KEY TAKEAWAYS
- The PALOMA trial aimed to evaluate the effectiveness of a vaginal gel containing coriolus versicolor in regressing HPV-related cervical atypia (ASCUS & LSIL), improving colposcopic findings, and clearing high-risk HPV (AR).
- The result demonstrated that the Papilocare® effectively normalized Pap smears and colposcopy findings in women with HPV-linked cervical issues, showing even greater promise in clearing high-risk HPV.
Papilocare®, a vaginal gel containing Coriolus versicolor, has demonstrated its capacity to significantly impact cervix re-epithelialization and promote the rebalancing of the vaginal microbiota, thereby supporting the natural process of vaginal immunity.
Researchers aimed to evaluate the effectiveness of a vaginal gel containing coriolus versicolor in regressing HPV-related cervical atypia (ASCUS & LSIL), improving colposcopic findings, and clearing high-risk HPV (AR).
The study included women aged 30-65 who hadn’t received the HPV vaccine and tested positive for HPV. They had slightly abnormal cell changes (ASCUS or LSIL) on a Pap test and similar findings during a colposcopy. Papilocare® was administered with one cannula daily for the first month, followed by one cannula every other day for the subsequent five months.
The control group received no treatment, following standard clinical practice. Cytology and HPV readings were centrally conducted at the HJRJ laboratory, and the Chi-square test was utilized for analysis.
In about 20 patients with a mean age of 41.3 years and a determined HPV genotype, notable findings emerged. After 6 months, Papilocare® treatment revealed an 80% (8/10) incidence of normal cytology with concordant colposcopy, surpassing the 50% (5/10) observed in the control group (P= 0.001).
Papilocare® demonstrated a substantial 70% (7/10) clearance of HR-HPV, contrasting with the 40% (4/10) clearance observed in the control group (P= 0.02).
The results indicate that Papilocare® effectively normalized Pap smears and colposcopy findings in women with HPV-linked cervical issues, showing even greater promise in clearing high-risk HPV.
Source: https://ijgc.bmj.com/content/33/Suppl_3/A343.2
Clinical Trial: https://clinicaltrials.gov/study/NCT04002154
Gonzalez EL, Salas MP, Cabalea ME#229 Effect of a vaginal gel with coriolus versicolor on cervical lesions and HPV clearanceInternational Journal of Gynecologic Cancer 2023;33:A343.
