Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial.
This study enrolled 125 premenopausal women diagnosed with bacterial vaginosis (BV) by presence of vaginal irritation, discharge and 'fishy' odor, and Nugent criteria and detection of sialidase enzyme. The subjects were treated with oral metronidazole (500 mg) twice daily from days 1 to 7, and randomized to receive oral Lactobacillus rhamnosus GR-1 (1 x 10(9)) and Lactobacillus reuteri RC-14 (1 x 10(9)) or placebo twice daily from days 1 to 30. Primary outcome was cure of BV as determined by normal Nugent score, negative sialidase test and no symptoms or signs of BV at day 30. A total of 106 subjects returned for 30-day follow-up, of which 88% were cured in the antibiotic/probiotic group compared to 40% in the antibiotic/placebo group (p<0.001). Of the remaining subjects, 30% subjects in the placebo group and none in the probiotic group had BV, while 30% in the placebo and 12% in the probiotic group fell into the intermediate category based upon Nugent score, sialidase result and clinical findings. High counts of Lactobacillus sp. (>10(5) CFU/ml) were recovered from the vagina of 96% probiotic-treated subjects compared to 53% controls at day 30. In summary, this study showed efficacious use of lactobacilli and antibiotic in the eradication of BV in black African women.
Anukam
Kingsley
K
Department of Pharmaceutical Microbiology, Faculty of Pharmacy, University of Benin, Nigeria. anukamkc@yahoo.com
Osazuwa
Emmanuel
E
Ahonkhai
Ijeoma
I
Ngwu
Michael
M
Osemene
Gibson
G
Bruce
Andrew W
AW
Reid
Gregor
G
D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D052200:Limosilactobacillus reuteri; D052201:Lacticaseibacillus rhamnosus; D008795:Metronidazole / Q000627:therapeutic use*; D009549:Nigeria; D010919:Placebos; D019936:Probiotics / Q000627:therapeutic use*; D014621:Vagina / Q000382:microbiology; D016585:Vaginosis, Bacterial / Q000188:drug therapy*
D000890:Anti-Infective Agents; D010919:Placebos; D008795:Metronidazole