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Effectiveness of Two Tinidazole Regimens in Treatment of Bacterial Vaginosis: A Randomized Controlled Trial

Livengood, Charles H. III MD; Ferris, Daron G. MD; Wiesenfeld, Harold C. MD, CM; Hillier, Sharon L. PhD; Soper, David E. MD; Nyirjesy, Paul MD; Marrazzo, Jeanne MD, MPH; Chatwani, Ashwin MD; Fine, Paul MD; Sobel, Jack MD; Taylor, Stephanie N. MD; Wood, Lindsey PhD; Kanalas, John J. PhD

doi: 10.1097/01.AOG.0000275282.60506.3d
Original Research

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

Tinidazole administered orally provides effective treatment for bacterial vaginosis when rigorous requirements for cure are applied.

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.

Funded by Mission Pharmacal Company, San Antonio, Texas.

Corresponding author: Charles H. Livengood III, MD, Room 242 Baker House, Box 3291 Duke Hospital, Durham, NC 27710; e-mail: liven001@mc.duke.edu.

Financial Disclosure All authors received financial support from Presutti Labs, now Mission Pharmacal Co, for their contributions to this trial. Dr. Livengood provides clinical trial support to Merck Pharmaceuticals (Whitehouse Station, NJ), Curatek Pharmaceuticals (Elk Grove Village, IL), and Amgen (Thousand Oaks, CA). Dr. Ferris has received grant support from Curatek and 3M Pharmaceuticals (St. Paul, MN) for clinical trials, and was also a speaker. Dr. Wiesenfeld is on the Speaker's Bureau for 3M Pharmaceuticals and GlaxoSmithKline (Research Triangle Park, NC), serves as a consultant to K-V Pharmaceuticals (St. Louis, MO), performs research under contract with Mission Pharmacal Co, and is a speaker for Merck Pharmaceuticals. Dr. Hillier attended an advisory board meeting for and received an honorarium from Mission Pharmacal. Dr. Soper serves on the advisory board for Mission Pharmacal and received grant support for participating in this study. Dr. Nyirjesy has given talks for and received an honorarium from Mission Pharmacal, as well as consulted for and received honoraria from K-V Pharmaceuticals. Dr. Marrazzo is a consultant for TherRx, Quidel, and Mission Pharmacal. Dr. Sobel consulted for and received an honorarium from Mission Pharmacal. Dr. Wood was the director of this study as an employee of Presutti Laboratories and is a consultant to Mission Pharmacal. Dr. Kanalas is an employee of Mission Pharmacal. Drs. Chatwani, Fine, and Taylor have no other potential conflicts of interest to disclose.

© 2007 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.