Dequalinium Is Noninferior to Metronidazole for Bacterial Vaginosis

Is dequalinium (not available in the United States) noninferior to metronidazole (Flagyl) for the treatment of bacterial vaginosis?

The study found that dequalinium is noninferior to metronidazole for the treatment of bacterial vaginosis. Patients who used dequalinium reported better tolerability and fewer adverse events than those treated with metronidazole. (Level of Evidence = 1b)

The recurrence rate of bacterial vaginosis within 6 months of treatment with metronidazole or clindamycin is 30% to 70%. Dequalinium is a broad-spectrum antiseptic that is effective against gram-positive and gram-negative bacteria. The investigators identified 147 women 18 years or older who were diagnosed with bacterial vaginosis using the Amsel criteria. Eligible patients randomly received dequalinium vaginal tablets, 10 mg/day for 6 days, or metronidazole oral tablets, 500 mg two times/day for 7 days. Double-dummy medication kits were used to mask patients, clinicians, and outcome assessors to group assignments. Complete follow-up occurred for 97.4% of participants at 7 to 11 days (visit 1) and 20 to 40 days (visit 2).

Using intention-to-treat analysis, clinical cure (defined as the resolution of vaginal discharge, a negative whiff test, and an absence of clue cells on microscopy at both visits) occurred similarly in the dequalinium group and metronidazole group at visit 1 (92.8% vs 93.2%, respectively) and visit 2 (79.7% vs 87.3%, respectively; the difference is not significant). Treatment discontinuation due to adverse events occurred in three patients who were taking metronidazole vs none for those taking dequalinium.

Study design: Randomized controlled trial (double-blinded)

Funding source: Industry

Allocation: Concealed

Setting: Outpatient (primary care)

Reference: Raba G, Durkech A, Malik T, et al.; Fluomizin Study Group. Efficacy of dequalinium chloride vs metronidazole for the treatment of bacterial vaginosis: a randomized clinical trial. JAMA Netw Open. 2024;7(5):e248661.