A report of the results of clinical study of the biologically active peptide bioregulator of brain origin:
The biologically active peptide bioregulator Cerluten® contains a complex of low-molecular peptides with molecular weight up to 10 000 Da, isolated from CNS of young animals – calves aged up to 12 months.
Cerluten® is manufactured in the form of capsules with a content of active substances of 10 mg.
Experimental studies have shown that the peptides possess tissue-specific action on the cells of the tissues from which they were isolated. Cerluten ® peptides regulate metabolism processes in the brain cells, increase brain safety margins, having a favorable effect on the organism adaptation processes in extreme conditions, the possess anti-oxidative properties, regulating peroxide oxidation processes in the brain cortex. So it is possible to extrapolate an efficiency of administration of Cerluten ® for restoration of the function of the central nervous system and its disorders of various origins.
Treatment of central nervous system diseases is of specific urgency, because they lead to social adaptation disorder and invalidation of patients (2).
Now the treatment of patients with disease of central nervous system diseases in view of pathogenetic mechanisms is carried out using the following traditional therapeutic agents of various action types: (1, 3)
The clinical studies of Cerluten® were carried out at the Medical Center of the Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences in 48 patients with various diseases of central nervous system: long-term effects of craniocerebral injury (the prescription of the injuries was from 1 year to 10 years), state after stroke, vascular encephalopathias, decrease in mental capacity, memory, attention during the period from October 2003 till February 2004. Distribution of the patients by clinical entities, sex and age is shown in the table 1. The patients of the main group have been taking Cerluten® in addition to the general purpose medicines – 1-2 capsules, 2-3 times a day before meal for 10-20 days depending on intensity of the pathological process.
The control group consisted of 37 similar patients, which have only general purpose treatment.
All the patients have been taking symptomatic and pathogenetic drugs, these drugs have resulted in short-term therapeutic effect, which required increase in a dose of the drugs per treatment course and duration of their administration.
Table 1
Distribution of the patients by clinical entities, sex and age
|
Diagnosis |
Age (years) |
Men |
Women |
In total |
|||
|
control group |
main group |
control group |
main group |
control group |
main group |
||
|
Long-term effects of craniocerebral injury |
32-58 |
5 |
8 |
2 |
2 |
7 |
10 |
|
State after stroke |
51-68 |
4 |
4 |
4 |
5 |
8 |
9 |
|
Vascular encephalopathies |
52-73 |
5 |
6 |
7 |
11 |
12 |
17 |
|
Signs of decreased mental capacity, memory, attention. |
43-65
|
6 |
7 |
4 |
5 |
10 |
12 |
|
In total |
|
20 |
25 |
17 |
23 |
37 |
48 |
Examination methods
Cerluten® efficiency was assessed by dynamics of subjective parameters and objectively, using correction task and electroencephalography (EEG) methods.
Examination results
After administration of Cerluten® in patients of the main group the clinical result was observed in 64.6% of cases, satisfactory – in 22.9%, absence of positive effect – in 12.5% of cases (control group – table 2). There were no negative influences of Cerluten on a condition of the patients.
Table 2
Cerluten ® efficiency in patients with diseases of central nervous system
|
Result of treatment
|
Group of patients |
|||
|
Treatment using general purpose medicines |
Treatment using Cerluten® |
|||
|
abs. |
% |
abs. |
% |
|
|
Good |
10 |
27,0 |
31 |
64,6* |
|
Satisfactory |
15 |
40,5 |
11 |
22,9 |
|
Not satisfactory |
12 |
32,5 |
6 |
12,5* |
|
In total |
37 |
100 |
48 |
100 |
* Р<0.05 in=”” comparison=”” with=”” parameters=”” patients=”” after=”” treatment=”” using=”” general=”” purpose=”” medicines=”” p=””>
At comparison of subjective parameters of t condition of the patients before and after use of Cerluten® it was established that the number of health complaints was 2-3 times less. The patients have noticed memory impairment, intelligence impairment, decrease in intensity and duration of headache, emotional disbalance, endurance and stamina, feeling of rest after night sleep (table 3).
In patients with consequences of craniocerebral injury and stroke there was a moderate regression of focal symptoms, improvement of speech function at motor and sensor aphasia, decrease in muscular spasticity.
Comparative assessment of influence of Cerluten® and other methods of treatment on the integral function of the brain – attention and bioelectric activity of the brain was assesses using correction task and electroencephalography accordingly
Table 3
Influence of Cerluten® on subjective parameters of the state of health of the patients.
|
Parameter |
Before treatment, % |
After treatment using general purpose medicines % |
After treatment using Cerluten®, % |
|
Head ache |
76,6 |
47,2# |
34,1# |
|
Sleep disturbances |
54,9 |
34,0# |
24,3# |
|
Emotional instability |
75,8 |
43,0# |
21,4*# |
|
Memory disturbance |
54,5 |
45,2 |
28,5*# |
|
Absent-mindedness |
48,7 |
43,9 |
14,6*# |
|
Rapid fatigability |
72,0 |
53,2# |
32,4*# |
# Р < 0.05 in comparison with the parameter in patients before treatment.
*Р<0.05 in=”” comparison=”” with=”” the=”” parameter=”” patients=”” after=”” treatment=”” using=”” general=”” purpose=”” medicines=”” p=””>
Table 4
Influence of Cerluten® on the dynamics of parameters of carrying out of correction task by the patients with diseases of central nervous system
|
Group of people examined. |
Number of symbols viewed |
Number of errors
|
|
Healthy
|
1835,2±83,7 |
7,15±1,01 |
|
Patients before treatment
|
1143,7±75,4 |
18,12±0,93 |
|
Patients after treatment with general purpose medicines.
|
1573,8±67,5*
|
11,1±0,86*
|
|
Patients after treatment using Cerluten® |
1682,6±62,8* #
|
8,67±0,96* # |
*Р<0.05 in=”” comparison=”” with=”” parameters=”” the=”” group=”” of=”” patients=”” before=”” treatment=”” p=””>
#Р<0,05 in comparison with parameters in the group of patients after treatment using general purpose medicines
The results of carrying out by the patients of the correction task after treatment using various methods are shown in table 4. According to the table, the patients after treatment using Cerluten® have higher number of symbols viewed and lower number of errors. The patients of the main group have received better results at analysis of the dynamics of carrying out of correction task before and after the treatment in comparison with the patients of the control group. It was expressed by absence of violent oscillations of the number of the symbols viewed per similar time periods, presence of “warming-up” period to the middle of the task performance and gradual decline of the curve to the end of the task, which is a sign of highest attention stability after treatment.
Assessment of Cerluten® influence on bioelectric activity of the brain was carried out using visual analysis of EEG with distribution by types and calculation of alpha index before and after the treatment. EEG was carried out selectively to the patients with more expressed signs of pathological processes. The examination results are shown in the table 5.
Table 5
Cerluten ® influence on electorencephalogram type characteristic in patients with diseases of central nervous system
|
Group of people examined. |
EEG type |
|||||
|
III |
IV |
V |
||||
|
before treatment |
after treatment |
before treatment |
after treatment |
before treatment |
after treatment |
|
|
After treatment with general purpose medicines. |
9 |
7 |
11 |
9 |
13 |
9 |
|
After treatment using Cerluten® |
11 |
7 |
10 |
6 |
15 |
7 |
Before treatment the people examined in various groups predominantly had pathological EEG types (III, IV, V). III type of EEG was characterized by so called non-dominant curve at low amplitude level (below 30-35 mcV), presence of irregular alpha-activity or even its absence. IV type of EEG was characterized by particularly emphasized regularity of the rhythms, blurring of zonal differences. V type of EEG was characterized by presence of irregular slow activity with an amplitude over 35 mcV, sharp waves, paroxysmal discharges.
Patients after treatment using Cerluten® had most intense changes of brain bioelectric activity. Is was seen on EEG first of all in the form of more clear modulation and restoration of zonal differences of alpha-rhythm, decrease in intensity of irritative processes, in some cases – elimination of paroxysmal discharges.
Table 27
Cerluten® influence on the dynamic of alpha index changes in patients with diseases of central nervous system
|
Group of people examined. |
Alpha-index |
|
|
Before treatment |
After treatment |
|
|
Healthy |
55,1±3,9 |
– |
|
Patients using general purpose medicines |
33,6±3,7 |
41,3±4,2 |
|
Patients using Cerluten® |
34,0±4,1 |
47,9±3,7*# |
* Р<0.05 in=”” comparison=”” with=”” parameters=”” the=”” group=”” of=”” patients=”” before=”” treatment=”” p=””>
#*Р<0.05 in=”” comparison=”” with=”” the=”” parameter=”” group=”” of=”” patients=”” after=”” treatment=”” using=”” general=”” purpose=”” medicines=”” p=””>
Besides visual EEG assessment there was a calculation of alpha index in patients before and after treatment (table 6). It was established that under the influence of the treatment there was a reliable increase in the alpha index in the patients of the groups examined. However the decree of change of alpha index in patients, receiving different treatment was different. Alpha-index value was reliably higher in the group of patients after treatment using Cerluten® in comparison with the parameters in other groups.
Conclusion
On the basis of the data received it is justifiably to draw a conclusion that activation of reserve capacity of the brain cortex using Cerluten® helps to improve integral functions of the brain.
Thus the results of clinical study testify the efficiency and expediency of use of Cerluten® for complex treatment and prophylaxis of the diseases of the central nervous system of various origins.
Cerluten® does not result in side effects, complications and drug dependence; there were no contraindications for carrying out of clinical studies.
Cerluten® can be used for treatment and prophylaxis, including in combination with any means of symptomatic therapy, used for neurological practice (vascular, nootropic, resolving, anticonvulsants, vitamins etc.)
Recommendations for use
Cerluten® is recommended for acceleration of restoration of the brain functions after the craniocerebral injury, stroke, intellectual disorders and the influence on the organism of various extreme factors. It’s also indicated to elderly people for maintenance of the mental capacity.
It is recommended to take Cerluten® per os 10-15 minutes before meals 1-2 capsules 2-3 times a day for 10-20 days.
It may be desired to have one more course in 3-6 months.
There are no contraindications and side effects for Cerluten® administration.
References
1. Kovalev G.V. Nootropic medicines. – Volgograd: Nizh.-Volzh. publishing house, 1990. – 368 pages
2. Treatment of nervous diseases: Translated from English/ Edited by V.K.Viderholt. – M.: Medicine, 1984. – 560 pages
3. Mashkovsky M.D. Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”, 1993.
