• Login
    View Item 
    •   Home
    • NHS Nottingham and Nottinghamshire Primary Care
    • Primary Care
    • Primary Care Publications
    • View Item
    •   Home
    • NHS Nottingham and Nottinghamshire Primary Care
    • Primary Care
    • Primary Care Publications
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of EMERCommunitiesPublication DateAuthorsTitlesSubjectsThis CollectionPublication DateAuthorsTitlesSubjectsProfilesView

    My Account

    LoginRegister

    Links

    About EMERPoliciesDerbyshire Community Health Services NHS Foundation TrustLeicester Partnership TrustNHS Nottingham and Nottinghamshire CCGNottinghamshire Healthcare NHS Foundation TrustNottingham University Hospitals NHS TrustSherwood Forest Hospitals NHS Foundation TrustUniversity Hospitals of Derby and Burton NHS Foundation TrustUniversity Hospitals Of Leicester NHS TrustOther Resources

    Statistics

    Most Popular ItemsStatistics by CountryMost Popular Authors

    Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Thumbnail
    Name:
    A randomised controlled trial ...
    Size:
    22.82Mb
    Format:
    PDF
    Download
    Author
    Armstrong-Buisseret, Lindsay
    Brittain, Clare
    Kai, Joe
    David, Miruna
    Anstey Watkins, Jocelyn
    Ozolins, Mara
    Jackson, Louise
    Abdali, Zainab
    Hepburn, Trish
    Griffiths, Frances
    Montgomery, Alan
    Daniels, Jane
    Manley, Alice
    Dean, Gillian
    Ross, Jonathan DC
    Show allShow less
    Keyword
    Bacterial Vaginosis
    Health Economics
    Lactic Acid Gel
    Metronidazole
    Microscopy
    Qualitative Research
    Randomised Controlled Trial
    Recurrence
    Sexual Health
    Date
    2022-01
    
    Metadata
    Show full item record
    DOI
    10.3310/ZZKH4176
    Abstract
    Background: Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur. Objectives: The objective is to assess whether or not intravaginal lactic acid gel is clinically effective and cost-effective for treating recurrent bacterial vaginosis compared with oral metronidazole (Flagyl, Sanofi). Design: This was an open-label, multicentre, parallel-arm, randomised (1 : 1) controlled trial. Setting: This took place in one general practice and 19 sexual health centres in the UK. Participants: Women aged ≥ 16 years with bacterial vaginosis symptoms and one or more episode(s) within the past 2 years took part. Interventions: The interventions were 5 ml of intravaginal lactic acid gel taken once daily for 7 days (intervention) or 400-mg oral metronidazole tablets taken twice daily for 7 days (control). Main outcome measures: The primary outcome was the resolution of bacterial vaginosis symptoms 14 days after randomisation. The secondary outcomes were time to first recurrence of symptoms; number of recurrences and treatment courses over 6 months; microbiological resolution on microscopy of vaginal smears at week 2; time to resolution of symptoms; tolerability, adherence and acceptability of the treatment; prevalence of concurrent sexually transmitted infections; quality of life; and cost-effectiveness. Results: Recruitment stopped prior to reaching the target of 1900 participants on recommendation from the Data Monitoring Committee and Trial Steering Committee after a planned review of the results indicated that the research question had been answered. Overall, 518 participants were randomised and primary outcome data were available for 409 participants (79%; 204 in the metronidazole arm, 205 in the lactic acid gel arm). Participant-reported symptom resolution at week 2 was higher with metronidazole (143/204; 70%) than with lactic acid gel (97/205; 47%) (adjusted risk difference -23.2%, 95% confidence interval -32.3% to -14.0%). Recurrence in 6 months in a subset of participants who had initial resolution and were available for follow-up was similar across arms (metronidazole arm: 51/72, 71%; lactic acid gel arm: 32/46, 70%). A higher incidence of some side effects was reported with metronidazole than with lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively). At week 2, the average cost per participant with resolved symptoms was £86.94 (metronidazole), compared with £147.00 (lactic acid gel). Some participants preferred using lactic acid gel even if they perceived it to be less effective than metronidazole. Limitations: Loss to follow-up for collection of the primary outcome data was 21% and was similar in both arms. There is a risk of bias owing to missing outcome data at 3 and 6 months post treatment. Conclusions: A higher initial response was seen with metronidazole than with lactic acid gel, but subsequent treatment failure was common with both. Lactic acid gel was less cost-effective than metronidazole. In general, women disliked taking repeated courses of metronidazole and preferred lactic acid gel, even when they were aware that it was less likely to provide symptom resolution. In the absence of effective curative therapy, further evaluation of non-antibiotic treatments to control the symptoms of recurrent bacterial vaginosis is required to improve quality of life for these patients. Further microbiological analysis of vaginal samples would be useful to identify additional factors affecting response to treatment.
    Citation
    Armstrong-Buisseret L, Brittain C, Kai J, David M, Anstey Watkins J, Ozolins M, Jackson L, Abdali Z, Hepburn T, Griffiths F, Montgomery A, Daniels J, Manley A, Dean G, Ross JD. Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT. Health Technol Assess. 2022 Jan;26(2):1-170. doi: 10.3310/ZZKH4176. PMID: 35057905
    Type
    Article
    URI
    http://hdl.handle.net/20.500.12904/15734
    Note
    This article relates to a research study that included patients or members of the workforce as study participants from GP practices in Nottingham and Nottinghamshire.
    Collections
    Primary Care Publications

    entitlement

     
    DSpace software (copyright © 2002 - 2023)  DuraSpace
    Quick Guide | Contact Us
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.