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Human studies on enzymes have been published in journal articles and books, as well as in literature from manufacturers. We start with the six human studies published in journals. Unfortunately, five of these were only available in abstract form (three articles were not in English and two were published only as abstracts); all five were uncontrolled. Briefly, one study reported that Wobenzym, a polyenzyme product, in combination with hyperthermia, immunostimulants, and hormone therapy, improved survival of patients with advanced pancreatic cancer.211 The second reported that unspecified prote-olytic enzymes degraded plasma proteins and reduced hyperviscosity symptoms in patients with hematological cancers.227 Hyperviscosity syndrome is a collective term for the multitude of clinical manifestations that result from impaired blood flow due to abnormal blood thickness; one cause in cancer patients is an abnormally high amount of plasma proteins, such as antibodies. The three other studies reported that polyenzymes could reduce bleomycin-induced lung toxicity, improve the boundaries of lymphoma masses for subsequent radiotherapy, and reduce fluid escape in the lungs due to me-213, 215, 228

tastasis.

The sixth study was a two-year, unblinded, uncontrolled, pilot study on 10 patients with inoperable pancreatic cancer.216 This study by Nicholas Gonzalez, M.D., and Linda Isaacs, M.D., was a continuation of work originally started by Dr. John Beard and others in the early 1900s and later carried on by William Kelly, a dentist from Texas.229,230,231 Dr. Gonzalez became interested in the effects of proteolytic enzymes and other modalities after reviewing the work of Dr. Kelly. In this study, patients were treated with an intensive program of diet, oral supplementation of nutrients and enzymes, and routines such as coffee enemas (for the purpose of liver detoxification). The proteolytic enzymes are the proposed anticancer element in the program, while the other components are considered supportive in nature. The daily dose of pancreas enzymes (derived from pigs) was 25 to 40 grams, which was spread out over multiple doses throughout the day and night. Although the exact protocol has not been published, based on public comments by Dr. Gonzalez it would appear the enzymes were ingested about every four hours on an empty stomach and treatments were given for 15 consecutive days, followed by a 5-day rest period.

The results are intriguing: 81 percent of the patients survived one year, 45 percent survived two years, and 36 percent survived three years. This is far above the average survival rates of 25 percent at one year and 10 percent at two years as reported in the National Cancer Data Base from 1995. Because of this success, Dr.

Gonzalez was awarded a large grant in June 2000 to conduct a larger clinical trial using his protocol.

Other human studies using enzymes have been published in books or appeared in articles published by the MUCOS pharmaceutical company, or they were articles not indexed in MEDLINE.3 These studies are discussed below.

Max Wolf, M.D., treated over 1,000 cancer patients in Germany using a multiple-enzyme product named WOBE-MUGOS, or similar multienzyme products.232, b Dr. Wolf began treating patients about 1949 with a variety of enzyme formulations, and after its introduction in 1959, WOBE-MUGOS was used exclusively. The original formula for WOBE-MUGOS contained chy-motrypsin, trypsin, papain, and calf thymus extract. It was reformulated in 1991, and the thymus extract was removed. Early treatment protocols used oral doses of 200 milligrams per day, and protocols in later years used 2 to 4 grams per day. Enzyme treatments were often combined with surgery, vitamins, heparin, or other agents. Where possible, treatment included intratumoral injection or topical application of the enzymes. With colon cancer, retention enemas were employed. Although it is difficult to evaluate the success of this early work based on available data, especially since the studies were not controlled and randomized, the following conclusions were suggested by Wolf:

• Enzyme therapy was generally not curative but appeared to inhibit metastasis and moderately prolong survival. For example, breast cancer was the most common cancer treated. Of 107 postmastectomy patients, the five-year observed survival rate was 84 percent. The authors reported that observed survival rates for conventional therapy at the time were 43 to 48 percent. The benefits gained with other types of cancers were less clear, although the authors asserted that patients generally benefited.

• Systemic treatment was less successful than localized treatment using intratumoral injections, topical salves, bladder infusions, or other treatments.

• The best results in inhibiting metastasis were seen in patients who were on long-term therapy.

• High doses and mixed plant and animal enzymes provided better results than low doses and single enzymes.

a The German company MUCOS Pharma GmbH is a leader in the production and testing of polyenzyme products.

b The name WOBE-MUGOS derives from the two early principal investigators, Max Wolf (WO) and Helen Benitez (BE) and from the MUCOS pharmaceutical company that later took over the production and investigative work.

This early work was continued by the MUCOS company. According to preliminary studies cited in the manufacturer's literature, initial clinical trials yielded promising results in patients with malignancies of the breast, colon, head, neck, and multiple myeloma. In multiple myeloma, retrospective cohort studies reported life span prolongation. Prospective studies are under way on patients with multiple myeloma, breast, and colon cancer to verify these results. In the completed studies, enzyme therapy commonly resulted in weight gain, reductions in fatigue and depression, and improved quality of life. A slowing of tumor progression was also suggested in some cases.226

Other doctors have used multienzyme formulas to treat cancer patients. For example, in the 1960s Frank Shively, M.D., treated more than 96 advanced cancer patients using a combination of chymotrypsin, trypsin, amylase, and other agents. The enzymes were administered intravenously, with more than 3,000 infusions given to these patients in total. Case studies of some of these and cautions and contraindications of the treatment are available.233 According to Dr. Shively, many patients responded favorably to the enzyme treatment. In many cases, the tumors apparently became necrotic, detached from their surrounding tissue, and were easily removed by surgery. The most commonly treated tumors were carcinomas of the breast, gastrointestinal tract, and genitals.

Other investigators have suggested that bromelain alone may be useful in treating cancer patients. Gerard was one of the first.234 In a case series on 12 patients with various tumors who were given bromelain, resolution of masses was reported in patients with ovarian and breast cancers. Nieper experimented with higher doses of bromelain in combination with standard chemotherapy and also reported some success.235 These physicians have suggested that the optimum dose of bromelain may be 1 to 2.4 grams daily.

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