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Vaginal clindamycin and oral metronidazole for bacterial vaginosis: a randomized trial.
Obstet Gynecol. 2000 Aug; 96(2):256-60.OG

Abstract

OBJECTIVE

To compare the efficacy and safety of clindamycin vaginal ovules with oral metronidazole for treatment of bacterial vaginosis.

METHODS

Women with bacterial vaginosis received either 100-mg ovules of clindamycin (intravaginally for 3 consecutive days) plus placebo capsules (orally twice daily for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice daily for 7 days) plus placebo ovules (intravaginally for 3 consecutive days). The sample was determined prospectively to provide a probability of.84 of correctly concluding that the rate of success for clindamycin is not more than 15% less than the expected 75% success rate for metronidazole. Clinical outcome was determined on the basis of vaginal fluid amine odor and clue cells.

RESULTS

Of the 399 patients enrolled, 233 could be evaluated for efficacy. Of those, 77 (68.1%) of 113 patients were cured with clindamycin, compared with 80 (66. 7%) of 120 who were cured with metronidazole (95% confidence interval -10.6%, 13.4%; P =.810). Treatment-related adverse events were reported more frequently in the metronidazole treatment group. Systemic symptoms, such as nausea and taste perversion, accounted for most of the difference between groups.

CONCLUSION

A 3-day regimen of clindamycin, given as intravaginal ovules, was as effective as and better tolerated than a 7-day regimen of oral metronidazole 500 mg, given twice daily, for treatment of bacterial vaginosis.

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Authors+Show Affiliations

Paavonen J
Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland. jpaavone@cc.helsinki.fi
Mangioni C
No affiliation info available
Martin MA
No affiliation info available
Wajszczuk CP
No affiliation info available

MeSH

Administration, IntravaginalAdministration, OralAdolescentAdultAnti-Bacterial AgentsAnti-Infective AgentsClindamycinDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationEuropeFemaleHumansMetronidazoleMiddle AgedVaginosis, Bacterial

Pub Type(s)

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

Language

eng

PubMed ID

10908773

Citation

Paavonen, J, et al. "Vaginal Clindamycin and Oral Metronidazole for Bacterial Vaginosis: a Randomized Trial." Obstetrics and Gynecology, vol. 96, no. 2, 2000, pp. 256-60.
Paavonen J, Mangioni C, Martin MA, et al. Vaginal clindamycin and oral metronidazole for bacterial vaginosis: a randomized trial. Obstet Gynecol. 2000;96(2):256-60.
Paavonen, J., Mangioni, C., Martin, M. A., & Wajszczuk, C. P. (2000). Vaginal clindamycin and oral metronidazole for bacterial vaginosis: a randomized trial. Obstetrics and Gynecology, 96(2), 256-60.
Paavonen J, et al. Vaginal Clindamycin and Oral Metronidazole for Bacterial Vaginosis: a Randomized Trial. Obstet Gynecol. 2000;96(2):256-60. PubMed PMID: 10908773.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vaginal clindamycin and oral metronidazole for bacterial vaginosis: a randomized trial. AU - Paavonen,J, AU - Mangioni,C, AU - Martin,M A, AU - Wajszczuk,C P, PY - 2000/7/26/pubmed PY - 2000/8/29/medline PY - 2000/7/26/entrez SP - 256 EP - 60 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 96 IS - 2 N2 - OBJECTIVE: To compare the efficacy and safety of clindamycin vaginal ovules with oral metronidazole for treatment of bacterial vaginosis. METHODS: Women with bacterial vaginosis received either 100-mg ovules of clindamycin (intravaginally for 3 consecutive days) plus placebo capsules (orally twice daily for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice daily for 7 days) plus placebo ovules (intravaginally for 3 consecutive days). The sample was determined prospectively to provide a probability of.84 of correctly concluding that the rate of success for clindamycin is not more than 15% less than the expected 75% success rate for metronidazole. Clinical outcome was determined on the basis of vaginal fluid amine odor and clue cells. RESULTS: Of the 399 patients enrolled, 233 could be evaluated for efficacy. Of those, 77 (68.1%) of 113 patients were cured with clindamycin, compared with 80 (66. 7%) of 120 who were cured with metronidazole (95% confidence interval -10.6%, 13.4%; P =.810). Treatment-related adverse events were reported more frequently in the metronidazole treatment group. Systemic symptoms, such as nausea and taste perversion, accounted for most of the difference between groups. CONCLUSION: A 3-day regimen of clindamycin, given as intravaginal ovules, was as effective as and better tolerated than a 7-day regimen of oral metronidazole 500 mg, given twice daily, for treatment of bacterial vaginosis. SN - 0029-7844 UR - https://www.unboundmedicine.com/medline/citation/10908773/Vaginal_clindamycin_and_oral_metronidazole_for_bacterial_vaginosis:_a_randomized_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0029-7844(00)00902-9 DB - PRIME DP - Unbound Medicine ER -