Recurrent bacterial vaginosis: metronidazole versus metronidazole plus combination of chlorhexidine, bromelain, vitamin E and hyaluronic acid

Aim. This study aims at evaluating the effectiveness of combination of metronidazole with vaginal suppositories containing chlorhexidine, bromelain, vitamin E and hyaluronic acid in preventing recurrence of Bacterial Vaginosis (BV) compared with antibiotic therapy alone. Materials and methods. It is a prospective multicentric randomized trial. Three-hundred and ten women, who received diagnosis of BV were enrolled. The patients were visited before and after (T0 and T1) therapy with metronidazole 500 mg orally 1 tb/day per 7 days, and then return control to 30, 90 and 180 days (T2-3-4). All patients found disease-free at T1 were divided into two groups: the study group performed therapy with suppositories containing chlorhexidine, bromelain, vitamin E and hyaluronic acid, 1 suppository/night per 10 nights vaginally, from the 1st day after the menstrual cycle and repeated for three cycles (group A); the control group had no further therapy (group B). In addition, in occasion of follow-up visits (T2-3-4), a self-evaluation questionnaire was administered, to evaluate the subjective perception of their pathophysiologic condition. The primary outcome was the recurrence rate of BV measured during three months of therapy with suppositories and three-month of follow-up. Secondary outcome was the quality of life of patients. Success is defined as the absence of relapses during treatment and followup periods. Data are presented as absolute frequency (percentage) and mean +/- SD (standard deviation). The analysis includes a chi-square test to compare the results in the two treatment groups and a Student's t-test to compare the results of the questionnaire. The analysis of all the data follows the principle of "intention to treat" and level of significance was set for p < 0.05. Results. In total, regarding group A, out of 140 patients enrolled, 16 (11.5%) resulted lost to follow-up (LFU) and 12 (8.5%) were excluded from the study; out of 112 (80%) remaining, 70 (62.5%) did not present signs and symptoms of relapse, 42 (37.5%) instead experienced new episodes of BV. Instead, with regard to group B, out of 137 patients enrolled, 13 (9.5%) were LFU, and 11 (8%) were excluded; out of 113 (82.5%) remaining, 55 (48.6%) had no relapse of BV, in contrast to 58 (51.4%) other women who became again ill. Data from the self-assessment questionnaire show a result clearly in favor of the study group for all analyzed domains. Conclusions. Treatment with suppositories containing chlorhexidine, bromelain, vitamin E and hyaluronic acid, after metronidazole, is advantageous compared with metronidazole therapy alone in terms of recurrence rate. Certainly beneficial is the finding of significant appreciation for patients regarding quality of life, being essential for every woman in everyday life to preserve a state of intimate well-being. These data will be confirmed in further placebo-controlled studies, as well as evaluated over a wide follow-up period. Further studies are needed to get more in depth reasons of such a wide occurrence of this pathological condition, as well as to develop therapeutic strategies increasingly targeted.