Memoplant and Memoplant forte

Vestibular disorders are a widespread multidisciplinary medical and social problem. Every third person over 50 years of age experiences dizziness [1, 2]. Dizziness and balance disorders are problems that are often encountered by doctors of various specialties, primarily neurologists, otorhinolaryngologists, therapists and psychiatrists. In 10% of patients who consult an ENT doctor, and in 5% who turn to specialists in other fields, the main complaint is dizziness [1, 3]. I would like to note that the cause of dizziness in the majority (80%) of cases is the pathology of the vestibular analyzer, which occurs in more than 80 different diseases [1, 4, 5].

The tactics and strategy for treating patients with dizziness and other vestibular disorders depends on the disease that caused it. However, due to the fact that vestibular disorders have poor subjective tolerance and can cause or aggravate psycho-emotional disorders, symptomatic therapy aimed at eliminating these disorders is of great importance in the treatment of vestibulopathy. Until recently, it was believed that one of the most effective approaches to drug therapy for vestibular disorders was the impact on the histaminergic system using a modern synthetic analogue of histamine, betahistine. However, studies in recent years have shown that there is another drug that has at least a similar effect on dizziness, but is better tolerated by patients than betahistine-containing drugs [6, 7]. This is the drug Memoplant, which has been produced by Germany since 1965. About 50 years ago, Dr. Wilmar Schwabe III (1907–1983), great-grandson of the founder, organized the first study of a simple Ginkgo leaf extract within his company. The first scientific publication of the Schwabe research group was devoted to the use of Ginkgo extract for cerebral and peripheral circulatory disorders.

In 1965, Ginkgo biloba leaf extract was registered and marketed under the trade name Tebonin (coated tablets and oral drops). Subsequently, in collaboration with Schwabe and a French pharmaceutical company, an extract was developed in a dosage of 40 mg for oral administration. Earlier formulations contained much less Ginkgo extract. This special Ginkgo extract received the patent name EGb 761. It is important to emphasize that the research results relate only to preparations containing Ginkgo extract EGb 761 with its special composition. In the 1990s, she improved production technology, replacing granulation of the extract with direct pressing, which made it possible to increase the dosage of the drug to 80 and 120 mg.

The purpose of this study is to study the effect of the drug Memoplant (Ginkgo biloba leaf dry extract EGb 761, Dr. Willmar Schwabe GmbH & Co. KG, Germany) in monotherapy (120 mg 2 times a day for 4 months) on vestibular function in patients with cochleovestibulopathy of various origins.

Nosological classification (ICD-10)

• F90.0 Impaired activity and attention
• G93.9 Brain damage, unspecified
• H81 Vestibular dysfunction
• H83.3 Noise effects of the inner ear
• I67.9 Cerebrovascular disease, unspecified
• I69 Consequences of cerebrovascular diseases
• I70.2 Atherosclerosis of the arteries of the extremities
• I73.0 Raynaud's syndrome
• I73.8 Other specified peripheral vascular diseases
• I79.2 Peripheral angiopathy in diseases classified elsewhere
• I99 Other and unspecified circulatory system disorders
• R26 Gait and mobility disorders
• R41.3.0* Memory reduction
• R41.8.0* Intellectual-mnestic disorders
• R42 Dizziness and loss of stability
• R51 Headache
• R54 Old age

Compound

conclusions

1. The drug Memoplant in the regimen of 120 mg 2 times a day for 4 months is a safe drug and can be used as monotherapy in the treatment of chronic vestibulopathy of peripheral and mixed origin in order to improve static and dynamic balance, tolerance of head and body movements in space, improving the quality of life of this category of patients, as well as as a means of preventing recurrence of dizziness.

2. The use of the drug Memoplant for 4 months does not affect the neurological status of patients with chronic vestibulopathy of peripheral and mixed origin.

3. The drug Memoplant has a positive effect on the psycho-emotional status of patients (reduces anxiety and depression) and does not cause side effects in patients with chronic cochleovestibular disorders.

The authors declare no conflict of interest.

Pharmacodynamics

The drug of plant origin increases the resistance of the body, especially brain tissue, to hypoxia, inhibits the development of traumatic or toxic cerebral edema, improves cerebral and peripheral blood circulation, and improves blood rheology.

It has a dose-dependent regulatory effect on the vascular system, dilates small arteries, and increases the tone of the veins. Prevents the formation of free radicals and lipid peroxidation of cell membranes. Normalizes the release, re-uptake and catabolism of neurotransmitters (norepinephrine, dopamine, acetylcholine) and their ability to bind to receptors. Improves metabolism in organs and tissues, promotes the accumulation of macroergs in cells, increases the utilization of oxygen and glucose, and normalizes mediator processes in the central nervous system.

Pharmacological properties of the drug Memoplant and Memoplant forte

A preparation containing a standardized dry extract from the leaves of the East Asian tree Ginkgo biloba EGb 761®. Increases tissue resistance to hypoxia, especially brain tissue; inhibits the development and accelerates the regression of cerebral edema caused by injury or intoxication; reduces retinal swelling and damage to the cornea; prevents the age-related decrease in the number of M-cholinergic receptors and α2-adrenergic receptors, as well as an increase in choline consumption in the hippocampus; improves memory and learning ability; improves compensation for imbalances; increases blood flow, improves microcirculation and rheological characteristics of blood; inactivates toxic oxygen radicals; has an antagonistic effect on platelet activating factor; has neuroprotective activity. After oral administration of ginkgo extract in liquid (solid) dosage form, the terpene lactones - ginkgolide A, ginkgolide B and bilobalide - have high bioavailability, which is 100% (98%) for ginkgolide A, 93% (79%) for ginkgolide B and 72% for bilobalide. After administration of 80 mg of extract, maximum plasma concentrations are 15 ng/ml for ginkgolide A, 4 ng/ml for ginkgolide B and approximately 12 ng/ml for bilobalide. The half-life is 3.9 hours (ginkgolide A), 7 hours (ginkgolide B) and 3.2 hours (bilobalide). Plasma protein binding is 43% for ginkgolide A, 47% for ginkgolide B and 67% for bilobalide.

Indications for the drug Memoplant

disorders of brain function (including age-related) associated with cerebral circulation, accompanied by symptoms such as memory impairment, decreased ability to concentrate and intellectual abilities, dizziness, tinnitus, headache;

peripheral circulatory disorders: obliterating diseases of the arteries of the lower extremities with such characteristic symptoms as intermittent claudication, numbness and coldness of the feet, Raynaud's disease;

dysfunction of the inner ear, manifested by dizziness, unsteady gait and tinnitus.

Contraindications

hypersensitivity to the components of the drug;

decreased blood clotting;

erosive gastritis;

peptic ulcer of the stomach and duodenum in the acute stage;

acute cerebrovascular accidents;

acute myocardial infarction;

patients with congenital galactosemia, glucose or galactose malabsorption syndrome, or congenital lactase deficiency (the drug contains lactose);

children under 18 years of age (insufficient data on use).

Patients and methods

In accordance with the purpose of our study, for the period from January 2016 to October 2021, on the basis of the audiology department of the Research Clinical Institute of Otorhinolaryngology named after. L.I. Sverzhevsky examined and treated 45 patients with chronic cochleovestibulopathy of various origins. Of these, 18 patients were diagnosed with peripheral cochleovestibular syndrome, 24 with cochleovestibular syndrome of mixed origin with a predominance of the peripheral component, and 3 with cochleovestibular syndrome of mixed origin with a predominance of the central component. The duration of the disease is from 4 to 10 years (6.7±2.42). The age of the patients ranged from 32 to 66 years (53.5±1.58), there were 29 women, 16 men.

The main criteria for including patients in the study were: patient age from 18 to 70 years; the patient has vestibular disorders (systemic and non-systemic dizziness); patient consent to participate in a clinical trial; the patient's ability to adequately cooperate. Exclusion criteria were: a history of glucose-galactose malabsorption, lactase deficiency, decreased blood clotting, individual intolerance to the active substance and auxiliary components of the drug Memoplant, as well as the need to take indirect anticoagulants; diseases of the gastrointestinal tract in the acute stage; pregnancy and lactation; acute hemodynamic disturbance. Increased dizziness during monotherapy with Memoplant, the need for complex therapy, and non-compliance of patients were also criteria for excluding this category of patients from the study. .

All patients underwent a comprehensive examination, including otorhinolaryngological, otoneurological, neurological with examination of cerebral vessels, as well as a study of psycho-emotional status.

The otorhinolaryngological examination included the collection of complaints, analysis of the medical history and life, as well as examination of the ENT organs with otomicroscopy using an operating microscope (SPECTRA 500 research and operating microscope with 8- and 16-fold magnification (Moller-Wedel GmbH, Germany) at admission, on the 14th, 30th, 60th, 120th days of the study).

The following indicators were studied:

1. Results of subjective and objective methods for studying the state of the vestibular analyzer: spontaneous vestibular symptoms (registration of spontaneous, optokinetic, cervical positional nystagmus, as well as saccadic movements of the eyeballs, horizontal slow tracking tests (0.1, 0.2 and 0.4 Hz ) with data recording using videooculography, as well as Bare-Fisher tests, pointing, coordination and diadochokinesis, straight gait and flank gait (0, 30, 60, 120 days of the study); results of bithermal bitemporal caloric test and positional maneuvers (0, 120th day of the study) - videonystagmography and videooculography system VO 425, Interacousitcs, Denmark; static computer stabilometry data (0, 30, 60, 120th day of the study - stabiloplatform ST-150, Biomera, Russia ).

2. Assessment of the neurological status of patients: intensity of headaches, pathology of cranial innervation, pyramidal signs, cerebellar signs, emotional disorders, memory impairment, sleep disturbance (0, 30, 120 days of the study).

3. Linear velocity of blood flow in the jugular veins, veins of Rosenthal and Galen during a duplex study of blood flow in the jugular veins and venous brain stems (0, 30, 120 days of the study - ultrasound scanner CX50, Philips, the Netherlands).

4. Psycho-emotional status of the patient - anxiety, depression according to the Hospital Anxiety and Depression Scale (HADS) (0, 14, 30, 60, 120 days of the study).

5. Side effects of the drug (0, 14, 30, 60, 120 days of the study).

5 patients were excluded from the study: 2 had increased dizziness by the 30th day of the study (in the absence of negative dynamics according to vestibulometry with video-oculography and stabilometry); 3 - due to non-compliance.

We present the results of examination and treatment of 40 patients with cochleovestibulopathy.

Side effects

Allergic reactions are possible (redness, skin rash, swelling, itching); in rare cases - gastrointestinal disorders (nausea, vomiting, diarrhea); headache, hearing impairment, dizziness, decreased blood clotting.

Isolated cases of bleeding have been observed in patients who were simultaneously taking anticoagulants (the cause-and-effect relationship of bleeding with taking Ginkgo biloba EGb 761® has not been confirmed).

If any adverse events occur, you should stop taking the drug and consult your doctor.

Results and discussion

Before starting treatment, all patients complained of dizziness, of which 36 patients complained of periodic attacks of systemic dizziness lasting from 20 minutes to 8 hours with an average frequency of 4 to 10 attacks per year, 4 patients complained of non-systemic dizziness lasting from several seconds to several minutes. In all 40 patients, attacks of systemic dizziness did not recur during observation.

By the 60th day of the study, patients noted better tolerance of head and body movements in space, improvement in daily activities, quality of life, emotional well-being ( t

<2).
However, a significant improvement in the indicators of “functional” and “emotional” dizziness was noted only on the 120th day of the study ( t
>2). Analysis of subjective assessment of dizziness in points on the Dizziness Handicap Inventory scale is presented in table. 1.

Table 1. Subjective assessment of dizziness in chronic vestibulopathy of peripheral and mixed origin during the use of the drug Memoplant (in points on the Dizziness Handicap Inventory scale)
At the start of the study, hidden spontaneous nystagmus was diagnosed in 26 (65%) patients; by the 30th day of the study it leveled out in 18 (69%) patients, in the remaining 8 patients it was observed throughout the study. At the start of the study, the labyrinth asymmetry coefficient (CACL) of more than 25% when performing the bithermal bitemporal caloric test was detected in 38 (95%) patients. Over time, by the 120th day of the study, a decrease in KASL by 16.4±2.42% was observed.

All 40 patients complained of periodic or constant imbalance. Computer stabilometry data over time are presented in table. 2.

Table 2. Computer stabilometry data

It should be noted that according to computer stabilometry, a score from 0 to 30 was regarded as poor balance function, from 30 to 70 as satisfactory, from 70 to 100 as good, and more than 100 as excellent. In dynamics, while taking the drug Memoplant, by the 30th day the balance function improved, but not significantly ( t

<2), and by the 60th day - significantly (
t
>2).
The area of ​​the statokinesiogram also significantly decreased by the 60th day of the study ( t
>2).

There were no changes in the neurological status of the patients included in the study. Also, no changes were detected in the linear blood flow velocity (LVR) in the jugular veins, veins of Rosenthal and Galen during a duplex study of blood flow (at the time of the start of the study and in the dynamics of LSV in the jugular veins, veins of Rosenthal and Galen was normal). Data on blood flow are presented in table. 3.

Table 3. Linear blood flow velocity in the jugular veins, veins of Rosenthal and Galen

The assessment of anxiety and depression on the Hospital Anxiety and Depression Scale is presented in Table. 4.

Table 4. Anxiety and depression (in points on the Hospital Anxiety and Depression Scale)

According to the data in Table. 4, anxiety during the use of the drug Memoplant in patients with cochleovestibular syndrome by the end of the study (day 120) decreased, but not significantly ( t

<2);
Depression significantly decreased by the 60th day of the study ( t
>2) and remained so until the end of the study.

We did not note any side effects when using the drug Memoplant for 4 months in the examined patients with cochleovestibulopathy.

Directions for use and doses

Orally, regardless of the time of meal, without chewing, with a small amount of liquid.

Unless another dosage regimen is prescribed, you should adhere to the recommendations listed below for taking the drug.

For the symptomatic treatment of cerebrovascular disorders: 40–80 mg 2–3 times a day. The duration of treatment is at least 8 weeks.

For peripheral circulatory disorders: 40 mg 3 times a day or 80 mg 2 times a day. The duration of treatment is at least 6 weeks.

For vascular and involutional pathology of the inner ear: 40 mg 3 times a day or 80 mg 2 times a day. The duration of treatment is 6–8 weeks.

Film-coated tablets, 120 mg - 1 tablet. 1–2 times a day. The duration of treatment depends on the severity of the symptoms and is at least 8 weeks. If there is no result after treatment within 3 months, the feasibility of further treatment should be checked.

If the next dose was missed or an insufficient amount of the drug was taken, the next dose should be taken in accordance with the instructions.

Use of the drug Memoplant and Memoplant forte

For dementia - 1-2 tablets of Memoplant 3 times a day or 1 tablet of Memoplant Forte 2-3 times a day. In case of impaired peripheral arterial circulation, dizziness and tinnitus - 1 tablet of Memoplant 3 times a day or 2 tablets 2 times a day, or 1 tablet of Memoplant Forte 2 times a day. The tablets should be taken without chewing, with a small amount of liquid, regardless of meals. For dementia, the duration of treatment depends on the severity of symptoms and should be at least 8 weeks. After 3 months of treatment, the advisability of further treatment should be assessed. For peripheral arterial circulation disorders, the minimum duration of treatment is 6 weeks. For dizziness and tinnitus after 6–8 weeks of treatment, further improvement is unlikely.