Abstract
ObjectiveTo establish the clinical relevance of S-carboxymethylcysteine in the treatment of glue ear in children using measures approximating those saving a child from operation for grommet insertion.Data sourcesCochrane Library, MEDLINE, EMBASE, PubMed, reference lists and reviews were used for randomised controlled trials comparing S-carboxymethylcysteine with placebo. Seven trials involving 283 children and 146 ears were found.Review methodsStudies were randomised, double-blind comparisons of S-carboxymethylcysteine (any dose and duration) with placebo in otitis media with effusion. Quality of trial reporting and validity of methods were assessed and used in sensitivity analysis. Main outcomes were relative benefit and number-needed-to-treat to prevent one grommet operation compared with placebo.ResultsSuccessful outcomes were obtained in 17% of children given placebo (range 5% to 38% in individual studies) and in 35% of children given S-carboxymethylcysteine (range 22 to 80%). For combined data (children and ears) the relative benefit was 2.0 (95%CI 1.4 to 2.8) and number-needed-to-treat 5.5 (95% confidence interval 3.8 to 9.8). Pooled data from trials of higher reporting quality (4/7) or methodological validity (3/7) tended to have lower efficacy but were not statistically different from those of lower quality or validity.ConclusionS-carboxymethylcysteine is effective in the treatment of children with glue ear. For every five or six children treated with S-carboxymethylcysteine over one to three months, one will not undergo surgery for grommet insertion who would have done had they been given placebo. The confidence in this conclusion is limited because studies included relatively few children.
Highlights
Glue ear is a common cause of hearing impairment in children, and was reviewed in an Effective Health Care Bulletin in 1992 [1]
It can result in a hearing loss of 0 to 50 dB HL, with an average of 20 dB HL
Unilateral glue ear is less of a problem, but bilateral glue ear with significant hearing loss is commonly considered to pose developmental problems to children
Summary
Glue ear is a common cause of hearing impairment in children, and was reviewed in an Effective Health Care Bulletin in 1992 [1]. It can result in a hearing loss (measured in decibels of hearing loss, dB HL) of 0 to 50 dB HL, with an average of 20 dB HL. Unilateral glue ear is less of a problem, but bilateral glue ear with significant hearing loss is commonly considered to pose developmental problems to children. Early surgery to introduce ventilation tubes significantly reduced behavioral problems nine months later [2]. Persistent bilateral hearing impairment of 25–30 dB HL is thought sufficient to justify surgery
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