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Selected Vegetables, Sun's Soup as an Anticancer Treatment
This complementary and alternative medicine (CAM) information summary provides an overview of the use of Selected Vegetables/Sun's Soup as an anticancer treatment. The summary includes a brief history of Selected Vegetables/Sun's Soup and a review of animal and human studies. Much of the information in the Human/Clinical Studies section is summarized in a table located at the end of that section. This summary contains the following key information: "Selected Vegetables" and "Sun's Soup" are names given to several different mixtures of vegetables and herbs that have been studied as treatments for cancer. These mixtures were developed by a single individual. At present, 2 formulations of Selected Vegetables/Sun's Soup are marketed in the United States as dietary supplements. | ||||||||
The vegetables and herbs in Selected Vegetables/Sun's Soup are thought to have anticancer and/or immune-system - stimulating properties. It has been reported that treatment with Selected Vegetables/Sun's Soup lengthened the survival of patients with advanced non-small cell lung cancer or other types of malignant tumors. However, different formulations of Selected Vegetables/Sun's Soup were used in the studies reported to date, making the comparison of results across studies difficult, and design weaknesses in the studies raise doubts about the reliability of the findings. Additional clinical studies of Selected Vegetables/Sun's Soup are being conducted or contemplated. Many of the medical and scientific terms used in the summary are hypertext linked (at first use in each section) to the NCI Dictionary 2, which is oriented toward nonexperts. When a linked term is clicked, a definition will appear in a separate window. All linked terms and their corresponding definitions will appear in a glossary in the printable version of the summary. Reference citations in some PDQ CAM information summaries may include links to external Web sites that are operated by individuals or organizations for the purpose of marketing or advocating the use of specific treatments or products. These reference citations are included for informational purposes only. Their inclusion should not be viewed as an endorsement of the content of the Web sites, or of any treatment or product, by the PDQ Cancer CAM Editorial Board or the National Cancer Institute (NCI). General Information "Selected Vegetables" and "Sun's Soup" are names given to several different mixtures of vegetables and herbs that have been studied as treatments for cancer and other medical conditions, including acquired immunodeficiency syndrome (AIDS). The original formulation contained shiitake mushroom (Lentinus edodes [Berk.] Singer), mung bean (Phaseolus radiatus L.), Hedyotis diffusa Willd. (also known by the Chinese herbal name Bai Hua She She Cao), and barbat skullcap (Scutellaria barbata D. Don, also known by the Chinese herbal name Ban Zhi Lian). A second formulation, specifically named "Selected Vegetables" (or "SV"), was tested in a phase I/II clinical trial that involved patients with advanced non-small cell lung cancer. SV, which is a freeze-dried vegetable and herb product, is marketed in the United States as a dietary supplement under the names "Freeze-dried SV" or "DSV." A third formulation, called "Frozen SV" or "FSV," has also been studied clinically in patients with advanced non-small cell lung cancer. FSV, like SV/DSV, is marketed in the United States as a dietary supplement. In the United States, dietary supplements are regulated as foods, not drugs. Therefore, premarket evaluation and approval by the Food and Drug Administration (FDA) are not required unless specific disease prevention or treatment claims are made. The FDA can, however, remove from the market dietary supplements that it deems unsafe. It should be noted that no formulation of Selected Vegetables/Sun's Soup has been approved by the FDA for the treatment of cancer or any other medical condition. Because dietary supplements are not formally reviewed for manufacturing consistency, there may be considerable variation from lot to lot, and there is no guarantee that ingredients identified on product labels are present in the specified amounts or present at all. SV/DSV and FSV are reported to contain soybean (Glycine max [L.] Merr.), shiitake mushroom, mung bean, red date (Ziziphus jujuba Miller), scallion (Allium bakeri Regel), garlic (Allium sativum L.), leek (Allium fistulosum L.), lentil (Lens culinaris Medic.), Hawthorn fruit (Crataegus monogyna Jacquin and/or Crataegus oxyacantha L.) , onion (Allium cepa L.), ginseng (Panax ginseng C.A. Meyer), Angelica root (Angelica sinensis), licorice (Glycyrrhiza glabra L.), dandelion root (Taraxacum officinale Weber), senega root (Polygala senega L.), ginger (Zingiber officinale Roscoe), olive (Olea europaea L.), sesame seed (Sesamum indicum L.), and parsley (Petroselinum crispum [P. Miller] Nyman ex A.W. Hill). Many of the ingredients in Selected Vegetables/Sun's Soup were chosen because previous biochemical research and traditional Chinese medicine suggested they contain molecules that have anticancer or immune-system-stimulating activity. Selected Vegetables/Sun's Soup is administered orally, as part of the diet. Reviewed in Studies in humans have not always specified a dose or an administration schedule, but daily doses either of 30 g SV/DSV, mixed with water or other soup, or of 10 oz (approximately 283 g) FSV were used in the above-mentioned clinical studies in patients with advanced non-small cell lung cancer. To conduct clinical drug research in the United States, researchers must file an Investigational New Drug (IND) application with the FDA. An IND must also be obtained for clinical evaluation of dietary supplements as agents for the treatment or prevention of disease. Because the IND application process is confidential and because the existence of an IND can be disclosed only by the applicants, it is not known whether an IND currently exists for the study of Selected Vegetables/Sun's Soup as a treatment for cancer or any other disease. In this summary, the specific formulation of Selected Vegetables/Sun's Soup given to individual patients or groups of patients will be identified wherever possible. History Selected Vegetables/Sun's Soup was first conceived as a treatment for cancer in the mid-1980s. In an effort to help a relative who was diagnosed with stage IV non-small cell lung cancer (metastasis to the left adrenal gland), the developer created a mixture that contained shiitake mushroom (Lentinus edodes [Berk.] Singer), mung bean (Phaseolus radiatus L.), Hedyotis diffusa Willd., and barbat skullcap (Scutellaria barbata D. Don) in the belief that these plant materials had anticancer and/or immune-system-stimulating properties. After the relative appeared to benefit from this treatment (the relative was reported to be alive and cancer free more than 13 years later), 3 additional patients (1 with stage IV kidney cancer that had metastasized to the lungs, 1 with stage IV kidney cancer that had metastasized to the liver and to the lungs, and 1 with stage IV non-small cell lung cancer that had metastasized to the brain) were treated with a variant of the original mixture, i.e., a combination of shiitake mushroom and mung bean. (Note: No explanation has been given for the omission of Hedyotis diffusa and barbat skullcap for these patients.) These additional patients were also said to benefit from vegetable/herb treatment. In June 1992, the developer filed a patent application for the "Herbal treatment of malignancy," and a patent was awarded in August 1995. Also in June 1992, the developer initiated a clinical trial in the Czech Republic to test Selected Vegetables/Sun's Soup as a treatment for advanced non-small cell lung cancer. A second clinical study (a nonconsecutive case series) that also involved patients with advanced non-small cell lung cancer was completed in 1997. It is unclear, however, when patient accrual for this second study began. In both reports of the clinical study results, the authors concluded that patients who received Selected Vegetables/Sun's Soup had prolonged survival. In 1998, the developer reported at a scientific conference that additional patients with various other types of cancer had benefited from treatment with Selected Vegetables/Sun's Soup. As noted previously (General Information 7), the proposed mechanism of action for Selected Vegetables/Sun's Soup involves anticancer and/or immune-system-stimulating activities associated with some of the ingredients. Reviewed in The following types of compounds likely found in Selected Vegetables/Sun's Soup have been investigated for these activities: protease inhibitors and autoclave-resistant factor, which are found in soybeans (Glycine max L. Merr.); plant sterols; saponin; inositol hexaphosphate (IP6); beta-glucans; lectins; coumestans such as coumestrol; and isoflavones such as daidzein, genistein, biochanin A, and formononetin. One beta-glucan found in shiitake mushroom, i.e., lentinan, has been used as an adjunctive therapy for cancer (primarily gastric cancer and colorectal cancer) in Japan. Reviewed in Treatment with lentinan has been reported to prolong the survival of patients with gastric cancer Reviewed in and to improve their quality of life. However, lentinan may not be an active component in Selected Vegetables/Sun's Soup. This compound has a large molecular mass and is believed to have only limited oral bioavailability. Reviewed in Therefore, lentinan has usually been given by intravenous injection. Nonetheless, other substances in shiitake mushroom have been identified as having greater oral bioavailability, and these substances have shown anticancer activity in animal experiments. Laboratory/Animal/Preclinical Studies Only limited information is available from laboratory or animal studies of Selected Vegetables/Sun's Soup. The developer's patent document describes 4 animal experiments that used 2 mouse tumor models (mouse sarcoma S1509a, which was used in 3 of the experiments, and mouse Line 1 lung carcinoma, which was used in 1 experiment) and that evaluated shiitake mushroom (Lentinus edodes [Berk.] Singer), mung bean (Phaseolus radiatus L.), Hedyotis diffusa Willd., and barbat skullcap (Scutellaria barbata D. Don). In these experiments, small groups of mice were fed either standard laboratory chow or laboratory chow that had been mixed with 1 or more of the 4 named substances. The mice were fed these diets both before and after they received subcutaneous injections of tumor cells. Results presented in the patent document show that tumor growth was slower in mice fed the experimental diets (i.e., containing the substances) than in mice fed standard laboratory chow. However, the greatest inhibition of tumor growth (up to 85% inhibition) was observed in animals fed diets that contained both mung bean and shiitake mushroom. Results of 2 additional animal experiments were reported by the developer in a peer-reviewed scientific journal. One experiment was a repetition of the Line 1 lung carcinoma experiment that was described in the developer's patent document. The results of this experiment were similar to those obtained previously: tumor growth was slower in animals fed the experimental diets, with the greatest inhibition of tumor growth (up to 82% inhibition) observed in animals fed a diet that contained both mung bean and shiitake mushroom. The second experiment also used the Line 1 lung carcinoma tumor model. In this experiment, tumor growth was measured in mice fed either standard laboratory chow or a mixture of standard laboratory chow and DSV (i.e., the commercially available freeze-dried formulation of Selected Vegetables/Sun's Soup). Tumor growth was approximately 2.3 times slower (i.e., approximately 65% growth inhibition) in mice fed standard laboratory chow plus DSV than in mice fed standard laboratory chow alone.
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