Nimesulide for the treatment of painful inflammatory process in the ear, nose and throat areas: a double-blind controlled study with benzydamine.

Nimesulide, 4-nitro-2-phenoxymethanesulphonanilide, a new non-steroidal anti-inflammatory drug endowed with potent anti-inflammatory, analgesic and antipyretic activities, was tested at a daily dose of 200 mg b.i.d. against Benzydamine on a double-blind basis, in a randomized trial with fifty out-patients suffering from inflammatory ear, nose and throat diseases (otitis media, sinusitis, rhinitis). Nimesulide treatment brought about an immediate and significant improvement in over-all pain, exudation, oedema and headache and produced a rapid lowering in body temperature. The recovery was more rapid and significant in patients with Nimesulide than in those with Benzydamine. The signs and symptoms under consideration reached almost complete resolution within the set treatment-period of 10 days. Clinical tolerability of Nimesulide was better than that of Benzydamine: one case of moderate gastric pyrosis and drowsiness was complained of by the Nimesulide-treated patients versus eleven cases of gastro-intestinal discomfort, mouth dryness, and/or drowsiness which were complained of by the Benzydamine-treated patients.