The effect of diindolylmethane on the course of HPV-associated cervical intraepithelial neoplasia in women treated in routine clinical practice (Cerera study)

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Abstract

Objective: The primary aim of the study was to evaluate the effect of Cervicon-DIM (diindolylmethane) on cytological and clinical signs of HPV-associated LSIL/HSIL in real clinical practice. The secondary aim was to obtain additional data on the safety of Cervicon-DIM.

Materials and methods: This was an open observational study on the assessment of the dynamics of the cytological picture of cervical intraepithelial neoplasia in patients who received diindolylmethane in the form of vaginal suppositories in routine clinical practice (CERERA study). The study included patients with confirmed CIN I/LSIL or patients after excision for CIN II/HSIL who were treated with vaginal suppositories containing diindolylmethane for 6 months. The results of cytological examination, PCR HPV testing, and colposcopy findings were assessed before and after treatment.

Results: A total of 140 female patients were included in 10 study centres, 132 of whom completed a 6-month course of treatment with diindolylmethane. The results of the cytological examination showed that the regression of the disease was observed in 81% (39/48 patients) in the CIN I/LSIL group, and there were no signs of intraepithelial lesion and malignant process in the group of patients after excision and treatment with diindolylmethane suppositories according to the results of the cytological examination of all women who presented at the follow-up visit. The colposcopy findings revealed positive dynamics in 79/88 (89%) patients with CIN I/LSIL and in 39/44 (89%) patients with CIN II/HSIL. Elimination of HPV infection was noted in 80% (106/132) of patients in both groups after 6 months of therapy.

Conclusion: The results of the CERERA study demonstrated the therapeutic effects of diindolylmethane administered as vaginal suppositories in mild to moderate cervical dysplasia in women treated in real clinical practice.

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About the authors

Inna A. Apolikhina

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia; I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia

Author for correspondence.
Email: i_apolikhina@oparina4.ru
ORCID iD: 0000-0002-4581-6295
SPIN-code: 6282-7435

Dr. Med. Sci., Professor, Head of the Department of Aesthetic gynecology and Rehabilitation, Professor at the Department of Obstetrics, Gynecology, Perinatology, and Reproductology, Institute of Professional Education

Russian Federation, 117997, Moscow, Ac. Oparin str., 4; 119991, Moscow, Trubetskaya str., 8-2

Nina V. Zarochentseva

Academician V.I. Krasnopolsky Moscow Regional Research Institute of Obstetrics and Gynecology, Moscow region

Email: ninazar11@mail.ru
ORCID iD: 0000-0001-6155-788X

Dr. Med. Sci., Professor of the Russian Academy of Sciences, Deputy Director for Research

Russian Federation, 101000, Moscow, Pokrovka str., 22A

Elena A. Gorbunova

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: el_gorbunova@oparina4.ru
ORCID iD: 0000-0002-4723-4299

obstetrician-gynecologist, Researcher at the Department of Aesthetic Gynecology and Rehabilitation

Russian Federation, 117997, Moscow, Ac. Oparin str., 4

Anna G. Kedrova

Federal Scientific and Clinical Centre for Specialised Medical Care and Medical Technologies of Federal Medical and Biological Agency

Email: Kedrova.anna@gmail.com

Dr. Med. Sci., gynecologist-oncologist, Head of Oncology Department, Head of the Educational Part of Department of Obstetrics and Gynecology

Russian Federation, 115682, Moscow, Orekhovy Boulevard, 28

Liana S. Mkrtchyan

A.F. Tsyb Medical Radiological Research Centre, National Medical Research Centre for Radiology, Ministry of Health of Russia

Email: iana6969@mail.ru
ORCID iD: 0000-0002-5027-5331

Dr. Med. Sci., Leading Researcher

Russian Federation, 249036, Kaluga region, Obninsk, 4 Koroleva St., 4

Tatiana E. Belokrinitskaya

Chita State Medical Academy, Ministry of Health of Russia

Email: tanbell24@mail.ru
ORCID iD: 0000-0002-5447-4223

Dr. Med. Sci., Professor, Head of the Obstetrics and Gynecology Department of the Pediatric Faculty and Faculty of Professional Retraining

Russian Federation, 672000, Chita, Gorky str., 39a

Sergey E. Krasilnikov

Federal Research Centre for Fundamental and Translational Medicine

Email: i_apolikhina@oparina4.ru
ORCID iD: 0000-0003-0687-0894
SPIN-code: 4030-8868

Dr. Med. Sci., Professor, Chief Researcher

Russian Federation, 630060, Novosibirsk, Timakova str., 2

Anastasia O. Shumeikina

Federal Research Centre for Fundamental and Translational Medicine

Email: i_apolikhina@oparina4.ru
ORCID iD: 0009-0008-1839-071X

PhD student, specialty "Oncology"

Russian Federation, 630060, Novosibirsk, Timakova str., 2

Natalia M. Pasman

V. Zelman Institute of Medicine and Psychology, Novosibirsk National Research State University
Novosibirsk State University

Email: nmpasman@gmail.com
ORCID iD: 0000-0002-6095-1954

Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology

Russian Federation, 630090, Novosibirsk, Pirogov str., 2

Larisa V. Suturina

Scientific Center for Family Health and Human Reproduction Problems

Email: lsuturina@mail.ru
ORCID iD: 0000-0002-6271-7803

Dr. Med. Sci., Professor, Head of the Department of Reproductive Health

Russian Federation, 664003, Irkutsk, Timiryazeva str., 16

Diana K. Islamidi

Ural State Medical University, Ministry of Health of Russia

Email: dishader@yandex.ru

PhD, Associate Professor, Department of Obstetrics and Gynecology with a course in Medical Genetics

Russian Federation, 620028, Yekaterinburg, Repin str., 3

Victoria A. Popandopulo

Mother and Child Centre (Basic Clinic of Kuban State Medical University)

Email: vik-krutova@yandex.ru
ORCID iD: 0000-0002-9907-7491

Dr. Med. Sci., Chief Physician, Center for Mother and Child (Clinic of Kuban State Medical University)

Russian Federation, 350010, Krasnodar, Zipovskaya str., 4/1, 4/3

Aleksei E. Golubenko

Orel Colposcopy Center LLC

Email: golubr@mail.ru
ORCID iD: 0000-0001-7197-4812

MD, CEO and Head of Orel Colposcopy Center, gynecological oncologist

Russian Federation, 302040, Orel region, Orel, per. Kinoprokatny, 2

Kirill A. Sokolov

Alcea LLC

Email: kirill.sokolov@alceapharma.ru
ORCID iD: 0000-0002-8358-3963

MD, obstetrician-gynecologist, Medical Director

Russian Federation, 129110, Moscow, Olimpiysky Ave., 16, bld. 5

Yulia S. Verbitskaya

Alcea LLC

Email: Yulia.verbitskaya@alceapharma.ru
ORCID iD: 0009-0004-2960-8455

MD, PhD, Medical Advisor

Russian Federation, 129110, Moscow, Olimpiysky Ave., 16, bld. 5

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Supplementary files

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2. Fig. 1. Distribution of patients in the study

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3. Fig. 2. Dynamics of the results of the cytological examination on the third visit after drug therapy with the drug "Cervicon-DIM" for 6 months

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4. Fig. 3. Dynamics of HPV testing results in cervical smear before and after treatment with Cervicon-DIM for 6 months. NA - total number of patients (%) without division into groups: NB - number of patients taking into account HPV+/HPV- and LSIL/HSIL

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