Clinical trial comparing the activity and efficacy of ibuprofen isobutanolammonium vs Benzydamine hydrochloride, applied as vaginal irrigations, in patients with vaginitis.

This study was conducted on 30 female patients (average age: 40.5 +/- 11 years, age range 19-65), affected by vulval and/or vaginal phlogosis with a prevalence of uterine fibromyomatosis and metrorrhagia of a varied nature. Sixteen patients were affected with vulvitis and 14 with vulvovaginitis. Fifteen patients were assigned to the treatment with Ibuprofen isobutanolammonium and 15 to the treatment with Benzydamine hydrochloride. Both the subjective symptoms (burning and itching) and the objective symptoms (erythema, oedema, exudation) showed a marked reduction as early as the third day of treatment and the comparison between the score at the start of treatment and on day three of the treatment was highly significant in both study groups (p < 0.01). This improvement was, however, more marked in the group of patients treated with ibuprofen isobutanolammonium, where a more rapid reduction of both the subjective and objective symptoms was observed on the third day. This trend, although not as marked as on the third day, was confirmed at the end of the study, on the seventh day.

RCT Entities:   Population Interventions Outcomes