Combined vaginal administration of nystatin, diiodohydroxyquin, and benzalkonium chloride versus oral metronidazole for the treatment of bacterial vaginosis

Abstract

Objective To compare combined vaginal administration of nystatin, diiodohydroxyquin, and benzalkonium chloride versus oral metronidazole for the treatment of bacterial vaginosis (BV). Methods A randomized controlled trial was conducted among women diagnosed with BV using the Amsel criteria (n=90) at a university hospital in Khon Kaen, Thailand, between June 27, 2017, and April 30, 2018. The oral metronidazole group (n=44) received 400 mg of metronidazole, administered three times per day. The combined vaginal tablet group (n=46) received a vaginal suppository once daily, which comprised nystatin (100 000 U), diiodohydroxyquin (100 mg), and benzalkonium chloride (7 mg). Treatment was administered for 7 days in both groups. Follow‐up visits at 14 and 42 days assessed treatment outcomes and adverse effects. Results Remission of BV occurred among 41 (93%) women in the oral metronidazole group and 39 (85%) women in the combined vaginal tablet group. The adjusted relative risk was 0.92 (95% confidence interval 0.80–1.06). The rate of nausea and/or vomiting was significantly higher in the oral metronidazole group than that in the combined vaginal tablet group. Conclusion Treatment efficacy of the combined vaginal tablet versus oral metronidazole was equivalent. Clinical trial registration: TCTR20170627001 (http://www.clinicaltrials.in.th).

The frequency and duration of side-effects associated with the use of oral metronidazole; A prospective study of VITA trial participants

“…GI related AE were commonly reported which is consistent with pharmacovigilance reports 4 and previous studies. 12,13 In addition, we found a high incidence of 14 The association between metronidazole and vaginal irritation is less clear, however, and could also be mediated through the development of thrush or the persistence of BV. The high frequency of reported GI AE may have implications for drug acceptability, adherence and clinical effectiveness.…”

“…GI related AE were commonly reported which is consistent with pharmacovigilance reports 4 and previous studies. 12,13 In addition, we found a high incidence of self-reported thrush (26% [40/155]), likely reflecting MTZ mediated changes to the vaginal flora. 14 The association between metronidazole and vaginal irritation is less clear, however, and could also be mediated through the development of thrush or the persistence of BV.…”

“…This is in contrast to other trials where around a third of women who received MTZ treatment for BV or trichomoniasis reported a sideeffect. 12,13 The higher incidence of side effects seen in our study may reflect recruitment of a specific sub-population of women who had recurrent BV and who may have had more experience in using MTZ and thus more aware of potential AE, and the prospective collection of self-reported data relating to specific symptoms.…”