Natural Standard Blog

Natural Standard Training Sessions

Natural Standard subscribers are invited to attend online training sessions to learn more about the resources available to them.

The summer training sessions are designed to help clients understand Natural Standard's mission, methodology and Evidence-based Validated Grading Rationale™. These guided tours will also demonstrate how to navigate the various databases and cross reference medical conditions and therapies.

The manufacturing/regulatory training sessions are specifically tailored for branded ingredient manufacturers, brand owners, pharmaceutical companies and law firms. Natural Standard provides custom research reports, white papers, clinical trial protocol design and grant writing services. Featured topics will include: GRAS certification, cGMP compliance initiatives, product compliance and submission, litigation, advertising claims, efficacy claims, health maintenance and structure function claims, functional ingredient claims, FDA/FTC warning letters and ingredient identification supporting health maintenance claims.

To sign up for a complimentary session, please click the links below.

Natural Standard Summer Training Sessions:

• Tue, Aug 17, 2010 2:00 PM - 2:40 PM EDT
• Thu, Aug 19, 2010 2:00 PM - 2:40 PM EDT
• Tue, Aug 24, 2010 2:00 PM - 2:40 PM EDT
• Thu, Aug 26, 2010 2:00 PM - 2:40 PM EDT
• Tue, Aug 31, 2010 2:00 PM - 2:40 PM EDT

Manufacturing/Regulatory Training Sessions:

• Thu, Aug 19, 2010 1:00 PM - 1:40 PM EDT
• Thu, Aug 26, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 2, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 9, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 16, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 23, 2010 1:00 PM - 1:40 PM EDT
• Thu, Sept 30, 2010 1:00 PM - 1:40 PM EDT
• Thu, Oct 7, 2010 1:00 PM - 1:40 PM EDT
• Thu, Oct 14, 2010 1:00 PM - 1:40 PM EDT
• Thu, Oct 21, 2010 1:00 PM - 1:40 PM EDT
• Thu, Oct 28, 2010 1:00 PM - 1:40 PM EDT

For more information, please e-mail questions@naturalstandard.com.

Natural Standard Contributes to NAPLEX® Review

Prepare for the North American Pharmacy Licensure Examination (NAPLEX®) with Mosby's Pharmacy Review for the NAPLEX.

The guide outlines important test topics, such as patient communication, clinical evaluations and preparing and dispensing medications safely and effectively.

The book also features evidence-based dietary supplement data from Natural Standard. The information will help individuals prepare for NAPLEX® questions about the documented uses, adverse effects and toxicities of these products.

Key features include:

• Focused and comprehensive outline format
• Content organized according to NAPLEX®
• New topics introduced by the NABP, such as dietary supplements
• Tips on how to prepare for the NAPLEX®
• 2,000+ review questions
• Patient-profile questions modeled after the NAPLEX®
• Two practice exams, each with 185 multiple-choice questions
• Appendices that summarize drug interactions
• Flashcards with generic and brand-name drugs

To order a copy of Mosby's Pharmacy Review for the NAPLEX, please visit http://portals.elsevier.com/portal/naturalstandard.

Erectile Dysfunction Supplement Recalled

Kanec USA Inc., is issuing a voluntary nationwide recall of Stud Capsules® for men (Lot #060607-01/060108-01 Exp 6-2013) because it contains an undeclared drug.

The recall was issued after the U.S. Food and Drug Administration (FDA) detected sildenafil, the active ingredient in the erectile dysfunction drug Viagra®. Stud Capsules® are not approved as drugs, and they do not list the active drug ingredient sildenafil on their labels.

The undeclared drug may interact with nitrates (found in some prescription drugs) and may cause dangerously low blood pressure.

Kanec advises consumers to return any unused Stud Capsules® to the retail locations from which they were purchased.

For more information about erectile dysfunction, please visit Natural Standard's Medical Conditions database.

Journal of Dietary Supplements: Call for Papers

Natural Standard, an international research collaboration that aggregates and synthesizes data on complementary and alternative therapies, invites researchers to submit articles to Journal of Dietary Supplements (JDS) - an international peer-reviewed forum for original research and review articles that focus on vitamins, minerals, herbs and other substances that make up the multibillion-dollar dietary supplement industry. The journal addresses important issues that meet a broad range of interests, not only in integrative healthcare, but also in academic, regulatory and industrial sectors.

The journal has an online submission system available at http://mc.manuscriptcentral.com/wjds. Full instructions for uploading submissions will appear online.

Natural Standard subscribers are eligible to receive a 60 percent discount on a one-year subscription to the journal. Subscribers will receive four issues for $100. Natural Standard also invites JDS authors to present their findings in webinars, which will be posted on the Natural Standard Web site (www.naturalstandard.com/webinars).

For more information, please e-mail jds@naturalstandard.com.

Catherine Ulbricht, PharmD: Chief Editor, Journal of Dietary Supplements, Co-Founder, Natural Standard Research Collaboration (ulbricht@naturalstandard.com).

Wendy Chao, PhD: Associate Editor, Journal of Dietary Supplements, Science Editor, Natural Standard Research Collaboration (wchao@naturalstandard.com).

Daniel Falatko: Managing Editor, Informa Medicine Journals (Daniel.Falatko@informausa.com).

David DeLuca: Electronic Production Manager, Informa Business Information (David.DeLuca@informausa.com).

The distinguished editorial board includes the following internationally known scientists:

• Brent A Bauer, MD, FACP: Director, Complementary and Integrative Medicine Program, Mayo Clinic, Rochester, MN.
• William Benda, MD: Assistant Clinical Professor, Department of Family and Community Medicine, University of California, San Francisco.
• Mark Blumenthal: Founder & Executive Director, American Botanical Council, Austin, TX.
• William Benda, MD: University of California, San Francisco, Board of Trustees, American Holistic Medical Association.
• Edzard Ernst, MD, PhD, FRCP, FRCP (Edin.): Professor of Complementary Medicine, Peninsula Medical School, Exeter, UK.
• Bradly Jacobs, MD, MPH: Founder and Director, Institute of Healthy Living, Sausalito, CA.
• Karta Purkh S. Khalsa, CD-N, RH: Botanical Medicine, Bastyr University, Eugene, OR.

2010 Publication Schedule

Cover month	Online Publication	Print Publication
Volume 7, Issue 1 (March)	1/29	2/26
Volume 7, Issue 2 (June)	5/1	5/28
Volume 7, Issue 3 (September)	8/1	8/27
Volume 7, Issue 4 (December)	11/3	11/26

Natural Standard Book Earns Rave Review

Patrick Morrison, an Honorary Professor of human genetics at the universities of Queens Belfast, Nottingham Trent and the University of Ulster, recently reviewed Natural Standard Herbal Pharmacotherapy: An Evidence-Based Approach in the Ulster Medical Society Journal, and called it “an excellent guide to herbal pharmacotherapies.”

The reference tool provides practical guidance on the use of herbal therapies for medical conditions. It is designed to be an essential part of herbal pharmacy core curricula for healthcare disciplines.

Chapters are organized by medical condition and present supportive evidence, including potential mechanisms of action and dosing, for selected herbal therapies. The chapters also include integrative therapy plans to help clinicians quickly assess patient needs and create cohesive treatment plans.

“This is an excellent book which fills the large gap in evidence that existed in this area,” Dr. Morrison states.

Several resources, including animations, Appendix C, Appendix D, Chapter 31, Grades A-F Tables and References, are available on the Evolve Web site. To order a copy of the book, please click here.

FDA: Ear Candles May Be Unsafe

The U.S. Food and Drug Administration (FDA) is warning patients and health professionals not to use ear candles because they may cause “serious injuries,” even when used as directed.

Ear candling, also called thermo-auricular therapy or coning, is a home remedy used for outer-ear hygiene and for general well-being. During an ear-candling session, a wax-impregnated fabric tube is inserted into the outer ear. It is then ignited and burns for about 10 minutes. (Since the tube is hollow, wax and burnt fabric may enter the outer ear.)

Some proponents claim that ear candles help treat earaches, sinus infections, tinnitus (ringing in the ears), sinus pain and pressure and vertigo. Some ear candlers propose that the process removes ear wax during the ear-candling session. Others allege that the procedure warms and softens ear wax, thus aiding its subsequent elimination. Another benefit cited is that smoke and heat directed into the outer ear may dry up moisture that might otherwise increase the risk of infection.

However, the FDA cautions that supportive evidence of effectiveness is lacking. Additionally, the agency has received reports of burns, perforated eardrums and blocked ear canals after use. According to the FDA, these products may be especially unsafe in children because they may be more likely to move during the procedure, and they have smaller ear canals.

For more information about ear candling, please visit Natural Standard’s Health & Wellness database.

Herbals and Heart Health

A new analysis suggests that herbal supplements, such as Ginkgo biloba and garlic, may cause dangerous interactions when combined with heart medications.

The authors searched PubMed and Medline databases for articles about herbs and heart disease that were published in 1966-2008.

They identified nearly 30 herbal products that could cause harmful effects and should not be taken with heart medications, including those that lower blood pressure, prevent blood clots, regulate cholesterol and stabilize heart rhythms.

Bleeding was among the most common interactions that were reported. The authors found that alfalfa, angelica (dong quai), bilberry, fenugreek, garlic, ginger, ginkgo and khella may increase the risk of bleeding when taken with anticoagulants like warfarin (Coumadin®). The researchers also identified herbs (such as capsicum, ginseng, licorice, St. John's wort and yohimbine) that may increase blood pressure.

Grapefruit juice may also cause dangerous interactions. The fruit inhibits an important enzyme that helps break down drugs. As a result, grapefruit may increase the amount of medication in the body to toxic levels. According to the researchers, grapefruit juice may increase the effects of cholesterol-lowering drugs (statins), blood pressure-lowering drugs (calcium-channel blockers) and cyclosporine (a drug that reduces the risk of transplant rejection).

"There is a clear need for better public and physician understanding of herbal products through health education, early detection and management of herbal toxicities, scientific scrutiny of their use, and research on their safety and effectiveness," the authors concluded in the Journal of the American College of Cardiology.

Like conventional drugs, herbs and supplements may cause side effects and interact with other therapies. Natural Standard offers various decision-support tools, including Interactions and Nutrient Depletions checkers to help patients and clinicians make more informed and safer therapeutic decisions. The collaboration rigorously reviews scientific data to provide objective information about the safety and effectiveness of therapies.

Natural Standard on CBC News

CBC News in Canada consulted Natural Standard for an investigative report on the controversial Herbal Magic® weight-loss program.

The program includes a healthy, calorie-restricted meal plan and dietary supplements. Clients also receive support from personal health coaches.

The report, Magic in a Bottle, questioned the effectiveness of program, particularly two supplements marketed as WM-2000™ and Chromagic™.

WM-2000™ is an herbal dietary supplement that consists of Siberian ginseng (Eleutherococcus senticosus), brindall berry (Garcinia cambogia), ginger root (Zingiber officinale), gymnema (Gymnema sylvestre), and kelp (Lessonia nigrescens).

According to manufacturer data, the herbs in WM-2000™ are combined to aid in weight loss and are intended to be used as a part of a complete weight-loss program.

Chromagic™ is a dietary supplement that contains chromium, vanadium, biotin and vitamin B6. According to manufacturer data, Chromagic™ is designed to assist in weight loss, proper insulin functioning and blood sugar regulation. It may also help decrease appetite and sugar cravings; increase muscle mass; regulate cholesterol and help break down carbohydrates, fats, and protein.

However, Natural Standard reviewed the scientific data and found that evidence of safety and effectiveness were lacking for both of these products. Although some of the individual ingredients have been studied, overall, supporting evidence is insufficient for these indications.

To watch the investigative report, please click here.

To learn more about the supplements discussed in the report, please visit Natural Standard's Health & Wellness database.

Wall Street Journal Interviews Natural Standard

The Wall Street Journal interviewed Dr. Catherine Ulbricht, co-founder of Natural Standard and senior attending pharmacist at Massachusetts General Hospital in Boston, to learn about the safety and effectiveness of detoxification foot pads.

These adhesive pads are applied to the soles of the feet in an effort to rid the body of toxins, such as lead, arsenic, cadmium, copper, nickel and zinc.

The news story, “Foot Pads: A Sticky Issue,” explains that manufacturer claims are not currently supported by credible scientific research. Dr. Ulbricht told the journal “’the bottom line is, there is not high-quality scientific evidence supporting its use.”

Some products have recently come under scrutiny. In 2009, the Federal Trade Commission (FTC) filed a lawsuit against Xacta 3000 Inc., for falsely marketing Kinoki® detox foot pads. The FTC alleges that the company used deceptive advertising by claiming that the product would not only remove toxins from the body, but it would also lower blood pressure, treat depression and even promote weight loss.

The article also notes that adverse reactions to foot pads are possible. According to Dr. Ulbricht, potential risks include skin irritation and allergic reactions to product ingredients.

To schedule an expert interview or book signing with Dr. Ulbricht, please e-mail questions@naturalstandard.com.

For more information about detoxification foot pads, please visit Natural Standard’s Health & Wellness database.

Meat Linked to Prostate Cancer

Eating large amounts of red and processed meats may be linked to an increased risk of prostate cancer, researchers report in the American Journal of Epidemiology.

The authors followed 175,343 men in the United States who were 50-71 years old from 1995 until 2003. They recorded the participants’ meat consumption, including the type of meat they ate and how they cooked it, and monitored their iron levels, nitrite/nitrate intake and the number of prostate cancer diagnoses.

By the end of the study, 10,313 developed prostate cancer, of which 419 died.

After adjusting for various factors known to increase the risk of prostate cancer, the authors found that men who ate the most red meat were 12 percent more likely to develop prostate cancer and 33 percent more likely to develop advanced prostate cancer than those who ate the least amount.

Processed meat was also linked to a higher risk of prostate cancer. However, the authors noted that red processed meats (like hot dogs and bacon) were linked to a greater cancer risk than white processed meats (like turkey sandwich meat).

Grilling was the only cooking method that was linked to an increased risk of prostate cancer. It has been suggested that cancer risk may be increased by compounds called heterocyclic amines (HCAs) and polycyclic aromatic hydrocarbons (PAHs), which are formed when meat (especially red meat) is cooked at high temperatures. When heated, the amino acids, sugars and creatinine are converted into HCAs and PAHs, which have been linked to various cancers, including stomach, colorectal, pancreatic and breast cancers, in humans.

Nitrate intake was also correlated with an increased risk of the disease. Nitrates are preservatives that are added to processed and cured meats such as cold cuts and bacon. The preservatives have been associated with cancer-causing chemicals called nitrosamines.

This study supports growing evidence that too much meat may be unhealthy. Earlier studies suggest that red or processed meat may increase the risk of colon cancer and death (particularly from cancer and heart disease) and may be linked to age-related macular degeneration. Red meat also contains high amounts of saturated fats, which have been shown to increase the risk of heart disease.

Some other dietary changes may help reduce the risk of prostate cancer. For instance, eating fewer dairy products that are high in fat (like ice cream, cheese and sour cream) may be beneficial. Also, cruciferous vegetables (such as broccoli, cabbage and cauliflower) have been reported to contain cancer-fighting phytochemicals that may decrease the chances of developing prostate cancer.

The American Urological Association (AUA) encourages men who are in good health to have annual PSA testing starting at age 50, or at age 40 if they are in high-risk groups, such as African American men or those with histories of the disease. For more information on prostate cancer screening and prevention, please visit Natural Standard's Medical Conditions database.

For more information about integrative therapies for prostate cancer, please visit Natural Standard's Comparative Effectiveness database.