In The News

New CAM Research Centers Target Stress-related Illnesses, Obesity, Cancer, and Other Conditions

Study Documents Safety Problems for Biological Products

Vitamin D Deficiency May Be More Common in Parkinson’s Disease Patients

Study Examines Association Between Caffeine Consumption and Breast Cancer Risk

New CAM Research Centers Target Stress-related Illnesses, Obesity, Cancer, and Other Conditions

The National Institutes of Health's National Center for Complementary and Alternative Medicine (NCCAM) has added 4 new Centers of Excellence for Research on CAM (CERCs) to its research centers program. The new centers will promote knowledge about CAM approaches and their potential in treating and preventing diseases and conditions common among Americans.

In NCCAM’s CERC program, highly accomplished researchers across a variety of disciplines apply cutting-edge technology to projects in CAM. The new centers and their projects are as follows.

Wisconsin Center for the Neuroscience and Psychophysiology of Meditation
Principal Investigator: Richard J. Davidson, PhD
Institution: University of Wisconsin, Madison
Dr Davidson’s team will examine the impact of 2 forms of meditation—loving-kindness/compassion meditation and mindfulness meditation—on the brain and body, focusing on the regulation of emotion and on emotional reactivity. Potential applications in health include biological and behavioral processes linked with emotions and/or stress, such as recurrent depression.

Metabolic and Immunologic Effects of Meditation
Principal Investigator: Frederick M. Hecht, MD
Institution: University of California, San Francisco
Dr Hecht and his colleagues will study a program combining mindfulness meditation, mindful eating (the practice of awareness and attentiveness in the present moment while eating), and a diet and exercise program for use in obesity and metabolic syndrome. They will test whether this program helps alter participants’ hormonal responses to stress and helps enhance and maintain weight loss.

CAM as Countermeasures Against Infectious and Inflammatory Disease
Principal Investigator: Mark A. Jutila, PhD
Institution: Montana State University, Bozeman
This center will study biologically based CAM therapies and their effects on immune system function in infectious and inflammatory diseases. One project focuses on effects of botanical extracts—from apple polyphenols, which are concentrated in apple skins, and from yamoa, which comes from the bark of an African gum tree—on white blood cells, using models of infection and inflammation of the intestinal mucosa. A second project examines 2 compounds in licorice root—glycyrrhizin and 18-glyrrhetinic acid—for their potential antiviral effects in models of influenza and stomach virus. A third project will focus on bacterial products to see how they treat autoimmune diseases like arthritis, which may also help build understanding of probiotics’ action.

Center for Herbal Research on Colorectal Cancer
Principal Investigator: Chun-Su Yuan, MD, PhD
Institution: University of Chicago
Dr Yuan and his colleagues will examine the anti-tumor effects of different preparations of the herbs American ginseng (Panax quinquefolius) and notoginseng (Panax notoginseng). They will seek to learn more, through laboratory and animal studies, about how these herbs act upon cellular and molecular pathways of the mechanisms of cancer inhibition.

The grants provide 5 years of support and bring the total number of CERCs to 11. To learn more about NCCAM’s research centers, go to nccam.nih.gov/training/centers/.

Study Documents Safety Problems for Biological Products

Approximately 1 in 4 biological medicinal products (eg, antibodies, enzymes, insulin) approved since 1995 in the United States and Europe have had at least 1 safety-related regulatory action issued for them 10 years after their approval, including about 11% receiving a “black box” warning (a warning of serious health hazards), according to a study in a recent issue of JAMA.

Biologicals are preparations in which the active substance is produced by or extracted from a biological source. They represent an important and growing part of medical therapies, with more than 250 biologicals having been approved since 1982. According to the study’s authors, biologicals represented 24% and 22% of all new chemical entities approved by US and European Union regulatory authorities, respectively, between 2003 and 2006.

Thijs J. Giezen, PharmD, and colleagues examined the nature and probability of safety-related regulatory actions issued for biologicals approved in the United States and/or the European Union between January 1995 and June 2007. Vaccines, allergenic products (substances capable of causing an allergic reaction), and products for further manufacture and transfusion purposes were excluded.

A total of 174 biological medicinal products obtained approval during the study period, including 136 biologicals approved in the United States and 105 in the European Union, of which 67 obtained approval in both regions during this time. The researchers found that between January 1995 and June 2008, 82 safety-related regulatory actions were issued for 41 of the 174 biologicals (23.6%). These included 46 written communications (warnings of health hazards) to healthcare professionals in the United States, 17 in the European Union, and 19 black box warnings. No biologicals were withdrawn for safety reasons.

The average time to a safety-related regulatory action was 3.7 years, and 70.7% of the safety-related regulatory actions were issued within 5 years after approval. The probability of a biological requiring its first safety-related regulatory action was 14% 3 years after approval and 29% 10 years after approval. Biologicals that were the first to be approved in their chemical, pharmacological, and therapeutic subgroup had a significantly higher risk for the occurrence of its first safety-related regulatory action compared with later approved products.

The safety-related regulatory actions issued for biologicals mostly involved the system organ classes of general disorders and administration site conditions (26.8% of 82); infections and infestations (22%); immune system disorders (15.9%); and benign, malignant, and unspecified neoplasms (12.2%).

Vitamin D Deficiency May Be More Common in Parkinson’s Disease Patients

Individuals with Parkinson’s disease appear more likely to be vitamin D–deficient than healthy adults of the same age or patients with Alzheimer’s disease, according to a report in the October issue of Archives of Neurology.

According to the study’s authors, patients with chronic neurodegenerative diseases often have many risk factors for vitamin D insufficiency, including advancing age, obesity, avoidance of sun exposure, residence in northerly latitudes, and having darker skin.

Marian L. Evatt, MD, MS, et al at the Emory University School of Medicine, Atlanta, compared vitamin D levels of 100 patients with Parkinson’s disease to vitamin D levels of 97 Alzheimer’s disease patients and 99 healthy individuals matched for age, sex, race, genotype, and geographic location.

The study found that significantly more patients with Parkinson’s disease (55%) had insufficient vitamin D than did controls (36%) or patients with Alzheimer’s disease (41%). The average vitamin D concentration in the group with Parkinson’s disease was considerably lower than the Alzheimer’s disease and healthy groups (31.9 ng/mL vs 34.8 ng/mL and 37 ng/mL, respectively).

“The finding of a high incidence of vitamin D deficiency in the Parkinson’s disease and other cohorts highlights the importance of routinely checking the level of 25(OH)D, particularly in elderly patients, since deficiency is strongly correlated with a higher incidence of osteoporosis, falls and hip fractures and has been associated with a higher incidence of several forms of cancer and autoimmune disorders,” the authors said.

Study Examines Association Between Caffeine Consumption and Breast Cancer Risk

Caffeine consumption does not appear to be associated with overall breast cancer risk, according to a report in a recent issue of Archives of Internal Medicine. There is, however, a possibility of increased risk for women with benign breast disease or for tumors that are hormone receptor–negative or larger than 2 cm.

It was hypothesized that caffeine, probably the most commonly consumed drug worldwide, may increase the risk of breast cancer after a study showed that women with noncancerous breast disease experienced relief from their symptoms after eliminating caffeine from their diet.

Ken Ishitani, MD, PhD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and Tokyo Women’s Medical University, Japan, and colleagues studied 38432 women aged 45 years or older who provided dietary information in 1992 to 1995. Over an average of 10 years of follow-up, 1188 of the women developed invasive breast cancer.

The study found that consumption of caffeine was not statistically significantly associated with overall risk of breast cancer. Among women with benign breast disease, a nonsignificant positive association with breast cancer risk was observed for those in the highest quintile (one-fifth) of caffeine consumption, and a significant association was observed for those in the highest category of coffee consumption (4 cups or more daily).

Consuming caffeine was also associated with a 68% increased risk of estrogen receptor–negative and progesterone receptor–negative breast cancer, or tumors to which the hormones estrogen and progesterone do not bind, and a 79% increased risk for breast tumors larger than 2 cm.

According to the authors, the study’s findings indicate that caffeine consumption may affect breast cancer progression, an effect that may be independent of the estrogen pathway.