A recent randomized clinical trial has shed light on the efficacy of dequalinium chloride versus metronidazole in treating bacterial vaginosis.
The study, published in JAMA Network Open, sought to address the need for effective nonantibiotic treatments for bacterial vaginosis (BV) amid antibiotic resistance concerns.
BV is typically treated with antibiotics like metronidazole or clindamycin. However, the high recurrence rates and adverse effects associated with these antibiotics have prompted the search for alternative treatments, according to study investigators led by Grzegorz Raba, MD.
The phase 4 trial, conducted from July 29, 2021, to August 25, 2022, involved 147 premenopausal women from Poland, Slovakia, and the Czech Republic. Participants were randomly assigned to receive either dequalinium chloride vaginal tablets (10 mg per day for 6 days) or oral metronidazole (5600 mg twice a day for 7 days). The study utilized a triple-blind, double-dummy design to ensure impartiality in treatment allocation and assessment.
The primary outcome measured was the noninferiority of dequalinium chloride compared to metronidazole in achieving clinical cure rates 7 to 11 days after the start of treatment. Secondary outcomes included bacteriologic cure rates, therapeutic cure rates, clinical improvement, time to symptom resolution, subjective efficacy, tolerability, recurrence, and safety.
Results indicated that dequalinium chloride was noninferior to metronidazole, with clinical cure rates of over 90% in both treatment groups. Furthermore, dequalinium chloride demonstrated better tolerability and fewer adverse events compared with metronidazole. Notably, none of the adverse events reported for dequalinium chloride were serious, whereas three patients in the metronidazole group suspended treatment due to adverse events.
The findings provide valuable insights into the efficacy and safety of dequalinium chloride as a potential first-line treatment for BV, according to investigators. With its broad spectrum, efficacy, safety profile, and reduced likelihood of resistance, dequalinium chloride presents a promising alternative to conventional antibiotics.
The trial underscores the potential of dequalinium chloride as an effective and well-tolerated treatment option for BV, offering a promising avenue for reducing antibiotic consumption and improving patient outcomes in the management of this common vaginal infection, investigators concluded. Further research and clinical trials are warranted to validate these findings and explore the long-ter
Study limitations included a short follow-up period and a predominantly white European patient population.
The investigators reported having no relevant conflicts of interest.
