Clinical evaluation of S-CMC syrup applied in the treatment of otitis media with effusion. Double blind comparative test with placebo.

We carried out a double blind comparative trial with placebo serving as control using 250 cases of infant otitis media with effusion (OME) in order to objectively evaluate the clinical usefulness of S-carboxymethylcysteine (S-CMC), an oral mucolytic agent, against OME. The results obtained were as follows. 1) Global improvement rate, when judged in items of overall improvement, was 79.8% in S-CMC group and 58.2% in placebo group, S group being significantly better when compared to P. 2) The degree of improvement in each item for evaluation revealed significantly better results in S group compared to P, in both objective findings of the effusion amount and its property, and in audiological findings. 3) Adverse reactions observed in 3 cases (2.5%) in S group and in 2 (1.5%) in P group were not serious, and were eliminated through suspension or discontinuation of the medication. The results obtained suggested the usefulness of S-CMC when used in the treatment of OME.

RCT Entities:   Population Interventions Outcomes