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Inhaled corticosteroids for cystic fibrosis - PubMed

  • ️Tue Jan 01 2019

Inhaled corticosteroids for cystic fibrosis

Ian M Balfour-Lynn et al. Cochrane Database Syst Rev. 2019.

Abstract

Background: The reduction of lung inflammation is one of the goals of cystic fibrosis therapy. Inhaled corticosteroids are often used in this respect to treat children and adults with cystic fibrosis. The rationale for this is their potential to reduce lung damage arising from inflammation, as well as their effect on symptomatic wheezing. It is important to establish the current level of evidence for the risks and benefits of inhaled corticosteroids, especially in the light of their known adverse effects on growth. This is an update of a previously published review; however, due to the lack of research in this area, we do not envisage undertaking any further updates.

Objectives: To assess the effectiveness of taking regular inhaled corticosteroids compared to not taking them in children and adults with cystic fibrosis.

Search methods: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We requested information from pharmaceutical companies manufacturing inhaled corticosteroids and authors of identified trials.Date of most recent search of the Group's Trials Register: 19 November 2018.

Selection criteria: Randomised or quasi-randomised trials, published and unpublished, comparing inhaled corticosteroids to placebo or standard treatment in individuals with cystic fibrosis.

Data collection and analysis: Two independent authors assessed methodological quality and risk of bias in trials using established criteria and extracted data using standard pro formas. The quality of the evidence was assessed using the GRADE criteria.

Main results: The searches identified 35 citations, of which 27 (representing 13 trials) were eligible for inclusion. These 13 trials reported the use of inhaled corticosteroids in 525 people with cystic fibrosis aged between 6 and 55 years. One was a withdrawal trial in 171 individuals who were already taking inhaled corticosteroids. Methodological quality and risk of bias were difficult to assess from published information.Objective measures of airway function were reported in most trials but were often incomplete and reported at different time points. We found no difference in forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) % predicted in any of the trials, although the quality of the evidence was low due to risks of bias within the included trials and low participant numbers. We are uncertain whether inhaled corticosteroids result in an improvement in exercise tolerance, bronchial hyperreactivity or exacerbations as the quality of the evidence was very low. Data from one trial suggested that inhaled corticosteroids may make little or no difference to quality of life (low-quality evidence).Three trials reported adverse effects, but the quality of the evidence is low and so we are uncertain whether inhaled corticosteroids increase the risk of adverse effects. However, one study did show that growth was adversely affected by high doses of inhaled corticosteroids.

Authors' conclusions: Evidence from these trials is of low to very low quality and insufficient to establish whether inhaled corticosteroids are beneficial in cystic fibrosis, but withdrawal in those already taking them has been shown to be safe. There is some evidence they may cause harm in terms of growth. It has not been established whether long-term use is beneficial in reducing lung inflammation, which should improve survival, but it is unlikely this will be proven conclusively in a randomised controlled trial.

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Conflict of interest statement

Ian Balfour‐Lynn has no potential conflict of interest.

Karen Welch has no potential conflict of interest.

Sherie Smith has no potential conflict of interest

Figures

1
1

Study flow diagram.

2
2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

1.1
1.1. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 1: Mean absolute FEV1

1.2
1.2. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 2: Mean absolute FEV1

1.3
1.3. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 3: Mean absolute FEV1 (withdrawal study)

1.4
1.4. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 4: Change in % predicted FEV1 post bronchodilator

1.5
1.5. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 5: Change in % predicted FEV1 (withdrawal study)

1.6
1.6. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 6: Mean absolute FVC

1.7
1.7. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 7: Mean absolute FVC (withdrawal study)

1.8
1.8. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 8: Change in % predicted FVC

1.9
1.9. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 9: Change in % predicted FVC (withdrawal study)

1.10
1.10. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 10: Average patient days in hospital

1.11
1.11. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 11: Average patient days on antibiotics

1.12
1.12. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 12: Growth velocity

1.13
1.13. Analysis

Comparison 1: Inhaled corticosteroid versus placebo, Outcome 13: Growth velocity (withdrawal study)

Update of

  • Inhaled corticosteroids for cystic fibrosis.

    Balfour-Lynn IM, Welch K. Balfour-Lynn IM, et al. Cochrane Database Syst Rev. 2016 Aug 23;(8):CD001915. doi: 10.1002/14651858.CD001915.pub5. Cochrane Database Syst Rev. 2016. PMID: 27552284 Updated. Review.

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References

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UK Trial 1997 {published data only}
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Australia Trial 2000 {published data only}
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USA Trial 1996 {published data only}
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References to studies awaiting assessment

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References to other published versions of this review

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