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From the Townsend Letter for Doctors & Patients
June 2004

Literature Review and Comment
by Alan R. Gaby, MD

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Food supplement for treatment of lung cancer
Sixteen patients with stage IIIB and IV non-small cell lung cancer received conventional therapy plus 283 g/day of "Selected Vegetables" (SV) with breakfast or lunch. SV is a freeze-dried commercial vegetable soup prepared by Sun Farm (Milford, Connecticut) that contains soybean, shiitake mushroom, mung bean, red date, scallion, garlic, lentil bean, leek, hawthorn fruit, onion, ginseng, angelica root, licorice, dandelion root, senegal root, ginger, olive, sesame seed, and parsley. In intent-to-treat analysis, the median survival time was 20 months, and the one-year survival rate was 55%. Among the 14 patients who ingested SV for at least 2 months (range, 2-46 months), the first patient remained tumor-free for more than 133 months, and the second showed complete regression of multiple brain lesions after using SV and radiotherapy. Among the remaining 12 patients, the median survival time was 33.5 months, and one-year survival was greater than 70%. The mean Karnofsky performance status of eligible patients was 55 at entry and improved to 92 after use of SV for 5 months or longer (p < 0.01). No adverse effects were seen.

Background: This study suggests that a proprietary vegetable soup product that contains a number of components with documented anticancer activity may improve survival and quality of life in patients with non-small cell lung cancer. In studies using a mouse lung cancer model, the addition of 5% SV (wt/wt) to the diet was associated with a 53 to 74% reduction in tumor growth rate. Because of its apparent safety, this preparation should be considered as part of a comprehensive treatment program for patients with lung cancer.

Sun AS, et al. Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients.
Nutr Cancer 2001;39:85-95.

Melatonin for lung cancer
Sixty-three patients with metastatic non-small cell lung cancer that was resistant to cisplatin were randomly assigned to receive supportive care plus melatonin (10 mg/day at 7 p.m.) or supportive care alone (control group). Melatonin was given daily for 21 days, followed by a 7-day rest; this cycle was repeated until the disease progressed. The mean survival time was significantly greater in patients receiving melatonin than in the control group (7.9 vs 4.1 months). The proportion of patients alive at one year was significantly higher in the melatonin group than in the control group.

Comment: Melatonin has demonstrated anticancer activity in a number of human and animal studies. The mechanism of action of melatonin may include stimulation of the immune system, inhibition of the production of growth factors, or a direct cytostatic effect. The results of the present study suggest that melatonin may prolong survival in patients with non-small cell lung cancer whose disease has progressed while receiving cisplatin therapy. Other studies of patients with various solid tumors have shown that melatonin increases survival, improves quality of life, and may reduce the side effects of some conventional cancer medications.

Lissoni P, et al. Randomized study with the pineal hormone melatonin versus supportive care alone in advanced nonsmall cell lung cancer resistant to a first-line chemotherapy containing cisplatin. Oncology 1992;49:336-339.

Smokers, take your B vitamins
Seventy-three male smokers who had bronchial squamous metaplasia (identified in one or more sputum samples) were randomly assigned to receive, in double-blind fashion, either placebo or 10 mg/day of folic acid plus 500 mcg/day of hydroxocobalamin (vitamin B12). After 4 months there was a significantly greater reduction of atypical cells in the supplemented group than in the placebo group.

Comment: Bronchial squamous metaplasia is a frequent forerunner of bronchogenic carcinoma. It has been suggested that certain components of cigarette smoke may inactivate folic acid, resulting in localized folic acid deficiency that renders the bronchial epithelium more susceptible to neoplastic transformation. Lower serum folate and vitamin B12 levels have been found in smokers, compared with non-smokers. Furthermore, plasma folate levels were lower in smokers with potentially premalignant bronchial squamous metaplasia than in smokers without metaplasia. These results suggest that supplementation with folic acid and B12 may help reduce the risk of lung cancer in cigarette smokers. Of course, quitting smoking would be of much greater benefit.

Heimburger DC, et al. Improvement in bronchial squamous metaplasia in smokers treated with folate and vitamin B12. JAMA 1988;259:1525-1530.

Preventing cancer with high-selenium yeast
Some 1,312 patients with a history of basal cell or squamous cell carcinoma of the skin were randomly assigned to receive, in double-blind fashion, 200 mcg/day of selenium (from high-selenium yeast [Nutrition 21]) or placebo. Patients were treated for a mean of 4.5 years, and the mean total follow-up period was 6.4 years. Selenium treatment did not affect the recurrence rate of skin cancers. However, compared with placebo, selenium treatment significantly reduced total cancer mortality (relative risk [RR] = 0.50; 95% CI, 0.31-0.80), total cancer incidence excluding skin cancers (RR = 0.63; 95% CI, 0.47-0.85), and the incidences of lung (RR = 0.54; 95% CI, 0.30-0.98), colorectal (RR = 0.42; 95% CI, 0.18-0.95), and prostate (RR = 0.37; 95% CI, 0.18-0.71) cancers. Selenium treatment also was associated with a nonsignificant 17% reduction in all-cause mortality. No cases of selenium toxicity occurred.

Comment: This study demonstrates a 37% reduction in total cancer incidence (excluding skin cancers) and a 50% reduction in total cancer mortality from the use of a selenium supplement for an average of 4.5 years. In addition, marked reductions were seen in the incidence of specific cancers (lung, colorectal, and prostate). A more recent follow-up study showed that selenium supplementation resulted in a 25% increase in the risk of squamous cell carcinoma in this cohort that already had had at least one previous episode of skin cancer (J Natl Cancer Inst 2003;95:1477-1481). Because squamous cell carcinoma is rarely fatal if treated early, that finding should not inhibit people from taking supplemental selenium to prevent more serious types of cancer. Individuals with a history of skin cancer who are taking selenium supplements should, of course, be closely followed by a dermatologist.

Since this study evaluated only people with a history of basal cell or squamous cell carcinoma of the skin, it is not clear whether the results can be generalized to the rest of the population. Moreover, the reductions in cancer incidence and mortality described above were all secondary outcomes of the study, the primary outcome being the recurrence rate of non-melanoma skin cancers. Secondary outcomes are somewhat less reliable than primary outcomes, so another study should be designed specifically to test the hypothesis that selenium supplements prevent cancer and reduce cancer mortality.

The high-selenium yeast used in this study is sold under the trade name Selenomax. The chemical forms of selenium in yeast are complex, and not all of the selenium compounds have been identified. Therefore, one cannot assume that other forms of selenium (such as selenite, selenomethionine, or selenocysteine) would have the same benefits as high-selenium yeast.

Clark LC, et al. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. JAMA 1996;276:1957-1963.

Lycopene beneficial for advanced prostate cancer
Fifty-four patients with metastatic prostate cancer (M1b or D2) were randomly assigned to receive orchiectomy alone (control) or orchiectomy plus lycopene, 2 mg twice a day. After 6 months the mean PSA level was nonsignificantly lower in the lycopene group than in the control group (9.1 vs. 26.4 ng/ml); after 2 years the difference between groups was significant (3.0 vs. 9.0 ng/ml; p < 0.001). Eleven patients in control group (40%) and 21 in the lycopene group (78%) had a complete PSA response (p < 0.05). Bone scans showed a complete response in 4 patients in the control group (15%), compared with 8 (30%) in the lycopene group (p < 0.02). The mortality rate was 22% in the control group and 13% in the lycopene group (p < 0.001).

Comment: These results indicate that adding lycopene to orchiectomy produced a more favorable outcome than did orchiectomy alone. Other preliminary studies have suggested that lycopene supplementation (in the form of a tomato extract) can either slow the growth, or induce regression, of prostate cancer in humans (Cancer Epidemiol Biomarkers Prev 2001;10:861-868). In addition, epidemiological studies have shown that habitual consumption of large amounts of tomato sauce, a major dietary source of lycopene, is associated with a reduced risk of prostate cancer. The absorption of lycopene from tomato sauce is greater than that from whole tomatoes or tomato juice. Aside from tomatoes, dietary sources of lycopene include watermelon, apricots, and pink grapefruit. While experimental evidence points to lycopene as an important active ingredient in tomatoes, it is possible that other constituents of tomatoes are also active; consequently, food sources of lycopene would be preferable to supplements.

Ansari MS, Gupta NP. A comparison of lycopene and orchidectomy vs orchidectomy alone in the management of advanced prostate cancer. BJU Int 2003;92:375-378.

Folic acid may prevent congenital heart defects
The association between folic acid intake and risk of congenital heart defects was assessed in 899 women who presented for prenatal care at about 10 weeks' gestation and 985 other women referred for fetal echocardiography. After adjustment for age, race, binge drinking, smoking, and other potential confounding variables, women who took a daily folic acid supplement during the first 6 weeks of pregnancy (the period during which the heart develops) were 54% less likely to have a baby with one of these defects, compared with women who did not take a daily folic acid supplement. The protective effect of folic acid increased with increasing daily doses of the vitamin, and it appeared that at least 400 mcg/day of supplemental folic acid was necessary to achieve a reduction in risk. No benefit was associated with starting the supplement after 6 weeks' gestation or with taking folic acid before, but not during, pregnancy. Analysis of stored blood samples showed that the maternal plasma folate level was inversely associated with risk.

Comment: Previous studies have demonstrated that folic acid supplementation around the time of conception greatly reduces the risk of neural-tube defects. Congenital heart defects such as conotruncal defect and ventricular septal defect are much more common than neural tube defects. The results of this new study suggest that supplementation with at least 400 mcg/day of folic acid during the first 6 weeks of pregnancy can reduce the risk of congenital heart defects. As different organs develop at different times during pregnancy, it makes sense for women of childbearing age to take a folic acid-containing multivitamin prior to, and for the entire duration of, pregnancy.

Jancin B. Folic acid slashes risk of congenital heart defects. Fam Pract News 2003(Dec. 15):10.

Burn victims need vitamin D supplements
Twelve children (aged 4-14 years) who had been burned on a mean of 52% of their total body surface area were studied a mean of 14 months after their burn injury. Eight of 11 children (73%) had a low serum 25-hydroxyvitamin D concentration, indicative of vitamin D deficiency. Skin biopsy samples revealed that the conversion of 7-dehydrocholesterol to previtamin D3 after exposure to ultraviolet B light was significantly reduced in both burn scar and adjacent healthy-appearing skin, compared with the conversion in the skin of normal, unburned children (p = 0.004).

Comment: Osteoporosis is a long-term consequence of severe burns, occurring in more than half of patients during long-term follow-up. In the early stages after a burn, immobilization and high concentrations of cortisol both contribute to bone loss. Vitamin D deficiency also plays a role in the development of osteoporosis. Children with burn scars often avoid sun exposure, because it causes itching and burning. The results of the present study suggest that impaired synthesis of vitamin D in response to sun exposure is another factor contributing to vitamin D deficiency. Long-term supplementation with vitamin D should be considered for all people who have suffered severe burns.

Klein GL, et al. Synthesis of vitamin D in skin after burns. Lancet 2004;363:291-292.
Garrel D. Burn scars: a new cause of vitamin D deficiency? Lancet 2004;363:259-260.

Herbal remedy for Alzheimer's disease
Forty-two patients (aged 65-80 years) with mild-to-moderate Alzheimer's disease were randomly assigned to receive, in double-blind fashion, 60 drops/day of sage (Salvia officinalis) extract (1:1 in 45% alcohol) or placebo for 4 months. After 4 months, cognitive function (as determined by the cognitive subscale of the Alzheimer's Disease Assessment Scale [p = 0.03 vs. placebo] and the Clinical Dementia Rating [p < 0.003 vs. placebo]) was significantly better in the active-treatment group than in the placebo group. Side effects were similar in the two groups, with the exception of agitation, which was more frequent in the placebo group (p = 0.09).

Comment: Sage has been used in traditional herbal medicine to improve memory and to enhance the senses. This herb has been shown to bind to cholinergic receptors in vitro, an effect that might be expected to improve cognitive function. The results of the present study indicate that an extract of sage is effective in the treatment of mild-to-moderate Alzheimer's disease. While the dose used in this study did not cause any significant side effects, excessive doses of sage can cause mental confusion or convulsions.

Akhondzadeh S, et al. Salvia officinalis extract in the treatment of patients with mild to moderate Alzheimer's disease: a double blind, randomized and placebo-controlled trial. J Clin Pharm Ther 2003;28:53-59.

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