RPA 'Ecomed',
129090, Russia, Moscow, POB no. 87,
tel. 963-11-22, tel./fax 963-05-97,
email: ecomednpo@mtu-net.ru,
site: www.npoecomed.com

R U S S I A N   F E D E R A L   M I N I S T R Y   O F   P U B L I C   H E A L T H
MOSCOW RESEARCH INSTITUTE OF PSYCHIATRY
3 Poteshnaya Street, MoscowTel.: 162-12-82


N _________ March 15, 1995

"Approved"
Professor V.N.Krasnov       /signature/
Director of Moscow Research Institute of Psychiatry
at Russian Federal Ministry of Public Health


C L I N I C A L   T E S T   R E P O R T

Re: Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes produced by ECOMED Research and Production Association

The Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes is applied widely to treatment of gastroenterological, gynaecological, oncologoical patients, as well as to postoperative atonia, clinics of nervous and infectious diseases. There are positive references to reduced hyperlipidaemia for patients of diabetes mellitus types I and II.

On the basis of the experience of therapists and endocrinologists, we selected a group of patients with sexual and affective problems on the background of somatic aggravations (excess nutrition and disordered metabolism).

The goal of this clinical test was to study the effect of the Autonomous Electrical Stimulator to the affective and emotional spheres and sexual function.

The objectives of our investigation were as follows:

  1. Effect of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes to the affective and emotional stability.
  2. Effect of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes to the male sexual enterprising.
  3. Effect of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes to the quality of physiological components of coitus (libido, erection, ejaculation, orgasm).

Methods: In addition to the clinical observation and self-reports of the patients, SFM method was applied to solution of the first objective. The first triad of numbers indicates to the structure and level of sexual enterprising, the second triad of numbers indicates to the quality of sexual parameters, the third triad of numbers indicates to the condition after completed sexual act. The solution of the second and third objectives included testing: Luscher test and laboratory test of blood plasma for hormones. The results were compared to the placebo effect.

Material of test: For six weeks, twenty men with sexual and affective disorders were placed under observation of professional sexual pathologist. All the patients under observation administered perorally the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes. The control (placebo) group included 19 patients. The peroral administration was double with the interval of two weeks. The age of patients ranged from 32 to 48 years. The duration of sexual disorder ranged from 2 to 7 years. With respect to the clinical diagnoses, they were related to the group of secondary sexual disorders on the background of endocrinic and somatic (including inflammatory urological) diseases.

Table 1 represents the frequency of complaints of observed patients, who administered the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes and placebo.

Symptoms Frequency of complaints 
 Before treatment  After treatment  Placebo 
 Reduced work ability 321211
 Irritability22812
 Headache24613
 Insomnia2048
 Sleepiness624
 Reduced libido32811
 Absence of erection27611
 Shortened coitus241212
 Nausea25712
 Reduced appetite2--
 Unpleasant feeling
 in genitals
1143
 Dry oval cavity20210

As seen from this table, administration of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes affected the numerous complaints, with the exception of coitus duration. The frequency of stochastic somatic complaints does not exceed the stochasticity as compared to the group of patients, who administered placebo.

Table 2 represents the laboratory test data.

ParametersNormal
levels
 Duration of treatment 
  un to 1 month  over 1 month 
 Bilirubin (mcmol / l)999
 Acid phosphatase (I.U. / l)101010
 Alkaline phosphatase (I.U. / l) 10074 ± 1274 ± 14
 Testosterone (nmol)8 to 248.0 ± 2.09.9 ± 1.7
 Estradiol (pmol) 40 to 120 85 ± 4086 ± 48
 Dihydrotestosterone (nmol)0.8 to 2.52.3 ± 1.32.3 ± 1.7

As we can see from this table, the major parameters acquire the stable tendency to stabilization at the optimum level.

The generalised SFM series before treatment with the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes was as follows:

2222132121-6651-18

and after treatment:

3333343321-91081-28

Therefore, as a result of treatment with the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes, the sexual enterprising increased (from 6 to 9) along with the quality of sexual acts (from 6 to 10).

For the first two days after administration of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes, we observed normalisation of affect (increased temper, reduced irritability, improved sleep, generated activity). The said parameters were retained for two weeks after the second administration of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes.

The application of Luscher colour test recorded the increase in the general working ability from 53 to 67 per cent as well as the decrease in the deviation from the autogenic standard from 43 to 28 per cent that indicated to the complex multilevel effect of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes.

C O N C L U S I O N S:

  1. The Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes provides an effective method for stabilisation of affective and emotional spheres and increase of potency for men with somatically aggravated background.

  2. The said results are most stable after the second administration of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes.

  3. Administration of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes provides the normalising effect to a series of metabolic and hormonal processes.

  4. The said clinical effect is statistically reliable as compared to the group of patients, who receive placebo.

  5. However, some patients in the period of administration of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes noted appearance of fine clonical jerking in the musculature of belly and limbs that were experienced by some patients for several days, feeling of foreign body inside the belly was used for the purpose of psychotherapy in order to confirm the biological action of the tested device.

It seems expedient to protect with the patent the effective method of the Autonomous Electrical Stimulator of Gastrointestinal Tract and Mucous Membranes to the affective and emotional spheres, because Patent No. 936931 dated February 23, 1982 does not include these spheres or sexual function.


  Director of the Ward of Sexual Pathology    /signature/    N.D. Kibrik
 
Academic Secretary of the Federal Centre
for Medical Sexology and Sexual Pathology,
Senior researcher
    /signature/    Yu.A. Reshetnyak
 Seal: Russian Federal Ministry of Public Health
Moscow Research Institute of Psychiatry


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