Mucolytic effects of domiodol in tracheostomized patients after total laryngectomy. Double-blind, placebo-controlled, randomized pilot study with four-month follow-up.

The results obtained in a controlled clinical trial aimed at evaluating the efficacy and tolerability of a mucolytic treatment in laryngectomized patients are described. Domiodol (Mucolitico Maggioni, CAS 61869-07-6), an organic iodinated mucolytic agent, was given at the dosage of 60 mg t.i.d. to 20 patients in the post-operative period after laryngectomy (average 2 weeks in hospital and 4 months follow-up at home). A matched series of patients received a placebo during the hospital period and no treatment after discharge. The patients receiving the active treatment showed a statistically and clinically significant improvement of respiratory parameters (cough intensity, sputum quantity, sputum quality, expectoration difficulty). Such improvement was earlier and greater than that observed in the placebo-treated patients. It is concluded that a mucolytic treatment may be helpful in the post-operative treatment of laryngectomized patients with permanent tracheostomy.