is a widely used inhaled corticosteroid for asthma.

Objectives

The objectives of this review was to compare the efficacy of budesonide with placebo in the treatment of chronic asthma.

Search methods

The Cochrane Airways Group Trial Register and reference lists of articles was searched. We contacted trialists for additional studies and searched abstracts of major respiratory society meetings (1997-1999).

Selection criteria

Randomised trials in children and adults comparing budesonide to placebo in the treatment of chronic asthma.

Data collection and analysis

Two reviewers independently assessed articles for inclusion and methodological quality. One reviewer extracted data.

Main results

43 studies met the inclusion criteria (2801 paticipants). In non-oral steroid treated asthmatics, budesonide led to significant improvements in a number of measures of airway function. These included FEV1, Weighted Mean Difference (WMD) 3.7% predicted (95% CI 0.1, 7.2%); improvement in morning peak flow (PEF) from baseline WMD 29 L/min (95% CI 22, 36 L/min); improvement in evening PEF from baseline WMD 21 L/min (95% CI 13, 29 L/min). Varying methods of reporting symptoms limited the pooling of studies but all high methodological quality studies demonstrated significant improvements compared to placebo. Health status was not reported. Risk of trial withdrawal due to asthma exacerbation was lower with budesonide compared to placebo, relative risk 0.17 (95% CI 0.09, 0.33). Doses of 500-800 mcg/d appeared to have slightly larger effect sizes than lower doses, but no advantage for high doses were apparent. A single high quality RCT reported significant reductions in daily prednisolone requirement and the number of patients able to discontinue prednisolone completely in budesonide treated subjects compared to placebo. No difference in risk of oropharyngeal soreness/hoarseness or oral Candidiasis was apparent for budesonide compared to placebo. Long-term risk of adrenal insufficiency was not reported.

Authors' conclusions

This review strongly supports use of budesonide in chronic asthma. Consensus guidelines for chronic asthma suggest titrating inhaled steroid dose to individual requirements. Evidence from this review of trials does not present a case for routine dose titration above 800 mcg/d.

 

Plain language summary

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

Budesonide versus placebo for asthma

Budesonide is highly effective preventative treatment for all patients with asthma, irrespective of age or severity of their disease. Most benefits are seen with low-moderate doses.

 

摘要

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

背景

比較budesonide 及安慰劑在兒童及成人慢性氣喘的治療

吸入式budesonide 為廣泛使用於治療氣喘的類固醇吸劑

目標

本回顧的目的是要比較budesonide與安慰劑在治療慢性氣喘之效益

搜尋策略

對CAGTR及文章之文獻表可作搜尋,我們聯絡其他研究之人員及搜尋主要呼吸學會會議之摘要(1997 – 1999)

選擇標準

以兒童及成人之受試者比較budesonide及安慰劑治療慢性氣喘之隨機試驗

資料收集與分析

二位審查者獨立地評估文獻之納入及方法學品質,一位審查者摘出數據

主要結論

43項研究符合納入校準(2801位受試者),非口服類固醇氣喘患者中,budesonide可顯著改善一些氣道功能測量指標。其中包括FEV1,權重平均差(WMD)預期3.7%(95% CI 0.1, 7.2%);清晨頂峰流量(PEF)較基準之改善WMD 29 L/min(95% CI 22, 36 L/min);夜間PEF較基準之改善WMD 21 L/min(95% CI 13, 29 L/min)。報告症狀採用不同的方法限制研究之pooling,但所有高方法學品質之研究較安慰劑呈現明顯改善。健康狀況並沒有報告,相較於安慰劑,budesonide能降低因氣喘惡化而退出試驗的風險,相對風險0.17(95% CI 0.09, 0.33)。在500 – 800 mcg/d 之劑量範圍看來比較低劑量稍具較大之效益,但較高之劑量並未呈現好處。某單一高品質PCT報告顯示較之使用安慰劑的受試者,budesonide治療受試者,每日prednisolone需求顯著減少而可完全停止budesonide之病人數更多,與安慰劑相較,使用budesonide含口咽疼痛及沙啞或口腔candidiasis之風險並無差異。腎上腺功能不足之長期風險沒有被報告。

作者結論

本回顧大力支持慢性氣喘使用budesonide。慢性氣喘之共識指標建議因分別需求來調整吸入式類固醇劑量。回顧試驗所得證據並未呈現任一例子例行劑量調整至超過800 mcg/d。

翻譯人

本摘要由中國醫藥大學附設醫院陳祖裕翻譯。

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

總結

無論年齡或疾病嚴重度Budesonide對所有氣喘病人是極為有效之預防性治療。大多數效益見於低中劑量。