9 mei 2022: zie ook dit artikel dat ik van een update heb voorzien: https://kanker-actueel.nl/coriolus-versicolor-bestrijdt-succesvol-hpv-virus-bij-patienten-met-baarmoederhalstumoren-en-reduceert-grootte-tumoren-en-graad-van-kwaadaardigheid-na-1-jaar-was-91-van-het-hpv-virus-verdwenen-in-suppletiegroep.html
18 december 2021: Zie ook dit artikel: https://kanker-actueel.nl/coriolus-versicolor-blijkt-effectief-natuurlijk-middel-tegen-hpv-virus.html
18 december 2021: Bron: JLow Genit Tract Dis. 2021 Apr; 25(2): 130–136.
Een vaginale gel gebaseerd op Coriolus versicolor bij vrouwen met HPV = humaan papillomavirus gerelateerde baarmoederhalsinfecties en tumoren is veel effectiever in het laten verdwijnen van tumoren en HPV - infecties dan een gecontroleerde conventionele benadering (N = 59 vs 44 patiënten) blijkt uit de resultaten van de PALOMA studie, een multicenter, open-label, gerandomiseerde parallelgroep.
Het percentage patiënten met een normaal uitstrijkje en vergelijkende colposcopie 3 en 6 maanden na behandeling (respectievelijk 78,0% en 84,9%) waarbij de HPV infectie was verdwenen was significant hoger dan zonder behandeling (54,8% en 64,5%), vooral bij hoog-risico HPV-patiënten (79,5% en 87,8% versus 52,0% en 56,0%). Na een bezoek van 6 maanden werd de algehele HPV-infectie verwijdering bereikt door een groter aantal patiënten dat werd behandeld (59,6%) in vergelijking met patiënten zonder behandeling (41,9%), vooral bij HPV-patiënten met een hoog risico (62,5% versus 40,0%).
De onderzoekers concluderen: Behandeling met Papilocare heeft een beter klinisch voordeel aangetoond dan de conventionele waakzame benadering in de klinische praktijk voor HPV-patiënten met een totaal en hoog risico in termen van werkzaamheid om HPV-gerelateerde cervicale laesies te behandelen en om alle HPV-stammen te verwijderen na een enkele 6-maandelijkse periode. Het heeft een adequate veiligheid en verdraagbaarheid aangetoond en biedt extra voordelen zoals een hogere re-epithelisatie, stressvermindering en een hoge therapietrouw.
Het volledige studierapport is gratis in te zien. Klik op de titel voor het abstract:
Efficacy of a Coriolus versicolor–Based Vaginal Gel in Women With Human Papillomavirus–Dependent Cervical Lesions: The PALOMA Study
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.
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.
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.
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.
Approximately 30% of Spanish women younger than 30 years are HPV carriers.25 The likelihood of HPV infection decreases over time, from 47% between the ages of 15 and 19 years to 12% in women older than 45 years.26 The HPV is a fundamental factor for the development of cervical cancer.27 The World Health Organization has recently established the elimination of cervical cancer as a priority medium-term objective.28 This trial aimed to explore whether treatment with Papilocare provides better results than the conventional watchful waiting strategy in improving low-grade cervical lesions, which are the first step in the natural history of cervical cancer.29 Clearance of LSILs after a conservative approach is of approximately 59% within 2 years of the diagnosis. Nevertheless, the likelihood of progression of these lesions to a high-grade squamous intraepithelial lesion within 5 years is 12.7%.30 In addition, treatments for cervical cancer severely compromise the reproductive health of women. In a systematic review of Cochrane, Kyrgiou et al.31 demonstrated a higher baseline risk for prematurity in women with cervical intraepithelial neoplasia, which increased with excisional and ablative treatments. Therefore, the scenario is conflicting, as choosing an excisional or ablative approach for the treatment of LSILs can result in negative reproductive outcomes, but avoiding treatment and just monitoring the disease results in its progression to high-grade lesions in 12 of 100 women. The current recommendation in Spain also includes monitoring the disease.32,33 However, based on the results of this present study, a novel strategy involving Papilocare has become available. The results of this treatment in the repair of low-grade lesions have demonstrated to significantly exceed those obtained with the watchful waiting approach (8 in 10 women achieved a normalization in their lesions).
Spontaneous clearance of the HR HPV occurs in approximately 29% and 41% of cases at 6 and 18 months, respectively.34 The HPV clearance rates seen in our study were higher, i.e., more than twice (63%) the established value at 6 months. This finding has important clinical implications considering the fact that the only guidelines that a physician can provide to their female patients to clear HPV is to maintain their vaginal health or, in the case or active smokers, to quit smoking. This absence of solutions may increase stress levels in many women. Indeed, the results of our study revealed a differential trend with respect to perceived stress, with increased reported levels in the control group and reduced ones in the treatment group. Thus, based on the results of our study, we believe that Papilocare should be included among the advices for the treatment of HPV considering its ability to double the clearance rate of HR HPV.
The results of our study have been replicated in several independent, observational, noncontrolled studies performed in Spanish public university hospitals.35–37 The 6-month effectiveness of Papilocare was evaluated and confirmed in all of the studies (between 53% and 72.5% of cases achieved a negative cytology and/or HPV clearance/reduced viral load). An update of the study by Riera et al.,38 which included a watchful waiting control group, revealed a significantly higher percentage of responders in the group treated with Papilocare compared with the controls (80.0% vs 51.4%). Recent interim results from the observational, multicenter, prospective, single-cohort PAPILOBS study (#NTC04199260) revealed a notable effect of Papilocare at 6 months in repairing HPV-dependent low-grade cervical lesions and clearing HPV (66% and 63% of patients, respectively) under real-life conditions.39 Data obtained in the present study in relation to the HPV clearance, especially in HR HPV patients, are consistent with real-world data obtained in other studies.40 Moreover, in this trial, the degree of cervical re-epithelization was significantly higher with Papilocare compared with the control group. This beneficial effect on re-epithelization was also observed by Palacios et al.15 in a pilot study performed with 21 asymptomatic non–HPV-infected women, in which women treated Papilocare achieved improved cervical re-epithelization (from 3.1 to 4.4 according to the same cervical epithelization scoring system used in the present study). Similarly, Gálvez et al.16 reported a significant 20% improvement in cervical re-epithelialization in HPV-positive lesion-free women treated with Papilocare (3.8 vs 4.5) compared with baseline.
In addition, treatment with Papilocare is safe, as most AEs reported in this study were mild or moderate in severity. Moreover, most of the participants were satisfied with the treatment, and therapeutic adherence exceeded 90%. Nevertheless, our study has certain limitations: (1) the lack of information about cofactors for the progression of cervical HPV infection to cancer, such as smoking41 (lacking in the present study), or adjusting all analyses by covariables in patients, which could have avoided potential interferences in the results, and (2) it should be noted that we used a cytology plus concordant colposcopic observations to evaluate the normalization of lesions. Biopsies were not performed in the study because all women presented low-grade cytological alterations with normal colposcopy or grade 1 changes, decision in agreement with guidelines recommendations,32,42 and also because biopsy can modify the natural history of the lesion. Thus, the present article does not provide evidence on the treatment and prevention of dysplasia; (3) colposcopic concordance and epithelization assessments were also performed in an unblinded manner; thus, subjectivity associated with these outcomes could have resulted in an assessment bias; (4) the “partial clearance” was included as part of the overall HPV clearance secondary end point (see method section) according to the concept that 1 HPV-related lesion is very frequently caused by just 1 viral subtype, despite the presence of multiple HPV types.43 With regression of the lesion as well as clearance of one of the oncogenic HPV subtypes, it is likely that the causative virus has been eliminated. Nevertheless, the risk of future lesions and dysplasia remains if the residual HPV subtype is a HR HPV, (5) Given the exploratory nature of the study and the concomitant determination of the sample size, the number of patients was insufficient for identifying statistical differences in certain secondary variables for which tendencies were observed. (6) Moreover, for our initial exploration, we aimed to analyze all women, not only those with HR HPV, and to obtain results that could be extrapolated for the general population. Additional subanalyses that already were planned in the protocol will determine the efficacy and safety of Papilocare on HR HPV patients. Further ongoing clinical trials have already included only HR HPV patients (the PAPILOCAN clinical trial #NCT04210336 and the PALOMA II clinical trial #NTC04199078). Besides these limitations, comparisons made with the conventional approach applied in standard clinical practice are very useful and provide evidence that new interventions for the management of HPV are required.
Treatment with Papilocare has demonstrated a better clinical benefit than the conventional watchful waiting approach in clinical practice for HPV-positive patients, especially for those with HR HPV. Papilocare has shown significant efficacy in the treatment of low-grade cervical lesions associated with HPV and a positive trend in increasing HPV clearance after a 6-month period. Moreover, it shows good safety and tolerability and confers additional benefits, such as a significant improvement in cervical re-epithelization, a positive trend in perceived stress reduction, and high therapeutic adherence.
The authors thank all the people and institutions that collaborated in developing this project, including Dr Juan Carlos Martínez Escoriza of Hospital General Universitario, Alicante, Spain; Dr Juan José Hernández, Dr Ester Martínez, and Dr Gema Aguión of Hospital Universitario Infanta Leonor, Madrid, Spain; Dr Jessica Martín, Dr Carmen González, Dr José Carlos Vilches, and Dr Laura López of Hospital Quironsalud, Málaga, Spain, for their cooperation as coinvestigators; Dr Alfonso Alba of Instituto de Estudios Celulares y Moleculares, Lugo, Spain, for his excellent work at the centralized laboratory; Dr Fernando Losa for his contributions during the drafting of the manuscript; Andrea Moral (project leader of the CRO Adknoma Health Research SL, Barcelona, Spain) for her invaluable operative support during the entire study; and Procare Health Iberia SL for financially supporting the project and its total transparency in all proceedings.
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.
Supported by Procare Health Iberia SL.
The study has been evaluated and approved by the following institutional review boards: the Comité Ético de Investigación Clínica del Hospital Universitario de la Princesa, the Comité Ético de Investigación Clínica de Clínica Tres Torres-Centre Cardiovascular Sant Jordi, the Comité de Ética de la Investigación Provincial de Málaga, the Comité Ético de Investigación Clínica del Grupo Hospitalario Quirón, the Comité Ético de Investigación Clínica del Hospital General Universitario Gregorio Marañón, the Comité Ético de Investigación Clínica de la Fundació Sanitària del Hospital de la Santa Creu i Sant Pau, the Comité Ético de Investigación Clínica del Hospital General de Alicante, and the Comité Ético Investigación Clínica GAE HCSC Area 7.
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- Coriolus Versicolor bestrijdt succesvol HPV virus bij patienten met baarmoederhalstumoren en reduceert grootte tumoren en graad van kwaadaardigheid. Artikel update 9 april 2010
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