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

Subjects were asked to return 7 to 14 days after initiation of treatment for questioning, re-examination, and vaginal specimen testing. Treatment compliance was verified verbally and by review of the drug diary log. A questionnaire including a 5-point Likert-type scale was used to record each patient?s satisfaction with her respective medication. Persistent vaginal symptoms, complications, side effects, and general comments were noted. A brief vaginal examination was performed, and vaginal specimens were obtained for test-of-cure analyses. The same diagnostic tests as those performed initially were then processed. Clinical treatment failure was defined as the persistence of two of the following: clue cells, a creamy adherent vaginal discharge, pH greater than 4.5, or a positive amine test. DNA treatment failure was defined as a positive DNA probe test for G vaginalis plus a pH greater than 4.5.

The DNA probe test is a combination of nucleic acid probes for the detection of G vaginalis, Trichomonas vaginalis, and Candida species. A trained and proficient medical technician prepared and processed the test and interpreted the results per the manufacturer's protocol in a fashion similar to methods previously described.[20,21] Vulvovaginal candidiasis by DNA was defined as the presence of a blue color on the PAC for Candida species.

The saline wet mount was prepared by combining a small amount of vaginal discharge specimen with one drop of normal saline, covering it with a cover slip, and examining it by light microscope for the presence of clue cells, trichomonads (motile protozoan organisms with flagella), pseudohyphae, leukocytes, and Lactobacillus sp.

The KOH test was performed by combining a small vaginal specimen with 10% KOH on a glass slide. The fluid was immediately evaluated for the presence of a fishy odor indicative of a positive amine or "sniff" test result. A cover slip was positioned and the specimen was then examined for fungal elements under high power of the light microscope. The presence of pseudohyphae or buds defined vulvovaginal candidiasis.

The pH determination was made following the application of the vaginal discharge specimen on pH paper (MicroEssential Laboratory, Inc, Brooklyn, NY) with a pH range of 3.0 to 5.5. The resulting colormetric reaction was compared with the corresponding pH reference scale to determine the vaginal pH.

The Gram's stain was prepared by rolling a small amount of vaginal specimen on a glass slide, heat-fixing, and then processing by the Gram's stain technique. A medical technician and a medical technologist independently interpreted the smears for the presence of microorganisms, clue cells, trichomonads, and pseudohyphae. Discordant interpretations were adjudicated by a third individual. The Gram's stain definition of bacterial vaginosis was the presence of squamous epithelial cells covered by adherent bacteria.

The proportion of cured subjects was compared between treatment groups by the chi-square test. For contingency tables with cells having expected counts of less than 5, the likelihood ratio chi-square statistic was used for tables larger than 2 X 2 and Fisher's exact test was used for 2 X 2 tables. Each subject's symptoms at the beginning and follow-up of the study were compared using the McNemar's test. Mean age of subjects was compared between treatment groups by analysis of variance. The time interval from treatment initiation to follow-up was compared between groups using the Kruskal-Wallis test.