Efficacy of a Coriolus versicolor-Based Vaginal Gel in Women With Human Papillomavirus-Dependent Cervical Lesions: The PALOMA Study
Por:
Serrano, L, Lopez, A, Gonzalez, S, Palacios, S, Dexeus, D, Centeno-Mediavilla, C, Coronado, P, de la Fuente, J, Lopez, J, Vanrell, C and Cortes, J
Publicada:
1 abr 2021
Resumen:
Objective
The aim of the study was to evaluate the efficacy of Papilocare, a Coriolus versicolor-based vaginal gel, in repairing human papillomavirus (HPV)-related low-grade cervical lesions. Methods
The study is a multicenter, open-label, randomized, parallel-group, watchful waiting approach-controlled trial involving 91 HPV-positive women with low-grade Pap smear alterations and consistent colposcopy. Results
The percentage of patients with normal Pap smear and concordant colposcopy 3 and 6 months after receiving treatment (78.0% and 84.9%) was significantly higher than without treatment (54.8% and 64.5%), especially in high-risk HPV patients (79.5% and 87.8% vs 52.0% and 56.0%). At 6-month visit, overall HPV clearance was achieved by a greater number of patients receiving treatment (59.6%) compared with those without treatment (41.9%), especially high-risk HPV ones (62.5% vs 40.0%). The cervical re-epithelization score was significantly higher with treatment (mean = 4.5) than without (mean = 4.1). Compared with baseline, perceived stress decreased in the treatment group (from 21.1 to 19.0) and increased in the control group (from 17.7 to 20.7). A total of 7 possible or probable treatment-related adverse events were reported, most of them (n = 6) being mild or moderate in severity. Conclusions
Treatment with Papilocare has demonstrated a better clinical benefit than the conventional watchful waiting approach in clinical practice for total and high-risk HPV patients in terms of its efficacy to treat HPV-related cervical lesions and to clear all HPV strains after a single 6-month period. It has demonstrated an adequate safety and tolerability and confers additional benefits such as higher re-epithelization, stress reduction, and high treatment adherence.
Filiaciones:
Serrano, L:
HM Gabinete Velazquez, Madrid, Spain
Lopez, A:
Hosp Quironsalud, Malaga, Spain
Gonzalez, S:
HM Gabinete Velazquez, Madrid, Spain
Palacios, S:
Inst Palacios Salud & Med Mujer, Madrid, Spain
Dexeus, D:
Womens Hlth Inst, Barcelona, Spain
Centeno-Mediavilla, C:
Clin Diatros, Barcelona, Spain
Coronado, P:
Hosp Clin San Carlos, Madrid, Spain
de la Fuente, J:
Hosp Univ Infanta Leonor, Madrid, Spain
:
Hosp Gen Univ, Alicante, Spain
Vanrell, C:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
hybrid, Green Published
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