The outcomes of a randomized managed trial performed in Europe point out {that a} widespread bacterial an infection in girls might be handled with out antibiotics.
The trial investigated the efficacy of the broad-spectrum antiseptic dequalinium chloride for treating bacterial vaginosis (BV), which impacts an estimated 25% of reproductive-age girls and has a excessive recurrence fee attributed to bacterial biofilm. The usual remedies are the antibiotics clindamycin and metronidazole.
The outcomes, revealed yesterday in JAMA Community Open, confirmed that compared with metronidazole, dequalinium chloride was not solely noninferior but in addition had higher tolerability and fewer hostile occasions. The investigators additionally observe that whereas dequalinium chloride has been in the marketplace for 30 years, there aren’t any reviews of clinically related resistance.
“Dequalinium chloride may assist cut back antibiotic consumption and thus warrants consideration as first-line remedy for BV as a result of its broad spectrum, efficacy, security, tolerability, and fewer chance of resistance,” the research authors wrote.
Equally efficient, extra tolerable than antibiotics
The section 4 trial enrolled girls aged 18 and older with symptomatic BV from 11 gynecology practices and 1 hospital in Poland, the Czech Republic, and Slovakia from July 29, 2021, to August 25, 2022, with a 1-month follow-up. Sufferers had been randomized 1:1 to obtain dequalinium chloride vaginal tablets (10 mg as soon as day by day for six days) or oral metronidazole (500 mg day by day for 7 days).
The first consequence measure was a noninferiority margin of 15 share factors within the absolute distinction in scientific remedy charges between dequalinium chloride and metronidazole 7 to 11 days after remedy within the intention-to-treat (ITT) and per-protocol (PP) populations. Investigators additionally assessed tolerability and security.
Of the 147 girls (imply age, 36.7 years) enrolled within the trial, 72 had been handled with dequalinium chloride and 75 with metronidazole. The scientific remedy fee within the ITT inhabitants was 64 of 69 (92.8%) within the dequalinium chloride group and 69 of 74 (93.2%) within the metronidazole group, with an absolute distinction in remedy charges of –0.5 share factors (95% confidence interval [CI], –10.8% to 9.8%).
Dequalinium chloride may assist cut back antibiotic consumption and thus warrants consideration as first-line remedy for BV as a result of its broad spectrum, efficacy, security, tolerability, and fewer chance of resistance.
Within the PP inhabitants, the scientific remedy charges had been 54 of 58 (93.1%) for the dequalinium chloride group and 48 of 53 (90.6%) within the metronidazole group, with an absolute distinction of two.5 share factors (95% CI, –9.4 to 14.4 share factors).
“These outcomes verify the noninferiority of dequalinium chloride,” the authors wrote.
Evaluation at a second go to 20 to 40 days after remedy discovered that the remedy charges had been decrease for each remedies (79.7% vs 87.3%), however dequalinium chloride remained noninferior.
Thirty of fifty (60%) sufferers rated the tolerability of dequalinium chloride as superb, in contrast with solely 21 of 54 (38.9%) sufferers who acquired metronidazole. Therapy-emergent hostile occasions had been reported by 8 sufferers within the dequalinium chloride group and 15 within the metronidazole group. None had been thought of severe, however three sufferers handled with metronidazole suspended remedy as a result of hostile occasions.
Different remedies wanted
The trial is the second to search out that dequalinium chloride is noninferior to the first-line antibiotic remedies for BV. An earlier trial discovered it was as efficient as clindamycin. Though it isn’t authorised by the US Meals and Drug Administration, dequalinium chloride has been utilized in Europe for many years and is really helpful by worldwide and European tips instead remedy for BV.
In a commentary that accompanies the research, researchers from the College of Maryland College of Drugs and the Johns Hopkins College College of Drugs say the findings from the 2 trials counsel dequalinium chloride might be a much-needed various remedy for BV. However they spotlight three vital proof gaps.
The primary is that the 2 trials had been performed in Europe, and vaginal microbiota composition and response to dequalinium chloride might differ regionally. The second is the dearth of long-term information on BV recurrence following remedy with dequalinium chloride. Lastly, information on the protection of intravaginal dequalinium chloride in pregnant girls is proscribed.
They name for strong scientific trials to assist fill these gaps and increase remedy choices.
“It’s crucial that we increase the toolkit of obtainable BV remedies,” the authors wrote. “Alternate options which can be no less than as efficient as nitroimidazoles and clindamycin could be welcome additions. Therapies that impact a long-lasting remedy could be paradigm-shifting.”