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.
July 3, 1996

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 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.

Definitions and Results of Parameters

Ascites-- Effusion and accumulation of serous fluid in the abdominal cavity. 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 group 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 bloodstream. The activity of OGT rises 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%.

Prothrombin 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. 

2nd Double Blind Study

Comparative study between a complex of flavonoids and polyphenols created from extracts of artichoke and sarsaparilla 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: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 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: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: 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: A 60% reduction in vascular lesions was noted in the treated group. A 3.33% reduction was seen in the placebo group.

Total Bilirubin:The treated group noted a reduction of total bilirubin by 38.95%. The placebo group increased by 5.68%.

Alkaline Phosphatase: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):The treated group noted a decrease of 23.83% in SGOT levels. The placebo group experienced a worsening of 11.71%.

Prothrombin Time:A 42% 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: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 Trans peptidase (GGT):The treated group noted a reduction of 23.79% in GGT. Th placebo group experienced an increase of 9.92%.

Scientific Research

Beneficial effects of flavonoids have been described for successfully treating many health conditions, including cancer, viral infections, diabetes, headaches liver disease, ulcers, and allergies. They can also bind to enzymes and DNA chelate heavy metals, and play a role in electron transport.
Van, Acker, S. et al; Structural Aspects of Antioxidant Activity of Flavonoids, Flavonoids in Health and Disease, Rice-Evans, C. editor,
Marcel Dekker, Inc. 1998.

It is highly unlikely that the therapeutic value of medicinal plants it due to either one flavonoid or an entire fiavonoid fraction alone.
Packer, Lester et al; Ginkgo bileba Extract Egb 761; Biological Actions, Antioxidant Activity, and Regulation of Nitric Oxide Synthase, Flavonoids in Health and Disease, Rice-Evans, C. editor Marcel Dekker, Inc. 1998.

Phytosterols are plant fats. Plants do not contain cholesterol, but phytosterols play a similar role in plants to that of cholesterol in humans, primarily the forming of cell membrane structures, sources of fuel for storage and transport, and protective surface coatings. The most common plant sterols are [beta]-sitosterol, campesterol, and stigmasterol. Recent studies have shown that phytosterols have antihyper-glycemic and insulin-releasing effects, anti-inflammatory and antipyretic activities, and important immune regulating and T-cell proliferative activities.
Ivorra MD, et al; Antihyperglycemie and Insulin-releasing Effects of [beta]-sitosterol 3-B-glucoside and Its Aglycone, [beta]-sitosterol, Archives of the international Phamnacodyn, V. 296, April 1988, 224-231.
Gupta R. et al; Anti-inflammatory and Antipyretic Activities of [beta]-sitosterol, Planta Medica (Journal of Plant Medicine) V. 39, 1980, 157-163.
Pegel, Karl, The Importance of Sitosterol and Sitosterolin in Human and Animal Nutrition, South African Journal of Science, V. 93, June 1997, 263-268.

Extracts of the artichoke leaf stimulates bile production in the liver and increased bile
release from the gall bladder, and thus has been effective in helping to eliminate toxic substances, normalizing blood cholesterol levels, lowering blood lipids, and providing liver protective qualities.
Adzet T, et al; Hepatoprotective Activity of Polyphenolic Compounds from Cynara Scolymnus Against CC14 Toxicity in Isolated Rat Hepatocytes, Journal of Natural Products, 50: 612, 1987.
Gebhart R; Inhibition of Cholesterol Biosynthesis in Primary Cultured Rat Hepatocytes by Artichoke Extracts. J Pharmacol Exp Ther 286; 3, 1998.
Fintelmann V; Therapeutic Profile and Mechanism of Action of Artichoke Leaf Extract; Hypolipemic, Antioxidant, Hepatoprotective and Choleretic Properties. Phytomedicine, 1996. Supplement 1:50.
Kirchoff R, et al; Increase in Choleresis By Means of Artichoke Extract. Results of' a Randomized Placebo-controlled Double-blind study. Phytomedicine 1: 107, 1994.

European physicians consider sarsaparilla root as an alterative tonic, blood purifier, diuretic, and diaphoretic. With its clinical uses as a blood purifier, it was registered as an official herb in the US Pharmacopoeia as a treatment for syphilis from 1820 to 1910. Clinical observations in China demonstrated that sarsaparilla is effective in about 90% of acute cases and 50% of chronic cases of syphilis. In 1942 it was shown to dramatically improve psoriasis, and in the 1950's the antibiotic properties of sarsaparilla were documented.

An herbal Saudi Arabian drug created from sarsaparilla has been used for many years to treat rheumatism and various forms of arthritis. Further studies showed that sarsaparilla inhibited carrageenan-induced inflammation in rats. Recent research from China has shown that an extract of sarsaparilla was able to prevent immunological liver damage. And three studies performed between 1994 and 1999, have shown that extracts of sarsaparilla have snake venom inhibitory activity.
Hobbs, C; Sarsaparilla, A Literature Review, HerbalGram, No. 17, 1988.
Lung, A, Footer, S; Encyclopedia of Common Natural Ingredients, John Wiley & Sons, Inc. New York, 1996.
Thurman, FM; The Treatment of Psoriasis with Sarsaparilla Compound, New England Journal of Medicine 337, 128-133, 1942.
D'Amico, ML; Ricerche Sulla Presenza Di Sostanze Ad Azione Antiiotica Nelle Piante Superiori, Fitoterapia, 21(1), 77-79, 1950.
Fitzpatrick, FK; Plant Substances Active Against Mycobacterium Tuberculosis, Antibiotics and Chemotherapy, 4(5),528-536 1954.
Ageel, AM et al; Experimental Studies on Antirheumatic Crude Drugs Used in Saudi Traditional Medicine, College of Pharmacy, Kind Daud University, Riyadh, Saudi Arabia, Drugs Exp Clin Res 1989, 15(8): 369-372.
Chen, T, et al; A New Flavanone Isolated From Rhizoma Smilacis Glabrae and the Structural Requirements of Its Derivatives for Preventing Immunological Hepatocyte Damage. Planta Med 1999, Feb;65(1):56-59.
Alam MI, et al; Isolation, Purification and Partial Characterization of Viper Venom Inhibiting Factor from the Root Extract of the Indian Medicinal Plant Sarsaparilla, Toxicon, 1994, Dec;32(12): 1551.1557.
Castro O, et al: Neutralization of the Hemorrhagic Effect Induced by Bothrops Asper (Serpentes Viperidae venom with Tropical Plant Extracts, Rev Biol Trop 1999, Sep;47(3): 605-616.

Comparison with Other Natural Substances

ASE is often compared to extracts of milk thistle, alpha-lipoic acid, other artichoke extracts, N-acetyl cysteine, and nucleic acids in its effectiveness to support liver detoxification and aid in liver disease. Since no side-by-side studies have been performed comparing these nutrients, we cannot say that any one of these natural, very valuable substances is better than the other. However, clinically, we have found that by combining the ASE with any of the above-mentioned nutrients, results can be enhanced tremendously. Another very effective common method is to alternate nutrients. This keeps the body from developing sensitivities or desensitivities to any one nutrient during prolonged treatments.