Dataset Information

Probiotics administered intravaginally as a complementary therapy combined with antibiotics for the treatment of bacterial vaginosis: a systematic review protocol.

ABSTRACT:

Introduction

Bacterial vaginosis (BV) is a highly prevalent vaginal polymicrobial disorder commonly encountered in women of childbearing age. Therapy with only recommended antibiotics results in low cure rates and unacceptably high recurrence rates. The use of probiotics as a complementary approach for use with antibiotics for the treatment of BV remains unclear. This review aims to assess the efficacy of lactobacilli administered intravaginally in conjunction with antibiotics for the treatment of BV.

Methods and analysis

The Cochrane Central Register of Controlled Trials in The Cochrane Library, Cochrane Library of Systematic Reviews, Medline/PubMed and Embase will be used to search for articles from database inception to November 2016. Randomised controlled clinical trials using lactobacilli administered intravaginally in conjunction with antibiotics to treat BV will be included. Primary outcome will be the BV cure rate. The recurrence rate will be examined as secondary outcome. Two reviewers will independently select trials and extract data from the original publications. The risk of bias will be assessed according to the Cochrane Risk of Bias tool. We will perform data synthesis using the Review Manager (RevMan) software V.5.2.3. To assess heterogeneity, we will compute the I² statistic.

Ethics and dissemination

This study will be a review of published data and it is not necessary to obtain ethical approval. Findings of this systematic review will be published in a peer-reviewed journal.

Trial registration number

International Prospective Register of Systematic Reviews 2014: CRD42014015079.

SUBMITTER: Ma L

PROVIDER: S-EPMC5706491 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Publications

Probiotics administered intravaginally as a complementary therapy combined with antibiotics for the treatment of bacterial vaginosis: a systematic review protocol.

Ma Liyan L Su Jianrong J Su Yanli Y Sun Wei W Zeng Zhaoying Z

BMJ open 20171015 10

<h4>Introduction</h4>Bacterial vaginosis (BV) is a highly prevalent vaginal polymicrobial disorder commonly encountered in women of childbearing age. Therapy with only recommended antibiotics results in low cure rates and unacceptably high recurrence rates. The use of probiotics as a complementary approach for use with antibiotics for the treatment of BV remains unclear. This review aims to assess the efficacy of lactobacilli administered intravaginally in conjunction with antibiotics for the tr ...[more]

PMID: 29038188

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Project description:Introduction The evidence for probiotic efficacy in preventing bacterial vaginosis (BV) recurrences among women aged 18 years and above is sparse. We aimed to ascertain the efficacy of probiotics in preventing BV recurrences after at least one menstrual cycle in this population. Methods We conducted a systematic literature search using PubMed, MEDLINE (Ovid interface), Web of Science (WoS), Scopus, Embase, ProQuest Dissertations and Theses Global, Cochrane Library databases and registries comprised of Open Science Framework (OSF) preprints registry, the ClinicalTrials.gov (USA), WHO International Clinical Trials Registry Platform (WHO-ICTRP), International Standard RCT Number (ISRCTN) registry, limited to randomized clinical trials (RCTs) in English published between January 2000 and December 2021. The inclusion criteria were trials that administered probiotics to BV-positive women in an experimental arm of at least 20 samples. The usage of probiotics should be preceded with standard antibiotic regimen and followed by a reassessment of BV status after at least a single menstrual cycle. Risk of bias assessment was completed using revised Cochrane risk-of-bias tool for randomized trials (RoB 2). The PROSPERO registration number of the review is CRD42022302044. Results From 8,162 identified records, we included 10 studies (n = 1,234 participants) for final analysis; 7 trials compared probiotics vs. placebo, whereas 3 trials compared probiotics vs. metronidazole alone. Using random-effects meta-analysis, probiotics were shown to reduce the risk of BV recurrences by 45% compared to either placebo or metronidazole [14.8 vs. 25.5%, RR: 0.55 (95%CI: 0.33, 0.91), p = 0.03, I2 = 45.4% (95%CI: 0, 73.7%)]. Sensitivity analysis revealed the robustness of results upon removal of studies with high risk of bias [RR: 0.54 (95%CI: 0.38, 0.77), p = 0.006] and reporting bias (RR: 0.53, 95%CI: 0.39, 0.74, p = 0.002). Meta-regression demonstrated that the route of administration (pvaginal = 0.67; poral = 0.44), the total dosage of probiotics (p = 0.17), cumulative days of probiotic administration (p = 0.76), and the number of species in probiotic preparation (p = 0.40) were not linked to BV recurrences. Interpretation Probiotics were associated with more than twofold reduction in BV recurrences when BV status was assessed after at least 1-month postintervention. Further high-quality and methodologically standardized RCTs should evaluate probiotic efficacy for BV prevention in a diverse community setting. Systematic review registration [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021290613], identifier [CRD42021290613].

Project description: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.

Project description:BACKGROUND:Bacterial vaginosis (BV) is one of the common vaginal infections among childbearing women. The usual treatment for BV is metronidazole; hence 30% of women have recurrence within 60 to 90?days after treatment. There are some studies which assessed the effect of secnidazole on BV. The aim of this systematic review was to investigate the effectiveness of secnidazole for treatment of BV. METHODS:The Cochrane Library, MEDLINE (PubMed), Scopus, and Web of Science (all databases from inception till October 28, 2018) were searched. Primary outcomes were clinical cure rate and microbiologic cure rate and the secondary outcomes were adverse events. Data was extracted from eligible studies by two review authors individually and analyzed by RevMan 5.3. RESULTS:Our search found six trials involving 1528 participants. Treatment with 2?g secnidazole could significantly reduce the risk of BV in patients with three or less episodes of BV in the last year by OR: 7.54 (95% CI, 3.89-14.60, p?<?0.00001) and in patients with four or more episodes of BV in the last year (OR: 4.74, 95% CI: 1.51-14.84, p?=?0.0.008). Secnidazole (2?g) could significantly increase the microbiologic cure rate in women with 3 or less episodes of BV in the last year (OR: 7.63, 95% CI: 2.30-25.33, p?=?0.0009) but not in the women with 4 or more episodes of BV in the last year (OR: 20.17, 95% CI: 1.06-382.45, p?=?0.05). The clinical cure rate, microbiological effect and the therapeutic cure rate of 2?g secnidazole was significantly more than that of 1?g secnidazole. The results showed that the clinical cure rate of 2?g secnidazole was not different from the following medications: metronidazole (500?mg bid for 5?days), secnidazole plus vaginal metronidazole, 2?g single dose of oral metronidazole and 2?g secnidazole plus vaginal ornidazole. CONCLUSION:This review showed that 2?g and 1?g secnidazole were better than placebo, however, 2?g secnidazole was more effective than 1?g. Secnidazole 2?g was not different from metronidazole (500?mg bid for 5?days), or from secnidazole plus vaginal metronidazole, or 2?g single dose of oral metronidazole or from 2?g secnidazole plus vaginal ornidazole.

Dataset Information

Probiotics administered intravaginally as a complementary therapy combined with antibiotics for the treatment of bacterial vaginosis: a systematic review protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Probiotics administered intravaginally as a complementary therapy combined with antibiotics for the treatment of bacterial vaginosis: a systematic review protocol.

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