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Efficacy of oral metronidazole with vaginal clindamycin or vaginal probiotic for bacterial vaginosis: randomised placebo-controlled double-blind trial.
PLoS One. 2012; 7(4):e34540.Plos

Abstract

BACKGROUND

To determine if oral metronidazole (MTZ-400 mg bid) with 2% vaginal clindamycin-cream (Clind) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol (Prob) reduces 6-month bacterial vaginosis (BV) recurrence.

METHODS

Double-blind placebo-controlled parallel-group single-site study with balanced randomization (1:1:1) conducted at Melbourne Sexual Health Centre, Australia. Participants with symptomatic BV [Nugent Score (NS) = 7-10 or ≥3 Amsel's criteria and NS = 4-10], were randomly allocated to MTZ-Clind, MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months. MTZ and Clind were administered for 7 days and Prob and Placebo for 12 days. Primary outcome was BV recurrence (NS of 7-10) on self-collected vaginal-swabs over 6-months. Cumulative BV recurrence rates were compared between groups by Chi-squared statistics. Kaplan-Meier, log rank and Cox regression analyses were used to compare time until and risk of BV recurrence between groups.

RESULTS

450 18-50 year old females were randomized and 408 (91%), equally distributed between groups, provided ≥1 NS post-randomization and were included in analyses; 42 (9%) participants with no post-randomization data were excluded. Six-month retention rates were 78% (n = 351). One-month BV recurrence (NS 7-10) rates were 3.6% (5/140), 6.8% (9/133) and 9.6% (13/135) in the MTZ-Clind, MTZ-Prob and MTZ-Placebo groups respectively, p = 0.13. Hazard ratios (HR) for BV recurrence at one-month, adjusted for adherence to vaginal therapy, were 0.43 (95%CI 0.15-1.22) and 0.75 (95% CI 0.32-1.76) in the MTZ-Clind and MTZ-Prob groups compared to MTZ-Plac respectively. Cumulative 6-month BV recurrence was 28.2%; (95%CI 24.0-32.7%) with no difference between groups, p = 0.82; HRs for 6-month BV recurrence for MTZ-Clind and MTZ-Prob compared to MTZ-Plac, adjusted for adherence to vaginal therapy were 1.09(95% CI = 0.70-1.70) and 1.03(95% CI = 0.65-1.63), respectively. No serious adverse events occurred.

CONCLUSION

Combining the recommended first line therapies of oral metronidazole and vaginal clindamycin, or oral metronidazole with an extended-course of a commercially available vaginal-L.acidophilus probiotic, does not reduce BV recurrence.

TRIAL REGISTRATION

ANZCTR.org.au ACTRN12607000350426.

Authors+Show Affiliations

Melbourne School of Population Health, University of Melbourne, Melbourne, Australia. cbradshaw@mshc.org.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

22509319

Citation

Bradshaw, Catriona S., et al. "Efficacy of Oral Metronidazole With Vaginal Clindamycin or Vaginal Probiotic for Bacterial Vaginosis: Randomised Placebo-controlled Double-blind Trial." PloS One, vol. 7, no. 4, 2012, pp. e34540.
Bradshaw CS, Pirotta M, De Guingand D, et al. Efficacy of oral metronidazole with vaginal clindamycin or vaginal probiotic for bacterial vaginosis: randomised placebo-controlled double-blind trial. PLoS One. 2012;7(4):e34540.
Bradshaw, C. S., Pirotta, M., De Guingand, D., Hocking, J. S., Morton, A. N., Garland, S. M., Fehler, G., Morrow, A., Walker, S., Vodstrcil, L. A., & Fairley, C. K. (2012). Efficacy of oral metronidazole with vaginal clindamycin or vaginal probiotic for bacterial vaginosis: randomised placebo-controlled double-blind trial. PloS One, 7(4), e34540. https://doi.org/10.1371/journal.pone.0034540
Bradshaw CS, et al. Efficacy of Oral Metronidazole With Vaginal Clindamycin or Vaginal Probiotic for Bacterial Vaginosis: Randomised Placebo-controlled Double-blind Trial. PLoS One. 2012;7(4):e34540. PubMed PMID: 22509319.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of oral metronidazole with vaginal clindamycin or vaginal probiotic for bacterial vaginosis: randomised placebo-controlled double-blind trial. AU - Bradshaw,Catriona S, AU - Pirotta,Marie, AU - De Guingand,Deborah, AU - Hocking,Jane S, AU - Morton,Anna N, AU - Garland,Suzanne M, AU - Fehler,Glenda, AU - Morrow,Andrea, AU - Walker,Sandra, AU - Vodstrcil,Lenka A, AU - Fairley,Christopher K, Y1 - 2012/04/03/ PY - 2011/11/27/received PY - 2012/03/01/accepted PY - 2012/4/18/entrez PY - 2012/4/18/pubmed PY - 2012/8/21/medline SP - e34540 EP - e34540 JF - PloS one JO - PLoS One VL - 7 IS - 4 N2 - BACKGROUND: To determine if oral metronidazole (MTZ-400 mg bid) with 2% vaginal clindamycin-cream (Clind) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol (Prob) reduces 6-month bacterial vaginosis (BV) recurrence. METHODS: Double-blind placebo-controlled parallel-group single-site study with balanced randomization (1:1:1) conducted at Melbourne Sexual Health Centre, Australia. Participants with symptomatic BV [Nugent Score (NS) = 7-10 or ≥3 Amsel's criteria and NS = 4-10], were randomly allocated to MTZ-Clind, MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months. MTZ and Clind were administered for 7 days and Prob and Placebo for 12 days. Primary outcome was BV recurrence (NS of 7-10) on self-collected vaginal-swabs over 6-months. Cumulative BV recurrence rates were compared between groups by Chi-squared statistics. Kaplan-Meier, log rank and Cox regression analyses were used to compare time until and risk of BV recurrence between groups. RESULTS: 450 18-50 year old females were randomized and 408 (91%), equally distributed between groups, provided ≥1 NS post-randomization and were included in analyses; 42 (9%) participants with no post-randomization data were excluded. Six-month retention rates were 78% (n = 351). One-month BV recurrence (NS 7-10) rates were 3.6% (5/140), 6.8% (9/133) and 9.6% (13/135) in the MTZ-Clind, MTZ-Prob and MTZ-Placebo groups respectively, p = 0.13. Hazard ratios (HR) for BV recurrence at one-month, adjusted for adherence to vaginal therapy, were 0.43 (95%CI 0.15-1.22) and 0.75 (95% CI 0.32-1.76) in the MTZ-Clind and MTZ-Prob groups compared to MTZ-Plac respectively. Cumulative 6-month BV recurrence was 28.2%; (95%CI 24.0-32.7%) with no difference between groups, p = 0.82; HRs for 6-month BV recurrence for MTZ-Clind and MTZ-Prob compared to MTZ-Plac, adjusted for adherence to vaginal therapy were 1.09(95% CI = 0.70-1.70) and 1.03(95% CI = 0.65-1.63), respectively. No serious adverse events occurred. CONCLUSION: Combining the recommended first line therapies of oral metronidazole and vaginal clindamycin, or oral metronidazole with an extended-course of a commercially available vaginal-L.acidophilus probiotic, does not reduce BV recurrence. TRIAL REGISTRATION: ANZCTR.org.au ACTRN12607000350426. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/22509319/Efficacy_of_oral_metronidazole_with_vaginal_clindamycin_or_vaginal_probiotic_for_bacterial_vaginosis:_randomised_placebo_controlled_double_blind_trial_ L2 - https://dx.plos.org/10.1371/journal.pone.0034540 DB - PRIME DP - Unbound Medicine ER -