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, Moscow

Tel.: 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.

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.