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Effectiveness of Two Tinidazole Regimens in Treatment of Bacterial Vaginosis

A Randomized Controlled Trial

From ¹Duke University Medical Center, Durham, North Carolina; ²Medical College of Georgia, Augusta, Georgia; ³University of Pittsburgh School of Medicine/Magee-Women's Research Institute, Pittsburgh, Pennsylvania; ⁴Medical University of South Carolina, Charleston, South Carolina; ⁵Drexel University College of Medicine, Philadelphia, Pennsylvania; ⁶University of Washington, Seattle, Washington; ⁷Temple University College of Medicine, Philadelphia, Pennsylvania; ⁸Planned Parenthood of Houston and Southeast Texas, Houston, Texas; ⁹Wayne State University School of Medicine, Detroit, Michigan; ¹⁰Louisiana State University Health Sciences Center, New Orleans, Louisiana; ¹¹Consultant, Mission Pharmacal Company, San Antonio, Texas; and ¹²Mission Pharmacal Company, San Antonio, Texas.

OBJECTIVE: To assess the effectiveness at 21–30 days after treatment of tinidazole administered orally at 1 g once daily for 5 days and 2 g once daily for 2 days, compared with placebo, in the treatment of bacterial vaginosis, using rigorous U.S. Food and Drug Administration (FDA)–recommended criteria to define cure.

METHODS: A total of 235 women at 10 U.S. centers participated in this prospective, randomized, double-blinded, placebo-controlled trial. Presence or absence of all five following criteria was required to define diagnosis or cure of bacterial vaginosis: 1) clue cells were at least 20% of squamous cells in microscopic examination of vaginal fluid; 2) positive potassium hydroxide whiff test; 3) a homogeneous, thin, white-gray vaginal discharge; 4) vaginal pH greater than 4.5; and 5) Nugent score greater than or equal to 4 on Gram-stained vaginal fluid. Compliance, tolerability, and safety were assessed using patient diaries and interviews at 8–10 days and 21–30 days after treatment. Cochran-Mantel-Haenszel statistical analysis with Bonferroni adjustment was used to compare outcomes.

RESULTS: Superior efficacy was demonstrated by tinidazole for the 1 g once daily for 5 days regimen (36.8% cured, P<.001, number needed to treat 3.2) and for the 2 g once daily for 2 days regimen (27.4% cured, P<.001, number needed to treat 4.5), when compared with placebo (5.1% cured) in the primary endpoint analysis. Using more traditional criteria for cure, efficacy was greater. Compliance with study therapy and tolerability were comparable in the three treatment groups.

CONCLUSION: Both tinidazole regimens studied provided effective treatment for bacterial vaginosis.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00229216

LEVEL OF EVIDENCE: I

This article has been cited by other articles:

				Tinidazole (Tindamax) A New Option for Treatment of Bacterial Vaginosis Obstet. Gynecol., January 1, 2008; 111(1): 208 - 209. [Full Text] [PDF]