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.
RCT Entities:
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: Robert L Cook; Julie S Downs; Jeanne Marrazzo; Galen E Switzer; Ozlem Tanriover; Harold Wiesenfeld; Pamela J Murray; Sharon L Hillier Journal: J Womens Health (Larchmt) Date: 2009-08 Impact factor: 2.681
Authors: Rita Palmeira-de-Oliveira; Paulo Duarte; Ana Palmeira-de-Oliveira; José das Neves; Maria Helena Amaral; Luiza Breitenfeld; José Martinez-de-Oliveira Journal: Pharmaceutics Date: 2014-10-21 Impact factor: 6.321