Comparing the effect of sucrose gel and metronidazole gel in treatment of clinical symptoms of bacterial vaginosis: a randomized controlled trial

Abstract

BackgroundLactobacilli, as normal vaginal flora, have a central role in controlling body environment and preventing the growth of pathogens. Sucrose, by promoting the growth of Lactobacilli, accelerates the suppression of pathogenic bacteria. The aim of this research was to compare the effects of sucrose gel with those of metronidazole gel in treating women with bacterial vaginosis (BV).MethodsThis triple-blind clinical trial (IRCT2016112631105N1) was conducted with 70 sexually active, premenopausal women diagnosed with bacterial vaginosis through meeting at least three out of four Amsel criteria. The subjects were randomly divided into two groups of 35 patients, one group treated with sucrose vaginal gel, and the other with metronidazole vaginal gel. The treatment period was 14 days for each group. At the end of the treatment period, the status of each woman’s improvement was determined by elimination at least three out of four Amsel criteria (homogeneous vaginal discharge, presence of clue cells > 20%, positive whiff test and vaginal pH value > 4.5), and clinical complaints and reported side effects of medication were recorded for the patients. Data were analyzed using the t test, chi-squared test and McNemar’s test).ResultsThe sucrose vaginal gel and metronidazole vaginal gel were not significantly different in reducing patients’ clinical complaints or in elimination at least three out of four of the Amsel criteria that were positive before treatment. With an 85.7% improvement rate with sucrose gel and an 88.5% improvement rate with metronidazole gel, the differences in therapeutic response were not significant, and neither was statistically different in improving the disease (p = 0.389).ConclusionIt seems that sucrose vaginal gel might be considered a possible alternative to metronidazole vaginal gel in the treatment of bacterial vaginosis.Trial registrationIranian Registry of Clinical Trials, IRCT2016112631105N1. Registered on 27 December 2016.

Longitudinal profiling of the macaque vaginal microbiome reveals similarities to diverse human vaginal communities: implications for use as a pre-clinical model for bacterial vaginosis

“…Despite previously reported positive results for this intervention(22,23), we found no clinical or microbial indications of improvement. In our hands, intravaginal sucrose gel did not lower vaginal pH, Nugent scores, or Amsel criteria positivity.…”

“…Clinical trials are currently underway to test the use of intravaginal Lactose (NTC03878511), Glucose (NCT03357666), and Glycogen (NCT02042287) to treat BV symptoms. Sucrose in particular has shown potential for improving clinical markers of BV in humans (22) and shifting the VM of rhesus macaques (23). However, the clinical study only examined changes in clinical symptoms and Amsel criteria at one-time point after 14 days of treatment and did not interrogate changes in microbial communities (22).…”

“…Sucrose in particular has shown potential for improving clinical markers of BV in humans (22) and shifting the VM of rhesus macaques (23). However, the clinical study only examined changes in clinical symptoms and Amsel criteria at one-time point after 14 days of treatment and did not interrogate changes in microbial communities (22). The preclinical study in macaques utilized animals with a vaginal microbial community that had >1% Lactobacillus; did not identify the Lactobacillus species present; nor did it report individual animal data (23).…”

Promising Drug Delivery Approaches to Treat Microbial Infections in the Vagina: A Recent Update

“…Results indicated no significance difference in the effectiveness of both the gels. This trial opens the new possibility of BV treatment compared to conventional treatment [169]. Similarly, the safety and efficacy of boric acid-based vaginal gel (TOL-463) was investigated for the treatment of BV with enhanced antibiofilm activity.…”

A review of current guidelines and research on the management of sexually transmitted infections in adolescents and young adults

“…A triple-blind trial on sucrose vaginal gel compared with metronidazole gel found no difference in the reduction of clinical complaints or elimination of Amsel criteria. 101 A study of 189 women with BV evaluating a higher dose metronidazole gel (1.3%) for 1, 3, and 4 days compared with standard 5-day treatment with metronidazole gel (0.75%) found that treatment with 1.3% gel demonstrated similar efficacy, safety and tolerability compared with treatment with 0.75% gel. 102 …”