Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial

BMC Women's Health

Research Article

Anna Tomusiak¹  Piotr B. Heczko¹  Magdalena Strus¹  Artur J. Jakimiuk²  Magdalena Suda-Szczurek³  Aleksandra Mikołajczyk-Cichońska³  Grzegorz Stefański³  Paweł Adamski⁴ 

[1] Chair of Microbiology, Jagiellonian University Medical College, Krakow, Poland;Clinical Department of Obstetrics and Gynecology, Central Clinical Hospital of Ministry of Interior and Administration, Warsaw, Poland;Department of Reproductive Health Research Institute of Mother and Child, Warsaw, Poland;IBSS BIOMED S.A, Krakow, Poland;Institute of Nature Conservation, Polish Academy of Sciences, Krakow, Poland;

关键词: Probiotics;    Lactobacillus;    Bacterial vaginosis;    Aerobic vaginitis;   

DOI  :  10.1186/s12905-015-0246-6

 received in 2014-06-16, accepted in 2015-10-06,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundThis multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag®) containing three Lactobacillus strains together with standard metronidazole treatment and also targeted antibiotic treatment (following the failure of metronidazole therapy) could reduce the recurrence rates of bacterial vaginosis (BV) and aerobic vaginitis (AV).MethodsPatients at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive metronidazole and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5–6 (I, II, II bis – if applicable, III, IV, V). One probiotic or placebo capsule was administered with metronidazole/targeted antibiotic twice daily for 10 days; during follow up, patients took one capsule daily for 10 days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n = 285; placebo, n = 293) 18–50-year-old women who were randomised.ResultsBV/AV was confirmed microbiologically in 241 (probiotic, n = 118; placebo, n = 123) participants, who continued the trial. Data from 154 (probiotic, n = 73; placebo, n = 81) participants who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n = 22; placebo, n = 15) participants who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51 % (p < 0.05) compared with placebo; AV relapse was delayed by up to 76 % (p < 0.05). Probiotic use also reduced and maintained low vaginal pH and Nugent score, and increased vaginal Lactobacillus counts following standard treatment.ConclusionThis study demonstrated that oral probiotics lengthened remission in patients with recurrent BV/AV and improved clinical and microbiological parameters.Trial registrationNCT01993524; 20 November 2013.

【 授权许可】

CC BY   
© Heczko et al. 2015