Document Detail


The posttrial effect of oral periodic presumptive treatment for vaginal infections on the incidence of bacterial vaginosis and Lactobacillus colonization.
MedLine Citation:
PMID:  22504600     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: We previously demonstrated a decrease in bacterial vaginosis (BV) and an increase in Lactobacillus colonization among randomized controlled trial (RCT) participants who received monthly oral periodic presumptive treatment (PPT; 2 g metronidazole + 150 mg fluconazole). Posttrial data were analyzed to test the hypothesis that the treatment effect would persist after completion of 1 year of PPT.
METHODS: Data were obtained from women who completed all 12 RCT visits and attended ≥ 1 posttrial visit within 120 days after completion of the RCT. We used Andersen-Gill proportional hazards models to estimate the posttrial effect of the intervention on the incidence of BV by Gram stain and detection of Lactobacillus species by culture.
RESULTS: The analysis included 165 subjects (83 active and 82 placebo). The posttrial incidence of BV was 260 per 100 person-years in the intervention arm versus 358 per 100 person-years in the placebo arm (hazard ratio = 0.76; 95% confidence interval, 0.51-1.12). The posttrial incidence of Lactobacillus colonization was 180 per 100 person-years in the intervention arm versus 127 per 100 person-years in the placebo arm (hazard ratio = 1.42; 95% confidence interval, 0.85-2.71).
CONCLUSIONS: Despite a decrease in BV and an increase in Lactobacillus colonization during the RCT, the effect of PPT was not sustained at the same level after cessation of the intervention. New interventions that reduce BV recurrence and promote Lactobacillus colonization without the need for ongoing treatment are needed.
Authors:
Jennifer E Balkus; Walter Jaoko; Kishorchandra Mandaliya; Barbra A Richardson; Linnet Masese; Ruth Gitau; James Kiarie; Jeanne Marrazzo; Carey Farquhar; R Scott McClelland
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Sexually transmitted diseases     Volume:  39     ISSN:  1537-4521     ISO Abbreviation:  Sex Transm Dis     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-04-16     Completed Date:  2012-07-26     Revised Date:  2013-05-16    
Medline Journal Info:
Nlm Unique ID:  7705941     Medline TA:  Sex Transm Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  361-5     Citation Subset:  IM    
Affiliation:
Department of Epidemiology, University of Washington, Seattle, WA 98104, USA. jbalkus@u.washington.edu
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Anti-Infective Agents / administration & dosage
Antifungal Agents / administration & dosage
Cohort Studies
Female
Fluconazole / administration & dosage
Follow-Up Studies
Humans
Incidence
Kenya / epidemiology
Lactobacillus / drug effects*,  growth & development
Metronidazole / administration & dosage
Proportional Hazards Models
Prospective Studies
Prostitution / statistics & numerical data*
Risk Factors
Treatment Outcome
Vagina / drug effects*,  microbiology
Vaginosis, Bacterial / drug therapy*,  epidemiology,  prevention & control
Young Adult
Grant Support
ID/Acronym/Agency:
K23 AI052480-05/AI/NIAID NIH HHS; K23 AI52480/AI/NIAID NIH HHS; K24 AI087399/AI/NIAID NIH HHS; K24 AI087399/AI/NIAID NIH HHS; K24 AI087399-03/AI/NIAID NIH HHS; P30 AI027757/AI/NIAID NIH HHS; P30 AI027757-19/AI/NIAID NIH HHS; T32 AI007140/AI/NIAID NIH HHS; T32 AI007140-32/AI/NIAID NIH HHS; T32 AI007140-32/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Infective Agents; 0/Antifungal Agents; 443-48-1/Metronidazole; 86386-73-4/Fluconazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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