A pilot clinical trial comparing an acid‐buffering formulation (ACIDFORM gel) with metronidazole gel for the treatment of symptomatic bacterial vaginosis

Abstract

AimTo compare the effectiveness of an acid-buffering formulation gel (ACIDFORM) with metronidazole gel in the treatment of symptomatic bacterial vag inosis (BV). MethodsAfter a confirmed diagnosis of BV according to the criteria established by Nugent and Amsel, 30 nonpregnant women were enrolled in a randomized, double-blind clinical study. The women were randomly assigned to receive either 5 g ACIDFORM gel ( n = 13) or 10% metronidazole gel ( n = 17) intravaginally once daily for five consecutive days. Participants were evaluated in two follow-up visits (7-12 days and 28-35 days after treatment). Therapeutic success was defined as the presence of less than three of Amsel's criteria. If three or more criteria were present at first or second follow-up visit, the woman was excluded from the study and treated orally with metronidazole. Nugent scores were recorded at each visit but these were not used to define cure. ResultsAt the first follow-up visit, 15 (88%) of the women in the metronidazole group were cured compared with only three (23%) in the ACIDFORM group ( P < 0.001). The remaining 12 women (10 of the ACIDFORM group and two of the metronidazole group) were considered as failure and were treated orally with metronidazole. At the second follow-up visit, two of the ACIDFORM-treated women and six of the metronidazole-treated women presented recurrent BV. Four women in the ACIDFORM group and one in the metronidazole group reported occasional burning and itching during product use. ConclusionACIDFORM gel was significantly less effective than high-dose metronidazole gel for the treatment of symptomatic BV.

Randomized clinical trial comparing the efficacy of the vaginal use of metronidazole with a Brazilian pepper tree (Schinus) extract for the treatment of bacterial vaginosis

“…However, it is well known that only a very small percentage of women are able to precisely identify the symptoms of bacterial vaginosis (25). The same is true regarding low rates of persistence of the main symptoms of bacterial vaginosis (14,25).…”

“…The length of follow-up is probably the most important variable in evaluating the effectiveness of any treatment for bacterial vaginosis (14). Cure measurements made just after concluding the treatment show higher cure rates (80-90%) than those made 1 month or more after treatment (60-70%) (16,17).…”

“…The clinical criteria evaluated were: white or grayish genital discharge, pH higher than 4.5, positive findings from the amine test (whiff test), or presence of clue cells at proportions of 20% or more on Gram-stained slides. Regarding bacteriological evaluation, patients needed to present a score ≥7 relative to the sum of the bacterial morphological types found in Gram-stained smears from vaginal secretions that were analyzed according to the criteria of Nugent et al (1,13,14).…”

New strategies for local treatment of vaginal infections

“…Polycarbophil, in particular, has been widely used for its bioadhesive properties especially after have an interesting buffer role for vaginal pH, this latter product failed to achieve an effectiveness rate similar to that of metronidazole when tested for the treatment of symptomatic VB [59].…”

Polyethylene Glycol-Based Hydrogels for Controlled Release of the Antimicrobial Subtilosin for Prophylaxis of Bacterial Vaginosis

“…Therefore, alternative options for the prophylaxis and treatment of BV, such as oral/vaginal administration of probiotics and vaginal acidification, are being explored (23)(24)(25)(26)(27). In addition, vaginal microbicide formulations designed for the prevention of HIV are currently being examined for their inhibitory effect on BVassociated pathogens given the significant correlation between BV and HIV incidence (28)(29)(30). The phase I safety trial of a microbicide candidate, BufferGel, showed a reduction in the incidence of BV from 30% at enrollment to 6% after 1 week (28).…”