Study shows SAMe useful in treatment of adults with major depressive disorders

(August 31) — A new study conducted by investigators at Harvard Medical School and Massachusetts General Hospital (MGH) suggests that S-Adenosyl Methionine (SAMe), an over-the-counter dietary supplement, can be an effective, relatively well-tolerated, adjunctive treatment for adults with major depressive disorders who do not respond to their treatment with antidepressant medication.

This first-of-its-kind study was published in the August 2010 American Journal of Psychiatry.

According to the National Institute of Mental Health, there are approximately 14.8 million people with major depressive disorders in the United States. The study, "S-Adenosyl Methionine (SAMe) Augmentation of Serotonin Reuptake Inhibitors for Antidepressant Nonresponders With Major Depressive Disorder: A Double-Blind, Randomized Clinical Trial," is the first randomized, placebo-controlled clinical trial conducted on SAMe in a population of patients with major depressive disorders.

A total of 73 adults were enrolled in this six week study and randomly assigned to the placebo control group or the SAMe treatment group. SAMe, in combination with standard depression treatment, was more effective than antidepressant treatment alone in improving measures of depression and remission rates of patients with significant clinical depression. SAMe-treated subjects had a greater response and remission rate to treatment than the placebo-treated group. SAMe was well-tolerated with no reported adverse reactions.

"With each study we continue to gain a better understanding of SAMe's role in treating depression. This new finding, albeit preliminary and in urgent need of replication, suggests significant, clinically meaningful differences in outcome among patients who had SAMe added to their antidepressant medication treatment compared to those taking a placebo with their medication," said George Papakostas, M.D., associate professor of psychiatry at Harvard Medical School, director of treatment-resistant depression studies in the Department of Psychiatry at MGH, lead author of the current study.

"These findings provide preliminary support for the efficacy, safety, and tolerability of SAMe as an additive therapy for patients with major depressive disorders who do not respond to antidepressant treatment alone. Continued research, however, is urgently needed to more definitively further our understanding of the role of SAMe in the treatment of adults diagnosed with depression. Adjunctive SAMe therapy is promising, but cannot yet be recommended for wide-spread clinical use," said Papakostas.

The National Institute of Mental Health funded the study. Pharmavite LLC, the manufacturer of Nature Made SAM-e Complete and the leading distributor of SAMe supplements in the United States, provided the SAMe supplements and placebo pills used in the study.

To date, at least 40 clinical trials have been conducted on SAMe directly and in combination with traditional antidepressant medications. Studies have evaluated SAMe's use in naturally restoring a healthy mood to the most recent research for treating major depressive disorders. This current study follows a pilot study published in 2004 in the Journal of Clinical Psychopharmacology, which concluded that antidepressants used in combination with SAMe were significantly more effective in relieving depression than medication alone.

In an accompanying editorial, J. Craig Nelson, M.D., professor of psychiatry at the University California, San Francisco, wrote, "The study of Papakostas, et al. is persuasive. It is the first adjunctive treatment trial of SAMe and the first placebo-controlled trial of oral SAMe since 1993. The era of development for new amine reuptake inhibitors appears to be coming to a close. Some novel approaches appear to be dead ends. SAMe offers a novel mechanism of treatment action and opens up a new area for future exploration. Of course this clinical trial requires replication. And there are numerous other questions about long-term safety and efficacy, comparisons with other adjunctive agents, and selection of appropriate patients. But demonstration of a new treatment for depression with a novel mechanism is exciting news."

Analysis of Acupuncture Studies
Suggests Benefit for Low Back Pain

(August 3) In a feature article published in the July 29 edition of the New England Journal of Medicine, researchers examine the current studies into acupuncture for low back pain and make treatment recommendations for a sample patient.

"Many studies in the past few years have found a benefit to acupuncture for low back pain, particularly when added to conventional therapy," says lead author Brian Berman, MD, director of the University of Maryland Center for Integrative Medicine and a professor of family and community medicine at the University of Maryland School of Medicine.

He adds, "Our review examined recent studies involving thousands of patients. However, questions still remain about the role of the placebo effect in acupuncture, particularly since many clinical trials showed that sham acupuncture could be as effective as real acupuncture."

The reviewers suggested more research into acupuncture for low back pain is needed, specifically looking at the environment in which acupuncture is performed to evaluate whether a psychological or emotional bias may be contributing to patients reporting improvement. They also recommend additional studies to evaluate sham acupuncture without needles penetrating the skin, to see if the benefits of acupuncture may be achieved without an invasive procedure.

Most acute back pain goes away in about six weeks. However, 25 percent of patients report recurring pain within a year, and 7 percent develop chronic low back pain.

For physicians contemplating whether to suggest acupuncture for their back pain patients, the article gives current recommendations from the American College of Physicians, the American Pain Society and the North American Spine Society for incorporating acupuncture into a treatment plan.

The authors report that it is essential for all patients with chronic or recurrent back pain to undergo a careful diagnostic evaluation before selecting a course of therapy. Certain conditions, such as cancer or infection, may preclude certain patients from receiving acupuncture treatment.

As part of the review, the researchers examined the case of a hypothetical 45-year-old man who had years of low back pain, but was not receiving adequate relief from his current treatments. He had concerns about losing his job as a construction worker and wondered whether acupuncture could help him.

Based on the patient's evaluation, which included MRI and a clinical examination, and the evidence for the potential benefits for acupuncture, the team would suggest a course of 10 to 12 acupuncture treatments over a period of eight weeks with a qualified practitioner.

"In a case such as this, we would first want to reassure the patient that the clinical exam and MRI showed no evidence of a serious underlying condition such as cancer or spinal infection. In addition to acupuncture, we would encourage this patient to stay active and consider a stretching and strengthening exercise program," explains Berman.

The idea to use acupuncture with standard treatments such as pain medicines and physical therapy is one of the keys to "integrative medicine," a growing field of medicine looking at combining conventional and complementary treatments where there is evidence about safety and effectiveness.

"Dr. Berman and his team at the University of Maryland Center for Integrative Medicine are international leaders in the field of integrative medicine; they are among the many innovative, world-class researchers at the University of Maryland School of Medicine. This article is just one example of the center's mission to provide scientifically valid information to help physicians and patients make informed decisions about complementary therapies," says E. Albert Reece, MD, PhD, MBA, vice president for medical affairs, University of Maryland, and dean, University of Maryland School of Medicine.

Other researchers on the New England Journal article include Helene Langevin, MD, Program in Integrative Health, University of Vermont College of Medicine, Burlington; Claudia Witt, MD, Institute for Social Medicine, Epidemiology and Health Economics, Charite University Medical Center, Berlin; and Ronald Dubner, DDS, PhD, University of Maryland School of Dentistry, Baltimore.

Back pain is one of the most common reasons people see a physician, with nearly three-quarters of people in Western countries experiencing back pain at some point in their lives. According to some estimates, patients with low back pain account for more than $90 billion in annual health care expenses in the United States.

The causes for back pain are complex and multifaceted, and about 85 percent of cases will be defined as "nonspecific," meaning a direct cause cannot be found. Back pain is also one of the most common reasons for acupuncture appointments.

Founded in 1991, the University of Maryland Center for Integrative Medicine was the first program within a U.S. academic medical center to investigate complementary and alternative medicine through research, patient care and education. It has been a National Institutes of Health Center of Excellence for Research of Complementary Medicine for the past 15 years.

The center's main research interests have included arthritis, pain and inflammatory conditions. Its researchers published results of a large clinical trial in the Annals of Internal Medicine in 2004 showing that acupuncture is a safe and effective adjunctive treatment for pain from osteoarthritis of the knee.

Vitamin E Associated With Lower Dementia Risk

(July 12) CHICAGO—Consuming more vitamin E through the diet appears to be associated with a lower risk of dementia and Alzheimer's disease, according to a report in the July issue of Archives of Neurology, one of the JAMA/Archives journals.

Oxidative stress—damage to the cells from oxygen exposure—is thought to play a role in the development of Alzheimer's disease, according to background information in the article. Experimental data suggest that antioxidants, nutrients that help repair this damage, may protect against the degeneration of nervous system cells. "Although clinical trials have shown no benefit of antioxidant supplements for Alzheimer's disease, the wider variety of antioxidants in food sources is not well studied relative to dementia risk; a few studies, with varying lengths of follow-up, have yielded inconsistent results," the authors write.

Elizabeth E. Devore, Sc.D., of Erasmus Medical Center, Rotterdam, the Netherlands, and colleagues assessed 5,395 participants 55 years and older who did not have dementia between 1990 and 1993. Participants underwent a home interview and two clinical examinations at the beginning of the study, and provided dietary information through a two-step process involving a meal-based checklist and a food questionnaire.

The researchers focused on four antioxidants: vitamin E, vitamin C, beta carotene and flavonoids. The major food sources of vitamin E were margarine, sunflower oil, butter, cooking fat, soybean oil and mayonnaise; vitamin C came mainly from oranges, kiwi, grapefruit juice, grapefruit, cauliflower, red bell peppers and red cabbage; beta carotene, from carrots, spinach, vegetable soup, endive and tomato; and flavonoids from tea, onions, apples and carrots.

Over an average of 9.6 years of follow-up, 465 participants developed dementia; 365 of those were diagnosed with Alzheimer's disease. After adjusting for other potentially related factors, the one-third of individuals who consumed the most vitamin E (a median or midpoint of 18.5 milligrams per day) were 25 percent less likely to develop dementia than the one-third of participants who consumed the least (a median of 9 milligrams per day). Dietary intake levels of vitamin C, beta carotene and flavonoids were not associated with dementia risk. Results were similar when only the participants diagnosed with Alzheimer's disease were assessed.

"The brain is a site of high metabolic activity, which makes it vulnerable to oxidative damage, and slow accumulation of such damage over a lifetime may contribute to the development of dementia," the authors write. "In particular, when beta-amyloid (a hallmark of pathologic Alzheimer's disease) accumulates in the brain, an inflammatory response is likely evoked that produces nitric oxide radicals and downstream neurodegenerative effects. Vitamin E is a powerful fat-soluble antioxidant that may help to inhibit the pathogenesis of dementia."

Future studies are needed to evaluate dietary intake of antioxidants and dietary risks, including different points at which consuming more antioxidants might reduce risk, the authors conclude. (Arch Neurol. 2010;67[7]:819-825.)

 

High blood levels of vitamin E reduces risk of Alzheimer's

(July 5) High levels of several vitamin E components in the blood are associated with a decreased risk for Alzheimer's disease (AD) in advanced age, suggesting that vitamin E may help prevent cognitive deterioration in elderly people. This is the conclusion reached in a Swedish study published in the July 2010 issue of the Journal of Alzheimers Disease.

"Vitamin E is a family of eight natural components, but most studies related to Alzheimers disease investigate only one of these components, tocopherol", says Dr. Francesca Mangialasche, who led the study. "We hypothesized that all the vitamin E family members could be important in protecting against AD. If confirmed, this result has implications for both individuals and society, as 70 percent of all dementia cases in the general population occur in people over 75 years of age, and the study suggests a protective effect of vitamin E against AD in individuals aged 80+."

The study was conducted at the Aging Research Center (ARC), Karolinska Institutet, Stockholm, Sweden, in collaboration with the Institute of Gerontology and Geriatrics, University of Perugia, Italy. The study included a sample of 232 participants from the Kungsholmen Project, a population-based longitudinal study on aging and dementia in Stockholm (Kungsholmen parish). All participants were aged 80+ years and were dementia-free at the beginning of the study (baseline). After 6-years of follow-up, 57 AD cases were identified.

The blood levels of all eight natural vitamin E components were measured at the beginning of the study. Subjects with higher blood levels (highest tertile) were compared with subjects who had lower blood levels (lowest tertile) to verify whether these two groups developed dementia at different rates. The study found that subjects with higher blood levels of all the vitamin E family forms had a reduced risk of developing AD, compared to subjects with lower levels. After adjusting for various confounders, the risk was reduced by 45-54%, depending on the vitamin E component.

Dr Mangialasche notes that the protective effect of vitamin E seems to be related to the combination of the different forms. Another recent study indicated that supplements containing high doses of the E vitamin form tocopherol may increase mortality, emphasizing that such dietary supplements, if not used in a balanced way, may be more harmful than previously thought.

"Elderly people as a group are large consumers of vitamin E supplements, which usually contain only tocopherol, and this often at high doses", says Dr Mangialasche. "Our findings need to be confirmed by other studies, but they open up for the possibility that the balanced presence of different vitamin E forms can have an important neuroprotective effect."

Source: Francesca Mangialasche, Miia Kivipelto, Patrizia Mecocci, Debora Rizzuto, Katie Palmer, Bengt Winblad, Laura Fratiglioni: "High plasma levels of vitamin E forms and reduced Alzheimers disease risk in advanced age", Journal of Alzheimer's Disease (JAD), 5 July 2010, DOI: 10.3233/JAD-2010-091450

 

Study Finds Shark Cartilage Extract Does Not Improve Lung Cancer Survival

(June 17) An extract derived from shark cartilage—AE‑941—did not improve overall survival in patients with non-small cell lung cancer, according to a study jointly funded by NCCAM and the National Cancer Institute. Shark cartilage has been reported to have antiangiogenic properties (preventing the growth of new blood vessels around tumors), and preliminary research in animals suggested that AE‑491 has antitumor activity. Findings from this study were published in the Journal of the National Cancer Institute.

Researchers throughout the United States and Canada, led by investigators from the University of Texas M.D. Anderson Cancer Center, enrolled 379 patients with inoperable, stage III non-small cell lung cancer. All patients received standard radiation and chemotherapy. Patients were randomly assigned to receive either AE‑941 or a placebo twice daily during and after radiation and chemotherapy, with approximately half of the participants assigned to each group. Compared with placebo, AE‑941 resulted in no significant differences in overall survival, progression-free survival, time to progression, or tumor response rates. Patients who received radiation, chemotherapy, and placebo had a median overall survival of 15.6 months, while those who received radiation, chemotherapy, and AE‑941 had a median survival of 14.4 months. AE‑941 was found to be well-tolerated.

The researchers concluded that this study, like several smaller clinical trials of shark cartilage preparations in cancer patients, does not support the use of products derived from shark cartilage during cancer treatment.

Reference Lu C, Lee JJ, Komacki R, et al. Chemoradiotherapy with or without AE‑941 in stage III non-small cell lung cancer: a randomized phase III trial. Journal of the National Cancer Institute. 2010;102(12):1–7.

 

Vitamin and Calcium Supplements May Reduce Breast Cancer Risk

• Risk of breast cancer was reduced by 30 to 40 percent.

• Calcium works by enhancing DNA repair capacity.

• Effect of vitamins is long term and independent of DNA repair capacity.

WASHINGTON, D.C. (April 18) — Vitamins and calcium supplements appear to reduce the risk of breast cancer, according to findings presented at the American Association for Cancer Research Annual Meeting.

“It is not an immediate effect. You don’t take a vitamin today and your breast cancer risk is reduced tomorrow,” said Jaime Matta, Ph.D., professor in the Ponce School of Medicine in Puerto Rico. “However, we did see a long-term effect in terms of breast cancer reduction.”

Matta said the findings suggest that the calcium supplements are acting to enhance DNA repair capacity, a complex biological process involving more than 200 proteins that, if disrupted, can lead to cancer. “This process involves at least five separate pathways and is critical for maintaining genomic stability,” said Matta. “When the DNA is not repaired, it leads to mutation that leads to cancer.”

The study included 268 women with breast cancer and 457 healthy controls. Women were more likely to have breast cancer if they were older, had a family history of breast cancer, had no history of breastfeeding and had lower DNA repair capacity.

Vitamin supplements appeared to reduce the risk of breast cancer by about 30 percent.

Calcium supplements reduced the risk of breast cancer by 40 percent. After controlling for the level of DNA repair capacity, calcium supplements were no longer as protective, but the link between vitamin supplements and breast cancer reduction remained.

“We’re not talking about mega doses of these vitamins and calcium supplements, so this is definitely one way to reduce risk,” said Matta.

 

Governor Signs Idaho Health Freedom Act

(March 17, 2010) – Hailing it as a reflection of public dismay with Washington, and a clear expression of state sovereignty, Gov. C.L. “Butch” Otter welcomed legislative sponsors to his office at the Capitol today for the signing of House Bill 391, the Idaho Health Freedom Act.

“Congress and the White House are working out their scheme for pushing through a healthcare ‘reform’ bill that has more pages than the U.S. Constitution has words. I guarantee you that not a single member of the House or Senate has a complete understanding of that legislation any more than they understood all the implications of the USA PATRIOT Act back in 2001,” Otter said. “What the Idaho Health Freedom Act says is that the citizens of our state won’t be subject to another federal mandate or turn over another part of their life to government control.”

The legislative cosponsors of House Bill 391 – Representatives Jim Clark of Hayden Lake, Raul Labrador of Eagle and Lynn Luker Boise, along with Senator Monty Pearce of New Plymouth – joined the Governor at the signing ceremony.

The Idaho Health Freedom Act also takes into account the work that Idaho already is doing on its own to promote greater accessibility and affordability to healthcare for all Idahoans. That involves working closely to create and nurture public-private partnerships to develop primary care medical homes throughout Idaho, expand medical residency programs, expand the safe and secure electronic exchange of health information, and improve the voluntary enrollment of Medicaid-eligible children.

Gov. Otter said it is a different approach to government than some people are used to, but one that respects the source of government authority and resources and understands the limited but crucial role that government should play in people’s lives.

“From addressing the ‘tax gap’ to managing our aquifers, from increasing the potential for charitable giving to reorganizing management of our State parks system, and from our insistence on maintaining a stable and predictable tax structure to our continuing efforts to find savings throughout State government, this has been a productive legislative session,” he said. “We have kept our priorities where they belong – on finding better, more efficient and effective ways to serve the individuals, families and communities with whose tax dollars we are entrusted.”