DODO NAPETVARIDZE – Doctor of Medical Sciences,
Center of Urgent Cardiology, Doctor-Cardiologist.
Ischemic heart disease is the most widespread disease in developed countries and represents the main cause of death. The pathologic basis of ischemic heart disease (IHD) is mainly the atherosclerosis of coronary arteries. Based on the data received from wide, multicentric clinical trials, tight correlation between blood cholesterol, triglycerides and lipoprotein level and atherosclerosis is revealed. Nowadays HMG-CoA reductase inhibitors – statins are one of the leading drugs along with other preparations, in the treatment of IHD. Their effect is approved by placebo controlled clinical trials (2007 2.1-4). A positive pleiotropic effect of statins is defined not only from their hypolipidemic action, but also by their anti-inflammatory effects and ability, to improve endothelial function and remodeling of vessels wall and atheromas.
The goal of our study was to assess effectiveness of Gold Ray in IHD - and particularly in the treatment hyperlipidemia.
Gold-Ray is composed of:
1. Royal jelly 1000 mg (contains 110 active components, main of them are essential and nonessential amino acids, preformed gamma-globulins, group B vitamins, microelements and minerals)
2. Carotene 1500 IU – the precursor of vitamin A
3. 500 mg of wheat germ oil – The natural form of active vitamin E.
4. 100 mg of garlic extract (contains pectines, which have anti-atherogenic effect)
There were included 15 patients with IHD in clinical trial. All of them were operated for coronary angioplasty or coronary bypass. Three of them had ischemic cardiomyopathy and two of them had infective-allergic pericarditis. Patient’s age was between 36-63 years. Blood was taken from the cubital vein of all patients after 16 hours of fasting state, before and after treatment with Gold Ray.
Lipid level in blood was measured by fermentic-colorimetric method - photometry. Heart ultrasonographic evaluation was conducted by sono-5500. The average measures of lipids before the treatment were following:
Total cholesterol – 246 +0,9 mg/dl
HDL-Chol – 32+0.02 mg/dl
LDL-Chol – 156 +0,6 mg/dl
Triglycerides – 250 mg/dl
Index of atherogenicity – 5,1
Measures of ventricular ejection fraction was between 50-52 % and heart transverse measures were normal in 10 patients.
In patients with cardiomyopathy and heart failure, systolic ejection fraction of left ventricle was 28-30%. Heart transverse size was considerably increased. Two of them had infectious allergic pericarditis.
Treatment with Gold ray was initiated with one capsule once a day in the morning. Treatment duration was 20 days.
There are different data about effects of Gold Ray on lipid spectrum. Based on the data provided by Yeh-Lui (2001 y.) based on the placebo controlled, double blind, randomized trials usage of old garlic extract in men, caused decrease of blood plasma total cholesterol level by 7%, and LDL-CHOL level by 10% compared to patients on placebo treatment and special diet. Based on Slowing and others (2001 y.) trial data both processed and unprocessed substances of garlic can protect mice form hypercholesterolemia. According to Woods, Gardnerc, Lawson and others, processed and unprocessed contents of garlic had not had any effects on high and low density lipoproteins, total cholesterol and triglyceride level in the plasma.
There are many hypotheses about action of Royal jelly. Studies revealed that some unprocessed substances, which contain amino acids can protect organism from vitamin E deficiency. Based on analyses of Vittek and others (1995 y.), usage of Royal jelly in diet considerably decreased plasma and liver lipid level and blocked development of atheroma in rabbit’s aorta. Clinical trials conducted in human showed, that including the Royal jelly in diet led to decreased cholesterol level by 14% and lipids level by 10%. According to Shen and others(1995 y.) trial data lyophilized Royal jelly can decrease cholesterol level in blood plasma and increase level of HDL.
Based on results of our study, treatment with Gold Ray for 20 days did not cause any significant changes of plasma lipid spectrum. Treatment with Gold Ray didn’t cause any decrease in plasma total cholesterol level, LDL and TG or increase of HDL. But these results doses not speak about ineffectiveness of this preparation in treatment of patients with IHD. We should consider other aspects of actions of Gold Ray like immuno-modulating and antioxidant effects. For this purpose should be conducted important clinical trial with following wide spectrum: C reactive protein, immune system- T lymphocytes, thrombocytes, and blood clotting ability- fibrinogen level, NO level and study of endothelial function.
Results of our study are reasoned by all mentioned above:
Patients with IHD, ischemic cardiomyopathy, and heart failure mentioned improvement of subjective and objective condition and self feeling. Despite the fact that treatment with traditional regimen (with glycosides, diuretics, antiagregatives and correspondingly potassium preparations) was conducted, left ventricular systolic function improved in heart failure patients and pericardial effusion decreased in patients with pericarditis We think that our preparation worked as antioxidant and immuno-modulating agent in this case. There are many important studies on these effects of Gold Ray. Many chronic diseases and chronic ischemic heart disease among them, is caused by disturbing of antioxidant system of the organism. In patients with IHD, during the occlusion of coronary arteries, condition of uncontrolled peroxidation processes is forming, due to lack of antioxidant ferments (2007. 5. p. 45) intensive process of oxidation and super oxidation of lipids occurs, and level of catalase and superoxide dismutase decrease. Endothelium is the main structure which regulates balance between vasodilatation and vasoconstriction processes. Many relaxing factors are formed here and nitric oxide NO among them. NO, along with neuromediators and hormones regulates cardiovascular system (2007. 5. 23-25). Almost all signaling pathways are fulfilled by it. In patients with IHD expression of synthesis of NO occurs. Action of garlic extract and its main component S-allilcystein on NO is conducted via macrophages and endothelial cells. Garlic extract and S-allilcystein caused increase on NO in macrophages by inhibiting i NOS. Also, garlic extract causes increase of action of antioxidant ferments – superoxide dismutase and catalase and glutathion dismutase, which leads to increases glutathione level. Garlic extract protects endothelium from oxidation products by inhibiting LDL-CHOL. KUM and Colleges (2001 y.) and OKA and colleges (1995 y.) showed by their experiments that Royal jelly inhibited Ig E antibody and histamine release by cells and restored function of macrophages. Based on studies conducted by Sver and others (1996 y.) trial data, using the Royal jelly in the experiment caused enhanced production of antibodies and increased number of immunocompetent cells. Fujji and others (1996 y.) established that Royal jelly although did not cause hypoglycemia in diabetic rats, but enhanced collagen formation and tissue granulation. According to Wittek and others (1995 y.) incorporating Royal jelly in the diet has immunomodulalting effect; it stimulates antibody production and growth of immunocompetent cells. Above mentioned approved not only antioxidant, but also anti-inflammatory effects of garlic extract.
Based on data provided by Uteshev and others (1996 y.) trial data, vitamin A acetate enhances immune reaction for T dependent antibodies, and beta carotene aggravates immune reaction for relatively T dependent and T independent antibodies. Vitamin A stimulates action of erythrocytes. Vitamin E inhibits prostaglandin E2 and enhances immune reaction. Vitamin E can protect immune system in the state of deficiency of Se and represents the important product for optimal function of immune system. Based on the studies of Bendich and others, natural antioxidants can protect immune system from the action of saturated fatty acids. Vitamin E can destroy lipophilic antioxidant chain in the plasma and tissues and prevent development of malignant tumors. According to studies conducted by Dumaitrov (1994 y.) and Canbaz (2003 y.) water soluble vitamin E can prevent lesion of myocardiocytes after occlusion of the aorta and protect myocardium from the ischemia during reperfusion. Based on clinical trials conducted in humans, Liu and others stated that combined tocoferol (alfa and gamma) enhances release of NO by activation of ec NOS.
Based on all discussed above, Gold Ray is powerful antioxidant and immunomodulating agent. Gold Ray can be used during ischemic heart disease and other chronic diseases not only for prophylactic purposes, but also as additive agent to therapeutic preparations.
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