The role of Mucodyne (R) in reducing the need for surgery in patients withpersistent otitis media with effusion

A recent meta-analysis suggested a possible beneficial effect of carbsxymet hylcysteine (Mucodyne(R)) in resolving otitis media with effusion (OME), bu t the methodology in several of the included trials was flawed. A double-bl ind randomised controlled trial (RCT) involving 163 patients (78 randomised to Mucodyne(R) and 85 to placebo) was therefore performed. Main outcome me asure: operative intervention or not. Of the 28 patients with resolved OME, 17 were in the Mucodyne(R) group and 11 in the placebo group. Although it appeared that patients treated with Mucodyne(R) were 1.68 times more likely to undergo resolution of OME than patients receiving placebo, this did not reach statistical significance. [Risk ratio of 1.68 (95% C.I., 0.74-3.37)] . chi(2) test (df = 162) = 2.24 (P = 0.134). The absolute risk difference i n the study was 8.5% (95% C.I., -3-20). We cannot exclude the possibility t hat Mucodyne(R) is as beneficial as a 20% additional resolution of OME, or as harmful as a 3% decrease in the resolution of OME.