Obstetrics & Gynecology · Medical Literature
Efficacy of live lactobacillus preparations in treating cervical inflammation and clearing viral infections in patients with HPV infection complicated by bacterial vaginosis.
Abstract
This study aimed to evaluate the efficacy and safety of Dingjunsheng, a live Lactobacillus preparation, as adjuvant therapy in patients with human papillomavirus (HPV) infection complicated by bacterial vaginosis (BV). A retrospective analysis was conducted on 152 eligible patients, randomly divided into two groups: the observation group (n=87) receiving standard BV antibacterial therapy plus Dingjunsheng, and the control group (n=65) who received standard BV antibacterial therapy alone. The patients were followed up for six months. Primary outcomes included HPV clearance rate and cervical cytological inflammation improvement, while secondary outcomes involved BV recurrence rate and adverse reaction incidence. The results showed that the observation group had a significantly higher HPV clearance rate (73.6% vs 53.9%) and inflammation improvement rate (90.8% vs 76.9%), as well as a lower BV recurrence rate (3.1% vs 13.9%) compared to the control group. Dingjunsheng was identified as an independent protective factor for HPV clearance (OR=2.5, 95%CI:1.3-5.1). The incidence of adverse reactions was similar between both groups. We conclude that Dingjunsheng adjuvant therapy demonstrated effectiveness in improving HPV clearance, alleviating inflammation, and reducing BV recurrence, with good safety, making it a valuable treatment strategy for these patients.
Clinical relevance
In patients with concurrent HPV infection and bacterial vaginosis, does the addition of Dingjunsheng (a live Lactobacillus preparation) to standard antibacterial therapy improve HPV clearance, cervical cytological inflammation, and BV recurrence rates compared with standard antibacterial therapy alone over a six-month follow-up period? __SNAPSHOT__ {"studyDesign":"Retrospective cohort study with reported random group allocation (described as 'retrospective analysis... randomly divided into two groups'; the methodological validity of this characterization is uncertain — see Limitations)","setting":"Not explicitly reported; institutional type and country not specified in the abstract. Publication in a Chinese OB/GYN-focused journal and use of a China-marketed probiotic product (Dingjunsheng®) suggest a Chinese clinical setting.","sampleSize":"n=152 total (observation group: n=87; control group: n=65); groups are unequal in size, allocation method not described","population":"Women with confirmed HPV infection complicated by concurrent bacterial vaginosis (BV); specific HPV genotype breakdown, disease severity, age range, parity, immunocompromise status, and prior treatment history not reported in the abstract","intervention":"Standard BV antibacterial therapy (specific agent and dosing not reported) plus Dingjunsheng® (a live Lactobacillus preparation; specific strain composition, dosing, route of administration, and treatment duration not reported in the abstract)","comparator":"Standard BV antibacterial therapy alone (specific regimen not reported)","primaryOutcome":"HPV clearance rate and cervical cytological inflammation improvement rate at six months","followUp":"Six months","fundingSource":"Not reported"}
Key findings
The observation group (Dingjunsheng + standard therapy) demonstrated a higher HPV clearance rate compared to the control group (73.6% vs. 53.9%), an absolute difference of 19.7 percentage points (calculated), corresponding to a number needed to treat of approximately 5.1 (calculated). The cervical cytological inflammation improvement rate was also higher in the observation group (90.8% vs. 76.9%), an absolute difference of 13.9 percentage points (calculated), NNT approximately 7.2 (calculated). BV recurrence was lower in the observation group (3.1% vs. 13.9%), an absolute risk reduction of 10.8 percentage points (calculated), NNH approximately 9.3 to prevent one recurrence (calculated). On multivariate logistic regression, Dingjunsheng use was identified as an independent protective factor for HPV clearance (OR=2.5, 95% CI: 1.3–5.1). The lower bound of this confidence interval just exceeds 1.0, indicating a statistically significant but modest effect size. P-values for individual comparisons were not reported in the abstract. The incidence of adverse reactions was reported as similar between groups; specific adverse event rates were not reported.
Practice implications
This study suggests that adjuvant use of the live Lactobacillus preparation Dingjunsheng alongside standard BV antibacterial therapy may improve HPV clearance rates and reduce BV recurrence in women with co-existing HPV infection and BV over six months. These findings are biologically plausible given the established association between Lactobacillus-dominant vaginal microbiota and HPV clearance, as well as BV's known role in promoting HPV persistence through immune dysregulation and mucosal barrier disruption. However, several critical caveats limit the applicability of these findings. First, this is a retrospective analysis with reportedly randomized group allocation — a methodological contradiction that raises significant concerns about selection bias and allocation concealment. Second, the standard antibacterial regimen and Dingjunsheng dosing, strain identity, route, and duration were not specified in the abstract, making replication impossible. Third, HPV genotype distribution (high-risk vs. low-risk), baseline viral load, and cytologic severity were not described, limiting risk stratification. Fourth, only an abstract was available for this review; the full methodology, statistical reporting, and baseline characteristics tables could not be assessed. Fifth, the study was conducted in a likely Chinese institutional setting, and Dingjunsheng® is a China-specific formulation whose specific Lactobacillus strain (reported in other sources as L. delbrueckii, a non-human-origin strain) may differ from strains used in Western or other international probiotic products, limiting direct generalizability. Patients who are immunocompromised, pregnant, postmenopausal, or have high-grade cervical lesions were not identified as included or excluded, making applicability to these groups unclear. __LIMITATIONS__ Retrospective design with internally contradictory 'random' allocation — true randomization cannot be confirmed, and concealment and blinding were almost certainly absent, introducing selection and performance bias.,Unequal group sizes (n=87 vs. n=65) with no explanation for allocation disparity, further raising allocation concerns.,Specific antibacterial regimen, Lactobacillus strain(s), dosing, and route of Dingjunsheng not reported in the abstract, preventing critical appraisal of the intervention.,HPV genotype, viral load, cervical cytology grade at baseline, and relevant comorbidities not reported — these are critical confounders for HPV clearance outcomes.,No p-values for individual outcome comparisons reported in the abstract; statistical methods for primary outcomes not described.,Short follow-up of six months is insufficient to assess durable HPV clearance or long-term BV recurrence, given known spontaneous HPV clearance rates.,No blinding of patients or outcome assessors, which may introduce ascertainment bias for subjective endpoints like inflammation improvement.,Adverse event data reported only as 'similar between groups' without specific rates or event types, precluding safety assessment.,Funding source not disclosed; potential conflicts of interest cannot be evaluated.,Generalizability limited to the specific population and product studied; Dingjunsheng® is a Chinese market product not available in many healthcare systems.,Only the abstract was available for review; full-text methodological details, CONSORT reporting, and baseline characteristic tables were not accessible. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This retrospective study reports that adding Dingjunsheng (a live Lactobacillus preparation) to standard BV antibacterial therapy was associated with higher HPV clearance (73.6% vs. 53.9%) and lower BV recurrence (3.1% vs. 13.9%) at six months in women with co-existing HPV infection and BV. However, the contradictory 'retrospective-but-randomized' design, unspecified intervention details, absent genotype and baseline data, and lack of blinding substantially limit confidence in these findings. Practice change is not warranted; a well-designed, prospectively registered RCT with defined strain, dosing, and HPV genotype stratification is needed before clinical adoption.