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Recommend high-dose vaginal probiotic capsules to prevent recurrent bacterial vaginosis.1
STRENGTH OF RECOMMENDATION
B: Based on a single high-quality randomized controlled trial (RCT)
Ya W, Reifer C, Miller LE. Efficacy of vaginal probiotic capsules for recurrent bacterial vaginosis: a double-blind, randomized, placebo-controlled study. Am J Obstet Gynecol. 2010;203:120.e1-120.e6.
ILLUSTRATIVE CASE
A 26-year-old nonsmoking woman with a single sexual partner comes in with the second bout of bacterial vaginosis (BV) she’s had this year. What can you give her to prevent a recurrence?
Bacterial vaginosis is the most common cause of vaginal discharge in women, responsible for 40% to 50% of clinical cases. Among American women ages 14 to 49, the general prevalence—including asymptomatic cases—is close to 30%.2
Recurrence rate, as well as prevalence, is high
BV is caused by a shift in vaginal flora from hydrogen peroxide-producing Lactobacillus species to anaerobes that raise the vaginal pH. Multiple species of anaerobic bacteria are implicated. The drug of choice for treatment of BV continues to be metronidazole, a drug prescribed for the past 45 years with minimal resistance.3 However, there is growing resistance among Bacteroides species. Oral or intravaginal clindamycin is another option for treating BV.4
Even with the use of metronidazole, recurrence is common—with as many as 50% of symptomatic infections recurring within a year.5 A randomized, double-blind placebo-controlled trial published in 2006 compared the results of 1 week of oral metronidazole (500 mg) twice daily plus 30 days of oral probiotics vs the same dose and duration of metronidazole plus 30 days of placebo.6 The rate of recurrence at the end of 1 month was 12% in the antibiotic/probiotic group vs 60% in the antibiotic/placebo group.
The RCT reviewed here evaluated the effectiveness of a vaginal probiotic capsule in preventing recurrent BV.
STUDY SUMMARY: Probiotic use lowered recurrence rate
Ya et al enrolled 120 Chinese women with a history of recurrent BV in a double-blind RCT.1 To be eligible, women had to be healthy, between the ages of 18 and 55, and free from BV (but have a history of ≥2 episodes in the previous year). They also could not have had any antibiotic treatment within a week of study participation, and had to be willing to refrain from using other intravaginal products during the course of the study.
The researchers excluded women who were found to have other causes of vulvovaginitis or urogenital infection within 21 days of participation, were pregnant or lactating, ate yogurt or fermented milk on a daily basis, were allergic to study product ingredients, or were immunosuppressed.
Participants were assigned to either BV prophylaxis with the vaginal probiotic capsule Probaclac Vaginal (a lactose capsule containing 8 billion colony-forming units [CFUs] of Lactobacillus rhamnosus, L acidophilus, and Streptococcus thermophilus) (n=58) or a placebo capsule containing lactose alone (n=62). Both groups had similar baseline characteristics; most of the women were nonsmokers who had had either one sexual partner or no partners within the previous year.
After a baseline evaluation, the participants used the vaginal capsules daily for 7 days, skipped usage for 7 days, and then used them again for a final 7 days. The women then returned for follow-up visits at 30 and 60 days after treatment began for the collection of vaginal swabs, an assessment of vaginal flora, and a report of adverse events. Researchers also contacted them by phone roughly 11 months after treatment started to ask about BV symptoms or diagnosis after treatment.
The primary end point was the diagnosis in the first 2 months of BV using Amsel criteria: the presence of thin, grey-white homogenous discharge coating the vaginal walls; vaginal pH >4.5; a positive whiff-amine test (presence of “fish smell” with potassium hydroxide [KOH] or KOH prep); and the presence of clue cells on normal saline wet mount.7
This end point—based on the presence of 3 of the 4 criteria—was reached in 15.8% of women in the probiotic group and 45% in the control group (odds ratio [OR]=0.23; 95% confidence interval [CI], 0.10-0.55; P<.001), with a number needed to treat (NNT) of 3.4.
A secondary end point was the confirmed diagnosis of BV between 2 and 11 months; only 10.6% of women in the probiotic group and 27.7% of women in the control group had confirmed BV (OR=0.31, 95% CI, 0.11-0.93; P=.04), with an NNT of 5.8. No adverse advents were reported.
WHAT’S NEW: A new use for probiotics is established
This trial supports the use of probiotic vaginal capsules in the prevention of recurrent BV. We found the specific formulation (Probaclac Vaginal) that was tested in this RCT on an online natural health site (http://www.lady tobaby.com/show.php?item=219). This Web site sells Probaclac Vaginal at a cost of $28 for 10 capsules. A full course of a week’s treatment, repeated once, would cost approximately $56.
CAVEATS: Will other formulations work?
This study was funded by the makers of Probaclac Vaginal, so we will be watching for independent replication of these findings in other populations. The vaginal probiotic tested had 80 times the current recommended concentration of lactobacilli required to restore and maintain normal vaginal flora, so we are unsure as to whether less concentrated formulations would be equally effective.
Probiotic formulations differ widely, although some are similar to the species/ concentration used in Probaclac Vaginal, including LactoViden ID by Metagenics (http://www.metagenics.com/products/az-products-list/LactoViden-ID), with 15 billion CFUs, and Therbiotic by Klaire Labs (http://www.klaire.com/prod/proddetail. asp?id=V775-06-CN), with 25 billion CFUs.
Also, this intervention has not been tested in populations outside of China, in heavy smokers, or in women with more than one sexual partner, so there is a small risk that these findings may not be confirmed in subsequent RCTs or may not be generalizable to other populations. Nonetheless, we think the potential benefit outweighs any possible harm, and we will be watching for studies that confirm or challenge these findings.
CHALLENGES TO IMPLEMENTATION: Finding the right probiotic
The brand used in the study is available only on the Web, which may be difficult for some patients to access, and some patients will find the probiotic to be fairly expensive. In addition, other brands of probiotics may not be available as a vaginal capsule with applicator. It should be noted, though, that it is possible to use an applicator to insert an oral probiotic capsule into the vagina.
Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.
Click here to view PURL METHODOLOGY
1. Ya W, Reifer C, Miller LE. Efficacy of vaginal probiotic capsules for recurrent bacterial vaginosis: a double-blind, randomized, placebo-controlled study. Am J Obstet Gynecol. 2010;203:120.e1-120.e6.
2. Allsworth JE, Peipert JF. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey Data. Obstet Gynecol. 2007;109:114-120.
3. Lofmark S, Edlund C, Nord CE. Metronidazole is still the drug of choice for treatment of anaerobic infections. Clin Infect Dis. 2010;50(suppl 1):S16-S23.
4. Joesoef MR, Schmid GP, Hillier SL. Bacterial vaginosis: review of treatment options and potential clinical indications for therapy. Clin Infect Dis. 1999;28(suppl 1):S57-S65.
5. Bradshaw CS, Morton AN, Hocking J, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis. 2006;193:1478-1486.
6. Anukam K, Osazuwa E, Ahonkhai I, et al. Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial. Microbes Infect. 2006;8:1450-1454.
7. Amsel R, Totten PA, Spiegel CA, et al. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med. 1983;74:14-22.
Recommend high-dose vaginal probiotic capsules to prevent recurrent bacterial vaginosis.1
STRENGTH OF RECOMMENDATION
B: Based on a single high-quality randomized controlled trial (RCT)
Ya W, Reifer C, Miller LE. Efficacy of vaginal probiotic capsules for recurrent bacterial vaginosis: a double-blind, randomized, placebo-controlled study. Am J Obstet Gynecol. 2010;203:120.e1-120.e6.
ILLUSTRATIVE CASE
A 26-year-old nonsmoking woman with a single sexual partner comes in with the second bout of bacterial vaginosis (BV) she’s had this year. What can you give her to prevent a recurrence?
Bacterial vaginosis is the most common cause of vaginal discharge in women, responsible for 40% to 50% of clinical cases. Among American women ages 14 to 49, the general prevalence—including asymptomatic cases—is close to 30%.2
Recurrence rate, as well as prevalence, is high
BV is caused by a shift in vaginal flora from hydrogen peroxide-producing Lactobacillus species to anaerobes that raise the vaginal pH. Multiple species of anaerobic bacteria are implicated. The drug of choice for treatment of BV continues to be metronidazole, a drug prescribed for the past 45 years with minimal resistance.3 However, there is growing resistance among Bacteroides species. Oral or intravaginal clindamycin is another option for treating BV.4
Even with the use of metronidazole, recurrence is common—with as many as 50% of symptomatic infections recurring within a year.5 A randomized, double-blind placebo-controlled trial published in 2006 compared the results of 1 week of oral metronidazole (500 mg) twice daily plus 30 days of oral probiotics vs the same dose and duration of metronidazole plus 30 days of placebo.6 The rate of recurrence at the end of 1 month was 12% in the antibiotic/probiotic group vs 60% in the antibiotic/placebo group.
The RCT reviewed here evaluated the effectiveness of a vaginal probiotic capsule in preventing recurrent BV.
STUDY SUMMARY: Probiotic use lowered recurrence rate
Ya et al enrolled 120 Chinese women with a history of recurrent BV in a double-blind RCT.1 To be eligible, women had to be healthy, between the ages of 18 and 55, and free from BV (but have a history of ≥2 episodes in the previous year). They also could not have had any antibiotic treatment within a week of study participation, and had to be willing to refrain from using other intravaginal products during the course of the study.
The researchers excluded women who were found to have other causes of vulvovaginitis or urogenital infection within 21 days of participation, were pregnant or lactating, ate yogurt or fermented milk on a daily basis, were allergic to study product ingredients, or were immunosuppressed.
Participants were assigned to either BV prophylaxis with the vaginal probiotic capsule Probaclac Vaginal (a lactose capsule containing 8 billion colony-forming units [CFUs] of Lactobacillus rhamnosus, L acidophilus, and Streptococcus thermophilus) (n=58) or a placebo capsule containing lactose alone (n=62). Both groups had similar baseline characteristics; most of the women were nonsmokers who had had either one sexual partner or no partners within the previous year.
After a baseline evaluation, the participants used the vaginal capsules daily for 7 days, skipped usage for 7 days, and then used them again for a final 7 days. The women then returned for follow-up visits at 30 and 60 days after treatment began for the collection of vaginal swabs, an assessment of vaginal flora, and a report of adverse events. Researchers also contacted them by phone roughly 11 months after treatment started to ask about BV symptoms or diagnosis after treatment.
The primary end point was the diagnosis in the first 2 months of BV using Amsel criteria: the presence of thin, grey-white homogenous discharge coating the vaginal walls; vaginal pH >4.5; a positive whiff-amine test (presence of “fish smell” with potassium hydroxide [KOH] or KOH prep); and the presence of clue cells on normal saline wet mount.7
This end point—based on the presence of 3 of the 4 criteria—was reached in 15.8% of women in the probiotic group and 45% in the control group (odds ratio [OR]=0.23; 95% confidence interval [CI], 0.10-0.55; P<.001), with a number needed to treat (NNT) of 3.4.
A secondary end point was the confirmed diagnosis of BV between 2 and 11 months; only 10.6% of women in the probiotic group and 27.7% of women in the control group had confirmed BV (OR=0.31, 95% CI, 0.11-0.93; P=.04), with an NNT of 5.8. No adverse advents were reported.
WHAT’S NEW: A new use for probiotics is established
This trial supports the use of probiotic vaginal capsules in the prevention of recurrent BV. We found the specific formulation (Probaclac Vaginal) that was tested in this RCT on an online natural health site (http://www.lady tobaby.com/show.php?item=219). This Web site sells Probaclac Vaginal at a cost of $28 for 10 capsules. A full course of a week’s treatment, repeated once, would cost approximately $56.
CAVEATS: Will other formulations work?
This study was funded by the makers of Probaclac Vaginal, so we will be watching for independent replication of these findings in other populations. The vaginal probiotic tested had 80 times the current recommended concentration of lactobacilli required to restore and maintain normal vaginal flora, so we are unsure as to whether less concentrated formulations would be equally effective.
Probiotic formulations differ widely, although some are similar to the species/ concentration used in Probaclac Vaginal, including LactoViden ID by Metagenics (http://www.metagenics.com/products/az-products-list/LactoViden-ID), with 15 billion CFUs, and Therbiotic by Klaire Labs (http://www.klaire.com/prod/proddetail. asp?id=V775-06-CN), with 25 billion CFUs.
Also, this intervention has not been tested in populations outside of China, in heavy smokers, or in women with more than one sexual partner, so there is a small risk that these findings may not be confirmed in subsequent RCTs or may not be generalizable to other populations. Nonetheless, we think the potential benefit outweighs any possible harm, and we will be watching for studies that confirm or challenge these findings.
CHALLENGES TO IMPLEMENTATION: Finding the right probiotic
The brand used in the study is available only on the Web, which may be difficult for some patients to access, and some patients will find the probiotic to be fairly expensive. In addition, other brands of probiotics may not be available as a vaginal capsule with applicator. It should be noted, though, that it is possible to use an applicator to insert an oral probiotic capsule into the vagina.
Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.
Click here to view PURL METHODOLOGY
Recommend high-dose vaginal probiotic capsules to prevent recurrent bacterial vaginosis.1
STRENGTH OF RECOMMENDATION
B: Based on a single high-quality randomized controlled trial (RCT)
Ya W, Reifer C, Miller LE. Efficacy of vaginal probiotic capsules for recurrent bacterial vaginosis: a double-blind, randomized, placebo-controlled study. Am J Obstet Gynecol. 2010;203:120.e1-120.e6.
ILLUSTRATIVE CASE
A 26-year-old nonsmoking woman with a single sexual partner comes in with the second bout of bacterial vaginosis (BV) she’s had this year. What can you give her to prevent a recurrence?
Bacterial vaginosis is the most common cause of vaginal discharge in women, responsible for 40% to 50% of clinical cases. Among American women ages 14 to 49, the general prevalence—including asymptomatic cases—is close to 30%.2
Recurrence rate, as well as prevalence, is high
BV is caused by a shift in vaginal flora from hydrogen peroxide-producing Lactobacillus species to anaerobes that raise the vaginal pH. Multiple species of anaerobic bacteria are implicated. The drug of choice for treatment of BV continues to be metronidazole, a drug prescribed for the past 45 years with minimal resistance.3 However, there is growing resistance among Bacteroides species. Oral or intravaginal clindamycin is another option for treating BV.4
Even with the use of metronidazole, recurrence is common—with as many as 50% of symptomatic infections recurring within a year.5 A randomized, double-blind placebo-controlled trial published in 2006 compared the results of 1 week of oral metronidazole (500 mg) twice daily plus 30 days of oral probiotics vs the same dose and duration of metronidazole plus 30 days of placebo.6 The rate of recurrence at the end of 1 month was 12% in the antibiotic/probiotic group vs 60% in the antibiotic/placebo group.
The RCT reviewed here evaluated the effectiveness of a vaginal probiotic capsule in preventing recurrent BV.
STUDY SUMMARY: Probiotic use lowered recurrence rate
Ya et al enrolled 120 Chinese women with a history of recurrent BV in a double-blind RCT.1 To be eligible, women had to be healthy, between the ages of 18 and 55, and free from BV (but have a history of ≥2 episodes in the previous year). They also could not have had any antibiotic treatment within a week of study participation, and had to be willing to refrain from using other intravaginal products during the course of the study.
The researchers excluded women who were found to have other causes of vulvovaginitis or urogenital infection within 21 days of participation, were pregnant or lactating, ate yogurt or fermented milk on a daily basis, were allergic to study product ingredients, or were immunosuppressed.
Participants were assigned to either BV prophylaxis with the vaginal probiotic capsule Probaclac Vaginal (a lactose capsule containing 8 billion colony-forming units [CFUs] of Lactobacillus rhamnosus, L acidophilus, and Streptococcus thermophilus) (n=58) or a placebo capsule containing lactose alone (n=62). Both groups had similar baseline characteristics; most of the women were nonsmokers who had had either one sexual partner or no partners within the previous year.
After a baseline evaluation, the participants used the vaginal capsules daily for 7 days, skipped usage for 7 days, and then used them again for a final 7 days. The women then returned for follow-up visits at 30 and 60 days after treatment began for the collection of vaginal swabs, an assessment of vaginal flora, and a report of adverse events. Researchers also contacted them by phone roughly 11 months after treatment started to ask about BV symptoms or diagnosis after treatment.
The primary end point was the diagnosis in the first 2 months of BV using Amsel criteria: the presence of thin, grey-white homogenous discharge coating the vaginal walls; vaginal pH >4.5; a positive whiff-amine test (presence of “fish smell” with potassium hydroxide [KOH] or KOH prep); and the presence of clue cells on normal saline wet mount.7
This end point—based on the presence of 3 of the 4 criteria—was reached in 15.8% of women in the probiotic group and 45% in the control group (odds ratio [OR]=0.23; 95% confidence interval [CI], 0.10-0.55; P<.001), with a number needed to treat (NNT) of 3.4.
A secondary end point was the confirmed diagnosis of BV between 2 and 11 months; only 10.6% of women in the probiotic group and 27.7% of women in the control group had confirmed BV (OR=0.31, 95% CI, 0.11-0.93; P=.04), with an NNT of 5.8. No adverse advents were reported.
WHAT’S NEW: A new use for probiotics is established
This trial supports the use of probiotic vaginal capsules in the prevention of recurrent BV. We found the specific formulation (Probaclac Vaginal) that was tested in this RCT on an online natural health site (http://www.lady tobaby.com/show.php?item=219). This Web site sells Probaclac Vaginal at a cost of $28 for 10 capsules. A full course of a week’s treatment, repeated once, would cost approximately $56.
CAVEATS: Will other formulations work?
This study was funded by the makers of Probaclac Vaginal, so we will be watching for independent replication of these findings in other populations. The vaginal probiotic tested had 80 times the current recommended concentration of lactobacilli required to restore and maintain normal vaginal flora, so we are unsure as to whether less concentrated formulations would be equally effective.
Probiotic formulations differ widely, although some are similar to the species/ concentration used in Probaclac Vaginal, including LactoViden ID by Metagenics (http://www.metagenics.com/products/az-products-list/LactoViden-ID), with 15 billion CFUs, and Therbiotic by Klaire Labs (http://www.klaire.com/prod/proddetail. asp?id=V775-06-CN), with 25 billion CFUs.
Also, this intervention has not been tested in populations outside of China, in heavy smokers, or in women with more than one sexual partner, so there is a small risk that these findings may not be confirmed in subsequent RCTs or may not be generalizable to other populations. Nonetheless, we think the potential benefit outweighs any possible harm, and we will be watching for studies that confirm or challenge these findings.
CHALLENGES TO IMPLEMENTATION: Finding the right probiotic
The brand used in the study is available only on the Web, which may be difficult for some patients to access, and some patients will find the probiotic to be fairly expensive. In addition, other brands of probiotics may not be available as a vaginal capsule with applicator. It should be noted, though, that it is possible to use an applicator to insert an oral probiotic capsule into the vagina.
Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.
Click here to view PURL METHODOLOGY
1. Ya W, Reifer C, Miller LE. Efficacy of vaginal probiotic capsules for recurrent bacterial vaginosis: a double-blind, randomized, placebo-controlled study. Am J Obstet Gynecol. 2010;203:120.e1-120.e6.
2. Allsworth JE, Peipert JF. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey Data. Obstet Gynecol. 2007;109:114-120.
3. Lofmark S, Edlund C, Nord CE. Metronidazole is still the drug of choice for treatment of anaerobic infections. Clin Infect Dis. 2010;50(suppl 1):S16-S23.
4. Joesoef MR, Schmid GP, Hillier SL. Bacterial vaginosis: review of treatment options and potential clinical indications for therapy. Clin Infect Dis. 1999;28(suppl 1):S57-S65.
5. Bradshaw CS, Morton AN, Hocking J, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis. 2006;193:1478-1486.
6. Anukam K, Osazuwa E, Ahonkhai I, et al. Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial. Microbes Infect. 2006;8:1450-1454.
7. Amsel R, Totten PA, Spiegel CA, et al. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med. 1983;74:14-22.
1. Ya W, Reifer C, Miller LE. Efficacy of vaginal probiotic capsules for recurrent bacterial vaginosis: a double-blind, randomized, placebo-controlled study. Am J Obstet Gynecol. 2010;203:120.e1-120.e6.
2. Allsworth JE, Peipert JF. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey Data. Obstet Gynecol. 2007;109:114-120.
3. Lofmark S, Edlund C, Nord CE. Metronidazole is still the drug of choice for treatment of anaerobic infections. Clin Infect Dis. 2010;50(suppl 1):S16-S23.
4. Joesoef MR, Schmid GP, Hillier SL. Bacterial vaginosis: review of treatment options and potential clinical indications for therapy. Clin Infect Dis. 1999;28(suppl 1):S57-S65.
5. Bradshaw CS, Morton AN, Hocking J, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis. 2006;193:1478-1486.
6. Anukam K, Osazuwa E, Ahonkhai I, et al. Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial. Microbes Infect. 2006;8:1450-1454.
7. Amsel R, Totten PA, Spiegel CA, et al. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med. 1983;74:14-22.
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