Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: A randomized controlled trial

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

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)302-309
Number of pages8
JournalObstetrics and Gynecology
Volume110
Issue number2 I
DOIs
StatePublished - Aug 1 2007

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Tinidazole
Bacterial Vaginosis
Randomized Controlled Trials
Numbers Needed To Treat
Placebos
Therapeutics
Vaginal Discharge
Gynecological Examination
United States Food and Drug Administration
Compliance
Epithelial Cells
Clinical Trials
Interviews
Safety

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis : A randomized controlled trial. / Livengood, Charles H.; Ferris, Daron Gale; Wiesenfeld, Harold C.; Hillier, Sharon L.; Soper, David E.; Nyirjesy, Paul; Marrazzo, Jeanne; Chatwani, Ashwin; Fine, Paul; Sobel, Jack; Taylor, Stephanie N.; Wood, Lindsey; Kanalas, John J.

In: Obstetrics and Gynecology, Vol. 110, No. 2 I, 01.08.2007, p. 302-309.

Research output: Contribution to journalArticle

Livengood, CH, Ferris, DG, Wiesenfeld, HC, Hillier, SL, Soper, DE, Nyirjesy, P, Marrazzo, J, Chatwani, A, Fine, P, Sobel, J, Taylor, SN, Wood, L & Kanalas, JJ 2007, 'Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: A randomized controlled trial', Obstetrics and Gynecology, vol. 110, no. 2 I, pp. 302-309. https://doi.org/10.1097/01.AOG.0000275282.60506.3d
Livengood, Charles H. ; Ferris, Daron Gale ; Wiesenfeld, Harold C. ; Hillier, Sharon L. ; Soper, David E. ; Nyirjesy, Paul ; Marrazzo, Jeanne ; Chatwani, Ashwin ; Fine, Paul ; Sobel, Jack ; Taylor, Stephanie N. ; Wood, Lindsey ; Kanalas, John J. / Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis : A randomized controlled trial. In: Obstetrics and Gynecology. 2007 ; Vol. 110, No. 2 I. pp. 302-309.
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abstract = "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.",
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T1 - Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis

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AU - Livengood, Charles H.

AU - Ferris, Daron Gale

AU - Wiesenfeld, Harold C.

AU - Hillier, Sharon L.

AU - Soper, David E.

AU - Nyirjesy, Paul

AU - Marrazzo, Jeanne

AU - Chatwani, Ashwin

AU - Fine, Paul

AU - Sobel, Jack

AU - Taylor, Stephanie N.

AU - Wood, Lindsey

AU - Kanalas, John J.

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N2 - 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.

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