Acetylcysteine and carbocysteine for acute upper and lower respiratory tract infections in paediatric patients without chronic broncho-pulmonary disease

  • Review
  • Intervention

Authors


Abstract

Background

Acetylcysteine and carbocysteine are the most commonly prescribed mucolytic drugs in many European countries. To our knowledge, no systematic review has been published on their efficacy and safety for acute upper and lower respiratory tract infections (ARTIs) in children without chronic broncho-pulmonary disease.

Objectives

The objective was to assess the efficacy and safety and to establish a benefit-risk ratio of acetylcysteine and carbocysteine as symptomatic treatments for ARTIs in children without chronic broncho-pulmonary disease.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, issue 4) which contains the Acute Respiratory Infections (ARI) Group's Specialized Register, MEDLINE (1966 to 2008), EMBASE (1980 to 2008); Micromedex (2008), Pascal (1987 to 2004), and Science Citation Index (1974 to 2008).

Selection criteria

To study efficacy, we used randomised controlled trials (RCTs) comparing the use of acetylcysteine or carbocysteine versus placebo either alone or as an add-on therapy.

To study safety, we also used trials comparing the use of acetylcysteine or carbocysteine versus active treatment or no treatment and case reports.

Data collection and analysis

At least two review authors extracted data and assessed trial quality. We performed a subgroup analysis of children younger than two years of age.

Main results

Six trials involving 497 participants were included to study efficacy. They showed some benefit from mucolytic agents, although differences were of little clinical relevance. No conclusion was drawn about the subgroup of infants younger than two years because the data were unavailable. Thirty-four studies including the previous six trials involving 2064 children were eligible to study safety. Overall safety was good but very few data were available to evaluate safety in infants younger than two years. However, 48 cases of paradoxically increased bronchorrhoea observed in infants were reported to the French pharmacovigilance system.

Authors' conclusions

The results of this review have to be interpreted with caution because it was based on a limited number of participants included in studies whose methodological quality is questionable. Acetylcysteine and carbocysteine seem to have a limited efficacy and appear to be safe in children older than two years. These results should take into consideration the fact that acetylcysteine and carbocysteine are prescribed for self-limiting diseases (for example, acute cough, bronchitis). Regarding children younger than two years, given concerns about safety, these drugs should only be used for ARTIs in the context of an RCT.

Plain language summary

Mucolytic drugs to treat acute upper and lower respiratory tract infections in children without chronic broncho-pulmonary disease

Acetylcysteine and carbocysteine are the most commonly prescribed mucolytic drugs. This systematic review aimed at assessing their efficacy and safety for treating acute upper and lower respiratory tract infections (ARTIs) in children without chronic broncho-pulmonary disease. A subgroup analysis among patients younger than two years was performed.

Forty-nine studies met the inclusion criteria. Six trials involving 497 participants were included to study efficacy and compared acetylcysteine or carbocysteine to placebo. Thirty-four studies including the previous six were eligible to study safety and involved 2064 paediatric patients.

The results of this review suggest actual but limited efficacy of acetylcysteine and carbocysteine and a good overall safety among children older than two years of age. However, the number of patients included was limited and the methodological quality was questionable. These results should also take into consideration the fact that acetylcysteine and carbocysteine are prescribed for self-limiting diseases (e.g., acute cough, bronchitis). Regarding children younger than two years, given concerns about safety, these drugs should only be used for ARTIs in the context of a randomised controlled trial.