|Title||Clinical Efficacy of Bio-Normalizer in the Management of Patients with Severe Cerebral Damage|
|Author||Maksakova Olga, Korkina Ludmila|
“Clinical Efficacy of Bio-Normalizer in the Management of Patients with Severe Cerebral Damage”
(Pilot, randomized, case-controlled, open clinical trial)
Institution: Neurosurgical Institute, 5 Fadeeva St.,
Moscow 125047, Russia
Principal Clinical Investigator – Dr. Maksakova Olga, MD, PhD
Tel: (095) 2505626
Scientific Supervison – Prof. Korkina Ludmila, MD, PhD, Dr. Sci.
Tel/Fax: (7095) 434 7187
The open randomized case-controlled clinical trial on the efficacy of Bio-Normalizer in patients with severe post-operative brain damage was performed. Fourteen patients of both sexes aged from 10 to 65 years (mean age ± years) participated in the study after their informed consent. The patients were given 6 g or Bio-Normalizer a day daily at bedtime for 1 month. They exhibited numerous neurological symptoms of traumatic brain disease. This diagnosis was confirmed by instrumental methods such as computer tomography and electroencephalography and by neurological-psychological tests. There were no drop-outs from the trial or any of side adverse effects including allergic reactions in the participants. A vast majority of the patients studied with severe operation-related impairment or memory, mental functioning and locomotive activity showed significant improvement in neurological, psychological and physical status after taking BN ( 12 patients, 93%). The results of instrumental assessment such as computer tomography and electroencephalography supported positive clinical observations revealing a significant decrease in EEG paroxysmal activity (10 patients, 71 %), improvement in the pathological diencephal symptoms (11 patients, 78%), and an increase in the hemisphere coherence (12 patients, 93%). The data or psychological tests showed BN-induced improvement or speech disorders particularly aphasia (9 patients, 64%), sharply increased self-assurance (12 patients, 93%), memory and social adaptivity (8 patients, 57%). At the same time, there were noticed temporal impairment or patients’ mood and their increased aggressiveness during first period of the trial (3 patients, 21%).
According to Dr. Osato’s ideas, BN contains several powerful neuro-agents capable of penetrating the blood-brain barrier and normalizing the cerebral metabolism. It has been shown in a number or works that BN suppressed significantly intensity or lipid peroxidation in the brain tissue [ ] and cured epilepsy [ ]. Furthermore, BN is found to be effective immunomodulator, regulator of redox status in the human body, adaptogen, and modulator or trace element distribution. It is well established that patients in the vegetative state due to severe brain damage are suffered a lot from the secondary immunodeficiency. Usually they lose completely the adequate response to the external stimuli (adaptive reaction). There is clear in vivo evidence of oxidative stress in such patients, which is a consequence of oxidant/antioxidant imbalance. Therefore, it was suggested that BN could ameliorate the stress and improve metabolism and psycho-neurological condition in-patients after massive brain operations they were undergone due to trauma, stroke or tumor.
Patients and Methods.
• patients of both sexes
• age from 10 to 65 years
• patients operated after accidental cerebral trauma
• patients suffered from stroke and operated
• patients after brain tumor operations
• patients at the post-acute (chronic) stage
• patients in acute stage of brain disease
• patients with life expectance less than 3 months
• patients suffered from any kind or allergy
• patients or their relatives with poor compliance
• patients with other than cerebral severe diseases
Fifteen patients fulfilled the eligibility criteria will participate in the clinical study after their or their relative’s informed consent. All patients will start being treated with 1 sachet of BN at bedtime. Then, according to their doctor observations and recommendations the individual doses will be gradually increased up to 4 sachets a day. The scheme and way (oral or intraesophagial) of BN application will depend on patients’ conditions and doctors’ conclusions. The total duration of the BN therapy course will be 1 month. Each patient will be further followed-up during 1 month after cessation of BN therapy. The results obtained for the same patient with and without BN will be compared and if possible statistically evaluated. If there is a very broad variability or background parameters, individual clinical cases will be described in details with the focus on the comparison of the results obtained with and without BN.
Result and Discussion.
The patients admitted to hospital will be examined frequently at least 4-5 times during each period or trial, the first one with BN therapy and the second one in the absence of BN treatment. The general conditions or the patients will be assessed by determination of neurological status, behavior status, mental functions and so on. All patients will be followed-up by neurologist therapist, specialists in ophthalmology, acoustical neurology, and rehabilitation. The patients at the different stages or vegetative state outcome will be subjected to a complex or neurological methods to determine a degree or motor and sensor deficiency, arousal level, muscular tonus, impairment of active and passive movements, reflexes, responsiveness to external signals, impairment or somatic functions, and so on.
The mental functions of patients will be examined frequently by the special tests, which allow to assess and document their cognitive processes such as speech, thinking, attention, visual-constructive activity, perception, practical skills (praxis), memory, etc. Psychologists will examine the emotional personal conditions.
Instruments and laboratory analyses.
The instrumental tests will include:
Doppler ultrasound analysis or cerebral blood flow
The general metabolism will be evaluated by routine biochemical analyses or blood such as: proteins, lipids including phospholipids, glucose, creatinine, urea, uric acid, electrolytes, ALT and AST activities.