Intervention Review

Inhaled sodium cromoglycate for asthma in children

  1. Johannes C van der Wouden1,*,
  2. Johannes HJM Uijen1,
  3. Roos MD Bernsen2,
  4. Marjolein JA Tasche3,
  5. Johan C de Jongste4,
  6. Francine M Ducharme5

Editorial Group: Cochrane Airways Group

Published Online: 20 JAN 2010

Assessed as up-to-date: 27 JUL 2010

DOI: 10.1002/14651858.CD002173.pub2

Database Title

Additional Information

How to Cite

van der Wouden JC, Uijen JHJM, Bernsen RMD, Tasche MJA, de Jongste JC, Ducharme FM. Inhaled sodium cromoglycate for asthma in children. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD002173. DOI: 10.1002/14651858.CD002173.pub2.

Author Information

  1. 1

    Erasmus Medical Center, Department of General Practice, Rotterdam, Netherlands

  2. 2

    Faculty of Medicine & Health Sciences (FMHS), Department of Community Medicine, Al Ain, United Arab Emirates

  3. 3

    University of Nottingham, c/o Cochrane Skin Group, Nottingham, UK

  4. 4

    Erasmus MC - Sophia Children's Hospital, Department of Pulmonology, Rotterdam, Netherlands

  5. 5

    University of Montreal, Research Centre, CHU Sainte-Justine and the Department of Pediatrics, Montreal, Québec, Canada

*Johannes C van der Wouden, Department of General Practice, Erasmus Medical Center, PO Box 2040, Rotterdam, 3000 CA, Netherlands. j.vanderwouden@erasmusmc.nl.

Publication History

  1. Publication Status: Edited (no change to conclusions), comment added to review
  2. Published Online: 20 JAN 2010

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Abstract

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

Background

Sodium cromoglycate has been recommended as maintenance treatment for childhood asthma for many years. Its use has decreased since 1990, when inhaled corticosteroids became popular, but it is still used in many countries.

Objectives

To determine the efficacy of sodium cromoglycate compared to placebo in the prophylactic treatment of children with asthma.

Search methods

We searched the Cochrane Airways Group Trials Register (October 2009), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2009), MEDLINE (January 1966 to October 2009), EMBASE (January 1985 to October 2009) and reference lists of articles. We also contacted the pharmaceutical company manufacturing sodium cromoglycate.

Selection criteria

All double-blind, placebo-controlled randomised trials, which addressed the effectiveness of inhaled sodium cromoglycate as maintenance therapy, studying children aged 0 up to 18 years with asthma.

Data collection and analysis

Two authors independently assessed trial quality and extracted data. We pooled study results.

Main results

Of 3500 titles retrieved from the literature, 24 papers reporting on 23 studies could be included in the review. The studies were published between 1970 and 1997 and together included 1026 participants. Most were cross-over studies. Few studies provided sufficient information to judge the concealment of allocation. Four studies provided results for the percentage of symptom-free days. Pooling the results did not reveal a statistically significant difference between sodium cromoglycate and placebo. For the other pooled outcomes, most of the symptom-related outcomes and bronchodilator use showed statistically significant results, but treatment effects were small. Considering the confidence intervals of the outcome measures, a clinically relevant effect of sodium cromoglycate cannot be excluded. The funnel plot showed an under-representation of small studies with negative results, suggesting publication bias.

Authors' conclusions

There is insufficient evidence to be sure about the efficacy of sodium cromoglycate over placebo. Publication bias is likely to have overestimated the beneficial effects of sodium cromoglycate as maintenance therapy in childhood asthma.

 

Plain language summary

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

The effects of sodium cromoglycate compared with placebo for chronic asthma in children

In this review we aimed to determine whether there is evidence for the effectiveness of inhaled sodium cromoglycate as maintenance treatment in children with chronic asthma. Most of the studies were carried out in small groups of patients. Furthermore, we suspect that not all studies undertaken have been published. The results show that there is insufficient evidence to be sure about the beneficial effect of sodium cromoglycate compared to placebo. However, for several outcome measures the results favoured sodium cromoglycate.

 

摘要

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

背景

吸入型sodium cromoglycate在兒童氣喘的治療

sodium cromoglycate作為兒童氣喘的維持治療已經有幾年的歷史。自從1990年吸入型皮質類固醇開始流行後，漸漸地用得比較少，但仍有許多國家持續使用。

目標

與安慰劑相比，確定sodium cromoglycate在兒童氣喘的預防性治療上的療效。

搜尋策略

搜尋Cochrane Airways Group Trials Register (2009 年10月)、Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2009)、MEDLINE (1966年 1月至2009年10月)、和EMBASE (1985年 1月至2009年10月)，及各文章的參考資料清單。連絡製造sodium cromoglycate 的藥廠。

選擇標準

研究對象為0到18歲的氣喘兒童、以吸入型sodium cromoglycate作維持治療的所有雙盲、安慰劑對照隨機試驗。

資料收集與分析

兩位審查員各別評估研究品質並擷取數據。匯整研究結果。

主要結論

從文獻找到的3500個標題中，本回顧選取23個研究的24篇文章報告。這些研究的發表時間從1970 年到1997年，共1026位參與者。大部分是交叉研究。少數幾個研究提供充分的資料足以判斷其隨機隱匿(concealment of allocation)的方式。四個研究的結果以無症狀天數的百分比表示。最後結果顯示：sodium cromoglycate和安慰劑之間並沒有統計學上有意義的差異。至於其他匯整結果，多數症狀相關結果和支氣管擴張劑的使用，顯示具有統計學上有意義的差異，但效果並不顯著。當考量到結果測量值的信賴區間時，無法排除sodium cromoglycate的臨床相關作用。漏斗散佈圖(funnel plot)顯示：負面結果的小型研究太少，可能是發表偏差(publication bias)。

作者結論

沒有足夠的證據可以確定sodium cromoglycate 的療效優於安慰劑。發表偏差可能高估了sodium cromoglycate作為兒童氣喘維持治療的效益。

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

在本回顧中，我們試著尋找證據，支持吸入型sodium cromoglycate作為慢性兒童氣喘維持治療的效果。大部分研究僅針對少數病患。此外，我們懷疑不是所有相關研究都有發表。結果顯示：與安慰劑相比，沒有足夠的證據可以確定sodium cromoglycate的效益。但是，有些結果測量值則顯示：建議使用sodium cromoglycate。

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