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.
Kumazawa
T
T
Department of Otolaryngology, Kansai Medical University, Osaka.
Ushiro
K
K
D000284:Administration, Oral; D002233:Carbocysteine / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003545:Cysteine / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D015337:Multicenter Studies as Topic; D010034:Otitis Media with Effusion / Q000188:drug therapy*
D002233:Carbocysteine; D003545:Cysteine