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

Results

One hundred one women were enrolled and randomizcd to receive one of three pharmaceutical agents. Twelve subjects failed to return for the test-of-cure visit, two subjects took their medication inappropriately, one subject discontinued the medication because of an allergic reaction, two subjects discontinued the medication for medical reasons, and two subjects discontinued medication because of pregnancy. Seven subjects reported no symptoms at the beginning of the study. Three subjects who had been initially enrolled by clinicians were later excluded from the data analysis because of coexisting vulvovaginal candidiasis or vaginal trichomoniasis discovered after confirmatory microscopic examination by the medical technician. Seventy-two subjects were considered evaluable: 19 treated with oral metronidazole, 24 treated with metronidazole vaginal gel, and 29 treated with clindamycin vaginal cream. There was no statistically significant difference in the proportion of subjects who completed therapy among the three cohorts ([X.sup.2]=4.516, df=2, P=.105).

The mean age of subjects was 28.6 (standard deviation [SD]=9.135) years with a range of 15 to 60 years. The three treatment groups did not differ significantly with regard to age, history of bacterial vaginosis, vulvovaginal candidiasis or vaginal trichomoniasis, presenting vaginal symptoms (itching, irritation, odor, abnormal discharge, or increased discharge), or study compliance.

The cure rates were 86.2% for clindamycin vaginal cream, 75.0% for metronidazole vaginal gel, and 84.2% for oral metronidazole. As shown in Table 1, the three medications did not differ significantly in clinical cure rate (Amsel's criteria) (P=.548), Gram's stain cure rate (P=. 168), or DNA criteria for cure (P=. 823). The effective cure rates were lower when based on Gram's stain criteria and even lower when based on DNA and pH criteria. The mean interval from treatment initiation to test of cure was 24.5 days for oral mctronidazole, 20.0 days for metronidazole vaginal gel, and 26.6 days for clindamycin vaginal cream (P=.125).

[TABULAR DATA 1 OMITTED]

Several bacterial vaginosis signs and symptoms resolved or improved following treatment (Table 2). There were significant improvements in clinician-observed and patient-observed vaginal discharge for women treated with oral metronidazole and clindamycin vaginal cream. A significant reduction in clue cells and amine odor detected by the laboratory technician was noted for all three medications. There was also a significant resolution of overall symptoms noted in all three cohorts following treatment. No significant differences were observed in the reported vaginal pH or in the symptoms of itching, irritation, or patient-reported odor after therapy with any of the three medications analyzed separately. When the medications were jointly considered, however, significant improvement in all clinical signs and symptoms except for vaginal pH were observed following treatment (Table 3).