The efficacy and safety of a combination of tinidazole and thioconazole in the treatment of vaginal infections

Torshin I.Yu., Apolikhina I.A., Baranov I.I., Tapilskaya N.I., Savicheva A.M., Gromova O.A.

1 Institute of Pharmacoinformatics, Federal Research Center of Informatics and Management, Russian Academy of Sciences, Moscow, Russia; 2 Big Data Storage and Analysis Center, M.V. Lomonosov Moscow State University, Moscow, Russia; 3 Acad. V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia, Moscow, Russia; 4 I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia; 5 D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology, Saint Petersburg, Russia; 6 Saint Petersburg State Pediatric Medical University, Ministry of Health of the Russian Federation, Saint Petersburg, Russia
The paper gives the results from a meta-analysis of clinical trials using Gainomax (its standard dose is thioconazole 100 mg, tinidazole 150 mg as a suppository or cream) for the therapy of vulvovaginal candidiasis (VVC), bacterial vaginosis (BV), and trichomaniasis (TM). The meta-analysis included 4 clinical trials (covering 209 patients). The patients’ mean age was 35±7 years (95% CI, 18-52); all the patients used Gainomax suppositories/cream at the standard dose for 7 days or double dose for 3 days. Gainomax therapy substantially increased the chances of clinical cure of BV (by 20 times; OR 20.4; 95% CI 9.5-43.6), microbiological cure of BV (by 16 times; OR 15.5; 95% CI 7.6-31.5), cures of VVC (by 21 times; OR 21.0; 95% CI 8.8-50.2) and TM (by 29 times; OR 28.8; 95% CI 7.4-111.8). Analyzing individual clinical symptoms revealed associations between drug use and a statistically significant reduction in pathological vaginal discharge (by 25 times; OR 0.04; 95% CI 0.02-0.08), inflammation symptoms (by 33 times; OR 0.03; 95% CI 0.02-0.06), and reddening (by 11 times; OR 0.09; 95% CI 0.06-0.15) during treatment. Only one of the four trials included in the meta-analysis described side effects (in 3 out of 209 patients in the entire sample), no side effects were noted in the remaining trials. Thus, the results of this meta-analysis confirm the high efficacy and safety of the intravaginal use of a combination of tinidazole and thioconazole for the treatment of BV, VVC, and TM.

Keywords

bacterial vaginosis (BV)
vulvovaginal candidiasis (VVC)
trichomoniasis (TM)
Gainomax
suppositories
meta-analysis
evidence-based medicine

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Received 08.04.2020

Accepted 17.04.2020

About the Authors

Ivan Y. Torshin, Cand. Phys.-Math. Sci., Cand. Chem. Sci.; Senior Researcher, Institute of Pharmacoinformatics, Federal Research Center of Informatics and Management, Russian Academy of Sciences; Senior Researcher, Big Data Storage and Analysis Center, Moscow State University Tel.: +7(499)135-24-89. E-mail: tiy135@ccas.ru. Scopus Author ID: 7003300274, RSCI SPIN Code: 1375-1114 Author ID: 54104, ORCID 0000-0002-2659-7998, WOS ID C-7683-2018. 42, Vavilov St., Moscow 119333, Russia
Inna A. Apolikhina, MD, Head, Department of Aesthetic Gynecology and Rehabilitation, Acad. V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia; Professor, Department of Obstetrics, Gynecology, Perinatology, and Reproductology, Institute of Professional Education,
I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia. Tel.: +7 (985) 410-08-11. E -mail: i_apolikhina@oparina4.ru.
4, Academician Oparin St., Moscow 117997, Russia
Natalia I. Tapilskaya, DM; Professor, Leading Researcher, Department of Assisted Reproductive Technologies, D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology; Professor, Department of Obstetrics and Gynecology, Saint Petersburg State Pediatric Medical University, Ministry of Health of the Russian Federation.
Tel.: +7(921)933-61-26. E-mail: tapnatalia@yandex.ru. RSCI Author ID: 3605-0413, Scopus Author ID: 23013489000,
WoS Researcher ID: A-7504-2016, ORCID 0000-0001-5309-0087. ORCID: 0000-0001-5309-0087. Individual scientist number in map of science: 00052162.
3, Mendeleevskaya Line, Saint Petersburg 199034, Russia
Alevtina M. Savicheva, MD; Professor, Honored Scientist of the Russian Federation; Head, Department of Medical Microbiology, D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology; Head, Department of Clinical Laboratory Diagnosis, Faculty for Postgraduate and Advanced Professional Education, Saint Petersburg State Pediatric Medical University, Ministry of Health of the Russian Federation. Tel.: +7(921)944-15-47. E-mail: savitcheva@mail.ru. WoS Researcher ID P-6788-2015; Scopus Author ID 6602838765; RSCI Author ID 8007-2630; ORCID 0000-0003-3870-5930.
3, Mendeleyevskaya Line, Saint Petersburg 199034, Russia; 2, Litovskaya St., Saint Petersburg 194100, Russia
Igor I. Baranov, MD, Professor, Head, Department for Scientific and Educational Programs, Scientific Organizational Support Service, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia. E-mail: i_baranov@oparina4.ru. 4, Academician Oparin St., Moscow 117997, Russia
Olga A. Gromova, MD; Professor, Leading Researcher, Research Supervisor, Institute of Pharmacoinformatics, Federal Research Center of Informatics and Management, Russian Academy of Sciences; Leading Researcher, Big Data Storage and Analysis Center, Moscow State University, Tel.: +7(916)108-09-03.
E-mail: unesco.gromova@gmail.com. Website: pharmacoinformatics.ru; http://bigdata-mining.ru. RSCI SPIN Code: 6317-9833,
Author ID: 94901, Scopus Author ID: 7003589812, ORCID 0000-0002-7663-710X, WOS ID J-4946-2017. 42, Vavilov St., Moscow 119333, Russia

For reference: Torshin I.Yu., Apolikhina I.A., Baranov I.I., Tapilskaya N.I., Savicheva A.M., Gromova O.A. The efficacy and safety of a combination of tinidazole and thioconazole in the treatment of vaginal infections.
Akusherstvo i Ginekologiya. 2020; 4: 214-222. (In Russian).
https://dx.doi.org/10.18565/aig.2020.4.214-222

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