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A novel non-antimicrobial treatment of bacterial vaginosis : An open label two-private centre study

Latham-Cork, Harriett C. ; Walker, Kate F. ; Thornton, Jim G. ; Gunnarsson, Omar Sigurvin LU orcid ; Säfholm, Annette LU ; Cardell, Monika LU and Strevens, Helena LU (2021) In European Journal of Obstetrics and Gynecology and Reproductive Biology 256. p.419-424
Abstract

Background: Bacterial vaginosis (BV) is the most common cause of vaginal discharge. It is caused by an imbalance in the normal vaginal microbiota. Symptoms include an offensive odour. Standard oral or vaginal antimicrobial treatments have high immediate cure rates but almost as high recurrence rates. pHyph, a vaginal pessary, contains glucono-delta-lactone (GDL) and sodium gluconate (NaG) which restore normal pH and disrupt the associated biofilm. Aim: To investigate the clinical performance of pHyph, for both treatment and recurrence prevention. Design An open-label, single arm, multi-centre first in women study. Setting: Two private gynaecology clinics in Skåne County, Southern Sweden. Methods: Twenty four adult women with confirmed... (More)

Background: Bacterial vaginosis (BV) is the most common cause of vaginal discharge. It is caused by an imbalance in the normal vaginal microbiota. Symptoms include an offensive odour. Standard oral or vaginal antimicrobial treatments have high immediate cure rates but almost as high recurrence rates. pHyph, a vaginal pessary, contains glucono-delta-lactone (GDL) and sodium gluconate (NaG) which restore normal pH and disrupt the associated biofilm. Aim: To investigate the clinical performance of pHyph, for both treatment and recurrence prevention. Design An open-label, single arm, multi-centre first in women study. Setting: Two private gynaecology clinics in Skåne County, Southern Sweden. Methods: Twenty four adult women with confirmed bacterial vaginosis received the investigational product for self-administration on days 0, 2, 4, and 6 and were assessed on day 7. Clinical cure was defined as absence of three of four Amsel's criteria (pH excluded) on day 7. Safety and tolerability were also recorded. Those not cured by day 7 received a prolonged treatment protocol. Results There were three withdrawals, two before the day 7 assessment. 18/22 (82 %) were clinically cured at day 7. The pessary was well tolerated. Recurrence rates at 14 days in patients cured at day 7 after receiving standard study treatment (n = 18) were 1/18 (5.6 %) with no additional recurrences reported at 35 days. Three of four patients not cured at 7 days received continued treatment (day 7, 9, 11, and 13), but none were cured at 14 days. Conclusion: pHyph has the potential for both high cure rates and a reduction in recurrence.

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Bacterial vaginosis, Biofilm, Odorous vaginal discharge, pH modifier, Treatment
in
European Journal of Obstetrics and Gynecology and Reproductive Biology
volume
256
pages
6 pages
publisher
Elsevier
external identifiers
  • pmid:33307324
  • scopus:85097463085
ISSN
0301-2115
DOI
10.1016/j.ejogrb.2020.11.059
language
English
LU publication?
yes
id
e7954c4c-6d71-430e-a956-f5bdd4956fde
date added to LUP
2020-12-21 12:08:47
date last changed
2024-04-17 21:33:21
@article{e7954c4c-6d71-430e-a956-f5bdd4956fde,
  abstract     = {{<p>Background: Bacterial vaginosis (BV) is the most common cause of vaginal discharge. It is caused by an imbalance in the normal vaginal microbiota. Symptoms include an offensive odour. Standard oral or vaginal antimicrobial treatments have high immediate cure rates but almost as high recurrence rates. pHyph, a vaginal pessary, contains glucono-delta-lactone (GDL) and sodium gluconate (NaG) which restore normal pH and disrupt the associated biofilm. Aim: To investigate the clinical performance of pHyph, for both treatment and recurrence prevention. Design An open-label, single arm, multi-centre first in women study. Setting: Two private gynaecology clinics in Skåne County, Southern Sweden. Methods: Twenty four adult women with confirmed bacterial vaginosis received the investigational product for self-administration on days 0, 2, 4, and 6 and were assessed on day 7. Clinical cure was defined as absence of three of four Amsel's criteria (pH excluded) on day 7. Safety and tolerability were also recorded. Those not cured by day 7 received a prolonged treatment protocol. Results There were three withdrawals, two before the day 7 assessment. 18/22 (82 %) were clinically cured at day 7. The pessary was well tolerated. Recurrence rates at 14 days in patients cured at day 7 after receiving standard study treatment (n = 18) were 1/18 (5.6 %) with no additional recurrences reported at 35 days. Three of four patients not cured at 7 days received continued treatment (day 7, 9, 11, and 13), but none were cured at 14 days. Conclusion: pHyph has the potential for both high cure rates and a reduction in recurrence.</p>}},
  author       = {{Latham-Cork, Harriett C. and Walker, Kate F. and Thornton, Jim G. and Gunnarsson, Omar Sigurvin and Säfholm, Annette and Cardell, Monika and Strevens, Helena}},
  issn         = {{0301-2115}},
  keywords     = {{Bacterial vaginosis; Biofilm; Odorous vaginal discharge; pH modifier; Treatment}},
  language     = {{eng}},
  pages        = {{419--424}},
  publisher    = {{Elsevier}},
  series       = {{European Journal of Obstetrics and Gynecology and Reproductive Biology}},
  title        = {{A novel non-antimicrobial treatment of bacterial vaginosis : An open label two-private centre study}},
  url          = {{http://dx.doi.org/10.1016/j.ejogrb.2020.11.059}},
  doi          = {{10.1016/j.ejogrb.2020.11.059}},
  volume       = {{256}},
  year         = {{2021}},
}