MIM Health - February 2008

Doctor's Corner

One of the most disturbing things I read about recently was how the reported effectiveness of every antidepressant medication was inflated by up to 70% by pharmaceutical companies. The greed of these companies has no doubt caused additional suffering by people who were prescribed medications that were never shown to be much better than placebo. Dr. Steve Pieczenik, MD, PhD and I wrote a Op-Ed article on this topic that was published in the Bozeman Daily Chronicle. I have reproduced our article for you as this month's Health Topic: The Depressing News About Antidepressants. If you know anyone who is on antidepressant medications but continues to suffer from depression, forward them this newsletter and encourage them to discuss this with their physician.

And if you're ever interested in reading back issues of the newsletter, they're posted on the clinic website, at www.montanaim.com/newsletter.

Wishing you good health,

Dr. Neustadt

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Upcoming Appearances

Dr. Neustadt will be co-hosting the Gesundheit! with Jacobus radio show on Sunday March 2 from 7:00-10:00 AM on KMMS 1450 AM. The topic will be hearing health. So tune in and turn your hearing aids up!

With Jacobus on vacation, Dr. Neustadt will be guest hosting the Gesundheit! with Jacobus radio shows for two consecutive weeks, Sundays, March 9 and 16 from 7:00-10:00 AM on KMMS 1450AM. Jacobus will be on vacation and asked Dr. Neustadt to guest host for him. On March 9 Dr. Neustadt will be interviewing Laryn Callaway, ND, CEO of Organic Bistro, the first line of fully organic frozen entrees. The topic: Eating Healthy in the Modern World. We will also be discussing the role nutrition plays in health and disease, with specific tips on reversing some diseases with optimal nutrition.

On March 16 Drs. Neustadt and Pieczenik will host an open-line Sunday, discussing health topics that have made news in the past month and taking listener calls.

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Health Topic: The Depressing News about Anti-Depressants

(Note: This article, written by Drs. Neustadt and Pieczenik, appeared as an Op-Ed article in the Bozeman Daily Chronicle newspaper on Saturday, February 9.)

Antidepressants are the most commonly prescribed drugs in the United States. They're prescribed more than drugs to treat high blood pressure, high cholesterol, asthma, or headaches. More than 118 million prescriptions are written each year for these drugs; however, new research shows that the drug companies overstated the effectiveness of these medications by as much as 70%.

A January 17, 2008 report from the New England Journal of Medicine (NEJM) titled, "Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy" (vol. 358, pp. 252-260) revealed that the effectiveness of a dozen popular antidepressant medications has been seriously exaggerated by selective publication of favorable results. Consequently, doctors and patients are getting a distorted view of the usefulness of antidepressants like Effexor, Zoloft, Welbutrin, Paxil and Prozac.

The researchers reviewed 74 studies registered with the FDA between 1987 and 2004. These clinical trials involved 12 antidepressants and 12,564 patients. All but one of the 38 studies reporting positive results was published. The other 36 studies reported negative or questionable results, and 22 of those studies were never published. Of the 14 that were published, the researchers said that at least 11 of these studies mischaracterized the results and presented a negative study as "positive." The bottom line according the researchers was that "the studies the FDA judged as positive were approximately 12 times as likely to be published in a way that agreed with the FDA analysis as were studies with nonpositive results."

For example, researchers discovered that five trials on the effectiveness of Zoloft were submitted to the FDA. The drug appeared to work better than the placebo in two of them; however, in three other trials, the placebo did just as well at reducing the symptoms of depression. But only the two favorable studies were published, and Pfizer, who manufactures Zoloft, discusses only the positive results in Zoloft's literature for doctors.

What Pfizer, the FDA and other major drug companies (Wyeth, Schering-Plough, GlaxoSmithKline, Eli Lilly and Forest) have done is to ignore the negative findings of studies when the results go against the corporate interests. Their selectiveness results in drugs being approved that have only questionable effectiveness, and minimizes the serious consequences of their side effects.

According to the researchers, these biases inflated the reported effectiveness of all 12 of the antidepressant medications studied that were approved between 1987 and 2004. These medications are Zoloft, Serzone, Remeron, Welbutrin SR, Paxil, Cymbalta, Effexor, Effexor XR, Celexa, Lexapro, Prozac and Paxil CR.

This skews the medical profession's understanding of how effective a drug is for a particular condition. It is especially significant in the evolving movement called "evidence based medicine," which depends heavily on the analyses of published studies to make treatment decisions. And it places physicians in an exceedingly awkward position, since we strive to make the best choices for our patients based on published research.

After analyzing all of the data, the researchers of the NEJM study determined that antidepressant medications really only work 40-50% of the time. The data was so blatantly biased the effectiveness of these medications was artificially inflated by nearly 70% in the case of Serzone and by 64% in the case of Zoloft.

This blatant distortion of data to meet the bottom-line goals of pharmaceutical companies is similar to the tobacco industry, which sat on research that showed nicotine was addictive. Several pharmaceutical companies have already been sued over this matter by the New York State Attorney General. Just like the tobacco companies did, the pharmaceutical companies continue to deny any wrongdoing.  

What should patients do? If your symptoms of depression don't seem to improve it may not be you that's the problem, it may be the drug. Other medications may be helpful for you, as may alternative therapies such as nutritional medicine, exercise and certain botanicals. However, it's important to not discontinue or change any medications, or take any dietary supplements without first discussing them with your doctor.

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Natural Tip: Ginkgo Gingko (Gingko biloba) comes from the maidenhair tree, which grows extensively in the mountain forests of Eastern China. It is the oldest living species of tree in the world, and dates back more than 200 million years in the fossil record. Charles Darwin once called the ginkgo tree a "living fossil," and the tree has a lifespan estimated at 2,000 to 4,000 years. The medicinal use of ginkgo in Chinese medicine dates back to 1505, and since that time, whole ginkgo leaf and its extracts have been used and studied for the treatment of many conditions. Ginkgo (Ginkgo biloba), the oldest living tree species in the world. Gingko is best known for its ability to increase blood flow to the brain and improve impaired memory and mental performance, especially in the elderly. However, gingko has been extensively researched for many other conditions, including diabetic retinopathy (damage to the eye in diabetics), intermittent claudication, macular degeneration, and more. What all these conditions have in common is a decrease in blood flow to the tissues, which ginkgo may be helpful in restoring. Diabetic retinopathy Diabetics are at an increased risk for vascular diseases, including diabetic retinopathy. This eye disease is caused by injury to blood vessels that deliver nutrients to cells in the eye. It is characterized by hemorrhages in the retina, the innermost layer of tissue inside the eye. Almost all people with type 1 diabetes for 20 years and nearly 80% of those with type 2 diabetes have signs of retinopathy.    In a pilot study 25 type 2 diabetics with retinopathy were administered 240 mg ginkgo leaf special extract Egb 761 (Dr. Willmar Schwabe GmbH & Co, Karlsruhe, Germany). After 3 months of taking Egb761, there was a significant improvement in red blood cell deformability (ability of red blood cells to change shape and deliver oxygen to tissues) and a significant decrease in blood viscosity (the "thickness" of blood, which is a risk factor for blood clots), and a significant decrease in the amount of free radical damage to cells. Tinnitus Tinnitus is characterized by a humming or ringing in the ears in the absence of any external stimulus. A review of the research conducted by the American Association of Family Physicians (AAFP) determined that ginkgo is "moderately" effective in the treatment of tinnitus. One study of 103 volunteers showed that 50% of these people had improvement or disappearance of their symptoms in 70 days versus 119 days for those receiving placebo. Cognition Cognition is the ability to process and use information. Ginkgo has been studied in multiple clinical trials for cognition, and has been approved by the German Commission E for the treatment of cognitive decline due to vascular insufficiency (decreased blood flow). Some clinical trials have supported the use of ginkgo for cognitive decline, while others have not; however, those that used the standardized extract EGB 761 in volunteers diagnosed with vascular insufficiency, have consistently shown improvement in cognitive function. One study showed short-term improvements in mental functioning in healthy young adults. In one study, 18 women and 2 men (mean age approximately 20 years), received placebo (0 mg), 120 mg, 240 mg, or 360  mg ginkgo extract GK 501 (Pharmaton SA, Lugano, Switzerland) standardized to contain 24% ginkgo flavone glycosides and 6% terpene lactones for five days. Significant improvements in attention to tasks were detected for the people taking 240 mg or 360 mg ginkgo. Improvements were not noted in participants taking placebo or the lower, 120 mg, dose of ginkgo. However, other studies did not find any benefit of ginkgo for age-related cognitive decline. Dosage Taking ginkgo for 12 weeks initially is recommended to determine if it is effective; however, results may be seen in as little as four weeks For memory problems and dementia: 120 to 240 mg daily, taken in two to three doses. For tinnitus and peripheral vascular disease 160 mg per day, taken in two or three doses. Herb-Drug Interactions A published review of human clinical trials by Dr. Neustadt showed that ginkgo decreased serum concentrations of alprazolam; however, warfarin, midazolam, and caffeine concentrations were not reduced. Consumers should be cautious about interpreting this data, as standardized extracts and other preparations may exert different effects. If you are taking any medications, consult a healthcare professional knowledgable in herb-drug interactions. References Gaby A. Ginkgo Biloba Extract: A Review. Alt Med Rev. 1996;1(4):236-242. Elsabagh S, Hartley DE, Ali O, Williamson EM, File SE. Differential cognitive effects of Ginkgo biloba after acute and chronic treatment in healthy young volunteers. Psychopharmacology. 2005;179(2):437-446. Frank RN. Diabetic Retinopathy. N Engl J Med. 2004;350(1):48-58. Kanowski S, Herrmann WM, Stephan K, Wierich W, Horr R. Proof of efficacy of the ginkgo biloba special extract EGb 761 in outpatients suffering from mild to moderate primary degenerative dementia of the Alzheimer type or multi-infarct dementia. Pharmacopsychiatry. Mar 1996;29(2):47-56. Kanowski S, Hoerr R. Ginkgo biloba extract EGb 761 in dementia: intent-to-treat analyses of a 24-week, multi-center, double-blind, placebo-controlled, randomized trial. Pharmacopsychiatry. Nov 2003;36(6):297-303. Kennedy DO, Scholey AB, Wesnes KA. The dose-dependent cognitive effects of acute administration of Ginkgo biloba to healthy young volunteers. Psychopharmacology. 2000;151(4):416-423. Neustadt J. Herb-Drug Interactions: What Clinicians Need to Know. Integrative Medicine. 2006;5(1):16-26. Pang Z, Pan F, He S. Ginkgo biloba L.: history, current status, and future prospects. J Altern Complement Med. Fall 1996;2(3):359-363. Sierpina V, Wollschlaeger B, Blumenthal M. Ginkgo biloba. American Family Physician. 2003;68(5):923-926. van Dongen MC, van Rossum E, Kessels AG, Sielhorst HJ, Knipschild PG. The efficacy of ginkgo for elderly people with dementia and age-associated memory impairment: new results of a randomized clinical trial. J Am Geriatr Soc. Oct 2000;48(10):1183-1194. * * *

Recipe: Spicy Bean Salad
(Have a recipe you want to share? Email it to us and it may appear in a future issue of MIM Health.)

This recipe is from Susan Navarrete, who posted it to www.allrecipes.com, an excellent source for healthy and tasty dishes. We're always on the lookout for good bean recipes, since they should be an important part of everyone's diet. Beans pack more protein than any other plant food, plus lots of fiber, B vitamins, zinc, complex carbohydrates, potassium, magnesium, calcium and iron--with no cholesterol and very little fat.

Ingredients

1 (15 ounce) can black-eyed peas

1 (15 ounce) can black beans, rinsed and drained

1 (15 ounce) can whole kernel corn, drained

1/2 cup chopped onion

1/2 cup chopped green bell pepper

1 (4 ounce) can diced jalapeno peppers

1 (14.5 ounce) can diced tomatoes, drained

1 cup Italian-style salad dressing

1/2 teaspoon garlic salt

Directions

1. In a medium bowl, combine black-eyed peas, black beans, corn, onion, green bell pepper, jalapeno peppers and tomatoes.
2. Season with Italian-style salad dressing and garlic salt; mix well.
3. Cover and refrigerate overnight to blend flavors.

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Montana Integrative Medicine
1087 Stoneridge Drive, Suite 1, Bozeman, MT 59718, tel. 406-582-0034