Intended for healthcare professionals

  1. Research
  2. Effect of...
  3. Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial
Primary Care

Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial

BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.38210.494977.DE (Published 02 September 2004) Cite this as: BMJ 2004;329:548
  1. Marie Pirotta, senior lecturer (m.pirotta{at}unimelb.edu.au)1,
  2. Jane Gunn, associate professor1,
  3. Patty Chondros, statistician1,
  4. Sonia Grover, senior obstetrician2,
  5. Paula O'Malley, research assistant1,
  6. Susan Hurley, associate lecturer3,
  7. Suzanne Garland, professor, department of microbiology and infectious diseases2
  1. 1 Department of General Practice, 200 Berkeley Street, Carlton, Victoria, Australia, 3053
  2. 2 Royal Women's Hospital, Women's and Children's Health, 132 Grattan Street, Carlton, Victoria
  3. 3 School of Population Health, University of Melbourne, Swanston Street, Carlton, Victoria
  1. Correspondence to: M Pirotta

    Abstract

    Objective To test whether oral or vaginal lactobacillus can prevent vulvovaginitis after antibiotic treatment.

    Design Randomised, placebo controlled, double blind, factorial 2×2 trial.

    Setting Fifty general practices and 16 pharmacies in Melbourne, Australia.

    Participants Non-pregnant women aged 18-50 years who required a short course of oral antibiotics for a non-gynaecological infection: 278 were enrolled in the study, and results were available for 235.

    Interventions Lactobacillus preparations taken orally or vaginally, or both, from enrolment until four days after completion of their antibiotic course.

    Main outcome measures Participants' reports of symptoms of post-antibiotic vulvovaginitis, with microbiological evidence of candidiasis provided by a self obtained vaginal swab.

    Results Overall, 55/235 (23% (95% confidence interval 18% to 29%)) women developed post-antibiotic vulvovaginitis. Compared with placebo, the odds ratio for developing post-antibiotic vulvovaginitis with oral lactobacillus was 1.06 (95% confidence interval 0.58 to 1.94) and with vaginal lactobacillus 1.38 (0.75 to 2.54). Compliance with antibiotics and interventions was high. The trial was terminated after the second interim analysis because of lack of effect of the interventions. Given the data at this time, the chances of detecting a significant reduction in vulvovaginitis with oral or vaginal lactobacillus treatment were less than 0.032 and 0.0006 respectively if the trial proceeded to full enrolment.

    Conclusions The use of oral or vaginal forms of lactobacillus to prevent post-antibiotic vulvovaginitis is not supported by these results. Further research on this subject is unlikely to be fruitful, unless new understandings about the pathogenesis of post-antibiotic vulvovaginitis indicate a possible role for lactobacillus.

    Footnotes

    • We thank all the women, general practitioners, and pharmacists who participated in this study. Nutrition Care and Institut Rosell kindly donated the treatments and placebos used. Health Care Network developed a software prompt for use in trial recruitment. Mayne Health and Gribbles Pathology provided free transportation of some microbiological specimens. We thank Professor Judith Lumley for chairing the Data Monitoring Committee and Ms Cate Nagle for managing the randomisation schedule.

    • Contributors MP and JG initiated the study and, together with PC, SGrover, SGarland, and SH developed the study design and wrote the grant application. MP and PO'M worked on data collection and literature searching. PCand MP worked on statistical analysis. All authors contributed to data interpretation, and manuscript preparation. MP is guarantor for the study.

    • Funding The study was funded by a Quality Use of Medicine Scholarship funded by the Australian Commonwealth Department of Health and Aging; the Shepherd Foundation; the Royal Australian College of General Practitioners; Nutrition Care; Institut Rosell; Health Care Network; and Mr Sean Howard.

    • Competing interests MP received active treatments, placebos, and funding for this research from Nutrition Care and Institut Rosell.

    • Ethical approval The Royal Australian College of General Practitioners and the Royal Women's Hospital, Melbourne, granted ethical approval.

    View Full Text
    Back to top