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The Berkson Clinical StudyThe following paper was written by an American physician Dr. Burton Berkson. Despite his impressive credentials and the implications of this limited study, the results of his work were not published in the American medical journals. The study results were published in Germany’s medical journal "Medizinische Klinik". The article has been transcribed in English but is provided basically unchanged for your review.
Dr. Berkson’s Biography:
Undergraduate and Graduate Education:
[As published in "Medizinishche Klinik", a German medical journal.]
According to a recent article, the number of adults seeking liver transplants for hepatitis C infection will skyrocket in the next 20 years . About 10,000 Americans die from this disease each year. Deaths are estimated to increase because of the increasing risk of infection, and the resulting cirrhosis, portal hypertension, thrombocytopenia, bleeding from varices, and liver cancer. Five years ago, 20% of these hepatitis C patients were candidates for liver transplantation and today the number has increased to about 50%.
An estimated 4 million Americans are infected with hepatitis C and many of them are being evaluated for liver transplant surgery. This expensive process costs roughly $300,000 during the first 3 months, and can be painful and incapacitating. Add to this the thousands of dollars for anti-rejection drugs and the costs of more frequent visits to health care facilities. Of course some people do require liver transplant surgery, however, the author believes that in many cases, an effective alternative therapy exists.
Often, patients with progressive hepatitis C, who seeks a more conservative treatment, prior to surgery present to our facility. These patients are treated with a program that includes and combines alpha-lipoic acid, silymarin and selenium. Most patients recover quickly, however, a few find it difficult to follow a healthy nutritional and lifestyle program, or their condition is so far advanced that they go on to liver transplant surgery. In this paper, the case histories of 3 patients are presented.
Background: There has been an increase in the number of adults seeking liver transplantation for hepatitis C in the last few years and the count is going up rapidly. There is no reliable and effective therapy for chronic hepatitis C since interferon and antivirals work no more than 30% of the time, and liver transplant surgery is uncertain and tentative over the long run. This is because, ultimately, residual hepatitis C viremia infects the new liver. Furthermore, liver transplantation can be painful, disabling and extremely costly.
Treatment Program: The author describes a low cost and efficacious treatment program in 3 patients with cirrhosis, portal hypertension and esophageal varies secondary to chronic hepatitis C infection. This effective and conservative regimen combines 3 potent antioxidants (alpha-lipoic acid [thioctic acid], silymarin, and selenium] that possess antiviral, free radical quenching and
immune boosting qualities.
Conclusion: There are no remarkably effective treatments for chronic hepatitis C in general use, Interferon and antiviral have less than a 30% response rate and because of the residual viremia, a newly transplanted liver usually becomes infected again. The triple antioxidant combination of alpha-lipoic acid, silymarin and selenium was chosen for a conservative treatment of hepatitis C because these substances protect the liver from free radical damage, increase the levels of other fundamental antioxidants, and interfere with viral proliferation. The 3 patients presented in this paper followed the triple antioxidant program and recovered quickly and their laboratory values remarkably improved. Furthermore, liver transplantation was avoided and the patients are back at work, carrying out their normal activities, and feeling health. The author offers a more conservative approach to the treatment of hepatitis C, that is exceedingly less expensive. One year of the triple antioxidant therapy described in this paper costs less than $2,000, as compared to more than $300,000 a year of liver transplant surgery. It appears reasonable, that prior to liver transplant surgery evaluation, or during the transplant evaluation process, the conservative triple antioxidant treatment approach should be considered. If there is a significant betterment in the patient’s condition, liver transplant surgery may be avoided.
Background: More than 20 years ago, when the author was in medical and pathology training at 2 hospitals in Cleveland, Ohio, he was assigned to 6 critical patients who were suffering from acute hepatic necrosis secondary to hepatotoxic mushroom poisoning. He ordered thiocgic acid (alpha-lipoic acid, ALA) from the National Institutes of Health and injected this antioxidant drug into the patients. In spite of their highly threatening condition the patients, as measured by laboratory values and clinical parameters, recovered quickly. Dr. Fred Bartter (then Chief of Hypertension and Endocrinology at the NIH) and the author were astounded by their recoveries and went on to treat many more mushroom poisoning patients. Over the years, the author continued to treat additional patients with other medial conditions using ALA, and observed similar results. The author has recently added silymarin and selenium to the regimen. In this paper he will discuss the use to this triple antioxidant regimen in the management of 3 chronic hepatitis c patients.
Patients and Method: The 3 basic antioxidants there were used in this report are alpha-lipoic acid (thioctic acid), silymarin and selenium (selenomethionine). The alpha-lipoic acid product was manufactured by Asta Medica at Frankfurt Am Main, Germany. The silymarin was a product distributed by NOW Foods of Bloomingdale, Illinois, and the selenium was encapsulated by Metabolic Maintenance Products Inc., of Sisters, Oregon.
The 3 patients were selected at random from a group of approximately 50 chronic hepatitis C charts at the Integrative Medical Center of New Mexico in Las Cruces. Each patient was maintained on a dose of 600 mg. of alpha-lipoic acid a day in 2 divided portions of 300 mg. each. The silymarin dose was 900 mg. Per day in 3 divided portions of 300 mg. The selenomethiomine dose was 400 mcg in 2 divided portions of 200 mcg.
acid depletes some of the B vitamins, the patients were
prescribed 2 B-100 capsules a day. In addition, each
patient also took between 1,000 and 6,000 mg. Of vitamin
C, 400 IU of vitamin E, and a mineral supplement. The
patients were also requested to eat a daily diet that
included at least 6 servings of fresh vegetables and
fruits, only 4 oz or less of meat per meal, and 8
glasses of fresh water. It was also suggested that the
patients reduce their stress levels, and take part in an
exercise program that included at least a 1-mile walk 3
times a week.
Mrs. M.P. is a 57-year-old woman who acquired hepatitis C after a blood transfusion during surgery about 10 years ago. She did not eat a nutritious diet and did not live a very healthy lifestyle at that time. About 5 years ago, she became very fatigues and nauseous, and was diagnosed with non-A, non-B hepatitis. She was treated with conventional therapies and continued to degenerate into a poorer state of health. About 3 years ago she was diagnosed with chronic hepatitis C. cirrhosis, portal hypertension. esophageal varcies, and thrombocytopenis, and treated with steroids and interferon. She did not improve. Her AFP (alpha-fetoprotein) level become elevated (16.1) and a mass was located in her liver. Mrs. M.P. was told that the mass was probably cancer and that there was no hope.
Mrs. M.P. presented at our office last year appearing fatigued, weak, pale, and her abdomen was grossly enlarged. The abdominal distention was due to ascites. She was administered oral furosaminde (40 mg) and potassium chloride (10 meq) with a balanced die and wholesome lifestyle. She lost almost 50 lb of fluid in 1 month. Mrs. M.P. was treated with 600 mg. Of oral apha-lipoic acid in 2 divided doses (300 mg each), 900 mg of silymarin in 3 divided doses (300 mg each) and 400 mg of selenium a day. A premium B complex vitamin was added to her regimen because alpha-lipoic acid depletes the body of thiamin, biotin and other B vitamins. Adequate amounts of vitamin C (2,000 mg), vitamin E (800 IU), Coenzyme Q10 (300 mg), and basic mineral supplements were also prescribed. Figures 1 and 2 track the favorable changes in her ALT levels and her AFP levels. Today, Mrs. M.P. is working 8 hours a day, feels healthy, looks good, and is not tired. She is free of the signs and symptoms of serious chronic hepatitis C infection.
Mrs. P.P. is a 49-year-old woman who was infected with hepatitis C following a blood transfusion prior to trauma surgery more than 10 years ago. During surgery, her spleen was excised because it was lacerated. About 3 years ago, a liver biopsy was performed that showed moderate cirrhosis with active inflammation. As a result of this pathology, Mrs. P.P. went on to develop portal hypertension with esophageal varices. She never acquired thrombocytopenia because of the spenectomy, and did not show an elevated AFG. Mrs. P.P. was treated with interferon therapy without any satisfactory results. She was told that her condition was hopeless and that a liver transplant was her only option. Her health continued to decline and she presented at our office with fatigue, anxiety, and insomnia.
Mrs. P.P. was prescribed 600 mg. Of alpha-lipoic acid each day in 2 divided doses (300 mg each). To that, was added silymarin (900 mg/day) and selenium (400 ug/day). To combat the anxiety and insomnia, 0.5 of aprazolam was prescribed, as needed at bedtime. Mrs. P.P. was put on a balanced health and lifestyle program, and within 7 months regained her health. Figure 3 to 5 trace the favorable changes in her ALT levels, viral load and platelet levels. She is doing very well today and is working at an arduous job and playing at sports without any fatigue or other symptoms of serious disease.
Mrs. L.M. is a 35-year-old mother of 3 children who developed hepatitis secondary to a blood transfusion during the birth of her baby girl 15 years ago. Three years ago she became ill and was diagnosed with cirrhosis of the liver, portal hypertension, and esophageal varcies. As a result of the portal hypertension, she developed splenomegaly and thrombcytopenia. Mrs. L.M.’s hepatologist sent here to the university hospital for liver transplant evaluation. When she presented to our office, she was anxious, tired, and pale, and complained of constant pain in the regions of her liver and spleen. Mrs. l.’s fasting blood sugars were in the 300-mg/dc range. She did not have hyperglycemia prior to the hepatitis C infection. Mrs. L.M. decided that prior to the liver transplant surgery, she wanted to investigate a more conservative treatment regimen.
Mrs. L.M. was prescribed alpha-lipoic acid (600 mg./day), silymarin (900 mg./day) and selenium (400 ug) per day with other supportive supplements. She was encouraged to follow a health lifestyle program with a 2,000 calorie diabetes diet. Within 2 weeks she began to feel much better and recovered quickly. Her blood sugar fell into the normal range and the pain in her liver and spleen ended. She became energized and was able to do her normal work as a housewife. She returned to college the next semester earning a 3.8 grade point average (A). Figures 6 and 7 trace her favorable progress.
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