Natural Standard Blog

Saw Palmetto for Enlarged Prostate

Gel capsules of saw palmetto may improve the symptoms of enlarged prostate, a new study reports.

Saw palmetto (Serenoa repens) is used popularly in Europe for the management of symptoms associated with benign prostatic hypertrophy (enlarged prostate). Although not considered standard of care in the United States, it is the most popular phytotherapy for this indication.

Numerous controlled trials have reported saw palmetto to be superior to placebo and possibly equivalent to the anti-androgenic agent finasteride/Proscar® (with fewer adverse effects) in the alleviation of nocturia (the need to frequently urinate at night), improvement of urinary flow, reduction of post-void residual bladder volume and improvement of quality of life (but possibly not measurable reduction in prostate size).

Saw palmetto was listed in the United States Pharmacopeia from 1906 to 1917 and in the National Formulary from 1926 to 1950.

Researchers from the People's Republic of China investigated the effect of Prostataplex™ (a saw palmetto gel capsule) in men with lower urinary tract symptoms associated with benign prostatic hyperplasia.

Researchers randomly assigned a total of 92 Chinese men between 49 and 75 years old with lower urinary tract symptoms to the intervention group (46 patients) or the control group (46 patients). The intervention group patients were given two Prostataplex™ soft gels daily for 12 weeks, and the control group patients were given two placebo soft gels for the same time.

The researchers found that after 12 weeks of intervention, the mean urinary flow rate was significantly higher in the treatment group than in the control group, while relative urinary resistance was significantly lower in the treatment group than in the control group. While there was no significant difference in mean prostate volume or International Prostate Symptom Score between the two groups, 18 of 46 patients (39.1 percent) in the treatment group showed an International Prostate Symptom Score improvement (decrease of three or greater) after intervention, whereas only one of 46 (2.2 percent) in the control group showed an International Prostate Symptom Score improvement.

The study authors concluded that Prostataplex™ may have short-term effects in improving symptoms and objective measures in Chinese men with lower urinary tract symptoms associated with benign prostatic hyperplasia.

For more information about saw palmetto, please visit Natural Standard’s Foods, Herbs & Supplements database.

 

EDTA and Anticancer Drugs

A new study reviewed the effects of EDTA, or ethylene diamine tetraacetic acid, used in the anticancer drug dexrazoxane.

Dexrazoxane hydrochloride (Zinecard®, Pharmacia) is a medication used to protect the heart against the cardiotoxic side effects of anthracycline chemotherapy. As a derivative of EDTA, dexrazoxane chelates iron, but the precise mechanism by which it protects the heart is not known.

EDTA is a chelating (claw-like) molecule used to remove heavy metals and calcium from the human body. It is one way of treating heavy metal toxicity and atherosclerotic deposits in arteries.

EDTA chelation became well known during the 1950s, when it was proposed as a method to cleanse the blood and blood vessel walls of toxins and minerals. The technique involves infusing EDTA into the blood. The therapy is sometimes given by mouth, and occasionally, other chemicals may be used.

Initially, chelation was used to treat heavy metal poisoning. It was felt by some observers that other benefits occurred in patients receiving this therapy. In current times, chelation practitioners may recommend this treatment for diabetes, for clogged arteries in the heart or legs (peripheral vascular disease) and for numerous other conditions.

Twenty or more sessions may be recommended and can cost several thousand dollars. It has been proposed that treatment with chelation may break down cholesterol plaques in the arteries. Other mechanisms, such as removal of calcium from these plaques and antioxidant properties, have also been suggested. However, there is little scientific evidence to support these theories.

Serious side effects have been associated with chelation therapy, such as dangerously low calcium blood levels, damage to bone marrow that decreases the ability to make new blood cells, kidney damage (with elevated creatinine levels), very low blood pressure, fast heart rate, increased risk of bleeding or blood clots (including interference with the effects of the blood thinning drug warfarin [Coumadin®]), bacterial blood infections, seizures, allergic or immune system reactions, heart rhythm abnormalities and unstable blood sugars. Other side effects may include fever, nausea, vomiting, gastrointestinal upset, excessive thirst, sweating (diaphoresis), headache, decreased thyroid function, fatigue, low white blood cell count (leukopenia) or low blood platelet count (thrombocytopenia). Severe reactions have occurred in which people have stopped breathing. Although deaths have been reported in people receiving chelation, is not clear that chelation therapy was the direct cause.

Researchers from the University of Manitoba in Canada explained that the use of the anthracycline anticancer drugs doxorubicin, daunorubicin, epirubicin and idarubicin sometimes results in accidental extravasation injury and can be a serious complication of their use.

They concluded that dexrazoxane has been shown in two clinical studies and in several case reports to be highly efficacious in preventing anthracycline-induced extravasation injury. Dexrazoxane likely acts by removing iron from the iron-anthracycline complex, thus preventing formation of damaging reactive oxygen species.

Bisphosphonates and Musculoskeletal Pain

The U.S. Food and Drug Administration (FDA) issued an alert highlighting the possibility of severe and sometimes incapacitating bone, joint and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Bisphosphonates are a family of non-hormonal drugs that are used to prevent and treat osteoporosis.

Osteoporosis is a disease of the bones that makes them weak and prone to fractures. In the United States, about eight million women and two million men have osteoporosis. Those older than 50 years of have greatest risk of developing osteoporosis and suffering from related fractures. In this age group, an estimated one in two women and one in six men will suffer an osteoporosis-related fracture at some point in their lives.

The FDA explained that although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment and necessitating the use of pain-relievers.

Pain is the most common reason individuals seek medical care. Pain is often classified as acute (immediate, short-term) or chronic (long-term). About 30-40 million Americans annually do not experience symptom relief with use of over-the-counter pain-relievers, such as acetaminophen (Tylenol®), aspirin and ibuprofen (Advil®). According to the American Medical Association (AMA), 13-15 million Americans suffer from chronic  and severe pain that is not easily managed. The annual cost of chronic pain in the United States, including healthcare expenses, lost income and lost productivity is estimated to be $100 billion.

The alert stated that the severe musculoskeletal pain may occur within days, months or years after starting a bisphosphonates. While some patients have reported complete relief of symptoms after discontinuing bisphosphonates, others have reported slow or incomplete resolution. The FDA cautioned that the risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

The FDA elaborated that this severe musculoskeletal pain is in contrast to the acute phase response characterized by fever, chills, bone pain, muscular pains and joint pains that sometimes accompanies initial administration of intravenous (injected into a vein) bisphosphonates and may occur with initial exposure to once-weekly or once-monthly doses of bisphosphonates taken by mouth. The symptoms related to the acute phase response tend to resolve within several days with continued drug use.

The FDA advised healthcare professionals to consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

Integrative therapies with good scientific evidence in the prevention and/or treatment of pain include: acupuncture, bromelain, comfrey, guided imagery, hypnotherapy, hypnosis, music therapy, physical therapy and therapeutic touch.

Integrative therapies with strong scientific evidence in the treatment of osteoporosis include calcium and vitamin D. For more information, please visit Natural Standard's Medical Conditions database.

Benefit of Probiotics Questioned

On the heels of a new lawsuit against Dannon™, America's founding national yogurt company, for allegedly misleading consumers about the effectiveness of its probiotics yogurt lines (Activia™ and DanActive™), a new study by researchers in Australia questioned the effectiveness of various probiotics strains, while maintaining that health benefits have been observed.

Probiotics are thought to be beneficial bacteria (sometimes referred to as "friendly germs") that help to maintain the health of the intestinal tract and aid in digestion. They also help keep potentially harmful organisms in the gut (harmful bacteria and yeasts) under control. Most probiotics come from food sources, especially cultured milk products. Probiotics can be consumed as capsules, tablets, beverages, powders, yogurts and other foods.

Probiotics work by colonizing the small intestine and crowding out disease-causing organisms, thereby restoring proper balance to the intestinal flora. They compete with harmful organisms for nutrients and may also produce substances that inhibit growth of harmful organisms in the gut.

Probiotics have been found to enhance the digestion and absorption of proteins, fats, calcium and phosphorus. They may help overcome lactose intolerance. They may also help restore healthy bacteria after a course of antibiotic therapy has altered the normal gastrointestinal flora.

Researchers from the Department of Primary Industries, one of 10 Victorian Government Departments in Victoria, Australia, suggested that amongst the many benefits associated with the consumption of probiotics, modulation of the immune system has received the most attention.

According to the review, several animal and human studies have provided definitive evidence that specific strains of probiotics are able to stimulate and regulate several aspects of natural and acquired immune responses. There is also evidence that intake of probiotics effectively prevents and/or manages acute gastroenteritis and rotavirus diarrhea, antibiotic-associated diarrhea and intestinal inflammatory disorders such as Crohn's disease and pouchitis (inflammation of the ileal pouch, which is created in the management of patients with ulcerative colitis, indeterminate colitis or other colitides) and pediatric atopic disorders.

The review stated that the efficacy of probiotics against bacterial infections and immune disorders, such as adult asthma, cancers, diabetes and arthritis, remains to be proven in humans. Additionally, major gaps exist in the knowledge of the mechanisms by which probiotics modulate immune function.

The authors added that optimum dose, frequency and duration of treatment required for different conditions in different population groups remains to be determined.

The review concluded that different probiotic strains vary in their ability to modulate the immune system; the authors suggested that the efficacy of each strain needs to be carefully demonstrated through rigorously designed (randomized, double-blind, placebo-controlled) studies

The Dannon Company, Inc. responded to the class-action lawsuit stating, "Dannon is aware of the lawsuit and we are reviewing it. Dannon proudly stands by the claims of its products and the clinical studies which support them. All of Dannon's claims for Activia™ and DanActive™ are completely supported by peer-reviewed science and are in accordance with all laws and regulations. Dannon's advertising has always been and will continue to be absolutely truthful, and Dannon will vigorously challenge this lawsuit."

The Dannon™ Company produces and sells about 100 different types of flavors, styles and sizes of cultured fresh dairy products. Dannon™ is owned by Groupe Danone™, one of the world's leading producers of packaged foods and beverages, and Dannon™ is the top-selling brand of yogurt products worldwide, sold under the names Dannon™ and Danone™, states the Dannon™ Web site.

For more information on probiotics, please visit Natural Standard's Foods, Herbs & Supplements database.

Nutritional Counseling for Pregnant Vegetarians

Pregnant women who adhere to a vegetarian diet should have tailored prenatal nutritional counseling, a new study suggests.

Researchers from the University of Utah explained that a woman's nutritional status directly affects pregnancy outcome and the quality of breast milk after birth.

The study authors asserted that clinicians who provide prenatal care have an important role in assessing the nutritional status of women and directing them to appropriate resources while respecting their choices. In particular, vegetarian and vegan diets may present unique nutrient deficiencies that can be addressed during prenatal nutritional counseling.

In a related study, the American Dietetic Association and Dietitians of Canada affirmed that appropriately planned vegetarian diets are healthy, nutritionally adequate and provide health benefits in the prevention and treatment of certain diseases. The researchers noted that about 2.5 percent of adults in the United States and four percent of adults in Canada follow vegetarian diets.

A vegetarian diet was defined as one that does not include meat, fish or fowl.

The study reviewed the current scientific data related to what it considered to be the key nutrients for vegetarians: protein, iron, zinc, calcium, vitamin D, riboflavin, vitamin B-12, vitamin A, n-3 fatty acids and iodine. The authors ascertained that both vegetarian and vegan diets can meet current recommendations for all of these nutrients. However, they also noted that in some cases, use of fortified foods or supplements may be helpful in meeting recommendations for individual nutrients.

The paper stated that well-planned vegan and other types of vegetarian diets are appropriate for all stages of the life-cycle, including during pregnancy, breastfeeding, infancy, childhood and adolescence. Additionally, the authors observed that vegetarian diets offer a number of nutritional benefits including lower levels of saturated fat, cholesterol and animal protein as well as higher levels of carbohydrates, fiber, magnesium, potassium, folate, antioxidants (such as vitamins C and E) and phytochemicals.

Reports have suggested that vegetarians have lower body masses than non-vegetarians, as well as lower rates of death from heart disease, lower blood cholesterol levels and lower rates of high blood pressure, type 2 diabetes and prostate and colon cancer.

Similar to the researchers in the first study, the study authors concluded that dietetics professionals have a responsibility to support and encourage those who express an interest in consuming a vegetarian diet as they have key roles in educating vegetarian clients.

For more information on vegetarian diets, please visit Natural Standard's Health & Wellness database. For more information on pregnancy, please visit Natural Standard's Comparative Effectiveness database.

Progesterone Therapy for Miscarriage Prevention

Progesterone and progestin (synthetically produced progesterone) supplementation during pregnancy may help prevent miscarriage in at-risk women, a new study conducted by researchers in Hungary suggests.

Progesterone is a female steroid hormone secreted by the ovaries and produced by the placenta in large quantities during pregnancy.

Progesterone belongs to a class of hormones called progestogens and is the major naturally occurring human progestogen.

Progesterone, commonly referred to as the hormone of pregnancy, has many roles relating to the development of the fetus.

Progesterone converts the lining of the uterus (called the endometrium) to its secretory stage to prepare the uterus for implantation. At the same time, progesterone affects the vaginal epithelium and cervical mucus, making the mucus thick and impermeable to sperm. If pregnancy does not occur, progesterone levels will decrease, leading to menstruation. Normal menstrual bleeding is progesterone withdrawal.

During implantation and gestation, progesterone appears to decrease the maternal immune response to allow for the acceptance of the pregnancy.

Progesterone decreases contractility of the uterine smooth muscle. In addition, progesterone inhibits lactation during pregnancy. The fall in progesterone levels following delivery is one of the triggers for milk production.

A drop in progesterone levels is possibly one step that facilitates the onset of labor.

Previous studies assessing serum progesterone in normal pregnancy were done from the early 1950s through the 1970s. However, very little subsequent work has been accomplished in this area.

Data on the level of progesterone in normal pregnancy, as it relates to a variety of pregnancy-related complications and features of previous reproductive history, have been generated in a study that was conducted from the years 1980 through 2001 at the Pope Paul VI Institute for Human Reproduction. Researchers from this study report using modern means of progesterone assessment with improved accuracy and precision along with more precise means of dating the pregnancies.

The study evaluated 610 patients through 830 pregnancies. The patient population consisted primarily of infertility patients who were receiving progesterone supplementation during the course of their pregnancies. The study reported that infertility was either primary or secondary. Additionally, researchers noted that some of the patients also had a history of previous spontaneous abortion or recurrent spontaneous abortion.

The study observed that the levels of progesterone in first and second trimester spontaneous abortions are statistically decreased and that this decrease in progesterone production, presumably by the placenta, during the second and third trimester of pregnancy, may be associated with a variety of different pregnancy-related complications.

According to their Web site, the Pope Paul VI Institute now has more than 25 years of experience in the use of progesterone support in pregnancy. For more information, please visit the link referenced below.

For more information on miscarriage, please visit Natural Standard's Comparative Effectiveness database.

Exercise Breaks at Work

Integrating physical activity into the average workday may improve health of employees, a new study reports.

Researchers from UCLA Jonsson Comprehensive Cancer Center in Los Angeles, CA, explained that proactive worksite strategies that change the physical or sociocultural environment(s) to incorporate obligatory physical activity may be necessary to engage sedentary people.

This study analyzed the implementation and evaluation of an intervention, Pausa para tu Salud (Pause for Your Health), that integrated a brief period of group exercise into the workday.

The study tested the effects of integrating daily 10-minute exercise breaks during paid work time during January 2003 through January 2004. A total of 335 Mexican Ministry of Health office workers provided baseline data as a part of routine annual clinical screening examinations.

Baseline mean body mass index and waist circumferences were recorded at 27.8 kilograms/meter squared and 87.6 centimeters for women and 26.6 kilograms/meter squared and 89.7 centimeters for men. Complete data were available for 271 (80.9 percent) employees at one-year follow-up.

The study found that the body mass index decreased by 0.32 kilograms/meter squared and waist circumference by 1.6 centimeters overall. The body mass index decrease, however, was significant only for men. Multivariate analyses revealed a significant decrease in diastolic blood pressure among women.

The study authors concluded that physical activity integrated into a work schedule may result in significant improvements in employee health. The authors suggested that substantive health and organizational benefits may result from integrating brief periods of physical activity into the workday if these findings are replicated in randomized controlled trials in other worksites.

For more information on fitness, please visit Natural Standard's Health & Wellness database.

New Antioxidant

Researchers have isolated a new compound with antioxidant potential, pedicularioside G, derived from the Chinese herb Pedicularis striata.

The genus Pedicularis contains several species referred to as louseworts. The common name was derived from the idea that livestock would get lice from eating the plant.

Pedicularis plants are found mainly in temperate northern hemisphere climates, although some are also found in South America.

Although animal studies have indicated that certain chemicals found in the plants may have antiproliferative or antioxidant activity, there is insufficient evidence in humans to support the use of Pedicularis species for any indication.

Researchers from Lanzhou University in Lanzhou, China, found that pedicularioside G inhibited two major angiogenic (involving the growth of new blood vessels from pre-existing vessels) responses, human umbilical vein endothelial cell proliferation and migration in a chicken embryo model. In addition, pedicularioside G inhibited human liver cancer cells proliferation and migration along with transplanting tumor formation and growth.

The study authors concluded that pedicularioside G has anti-angiogenic, antitumour growth and antimetastatic  effects. Additionally, the results suggest that the anti-angiogenic and antitumor effects of pedicularioside G might be partially attributed to its antioxidative activity.

Pedicularis is in the same family as snapdragons (Scrophulariaceae) and also has similar hood flowers. The genus has a wide array of flower designs that are sometimes correlated to the insects or hummingbirds that pollinate them. The plants are also hemiparasitic and produce opportunistic nutrient-absorbing outgrowths upon contact with the roots of surrounding host plants.

For more information on louseworts, please visit Natural Standard's Foods, Herbs & Supplements database.

Behavioral Approach to Fitness

Behavioral fitness programs proved no more effective than informational pamphlets, a new study reports.

Researchers from the University of Cambridge, UK, explained that declining physical activity is associated with a rising burden of global disease. Efforts to reverse this trend have not been successful.

The study assessed the efficacy of a facilitated behavioral intervention to increase the physical activity of sedentary individuals at familial risk of diabetes. Researchers recruited 365 sedentary adults who had a parental history of type 2 diabetes from either diabetes or family history registers at 20 general practice clinics in the UK.

Participants were randomly assigned to one of two intervention groups or to a comparison group. All participants were sent a brief advice leaflet. One intervention group was offered a one-year behavior-change program to be delivered by trained facilitators in participants' homes, and the other the same program by telephone. The program was designed to alter behavioral determinants, as defined by the theory of planned behavior, and to teach behavioral-change strategies.

The principal outcome at one year was daytime physical activity, which was objectively measured as a ratio to resting energy expenditure. Analysis was by intention to treat.

Out of 365 patients, researchers analyzed primary endpoints for 321 (88 percent) for whom they had data after one-year of follow-up. At one year, the physical-activity ratio of participants who received the intervention, by either delivery route, did not differ from the ratio in those who were given a brief advice leaflet. The physical-activity ratio did not differ between participants who were delivered the intervention face-to-face or by telephone.

The study authors concluded that a facilitated theory-based behavioral intervention was no more effective than an advice leaflet for promotion of physical activity in an at-risk group. The authors suggested that healthcare providers remain cautious about commissioning behavioral programs into individual preventive healthcare services.

For more information on exercise, please visit Natural Standard's Health & Wellness database.

Korean Red Ginseng for Diabetes

Korean red ginseng may help control blood sugar levels in patients with diabetes, a new study reports.

Researchers from the University of Toronto in Canada investigated the clinical antidiabetic efficacy and safety of 12 weeks of supplementation with a Korean red ginseng preparation.

The study included 19 participants with well-controlled type 2 diabetes (11 men, eight women). Researchers gave participants the selected Korean red ginseng preparation (rootlets) and placebo at the selected dose (2 grams/meal=6 grams/day) for 12 weeks as an adjunct to their usual anti-diabetic therapy (diet and/or medications).

Outcomes included measures of efficacy; safety (liver, kidney, haemostatic, and blood-pressure function); and compliance (returned capsules, diet-records, and body-weight).

The study found no significant changes. The participants, however, remained well-controlled throughout. Safety and compliance outcomes remained unchanged.

The study authors concluded that although clinical efficacy was not demonstrated, 12 weeks of supplementation with the selected Korean red ginseng treatment maintained good blood sugar control and improved PG and PI regulation safely beyond usual therapy in people with well-controlled type 2 diabetes. The authors called for further investigation with similarly selected Korean red ginseng treatments.

Korean ginseng (Panax ginseng) is the most used and most researched species of ginseng. Korean ginseng has also been shown to improve sexual performance in men with erectile dysfunction.

For more information about ginseng, please visit Natural Standard’s Foods, Herbs & Supplements database.