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

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.

La prevención del cáncer ginecológico en la asistencia privada / Prevention of gynecologic cancer in private assistance

Están definidos dos escenarios para la aplicación de las estrategias preventivas de un cáncer, los que se desarrollan en el ámbito de las iniciativas de salud pública y aquellos que se circunscriben a la actividad asistencial personalizada. Saber dónde estamos trabajando y no mezclar estos ámbitos preventivos es imprescindible para alcanzar bien los objetivos, que son diferentes en su ambición, por lo que en su consecución, en pura lógica, deberán ser usadas metodologías también diferentes. A continuación detallamos las que en opinión de los firmantes podrían ser los modelos de conducta a seguir en la actividad asistencial personalizada enfocados a la prevención de los cánceres ginecológicos (AU)

Two scenarios are defined for the application of preventive strategies of cancer, those developed within the scope of public health initiatives and those that are confined to the personalized care activity. Knowing where we are working and not mixing these preventive areas is essential to achieve the objectives properly, which are different in their ambition, so that in their pursuit, in pure logic, there should be used different methodologies. Next are detailed, in the opinion of the signatories, which could be the models of conduct to be followed in the personalized care activity focused on the prevention of gynecological cancers (AU)

Beneficial effects of a Coriolus versicolor-based vaginal gel on cervical epithelization, vaginal microbiota and vaginal health: a pilot study in asymptomatic women.

BACKGROUND: To assess the effect of a 12-day treatment using a vaginal gel based on niosomes containing hyaluronic acid, ß-glucan, alpha-glucan oligosaccharide, Coriolus versicolor, Asian centella, Azadirachta indica and Aloe vera on vaginal microbiota, cervical epithelization and vaginal health. METHODS: Open-label, prospective pilot study conducted in asymptomatic women in daily practice. Cervical epithelization was evaluated by colposcopy using an ectopy epithelization score (from 5: no ectopy to 1: severe ectopy and bleeding), vaginal microbiota using the VaginaStatus-Diagnostic test (Instiüt für Mikroökologie, Herborn, Germany) and further rated by the investigator using a 5-point Liker scale (from 5: normal to 1: very severe deterioration in which all evaluated species were altered), and vaginal health using the Vaginal Health Index. RESULTS: In 21 women, a positive effect to improve epithelization of the cervical mucosa, with a mean score of 4.42 at the final visit as compared to 3.09 at baseline (P < 0.0001) (43% improvement). In 10 women, there was a trend of improving of vaginal microbiota status, with a mean score of 4.0 at the final visit vs. 3.3 at baseline (P = NS) (21.2% improvement). In 11 women, the Vaginal Health Index increased from 19.0 at baseline to 22.3 at the final visit (P = 0.007). The concentration of Lactobacillus spp. increased 54.5% of women and pH decreased from 4.32 to 4.09. CONCLUSIONS: These encouraging preliminary results provide the basis for designing a randomized controlled study, and for potential use in human papilloma virus infection. TRIAL REGISTRATION: ISRCTN77955077 . Registration date: February 15, 2017. Retrospectively registered.

Situación de las unidades de patología cervical en España. Resultados de una encuesta nacional / Cervical pathology units in Spain today. Results of a national survey

Objetivos. Conocer el grado de implementación de las Unidades de Patología Cervical (UPC) en los hospitales españoles. Describir su organización asistencial y volumen de trabajo, así como sus necesidades formativas, de protocolización y control de calidad, como base para la elaboración de un proyecto conjunto de la Sociedad Española de Ginecología y Obstetricia (SEGO) y la Asociación Española de Patología Cervical y Colposcopia (AEPCC) de Acreditación de UPC. Material y métodos. Análisis descriptivo de los resultados de una encuesta dirigida a los Servicios de Ginecología de los hospitales españoles, entre noviembre del 2012 y enero del 2013. De las 220 encuestas enviadas, se obtuvo respuesta en 128 (58%), representando a todas las comunidades autónomas españolas. Resultados. El 70% de los hospitales encuestados disponen de UPC. La media de ginecólogos que trabajan a tiempo completo en la UPC es de 3 y a tiempo parcial, de 20. El promedio de actividad anual reportada fue de 178 nuevos diagnósticos, 79 casos de neoplasia intraepitelial de cérvix 2 positivas y 87 cirugías de conización cervical. El 60% de los hospitales disponen de registros de complicaciones y de correlaciones citológicas, colposcópicas e histológicas. Un 90% sigue las recomendaciones de AEPCC y SEGO para la prevención primaria y secundaria del cáncer de cérvix. Más del 90% de los médicos consultados considerarían adecuado que la AEPCC y la SEGO promoviesen la acreditación de las UPC. Conclusiones. La situación global de las UPC en España es buena pero mejorable en algunos aspectos. La mayoría de los centros ven adecuada la existencia de una acreditación para las UPC (AU)

Objectives. To determine the extent to which Cervical Pathology Units (CPU) are implemented in Spanish hospitals and to describe their organization and workload and requirements for training, standardization, and quality assurance, as a basis for a joint project of the Spanish Society of Obstetrics and Gynecology (SEGO) and the Spanish Association of Cervical Pathology and Colposcopy (AEPCC) for CPU accreditation. Material and methods. We performed a descriptive analysis of the results of a survey of Gynecology Services at Spanish hospitals between November 2012 and January 2013. A total of 220 surveys were sent and replies were received from 128 services (58%) representing all the Spanish regions. Results. A total of 70% of the hospitals in the survey had a CPU. There was an average of 3 full-time gynecologists and 20 part-time gynecologists at each CPU. The mean annual reported activity was 178 new cases, 79 cervical intraepithelial lesions 2 positive, and 87 conizations. Sixty percent of the hospitals had a register of complications and cytological, colposcopic and histological correlations. Ninety percent followed the recommendations of the AEPCC and the SEGO for primary and secondary prevention of cervical cancer. More than 90% of the gynecologists believed it would be appropriate for the AEPCC and the SEGO to promote CPU accreditation. Conclusions. The overall situation of CPU in Spain is good but could be improved. Most hospitals in the survey believe that implementing the accreditation process would not be difficult (AU)