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COMPARATIVE EVALUATION OF EFFICIENCY OF DIFFERENT HERBAL MEDICINAL PRODUCTS CONTAINING ORTHILIA SECUNDA IN TREATMENT OF CHRONIC
Altai State Medical University, Barnaul
N.I. Fadeyeva, O.V.Remneva, S.D.Yavorskaya, O.A.Skoropatskaya
A comparative analysis of the effectiveness of phytopreparations containing ortilia secunda was carried out in the treatment of chronic endometritis in 87 patients of reproductive age with chronic endometritis. For therapy there were selected three herbal medicinal products of Altai manufacturers: "Malavit-Ona", "Ortilida", and an extract of orthilia secunda. At the end of treatment, regardless of the choice of phytopreparation, all patients noted improvement in overall health, disappearance of symptoms of premenstrual tension, normalization of menstrual function. Clinical effects of phytotherapy are confirmed by echoscopic data: normalization of the M-echo, improvement of the endometrium structure. Key words: orthilia secunda, phytotherapy, chronic endometritis.
Phytotherapy as a method of treatment of various human diseases has been officially used since the XVIth century. The effectiveness of many medicinal plants has been proved experimentally and clinically, which allowed to consider phyto-therapy as a medical specialty of official medicine [1, 2]. Flora of Altai Krai is rich in medicinal plants with proven healing properties. One of such plants is the ortilia secunda. Anti-inflammatory, immuno-modulating, anticoagulant properties of dry extract of ortilia secunda have been proved by the experiment [3]. The antimicrobial activity of decoction of leaves of ortilia against enterobacteria, pseudo-monads, staphylococci, fungi of the genus Candida [4] has been confirmed. On the basis of Altai State Medical University, we previously conducted clinical studies on the efficacy and safety of use of various phytocomplexes, which included ortilia secunda [5].
The research objective was to perform a comparative analysis of the effectiveness of various herbal medicinal products of Altai producers containing ortilia secunda in the treatment of chronic endometritis in patients of reproductive age.
Materials and methods
The study involved 87 patients of reproductive age, diagnosed with «chronic endometritis,» which was confirmed by histological examination. Previously, taking into account the sensitivity of the detected infectious agent, all patients received antibacterial therapy according to the standards of management of patients, but at the time of their inclusion in the study, they had clinical, echoscop-ic and histological markers of chronic endometri-tis, which served as the basis for the second stage of treatment - rehabilitation.
Inclusion criteria:
• age of women - under 35 years old;
• patients who received a course of complex therapy of endometritis (antibacterial, antiviral and immunomodulating therapy) for three months before the study;
• patients with histologically confirmed chronic endometritis;
• informed consent of patients to participate in the study.
Exclusion criteria:
• uterine myoma requiring surgical treatment;
• adenomyosis 2-3 stage;
• adhesive process of the pelvis 2-3 stage;
• exacerbation of chronic or acute endometritis;
• somatic pathology in the stage of decompensation.
For the rehabilitation course of therapy of patients with chronic endometritis, three phytoprepa-rations of Altai producers were selected, the main component of which was Orthilia secunda:
"Malavit-Ona" (OOO (Limited Liability Company) "Malavit", Barnaul). Contains herbal extracts orthilia secunda 100.0 mg, Rhodiola quadrifida 50.0 mg, dry milfoil 50.0 mg, copper sulphate pen-tahydrate 0.1 mg, excipients (food lactose, calcium stearate) up to a weight of 500 mg. 2 capsules (500 mg) are taken 2 times in the morning with meals. Course of administration - 1-3 months.
"Ortilida. Formula 1 and 2 "(CJSC "Balsam", Biysk). Formula 1 contains: orthilia secunda, rhizomes and roots of sulla (red root), herbs and roots of marsh cinquefoil, rhizome and roots of elecampane, yarrow extract, vitamins B1 and B6. Formula 2 contains: orthilia secunda, burdock roots, calendula flowers, avian mountain herb, oregano herb, St. John's wort extract, vitamins E and C. both formulas include microcrystalline cellulose (MCC) as the auxiliary component. Usage: formula 1 - from the 1st day of the sexual cycle to 2 tablets 2 times
a day during meals for 2 weeks; formula 2 - from 12-15th day of the sexual cycle to 2 tablets 2 times a day for the next 2 weeks. Course of administration - 1-3 months.
Instructions for use: formula 1 - 2 tablets 2 times a day during meals from the 1st day of the ovary cycle for 2 weeks; formula 2 - 2 tablets 2 times a day for the next 2 weeks from the 12th to 15th day of the sexual cycle.
"Orthilia secunda extract (HARMS, Barnaul)" -2.5 mg / day, as an aqueous extract once a day with meals. Course of administration - 3-5 months.
By random sampling, all patients were divided into three equivalent groups. Patients of the first group (n = 29) received the phytopreparation "Malavit-Ona", the second group (n = 28) - the vitaminized phytocomplex "Ortilida", the third group (n = 30) - ortilia extract. The course of therapy was three months.
Before and after the end of the course of therapy, all patients underwent a complete clinical examination including assessment of somatic and gynecological status, bacterioscopic examination of the separated cervical canal on the flora
When assessing the obstetric-gynecological history of the patients of the comparison groups, it was established that all of them had a high incidence of reproductive losses and medical abortions in the anamnesis (Table 2).
In addition to inflammatory diseases of the en-dometrium, they more often than in the population had hormone-dependent diseases of the genitals. Thus, the patients of the first group (24.1%) had an adenomyosis of the 1-2 degree somewhat more often than the patients of the second group (17.9%) and the third group (6.6%). In turn, the patients of the third group (23.3%) had uterine fibroids of a smaller size more often than the patients of the first group (13.8%) and the second group (5.6%). Both diseases are related to hormone-dependent (estrogen-dependent) pathology.
Patients of the second group had a history of not
and sensitivity to antibiotics, PCR-based diagnostics of STIs, and ultrasound examination of pelvic organs. Clinical and echoscopic signs of endome-tritis are confirmed hysteroscopically and histolog-ically once before the course of herbal medicine, since it is inadvisable to double the histological study to evaluate the effectiveness of the rehabilitation course of therapy [1].
Statistical processing of the obtained results was carried out with the help of the program Statistic 10, the values of the qualitative characteristics are represented in the form of frequencies and in percent, for comparison, the chi-square criterion was used with the Yates correction for continuity (at a frequency of fewer than 10 cases). Differences at a value of p <0.05 were accepted as statistically significant.
Results and discussion
The mean age of patients of all comparison groups was almost identical (27 ±1.2; 30 ± 2.3; and 31.1± 3.5, p> 0.05). The structure and frequency of extragenital pathology in the patients of the comparison groups did not significantly differ and is presented in Table 1.
only chronic endometritis but also chronic adnexitis (34.5%, 53.6% and 23.3%), which can indirectly speak of their low immune status. On the other hand, this may be a consequence of a higher incidence of induced abortions in patients in this group (10.3%, 17.9%, and 6.7% respectively).
At the time of enrollment, most patients in the comparison groups had complaints of menstrual dysfunction in the form of hyperpolymen-orrhea or hypomenstrual syndrome and / or pain syndrome during the second phase of the cycle (Table 3). Echoscopic signs of chronic endometritis were established in all patients of the comparison groups.
After the end of treatment, all patients noted improvement in overall health (questionnaire SF-36), disappearance of symptoms of premenstrual tension and normalization of the menstrual cycle.
Table 1
Structure and frequency of extragenital pathology in patients of the comparison groups
parameters Malavit-Ona n=29 abs. (%) Ortilida 1,2 n=28 abs. (%) Orthilia extract n=30 abs. (%) P Malavit/ Ortilida Malavit/ extract Ortilida / extract
vegetative-vascular dystonia by hypotonic type 7 (24) 10 (35,7) 6 (20) 0,3/0,7/0,1
arterial hypertension 3 (10,3) 5 (17,9) 4 (13,3) 0,3/ 0,7/ 0,6
chronic pyelonephritis 10 (34,5) 6 (21,4) 10 (33,3) 0,2/0,8/0,3
chronic cystitis 3 (10,3) 4 (14,3) 4 (13,3) 0,6/ 0,7/ 0,9
AIT, euthyroidism 7 (24,1) 12 (42,8) 10 (33,3) 0,1/0,4/ 0,4
Table 2
Frequency and structure of obstetric-gynecological pathology in patients of comparison groups
parameters Malavit-Ona n=29 abs. (%) Ortilida 1,2 n=28 abs. (%) Orthilia extract n=30 abs. (%) P Malavit/ Ortilida Malavit/ Extract Ortilida / Extract
Term birth in time 15 (51,7) 17 (60,7) 11 (36,7) 0,8/ 1,3/ 1,7
Artificial abortions 3 (10,3) 5(17,9) 2(6,7) 0,7/ 1,2/ 1,6
Reproductive losses 17(58,6) 15 (53,6) 21 (70) 1,1/0,8/ 0,7
Chronic adnexitis 10 (34,5) 15 (53,6)* 7 (23,3) 0,7/ 1,3/1,9
uterine fibroids of a small size 4 (13,8) 2 (5,6) 7 (23,3) 1,4/0,7/ 0,4
Adenomyosis 1-2 stage 7 (24,1)* 5 (17,9) 2(6,6) 1,1/1,7 /1,6
Table 3
Clinical characteristics of the patients of the comparison groups before and after the course of phytotherapy
parameters Malavit-Ona n=29 abs./% Ortilida 1,2 n=28 abs./% Orthilia extract n=30 abs./%
before after p before after P before after P
premenstrual syndrome 28 /100 1/3,4 0,03 15/53,6 1/3,5 0,03 10/33,3 2/6,7 0,04
Hyperpolymenorrhea 14/48,3 1/3,4 0,048 7/25 4/14,3 0,046 4/13,3 1/3,3 0,047
Hypomenorrhea 3/10,3 1/3,4 0,5 7/25 3/10,7 0,46 18/60 2/6,7 0,3
Pain syndrome 9/31,3 3/10,3 0,43 7/25 1/3,5 0,44 3/10 2/6,7 0,49
Clinical improvement was confirmed by echo-scopic data (ultrasound with CDC on the 21-25th day of the cycle): a tendency to normalize the M-echo
was established, an improvement in the structure of the endometrium was established (Table 4).
Table 4
Echoscopic characteristics of patients in comparison groups before and after the course of phytotherapy
parameters Malavit-Ona n=29 abs./% Ortilida 1,2 n=28 abs./% Orthilia extract n=30 abs./%
before after P before after P before after P
M-echo, mm (21-23d day of cycle) 7,3±1,2 9,1±1,1 0,05 5,4±1,3 7,9±2,3 0,05 6,3±2,2 8,5±1,2 0,07
Inhomogeneity of the structure and uneven contours of the endometrium 29/100 14/48,2 0,03 28/100 17/60,7 0,04 24/80 16/53,3 0,06
Hyperechoic inclusions of the basal layer 29/100 25/86,2 0,8 28/100 26/92,8 0,8 30/100 23/76,7 0,7
All patients noted good drug tolerance; side effects in the course of the study were not established.
Thus, the conducted research demonstrated the high effectiveness of herbal medical products of Altai producers, containing orthilia secunda, in the rehabilitation of patients with chronic endo-metritis.
In the course of the study, additional positive clinical effects of phytopreparations containing orthilia secunda were recorded: reduction of pre-
menstrual tension, normalization of the menstrual cycle.
Complex herbal medical products "Mala-vit-Ona" and "Ortilida 1,2" are comparable in clinical efficacy with Orthilia secúnda extract, but more convenient for use in practice.
References
1. Gynecology. National manual. Edited by V.I. Kulakov, G.M. Savelyeva, I.B. Manukh-in. Moscow, 2009.
2. Radzinsky V.E. Medicinal plants and biologically active additives in obstetrics and gynecology. Moscow, 2000.
3. Skoropatskaya O.A., Fadeyeva N.I., Taranina T.S., Bolgova T.A., Belnitskaya O.A. Evaluation of the effectiveness of the Or-thilia secunda aqueous extract in the treatment of chronic endometritis. Tavrichesky medico-biological bulletin. 2016; 2: 136-138.
4. Fadeyeva N.I., Remneva O.V., Yavorskaya S.D., Gorbachev T.I. Prophylaxis of placental insufficiency in patients with reproductive dysfunction against a background of chronic endometritis. News of higher educational institutions. Povolzhsky region. 2011; 2 (18): 135-142.
5. Yavorskaya S.D., Makarova E.V., Remneva O.V., Danilova I.M. Phytocomplex "Mala-
vit-Ona" as a buffer on the way of inflammatory and proliferative diseases of the female sexual sphere. Model. - Modern diagnostic and medical technologies. A collection of scientific and practical works dedicated to the 20th anniversary of the Regional Public Health Institution "Diagnostic Center of Altai Krai", Barnaul, 2013.
Contacts:
Corresponding author - Fadeyeva Natalia Ily-inichna, Doctor of Medical Sciences, Professor of the Department of obstetrics and gynecology with the course of further vocational education of Altai State Medical University, Barnaul. Barnaul, 656038, Molodezhnaya Ulitsa, 19. Tel.: (3852) 368587. Email: nat2fad@hotmail.com
