Experience of restoring menstrual cycle in patients with oligo-/amenorrhoea and obesity with a complex containing myoinositol and D-chiroinositol in the ratio 5:1, folic acid and manganese
Efendieva R.M., Dikke G.B., Abusueva Z.A., Shilova N.V.
Objective: To evaluate the effect of taking a dietary supplement containing myoinositol and D-chiroinositol in the ratio of 5:1, folic acid and manganese on the menstrual cycle in patients with oligo-/amenorrhea and obesity.
Materials and methods: This prospective open-label randomized controlled study included 80 female patients with oligo/amenorrhea and obesity: group I (n=40) received a food supplement containing a combination of myoinositol (1000 mg) and D-chiroinositol (200 mg) in the ratio of 5:1, folic acid (200 µg) and manganese (5 mg) (Dikirogen) one sachet twice daily; group II (n=40) received metformin 1000 mg once daily. The course duration was 6 months. Group III (n=30) included healthy women. Clinical, laboratory and instrumental methods of investigation were used before and after treatment with evaluation of long-term results after 6 months.
Results: Dikirogen was 2.5 times more effective than metformin in restoring menstrual cycle regularity; it was 3 times more effective in reducing hypermenorrhea, and 2 times more effective in restoring ovulation. The efficacy of both treatments was comparable in reducing body mass index (on average by 2.6 and 2.7 kg/m2) and waist circumference (on average by 4.5 and 5.5 cm), indicators of carbohydrate and lipid metabolism, in reducing DHEA-C levels and increasing progesterone. The levels of free testosterone decreased twice during the administration of Dikirogen, while the levels of free testosterone remained at baseline during metformin treatment. Blood folate concentrations increased by 2.6 times and manganese concentrations by 2.5 times during the administration of Dikirogen, but these parameters did not change after taking metformin. The patients treated with Dikirogen had regular menstrual cycles after 6 months twice as often as those treated with metformin, and ovulation was 1.6 times more likely to occur in women treated with Dikirogen compared with those who received metformin. In terms of the incidence of side effects, Dikirogen is safer than metformin.
Conclusion: The results of taking Dikirogen are not worse than metformin as for reducing body weight, the degree of abdominal obesity, and improving carbohydrate and lipid metabolism, but better than metformin effects in restoring a regular menstrual cycle, reducing menstrual blood loss, and increasing the frequency of ovulation by decreasing insulin resistance, free testosterone levels, and increasing blood concentrations of folic acid and manganese.
Authors’ contributions: Efendieva R.M. – collecting clinical material, formation of the electronic database, writing fragments of the article; Dicke G.B. – developing the concept and design of the study, supervision during the study, analysis of the results of statistical processing of the data and their interpretation, search for literature sources, writing fragments of the article and its editing after review; Abusueva Z.A. – organization of the study at the clinical base, supervision during the study; Shilova N.V. – conducting statistical analysis, preparation of illustrative material, writing the text fragments.
Conflicts of interest: The authors declare that there is no conflict of interests and guarantee that the article is the original work of the authors.
Funding: Publication of the article was supported by Invar LLC. Company employees did not take part in writing the text of the article or editing it.
Ethical Approval: The research protocol met the requirements of the Helsinki Declaration of the World Medical Association (revision of the 64th General Assembly of the World Medical Association, Fortaleza, Brazil, 2013), regulations of the International Ethical Guidelines for Biomedical Research Involving Human Subjects (ed. 2002), the National Standard of the Russian Federation R52379-2005 “Good Clinical Practice” (2005), other legislative and regulatory documents of the Russian Federation. The permission of the local Ethics Committee was not required (the funds were used in accordance with the instructions of the manufacturers).
Patient Consent for Publication: The patients provided an informed consent for 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: Efendieva R.M., Dikke G.B., Abusueva Z.A., Shilova N.V. Experience of restoring menstrual cycle in patients with oligo-/amenorrhoea and obesity with a complex containing myoinositol and D-chiroinositol in the ratio 5:1, folic acid and manganese.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2025; (2): 110-120 (in Russian)
https://dx.doi.org/10.18565/aig.2025.31
Keywords
obesity
oligomenorrhea
amenorrhea
myoinositol
D-chiroinositol
Dikirogen
metformin
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Received 12.02.2025
Accepted 20.02.2025
About the Authors
Ramina M. Efendieva, PhD student at the Department of Obstetrics and Gynecology of the Medical Faculty, Dagestan State Medical University, Ministry of Health of Russia, 367000, Russia, Republic of Dagestan, Makhachkala, Lenin sqr., 1, romidok@mail.ru, https://orcid.org/0009-0002-1729-478Galina B. Dikke, Dr. Med. Sci., Professor at the Department of Obstetrics and Gynecology with the Course of Reproductive Medicine, F.I. Inozemtsev Academy of Medical Education, 190013, Russia, Saint Petersburg, Moskovsky Ave., 22, litera M, galadikke@yandex.ru, https://orcid.org/0000-0001-9524-8962
Zukhra A. Abusueva, Dr. Med. Sci., Professor at the Department of Obstetrics and Gynecology of the Medical Faculty, Dagestan State Medical University, Ministry of Health of Russia, 367000, Russia, Republic of Dagestan, Makhachkala, Lenin sqr., 1, zuhraabusueva@mail.ru, https://orcid.org/0000-0002-7729-1606
Natalya V. Shilova, PhD, Associate Professor at the Department of Industrial Pharmacy, National Research Nuclear University MEPhI (Moscow Engineering Physics Institute), 115409, Russia, Moscow, Kashirskoe shosse, 31, +7(495)788-5699, nvshilova@gmail.com, https://orcid.org/0000-0001-6734-0147
Corresponding author: Ramina M. Efendieva, romidok@mail.ru
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