A double-blind placebo-controlled trial of single-dose intravaginal versus single-dose oral metronidazole in the treatment of trichomonal vaginitis.

Abstract

Since metronidazole is a mutagen in vitro, there is concern about the widespread systemic use of this drug in women with trichomoniasis, particularly those who are pregnant. A randomized, double-blind, placebo-controlled trial compared a single 2-g intravaginal dose of metronidazole cream with a single 2-g oral dose of metronidazole in patients with a culture positive for Trichomonas organisms. Of the 302 preenrollment cultures completed, 94 (31%) were positive. Sixty-one patients were enrolled in the study. Each received either oral placebo and intravaginal metronidazole or intravaginal placebo and oral metronidazole. Follow-up cultures were done on posttreatment day 3-5. Of the 53 evaluatable patients, 14 (50%) of 28 in the intravaginal group and 22 (88%) of 25 in the oral group were microbiologically cured (P = .0037). Single-dose intravaginal metronidazole is inferior to single-dose oral metronidazole and cannot be relied on as an alternative therapy.

• Authors: B H Tidwell, W B Lushbaugh, M D Laughlin, J D Cleary, R W Finley
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 170 Issue 1 Pg. 242-6 (Jul 1994) ISSN: 0022-1899 [Print] United States
• PMID: 8014510 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Placebos
• Metronidazole

Topics

• Administration, Intravaginal
• Administration, Oral
• Adolescent
• Adult
• Aged
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Metronidazole (administration & dosage, therapeutic use)
• Middle Aged
• Placebos
• Trichomonas Vaginitis (drug therapy)