ORIGINAL ARTICLES   

Otorinolaringologia 2001 June;51(2):69-75

Copyright © 2009 EDIZIONI MINERVA MEDICA

language: Italian

Double blind comparison between diclofenac mouthwash and placebo in pharyngotonsillitis

Steinbeck C., Hrobon M.

Otorhinolaryngological Practice, Dresden, Germany *Otorhinolaryngological Clinic Charles University, General Medical Faculty Prague, Czech Republic

Background. Aim of the study was to compare the efficacy and safety of diclofenac mouthwash 0.074% and a placebo mouthwash in patients suffering from pharyngitis or pharyngotonsillitis.
Methods. Patients suffering from pharyngitis or pharyngotonsillitis were randomly treated with diclofenac mouthwash or placebo twice a day (morning and evening) for 2-7 days. Clinical signs (tonsillar or pharyngeal edema or swelling, plaques or pus, tonsillar or pharyngeal redness or inflammation, swelling of the lymphatic glands of the neck) were evaluated at the beginning and at the end of treatment. Pharyngeal pain (pharyngodynia) and pain/difficulty on swallowing (odynophagia) were recorded by the patient in a diary card. At the final visit patients expressed an opinion on acceptability and practicality/ease of administration of the drug. Safety was evaluated in 146 patients (72 diclofenac mouthwash and 74 placebo mouthwash), efficacy on symptoms in 141 patients (71 diclofenac and 70 placebo) and efficacy on clinical signs in 138 (69 diclofenac and 69 placebo).
Results. Diclofenac showed very good results on pharyngodynia and odynophagia with a marked statistically significant difference versus placebo. Inflammation/redness, pharyngeal swelling and plaques showed a constantly higher improvement with diclofenac. Acceptability and practicality of the treatment were good in both groups. None adverse reaction was reported.
Conclusions. The study showed the efficacy of diclofenac mouthwash in treating pharyngitis and pharyngotonsillitis. Primary criteria of efficacy were dramatically improved during the treatment with a significant and clear difference in favour of diclofenac mouthwash. In conclusion, diclofenac mouthwash 0.074% administered twice a day is effective and safe in the treatment of pharyngitis and pharyngotonsillitis with high acceptability and practicality of use.