2nd Double Blind Study COMPARATIVE STUDY BETWEEN A COMPLEX OF FLAVONOIDS AND POLYPHENOLS CREATED FROM EXTRACTS OF ARTICHOKE AND SARSAPRILLA AND A PLACEBO IN ALCOHOL RELATED LIVER DISEASE DECEMBER 12, 1998 In a previous study, completed over two years ago in this same hospital, an extract of artichoke (Cynara Floridanum) and sarsaparilla (Smilax Aristolochiaefolia) was evaluated in addressing the symptoms related to alcoholic liver disease. This study was accomplished over a fifteen-day period with exceptional results. Because of these results noted over a very short period of time, the hospital researchers were anxious to set up the same study over a longer period (30 days). Please refer to the July 3, 1996, study for descriptions of symptoms and study parameters. Results of this study are as follows: ASCITES- (accumulation of serous fluid in the spaces between tissues and organs in the cavity of the abdomen) A 72.38% reduction of the accumulation of serous abdominal fluid was noted in the treated group. The placebo saw a 6.35% increase in abdominal fluid. ENCEPHALOPATHY- (a disease of the brain) A 66.08% reduction of symptoms related to encephalopathy was noted in the treated group. The placebo group saw a 12.24% increase in these symptoms. HEPATOMEGALY (enlargement of the liver) The treated group experienced a 93.33% reduction in enlarged livers. In the placebo group their livers continued to enlarge by another 7.14%. SPLENOMEGALY (enlargement of the spleen) An 88.40% reduction in spleen enlargement was noted with the treated group. The placebo group worsened by 11.54%. WEAKNESS The treated group noted a 73.64% increase in strength. There was a decrease in muscle strength by 7.41% in the placebo group. PERIPHERAL EDEMA Edema in the extremities of the treated patients decreased by 48.21%. There was no change in the placebo group. HEMORRHAGES The treated group noted a 100% decrease in capillary hemorrhaging in the skin, gums, and nasal membranes. The placebo group saw an increase of 28.57% in hemorrhaging. ANOREXIA Loss of appetite decreased in the treated group by 76.98%. The placebo group noted a decrease of 3.70%. ABDOMINAL WALL VEINS The treated group experienced a 60.62% decrease in tortuous veins in the abdomen related to ascites. The placebo group saw a 3.33% decrease. PALMAR ERYTHEMA The treated group noted a 26.67% decrease in red and swollen palms. In the placebo group there was no change. TELANGIECTASIA (dilatation of capillary vessels & arterioles that often forms an angioma) A 60.00% reduction in vascular lesions was noted in the treated group. A 3.33% reduction was seen in the placebo group. TOTAL BILIRUBIN (a reddish yellow water insoluble pigment occurring especially in bile and blood and causing jaundice if accumulated in excess) The treated group noted a reduction of total bilirubin by 38.95%. The placebo group increased by 5.68%. ALKALINE PHOSPHATASE (any of the phosphatases that are optimally active in alkaline medium and occur in especially high concentrations in bone, the liver, the kidneys, and the placenta) The treated group obtained 25.91% reduction in alkaline phosphates. There was an 11.69% increase in the placebo group. SERUM GLUTAMIC OXALCETIC TRANSAMINASE (SGOT) (an enzyme promoting transamination) The treated group noted a decrease of 23.83% in SGOT levels. The placebo group experienced a worsening of 11.71%. PROTHROMBIN TIME (a plasma protein produced in the liver in the presence of vitamin K and converted into thrombin in the clotting of blood) A 42.00% reduction in clotting time was noted with the treated group. An increase in clotting time was noted in the placebo group of 6.60%. SERUM ALBUMIN (a crystallizable albumin or mixture of albumins that normally constitutes more than half of the protein in blood serum and serves to maintain the osmotic pressure of the blood) An increase of 37.27% in serum albumin was noted in the treated group. There was a decrease in the placebo group of 1.95%. GAMMA GLUTAMYL TRANSPEPTIDASE (GGT) The treated group noted a reduction of 23.79% in GGT. The placebo group experienced an increase of 9.92%

DR. CHARLES COCHRAN

1st Double Blind Study

INTERPRETATION OF RESULTS OBTAINED IN A DOUBLE BLIND TEST MADE IN THE GENERAL HOSPITAL MEXICO WITH THE PRODUCT LIVER SUPPORT ON PATIENTS HAVING CHRONIC ALCOHOLIC HEPATIC DISEASE.

In order to analyze carefully the results of this study, it is necessary to know the importance of the two clinical and laboratory parameters intervening in the calculations of Orrego and Maddrey Indexes.

We will compare the results of the parameters, the placebo control and the Liver Support groups on both indexes. The results are presented as percentages of recovery and are obtained from the data obtained from each group of 30 patients, we will get an average of those results at the beginning and at the end of the study. Both averages will give us a final recovery compared to the initial values. This way we may demonstrate the effectiveness of Liver Support.

DEFINTIONS AND RESULTS OF PARAMETERS

ASCITES- Effusion and accumulation of serous fluid in the abdominal cavity. The experimental group (Liver Support) experienced a 28.8% reduction of ascites while the placebo group experienced no change.

ENCEPHALOPATHY- a DEGENERATIVE DISEASE OF THE BRAIN. Hepatic encephalopathy- a condition usually occurring secondarily to advanced disease of the liver. It is marked by disturbances of consciousness that may progress to deep coma (hepatic coma), psychiatric changes of varying degree, flapping tremor and fetor hepaticas. Also called portal-systemic encephalopathy. Patients on Liver Support experienced a 34.55% reduction of hepatic encephalopathy. The placebo group experienced a 5.5% reduction.

SPLENOMEGALIA- Enlargement of the spleen. An 18.18% reduction was observed in the Liver Support group and a 55% reduction was observed in the placebo group.

WEAKNESS- Lacking physical strength or vigor marked by asthenia, atony, cardiasthena, enervation, fatigue and lassitude. The Liver Support group experienced an 83.45% decrease in the incidence of weakness while the placebo group reported no change.

PERIPHERAL EDEMA- A condition in which the body tissues contain an excess amount of fluid. The Liver Support Group experienced an 11.10% reduction in peripheral edema while the placebo group had a 0.69% reduction.

HEMORRHAGES- Bleeding. This was one of the most important benefits observed in the Liver Support group. The Liver Support group had an 89.41% reduction in hemorrhages while the placebo had a 31% reduction.

ANOREXIA- Loss of appetite. Seen in depression, malaise, commencement of fevers and illness, also in disorders of the alimentary tract, especially of the stomach, and as a result of alcoholic excess and drug addiction. Anorexia was diminished by 86.07% in the Liver Support group. There was no change in the placebo group.

TOTAL BILIRUBIN LEVEL - The predominant pigment of human bile. Total serum bilirubin may be increased in cirrhosis of the liver and acute viral hepatitis. The Liver Support group obtained 25.11% reduction in bilirubin, whereas the placebo group had a 7.2% increase.

OGT - (Oxalacetic Glutamic Transaminase). It is distributed all over body tissue, especially in the heart and liver. Fewer amounts are found in the spleen, pancreas, kidneys, lungs and brain. Any lesion of a tissue leads to the secretion of this enzyme to the blood stream. The activity of OGT is risen under hepatic necrosis, cirrhosis of the liver or hepatic metastasis. In those patients who received Liver Support this level diminished 22.56% in only 15 days of treatment and in the placebo group it diminished 8.51%.

PROTHROMBINE TIME - A test of clotting time made by determining the time for clotting to occur after thromboplastin and calcium are added to decalcified plasma. There was 30.82% reduction in prothrombin time for Liver Support patients, whereas the placebo group's time increased 1.25%. This is very important data, because it means that Liver Support helps the healing of wounds faster.

SERUM ALBUMIN - One of a group of simple proteins widely distributed in tissues. Albumin is a constituent of blood. Low levels of albumin in blood plasma are associated with a pathologic condition of the liver. The Liver Support group experienced an increase of 8.85% of total albumin levels while the placebo group experienced a 5.35% increase.

Liver Support System Ingredient Rationale

A proprietary blend of artichoke (Cynara Floridanum) and sarsaparilla (Smilax Aristolochiaefolia) that contains the following naturally occurring bioflavonoids and polyphenols: silymarin, quercetin, catechin, hesperidin, rutin, cynarin, and chlorogenic acid. Bioflavonoids are a class of water-soluble plant pigments (colors) that have anti-inflammatory, antihistaminic and anti-viral properties. Health professionals formulated The Liver Support System specifically for detoxifying the liver and gall bladder and supporting each of their functions.

Included Bioflavonoids

1. Silymarin

Numerous clinical studies have shown silymarin to be among the most powerful natural agents available for the prevention and treatment of liver damage caused by exposure to human-made chemicals including alcohol induced liver degeneration and cirrhosis.

References:

Wagner, H., "Antihepatotoxic flavonoids" in Cody, V., Middleton, E., and Harbourne, J.B., (eds.) Plant Flavonoids in Biology and Medicine: Biochemical, Pharmacological, and Structure-Activity Relationships, Alan R. Liss. New York, NY, 1986: pp. 545-58.
Salmi, H.A. and Sarna, S. "Effect of Silymarin on chemical, functional, and morphological alterations of the liver. A double-blind controlled study." Scand J Gastroentrol., 1982, 17: pp.417-21.
Boari, C., Montanari, M., Galleti, G.P., et al. "Occupational toxic liver diseases. Therapeutic effects of silymarin." Life Sci, 1981, 29: pp. 2,751-5.

2. Quercetin

Quercetin is a bioflavonoid with antioxidant effects. It is used for the prevention of atherosclerosis, hypercholesterolemia (excess cholesterol in the blood), and coronary heart disease. It can inhibit carcinogenesis and reduce capillary fragility. Quercetin is used extensively in the treatment of athletic injuries because it relieves pain and bruising and acts synergistically with Vitamin C to protect and preserve the structure of capillaries. It also promotes circulation, lowers cholesterol levels and treats and prevents cataracts. Quercetin fights cancer, diabetes, capillary fragility, and arthritis; stabilizes membranes; protects against heart disease and allergies; normalizes blood pressure; helps lowers cholesterol; and slows aging.

References:

Lininger, SW, et al. The Natural Pharmacy. 1st ed. Rocklin, CA: Prima Publishing; 1998.

Lean ME, Noroozi M, Kelly I. "Dietary flavonols protect diabetic human lymphocytes against oxidative damage to DNA." Diabetes, (Jan. 1999), 48(1): 176-81.

Encyclopedia of Nutritional Supplements. Prima Publishing, Michael T. Murray, ND, 1996: pp. 324-5.

Satvric, B. "Quercetin in our diet: from potent mutagen to probable anticarcinogen." Clin Biochem 27, 1994: pp.245-8.

Ferrandiz, M.L. and Alcaraz, M.J. "Anti-inflammatory activity and inhibition of arachidonic acid metabolism by flavonoids." Agents Action 32, 1991: pp.238-287.

3. Catechin

Catechin, another naturally occurring flavonoid, is similar in effect to silymarin. Catechin is a powerful anti-oxidant that helps prevent free radical oxidative damage to cells. It also helps in the treatment and prevention of alcohol and chemical-induced liver disease or damage. Catechin is also valuable for its ability to neutralize intestinal toxins and assist in the stabilization of cell membranes.

Reference:

Golan, R. Optimal Wellness. Ballantine Publishing, 1995. P. 179.

4. Hesperidin

Hesperidin has been shown to be useful in clinical trials as an analgesic and anti-inflammatory.

Reference:

E.M. Galati, et al. "Biological effects of hesperidin, a citrus flavonoid. (Note 1): Anti-inflammatory and analgesic activity." Farmaco 40 (11), Nov. 1994: pp. 709-12.

Null, G. "Clinician's Handbook of Natural Healing." Kensington Publications, 1997: pp. 170-71.

5. Rutin

A antioxidant bioflavonoid, free radical scavenger, and an iron-chelator. It is used as a vascular protector for reducing capillary fragility, permeability, and bleeding; as a treatment for varicose vein symptoms; and as preventive for stroke (the sudden rupture or clotting/blockage of a blood vessel to the brain). Some studies show that Rutin offers protection from damage induced by asbestos, the cytotoxic effects of oxidized low-density lipoproteins (LDL), and gastric injury from ethanol. It also offers some protection against DNA damage caused by hepatocarcinogens. Rutin is used extensively in the treatment of athletic injuries because it relieves pain and bruises and acts synergistically with Vitamin C to protect and preserve the structure of capillaries. It also promotes circulation, lowers cholesterol levels, and treats and prevents cataracts.

Reference:

Kostyuk, V. and Potapovich, A. "Antiradical and chelating effects in flavonoid protection against silica-induced cell injury." Arch Biochem Biophys, 355(1), 1998: 43-48.

Schmitt, A., Salvayre, R., Delchambre, J., and Negre-Salvayre, A. "Prevention by alpha-tocopherol and rutin of glutathione and ATP depletion induced by oxidized LDL in cultured endothelial cells." Br J Pharmacol, 116(3), 1995: 1985-1990.

C Balch, James F., and Balch, Phyllis A. Prescription for Nutritional Healing. Avery Publishing Group, Garden City Park, NY. 1997: 20.

6. Cynarin

Cynarin assists in the detoxification of the liver and gall bladder. It also supports the function of these two important organs while and assists in their regeneration following damage. Cynarin stimulates the clearance of bile from the liver, preventing congestion in the liver and thus diminishing the chances of liver damage.

Reference:

A. Encyclopedia of Nutritional Supplements. Prima Publishing, Michael T. Murray, ND, 1996: p. 353.

7. Sarsaparilla

Sarsaparilla has been used in the treatment of the following conditions: gout, arthritis, digestive disorders, skin diseases, and cancer. Sarsaparilla contains saponins, which are steroid-like agents that bind with toxins in the digestive tract. Historically, sarsaparilla has been used as a 'blood purifier' and a general tonic for diseases associated with increased endotoxin levels, including arthritis, intestinal ulcerative conditions, eczema, and psoriasis.

The tonic effect of sarsaparilla is the result of its ability to stimulate the removal of accumulated waste products from the cells, blood, and lymph. These actions tend to increase the health of the entire body and increase vitality, thereby increasing energy and endurance.

Reference:

The Natural Pharmacy. Prima Publishing, Liniger, Wright, Austin, Brown & Gaby, 1998: pp. 305-6.

Herbal Tonic Therapies. Keats Publishing, Mowrey, D., 1993: p. 354.

8. Chlorogenic Acid (16%)

Chlorogenic Acid is a naturally occurring, water soluble, phenolic acid that is a potent anti-oxidant, carcinogenic inhibitor and protector against lipid peroxidation and free radical mediated cell injury.

Reference:

J Chromatogram A 1996; 741(2): pp.223-31
Biosci Biotechnol Biochem 1996; 60 (5): pp. 765-68.
Biochem Pharmacol 1987; 36 (5): pp.717-20.
Plant Foods Hum Nutr 1994; 45 (3): pp.287-98.
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