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Randomized Controlled Trial
. 2021 Apr 1;25(2):130-136.
doi: 10.1097/LGT.0000000000000596.

Efficacy of a Coriolus versicolor-Based Vaginal Gel in Women With Human Papillomavirus-Dependent Cervical Lesions: The PALOMA Study

Luis Serrano  1 , Andrés Carlos López  2 , Silvia P González  1 , Santiago Palacios  3 , Damián Dexeus  4 , Cristina Centeno-Mediavilla  5 , Pluvio Coronado  6 , Jesús de la Fuente  7 , José Antonio López  8 , Cristina Vanrell  9 , Javier Cortés  10
Affiliations
Randomized Controlled Trial

Efficacy of a Coriolus versicolor-Based Vaginal Gel in Women With Human Papillomavirus-Dependent Cervical Lesions: The PALOMA Study

Luis Serrano et al. J Low Genit Tract Dis. .

Abstract

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.

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Conflict of interest statement

J.C. declares that he has received travel and/or research grants and/or honoraria for conferences and/or consultancy fees from Genómica, GSK, Merck, Procare Health, Qiagen, Roche, and SPMSD. S.P. declares that he has a financial relationship (as a scientific advisor, member of the advisory board, or consultant) with Pfizer, Amgen, MSD, Sandoz, Procare Health, Bayer, MSD, Serelys, and Shionogi. Furthermore, as a speaker or member of the advisory board, he has received research grants or honoraria from Servier, Pfizer, Abbott, Shionogi, Amgen, Novo Nordisk, Theramex, Bayer Healthcare, Serelys, and Gedeon Richter. D.D. declares that he has received speaking and consultancy fees from Sanofi Pasteur, MSD, and Procare Health. L.S. declares that he has received speaking and consultancy fees from Shionogi, Iprad, and Procare Health. A.C.L. declares that he has received consultancy fees from Procare Health. S.P.G. declares that she has received travel and/or research grants and/or honoraria for conferences and/or scientific advisory and consultancy fees from Isdín, Pfizer, Servier, Amgen, MSD, Kern-Gynea, Casen Recordati, Sandoz, Procare Health, Bayer, Lacer, Shionogi, GSK, Bioiberica, Theramex, Gedeon Richter, Iprad, Seid, Ordesa, and Zambon. C.V. declares that she has received speaking fees from Procare Health. C.C.-M. declares that she has received speaking fees from Bayer and a grant for congress attendance from GSK. P.C. declares that he has received travel grants, conference registration grants and/or honoraria for conferences, and/or consultancy fees from Genómica, GSK, MSD, Abex, Shionogi, Amgen, Lacer, and Pfizer. J.d.l.F. declares that he has received travel and/or research grants and/or honoraria for conferences and/or consultancy fees from GSK, Merck, Procare Health, Roche, SPMSD, Italfármaco, Adamed, Pfizer, and Effik. J.A.L. declares that he has received honoraria for lectures from Procare Health, Gedeon Richter, and Sanofi. The other authors have declared they have no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Patient flowcharts showing the study groups, the total and HR HPV patient pools, and the timeline.
FIGURE 2
FIGURE 2
Repair of HPV-dependent cervical lesions after 3 and 6 months of treatment in the total and HR HPV patient pools. *Normalized cytology together with concordant colposcopic observations. **χ2 test. One high-risk HPV patient of the control group had missing data.
FIGURE 3
FIGURE 3
Changes in the cervical re-epithelization score (Likert scale) between baseline and the 3- and 6-month visits. Values are expressed as the mean together with the SD (between parentheses). *χ2 test.
See this image and copyright information in PMC

Comment in

References

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