A meta-analysis published in 2019 [44] showed that probiotics alone were more effective in treating BV in both short and long term, whereas probiotics after antibiotic treatment was only effective in the short term.
According to the established retrieval strategy, 926 relevant literatures were preliminarily retrieved. After removing the repeated 455 literatures, there were 471 literatures that can be screened. After excluding reviews, meeting minutes, and others non relevant article types, 382 papers remained. After reading the title and abstract, there were 57 articles left. An additional 37 articles were excluded based on inclusion and exclusion criteria. Finally, 20 relevant articles were included in this study, involving 2093 participants. The flowchart shows the process of literature selection (Fig. 1).
Fig. 1 PRISMA flow diagram Full size image
Risk of bias assessment
The assessment of risk of bias for the included 20 RCTs are shown in Fig. 2. Risk of bias were mainly derived from Random Sequence Generation, eight studies in this section had uncertain bias risk. Six of the included studies achieved a score of seven, indicating good quality. Overall, the quality of the included studies was moderate. Of the 20 studies, most had an uncertain risk of bias, and only five were considered high risk of bias.
Fig. 2 Risk of bias assessment Full size image
Characteristics of the studies
The main characteristics of the 20 randomized controlled trials included in this meta-analysis are shown in Table 1. The included trials were published between 1992 and 2021, and consist of 1067 patients in the experimental group and 1026 patients in the control group. These twenty articles can be divided into three cases according to different experimental schemes. Fourteen randomized controlled trials compared the efficacy of antibiotics in addition to probiotics in BV (antibiotics + probiotics group) and antibiotics alone (or with placebo) in BV (antibiotics (+ placebo) group). Three trials compared the efficacy of probiotics (probiotics group) with antibiotics (antibiotics group) for BV, and three randomized controlled trials compared the efficacy of probiotics (probiotics group) with placebo (placebo group) for BV.
Table 1 Characteristics of the included studies in the meta-analysis Full size table
Meta-analysis of treatment efficacy
A total of 20 RCTs were included in this study which were divided into three groups (G1, G2, G3) for analysis according to the different intervention methods. Funnel plots suggested the heterogeneity between those studies (Fig. 3).
Fig. 3 Funnel plot for risk of bias Full size image
G1: Fourteen randomized controlled trials [19, 24,25,26,27,28,29,30,31,32,33,34,35,36] compared the efficacy of probiotic-assisted antibiotic therapy for BV with antibiotics alone (or plus placebo), including data from 1662 patients with BV. The cure rate was 72.98% (624/855) in the antibiotics + probiotics group and 62.70% (506/807) in the antibiotics (+placebo) group, with P = 0.009, reaching a statistically significant difference. The results showed that RR was 1.23 with 95% CI (1.05, 1.43). However, the results were heterogeneous (I2 = 83%, P < 0.00001), indicating the combined analysis could not be carried out directly, and the subgroup analysis was needed (Fig. 4A).
Fig. 4 Forest plot of efficacy outcome. A Forest plot of Antibiotics + Probiotics/Antibiotics (+Placebo), used the random effect model. B Forest plot of Probiotics/Antibiotics, used the random effect model. C Forest plot of Probiotics/Placebo, used the fixed effect model Full size image
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G2: Three randomized controlled trials [21, 36, 37] were conducted to compare the effects of probiotics and antibiotics. Among them, 92 cases (64.79%) were cured in the probiotics group and 127 cases (77.44%) were cured in the antibiotics group. There was no significant difference in the cure rate of BV between the two treatments (P = 0.72), and there was evidence of obvious heterogeneity (I2 = 92%, P < 0.00001), therefore random effect analysis was used for further analysis. In conclusion (RR = 1.12, 95% CI (0.60, 2.07)), the result of G2 analysis cannot be considered that probiotics alone is more effective in treating BV than using antibiotics alone. The number of articles in G2 is so small that we cannot make further analysis. Therefore, more studies are needed to compare the efficacy of antibiotics alone versus probiotics alone in the treatment of BV (Fig. 4B).
G3: Three randomized controlled trials [38,39,40] compared the efficacy of probiotics with placebo, involving a total of 125 eligible patients with BV. In the probiotics group, 39 out of 70 patients were cured (55.71%), compared to 1 out of 55 patients (0.02%) in the placebo group (P < 0.0001, indicating a statistically significant difference in cure rate). The results of G3 analysis shown I2 = 0% and P = 0.68, indicating that there was a low heterogeneity in the included studies, so a fixed model was used to analyze G3, with a result of RR equaled to 15.20 with 95% CI (3.87, 59.64). We can extrapolate from these results that probiotics might has a therapeutic effect on BV compared to placebo (Fig. 4C).
Subgroup analysis
For studies with large heterogeneity (G1), we set up a subgroup analysis and used a random effects model to explore the causes of heterogeneity (Table 2).
Table 2 Summary of subgroup analysis results Full size table
There were no significant differences in other subgroups, such as vaginal administration of probiotics, diagnostic criteria, recruitment areas and species of probiotics. Although the results of short-term follow-up were statistically significant, the removal of any study could not reduce its heterogeneity, and the high heterogeneity made the results unreliable.
Although studies of oral administration to probiotics had great heterogeneity (P = 0.003, I2 = 72%), but it was statistically significant (P = 0.0001). Sensitivity analysis would be carried out in the next step to further explore the cause of heterogeneity.
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The results of L. rhamnose group and high dose group were statistically significant (P = 0.03, P = 0.006), but mainly affected by route of administration. High-dose probiotics (≥ 1 × 109 CFU) was more effective than low-dose probiotics (< 1 × 109 CFU). When L. rhamnose was taken orally, the results were statistically significant (P = 0.04), but the heterogeneity was high (I2 = 76% P = 0.0008). When L. rhamnose was used in the vagina, the results were not statistically significant. It may be because L. rhamnose is an intestinal isolate.
Sensitivity analysis
Following subgroup analysis of G1, the oral administration route showed higher heterogeneity (I2 = 71%, P = 0.008). When Zhang Y.2021 was excluded, the whole oral administration group showed no heterogeneity (I2 = 0%, P = 0.43). After being analyzed by fixed effects, the results were statistically significant (RR = 1.93, 95% CI (1.59, 2.35), P < 0.00001). This result indicated that when probiotics was added adjunctively in conventional antibiotic therapy for BV treatment, the cure rate was higher than antibiotic therapy alone (or plus placebo) in oral administration. The heterogeneity of Zhang Y.2021 may come from its research method: vaginal administration of metronidazole and oral probiotic, because the research methods of the other four articles were oral antibiotics and oral probiotics.
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