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Dequalinium Chloride Found Noninferior to Metronidazole for BV Treatment

ReachMD Healthcare Image
05/13/2024
contemporaryobgyn.net

Dequalinium chloride found noninferior to metronidazole for BV treatment | Image Credit: © Arif Biswas - © Arif Biswas - stock.adobe.com.

Dequalinium chloride and metronidazole have similar efficacy for treating bacterial vaginosis (BV), according to a recent study in Jama Network Open.1

Takeaways

  1. Dequalinium chloride showed noninferiority to metronidazole in treating bacterial vaginosis (BV), with similar clinical cure rates observed in both groups.
  2. Dequalinium chloride presents itself as a viable alternative to metronidazole for BV treatment, offering a potential reduction in antibiotic consumption.
  3. Both treatments demonstrated high adherence rates, with over 90% of patients adhering to the prescribed regimen, highlighting the feasibility of both options in clinical practice.
  4. Patients in both groups experienced a similar mean time to resolution of clinical symptoms, suggesting comparable effectiveness in symptom management.
  5. Dequalinium chloride exhibited favorable tolerability compared to metronidazole, as indicated by lower rates of reported tolerability issues, emphasizing its potential as a well-tolerated treatment option for BV.

BV is a common source of vaginal infection in reproductive-aged women, with characteristics including a “fishy” smell, vaginal discharge, vaginal pH above 4.5, and clue cells. Metronidazole and clindamycin are common fast-line treatments for BV, having a 1- to 4-week cure rate of 55% to 90%, but also a 6-month recurrence rate of 30% to 70%.

Despite the high recurrence rate, metronidazole is recommended by the Centers for Disease Control and Prevention (CDC) for the treatment of BV.2 The CDC recommends 500 mg oral treatment twice per day for 7 days or administration of a metronidazole 0.75% gel intravaginally once per day for 5 days.

Dequalinium chloride has been proposed as an alternative treatment method with a large body of safety and efficacy data.1 Since this treatment adsorbs into the cell surface, it is unlikely to encounter resistance.

To determine the efficacy of dequalinium chloride vs metronidazole for treating BV, investigators conducted a noninferiority randomized clinical trial. Participants included premenopausal women aged 18 years and older with BV, which could also be determined by a Nugent score of 7 or higher.

Exclusion criteria included uterine bleeding, candidiasis, erosions of the vaginal mucosa or cervix, sexually transmitted infections, aerobic vaginitis, hypersensitivity to a study medication, severe system diseases, vaginal medication in the past 7 days, lactation, and inability or refusal to follow the study procedure.

Participants underwent a pregnancy test and gynecologic examination to obtain samples necessary for clue cell evaluation. Following randomization, patients began treatment using their assigned medical kit. Recorded data included demographics, somatometrics, medications, and medical history.

Dequalinium chloride was administered as 10-mg vaginal tablets, while metronidazole was administered as 500-mg oral tablets. Vaginal tablets were taken once per day for 6 days and oral tablets twice per day for 7 days. Patients completed follow-up visits at days 7 to 11 and days 20 to 40 after treatment initiation.

A noninferiority margin within 15% for clinical cure rates between dequalinium chloride and metronidazole was considered the primary objective of the analysis. Secondary measures included clinical cure rate, bacteriologic cure rate, therapeutic cure rate, efficacy and tolerability, clinical improvement, time to symptom resolution, recurrence, and safety.

There were 151 participants included in the final analysis, 73 of whom were in the dequalinium chloride group and 78 in the metronidazole group. BV by Nugent score was reported in 54.2% of the dequalinium chloride group and 54.7% of the metronidazole group.

A normal Nugent score was less common in the dequalinium chloride group vs the metronidazole group. Adherence to treatment was reported in 97.2% and 94.7% of patients in these groups, respectively.

Clinical cure rates in the intention-to treat dequalinium chloride and metronidazole groups at visit 1 were 92.8% and 93.2%, respectively, indicating a difference of -0.5%. In the per-protocol groups, these rates were 93.1% and 90.6%, respectively, indicating a difference of 2.5%. Similar results were reported when judging efficacy based on Amsel criteria.

The dequalinium chloride group had a clinical improvement rate of 88.1% vs 92.9% for the metronidazole group. The mean time to resolution of clinical symptoms in these groups were 6.7 and 6.5 days, respectively.

Of participants in the dequalinium chloride group, 90% rated treatment as good or very good, vs 92.8% of investigators. These rates were 85.2% and 93.2%, respectively, for metronidazole. Tolerability was reported by 60% of the dequalinium chloride group vs 38.9% of the metronidazole group, indicating a statistically significant difference.

These results indicated no inferiority from dequalinium chloride vs metronidazole for BV treatment. Investigators concluded dequalinium chloride may help reduce antibiotic consumption with evidence supporting its efficacy, safety, and tolerability.

References

  1. Raba G, Ďurkech A, Malík T, et al. Efficacy of dequalinium chloride vs metronidazole for the treatment of bacterial vaginosis: A randomized clinical trial. JAMA Netw Open. 2024;7(5):e248661. doi:10.1001/jamanetworkopen.2024.8661
  2. Bacterial vaginosis. Centers for Disease Control of Prevention. Accessed May 9, 2024. https://www.cdc.gov/std/treatment-guidelines/bv.htm

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Schedule27 May 2024