Activated glycyrrhizic acid in the combination treatment of patients with vaginitis and dysbiosis:results of a multicenter study
Objective: To study the effect of 0.1% activated glycyrrhizic acid spray on the relief of vulvar discomfort and pathological leucorrhoea in women with nonspecific (aerobic), vulvovaginal candidiasis and bacterial vaginosis.Kachalina O.V., Matuzkova A.A.
Materials and methods: The study was conducted under the supervision of the principal investigator with the participation of outpatient healthcare facilities providing obstetric and gynecological care in the cities: Moscow, Saint Petersburg, Voronezh, Belgorod, Krasnodar, Rostov-on-Don, Stavropol, Yekaterinburg, Chelyabinsk, Ufa, Novosibirsk , Krasnoyarsk, Irkutsk, Samara, Saratov, Kazan, and Nizhny Novgorod. The investigation enrolled 8,249 patients aged 18 to 45 years who complained of pathological vaginal discharge, discomfort in the external genital area with a clinical diagnosis of nonspecific (aerobic) vaginitis, vulvovaginal candidiasis, or bacterial vaginosis. All the patients underwent a comprehensive examination, including a physical and gynecological examination, bacterioscopy of vaginal smears, and comprehensive quantitative assessment of the vaginal microflora using a real-time polymerase chain reaction assay. All the patients were prescribed etiotropic therapy depending on the pathogen and clinical diagnosis at the discretion of an attending physician, by adding 0.1% activated glycyrrhizic acid (Epigen Intim) spray.
Results: The combination therapy resulted in a reduction of discomfort symptoms, such as itching (from 1.45 to 0.35 scores), burning (from 1.44 to 0.35 scores), unpleasant odor (from 1.31 to 0.51 scores), profuse discharge (from 1.8 to 0.30 scores), vulvar and vaginal mucosal dryness (from 0.44 to 0.16 scores), painful urination (from 0.37 to 0.14 scores), and dyspareunia (from 0.71 to 0.16 scores). The nature of discharge and its volume were stated to normalize (the proportion of patients with an abnormal discharge volume decreased from 3,812/8,249 (46.6%) to 101/8,249 (1.1%)).
Conclusion: When included in the combination treatment of patients with clinical manifestations of aerobic vaginitis, vulvovaginal candidiasis, and bacterial vaginosis, the drug based on 0.1% activated glycyrrhizic acid spray for local and topical application was found to relieve (cease) complaints of pathological vaginal discharge and vulvovaginal discomfort and to be safe and well tolerated.
Authors' contributions: Kachalina O.V. – development of the design of the study, material collection and processing, writing the article; Matuzkova A.A. – participation in the compilation of a literary review, work with the sources.
Conflicts of interest: The authors declare that there are no conflicts of interest.
Funding: The investigation has not been sponsored.
Acknowledgements: The authors are grateful to the research participants: Rosyuk E.A. (Yekaterinburg), Smolyanko I.V. (Samara), Zavodskaya O.N. (Samara), Skidan T.N. (Moscow), Skvortsova M.A. (Saratov), Aleshina E.A. (Moscow), Berger A.L. (Moscow), Gerasimova (Nelepova) Yu. V. (Moscow), Kharitonova Z.M. (Moscow), Gitinova Kh.Kh. (Moscow), Prismakova N.G. (Moscow), Otyutskaya A.V. (Moscow), Berestyanskaya I.B. (Moscow), Smagina E.N. (Moscow), Goyaeva R.Yu. (Moscow), Samarina E.A. (Moscow), Azimova D.M. (Ufa), Petrosyan P.A. (Moscow), Kolomytsina N.V. (Moscow), Aboneeva N.G. (Stavropol), Belousova V.A. (Stavropol), Dikanskaya K.V. (Stavropol), Nazhmudinova S.Z. (Moscow), Spiridonova O.A. (Moscow), Lipanina T.S. (Moscow), Sheshegova E.N. (Moscow), Feoktistova T.Yu. (Krasnoyarsk), Borisova T.P. (Krasnoyarsk), Kovalenko I.A. (Novosibirsk), Alibekova N.A. (Moscow), Zavodskaya O.N. (Samara), Neverova L.E. (Novosibirsk), Kosolapova E.V. (Kazan), Burnasheva F.A. (Kazan), Perminova E.I. (Novosibirsk), Semakina I.V. (Yekaterinburg).
Ethical Approval: The investigation has been approved by the Ethics Committee «BioEthic».
Patient Consent for Publication: The patients have signed an informed consent form to the publication of their data.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Kachalina O.V., Matuzkova A.A.
Activated glycyrrhizic acid in the combination treatment of patients
with vaginitis and dysbiosis:results of a multicenter study.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; (3): 115-120 (in Russian)
https://dx.doi.org/10.18565/aig.2023.26
Keywords
nonspecific vulvovaginitis
vulvovaginal candidiasis
bacterial vaginosis
pathological discharge
itching
vulvovaginal discomfort
activated glycyrrhizic acid
References
- Савичева А.М. Современные представления о лабораторной диагностике репродуктивно значимых инфекций у женщин репродуктивного возраста. Мнение эксперта. Вопросы практической кольпоскопии. Генитальные инфекции. 2022; 3: 34-9. [Savicheva A.M. Modern ideas about the laboratory diagnosis of reproductively significant infections in women of reproductive age. Expert opinion. Issues of Practical Colposcopy&Genital Infections. 2022; (3): 34-9. (in Russian)]. https://dx.doi.org/10.46393/27826392_2022_3_34.
- Донников А.Е., Витвицкая Ю.Г., Кан Н.Е., Тютюнник В.Л., Припутневич Т.В., Межевитинова Е.А., Никитина И.В., Абакарова П.Р., Зубков В.В., Рюмина И.И., Гамаюнов Б.Н., Ломова Н.А., Долгушина Н.В., Калинина Е.А., Павлович С.В. Диагностика инфекций в акушерско- гинекологической и неонатологической практике. Учебное пособие. М.: Центр полиграфических услуг «Радуга»; 2018. 124 с. [Donnikov A.E., Vitvitskaya Yu.G., Kan N.E., Tyutyunnik V.L., Priputnevich T.V., Mezhevitinova E.A., Nikitina I.V., Abakarova P.R., Zubkov V.V., Ryumina I.I., Gamayunov B.N., Lomova N.A., Dolgushina N.V., Kalinina E.A, Pavlovich S.V. Diagnosis of infections in obstetric-gynecological and neonatological practice: a textbook. Moscow: Center for Printing Services "Rainbow"; 2018. 124 p. (in Russian)].
- Баранова Е.Е., Батенева Е.И., Галкина И.С., Донников А.Е., Зорина В.В., Тумбинская Л.В., Шигорина Г.Г. ПЦР в реальном времени: новые возможности технологии в решении репродуктивных проблем. М.: OOO «ДНК-Технология»; 2013. 63с. [Baranova Ye.Ye., Bateneva Ye.I., Galkina I.S., Donnikov A.Ye., Zorina V.V., Tumbinskaya L.V., Shigorina G.G. Real-time PCR: New technology capabilities in addressing reproductive problems. Moscow: "DNA-Technology" LLC; 2013. 63p. (in Russian)].
- Ворошилина Е.С., Плотко Е.Э., Исламиди Д.К., Лаврентьева И.В., Зорников Д.Л. Микробиоценоз влагалища с точки зрения ПЦР в реальном времени. Возможности коррекции дисбиотических нарушений влагалища. Учебное пособие. Екатеринбург; 2018. [Voroshilina E.S., Plotko E.E., Islamidi D.K., Lavrentieva I.V., Zornikov D.L. Microbiocenosis of the vagina in terms of real-time PCR. Possibilities for treating dysbiotic vaginal disorders. Tutorial. Yekaterinburg; 2018. (in Russian)].
- Pacha-Herrera D., Vasco G., Cruz-Betancourt C., Galarza J.M., Barragán V., Machado A. Vaginal microbiota evaluation and Lactobacilli quantification by qPCR in pregnant and non-pregnant women: a pilot study. Front. Cell. Infect. Microbiol. 2020; 10: 303. https://dx.doi.org/10.3389/fcimb.2020.00303.
- Wang H., Huang Z., Wu Z., Qi X., Lin D. An epidemiological study on vaginitis in 6,150 women of reproductive age in Shanghai. New Microbiol. 2017; 40(2):113-8.
- Радзинский В.Е., Ордиянц И.М., Побединская О.С., Буянова Н.В. Современные аспекты коррекции дисбиотических нарушений в гинекологической практике. Акушерство и гинекология: новости, мнения, обучение. 2013; 2: 72-6. [Radzinsky V.E., Ordiyants I.M., Pobedinskaya O.S., Buyanova N.V. Current aspects of correction of dysbiotic disorders in gynecologic practice. Obstetrics and Gynecology: News. Opinions. Training. 2013; (2): 72-6. (in Russian)].
- Доброхотова Ю.Э., Маркова Э.А. Смешанный вагинит в современных условиях: особенности течения и выбор подходов к лечению. Проблемы репродукции. 2022; 28(4): 137-44. [Dobrokhotova Yu.E., Markova E.A. Mixed vaginitis. What's new? Features of the course and therapy of mixed vaginitis. Russian Journal of Human Reproduction. 2022; 28(4): 137 44. (in Russian)]. https://dx.doi.org/10.17116/repro202228041137.
- Савичева А.М., Тапильская Н.И., Шипицына Е.В., Воробьева Н.Е. Бактериальный вагиноз и аэробный вагинит как основные нарушения баланса вагинальной микрофлоры. Особенности диагностики и терапии. Акушерство и гинекология. 2017; 5: 24-31. [Savicheva A.M., Tapilskaya N.I., Shipitsyna E.V., Vorobyeva N.E. Bacterial vaginosis and aerobic vaginitis as major vaginal microflora balance disorders: diagnostic and therapeutic characteristics. Obstetrics and Gynecology. 2017; (5): 24-31. (in Russian)]. https://dx.doi.org/10.18565/aig.2017.5.24-31.
- Ворошилина Е.С, Литусов Н.В., Плотко Е.Э., Зорников Д.Л., Хаютин Л.В. Микробиоценоз влагалища во время беременности. Возможности коррекции дисбиотических состояний. Учебно-методическое пособие для врачей, клинических интернов, ординаторов и студентов. Екатеринбург; 2017. [Voroshilina E.S., Litusov N.V., Plotko E.E., Zornikov D.L., Hayutin L.V. Vaginal microbiocenosis during pregnancy. Possibilities for correcting dysbiotic conditions. Educational and methodological manual for doctors, clinical interns, residents and students. Yekaterinburg; 2017. (in Russian)].
- Тапильская Н.И., Долгушина В.Ф., Мингалёва Н.В. Оценка влияния интимной гигиены гелем «Эпиген Интим» на дискомфорт в области наружных половых органов: результаты наблюдательного исследования. Акушерство и гинекология. 2020; 9: 172-8. [Tapilskaya N.I., Dolgushina V.F., Mingalyova N.V. Evaluation of the impact of intimate hygiene with Epigen Intim gel on discomfort in the area of external genital organs: results of an observational study. Obstetrics and Gynecology. 2020; (9): 172-8. (in Russian)]. https://dx.doi.org/10.18565/aig.2020.9.172-178.
- Зароченцева Н.В., Белая Ю.М. Опыт применения геля Фагогин в составе терапии неспецифического вульвовагинита. Мнение эксперта. Вопросы практической кольпоскопии. Генитальные инфекции. 2022; 3: 48-52. [Zarochentseva N.V., Belaya Yu.M. Experience of using Phagogyn gel in the therapy of non- specific vulvovaginitis. Issues of Practical Colposcopy&Genital Infections. 2022; (3): 48-52. (in Russian)]. https://dx.doi.org/10.46393/27826392_2022_3_48.
- Савичева А.М., Шипицина Е.В., Воровьева Н.Е. Инфекционные заболевания влагалища и современные подходы к их диагностике и лечению. Акушерство и гинекология 2016; 2: 120-6. [Savicheva A.M., Shipitsyna E.V., Vorobyeva N.E. Vaginal infectious diseases and current approaches to their diagnosis and treatment. Obstetrics and Gynecology. 2016; (2): 120-6.(in Russian)]. https://dx.doi.org/10.18565/aig.2016.2.120-126.
- Министерство здравоохранения Российской Федерации. Клинические рекомендации. Бактериальный вагиноз. М.; 2022. [Ministry of Health of the Russian Federation. Clinical guidelines. Bacterial vaginosis. Moscow; 2022.(in Russian)].
- Громова О.А., Торшин И.Ю., Тетруашвили Н.К. Систематический обзор экспериментальных и клинических исследований по фармакологии глицирризина и его производных. Акушерство и гинекология. 2022; 4: 34-46. [Gromova O.A., Torshin I.Yu., Tetruashvili N.K. A systematic review of experimental and clinical studies on the pharmacology of glycyrrhizin and its derivatives. Obstetrics and Gynecology. 2022; (4): 34-46. (in Russian)].https://dx.doi.org/10.18565/aig.2022.4.34-46.
- Рахматулина М.Р., Большенко Н.В., Липова Е.В. Опыт применения активированной глицирризиновой кислоты при вульвовагинитах, цервицитах и генитальной папилломавирусной инфекции. Акушерство и гинекология. 2019; 9: 153-8. [Rakhmatulina M.R., Bolshenko N.V., Lipova E.V. Experience of application of activated glycyrrhizic acid in vulvovaginitis, cervicitis, and genital papillomavirus infection. Obstetrics and Gynecology. 2019; (9): 153-8. (in Russian)]. https://dx.doi.org/10.18565/aig.2019.9.153-158.
Received 31.01.2023
Accepted 16.03.2023
About the Authors
Olga V. Kachalina, Professor, Department of Obstetrics and Gynecology, FDPE, Volga Research Medical University, Ministry of Health of Russia, yander24@bk.ru,603005, Russia, Nizhny Novgorod, Minin and Pozharsky sqr., 10/1.
Alina A. Matuzkova, student, Volga Research Medical University, Ministry of Health of Russia, matuzkova27.00@mail.ru, 603005, Russia, Nizhny Novgorod,
Minin and Pozharsky sqr., 10/1.