"APPROVED"
General Director of ECOMED Research & Production Association
S.A.Khvorostov
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Seal: ECOMED Research & Production Association Company Limited (Moscow)
State Registration No. 9624 |
"APPROVED"
Director of State Research Center of Coloproctology
Corresponding Member of Russian Academy of Medical Science
Professor G.I.Vorobiov
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Seal: State Research Center of Coloproctology,
Russian Federal Ministry of Public Health and Medical Industry |
R E P O R T
on clinical examination of autonomous electrostimulator of alimentary canal and mucosa provided by ECOMED Research and Production Association for the patients with disordered function of large intestine
The goal of this work is investigation of of the influence of the autonomous electrostimulator on the functional state of large intestine for the proctological patients with some nosological forms.
The most common diseases of digestion organs are chronic stasis of large intestine and irritation syndrome of large intestine: their frequency in the structure is up to 70% according to the data of various authors. These diseases are characterized by various forms of functional disorders of motor system, absorbtion, and secretion, primarily of large intestine. The clinical pattern shows disorder of stool, often with complete absence of independent defecation. Most patients shows various disorders in the personal structure: tendency to depression, sense of fault, fear, aggressive and hysteric reactions. They are characterized by a low adaptability to the environment and a inadequate reaction on the external effects both under common conditions and in the extreme situations.
An essential factor of development of functional disorders of large intestine is congenital or acquired injury of nervous and muscular structures of intestinal parties. Disorder of nervous regulation of motor activity of large intestine results in discoordination of peristaltic waves, changes in tonicity of intestinal paries, and finally in disorder of permeability of the alimentary canal. The treatment with purgative enemas or purgative preparations normally increase the disorder of functions of large intestine. Taking into consideration the importance of disorders of nervous regulation in pathogenesis of these diseases, application of electrostimulation in therapeutical complex is accounted from parhogenetic point of view. Electrostimulation is widely applied as a physiotherapeutic facility under hospital conditions and the efficiency of electrostimulation is sufficiently high (V.G.Yasnogorodskii, Electrotherapy, Moscow: Mir, 1987).
Autonomous electrostimulation using the autonomous electrostimulator of alimentary canal and mucosa can have a number of advantage with respect to stationary electrostimulators, because the autonomous electrostimulator affects all the intestines in series without overcoming the resistance of soft tissues that enables to apply the electric signals, which are most corresponding to psysiological ones. However, it is of interest to make an objective estimation of the influence of the autonomous electrostimulator on the functional state of large intestine in the case of sufficiently serious functional disorders thereof.
The autonomous electrostimulators (technical conditions 944414-115555014-015-05) are provided by ECOMED Research and Production Association.
| Place of investigation: | State Research Center of Proctology, Russian Federation Ministry of Health Protection and Medical Industry, Laboratory of clinical pathophysiology with the group of physical therapy. |
Executors: L.F.Podmarenkova, senior researcher, candidate of medical science.
Patients: 23 persons with disorder of functional state of large intestine.
Description of patients. The group of patients included 23 persons (8 men and 15 women) at the age of 38 to 57. All the patients had complete absence of independent stool. Seven patients had the diagnosis of chronic stasis of large intestine. All the patients passed general clinical examination, including general clinical blood test and biochemical investigations characterizing the state of metabolism, of proteins, carbohydrates, and pigments. The special investigations included the study of electric activity of muscular structures of alimentary canal and also the motor system of large intestine. Before the investigations, all the patients were characterized by a significant decrease in electric activity and strong depression of the motor function. In average, the activity index of large intestine was 1.12, while the normal value is 1.25 and, the time of activity was reduced to 32.5 ± 2.7%, while the normal value is 60.5 ± 3,7%). The amplitude and duration of waves of motor activity were certainly below the normal value and were, respectivbely, 8.2 ± 0.7 mm of water column and 3.2 ± 0.5 seconds. We observed a significant shift of wave spectrum of motor activity towards the low-amplitude segmentary waves.
The preliminary selection of patience, who satisfied the criteria of inclusion in investigation, was performed by medical histories. The investigations were carried out after receiving the informed consent of patients (in accordance with Helsinki Agreement on human rights).
Autonomous electrostimulation therapy: The autonomous electrostimulator of alimentary canal and mucosa is a metal capsule with the dimensions of 11 x 22.5 mm and the weight of 5.5 g with two metal hemispheres used as electrodes. Upon swallowing the autonomous electrostimulator and entering the electrolyte medium, the hemisphere are shortened, the power source and the generator of pulse current are switched on. The therapy by means of the autonomous electrostimulator included application of one capsule (for six patients with irritation syndrome of large intestine) or two capsules (for 17 other patients). The general and special investigations were carried out before and after the therapy. During the therapy, the patients were under permanent medical observation, special investigations, including roetgenological studies, were carried out. The prolonged therapeutical effect was estimated in 8 weeks after application of the autonomous electrostimulator.
Methods of investigation
The electric activity of muscular structures was estimated by means of electrogastrography, electroenterography, and colography. We estimated the changes in rhythm frequency and amplitude of propulsive waves.
The motor and evacuation functions of large intestine were determined by means of multichannel stimulation balloonography (Methodical Recommendations, Russian Federation Ministry of Health Protection, Moscow, 1993).
Monotoring over passage of stimulator was performed using a Medicor electromyograph with skin electrodes. The amplitudes of acoustic signal from selector of the myograph and the presence of characteristic pulsation of the electric signal from the capsule enabled us to determine its location in alimentary canal. This monitoring was carried out every two hours on the first day and then once a day. In the case of prolonged staying of the capsule in the cavity of large intestine, we performed roentgenological investigation using a standard technique.
Basic results.
For 50% of patients (12 persons), evacuations of the capsule with independent stool was observed during two first days after application. For other patients, the time of evacuation was 3 to 5 days, and one woman with decompensated form of chronic stasis of large intestine evacuated the capsule only on the seventh day after applications of purgative. In a day after evacuation of the first capsule, 17 patients from the group applied the second one. We observed some showering in passage of the capsule upon the second application (the average time of evacuation was 3.2 days for the group). Further, during all the time of observation, 75% of patients had regular stool. Five patients with chronic stasis of large intestine still had constipations.
Upon the functional investigations, which were carried out immediately after evacuation of the capsule, we observed a significant intensifications of motive activity of large intestine that was indicated by the 1.5-fold increase in the activity index, the increase in the amplitude and duration of waves of motor activity up to 14.2 ± 2.7 mm of water column and 5.2 ± 1.1 seconds, respectively. In most complicated cases (four patients with chronic stasis of large intestine), activation of the motor function was less pronounced (the index was increased insignificantly). Apparently, application of 1 or 2 capsules is insufficient in such cases to obtain good clinical and functional effects.
The obtained results certainly indicate the efficiently of the autonomous electrostimulator for treatment of serious functional disorders of motor and evacuation functions of large intestine. However, in order to obtain the necessary effect, the individual selection of the number of electrostimulators is required, at least two with the interval of 15 to 20 days. A smaller number may result some slowing of passage. The absence of effect and the necessity of application of additional facilities for evacuation of the capsule that was observed in one case seems to correlate with decompensated form of colostasis.
Since electrostimulation directly affects the muscular system and nervous endings of intestines and simultaneously affects the regional blood circulation (V.G.Yasnogorodskii, 1987), we can suppose the positive influence of the autonomous electrostimulator in treatment of hemorrhoid, ishemic colitis, and also for insufficiently of anal sphincter. We cannot exclude its application for strengthening the muscles of pelvic fundus. However, all these applications require further clinical investigations.
Conclusions:
- The autonomous electrostimulator of alimentary canal and mucus is an efficient facility for normalization of functional state of large intestine and regeneration of its motor and electric activities.
- One capsule is insufficient to obtain the effects for the patients with decompensated colostasis, selection of the necessary number of capsules should be done individually with respect to the degree of decompensation.
- The autonomous electrostimulator should be applied again not earlier than in 15 to 20 days after application of the first capsule.
RESOLUTION
Application of electrostimulation for regeneration of motor and electric activities of large intestine is substantiated pathogenetically. The autonomous electrostimulator of alimentary canal and mucosa effectively regenerates muscular activity of large intestine. It seems to be accounted for by its influence on nervous and muscular endings and regeneration of receptor system. For most patients, improvements of the clinical pattern of the disease was accompanied by improvement of neuropsychological status, decrease in weakness and fatiguability, normalization of sleep, and other symptoms of asthenoneurotic syndrome.
Taking into consideration the efficiency of the autonomous electrostimulator for normalization of function of large intestine and the feature of effect of autonomous electrostimulation characterized by the opportunity of affecting all the intestines in series, particularly, the sections with reduced motor activity, where the stimulator is retained, we can recommend its wide application in practical health protection not only in hospitals, but also under home conditions. No side harmful effects of the autonomous electrostimulator were observed.
Supervisor of investigations,
candidate of medical sciences,
senior researcher of the laboratory of clinical pathophysiology with group of physical therapy at the State Research Center of Proctology,
Russian Federation Ministry of Health Protection and Medical Industry
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L.F.Podmarenkova
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/signature/
July 28, 1995 |
| General Director of ECOMED Research and Production Association |
S.A.Khvorostov |
/signature/ |
Original products have laser marking on the box with written title "Electronic normalizer", factory number, little star and the RPA "Ecomed" trade mark.