Issues
A prospective observational study to evaluate impact of oral supplementation with AHCC and Lactobacillus Crispatus M247 on HPV clearance and low-grade squamous intraepithelial lesion regression
ABSTRACT
Human papillomavirus (HPV), especially high-risk types like HPV 16 and 18, can progress from low-grade lesions (LSIL) to cancer. While HR-HPV and LSIL often regress naturally, some cases may advance to malignancy. Current treatments vary in efficacy and can have adverse effects. Emerging research on Lactobacillus Crispatus M247 and Active Hexose Correlated Compound (AHCC) shows potential for enhancing HPV clearance and LSIL regression with minimal side effects. However, the precise impact of these treatments remains under study.
The primary endpoint is to evaluate the effectiveness of AHCC and L. Crispatus M247 in treating women with chronic cervicitis or low-grade squamous intraepithelial lesions (L-SIL) caused by high-risk HPV. The secondary endpoint is to monitor any side effects and measure patient adherence to the treatment regimen.
This prospective observational cohort study followed 40 women with abnormal cervical cytology up to L-SIL and HR-HPV infection over 6 months. Cohort A (20 patients) underwent AHCC and L. Crispatus treatment, while Cohort B (20 patients), received regular follow-up without specific treatment. The study assessed the treatment’s impact, controlling for age, BMI, sexual history, contraception use, and smoking habits. Key evaluations included molecular tests, colposcopy, and biopsy at the start and end of the study period, with additional monitoring of dropout and adherence rates and any side effects to determine the treatment’s feasibility and safety.
With a 17.5% dropout rate (mostly COVID-related) from the initial 40 patients, no side effects were noted. HR-HPV clearance was achieved by 73.3% in Group A, versus 0% in Group B (p <0.001) at the 6th month. L-SIL regressed to chronic cervicitis in 13% of Group A (p = 0.048), while 26.3% of Group B progressed to H-SIL, significantly differing from Group A (p = 0.042) at the 6th month.
This observational cohort study confirms the feasibility and efficacy of AHCC and L. Crispatus M247 supplementation for improving HR-HPV clearance and L-SIL regression, with no side effects and good adherence. Results support further investigation through randomized controlled trials and studies on the vaginal microbiota’s role in cancer prevention.
IMPACT STATEMENT
Combining AHCC and L. Crispatus M247 significantly enhances HR-HPV clearance and LSIL regression, potentially reducing future oncogenesis risks in patients without adverse effects.