Vaginal
infection and
inflammation with or without vulvar involvement are very common gynecologicaly clinical conditions associated with morbidity and reduced quality of life. Vaginal
infections are commonly treated with causal antimicrobial treatments. In addition to specific antimicrobial treatment, anti-inflammatory
therapy, both systemic or topical (vaginal douche), could be useful in the integrated treatment approach of these conditions reducing symptoms and speeding up the recovery in
vulvovaginitis.
Ibuprofen is a well-known effective and well-tolerated anti-COX (anti-COX1 and COX2) compound. In addition, several in vitro studies suggest that
Ibuprofen shares antimicrobial and antifungal activities.
Ibuprofen isobutanolammonium (Ib-isb) (Ginenorm) is a soluble
salt from formulation suitable for external and intravaginal use. This
salt completely dissociates in aqueous
solution. Ib-isob is available in sachet and vaginal douche
pharmaceutical formulations. Clinical efficacy of Ib-isob has been documented in 10 clinical studies (6 controlled and 4 open trials) which have enrolled in total 399 women with
vulvovaginitis. The six controlled clinical trials were performed both versus placebo (2 studies) or versus active comparators such as
benzydamine. In these studied, Ib-Isb has been used in general for 7 consecutive days with a twice application daily regimen at the dose of 1 g per application. Topical application of Ib-isob induced a marked and rapid reduction in signs (
erythema, oedema) and symptoms (
itching and burning sensation) of
vulvovaginitis. In head-to-head studies carried out in comparison with other topical products, Ib-isob induced a more rapid reduction in both subjective and objective symptoms. In particular a remarkable significant improvement of all the symptoms has been observed in the group of patients treated with Ib-isob in comparison with women receiving
benzydamine. The clinical data available for Ib-isob confirm that this
salt, specifically developed for gynecological use, is effective and well tolerated in vulvovaginal
inflammation conditions. Efficacy of Ib-isob was greater in comparison with commonly used products.
Ibuprofen-isob may be considered a useful and effective tool for the topical treatment of nonspecific
vaginal diseases.