Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial.
OBJECTIVE
To test whether oral or vaginal lactobacillus can prevent vulvovaginitis after antibiotic treatment.


METHODS
Randomised, placebo controlled, double blind, factorial 2x2 trial.


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


METHODS
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.


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


METHODS
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 enrollment.


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.
Pirotta
Marie
M
Department of General Practice, 200 Berkeley Street, Carlton, Victoria, Australia, 3053. m.pirotta@unimelb.edu.au
Gunn
Jane
J
Chondros
Patty
P
Grover
Sonia
S
O'Malley
Paula
P
Hurley
Susan
S
Garland
Suzanne
S
D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D002181:Candidiasis, Vulvovaginal / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007778:Lactobacillus; D008875:Middle Aged; D016896:Treatment Outcome; D014848:Vulvovaginitis / Q000517:prevention & control
D000900:Anti-Bacterial Agents