The Posttrial Effect of Oral Periodic Presumptive Treatment for Vaginal Infections on the Incidence of Bacterial Vaginosis and Lactobacillus Colonization
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...
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| Veröffentlicht in: | Sexually transmitted diseases 2012-05, Vol.39 (5), p.361-365 |
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| creator | Balkus, Jennifer E. Jaoko, Walter Mandaliya, Kishorchandra Richardson, Barbra A. Masese, Linnet Gitau, Ruth Kiarie, James Marrazzo, Jeanne Farquhar, Carey McClelland, R. Scott |
| description | 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. |
| doi_str_mv | 10.1097/OLQ.0b013e31824790d7 |
| format | Article |
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Scott</creator><creatorcontrib>Balkus, Jennifer E. ; Jaoko, Walter ; Mandaliya, Kishorchandra ; Richardson, Barbra A. ; Masese, Linnet ; Gitau, Ruth ; Kiarie, James ; Marrazzo, Jeanne ; Farquhar, Carey ; McClelland, R. Scott</creatorcontrib><description>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.</description><identifier>ISSN: 0148-5717</identifier><identifier>EISSN: 1537-4521</identifier><identifier>DOI: 10.1097/OLQ.0b013e31824790d7</identifier><identifier>PMID: 22504600</identifier><identifier>CODEN: STRDDM</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject><![CDATA[Adolescent ; Adult ; Anti-Infective Agents - administration & dosage ; Antifungal Agents - administration & dosage ; Antiretroviral drugs ; Bacteria ; Bacterial diseases ; Bacterial diseases of the genital system ; Biological and medical sciences ; Clinical trials ; Cohort Studies ; Epidemiology. Vaccinations ; Female ; Fluconazole - administration & dosage ; Follow-Up Studies ; General aspects ; Gram-positive bacteria ; Human bacterial diseases ; Human infectious diseases. Experimental studies and models ; Humans ; Incidence ; Infectious diseases ; Kenya - epidemiology ; Lactobacillus ; Lactobacillus - drug effects ; Lactobacillus - growth & development ; Medical sciences ; Medical treatment ; Metronidazole - administration & dosage ; Original Study ; Proportional Hazards Models ; Prospective Studies ; Risk Factors ; Sex Work - statistics & numerical data ; Sexually transmitted diseases ; STD ; Treatment Outcome ; Vagina - drug effects ; Vagina - microbiology ; Vaginosis, Bacterial - drug therapy ; Vaginosis, Bacterial - epidemiology ; Vaginosis, Bacterial - prevention & control ; Young Adult]]></subject><ispartof>Sexually transmitted diseases, 2012-05, Vol.39 (5), p.361-365</ispartof><rights>Copyright © 2012 American Sexually Transmitted Diseases Association</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Lippincott Williams & Wilkins May 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c466t-9bf7272dde73d8e41827a467e0eb2083f70d43237ca2a3edab6d321a68f4c37f3</citedby><cites>FETCH-LOGICAL-c466t-9bf7272dde73d8e41827a467e0eb2083f70d43237ca2a3edab6d321a68f4c37f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/44981694$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/44981694$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,780,784,803,27924,27925,30999,58017,58250</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25839540$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22504600$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Balkus, Jennifer E.</creatorcontrib><creatorcontrib>Jaoko, Walter</creatorcontrib><creatorcontrib>Mandaliya, Kishorchandra</creatorcontrib><creatorcontrib>Richardson, Barbra A.</creatorcontrib><creatorcontrib>Masese, Linnet</creatorcontrib><creatorcontrib>Gitau, Ruth</creatorcontrib><creatorcontrib>Kiarie, James</creatorcontrib><creatorcontrib>Marrazzo, Jeanne</creatorcontrib><creatorcontrib>Farquhar, Carey</creatorcontrib><creatorcontrib>McClelland, R. Scott</creatorcontrib><title>The Posttrial Effect of Oral Periodic Presumptive Treatment for Vaginal Infections on the Incidence of Bacterial Vaginosis and Lactobacillus Colonization</title><title>Sexually transmitted diseases</title><addtitle>Sex Transm Dis</addtitle><description>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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anti-Infective Agents - administration & dosage</subject><subject>Antifungal Agents - administration & dosage</subject><subject>Antiretroviral drugs</subject><subject>Bacteria</subject><subject>Bacterial diseases</subject><subject>Bacterial diseases of the genital system</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Cohort Studies</subject><subject>Epidemiology. Vaccinations</subject><subject>Female</subject><subject>Fluconazole - administration & dosage</subject><subject>Follow-Up Studies</subject><subject>General aspects</subject><subject>Gram-positive bacteria</subject><subject>Human bacterial diseases</subject><subject>Human infectious diseases. Experimental studies and models</subject><subject>Humans</subject><subject>Incidence</subject><subject>Infectious diseases</subject><subject>Kenya - epidemiology</subject><subject>Lactobacillus</subject><subject>Lactobacillus - drug effects</subject><subject>Lactobacillus - growth & development</subject><subject>Medical sciences</subject><subject>Medical treatment</subject><subject>Metronidazole - administration & dosage</subject><subject>Original Study</subject><subject>Proportional Hazards Models</subject><subject>Prospective Studies</subject><subject>Risk Factors</subject><subject>Sex Work - statistics & numerical data</subject><subject>Sexually transmitted diseases</subject><subject>STD</subject><subject>Treatment Outcome</subject><subject>Vagina - drug effects</subject><subject>Vagina - microbiology</subject><subject>Vaginosis, Bacterial - drug therapy</subject><subject>Vaginosis, Bacterial - epidemiology</subject><subject>Vaginosis, Bacterial - prevention & control</subject><subject>Young Adult</subject><issn>0148-5717</issn><issn>1537-4521</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>7QJ</sourceid><recordid>eNqNkd-KEzEUxoMobl19A5WACN7Mmn8zmblcy6qFQitUb4dMcqIp06QmGUHfxLc1s60r7JVX4eT8vu8czofQc0quKOnk28360xUZCOXAacuE7IiRD9CC1lxWomb0IVoQKtqqllReoCcp7clcE_oYXTBWE9EQskC_d98Ab0PKOTo14htrQWccLN7EUm4humCcxtsIaTocs_sBeBdB5QP4jG2I-Iv66nxBV35WuuATDh7n4rry2hnwGma7d0pnuB1xKwjJJay8wevyHwal3ThOCS_DGLz7pWafp-iRVWOCZ-f3En1-f7NbfqzWmw-r5fW60qJpctUNVjLJjAHJTQui3EIq0UggMDDSciuJEZxxqRVTHIwaGsMZVU1rhebS8kv05uR7jOH7BCn3B5c0jKPyEKbUU8Jawhom2_9ACe3qlneyoK_uofswxXKomSqWddOJulDiROkYUopg-2N0BxV_FqifU-5Lyv39lIvs5dl8Gg5g7kR_Yy3A6zOgklajjapkkf5x8461mLkXJ26fcoh3fSG6lpYF-R9IvLs2</recordid><startdate>20120501</startdate><enddate>20120501</enddate><creator>Balkus, Jennifer E.</creator><creator>Jaoko, Walter</creator><creator>Mandaliya, Kishorchandra</creator><creator>Richardson, Barbra A.</creator><creator>Masese, Linnet</creator><creator>Gitau, Ruth</creator><creator>Kiarie, James</creator><creator>Marrazzo, Jeanne</creator><creator>Farquhar, Carey</creator><creator>McClelland, R. Scott</creator><general>Lippincott Williams & Wilkins</general><general>Lippincott Williams & Wilkins Ovid Technologies</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QJ</scope><scope>7QL</scope><scope>7T2</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>7T7</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope></search><sort><creationdate>20120501</creationdate><title>The Posttrial Effect of Oral Periodic Presumptive Treatment for Vaginal Infections on the Incidence of Bacterial Vaginosis and Lactobacillus Colonization</title><author>Balkus, Jennifer E. ; Jaoko, Walter ; Mandaliya, Kishorchandra ; Richardson, Barbra A. ; Masese, Linnet ; Gitau, Ruth ; Kiarie, James ; Marrazzo, Jeanne ; Farquhar, Carey ; McClelland, R. Scott</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c466t-9bf7272dde73d8e41827a467e0eb2083f70d43237ca2a3edab6d321a68f4c37f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Anti-Infective Agents - administration & dosage</topic><topic>Antifungal Agents - administration & dosage</topic><topic>Antiretroviral drugs</topic><topic>Bacteria</topic><topic>Bacterial diseases</topic><topic>Bacterial diseases of the genital system</topic><topic>Biological and medical sciences</topic><topic>Clinical trials</topic><topic>Cohort Studies</topic><topic>Epidemiology. Vaccinations</topic><topic>Female</topic><topic>Fluconazole - administration & dosage</topic><topic>Follow-Up Studies</topic><topic>General aspects</topic><topic>Gram-positive bacteria</topic><topic>Human bacterial diseases</topic><topic>Human infectious diseases. Experimental studies and models</topic><topic>Humans</topic><topic>Incidence</topic><topic>Infectious diseases</topic><topic>Kenya - epidemiology</topic><topic>Lactobacillus</topic><topic>Lactobacillus - drug effects</topic><topic>Lactobacillus - growth & development</topic><topic>Medical sciences</topic><topic>Medical treatment</topic><topic>Metronidazole - administration & dosage</topic><topic>Original Study</topic><topic>Proportional Hazards Models</topic><topic>Prospective Studies</topic><topic>Risk Factors</topic><topic>Sex Work - statistics & numerical data</topic><topic>Sexually transmitted diseases</topic><topic>STD</topic><topic>Treatment Outcome</topic><topic>Vagina - drug effects</topic><topic>Vagina - microbiology</topic><topic>Vaginosis, Bacterial - drug therapy</topic><topic>Vaginosis, Bacterial - epidemiology</topic><topic>Vaginosis, Bacterial - prevention & control</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Balkus, Jennifer E.</creatorcontrib><creatorcontrib>Jaoko, Walter</creatorcontrib><creatorcontrib>Mandaliya, Kishorchandra</creatorcontrib><creatorcontrib>Richardson, Barbra A.</creatorcontrib><creatorcontrib>Masese, Linnet</creatorcontrib><creatorcontrib>Gitau, Ruth</creatorcontrib><creatorcontrib>Kiarie, James</creatorcontrib><creatorcontrib>Marrazzo, Jeanne</creatorcontrib><creatorcontrib>Farquhar, Carey</creatorcontrib><creatorcontrib>McClelland, R. Scott</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Sexually transmitted diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Balkus, Jennifer E.</au><au>Jaoko, Walter</au><au>Mandaliya, Kishorchandra</au><au>Richardson, Barbra A.</au><au>Masese, Linnet</au><au>Gitau, Ruth</au><au>Kiarie, James</au><au>Marrazzo, Jeanne</au><au>Farquhar, Carey</au><au>McClelland, R. Scott</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Posttrial Effect of Oral Periodic Presumptive Treatment for Vaginal Infections on the Incidence of Bacterial Vaginosis and Lactobacillus Colonization</atitle><jtitle>Sexually transmitted diseases</jtitle><addtitle>Sex Transm Dis</addtitle><date>2012-05-01</date><risdate>2012</risdate><volume>39</volume><issue>5</issue><spage>361</spage><epage>365</epage><pages>361-365</pages><issn>0148-5717</issn><eissn>1537-4521</eissn><coden>STRDDM</coden><abstract>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.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>22504600</pmid><doi>10.1097/OLQ.0b013e31824790d7</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Sexually transmitted diseases, 2012-05, Vol.39 (5), p.361-365 |
| issn | 0148-5717 1537-4521 |
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| subjects | Adolescent Adult Anti-Infective Agents - administration & dosage Antifungal Agents - administration & dosage Antiretroviral drugs Bacteria Bacterial diseases Bacterial diseases of the genital system Biological and medical sciences Clinical trials Cohort Studies Epidemiology. Vaccinations Female Fluconazole - administration & dosage Follow-Up Studies General aspects Gram-positive bacteria Human bacterial diseases Human infectious diseases. Experimental studies and models Humans Incidence Infectious diseases Kenya - epidemiology Lactobacillus Lactobacillus - drug effects Lactobacillus - growth & development Medical sciences Medical treatment Metronidazole - administration & dosage Original Study Proportional Hazards Models Prospective Studies Risk Factors Sex Work - statistics & numerical data Sexually transmitted diseases STD Treatment Outcome Vagina - drug effects Vagina - microbiology Vaginosis, Bacterial - drug therapy Vaginosis, Bacterial - epidemiology Vaginosis, Bacterial - prevention & control Young Adult |
| title | The Posttrial Effect of Oral Periodic Presumptive Treatment for Vaginal Infections on the Incidence of Bacterial Vaginosis and Lactobacillus Colonization |
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