Treatment of bacterial vaginosis: a comparison of oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream

Journal of Family Practice, Nov, 1995 by Daron G. Ferris, Mark S. Litaker, Lisa Woodward, Dianne Mathis, Julie Hendrich

Methods

Women were recruited from three clinics, the Family Medicine Center and Student Health Center at The Medical College of Georgia, and the Richmond County Health Department, Augusta, Georgia. Women 15 years of age or older who had symptoms of a vaginal infection (an abnormal or increased vaginal discharge, itching, irritation, or odor) and a clinical or laboratory diagnosis of bacterial vaginosis were enrolled in the study. Bacterial vaginosis was defined as the presence of clue cells in a vaginal specimen and at least two of the following findings: a vaginal discharge, vaginal specimen pH greater than 4.5, or a positive amine test following the addition of 10% potassium hydroxide (KOH) to the specimen.[12] Bacterial vaginosis was also defined as a positive DNA probe test result for G vaginalis (Affirm VPIII, Microprobe, Bothell, Wash) and a pH greater than 4.5.[19] The exclusion criterion was a history of hypersensitivity to metronidazole, parabens, propylene glycol, clindamycin, or mineral oil. Nursing mothers, pregnant women, patients treated for a vaginal infection within 14 days of enrollment, those with coexisting vulvovaginal candidiasis or vaginal trichomoniasis, and patients receiving lithium, anticoagulant therapy, or disulfiram were excluded. Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis were also excluded from the study. Women treated with metronidazole were told to abstain from alcohol ingestion during the treatment phase of the study. Subjects were also encouraged to abstain from sexual intercourse, douching, and using intravaginal products until after the follow-up visit.

Subjects were asked to volunteer for the study if their condition was diagnosed as bacterial vaginosis. The purpose of the study and their involvement was explained to each subject and each gave informed consent.

Following visualization of the vagina with a vaginal speculum, the lateral vaginal walls and adherent discharge were sampled using three swabs. The first swab was placed into a tube containing several drops of normal saline for saline and KOH microscopic examination. The second specimen swab was rolled onto a glass slide for Gram's stain and then rolled across pH paper to determine the vaginal pH. Care was taken to avoid sampling the cervical os, mucus, and the posterior vaginal fornix. The third swab was used to obtain a specimen for DNA testing. Subjects determined to have bacterial vaginosis by the criteria of Amsel and co-workers,[12] or by a positive DNA probe test for G vaginalis plus a pH greater than 4.5,[19] were considered eligible for treatment.

Subjects were randomly assigned to one of the three treatment groups, either oral metronidazole 500 mg twice a day for 1 week, or 0.75% metronidazole vaginal gel (Curatek Pharmaceuticals, Elk Grove Village, Ill) 5 g twice a day for 5 days, or 2% clindamycin phosphate vaginal cream (Upjohn Pharmaceutical Company, Kalamazoo, Mich) 5 g once a day for 7 days. Subjects were given a drug diary log to record each dose, written instructions and illustrations of proper drug dosing, and a return appointment for follow-up testing.