世界規模でのグリーンパパイヤの研究、土壌細菌叢の研究

APPLICATIONS OF THE ORAL PREPARATION “BIO-NORMALIZER” IN THE STAGES OF REHABILITATION OF PATIENTS WITH SUBSTANCE ABUSE

This paper assesses the possibility of using BN for patients who decided to stop from taking alcohol and drugs during their period of rehabilitation as measured by liver and cardiac function tests, compared with patients with non-alcoholic liver damage. During the early period of BN intake (2^nd -3^rd day), it was already noted that functions of the liver stabilized, indicating a protective effect on the liver. Functions of the heart likewise was stabilized by mid-course of treatment, indicating stabilization of the cellular membrane of the heart muscles against damage, thus also exhibiting a protective effect in the heart. An incidental finding of improvement of iron-deficiency anemia was noted in two patients. Findings also showed improvement of the patients’ clinical conditions. It was therefore concluded in this study that BN indeed is of proven help to patients during periods of rehabilitation from alcohol and drugs.

Towards a practical application in various stages of rehabilitation of patients with chemical (or substance) dependence, including those with accompanying alcoholism and serious somatic disturbances and diseases.

APPLICATIONS OF THE ORAL PREPARATION “BIO-NORMALIZER” (Japan) IN THE STAGES OF REHABILITATION OF PATIENTS WITH SUBSTANCE DEPENDENCE

T.V.  CHERNOBROVKINA, A.S. OVCHINSKAYA

Russian State Medical University

(NIL Clinical Research on Drugs)

Faculty of Drugs and Psychotherapy Institute for Quality Advancement of the Federal Administration for Medical, Biological and Special Problems, Russian Federation Drug Dispensary of the Southern Administrative District, City of Moscow

Analysis of the functions of the popular food supplement Bio-Normalizer (BN) allows an assumption of its influence on a number of complications accompanying substance dependence. Among these complications, the most widespread and serious are those involving the liver, heart, pancreas and kidneys. It is well-known that active drug substances (NDV) including alcohol, opiates, addictive hemps, ephedrine, even hallucinogenic and toxic stupor-inducing agents, are very popular among teenagers and young people, exerting harmful effects on the morphological and functional conditions of organs including the liver. Clinically, this is manifested through symptomatic disturbances in nutrition (malabsorption) and other features which can be classified by the stage and severity of substance deprivation, e.g.  inflammation of the liver (hepatitis), connective tissue degeneration (liver cirrhosis) and liver cancer. Biochemical staging/grading of alcohol (or drug) deprivation in the liver can be gauged by the accompanying metabolic imbalance, enzymatic dysfunction and dyslipidemia as evaluated by the qualitative and quantitative deviation from normal levels through laboratory analysis.

Aside from these, patients with chemical dependence are also characterized by varied disturbances in the cardiovascular system and, in particular, a disturbance in the nourishment and adequacy of energy supply of the myocardium. Clinically, this is manifested by dysrhythmia, shortness of breath, acute onset of localized pain, progressive fatigue or general weakness; in the laboratory on the other hand, this may manifest as altered levels (hypo- or hyperactivity) of “cardiac profile” enzymes in the patient’s serum, including abnormalities correlated with the patient’s cholesterol profile.

Taking into account the numerous scientific evidence of the capability of BN to stimulate and regulate the “detoxification” of a living organism (1, 2), its immunomodulating activity (2, 3), antioxidant capabilities (2, 4) and hepatoprotective activity in the management of viral hepatitis (1-4), this study will try to introduce this food supplement and prove its usefulness in the management of drug/alcoholic patients with hepatic complications in different stages of severity. Aside from this, justification for the use of this preparation as a quality biocorrective agent in metabolic disturbances of the myocardium, particularly patients in serious condition during the post-intoxication and abstinence periods, will be explored.

The objectives of the present study therefore, include the following:

1. To assess the efficacy of BN as a hepatoprotective agent in patients with hepatitis of different etiologies;
2. To assess the efficacy of BN in correcting abnormal levels of “cardiac profile” enzymes in the blood of patients with chemical/substance dependence and  myocardial strain/fatigue;
3. To study the influence of BN on the blood lipid profile and uncover possible effects on other parameters of biochemical homeostasis.

METHODOLOGY:

Clinical methods of investigation include inquiry and examination of patients and anamnestic studies.

Reflotron provided automated analysis of the blood samples; Urotron for urine samples (Boehringer-Mannheim, FRG, and manufacturer).

In the series of complex clinical-biochemical studies, we investigated the dynamics (using 2-5 samplings) of common complications in 26 patients, among who are: 6 patients with alcoholic hepatitis in the “middle?” stage of severity and 1 patient with alcoholic cirrhosis of the liver; 4 patients with opioid addiction intoxication in combination with toxic hepatitis. For the control group, 5 patients with narcotic/alcoholic complications were investigated, from whom 2 patients were diagnosed with hepatitis secondary to food contamination and 3 were with chronic cholecystitis- hepatitis in the severe stage. All examined patients received BN at dose of 3 grams once a day (in the evening, melted under the tongue without water). 1 patient took BN in the course of two months as a solution (3 grams in 1 liter of cooled boiled water), such dose being estimated for 2 days. It was necessary to note that nobody among those examined manifested a marked aggravation of their current illnesses or complications secondary to the effect of BN when used as monotherapy.

All the patients with alcoholic hepatitis were observed for dynamics which would indicate normalization or optimization (or when the patients have not attained or approached normal limits but have considerably improved to approximate normal, stabilized levels) of all liver function tests: activities of liver enzymes (AST, ALT, GGT) and levels of bilirubin and cholesterol fraction-alpha-cholesterol. As soon as any patient has significantly demonstrated an improvement, ____________________________________________________________.  Significant normalization of their biochemical homeostasis should parallel that of their general conditions including reduction of pain sensation in the epigastric and hepatic Regions, disappearance of heartburn, improvement of appetite, normalization of sleep, elevation of mood or spirit, increased efficiency in activities.

DISCUSSION:

In two patients who were in the 2^nd – 3^rd stages of alcoholism, a marked reduction in their desire to take alcohol, manifested as an indifferent attitude towards alcohol intake and concomitant improvement of their clinical symptoms was observed. This effectiveness of BN was already manifested on the 2^nd -3^rd  day in  the course of treatment which certainly may  have promoted the  patients’ confidence toward  this preparation so as to exert an influence on the patients’ attitude towards their rehabilitation process, especially combined with psychotherapy.

Two patients suffering from food intoxication/poisoning at the time of their laboratory examinations manifested gross disturbances in their biochemical homeostasis which are characteristic of liver and pancreatic dysfunctions. These disturbances gradually declined starting from the 2^nd – 4^th day in the course of treatment, completely returning to normal on the 12^th day, thus objectively confirming BN’s restorative effects on the morphological functional state of the digestive organs (a process which normally would last not less than 3-4 weeks). Particularly striking is the biocorrective activity of BN as manifested in the normalization of protein synthesis as well as in the secretory functions of the liver such as activities of AST, ALT, GGT, bilirubin levels, protein fractions and levels of blood urea nitrogen exchange in the blood. A similar change in the triglyceride and cholesterol levels of all patients in a subgroup was notably stabilized by BN.

4 patients with viral hepatitis ( C, B and a combined form of C+B not associated  with substance dependence manifested a marked improvement of all the biochemical parameters of “liver profile” within the first 10-15 days. Treatment of other patients with other expensive immunomodulating agents evidently gave results much later than this. Effect was of a consistent nature for Hepatitis B (2 observations). In the case of the combined form of Viral Hepatitis in a 34 year old patient, the hepatoprotective activity of BN took a longer time, was of a temporary/transitory character, i.e., hepatic indexes destabilizing after a period of normalization. This  may  illustrate  either  an  autoimmune  nature  of  the  disease and/or an insufficient dose or non-optimal regimen of BN intake as necessitated by a research/examination like this.

2  patients  with  hypofunctioning liver ( 1 patient was 52 years old with alcoholic cirrhosis and one was 31 years old with a malfunctioning gallbladder) who received BN manifested a slow but remarkable and stable improvement of the indexes of their liver function increased activities of ALT, GGT, and regulated urea and uric acid levels within 2-3 weeks at 15-25%. Likewise remarkable was the incidental finding of a rapid reversal of iron­ deficiency in the blood and normalization of hemoglobin levels associated with a marked improvement in their general health condition as well as disappearance of the clinical signs/features of anemia.

Two patients in the control group with non- alcoholic liver conditions and with features of cholecytitis-hepatitis along with fluctuations of enzymatic levels reflective of the functional state of their liver had a steady increase in their triglyceride and cholesterol fractions and bilirubin. This abnormal/inadequate lipid metabolism/exchange however, was easily corrected by BN in the dose they were given (1 sachet, 3 grams in a day).

A separate interest is generated by an early and remarkable positive influence of BN on the energy balance of the myocardium, as manifested by patients with substance dependence  (3 patients), a patient who exhibited myocardial fatigue as a consequence of psycho-physical overloading (1 patient) and  myocardial fatigue in geriatrics or patients older than 60 years (3 patients). In all these cases, there was a notable/substantial decrease in the production of CPK (between 30-60%). This remarkable demonstration of BN’s cardioprotective effect which was already noticeable by mid-course of treatment may be related to its antioxidant property resulting to cellular membrane stabilization. A result which merits further examination.

Also, attention must be given to BN’s beneficial effect on substance-dependent youths with early liver involvement (of different etiologies) who, when examined a year ago, were afflicted with serious complications resulting from heavy episodes of alcoholism and drug use.

Enumeration of the above-mentioned clinical-biochemical results of alcoholic patients under therapy, non-alcoholic patients under therapy, NDV-dependent patients, and healthy medical workers acting as volunteers corroborate/confirm earlier demonstrated therapeutic effects of BN. As the results further show, BN is a food supplement which possesses biocorrective qualities under a wide spectrum of activities, with applications in the management of liver and pancreatic conditions of different etiologies; in energy/metabolic disturbances; in providing adequate protective provisions for the myocardium; in assisting patients during states of abstinence or physical and/or intellectual over-fatigue. Biological schema of BN’s effects and applications in substance dependence are presented below.

CONCLUSIONS AND RECOMMENDATIONS:

Thus considered, further trials are merited to show that BN, a new supplemental preparation, can regulate the metabolic and enzymatic activities in organs and systems in a highly effective manner, a worthy representative of a new generation of preparations with curative properties—- biocorrective agents which belong to a class of natural remedies with systemic enzymotherapeutic effects and are optimizers of homeostasis.

Results of this preliminary trial in substance dependent patients with multi-organ complications in comparison with other prepathological and pathological conditions reveal new mechanisms of the biological effects of BN and denote new perspectives of its curative as well as prophylactic uses in a broad spectrum of medical and ecological practices.

LITERATURE

1. OSATO, J.A., Cuadra, M.S., et.al. Proceedings in International Conference on Bioradicals Detected by ESR-Spectroscopy (in pres).
2. SANTIAGO, L.A., Osato, J.A., et.al. 1991. Free Radical Biol.Med. 11:379-383
3. SANTIAGO, L.A., Osato, J.A., and Mori, A., 1992. Neurosci. 18:189-194
4. WEBMAN, E.J., Edlin G., and Mower, H.F., 1989. Intl. J. Radiat. Biol. 55:347-351