Clinical testing of dietary supplements GEPATON 2
EI Beloborodov, Head. Chair of Internal Medicine FPC and PPP SSMU, Honoured Doctor of the Russian Federation, Ph.D., Professor, Tomsk
Relevance of biologically active additives (BAA)
In recent years, public health is characterized by negative trends that affect life expectancy. Increased number of diseases caused by inadequate intake of nutrients (BAA). Increased demands on medical therapy. It must have minimal side effects.
A priority in the treatment of many diseases of internal organs is the use of herbal drugs - they are almost atoksichny not have a damaging effect on body organs and systems.
For liver diseases at early stages of the disease suffer choleresis and biliary excretion, violated all kinds of metabolism, decreased detoxifying function of the liver, which reflects the entire body.
In recent years, safe method of treatment is the use of biologically active additives (BAA).
In liver disease for many years widely used herbal hepatoprotectors: EPLIR, lohein, Maksarov and others. Proved their high therapeutic efficacy in toxic hepatitis, especially alcohol, drugs. They are used in the treatment of viral hepatitis.
The purpose of the study
Explore the possibility of use, portability, and assess the effectiveness of dietary supplements (supplements) GEPATON 2 in patients with liver and biliary tract.
The composition of the drug include: Salsola collina (extract), vitamin C, tansy, glutamic acid; hips (fruit), vitamin A, glutathione, sodium selenite; thoroughwax, vitamin D3, lipoic and folic acid, dandelion (root), Vitamin B1 , D-biotin, D-calcium pantothenate; sublimed beet, vitamin B2, methionine, everlasting, yarrow (extract), vitamin Be, lecithin, St John's wort, peppermint, vitamin B12; vitamin E, burdock (root), cysteine, vitamin PP .
Salsola collina has an antioxidant effect, reducing the formation and accelerating the disposal of toxic substances contributes to the restoration of cell membranes, normalizes the process of bile secretion, prevents the fatty liver. Useful properties of Salsola collina amplified by other integral components of the drug.
Vitamin C, A, E, PP, glutathione possess antioxidant activity.
Beet fiber content by stimulating peristalsis, accelerating excretion of toxic substances and toxins from the body.
Lecithin, methionine, vitamin B, folic acid - lipotropic substances promoting the restoration of the membranes of liver cells and prevent fatty liver.
Tansy, thoroughwax, everlasting flower, dandelion, rosehips, peppermint, yarrow increases formation of bile, reduces its viscosity, thereby preventing the formation of gallstones, improves bile secretion, raising the tone of the gall bladder and reduces the tone of the biliary tract. In addition, yarrow, St. John's wort, rosehips have anti-inflammatory effect, and St. John's wort, and peppermint spasmolytic activity, burdock root increases the deposition of glycogen in the liver.
Materials and methods In this study, we used data obtained during the examination and observation of 64 patients with chronic hepatitis, of which a core group consisted of 30 patients and a comparison group, 34 people who had previously treated BAA GEPATON not carried out.
30 patients with the main group received monotherapy GEPATON 2 to 2 tablets (0,1) 3 times a day during meals.
A comparison group received monotherapy known fitogepatoprotektorom karsilom 2 tablets, 70 mg 3 times daily with meals.
The course of treatment in both groups was 4 weeks (30 days).
In accordance with the modern classification of chronic hepatitis proposed by the World Congress of Gastroenterology in Los Angeles in 1994, both groups of patients diagnosed with chronic hepatitis moderate activity, alcoholic etiology and 10 of them as the main and the control group was discovered hepatitis virus aetiology. The average age of the groups was 30,62 ± 0,98 years with disease duration 3,61 ± 0,6 years. The groups were matched by sex, age and duration of the disease. The diagnosis of chronic hepatitis was conducted in accordance with modern requirements and include the identification of the etiology, the degree of activity and stage of disease. Survey methods included, besides physical, the following: biochemical blood analysis to determine the parameters of liver function (the definition of transaminases ALT, AST, direct and indirect bilirubin, alkaline phosphatase, glutamate-mintranspeptidazy, cholesterol (beta-lipoprotein, glucose, uric acid, total protein and its fractions), the definition of serologic markers of viral hepatitis (B, C), duodenal intubation with the definition in the gallbladder bile major biliary lipids (bile acids, phospholipids, cholesterol), ultrasound of the abdominal cavity with the definition of volume and contractility of the gallbladder ; gepatobilistsintigrafiyu (with the radiopharmaceutical technetium 99m); hepatic biopsy (if necessary).
Clinical characteristics of patients in most patients - 83% of the principal and 82% of the control group - there were weakness, fatigue, a third of patients had decreased appetite (34% in the control group), weight loss was two in the main and three patients in the control group. Heaviness in the right upper quadrant was noted in 40% of patients in primary and 42% in the control group, pain in right hypochondrium were observed in a third study group (27%) and u29% in the control group, the bitterness in the mouth and intolerance of fatty foods, 50% patients with primary and 42% in the control group, yellow sclera was observed in 7% of primary and 6% of the control group.
The vast majority of patients had hepatomegaly (87% primary and 88% of the control group), tenderness on palpation of the liver was observed in 57% of patients with primary and 59% of the control group. Consistency of the liver was mild in 2 / 3 of patients with primary (63%) and 62% of the control group, plotnovataya - 30% of patients in both groups.
By biochemical tests Stand cytological, cholestatic, mezenhialny, inflammatory syndromes. In the study group cytolytic syndrome was diagnosed in most patients - ALT was above normal in 1,9 times, in the control group - in 1,6 times. Approximately half of the surveyed patients had hyperbilirubinemia - the main group due to the indirect fraction (increase of direct bilirubin was noted in 17% of cases), and in the control group - 12%. In these patients, there was an increase of alkaline phosphatase, GTR, as well as cholesterol and beta-lipoprotein, reflecting cholestatic syndrome in approximately the same number of patients (19%) primary and 12% in the control group.
Products of lipid peroxidation (LPO) were closely associated with the syndrome of cytolysis and malondialdehyde, exceeding the rate of 1,9 times in both groups. Diffuse liver damage was confirmed by ultrasound of the liver. In order to study the state of absorptive-excretory function of liver and biliary tract, 8 patients the primary and 10 patients of the control group performed dynamic gepatobilistsintigrafiya in scintillation camera «Siemens» with multichannel analyzer and computer. Used radiopharmaceuticals labeled with 99m Te-NIDA, which has expressed the ability to selectively accumulate in the hepatocytes. Calculating the following parameters: time of maximum accumulation of radiotracer in the liver (Tmah liver), while half-life of the radiopharmaceutical from the liver (T1 / 2 pin. Livers), the start time income radiopharmaceutical in the gall bladder (T beg. Visas. Yellow. QSP) and the rate of early admission radiotracer into the gallbladder.
Results and discussion
In the process of BAA ART LIFE GEPATON 2, starting from 4-5 days, decreased subjective symptoms of liver damage and degree of severity. Markedly reduces the severity of dyspeptic symptoms and asthenic syndrome, recovered a regular chair, a decreased feeling of heaviness and soreness in the right upper quadrant and epigastric pain. Maximum clinical effect of therapy, dietary supplements GEPATON 2 marked the end of week 1, which is supported in the next 2-3 weeks of observation in virtually all patients.
The maximum effect in the treatment of karsilom reached somewhat later (by the end of the third week).
Noted a marked positive effect of dietary supplements GEPATON 2 on asthenic and dyspeptic symptoms, which manifested itself in the complete absence of complaints of weakness, fatigue, intolerance to any food, bitter taste in your mouth after two weeks of treatment. Nearly all patients improved appetite, and marked weight gain. In the comparison group remained bitter taste in the mouth, nausea, poor appetite and complained of headache.
In the course of treatment noted positive dynamics in the objective status.
First of all, decreased soreness of the liver, as well as its density.
In the control group after treatment karsilom often remained enlarged liver, her tenderness to palpation.
Under the influence of GEPATON two markedly disappeared yellowness of skin and sclera, while the comparison group jaundice syndrome decreased in all patients, but subikterichnost sclera preserved in all cases.
Size of the liver decreased in all patients after treatment GEPATON 2.
In the comparison group hepatomegaly persisted in 7 patients (40%).
Careful monitoring of patients during treatment revealed no amplification of existing complaints or appearance of new, worsening of objective symptoms.
When the original study changes in the basic biochemical parameters of blood, expressed dysproteinemia, increased enzyme levels (ALT, AST) - at a reception GEPATON 2 reduction of basic laboratory syndromes marked by the end of the second week, but after a full course of treatment GEPATON 2 (ie, by the end of the month), the effect of these drugs was more effective. ALT activity decreased in 2,4 times, while in the control group - only 1.76 times. Indicators of alkaline phosphatase and GTP decreased in 1,5 times, total bilirubin of 1.68 times, while after taking the Kars - respectively 1.24 and 1.38 times. This indicates the presence of BAD ART LIFE GEPATON 2 antitsitoliticheskogo and antiholestaticheskogo action, which is a valuable property, because According to some authors, hepatoprotectors reinforce cholestasis syndrome.
It is important to note that the positive dynamics of laboratory data was more pronounced at the reception GEPATON 2 with hepatitis of alcoholic etiology than the virus.
GEPATON 2 reduced the level of gamma-globulin in 1,6 times, the content TsIKov significantly decreased in the group treated with GEPATON 2 and the comparison group (CARS). The results obtained showed a positive effect BAA GEPATON 2 mezenhialno-inflammatory syndrome. In general, showed a significant increase in total protein as in the treatment GEPATON 2 and the comparison group, which indicated the strengthening of protein-synthetic function of the liver under the influence study drug. Control blood samples for the presence of malonic aldehyde (2 and 4 weeks) showed that GEPATON 2 has a pronounced ability to inhibit lipid peroxidation (LPO) in comparison with karsilom. Noted that the MDA level after treatment GEPATON 2 in patients with hepatitis of alcoholic etiology declined by 1,5 times, while in control at 1.05 times.
Positive dynamics of sonographic patterns of liver in patients after treatment GEPATON 2 is to reduce the size of the liver and improve its echostructure.
According to the U.S. can be judged, and improve contractility of the gallbladder based on the positive dynamics of its volume, due to improved colloidal properties of bile. Under the influence of GEPATON 2, this improvement was obvious - the size of the gallbladder were normalized in all 10 patients, in addition, significantly reduced the phenomenon sladzhirovaniya bile. Positive developments marked a major character in the application GEPATON 2 in the state of biliary system, he spoke of his pronounced choleretic effect. So, start visualizing the gall bladder (data gepatobilistsintigrafii) - Tnach.viz.zhel.puz. occurred much earlier in the vast majority of patients. After treatment, the average Tpoyavl. yellow. Pughs. significantly increased in half of patients. Noted a clear reduction Tmah zhel.puz. almost all patients. His averages approaching normative, that show an improvement in the concentration function of the gallbladder.
As for the comparison group, the average degree of emptying of the gallbladder remained reduced.
Holatoobrazuyuschey study of liver function (as defined in the gallbladder bile phospholipids, fatty acids, bilirubin) showed that after a course (four weeks) treatment of the most significant was the increase in phospholipids (1,9 times) in 80% of patients. The concentration of bile acids increased 1.8-fold, and cholesterol in 1,6 times, although complete normalization of these indicators are not reached.
1. BAA ART LIFE GEPATON 2 - effective support for the liver created on the basis of herbal extracts, including fitogepatoprotektory, choleretic herbs, vitamins and herbal extracts that have antispasmodic effect.
2. BAA ART LIFE GEPATON 2 has hepatoprotective activity in patients with chronic hepatitis B virus and alcoholic etiology.
3. In exchange application GEPATON 2, starting from the second week, has a more pronounced therapeutic effect compared karsilom:
- Completely suppresses or weakens the clinical manifestations of disease;
- A positive effect on the functional state of the liver, improving belkovosinteticheskuyu, absorption and excretory functions kupiruya and relaxing the severity of the major syndromes: cytolytic, cholestatic and mezenhialno-inflammatory.
4. BAA ART LIFE GEPATON 2 has a marked choleretic effect holatoobrazuyuschuyu improving liver function and the colloid properties of bile.
5. In exchange application BAD ART LIFE GEPATON 2 has a stronger (compared to karsilom) inhibitory effect on lipid peroxidation processes.
6. Hepatoprotective effect GEPATON 2 is more pronounced when genesis of toxic hepatitis.
7. GEPATON 2 is well tolerated and does not cause any side effects.
How to use: 2 tablets 3 times daily before or during meals, course duration 4 weeks.
Maintenance dose: 1 tablet 2 times a day for 4 weeks.