Table of Contents
ISRN Obstetrics and Gynecology
Volume 2012, Article ID 183403, 5 pages
http://dx.doi.org/10.5402/2012/183403
Clinical Study

Efficacy and Tolerability of Fitostimoline (Vaginal Cream, Ovules, and Vaginal Washing) and of Benzydamine Hydrochloride (Tantum Rosa Vaginal Cream and Vaginal Washing) in the Topical Treatment of Symptoms of Bacterial Vaginosis

1Department of Obstetrics and Gynecology, University Hospital, 4121 Modena, Italy
2Unità Operativa Complessa del Dipartimento Materno Infantile, Azienda Sanitaria Locale Napoli 1, Distretto Sanitario No. 50, Miano, 80145 Napoli, Italy
3ISPharm s.r.l., Via dei Pubblici Macelli 194, 55100 Lucca, Italy

Received 27 July 2012; Accepted 2 October 2012

Academic Editors: F. M. Reis and K. Yang

Copyright © 2012 F. Boselli et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Two hundred and 91 patients showing signs and symptoms of bacterial vaginosis (BV) were randomized to receive topical treatment with Fitostimoline (vaginal cream and vaginal ovules + vaginal washing) or benzydamine hydrochloride (vaginal cream + vaginal washing) for 7 days. Signs (leucorrhoea, erythema, oedema, and erosion) and symptoms (burning, pain, itching, vaginal dryness, dyspareunia, and dysuria) (scored 0–3) were evaluated at baseline and at the end of treatment; the total symptoms score (TSS) was also calculated. In 125 patients, a bacterial vaginosis was confirmed by vaginal swab test. The primary efficacy variable analysis, that is, the percentage of patients with therapeutic success (almost complete disappearance of signs and symptoms), demonstrated that Fitostimoline ovules and vaginal cream were therapeutically equivalent and that pooled Fitostimoline treatment was not inferior to benzydamine hydrochloride. All the treatments were well tolerated, with only minor local adverse events infrequently reported. The results of this study confirmed that gynaecological Fitostimoline is a safe and effective topical treatment for BV.