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Randomized, single-blinded comparison of efficacy, safety and tolerability of metronidazole 750mg - miconazole 200mg vaginal suppository vs. metronidazole 500mg - nystatin 100,000 IU vaginal suppository in the treatment of bacterial vaginosis, vulvovagina

Ma. Stephanie Fay S. Cagayan, MD, FPOGS; Sybil Lizanne R. Bravo, MD, FPOGS; Analyn F. Fallarme, MD, FPOGS; Olive Sison, MSPH; May S. Gabaldon, MD, FPOGS
Department of Obstetrics and Gynecology, Philippine General Hospital

Objective: This randomized, single-blind, two-arm controlled study compared the efficacy, safety, and tolerability of an intravaginal suppository preparation containing metronidazole 750mg + miconazole 200mg (Neopenotran Forte) with another vaginal preparation containing metronidazole 500 mg + nystatin 10000 IU (Flagystatin) in the treatment of bacterial vaginosis (BV), candidal and trichomonial vulvovaginitis (CVV, TV), mixed vaginitis and in the prevention of secondary candidal vulvovaginitis.

Materials and Methods: Women ages 18-45 years with chief complaints of abnormal vaginal discharge or vaginal/vulvar itching were examined and microbiologic confirmation of BV, VVC, TV or mixed infection was made. They were then randomly assigned to receive either treatment once daily (nightly) for 7 days. A total of 261 subjects had evaluable clinical and microbiological findings at the end of the study. Test of cure by Amsel criteria and Nugent score were performed twice after treatment.

Results: The overall test revealed that microbiological cure rate is significantly different between the two treatment groups.

Conclusion: The odds of being cured microbiologically is 2.35 times more in the metronidazole 750mg + miconazole nitrate 200mg group compared to the metronidazole 500 mg + nystatin 10000 IU group. However, no significant difference in the clinical cure between the two groups was found. Both drugs are safe and convenient to use.