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Efficacy of clindamycin vaginal cream versus oral metronidazole in the treatment of bacterial vaginosis.
Obstet Gynecol. 1993 Sep; 82(3):405-10.OG

Abstract

OBJECTIVE

To compare the efficacy and tolerance with 2% clindamycin vaginal cream versus oral metronidazole for the treatment of bacterial vaginosis.

METHODS

This was a multicenter, randomized, double-blind study in which patients were randomly assigned to one of the following two regimens in a 1:1 ratio: clindamycin phosphate vaginal cream 2% (5 g intravaginally at bedtime for 7 days) plus two placebo capsules (twice a day for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice a day for 7 days) plus placebo vaginal cream (5 g intravaginally at bedtime for 7 days). The patients were seen for follow-up at 5-10 days and 25-39 days after completion of therapy.

RESULTS

Seven investigators, four in Germany, two in Austria, and one in Switzerland, enrolled 407 patients. Four patients never received either protocol drug, leaving 403 evaluable for safety. Two hundred thirty-four patients were evaluable for efficacy. The analysis for all evaluable patients showed no significant difference between treatment groups. The cure or improvement rate at 1 month after therapy was 83% in the clindamycin group versus 78% in the metronidazole group. The incidence of drug-related adverse medical events was approximately 12% in both groups.

CONCLUSIONS

Oral metronidazole and intravaginal clindamycin cream had a similar efficacy of 78 to 83%. Both drugs were tolerated, with vaginal candidiasis developing in 8.5 and 4.7% of the patients in the clindamycin and metronidazole groups, respectively.

Authors+Show Affiliations

Frauenklinik, TU München, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

8355942

Citation

Fischbach, F, et al. "Efficacy of Clindamycin Vaginal Cream Versus Oral Metronidazole in the Treatment of Bacterial Vaginosis." Obstetrics and Gynecology, vol. 82, no. 3, 1993, pp. 405-10.
Fischbach F, Petersen EE, Weissenbacher ER, et al. Efficacy of clindamycin vaginal cream versus oral metronidazole in the treatment of bacterial vaginosis. Obstet Gynecol. 1993;82(3):405-10.
Fischbach, F., Petersen, E. E., Weissenbacher, E. R., Martius, J., Hosmann, J., & Mayer, H. (1993). Efficacy of clindamycin vaginal cream versus oral metronidazole in the treatment of bacterial vaginosis. Obstetrics and Gynecology, 82(3), 405-10.
Fischbach F, et al. Efficacy of Clindamycin Vaginal Cream Versus Oral Metronidazole in the Treatment of Bacterial Vaginosis. Obstet Gynecol. 1993;82(3):405-10. PubMed PMID: 8355942.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of clindamycin vaginal cream versus oral metronidazole in the treatment of bacterial vaginosis. AU - Fischbach,F, AU - Petersen,E E, AU - Weissenbacher,E R, AU - Martius,J, AU - Hosmann,J, AU - Mayer,H, PY - 1993/9/1/pubmed PY - 1993/9/1/medline PY - 1993/9/1/entrez SP - 405 EP - 10 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 82 IS - 3 N2 - OBJECTIVE: To compare the efficacy and tolerance with 2% clindamycin vaginal cream versus oral metronidazole for the treatment of bacterial vaginosis. METHODS: This was a multicenter, randomized, double-blind study in which patients were randomly assigned to one of the following two regimens in a 1:1 ratio: clindamycin phosphate vaginal cream 2% (5 g intravaginally at bedtime for 7 days) plus two placebo capsules (twice a day for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice a day for 7 days) plus placebo vaginal cream (5 g intravaginally at bedtime for 7 days). The patients were seen for follow-up at 5-10 days and 25-39 days after completion of therapy. RESULTS: Seven investigators, four in Germany, two in Austria, and one in Switzerland, enrolled 407 patients. Four patients never received either protocol drug, leaving 403 evaluable for safety. Two hundred thirty-four patients were evaluable for efficacy. The analysis for all evaluable patients showed no significant difference between treatment groups. The cure or improvement rate at 1 month after therapy was 83% in the clindamycin group versus 78% in the metronidazole group. The incidence of drug-related adverse medical events was approximately 12% in both groups. CONCLUSIONS: Oral metronidazole and intravaginal clindamycin cream had a similar efficacy of 78 to 83%. Both drugs were tolerated, with vaginal candidiasis developing in 8.5 and 4.7% of the patients in the clindamycin and metronidazole groups, respectively. SN - 0029-7844 UR - https://www.unboundmedicine.com/medline/citation/8355942/Efficacy_of_clindamycin_vaginal_cream_versus_oral_metronidazole_in_the_treatment_of_bacterial_vaginosis_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=8355942.ui DB - PRIME DP - Unbound Medicine ER -