title: Women's satisfaction with an intravaginal Lactobacillus capsule for the treatment of bacterial vaginosis.
abstract: OBJECTIVE
  To assess women's satisfaction with a vaginal capsule containing human-derived, H(2)O(2)-producing Lactobacillus crispatus at completion of a randomized, placebo-controlled study for treatment of bacterial vaginosis (BV).
  
  
  METHODS
  Women aged 14-35 years with BV were randomized to Lactobacillus or placebo intravaginal capsule twice daily for 3 days monthly for 3 months. Attitudes were assessed with a standardized scale at the final follow-up visit, and associations of satisfaction with clinical and gram stain cure of BV were determined.
  
  
  RESULTS
  Four hundred twenty-four women were randomized at enrollment, and 232 (55%) provided data on satisfaction at the final visit. Overall, satisfaction with the capsule was high and was independent of subjects' race, age, and prior history of BV. Report of satisfaction with the capsule, belief that it contained healthy bacteria, and belief that its use improved vaginal health were directly related to clinical cure and to improved Nugent score. Except for women who had BV at the final follow-up visit, most subjects believed that the capsule contained healthy bacteria independent of any outcome reflecting cure. Willingness to use the capsule again was not significantly related to whether subjects experienced clinical cure or normalization of Nugent score at either visit. Adverse effects were rare and were largely related to a perceived difference in vaginal discharge.
  
  
  CONCLUSIONS
  Satisfaction with an intravaginal capsule and positive beliefs about its use for BV treatment were prevalent, especially among women with a clinical and microbiological response to BV therapy. However, most women expressed willingness to use the product again regardless of clinical response. Acceptability of and interest in alternative BV treatments, such as L. crispatus intravaginal applications, are high.
authors.affiliation: Department of Medicine, University of Washington, Seattle, Washington, USA. jmm2@u.washington.edu
authors.forename: Jeanne M
authors.initials: JM
authors.lastname: Marrazzo
authors.forename: Robert L
authors.initials: RL
authors.lastname: Cook
authors.forename: Harold C
authors.initials: HC
authors.lastname: Wiesenfeld
authors.forename: Pamela J
authors.initials: PJ
authors.lastname: Murray
authors.forename: Barbara
authors.initials: B
authors.lastname: Busse
authors.forename: Marijane
authors.initials: M
authors.lastname: Krohn
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Hillier
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D002214:Capsules; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007778:Lactobacillus; D015999:Multivariate Analysis; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D019936:Probiotics / Q000627:therapeutic use*; D016896:Treatment Outcome; D016585:Vaginosis, Bacterial / Q000178:diet therapy* / Q000382:microbiology*; D016387:Women's Health
chemical_list: D002214:Capsules