T. Ovesen et al., Effect of N-acetylcysteine on the incidence of recurrence of otitis media with effusion and re-insertion of ventilation tubes, ACT OTO-LAR, 2000, pp. 79-81
Previous studies have demonstrated the anti-inflammatory, anti-oxidant, and
mucolytic nature of N-acetylcysteine (NAC). Theoretically, these propertie
s make the substance ideal for therapeutic use against otitis media with ef
fusion (OME). The disease is characterized as a sustained non-specific infl
ammation of the middle ear mucosa with secretory. transformation of the epi
thelium resulting in accumulation of fluid in the middle ear space. To inve
stigate the: effects of instillation of NAC in the middle ear, a double-bli
nd, placebo-controlled, randomized trial was carried out. A total of 75 chi
ldren who were undergoing their first bilateral insertion of ventilation tu
bes (VT) due to OME were randomized to Mucomyst (NAC) or placebo, (the Vehi
cle) on one ear in relation to the VT insertion. The contralateral ear unde
rwent VT insertion exclusively. Instillation of Mucomyst or placebo was rep
eated 3 and 7 days afterwards. The children were followed regularily for 11
-39 months. Episodes of otorrhea the recurrence of OME after VT extrusion a
nd re-insertion of VTs were registered as primary outcome parameters. The r
esults demonstrated that Mucomyst significantly reduced the recurrence of O
ME: and re-insertion of VTs (p < 0.025) and significantly increased the tim
e until VT extrusion (p < 0.0167). In addition, the number of episodes of c
ar problems and visits at the ENT clinic were reduced significantly by NAC
(p < 0.0383).