Search

Puritan’s Pride, which is one of the world’s leading mail-order marketers of dietary supplements, would like you to believe that its “Vitamin Advisor” provides a “personalized supplement plan” with “expert recommendations chosen just for you.” The “experts” are not identified, but the program is licensed from Healthnotes, a company that markets “decision tools” that promote product sales. Healthnotes was founded more than 15 years ago by chiropractor named Skye Lininger. It states that its online Vitamin Advisor “has proven itself to be a sales machine” with “add-to-cart rates 2x over the industry average.” [1] The “personalized” recommendations are generated by an interactive questionnaire. On the Puritan’s Pride Web site, everyone is asked:

• Your age group: 13-18, 19-49, 50-plus?
• Male or female?
• What are your health concerns? Heart health, blood sugar, eyes, joints, urinary tract, blood pressure?
• Do you have any digestive health concerns?
• Any personal or family history of hip fracture or low bone density?
• Are you regularly exposed to air pollution?
• Do you get at least 15 minutes of direct sunlight 3 times a week?
• Are you often exposed to cigarette smoke?
• Do you feel that stress may be affecting your health?
• Do you often feel tired?
• How would you describe your overall emotional well-being and mood? (poor, good, excellent)
• Are you a vegetarian?
• Each week, do you eat at least some cold-water fish?
• How many daily servings of dairy or calcium-fortified foods do you eat? (0, 1-2 , 3 or more)

Women are also asked:

• Have you entered or completed menopause?
• Any menopause or perimenopausal-related hot flashes, night sweats, or changes in mood?
• Pregnant or trying to become pregnant?
• Do you experience PMS?

Men are also asked:

• Do you urinate frequently or wake up to urinate during the night?

Something for Everyone

During the past two weeks, we took the test repeatedly and discovered that no matter how you answer the questions, you will be advised to buy at least one product. EVERYONE is advised to buy a multivitamin. Teenagers are advised to take Mega Vita Min Multivitamins for Teenagers, and everyone 19-49 and 50+ is advised to take a multivitamin that supposedly is formulated for their age and gender. All of these products include some ingredients that are unnecessary and others that exceed standard recommended amounts. Most people should not take multivitamins [2,3].

The algorithm for the other recommendations is easy to figure out.

• Selecting “tired” gets you a vitamin B12 supplement. This recommendation is senseless. Although fatigue could be a symptom of B12 deficiency, only a tiny percentage of people who are tired have this condition and people who have it do not need a product. They need a diagnosis, which no questionnaire can give them.
• Selecting “eye concerns” yields a product containing lutein and zeaxanthin. These substances, combined with zinc and omega-s fatty acids, have been shown to slow the progression of moderate to severe macular degeneration, but no supplements have been shown to prevent the disease, improve the outcomes of people with early disease, or benefit any other eye condition. However, they have not proven useful in preventing or treating any other eye condition.
• Concern about “joints” yields a “triple strength” product that contains glucosamine, chondroitin, and MSM. The product is described as “perfect for anyone looking for extra nutritional support for their cartilage and joints.” However, these substances have not been proven useful for treating any joint problem.
• Air pollution gets you vitamin C, selenium, and vitamin E, none of which has been proven useful for countering the effects of air pollution.
• Cigarette smoke exposure gets you vitamin C with bioflavonoids and rose hips, none of which can protect against the ravages of tobacco use.
• Concern about the urinary tract gets you cranberry fruit concentrate with vitamins C and E. The evidence that cranberry juice or pills can reduce the frequency of recurrent urinary tract infections is questionable [4].
• Stress, tiredness, and poor emotional well-being gets you vitamin B complex, vitamin C/bioflavonoids/rose hips, vitamin B12, fish oil, and vitamin D, none of which would be appropriate treatment for emotional stress, fatigue, or depression.
• Digestive concerns get a recommendation for a probiotic. Probiotics may have a useful role in a few situations, but any such problem should be addressed with a medical diagnosis. Giving the same recommendation for all types of digestive problems is irresponsible.
• Blood sugar concerns trigger a recommendation for cinnamon/chromium and magnesium, which have no practical use for blood sugar control.
• Little or no sun exposure gets a recommendation for vitamin D 2000 IU. Although vitamin D supplementation is advisable for some people, this amount is more than most people should take.
• For vegetarians, B12, fish oil, calcium, and vitamin D are recommended. B12 supplements are important for vegetarians who eat no animal products, but the use of any other supplements should be based on a detailed analysis of the person’s diet.
• Concerns about heart health yields recommendations for fish oil, coenzyme Q10, and magnesium. A fish oil supplement may be useful for people who eat little or no fish, but the others have no proven value.
• Concerns about blood pressure yields recommendations for coenzyme Q10 and fish oil, neither of which is useful for blood pressure control.
• Concerns about bone density triggers a recommendation for calcium, magnesium, and a vitamin D pill with 2000 IU. Any such recommendations should be part of a medically supervised program.
• Women trying to get pregnant are advised to take Puritan Pride’s Pre-Natal Complex, which contains folic acid and 28 other ingredients. A folic acid supplement should be taken before and during pregnancy, but there is no good evidence that well-nourished women will benefit from the other ingredients in this product [5].
• The recommendations for PMS include a B-complex product, magnesium, and vitamin D. The evidence for using these is questionable.
• For menopausal symptoms, take a B-complex product, magnesium, and Estrobalance, which includes vitamin E, folic acid, calcium, and phytonutrients found in soy and black cohosh. The evidence for using these is questionable.
• Men who wake up to urinate during the night are advised to take a saw palmetto product. However, well-designed studies have found that saw palmetto does not improve urinary flow or prostate size in men with benign prostatic enlargement [6].

In short, nearly all of the recommended products are a complete waste of money. In a few instances, one or two ingredients might be useful but the product provides too much of them or contains other substances that are not.

Some ingredients are found in more than one product. For this reason, when several products are recommended, the total amount of these ingredients may be way too high. When Dr. Hall answered all questions honestly, she was advised to take six products. The recommendations were not based on any credible scientific evidence. But even worse, their combination would provide a daily total of 8000 IU vitamin D and 2044 mg of calcium in addition to the amount from food. The tolerable upper intake levels of these nutrients are 4000 IU of vitamin D and 2000 mg of calcium. For women over 60, the recommended dietary allowance (from food plus supplements) is 800 IU of vitamin D and 1200 mg of calcium. The usefulness of calcium and vitamin D supplementation remains uncertain, and calcium supplementation has been associated with increased cardiovascular risks. When Dr. Barrett answered the questions honestly, he was also advised to take six product, none of which he needed. His products included a total of 4000 IU of vitamin D. They also included 2000 mg of fish oil (an excessive amount) even though he indicated that he eats cold-water fish at least once a week.

Disclaimers

Both Puritan’s Pride and Healthnotes provide disclaimers. The footer of every page on the Puritan’s Pride Web has three of them:

Puritan’s Pride provides these articles for information only. They are not approved or recommended by us, do not provide medical advice, diagnosis, or treatment, and are not meant to replace professional medical advice or apply to any product.

These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

The information provided on this site is intended for your general knowledge only and is not a substitute for professional medical advice or treatment for specific medical conditions. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition. The information on this website is not intended to diagnose, treat, cure or prevent any disease. Never disregard medical advice or delay in seeking it because of something you have read on the Puritan’s Pride site. . . .

Healthnotes says:

The information presented in the Vitamin Advisor is for informational purposes only and should not be considered medical advice. Nutritional recommendations are based on established guidelines for people of average health and on associations between vitamins, minerals, and herbs with health conditions from published scientific studies (human, animal, or in vitro), clinical experience, or traditional usage. These associations may not be true for all individuals and are not based on specific product brands or formulations. Nutritional and herbal products may vary widely in ingredient purity, concentration, and combinations, which may affect people differently. Consult your doctor, pharmacist, or other professional for any health problem and before adding supplements to your self-care practices or discontinuing any prescribed medications. It is important not to make any changes in your self-care, including taking supplements, before or after a surgery without your doctor’s express recommendation. . . . The Vitamin Guide recommendations are in no way intended as a substitute for medical counseling and neither the publisher nor the authors have liability or responsibility to any person or entity receiving or using this information.

A more truthful disclaimer would read like this:

We’d like to sell you products, so here is a questionnaire that will recommend something no matter how you answer it. Our information is not necessarily derived from sources that are trustworthy or even relevant to humans. When ingredients are included in more than one product, the combined amounts can exceed safe levels, but our recommendations won’t take this into account. We would like you to believe that our products are useful. However, our words are not intended to suggest that they can help treat, cure, or prevent any disease. They are merely “informational.” We say that you should not consume any product we recommend without discussing it with your doctor. However, we really don’t mean this, because most doctors will advise you not to take the products. We just say it as part of our effort to avoid legal responsibility for any harm caused by our advice or products.

The Bottom Line

For all of the above reasons and more, we do not believe that Puritan Pride’s questionnaire provides trustworthy advice. Its questions and answers related to dietary adequacy are simplistic. Its disease-related questions lead to products that are useless, poorly formulated, or both. In proper professional hands, a well-designed questionnaire that includes a detailed dietary history can identify areas of overall diet that could use improvement. However, no questionnaire can be customized to make appropriate supplement recommendations, either for dietary improvement or for treatment. If someone’s diet is inadequate, the best way to fix it is to eat more sensibly. If a diet is missing any nutrients, it may also lack components (such as fiber) that will not be supplied by pills. If you think your diet may be deficient, analyze it with the tools provided on the U.S. Department of Agriculture’s Choose MyPlate Web site or seek professional advice from a registered dietitian (R.D.) or physician.

References

1. How Vitamin Advisor works. Healthnotes Web site, accessed Feb 3, 2016.
2. Hall HA. Should I take a multivitamin? Science-Based Medicine Blog, July 15, 2008.
3. Barrett S. Dietary supplements: Appropriate use. Quackwatch, Nov 12, 2010.
4. Crislip M. Cranberry juice. Science-Based Medicine Blog, Jan 14, 2011.
5. Hall H. Prenatal multivitamins and iron: Not evidence-based. Science-Based Medicine Blog, Feb 2, 2016.
6. Taklind J and others. Serenoa repens for benign prostatic hyperplasia. Cochrane Database for Systematic Reviews, Dec 12, 2012.

This article was revised on February 9, 2016.

Power Balance products will supposedly improve your athletic performance and cure what ails you. The alleged mechanism (“frequencies” in an embedded hologram) is laughable pseudoscientific bunk.

Remember when professional golfers were wearing Q-ray bracelets to improve their game? The Q-ray folks recently had a run-in with the courts. They admitted their product was only a placebo but argued that it was acceptable to lie to elicit the placebo response. The Federal Trade Commission disagreed and obtained a court order fining the company and banning further deceptive advertising [1]. Now they have a competitor: Power Balance Performance Technology. Like the Q-ray bracelet, it is based on “resonance.” It doesn’t even have to come in contact with your body: one version is a card that you simply put in your pocket.

Imaginative Claims

Power Balance representatives demonstrate their products in sports stores at malls. They purport to test your strength and balance and then give you a Power Balance card to hold or put in your pocket. When they retest you, you miraculously do better. There are some revealing videos on YouTube, including a short clip that shows the subject standing on one foot with arms outstretched. The salesman pushes down on the subject’s arm near the wrist, and the subject starts to fall over. After the subject puts a Power Balance card in his pocket, the salesman repeats the test but this time pushes down near the elbow, creating a shorter lever arm that of course reduces the effect of the force applied, so the subject doesn’t fall over. In other demonstrations, they use other simple biomechanical tricks like this to create false impressions of improved strength. The amount of force applied is subjective, both parties know when the card is in use, and they know what is expected to happen—it’s a recipe for self-deception.

What’s in these magic cards? I will quote at length from their Web site for the entertainment value:

POWER BALANCE Performance Technology has been embedded with naturally occurring frequencies found in nature that have been known to react positively with the body’s energy field. This helps to promote balance, flexibility, strength and overall wellness.

For thousands of years, eastern medicine has been using the same techniques for personal wellness through finding things in nature that react positively with your body, such as rocks, minerals, crystals, etc. Through kinesiology we have learned that certain foods cause the body to react either positively or negatively as well. Although not all substances found in nature work the same on everyone, we have narrowed it down to a few that we believe are highly beneficial and have put them together to create Power Balance Performance Technology.

It’s hard to argue with nature and the fact is that everything in nature resonates at a particular frequency. That is what keeps it all together. We react with frequency because we are a frequency. Most simply, we are a bunch of cells held together by frequency. If you hold processed sugar or a cell phone in your hand and hold your arm straight out to your side and have someone push your arm down while you resist, it goes down pretty easily because processed sugar and cellular telephones do not react positively with the human body. Basically, the frequencies in sugar and cell phones create a reaction that makes your body weaker. Adversely, if you put certain vitamins or minerals in your hand and do the same test with your arm, you will find it is much harder for that person to push your arm down. Your body’s energy field likes things that are good for it and craves to be around those things. At Power Balance, we have taken a few of those items and through advances in technology, have been able to duplicate those positive energies and imprint them onto our holographic media.

Why Holograms? We use holograms because they are composed of Mylar—a polyester film used for imprinting music, movies, pictures, and other data. Thus, it was a natural fit. In fact, the hologram is so complex with such infinite depth and minimal surface area, that many companies are now using them as hard drives. Along those same lines, we felt that it would be a lot easier to get someone to put a hologram in there [sic] shoe rather then [sic] a Power Balance equipped rock or apple.

Power Balance products include a ten-pack of stick-on embedded holograms ($59.95), a pendant ($39.95), a wristband ($29.95), and an eight-pack of pocket cards ($59.95).

The company targets athletes, 36 of whom appear with testimonials on its Web site. According to numerous testimonials, Power Balance seems to improve performance. One surfer claims he can even sense the presence of the card: “I can feel it on me.” Another testimonial is from Tommy Grunt, United States Marine Corps. Maybe Grunt is real, but ads for quack products have been known to feature fabricated testimonials, and I can easily imagine a copywriter putting tongue in cheek and creating a name like that to relieve the boredom. There are reports of the products’ effectiveness in animals, from horses to birds. The products allegedly relieve headaches, menstrual pain, and all kinds of other symptoms. The testimonials give the impression that if you feel unwell in any way, the magic card will restore you to normal. If you already feel well, it will make you better than normal.

“A primitive form of this technology was discovered when someone, somewhere along the line, picked up a rock and felt something that reacted positively with his body.” I don’t doubt that someone believed he felt something, but I seriously doubt it was due to the frequency of the rock resonating with the frequency of his body. For resonance to occur, something has to vibrate. You may be able to make a rock resonate, but the rock doesn’t create its own vibrations. Crystalline structures can be made to vibrate. The tympanic membrane and the vocal cords vibrate, but the whole body doesn’t. When a soprano wants to break a glass with her voice, she can first listen to the sound made by tapping it with a spoon; if she can match that sound frequency, the glass will resonate and possibly shatter. How can you tap a cat to see what its frequency is? Can you imagine a soprano shattering a cat?

This whole resonance and vibration business is pseudoscience emanating from the myth of the human energy field—not the kind of energy physicists measure but some vague life energy like the acupuncturists’ qi, the chiropractors’ Innate, and the imaginary fields that Therapeutic Touch practitioners claim they are smoothing down with their hands. “We are a frequency” and “We are a bunch of cells held together by frequency” and “Your body’s energy field likes things that are good for it” are statements so incoherent, so much at odds with scientific knowledge, that they “aren’t even wrong.”

The definition of frequency is “the number of repetitions of a periodic process in a unit of time.” A frequency can’t exist in isolation. There has to be a periodic process, like a sound wave, a radio wave, a clock pendulum, or a train passing by at the rate of x boxcars per minute. The phrase “33 1/3 per minute” is meaningless: you can’t have an rpm without an r. A periodic process can have a frequency, but an armadillo and a tomato can’t. Neither a periodic process nor a person can “be” a frequency.

Omitting for a moment the crucial question “Frequencies of what?” how did the Power Balance creators determine which frequencies to use? “We have narrowed it down to a few that we believe are highly beneficial.” Okay . . . exactly how did they measure the frequencies, and what criteria did they use to narrow them down? I think the wording of the ad is revealing: the company says they “believe” they are highly beneficial, not that they have any evidence that they are. Another crucial question is—assuming there really are frequencies—how can they be put into a hologram? I e-mailed the company and asked simple questions like “How do you measure the frequency of a rock?” They didn’t answer.

Test Results

Pushing down on the arm is a bogus muscle-testing technique known as applied kinesiology. It is supposedly used to diagnose allergies: if you hold a sealed vial of an allergen, your strength supposedly diminishes. It only works if the practitioner and patient know what substance is being tested; when double-blind controls have been used, kinesiology has failed every test [2].

In online discussions, one man “tested” the product by having one hundred athletes try it, with no controls of any kind. Not surprisingly, all of the athletes reported improvement. A man watching a demonstration suggested a real test, blinding the subject as to whether the card was present, but (not surprisingly) the salesman wouldn’t cooperate.

This would be so simple to test properly. Take five Power Balance cards and five credit cards, put them in opaque envelopes, shuffle, number the envelopes 1 through 10, have a third party slip an envelope in the subject’s pocket, and then challenge the salesman to tell which envelopes have the real card. I could not find evidence that they have ever done such a test, presumably because they know it would fail. A more elaborate test could hook subjects up to a machine that tests muscle strength and have them exercise repeatedly without knowing whether or not they were in contact with the magic hologram.

Tests of the first type were actually carried out on an Australian television show called Today Tonight. During the program, Tom O’Dowd, who sells the bracelets in Australia, carried out his usual balance and strength routine with six volunteers. First he used a card supposedly embedded with the hologram, then used a bracelet. All six volunteers reported a positive reaction, but all the volunteers were aware when they came into contact with the hologram and the bracelet. Richard Saunders from the Australian Sceptics Society, who observed the demonstration, thought that the “increased arm strength” occurred because the force O’Dowd varied the angles from which he applied the force. Then the tests were repeated using six cards, without either O’Dowd or the volunteers being able to tell which card was in their pocket. Six cards were randomly placed in the pockets of the six volunteers. Only one had the card with the hologram. O’Dowd was unable to tell who it was. The same experiment was repeated using the bracelet. O’Dowd again failed. He also failed a second time when Saunders had a hologram hidden in his pocket [3]. The program’s moderator went out of his way to be kind, but the tests results are clear:

Marketing Strategies

The marketing is pure genius. If I were a professional scam artist, I don’t think I could come up with anything better. The company has an impressive trick demonstration that easily fools most people. They spout a lot of pseudoscientific hooey that sounds impressive to the scientifically illiterate, but they are careful to make only vague claims that the Federal Trade Commission can’t object to. The harmless products are inexpensive to manufacture, but the company charges enough to afford a money-back guarantee and still make money. They package the cheaper cards and stickers in multiples so they can charge more, but the prices are still low enough that the average person is willing to take a chance. Who knows what is actually in the products? If it were my scam, I’d put in any old hologram or none at all. No one is likely to investigate your production line to see how you get all those “beneficial frequencies” into the Mylar.

In August 2010, Power Balance added another clever dimension to its marketing—a “partnership” with the Ovarian Cancer Research Fund to raise money for ovarian cancer research. On August 23, 2010, OCRF Web site stated:

Ovarian Cancer Research Fund is teaming up with Power Balance, maker of revolutionary Performance Technology wristbands, in an exciting new partnership to raise funds for the cause

OCRF was approached by Power Balance when founders Josh and Troy Rodarmel, whose mother lost her battle with ovarian cancer in 1998, chose to join forces to help fight a disease that has affected them personally. . . .

On August 3, Power Balance celebrated the launch of the on-going partnership in style, with a glittering V.I.P. “All In For The Cure Poker Party” at Drai’s nightclub in Hollywood’s W Hotel. Power Balance athletes Derrick Rose and Lamar Odom were joined by some of the biggest names in sports and entertainment to raise funds for OCRF.

As part of the launch, Power Balance unveiled two specially designed OCRF wristbands, available at http://ocrf.powerbalance.com. 50 percent of proceeds from every band sold will be donated directly to OCRF.

In addition, beginning August 11, Power Balance will host an online art auction to benefit OCRF. The auction features 30 exclusive signed works of art depicting a selection of athletes, created by local California artist, Brian Bent. The athletes featured include: Drew Brees, Chad Ochocinco, Bode Miller, Julia Mancuso, Derrick Rose, Matthew Stafford, Shaquille O’Neal, Matt Kemp and Lamar Odom. Bids are placed through the Power Balance website, with 100% of proceeds benefiting OCRF [4].

It seems to me that many people will regard this “partnership” as an implied endorsement of the bracelets. On August 23, when Dr. Stephen Barrett phoned OCRF to complain, he was told that the staff sees nothing wrong with accepting the help as long as the device is not marketed with health claims [5]. During the conversation, Barrett noted that the word “revolutionary” in the first paragraph looked like an endorsement to him. Apparently in response to his complaint, the word “revolutionary” was removed and this disclaimer was added to the end of the article.

While OCRF appreciates the support of all of its corporate supporters, any reference to a specific commercial product or service does not constitute or imply an endorsement by OCRF of the product or service or its producer or provider. The views and opinions expressed in any referenced document or on any referenced website do not reflect those of OCRF.

Scientific Test Shows No Benefit

A controlled trial of college athletes has found that wearing a Power Balance bracelet did not enhance their performance. The study, sponsored by the American Council on Exercise (ACE), was conducted by John Porcari, Ph.D. and other researchers from the University of Wisconsin. Each athlete completed two trials of four tests: trunk flexibility, balance, strength and vertical jump. For one trial, the subjects wore a Power Balance bracelet ($30), and for the other they wore a placebo ($0.30 rubber bracelet). The order of bracelets worn was completely randomized and double-blinded so that neither the subjects nor the examiners knew which bracelet was being worn for which trial. Analysis of the data showed no significant difference in flexibility, balance, strength, or vertical-jump height between the Power Balance and placebo trials. Curiously, the subjects did better in the second trial than the first, a phenomenon called the “order effect.” ACE’s report stated:

The improvements in the second trials were attributed to the fact that subjects were either: (1) more warmed up, or (2) habituated to the task. This would explain why the public sales demonstrations of Power Balance and similar performance-jewelry products appear to have beneficial effects on flexibility, balance and strength. But in reality, these sales demonstrations are essentially carnival tricks. By altering the way you apply force to the body, explains Porcari, you can easily change the outcome. “If I’m pushing a certain direction, and then I change the angle of pull or push a little bit, I can get you to lose your balance easily,” he says [6].

Government Action

In December 2010, the Australiian Competition and Consumer Commission (ACCC) announced that Power Balance Pty Australia Ltd admitted that there is no credible scientific basis for the claims and therefore no reasonable grounds for making representations about its wristbands being beneficial [7]. To settle ACCC’s concerns, the company signed an undertaking [8] in which it promised to:

• Not make any claims about its products that are not supported by a written report from an independent testing body that meets certain standards
• Offer a refund to consumers who feel they have been misled
• Publish corrective advertising to prevent consumers from being misled in the future. The undertaking included an announcement that must be posted to the Web site and advertised in 20 magazines
• Remove any misleading representations from its Autralian Web site
• Remove the words ‘performance technology’ from the brand itself
• Implement a compliance program

In May 2011, Power Balance Pty Australia Ltd was placed into receivership (a form of bankruptcy). The company said that negative publcity combined with threats by the ACCC to retailers and athletes who endorsed the product cause had sales to plummit [9]. The video below was one of several media appearances in which the ACCC chairman Graeme Samuel ridiculed Power Balance products.

The Bottom Line

Tell me you use the Power Balance card and it makes you feel better, and I can readily believe you. Tell me your performance improves when you carry it, and I will believe you. But that won’t convince me that the improvement has anything to do with bioresonating frequencies in the holograms—or even with the cards themselves.

It’s like the tooth fairy. Tell me money appears under your pillow, and I will believe you. But that won’t convince me that the tooth fairy did it. The tooth fairy phenomenon is easily explained by human psychology and parental behavior. The Power Balance phenomenon is easily explained by suggestion, confirmation bias, the placebo response, and other well-known aspects of human psychology that conspire to persuade people that ineffective things work.

Whether Power Balance bracelets do more good than harm would be difficult to measure. Modern versions of an amulet or rabbit’s foot (without harm to rabbits), they can elicit a placebo response, giving people confidence and possibly making them try harder. They are not exorbitantly expensive and even come with a money-back guarantee. On the other hand, for many people they will be a waste of money and, if enough people buy them, it can be argued that the collective amount could certainly be used for a more noble purpose.

The Australian Competition & Consumer Commission deserves congratulations for curbing Power Balances’s marketing.

References

1. Barrett S. Q-Ray bracelet marketed with preposterous claims. Quackwatch, Jan 6, 2008.
2. Barrett S. Applied kinesiology: Phony muscle-testing for “allergies” and “nutrient deficiencies.” Quackwatch, March 10, 2009.
3. Pangallo P. Bracelet claims put to the test. Today Tonight, Dec 22, 2009.
4. OCRF launches partnership with Power Balance. Ovarian Cancer Research Fund news release, Aug 11, 2010.
5. Telephone discussion between Dr. Stephen Barrett and OCRF’s research director, Aug 23, 2010.
6. Porcari JP and others. Power Balance or power of persuasion? ACE Web site, March 2011.
7. Power Balance admits no reasonable basis for wristband claims, consumers offered refunds. ACCC press release, Dec 22, 2010.
8. Undertaking to the Australian Competition and Consumer Commission by Power Balance Australia Pty Ltd. ACN 136 576 997, Dec 22, 2010.
9. Thompson J. Australian distributor of Power Balance wristbands collapses, owner admits he was “naive.” Smart Company news, May 23, 2011.

This article was revised on May 23, 2011.

During the past year, a few companies have begun offering genetic testing combined with guidance on diet, supplement strategies, lifestyle changes, and/or drug usage which they claim can improve health outcomes. This article explains why such testing should be avoided.

Until recently, hereditary tendencies were determined mainly by examining the family history of the individuals involved. Within the past decade, however, genes have been identified that cause or contribute to Alzheimer’s disease, amyotrophic lateral sclerosis (Lou Gehrig’s disease), cystic fibrosis, neurofibromatosis, familial colon cancer, Huntington’s disease, myotonic dystrophy, and many other conditions. Many laboratories and clinics provide genetic testing and counseling; and scientific research in this field is progressing very rapidly.

Genetics tests analyze human DNA, RNA, chromosomes, proteins, or certain metabolites in order to detect alterations related to a heritable disorder. Tests that identify carriers of various diseases can be used to help couples decide whether or not to have children. Scientists hope that further research will lead to strategies for preventing or treating hereditary diseases. Genetic tests can also help diagnose inherited diseases caused by problems with a single gene and lead to earlier treatment. At present, however, only a few such strategies are known, and none justify the commercial activities described in this article.

Most of the tests being marketed directly to consumers are for common gene variations that have been linked to major illnesses, such as coronary heart disease, which have hereditary aspects but are heavily influenced by lifestyle and environmental factors. At best, for such diseases, genetic testing can indicate that an individual is more susceptible than most people, but it cannot predict with certainty that the disease will develop [1]. For these reasons, the screening tests described in this article are not recommended by any authority and are not FDA-approved as a basis for recommending supplementation.

Sciona’s “Body Benefits” Tests

Sciona, a British company, offers a “Body Benefits” test that yields “a personalised report describing your lifestyle results and genetic results, together with further informative sections on food groups, vitamins & minerals and an easy to understand guide to the science behind the service.” The report is based on a lifestyle questionnaire and a DNA sample obtained by rubbing a brush swab on the inside of your cheek. The DNA sample is said to involve testing of several genes related to free radical damage, detoxification, alcohol metabolism, and skin and hair repair. According to Sciona:

Small differences in your genes can influence how well your body metabolises foods, utilises nutrients and excretes damaging toxins, all of which can affect your general state of health. By finding out if you have any of these small variations, Body Benefits nutrition can provide you with specific dietary information that cannot be obtained from any other source [2].

The test is now available through physicians, pharmacists, and nutritionists. In 2002, the company began marketing it through retail stores on High Street, but protests from GeneWatch UK caused the shopkeepers to stop offering it [3]. GeneWatch UK had three main objections:

• For most people, eating a healthy, balanced diet, getting enough exercise and not smoking are much more important in determining your health than your genes are. You can get advice on diet for free from the Food Standards Agency and advice on quitting smoking from national helplines, or you can ask your doctor. You should follow this advice whatever genes you have. It is particularly important that you are not misled into thinking that your “good genes” can cope with a bad diet or with smoking or excessive drinking.
• Many scientists are exploring possible links between the genes Sciona tests and serious diseases like heart disease, cancer and mental illness, including workplace-related illnesses. Although genes are usually poor predictors of your future health (which depends on many other factors), you may learn something you don’t want to know. This could also be information your insurer or employer might ask for in the future, and one day use to exclude you from insurance or employment or compensation for a work-related illness.
• Sciona plans to keep your sample and your personal genetic information in a database (known as a “biobank”) whilst you remain a subscriber. Although Sciona has a “privacy policy” regarding your name and address, you should remember that your personal genetic profile is unique to you and could be used to identify you, and who is related to you, in the future. Many companies will be prepared to pay to do genetic research on your sample and may want to claim exclusive rights to your genes by patenting them—once a gene is patented this means no other company can sell new genetic tests or treatments using the same gene. There is growing evidence that privatising genes in this way can stifle medical research and increase costs and many people believe it is immoral. The law does not require Sciona to inform you if it patents or sells your genetic information [4].

After GeneWatch UK protested, Sciona changed its policy so they now destroy the test samples (although they keep the data) [5].

Great Smokies’ Genovations™ Test

Great Smokies Diagnostic Laboratory (GSDL), of of Asheville, North Carolina, claims that its Genovations test line “empowers physicians and patients to realize earlier, more effective preventive interventions—years before disease develops; precise, customized therapies that truly address each individual’s needs; and improved clinical insight into patients with treatment-resistant ‘chronic’ conditions.” [6 ] Genovations testing is one of many questionable tests that GSDL offers through “holistic physicians,” chiropractors, and other offbeat practitioners or directly to the public. According to the Genovations Web site:

Genovations™ tests measure individual genetic variations, called single nucleotide polymorphisms (SNPs) that, under the influence of environmental triggers, can make even a healthy person more prone to develop certain diseases or physiological imbalances. Knowledge of these variations will allow physicians to intervene with customized preventive therapy earlier and with greater specificity than ever before, to reduce a patient’s disease risk years before symptoms appear. With Genovations™, Great Smokies Diagnostic Laboratory becomes the first clinical laboratory to provide predictive genomic tests to the primary care physician [7].

The tests currently offered include: CardioGenomic™ Profile (to identify SNPs associated with cardiovascular disease), OsteoGenomic™ Profile (to identify SNPs associated with osteoporosis), DetoxiGenomic ™ Profile (to identify SNPs associated with “detoxification defects” related to with increased risk for certain cancers, chronic fatigue, multiple chemical sensitivity, and alcoholism), and ImmunoGenomic™Profile (to identify SNPs associated with immune system defects, asthma, atopy, osteopenia, heart disease, and infectious diseases). [8] The Genovations Web site further states:

Seeing the results of your Genovations™ test is like seeing the cards you’ve been dealt by Nature. Once you know the cards, you can develop the most effective strategy to play out your hand. That means working with your healthcare provider to carefully develop a diet, lifestyle, and supplement program that matches the unique health risks for your body. . . .

Are you plagued by a chronic condition that resists medical treatment? Testing can reveal whether you have genetic variations that make you more vulnerable to the harmful effects of toxins. Or if you are less likely to respond well to certain drugs or nutrients.

Do you have a family history of a condition like heart disease or osteoporosis? When conditions “run in families” they often have a genetic component. Testing can show what specific genetic factors could pose a potential problem for you. For example, are your cholesterol levels more sensitive to a fatty diet than other people? Is your blood more likely to clot during long periods of inactivity? Do your bones properly utilize the nutrients they need? Is your blood pressure apt to be highly influenced by your salt intake? Once you have this information, you can develop a focused, plan to “break the pattern”—and better prevent your family risks from turning into realities.

Do you take a very active role in optimizing your health? These tests can help you and your practitioner design a preventive program that works best for your body’s unique needs and health risks. One that “takes aim” at your most important targets years before symptoms ever have a chance to develop. Knowing your genetic “strong” points and “weak” points allows you to devise a targeted, personal approach that increases your chances of remaining fit and active as you grow older. . . .

Based on your genetic test results, your health care practitioner can work with you to develop a customized treatment plan. But the support doesn’t stop there. Testing is also available that can monitor whether your personal healthcare strategy is having a positive impact on your genetic risks. These tests, called “functional assessments,” give your physician a concrete way to evaluate how your body is responding to treatment. This is an important way to ensure that powerful environmental factors, such as hormones and nutrients, are in a state of optimal balance that minimizes your in-born genetic health risks [9].

The above quotations clearly promise more than Genovations can deliver. In order for a test to be cost-effective, it has to provide information that is not available elsewhere that can steer the patient toward beneficial treatment. No studies have shown that genetic testing is as good as a simple family history or ordinary laboratory tests for determining what people should do to prevent osteoporosis or cadiovascular disease. And the idea that people who have “chronic conditions” are likely to benefit from genetic testing is preposterous. Nor have any studies demonstrated that nutrient formulas based on genetic testing are as good as standard medical treatment based on appropriate diagnostic testing or that GSDL’s nonstandard “functional assessments” are valid.

Most of the conditions related to Genovations testing are either poorly understood (such as chronic fatigue syndrome) or are known to be have many contributing factors (eg, coronary heart disease). Many different genes are involved, often on different chromosomes, and the expression of the genes is affected by environmental factors. The same gene might be good for one person and bad for another, depending on the rest of the person’s genetic makeup and environment. Genetic variants may well influence the development of common diseases, but it is far too early to be guessing what variants affect what disease, much less to be recommending “treatment” in the form of diet and supplements. Commenting on the claims made for Genovations’ “Osteo” “Cardio,” and “Immuno” profiles, GeneWatch UK concluded:

These claims are misleading and unethical because: the risks associated with particular genes are still poorly understood and for most people diet, lifestyle and environment will be much more important than genetic make-up in the development of common future illnesses; selling supplements, medicines and follow-up tests to people based on their genetic make-up means treating them for illnesses they do not have but are worried they will get. At best, this is exploiting people’s fears in order to make a profit. Taking unnecessary medication could also be harmful to your health, as could being unnecessarily worried or falsely reassured about your risk of future illness; you may be informed of risks you didn’t want to know about without proper counselling or advice (for example, an increased risk of Alzheimer’s Disease has been associated with one of the genes in Genovations’ “Cardio” genetic test). [10]

CARE Clinics, of Austin, Texas, is using Genovations to test children with autistic spectrum disorders. The tests are part of an expensive test package that is claimed to guide “biomedical treatment” with dietary supplements and other modalities said to correct “biomedical imbalances” and provide “detoxification.” In 2008, one of us (Dr. Barrett) examined test reports and concluded that the tests do not appear to be related to autism and contain no information that would provide a rational basis for treatment [11].

NuGenix

GeneLink, NuGenix, and Garden State Nutritionals have teamed up to market genetic tests accompanied by supplement recommendations. GeneLink, headquartered in Margate, New Jersey, provides the genetic tests. Its reports to the Securities and Exchange Commission state that it was formed to “to offer to the public the safe collection and preservation of a family’s DNA material for later use by the family to determine genetic linkage [12], but a recent press release describes it as “a leader of genetic assessments direct-to-consumer” [13], which is a very different purpose. The company’s Web site states:

GeneLink has recently created a breakthrough methodology for “genetic profiling” (patents pending) and is beginning to license these proprietary assessments to companies that manufacture or market to the $100 Billion plus nutraceutical, personal care, skin care, and weight-loss industries.

GeneLink’s innovative Nutragenetic & Dermagenetic Profiles now offer companies the information they need to create and sell more effective products—unique wellness and “quality of life” products tailored to their customer’s individual needs—based on the science of genetics.

No longer will people be forced to speculate, guess or use trial and error to determine which nutritional supplements or skin-care products are best for them. For the first time, by simply swabbing the inside of mouth (using GeneLink’s Patented Collection Kit) and sending the collected sample to GeneLink’s laboratories—people can be directed to personalized products – specifically formulated to help compensate for predicted deficiencies.

GeneLink’s clear mission is to utilize the latest genetic research information and applied technologies to provide products and services that can assist in improving and extending human life [14].

Garden State Nutritionals, a custom manufacturer in West Caldwell, New Jersey, supplies the supplement products. NuGenix, of Berwyn, Pennsylvania, is operated by the children of GeneLink’s president. It markets the testing through multilevel marketing structure. Its “medical advisor” is Alan H. Pressman, DC, PhD, DACBN, CCN, a chiropractor who for many years has hosted a supplement-promoting radio talk show called “Healthline” and marketed his own line of supplements.

In December 2002, NuGenix’s “genetic profiling kit” plus a month’s supply of the “Bodygenix Nutrition Regimen” cost $299.95 plus shipping and handling. The regimen is said to be “focused on” seven formulas:

• Multi-Base Formula (a multivitamin with additional ingredients that “protect and support the antioxidant and detoxification systems”)
• Oxidative Stress Supplement 1 (to “benefit mitochomdrial function”),
• Oxidative Stress Supplement 2 (to “help detoxify the body”),
• Detoxification Supplement 1 (to support optimal function of detox systems),
• Heart and Circulatory 1 (contains ingredients intended to help lower homocysteine and cholesterol levels)
• Heart and Circulatory 2 (provides folic acid to help lower homocysteine levels), and
• Immune Health Supplement 1 (to help “balance certain aspects of immunity”).

The Web site doesn’t indicate how the test results influence the composition of the supplement products the customers receive. But the descriptions of the ingredients make it clear that the final product is likely to be irrational. For example, the site correctly notes that high levels of amino acid homocysteine may be an important factor in causing coronary heart disease and that lowering homocysteine levels may be beneficial. But the correct way to deal with this is to measure blood levels and take the amounts of B-vitamins that can normalize high levels [15]. Genetic testing contributes nothing to this process. Similarly, the correct way to deal with abnormal cholesterol levels is to measure them with blood tests and use lifestyle and proven drugs to improve them.

Seryx’s Signature Genetics

Seryx, which is based in Montreal Canada and Cherry Hill, New Jersey, invited patients to use its Signature Genetics ™ service to “discover how your genes hold the secret to your well-being.” [16] The service, which is available by annual subscription, must be obtained from a doctor who has been trained by the company. The company promises—based on a genetic blood test and answers to a detailed questionnaire—”detailed, individualized, practical recommendations on nutrition, lifestyle, and medications—with actions you can take immediately to improve your well-being and uncover your optimal health.” To obtain the service, patients must puchase a membership and pay an annual fee that entitles them to notification when new discoveries pertain to their genetic profile. The Web site offers physicians a “significant practice-building opportunity,” but it offers no objective evidence that such practice-building will benefit patients. According to a company spokesperson, the cost of the service depends on how many test “modules” the doctor recommends after interpreting the patient’s information. Payment is made to the doctor, with a minimum charge of $500.

The effectiveness and toxicity of most medications can vary considerably from patient to patient and that for many medications these individual differences are partly due to variations in the genes related to drug-metabolizing enzymes, drug transporters, and/or drug targets [17]. For example, someone who metabolizes a drug more slowly than someone else may respond to the drug at a lower dose and be more likely to develop side effects. On the other hand, the difference may not be significant and the effect may be influenced by other genetic factors or interactions with other drugs. In addition, the dosage of most drugs is easily adjusted to compensate for individual differences. No studies have shown improved patient outcomes from selecting drugs based on genetic information. Thus the idea of using genetic information for prescribing medications has considerable promise, but its time has not yet come.

Imagene

DocBlum.com offers Imagene™ “genetic testing for the millennium.” The company’s Web site states:

Are you compulsive? Have you ever wondered why you crave certain things and/or act in an irrational manner? Would you like to know if you have the genetic predisposition to abuse drugs and alcohol? Are you concerned about your children’s future? Does your child have the genetic trait that leads to disruptive and addictive personalities? DNA testing can help you understand and manage a child’s behavior before it gets out of control.

Imagene will test a panel of dopaminergic related Reward Deficiency Syndrome (RDS) genes. This will allow you to know if there is a genetic predisposition towards any of the associated addictions. The Reward product line is then available to treat the genetic predisposition towards RDS [1].

The test involves swabbing the inside of the cheek with a foam-tipped applicator, applying the applicator to an indicator card, and mailing the card to a lab. A home test kit sells for $275, and the products cost $59.95 per month for pills and $29.95 for a corresponding oral spray that is said to provide 1-2 hours of relief from “cravings.” The Web site also includes an application for becoming a “Reward” distributor for Nutrigenomic products.

“Reward Deficiency Syndrome” is not a medically recognized disorder, but a hypothesis originated by Kenneth Blum, Ph.D., a pharmacology professor in Texas, and promoted through the Web site, which is registered to pediatrician Michael A Blum, D.O., of Overton Park, Kansas. The site indicates that the technology and products are patented or licensed by Kenneth Blum and that the University of Texas and the University of California own some of them [18].

The Blums consider dopamine (a neurotransmitter in the brain) to be the key factor in a cascade of neurophysiologic reactions leading to increased feelings of well-being and stress-reduction. They claim that a genetic defect in the D2 dopamine receptor gene causes “reward-seeking conditions” such as alcoholism, drug dependency, obesity, smoking, pathological gambling, attention-deficit-hyperactivity disorder (ADHD), Tourette syndrome, sex addiction, autism, chronic violence, posttraumatic stress disorder, schizoid/avoidant cluster, conduct disorder, antisocial behavior, and other compulsive behaviors [18]. The tests are claimed to detect a genetic predisposition to such disorders. If the test is “positive,” the corresponding formula is recommended for lifetime use [20].

The “Reward” product line is marketed by Nutrigenomics, Inc., of San Antonio, Texas. It includes six formulas: Alcoholism/Heroin, Cocaine/Stimulants, Smoking/Tobacco, Weight Management, INFOCUS/ADD, and PMS, each of which contains vitamins, herbs, and amino acids. The “anti-alcohol” formula, for example, contains vitamin C, vitamin E, thiamine, riboflavin, niacin, vitamin B-6, folic acid, vitamin B12, biotin, pantothenic acid, calcium, magnesium, zinc, manganese, chromium, 5-hydroxytrypthophan, dl-phenylalanine, l-glutamine, rhodiala rosea, chamomile flower, passion flower, hops flower, oat straw powder, skullcap herb, motherwort herb, valerian root extract, and Jamaican dogwood extract. As far as we can tell, neither the test kit nor the products have FDA approval for their intended uses.

The scientific literature does not support Blums’ theories or methodology. Most scientists believe that alcoholism has both genetic and environmental factors and that the inheritable component is most involves multiple genes rather than something that could be detected with a simple test [21-25]. Tourette syndrome is hereditary; and autism, ADHD, and schizoid disorders may have as-yet-undiscovered genetic causes; but the rest of the Blums’ list are probably unrelated to genetic makeup. Moreover, there is no scientific evidence that a combinations of vitamins, amino acids, or herbs are effective against any of the listed conditions. In fact, it is difficult to imagine any rationale for the large number of ingredients in the Reward formulas.

The Imagene Web site lists 27 references to studies that supposedly support claims for the products [26]. We have not read the full text of these articles, but the titles or abstracts indicate that most do not involve tests of either the products or the ingredients. A few involve tests of products similar to one or more ingredients of the Reward products, but none of the studies appears to involve the actual products. Some of the studies lack proper controls; some are too short to be meaningful; and one even has a negative result. Many of the conditions that the Reward system is supposed to help are not covered by any of the studies; and none of the studies appears to involve use of genetic testing to select any of the products or their ingredients. Documents related to patents held by Kenneth Blum include additional studies that relate the various disorders to genetic factors but, again, these do not appear to be studies in which actual Reward products were administered to patients or selected on the basis of genetic testing [27]. In short, the references absolutely no support for use of the system. Moreover, since the products are recommended for lifetime use and involve alleged manipulations of chemicals in the brain, any such use should be supported by long-term safety studies—which do not appear to have been done.

The Bottom Line

Genetic testing to identify alleged risk factors that have no proven corrective measures is simply a waste of money. As noted by Helen Wallace, Ph.D., Deputy Director of GeneWatch UK: “For most people, tailoring your diet to your genetic make-up is about as scientific as tailoring your diet to your star sign.” [28] GeneWatch has also expressed concern that without proper regulation, genetic testing could be used to expand the drug market to healthy people identified as at high genetic risk; many people could receive unnecessary medication and suffer the associated side effects, and the underlying causes of heart disease, cancer, obesity, adult-onset diabetes, and other diseases could be ignored, with serious implications for future health [28]

For Additional Information

• Aetna Clinical Policy Bulletin on Genetic Testing
• Gene Tests – Gene Clinics Web site, administered by the University of Washington, lists the diseases for which screening can be done; reputable laboratories and clinics; and a wealth of other reliable information.
• GeneWatch UK, a British organization whose goal is to ensure that genetic technologies are developed and used in the public interest, has issued useful position statements.
• Human Genome Project: Provides a glossary and describes the mapping of human chromosomes.
• More on Dubious Genetic Tests
• At Home DNA Tests: Marketing Scam or Medical Breakthrough? U.S. Senate hearing, July 26, 2006.

References

1. Unregulated genetic testing on the High Street and the Internet. GeneWatch UK, April 2002.
2. Body benefits – nutrition. Sciona Web site, accessed Dec 29, 2002.
3. High Street stores reject Sciona’s human genetic testing. GeneWatch press release, June 7, 2002.
4. Genetic testing on the High Street. GeneWatch UK, March 2002.
5. Wallace H. Email to Dr. Stephen Barrett, Jan 7, 2003.
6. Genovations™ is the advent of truly personalized healthcare. Genovations Home page, accessed Dec 29, 2002.
7. Great Smokies Diagnostic Laboratory announces new Genovations™ product line: Predictive genomics for personalized medicine. GSDL news release, March 15, 2002.
8. Genovations profiles. Genovations Web site, accessed Dec 29, 2002.
9. Patients guide to genomics. Genovations Web site, accessed Dec 29, 2002.
10. “Genovations” genetic test kits. GeneWatch UK, July 2002.
11. Barrett S. Be wary of CARE Clinics and the Center for Autistic Spectrum Disorders (CASD). Autism Watch, Nov 26, 2008/
12. GeneLink, Inc. Form 10-QSB quarterly report for the quarterly period ended September 30, 2002.
13. GeneLink, Inc. reports revenue for third quarter. 2002. Business Wire, Nov. 14, 2002.
14. GeneLink Inc —Growing, Expanding, Evolving! GeneLink Web, site accessed, Dec 29, 2002.
15. Barrett S. Homocysteine: A cardiovascular risk factor worth considering. Quackwatch, Aug 29, 2002.
16. Evans WE., Johnson J. Pharmacogenetics: the inherited basis for interindividual differences in drug response. Annual Review of Human Genetics 2:9-39, 2001]
17. Imagene: Genetic testing for the millenium. Docblum.com, accessed May 30, 2003.
18. Patents (awarded and or licensed to DocBlum). Docblum.com, accessed May 30, 2003.
19. Blum K and others. Dopamine D2 receptor gene variants: association and linkage studies in impulsive-addictive-compulsive behaviour. Pharmacogenetics 5:121-141, 1995.
20. Frequently asked questions. Docblum.com, accessed May 30, 2003.
21. Freund G. Biomedical causes of alcohol abuse. Alcohol 1(2):129-131, 1984.
22. Goldman D and others. A functionally deficient DRD2 variant is not linked to alcoholism and substance abuse. Alcohol 16:47-52, 1998.
23. Chen WJ and others. Psychiatric Genetics 11:187-195, 2001.
24. Hill EM and others. Antisocial alcoholism and serotonin-related polymorphisms: association tests. Psychiatric Genetics12:143-153, 2002.
25. Goldman D and others. Linkage and association of a functional DRD2 variant and DRD2 markers to alcoholism, substance abuse and schizophrenia in Southwestern American Indians. American Journal of Medical Genetics 74:386-394, 1997.
26. Product support page. Docblum.com, accessed May 30, 2003.
27. GeneWatch UK response to the Human Genetics Commission’s announcement of a consultation into genetic testing services. GeneWatch press release, July 18, 2002.
28. Genetics and ‘predictive medicine’: Selling pills, ignoring causes. GeneWatch UK Briefing Number 18, May 2002.
29. Blum K. Allelic polygene diagnosis of reward deficiency syndrome and treatment. Patent #6,132,724, October 17, 2000.
30. Sterling R. The on-line promotion and sale of nutrigenomic services. Genetics in Medicine 10:784-796, 2008.
31. Genetic horoscopes. Genewatch Web site, accessed Nov 24, 2008.

Dr. Hall is a retired family practitioner and Air Force colonel who resides in Puyallup, Washington.

The main article above describes the marketplace as it was in 2002–2003.
The addendum was posted on November 24, 2008.

Authors: Simon Singh, PhD and Edzard Ernst, MD, PhD
Publisher: W.W. Norton Co., New York, London
ISBN: 978-0-393-06661-6
Publication date: 2008
Reviewed by: Harriet Hall, MD

Edzard Ernst, based at the University of Exeter in England, is the world’s first professor of complementary medicine, a post he has held for 15 years. An MD and a PhD, he has done extensive research and published widely. His stated objective is “to apply the principles of evidence-based medicine to the field of complementary medicine such that those treatments which demonstrably do generate more good than harm become part of conventional medicine and those which fail to meet this criterion become obsolete.” His most important accomplishment has been to “demonstrate that complementary medicine can be scientifically investigated which, in turn, brought about a change in attitude both in the way the medical establishment looks upon complementary medicine and in the way complementary medicine looks upon scientific investigation.”

Simon Singh is a science writer with a PhD in particle physics. As a team, he and Ernst are uniquely qualified to ferret out the truth about “alternative medicine” and explain it to the public.

Ironically, the book is dedicated to HRH The Prince of Wales, who is infamous for encouraging unproven treatments. Prince Charles has called for scientific studies of alternative medicine but has consistently disregarded the results of such studies.

The first chapter asks “how do you determine the truth?” and explains the scientific method. Four chapters address the scientific evidence for four major alternative approaches: acupuncture, homeopathy, chiropractic, and herbal medicine. Thirty-six lesser modalities are covered in an appendix. The final chapter asks “does the truth matter?”

Chapter 4 provides a beautiful example of the value of rigorous science. Dr. Bill Silverman was frustrated by seeing premature babies go blind with retinopathy of prematurity (ROP). He tried treating them with ACTH and had astounding success: only 2 out of 31 infants lost their sight. In another hospital where ACTH was not used, 6 out of 7 babies lost their sight. Most doctors would have simply continued using ACTH treatments and would have recommended them to everyone, but Silverman was a true scientist. He recognized that it might not be fair to compare babies in two different hospitals and that a proper randomized controlled trial was needed. When he did such a trial, 70% of the babies on ACTH recovered, but 80% of the untreated babies recovered, and more babies in the ACTH group died. A follow-up study confirmed these results. If Silverman had not had the integrity to question his own hypothesis, a useless and possibly harmful treatment might have become standard, and more babies might have ended up blind or dead.

Singh and Ernst provide many other noteworthy examples of good and not-so-good science, from James Lind’s life-saving experiments on British sailors with scurvy to Benveniste’s discredited homeopathy study in Nature. They debunk many of the fallacies of alternative medicine: the “natural” fallacy, the “traditional” fallacy, the “holistic” fallacy, the “science can’t test alternative medicine” fallacy, the “science doesn’t understand alternative medicine” fallacy, and the “science is biased against alternative ideas” fallacy. They discuss placebos and explain why they don’t condone using them. They name ten classes of culprit in the promotion of unproven and disproven medicine, from the media to alternative gurus to the World Health Organization. They discuss the role of prior plausibility in deciding directions for future research. They quote Carl Sagan:

It seems to me what is called for is an exquisite balance between two conflicting needs: the most skeptical scrutiny of all hypotheses that are served up to us and at the same time a great openness to new ideas… [I]f you are open to the point of gullibility… then you cannot distinguish useful ideas from worthless ones. If all ideas have equal validity then you are lost, because then it seems to me, no ideas have any validity at all.

Their conclusions about the four major approaches are quite unfavorable:

• While there is tentative evidence that acupuncture might be effective for some forms of pain relief and nausea, it fails to deliver any medical benefit in any other situations and its underlying concepts are meaningless.
• With respect to homeopathy, the evidence points towards a bogus industry that offers patients nothing more than a fantasy.
• Chiropractors, on the other hand, might compete with physiotherapists in terms of treating some back problems, but all their other claims are beyond belief and can carry a range of significant risks.
• Herbal medicine undoubtedly offers some interesting remedies, but they are significantly outnumbered by the unproven, disproven and downright dangerous herbal medicines on the market.

These strong words have met with understandable hostility from the alternative community. Simon Singh has already been sued by the British Chiropractic Association for libel in response to an article saying that chiropractors knowingly promoted bogus treatments for illnesses including asthma and ear infections.

Criticisms of Trick or Treatment reveal an appalling poverty of thought. No one can seriously question the authors’ reasoning, so opponents resort to other tactics. A homeopathy Web site resorts to denying that science is a useful tool. It essentially calls evidence-based medicine quackery! Other critics simply criticize every defect of conventional science-based medicine, as if imperfections in applied science somehow prove that a nonscientific approach is better! They misrepresent what the book says and use ad hominem insults, ridiculously attacking Ernst as “desperate to find ANYTHING to discredit CAM.” I haven’t found any critics who have even tried to cogently address the points the book makes.

It’s easy to criticize with generalizations. Emily Rosa’s therapeutic touch study was accused of “poor design and methodology,” but as Singh and Ernst point out, “[her] protocol was simple and clear and her conclusion was hard to fault. Moreover, nobody has ever come up with an experiment that has overturned her findings.” If proponents of alternative medicine come up with good experiments that overturn the present findings, Singh and Ernst have made it clear that they will gladly accept them. In fact, Ernst has offered a prize of £10,000 to the first person who can show homeopathy is better than a placebo in a scientifically controlled trial. No one has applied for his money.

Ernst’s criticisms deserve special credibility because he is an avowed supporter of everything “alternative” that can be shown to work. At one time, he even prescribed homeopathic remedies. He accepts claims about herbs that many of us reject (for instance, echinacea to prevent and treat the common cold). He has demonstrated his ability to change his mind and follow the evidence. He has no ax to grind; his only agenda is to find the truth. He warns that, “People must not confuse the perceived benefits of so-called alternative medicine with the medical facts.” Years ago, Daniel Patrick Moynihan put it similarly when he said that “Everyone is entitled to his own opinion, but not his own facts.”

Trick or Treatment can be ordered from Amazon Books by clicking this link.

Other Recommended Books

• Natural Causes: Death, Lies, Politics in America’s Vitamin and Herbal Supplement Industry
• Snake Oil Science: The Truth about Alternative and Complementary Medicine
• Suckers: How Alternative Medicine Fools All of Us

Dr. Hall is a retired family practitioner and Air Force colonel who resides in Puyallup, Washington. She contributes frequently to Skeptic, Skeptical Inquirer, and the Science-Based Medicine Blog.

Daniel G. Amen, M.D., runs the Amen Clinics, writes books, gives lectures, maintains a Web site, and makes other media appearances. He recommends single photon emission computed tomography (SPECT) to help diagnose and manage cases of brain trauma, underachievement, school failure, depression, obsessive compulsive disorders, anxiety, aggressiveness, cognitive decline, and brain toxicity from drugs or alcohol. He claims to use SPECT to “re-balance a brain whose activity patterns are clearly abnormal.” He describes SPECT as a “window into the hardware of the soul.” He claims that SPECT scanting provides “guidance in the application of specific medications or other treatments such as supplements, neurofeedback, transcranial magnetic stimulation, and hyperbaric oxygen therapy.”

For about four years (2002 to 2006), the The Amen Clinic’s home page stated:

Everything starts and ends in your Brain-Soul connection.

How your brain and soul work together determines how happy you feel, how successful you become, and how well you connect with others. The brain-soul connection is vastly more powerful than your conscious will. Will power falters when the physical functioning of the brain and the health of your soul fail to support your desires, as seen by illogical behaviors like overeating, smoking, drug and alcohol abuse, and compulsive spending.

It is the aim of The Amen Clinics to provide instructional programs and materials, evaluations and medical treatment where necessary to help you to understand and direct your mind to enhance your relationships, your work, and your health!

The site currently (2007) states:

SPECT . . . . basically tells us three things: areas of the brain that work well, areas of the brain that work too hard and areas of the brain that do not work hard enough. Once we know how the brain works, the goal of treatment is to balance brain function, such as calm the overactive areas and enhance the underactive ones.

SPECT creates a colored picture representing blood flow or chemical reactions in different areas of the brain. It requires the injection of a radioactive material. Areas of low blood flow show up as apparent “holes” on colored pictures of the brain, giving a moth-eaten appearance. Amen says that when patients improve clinically, the appearance of their follow-up scan typically improves. For example, patients using marijuana had areas of low activity in the temporal lobes compared to patients not using the drug. Dr. Amen says he can literally show his patients “this is what your brain looks like on drugs.” In one case he reported, a patient with attention deficit disorder, obsessive thinking, anger outbursts, and depression had demonstrable defects on the initial scan which were visibly improved after three years of clomipramine therapy. Dr. Amen says that this kind of graphic demonstration can help persuade patients that their problem is physical or physiological and might be helped with medication or other treatments.

The Amen Clinics charge $3,250 for a “comprehensive evaluation,” which included the patient’s history, two SPECT scans (concentration scan and baseline scan), a physician consultation, and a 30-minute treatment follow-up appointment. Follow-up scans after treatment are $795 each.

Key Questions

The key question in evaluating a diagnostic test is whether or not its findings are useful in determining what treatment the patient should have. SPECT is a research tool useful for exploring how the brain functions, but the findings are nonspecific, and uses related to treatment of emotional or behavioral problems should be considered experimental. Dr. Amen has vast clinical experience and says he has performed and interpreted more than 35,000 scans. However, I do not believe he has demonstrated that specific scan patterns reliably reflect specific clinical problems and how they should be treated. Even when he is able to show a correlation between a diagnosis and an area of low perfusion (blood flow), he has not shown what this really means and how it could aid clinical treatment. Is low perfusion an indication of the primary pathology or perhaps just a secondary brain response to the symptoms? His published research comprises “preliminary studies,” and most psychiatrists believe it is premature to use SPECT clinically. In fact, the American Psychiatric Association (APA) has issued two skeptical reports, one pertaining to children and adolescents and the other pertaining to adults.

In 2005, the APA Council on Children, Adolescents and Their Families concluded:

Although knowledge is increasing regarding specific pathways and specific brain areas involved in mental disease states, at present the use of brain imaging to study psychiatric disorders is still considered a research tool. . . . . Particular caveats are indicated with regard to brain imaging involving radioactive nucleotides for children and adolescents because of children’s known greater sensitivity to radiation and risk of radiation induced-cancer. At the present time, the available evidence does not support the use brain imaging for clinical diagnosis or treatment of psychiatric disorders in children and adolescents.

The APA’s Psychiatric Evaluation of Adults Guideline (2006) states:

In patients with schizophrenia and mood and anxiety disorders, structural and functional neuroimaging studies have reported differences between patients and healthy control persons as well as differences in some patient subgroups and in responders and nonresponders to some treatments. Nevertheless, the clinical utility of neuroimaging techniques for planning of individualized treatment has not yet been shown. Further research is needed to demonstrate a clinical role for structural and functional neuroimaging in establishing psychiatric diagnoses, monitoring illness progression, and predicting prognoses.

Dr. Amen claims to be able to choose the best therapy based mainly on scan results, but this claim is supported only by anecdotal evidence and testimonials.

The following questions might be useful for evaluating Dr. Amen’s claims:

• Do patients treated at the Amen Clinics do better than patients treated by competent professionals who do not use SPECT?
• Are the SPECT findings consistent enough that blinded observers could agree on the diagnosis from the scan alone?
• What are the rates of false positives and false negatives?
• Have the effects of different treatments on the scans actually been compared?
• What is “brain balance,” and how is it measured?
• What does the scan tell us that would change how we treat a patient?
• Does Dr. Amen claim that SPECT can help evaluate the patient’s “soul”? If so, what gets measured?
• Why did Dr. Amen leap into clinical applications, writing for the public, appearing on television, and lecturing about findings that most doctors would consider preliminary?

I believe it is improper to charge thousands of dollars for a test that has not been validated and may not be safe. I don’t think any of Amen’s research has provided clear evidence that patients who have had SPECT scans have superior clinical outcomes to adequately treated patients who have not been scanned. That’s really the bottom line—especially with an expensive test that involves significant radiation. At the very least, he should be describing the test as experimental.

Some of Dr. Amen’s treatment suggestions also worry me. For example, he recommends: (a) uses for dietary supplements that are not supported by good evidence, (b) EMDR (a highly questionable approach), and (c) hyperbaric oxygen therapy for conditions not generally considered to warrant such therapy.

I don’t doubt that many patients who visit the Amen Clinics are helped. The key question, however, is whether or not SPECT scanning is justifiable for most of them. I, personally, would not undergo the test at Dr. Amen’s clinic even if it were free. In my opinion, based on current knowledge, the possibility of harm outweighs any potential benefit. Pictures showing that “this is your brain on drugs” may impress some people, but I am far more impressed by quantifiable data (such as tests of mental performance) and clinical consequences (such as improved behavior) than by nonspecific pictures of “holes” in the brain.

Amen Responds

This article was originally posted in 2005. In 2007, attorneys representing Amen complained to Dr. Stephen Barrett that it was unfairly negative. Our response included questions similar to those above. To read the answers we received and my comments on these answers, click here. For a more recent analysis my me, click here.

For Additional Information

• Aetna Clinical Policy Bulletin on SPECT
• Aetna Clinical Policy Bulletin on Hyperbaric Oxygen Therapy
• APA Report on Brain Imaging and Child and Adolescent Psychiatry
• Brain Scans As Mind Readers? Don’t Believe the Hype.
• CIGNA HealthCare Coverage Position on SPECT
• Dr. Amen’s Love Affair with SPECT Scans
• Eye Movement Desensitization and Reprocessing (EMDR)
• Amen’s Response to Criticism on Quackwatch

Dr. Hall is a retired family practitioner and Air Force colonel who resides in Puyallup, Washington. She contributes frequently to Skeptic, Skeptical Inquirer, and the Science-Based Medicine Blog.

This article was revised on November 15, 2007.

Daniel G. Amen, M.D., runs the Amen Clinics, writes books, gives lectures, maintains a Web site, and makes other media appearances. He recommends single photon emission computed tomography (SPECT) to help diagnose and manage cases of brain trauma, underachievement, school failure, depression, obsessive compulsive disorders, anxiety, aggressiveness, cognitive decline, and brain toxicity from drugs or alcohol. He claims to use SPECT to “re-balance a brain whose activity patterns are clearly abnormal.” He describes SPECT as a “window into the hardware of the soul.” He claims that SPECT scanning provides “guidance in the application of specific medications or other treatments such as supplements, neurofeedback, transcranial magnetic stimulation, and hyperbaric oxygen therapy.”

In 2005, Quackwatch published an article in which I expressed skepticism about Amen’s work. In 2007, attorneys representing Amen complained that the article placed him in a negative light that was unfair. Our response included questions similar to those I raised in my article. Here are the questions, the answers we received from Attorney Gayle Mayfield-Venieris of Mayfield & Associates, and my comments about the answers.

Question: What evidence is there that patients treated at the Amen Clinics that have SPECT tests do better than patients treated by competent professionals who do not use SPECT? Has any case series or controlled trial demonstrated such benefit?

Amen response: Amen Clinics tracks treatment response among its patients. 85% of our patients report a high degree of satisfaction with our services. We are not a typical psychiatric clinic. We typically see patients who have failed 3 or 4 other mental health professionals, and who have an average of 3.5 psychiatric disorders using standard DSM diagnostic measures. No one keeps response rates on such a complex diagnostic group, yet our results are very encouraging.

Comment by Dr. Hall: This is an admission that there is no evidence. High satisfaction rates are not relevant to the question of efficacy. I don’t doubt that Dr. Amen helps many of the people who consult him. The key question, however, is whether or not SPECT scanning is justifiable for most of them.

Question: Are Dr. Amen’s SPECT findings consistent enough that blinded observers could agree on the diagnosis from the scan alone?

Amen response: We never make the diagnosis from the scan alone. We treat whole people, not brain scans. Having said that, we have a high degree of inter-rater reliability in reading the scans and teach others how to read them with the same accuracy.

Comment by Dr. Hall: This admits that their scans have a low specificity, and that they are relying in part on subjective factors to make their diagnoses.

Question: What are the rates of false positives and false negatives?

Amen response: For which disorders? Children, adults and the elderly are all treated at Amen Clinics. SPECT is a very reliable measure of blood flow and activity patterns in the brain. We always use it with clinical information. If you take our work with ADHD, we have scan patterns that predict with 85% accuracy who will respond and who will get worse with stimulant medication.

Comment by Dr. Hall: The answer is “We don’t know.” And unless it is published for peer review, and replicated, the 85% claim for ADHD remains questionable.

Question: Have the effects of different treatments on the scans actually been compared? If so, how and where has such data been published?

Amen response: We have published a study on EMDR and have one in the works on meditation. On Amen Clinic’s Web site, we have a “medication and treatment response section” where we list many scientific abstracts concerning before and after treatment with SPECT.

Comment by Dr. Hall: Since EMDR itself has not been validated, I do not believe it is possible to use it to validate SPECT results. Before-and-after treatment scans are meaningless until they are put into perspective in a controlled study. If a scan changes after treatment, it should be asked whether other treatments or placebo might lead to the same change. Amen is claiming to base treatment choices on scans, but he hasn’t established a firm basis for those choices. 

Question: What is “brain balance,” and how is it measured?

Amen response: We measure it through before and after SPECT studies. We look for three things: (i) areas of the brain that work well; (ii) areas of the brain that work too hard; and (iii) areas of the brain that do not work hard enough. We also compare our work through a large normal database that we have. The goal is to balance brain function, such as calm the overactive areas and enhance the underactive ones.

Comment by Dr. Hall: The statement above does not define balance or state how it is quantified.

Question: What do SPECT scans show that should change how a patient is treated?

Amen response: Many things:

• SPECT shows the function or dysfunction of specific brain regions implicated with specific problems, such as the prefrontal. cortex with executive function and the medial temporal lobes with getting information into long-term storage. Thus, we can target brain systems, not just vague DSM diagnoses.
• SPECT shows unexpected findings that may be contributing to the problem(s), such as toxicity, potential areas of seizure activity, or past brain trauma. This dramatically changes treatment,’ such as eliminating the toxin.
• SPECT shows potential underlying seizure activity that may be contributing to the problem (often more accurately seen by SPECT than standard EEG, especially in the areas of the medial temporal lobes).
• SPECT shows specific target areas for treatment, such as an overactive anterior cingulate gyrus (seen with OCD spectrum disorders) or an underactive temporal lobe (seen in seizure disorders and other disorders such as trauma).
• SPECT shows the specific effect of medication on the brain and subsequently how to adjust dosages. Patients often report that SSRI’s are helpful but also cause demotivation or memory problems. SPECT studies can show when SSRI’s are causing excessive decreased prefrontal or temporal lobe activity that clinical evaluation only hints at.             .
• SPECT scans helps provide real, demonstrable answers to refractory symptoms and, in addition, helps clinicians ask better and more targeted questions—about toxic exposure, brain injuries, anoxia, inflammation, or infection, that patients may have initially denied or forgotten.
• SPECT scans help clinicians prevent mistakes or hurting patients by prescribing the wrong treatments, such as unnecessarily stimulating an already overactive brain or calming an underactive one.
• SPECT scans help to evaluate those who may be. at risk for dementia—the brain starts to change long before people show symptoms of dementia. One. study reported that there has to be a loss of 30% in the hippocampus before symptoms occur. Using autopsy data in 54 patients, Bonte reported that brain SPECT had a positive predictive value for Alzheimer’s disease of 92% . SPECT scans can help differentiate between types of dementia.
• SPECT scans can identify specific areas of the brain hurt by trauma to better target treatment and help deal with insurance, legal and rehabilitation issues.
• SPECT scans can often identify a specific cause or reason that contributes to recovering alcoholics, drug addicts, eating disordered, or sexual addicts relapse behavior in their recovery from an addictive process. For example, the patient may have suffered ‘an injury in the prefrontal cortex or temporal lobes or have overactivity in basal ganglia, limbic system, or prefrontal cortex, each of which could contribute to the relapsing behaviors.
• SPECT scans allow patients to have a specific physical representation of their problems that is accurate and reliable.
• SPECT scans help develop a deeper understanding of the problem and lead to decreased shame, guilt, stigma and self-loathing. They can increase self-forgiveness. Patients can see that their problems are, in part, a medical problem.
• SPECT scans help to increase compliance. The images can powerfully influence a patient’s willingness and ability to accept and adhere to a treatment program as they realize they are not taking medication for their problems of anxiety, depression, rage, or ADD, but rather to optimize brain function, an idea similar to needing glasses for their eyesight.
• SPECT scans may help families understand when things will not get better, such as having permanent brain damage from an injury, which allows patients and families to accept the condition and provide accordingly.
• SPECT scans help substance abusers decrease denial and increase motivation for treatment by seeing the damage they have done to their own specific brain. SPECT scans can help motivate recovering alcoholics and addicts to continue in sobriety as it becomes clear that further use will cause increased brain damage.
• SPECT scans. physically show patients, how treatments have impacted (improved or worsened) brain function.
• SPECT scans help motivate verbally and physically abusive spouses to follow medication protocols by seeing they have a physical abnormality that may be contributing to their problems.
• SPECT scans are useful for. patients who are suffering with a “post chemotherapy toxic brain.” It gives them insight into their cognitive struggles and also helps their doctors see what is physical and what might be emotional or traumatic sequelae of having cancer.
• SPECT scans allow patients to understand why specific treatments are indicated, which medications are helpful, and why certain medical interventions are chosen.

Comment by Dr. Hall: The above list contains lots of claims but little substance. For instance, do we really need thousands of dollars worth of radioactive injections and scans to “help patients understand” the treatments we prescribe? Where are the objective data showing what percentages of patients have a better outcome with this information?  This reminds me a bit of the ultrasound pictures of fetuses offered at some malls—nice to have for your scrapbook, but not medically necessary or useful..

Question: Does Dr. Amen claim that SPECT can help evaluate the patient’s “soul”? If so, what gets measured?

Amen response: No. Dr. Amen uses the analogy that the brain is the Hardware of the Soul, but has never said he could measure the soul. You can read his book, “Healing the Hardware of the Soul,” to get a better understanding of his thoughts in this area.

Comment by Dr. Hall: The first chapter of the book is called “The Brain Is the Soul’s Fragile Dwelling Place: The Feedback Loop Between the Brain and the Soul Offers New Answer.” It claims that the brain-soul connection can “help us understand good . . . evil . . . sin. . . . love . . . hate . . . and. . . child abuse.” The passage in which this claim appears also speculates that “Mother Teresa and Mahatma Gandhi had optimal brain function” whereas “Adolph Hitler and other brutal dictators had faulty brain wiring.” The book describes SPECT as a “window into the hardware of the soul.” The book also promises that “clinically based brain-soul healing techniques . . . will help you optimize your brain and improve your relationships, work, and spiritual connections in the deepest ways possible.” It seems to me that Dr. Amen regards the soul as more than an analogy.

Question: Why did Dr. Amen leap into clinical applications, writing for the public, appearing on television, and lecturing about findings that most doctors would consider preliminary?

Amen response: Dr. Amen started this work in 1991. At the time, other doctors, including academics, were using this technique, including Ismael Mena at UCLA, Nora Milne at UC, Irvine, James Merikangas at Georgetown, and Thomas Jaeger at Creighton. The American Psychiatric Association sponsored all-day workshops on brain SPECT in child and adult psychiatry. Dr. Amen has taught at the APA annual meeting on five occasions. He also started publishing on his work. The Society of Nuclear Medicine has procedure guidelines on the use of SPECT in clinical practice and recommends it for brain injury and dementia, two common uses of the Amen Clinics. Dr. Amen is a clinician and he found dramatic positive results from using the scans. Others were doing the work as well in 1991. Dr. Amen is the most visible because of his writing and speaking skills, and his ability to attract patients.

Comment by Dr. Hall: The fact that Amen “believed” he was seeing dramatic positive results does not mean that his explanation for what he saw was correct. It is all too common for clinicians and patients to deceive themselves. That is why beliefs should be tested with scientific studies. The APA may welcome Amen’s opinions, but its current (2006) Psychiatric Evaluation of Adults Guideline states that “the clinical utility of neuroimaging techniques for planning of individualized treatment has not yet been shown.”

Question: Do the Amen Clinics use a consent form that indicates what uses of SPECT are experimental? If so, please supply me with a copy.

Amen response: Amen Clinics has a general. consent form for SPECT. It states some professionals consider SPECT experimental, but many do not: Amen Clinics has nearly 2,000 mental health professionals who refer patients to its clinics. You can see Amen Clinics’ SPECT Consent form in its intake packet.

Comment by Dr. Hall: The pertinent paragraph in the consent form states:

Brain SPECT studies are widely recognized as an effective tool for evaluating brain function in seizures, strokes, dementia and head trauma. There are literally thousands of research articles on these topics. In our clinic, based on our fifteen years of experience, we have developed this technology further to evaluate neuropsychiatric conditions.  Unfortunately, many physicians do not fully understand the application of SPECT imaging and may tell you that the technology is experimental, but over 1,000 physicians and mental health professionals from across the United States have referred patients to us for scans.

This is not a fair representation of the facts. Doing research that follows a clearly stated protocol that can lead to valid conclusions is one thing. But exposing patients to expense and unnecessary radiation based on hunches is something else. A consent form is supposed to place a procedure in proper perspective. It’s true that SPECT has been extensively studied and has recognized medical uses. However, the above paragraph fails to make it clear that many (and possibly most) of the Amen Clinic’s scans are taken for nonrecognized uses—such as a “general brain health checkup.” The consent form acknowledges that opposition exists, but it implies that physicians who consider SPECT experimental for these purposes are ignorant. It should state that the prevailing medical opinion does not support SPECT use for most psychiatric disorders.

The front page of the 20-page intake packet states that the clinic does not bill insurance but provides receipts that may be submitted to insurance carriers for reimbursement. I believe this statement is misleading because insurance companies do not cover SPECT scans for most of Amen’s patients. SPECT is indeed approved for a few specific indications, but the Amen Clinic is using it for other indications that are clearly experimental at this stage. The policy statements of Aetna, BlueCross BlueShield of Georgia, CIGNA provide detailed discussions of what these companies considers proven versus experimental uses.

The letter from Attorney Mayfield-Venieris also stated:

There is no indication that Dr. Hall has any clinical experience with SPECT or any other experience that justifies her assertions or qualifies her as an expert in this field. On the contrary, Dr. Hall is a family physician and cites no references in support of her opinions.

No, I do not have any clinical experience with SPECT, but I am as qualified as any other critical thinker to read the claims on Amen’s Web site and recognize that they are not backed up with good evidence. Experience is not an issue; I would not have to have experience practicing homeopathy to determine that it is bogus, or experience doing C-sections to determine that they save babies’ lives. Experience can even be a detriment because those who work in the field may be unduly influenced by personal experiences, testimonials, and financial interests, and sometimes it takes an outsider to see things more objectively.

It is natural to be enthusiastic about any new imaging or treatment procedure, but initial promises are not always fulfilled. If Dr. Amen’s method is not as good as he thinks, he is subjecting patients to unnecessary radiation and expense; if it is as good as he thinks, his lack of rigorous research is postponing the day when it will be generally recognized and offered to everyone and paid for by insurance. There are arguments for doing everything possible to help difficult patients before the research is complete, but there are also arguments for limiting treatment to closely monitored research settings until the truth is known.

For Additional Information

• Aetna Clinical Policy Bulletin on SPECT
• Aetna Clinical Policy Bulletin on Hyperbaric Oxygen Therapy
• CIGNA Coverage Position on SPECT
• Eye Movement Desensitization and Reprocessing (EMDR)

Dr. Hall is a retired family practitioner and Air Force colonel who resides in Puyallup, Washington.

This article was posted on November 12, 2007.

Nicholas Perricone, M.D., has written three similar books: The Wrinkle Cure [1], The Perricone Prescription [2]; and The Acne Prescription [3]. All contain many claims that are questionable, controversial, fanciful, unsupported by published evidence, or just plain wrong. Although he mentions standard skin-care treatments, sometimes favorably, his books provide little guidance about when they might be appropriate or sufficient. Although he provides long lists of references, practically none of them directly support what he promises. Despite this, his books have made best seller lists and the Public Broadcasting System (PBS) has featured him during fundraising campaigns.

Perricone claims that following his advice can quickly improve appearance, improve general health, increase mental sharpness, and make people more energetic. In The Perricone Prescription, for example, he promises to “stop skin from wrinkling, sagging and dulling” and says that, “being wrinkle free for life is achievable” if you follow his 28-day program. He offers “increased vitality, sharpened cognitive and problem-solving skills, and improved memory” and claims that “looking and feeling old is now an option.” He also describes his program as “proven . . . to reverse the many signs of premature aging and stop its progress.” [2:1-5]

Background History

Dr. Perricone makes much of his connection with Yale University. He is a former assistant clinical professor of dermatology at Yale University School of Medicine—an unpaid position in which he supervised students from time to time. However, his affiliation ended in 2002 when his contract was not renewed. In an interview reported in the Washington Post, Perricone said that the school authorities had been very critical of his books, public appearances, and anti-inflammation theories [4]. The report also noted that he subsequently became an adjunct (visiting) professor at Michigan State University’s College of Human Medicine and pledged $5 million to establish the Perricone Division of Dermatology there.

Perricone’s books are sprinkled with statements that his ideas are based on his own research. However, the extent and quality of this research is unclear. A PubMed search for his name brought up only six citations, of which only two appear to be original research, both on topical glycolic acid [5,6]. His books describe situations in which he tested various ideas in a few patients, usually over a short period of time, but he provides few details and apparently published none of those findings in medical journals.

Most of Perricone’s recommended strategies are nutrition-related. In The Wrinkle Cure, he describes how his interest in this subject developed:

My own fascination with nutrition was sparked during my undergraduate days, before I entered medical school. I had always suffered from sallow, acne-plagued skin, allergies, and fatigue, so I started reading everything I could find on the subject—which, at the time, meant pretty much everything written by Linus Pauling, Ph.D. . . . and Adelle Davis. I began experimenting with vitamins on my own, and the results were gratifying. My skin and allergies improved, and I had much more energy. . . .

When I entered medical school, however, my interest in nutrition made me an eccentric. My classmates thought I was nuts because I popped vitamins after meals and bundled up to go running in the dark, cold mornings of Michigan winters. [1:3,6].

The references to Pauling and Davis may help explain why Perricone spouts so many strange ideas. Although Pauling was a great chemist, his late-in-life beliefs in vitamin megadoses have been thoroughly discredited [7]. Adelle Davis achieved great popularity during the 1970s, but close examination of her writings indicates that she consistently misinterpreted research reports or simply made things up [8]. The irrational nutrition-related beliefs Perricone absorbed before going to medical school were apparently untouched by his science-based education.

Perricone’s “Prescription”

The Perricone Prescription provides detailed instructions that include exactly what foods to eat, when and in what order to eat them (proteins first), what exercises to do, what supplements to take with each meal, and what to apply to your skin at what times of day. He even includes a section of recommended recipes. His program includes:

• Diet: Three meals and two snacks daily, high quality protein (above all, wild salmon), “good” fats, and carbohydrates with a low glycemic index. No sugar. A long list of prohibited foods including carrots, bananas, duck, potatoes, flour, raisins, corn, soda (even diet soda) and many others.
• Nutrient supplements: 25 different ones, some taken more than once a day: alpha lipoic acid, vitamins A, B1, B2, B3, B5, B6, B12, folate, biotin, vitamin C, vitamin C ester, vitamin E, calcium, chromium, magnesium, selenium, l-carnitine, acetyl l-carnitine, coenzyme Q10, l-glutamine, omega-3 fatty acids, grape seed extract, gamma linoleic acid, and turmeric.
• Skin treatments: sunscreens, cleansers, moisturizers, eye-care products and enriched night cream; various creams with ingredients such as vitamin C, vitamin C ester, alpha lipoic acid, DMAE, PPC, tocotrienol, and olive oil.
• Exercise: For strength, endurance, and flexibility; 40 minutes a day, 6 days a week.
• Miscellaneous advice: 8-10 glasses of spring water a day; no tobacco, coffee, or alcohol (but tea is allowed); melatonin for sleep if needed.

Perricone markets his own line of high-priced nutritional supplements and skin care products worldwide. Typical prices from his Web site include:

$120 for 4 oz alpha lipoic acid and other ingredients for spider veins

$570 for 2 oz neuropeptide facial conformer

$195 for a 30-day supply of supplements for weight loss

$438-458 monthly for the entire skin and nutrient program based on skin type [9].

In November 2003, The Wall Street Journal reported that Perricone’s company (N.V. Perricone) grossed $11.9 million in 2001, $42.4 million in 2002, and was expected to top $52 million in 2003 [10]. The article also noted that Perricone’s PBS fundraising specials had generated over $4 million for PBS in both 2001 and 2002.

Questionable, Unverifiable, and Erroneous Statements

Perricone says that he gradually came to believe inflammation is the underlying cause of aging and of many diseases and that his own research shows that treating inflammation would reverse the aging process. In fact, he characterizes inflammation as “the key to the whole process of disease of every type.” [2:20] Inflammation is indeed associated with many diseases, but it is not always clear whether the inflammation is a cause or a result. Nor is it clear that nutrients that help fight inflammation (such as vitamins C and E) do anything to reverse most of those diseases. Inflammation is characterized by the presence of white blood cells in a skin biopsy specimen. However, their presence can be due to hundreds of different causes, including systemic diseases, infections, foreign substances, insect bites, autoimmune processes, viruses, genetic abnormalities, and malignancies. Inflammation can be nonspecific and even be due to scratching. And the presence of white cells doesn’t necessarily mean there are any associated clinical or molecular abnormalities [11]. Inflammation doesn’t always increase with age; the inflammatory response to skin injuries actually decreases as you get older [12].

Dietary deficiencies can cause inflammation in the skin (pellagra is a classic example), but there’s no evidence that supplementing an already adequate diet would prevent inflammation. Nor is there evidence that inflammation causes wrinkles. (The leading controllable factors are sun damage and cigarette smoking.) If Perricone truly wanted to test his theories, it would not be difficult. They could be tested on an animal model with biopsies before and after various treatments. Also, one could look for epidemiologic data on patients taking prednisone or nonsterioidal antiinflammatory drugs (NSAIDS) to see whether they have fewer wrinkles [13].

In acne, hair follicles become plugged with comedos composed of dead skin cells and sebum (a mixture of fats and waxes). If bacteria invade, the surrounding skin can become inflamed, and pimples or pustules may form. Most people with acne have a mild (noninflammatory) form and get occasional whiteheads or blackheads. There is little evidence that acne is related to diet. If self-experimentation suggests that a specific food aggravates acne, avoiding the food may be reasonable, but Perricone’s sweeping claims have no scientific support.

Page 33 of The Perricone Prescription illustrates an extraordinary degree of illogical thinking about nutrition. After describing a breakfast consisting of orange juice, cold cereal with banana, skim milk, a low-fat bran muffin, margarine and coffee, the book states:

As [Megan] drinks the juice, she is causing a burst of inflammation in her body as the juice floods her bloodstream with sugar. This causes a sharp spike in her insulin levels, resulting in a rapid acceleration of the aging process, increasing the risk of heart disease, every form of cancer, memory loss, and mental deterioration. To add to the problems, the sugar flood is causing the collagen to cross-link, laying the foundation for the birth of wrinkles, sagging, and loss of tone.

Page 45 contains an equally ridiculous passage which concludes that eating bagels, cookies, or caffeinated, sugary sodas—which Perricone inappropriately regards as addicting—places people at risk for “exhausting our pancreas, burning out our adrenals, and placing us at risk for insulin resistance and diabetes.”

Here are more of Perricone’s claims followed by our comments in brackets:

• Substances like olive oil “penetrate, strengthen, and refresh your skin cells.” [What do “strengthening” and “refreshing “your skin cells mean?]
• You look puffy the morning after eating Chinese food because of an inflammatory response to what you ate. [Any puffiness would probably be because the salt and MSG caused the body to temporarily retain water.]
• When you are mildly dehydrated your metabolism drops and you gain weight. [Actually, dehydration usually decreases appetite and results in weight loss.]
• His program works by a synergy between diet, supplements, skin care, and exercise. [Synergy means the combination works better than the sum of the individual components. There are no published data comparing the combination with each factor alone or with other combinations.]
• Slow, steady release of insulin into our bloodstream keeps us younger. [He doesn’t indicate how he thinks this could be measured. It can’t.]
• Sugar makes the insulin receptors on the cells burn out. [Untrue]
• The contemporary American diet rarely contains enough protein. [Untrue. Americans tend to consume more protein than they need.]
• DMAE is your magic bullet for great skin tone. [A PubMed search shows only one small study that showed an effect of topical DMAE on skin [14]]
• There are probably unidentified components of salmon that promote health and slow aging. [This possible, but he has no basis for saying it is probable.]
• Salmon improves manic-depressive patients who don’t respond to medication. [He mentions a study but doesn’t give a citation for it, and it is not listed in PubMed.]
• Socrates prescribed olive oil for various diseases. [So what?]
• Olive trees live for centuries and re-grow after being cut to the ground. [Implied benefits from olive oil for human longevity by magical analogy.]
• Adults should limit milk intake because they may have lactose intolerance or allergies. [It would make far more sense to base an individual decision on whether the individual actually is intolerant.]
• Alcohol is bad, so hard liquor is bad, but wine is OK. [A glass of wine and a shot of whiskey contain approximately the same amount of alcohol.]
• Avoid tap water; drink spring water. [Bottled water is not tested as thoroughly as public water supplies and many brands fail to meet tap water standards. Several surveys have found more contaminants, bacteria, etc. in some bottled waters than in tap water. Tap water is generally safer.]
• Spring water flushes toxins from the body. [What toxins? What difference does it make whether it’s spring water or other fluids?]
• Everyone needs 8-10 glasses of water a day. [A comparison of two diets, one with and one without plain water, showed no difference in hydration whether water was supplied by plain water or other beverages [15]].
• The same substances work on the central nervous system and the skin. [A personal observation, not otherwise supported. He theorizes that the nervous stem and skin are alike because they originated in the same one of three cell layers of the early embryo.]
• Vitamin C deficiency causes wrinkles. [Sun exposure and tobacco use are the only recognized factors known to cause wrinkles.]
• Growth hormone is the true “youth hormone.” [Only in the sense that it helps youths grow into adults!]
• Coffee causes weight gain, while tea cause weight loss. [Neither is correct.]
• Lack of essential fatty acids can cause miscarriage. [A PubMed search for fatty acids and miscarriage showed only one study in the blue fox; it showed just the opposite—that supplementing the diet with essential fatty acids in the form of evening primrose oil increased the rate of miscarriage.]
• Alpha-lipoic acid is an anti-aging drug. [There are no known anti-aging drugs.]

Lack of Science

Dr. Perricone would be more credible if he could show us a study demonstrating that people who followed his prescription lived longer, had “younger” skin demonstrated by objective measures, or felt better compared to those on a placebo program—or that they were better in any measurable way. Instead, he provides only testimonials, exaggerated claims, partial truths, and incorrect statements. He cherry-picks possibly supportive studies from the literature and ignores contradictory studies. He cites lots of lab studies (in vitro or in animals), but few that demonstrate any clinical effects in humans. The diet he recommends is low in calories, and weight loss alone may improve the way his patients look and feel. His advice about tobacco and sunscreens is appropriate, but there is little science behind the rest of his program. He seems to have gathered every nutrient and skin cream he had any reason to hypothesize might work and advised using all of them. A more rational approach would have been to first see which ones really worked, and later to see if any combinations of the effective agents worked better than a single agent. No scientist worth his salt does experiments without controls; Perricone treats everyone, so that there is no basis for comparison.

The Perricone Prescription includes full-color before-and-after photographs of women who tried its 28-day program. These photos are far from convincing, with differences in position, lighting, facial expression, makeup, and weight loss that could affect the appearance. The reader is asked to make purely subjective judgments and to notice undefined qualities such as “vibrancy,” “radiance,” and “improved contours.” Dr. Hall’s own informal poll indicated that most people prefer some of the “befores” to the “afters.”

A Washington Post reporter’s experience illustrates how inexact this type of study can be. Page 12 of The Perricone Prescription states that, “Without exception, every patient who has tried the Three-Day Nutritional Face-lift has had good results, and has returned convinced that my Wrinkle-Free Program works. And you will, too.” Noting that this statement is preposterous, the reporter decided to test the program on herself. On the fourth day, she had lost three pounds, and it seemed to her that her pores were smaller, her eyelids less heavy and her chin line “less blurry.” However, 18 out of 26 of her friends who looked at before-and-after photographs said she looked younger before she started the program [4].

Perricone and his patients may agree that they look better after treatment, but the photographs are the only attempt he makes to present objective evidence. It seems rather silly to depend on subjective impressions and photographs when several objective methods of measuring improvement are available. Reputable published skin studies have used skin surface measurements by semi-automated computer morphometry, laser profilometry, and skin biopsies whose specimens are examined with immunohistochemistry and electron microscopy [16]. Moreover, the creams and lotions he recommends could easily have been evaluated by applying them to one side of the face and using the other side as a control.

Perricone provides little information from sources that disagree with him. Mercury in fish is a possible concern with a high salmon diet, but he doesn’t even mention it. He lists all the positive effects of nutrients but omits to mention the toxic effects of high doses, even though some of his supplements may push people into the toxic range. He does not mention that only three nutritional factors have ever been found to correlate with longer life in mammals: calorie restriction, and restriction of methionine and tryptophan—in rodents [17].

Overview

Dr. Perricone has mixed a pinch of science with a gallon of imagination to create an elaborate, time-consuming, expensive, prescription for a healthy life and younger skin. There is no reason to think his program is more effective than standard measures. Although some of his advice is standard, most of his recommendations are based on speculation and fanciful interpretation of selected medical literature. He makes lots of money by convincing patients and consumers, but he hasn’t succeeded in convincing critical thinkers, doctors, scientists, or anyone who wants to see hard evidence. Perricone’s “prescription” isn’t science; it’s creative salesmanship.

For Additional Information

• Paula Begoun’s Product Review

References

1. Perricone N. The Wrinkle Cure: Unlock the Power of Cosmeceuticals for Supple, Youthful Skin. New York: Warner Books, 2000.
2. Perricone N. The Perricone Prescription: A Physician’s 28-Day Program for Total Body and Face Rejuvenation. New York: HarperCollins, 2002.
3. Perricone N. The Acne Prescription: The Perricone Program for Clear and Healthy Skin at Any Age. New York: HarperCollins, 2003.
4. Weiss S. Got wrinkles? Go fish. Washington Post, Dec 17, 2002.
5. Perricone NV, DiNardo JC. Photoprotective and antiinflammatory effects of topical glycolic acid. Dermatologic Surgery 22:435-437, 1996.
6. Perricone NV. Treatment of pseudofolliculitis barbae with topical glycolic acid: a report of two studies. Cutis 52:232-235, 1993.
7. Barrett S. The dark side of Linus Pauling’s legacy. Quackwatch Web site, May 5, 2001.
8. Barrett S. Adelle Davis’s legacy. Quackwatch, March 27, 1999.
9. Supplements. N.V. Perricone, M.D., Cosmeceuticals, accessed Feb 27, 2004.
10. Beatty S. Hot at the mall: Skin-care products from physicians. The Wall Street Journal, Nov 14, 2003, pp A1, A8.
11. Bosset S and others. Photoageing shows histological features of chronic skin inflammation without clinical and molecular abnormalities. British Journal of Dermatology 149:826-835, 2003.
12. Swift ME, et al. Age-related alterations in the inflammatory response to dermal injury. Journal of Investigative Dermatology 117:1027-1035, 2001.
13. Bredt R. Personal communication to Harriet Hall. M.D., Feb 6, 2004.
14. Uhoda I and others. Split face study on the cutaneous tensile effect of 2-dimethylaminoethanol (deanol) gel. Skin Research and Technology 8:164-167, 2002.
15. Grandjean AC and others. The effect on hydration of two diets, one with and one without plain water. Journal of the American College of Nutrition 22:165-173, 2003.
16. Beitner H. Randomized, placebo-controlled, double blind study on the clinical efficacy of a cream containing 5% alpha-lipoic acid related to photoageing of facial skin. British Journal of Dermatology 149:841-849, 2003.
17. Zimmerman JA and others. Nutritional control of aging. Experimental Gerontolology Jan-Feb;38(1-2):47-52, 2003.

Dr. Hall is a retired family practitioner and Air Force colonel who resides in Puyallup, Washington.

This article was revised on August 12, 2004.

AI’ve been discussing “alternative medicine” with a friend who is very intelligent but has no training in science. She uses chiropractic, magnets, vitamins, and acupuncture, and she says she doesn’t care what science says because science can be wrong, she trusts her personal experience more, and if something “works” for her, she doesn’t care how it works—she’ll just keep using it. She is sure that any beneficial effects are genuine because the methods work for some things and not others. She assumes that a placebo would work reliably every time and that that any pain suppressed by a placebo effect would immediately return when the placebo was discontinued. She doesn’t seem to realize that well-designed studies are needed to tell whether a product works or whether improvement is just the natural course of the ailment. I tried to explain that the very concept of a placebo-controlled trial depends on the fact that people can’t distinguish between placebo and active drug. I tried to explain the difference between something that “worked” (i.e. pain gone after treatment) and something that WORKED (it was the treatment that made pain go away). As far as continuing to use what “works,” I told her:

I go by my experience too. But I recognize that my experience may have misled me. I understand how that can happen, and I have seen it happen too often to imagine I am exempt. If a baseball player has found that he plays better when wearing his lucky underwear, that’s may be sufficient reason to keep wearing it but not enough evidence to conclude that underwear affects athletic performance.

She depends on testimonials for her information: she chooses to try a method by talking to friends with a similar problem and hearing what works for them. If the method appears to be safe and reasonably inexpensive, she figures she can’t lose anything by trying it. So I told her about Perkins tractors. They had plenty of testimonials; even George Washington used them. They went out of fashion after it was discovered that wooden sticks painted to look like tractors worked equally well. So they met her requirements: testimonials, low expense, safety. I asked her whether she would try the real ones or the wood ones first, since they both worked. She declined to answer on the basis that they weren’t around any more and none of her friends were really using them.

She uses Nikken magnets and says she wouldn’t trust any studies on magnetism that didn’t use that particular brand because they were better. I sent her a list of links with studies specifically done with Nikken magnets, with information debunking magnets in general and specifically Nikken magnets, and about the Nikken company and regulatory action taken against them for false claims. She said she didn’t have time to read them, but it wouldn’t change her mind anyway, because Nikken magnets worked for her. She ended the discussion, agreeing to disagree, saying, “You have raised some valid points and made me think about my choices, which is good. I hope that some of the points I’ve made have done the same for you.” I answered:

I’m afraid your points have not made me think, because I’ve heard them all before, and have already researched the facts, evaluated the arguments and rejected them. I work with these issues on a daily basis; I’ve read lots of books and articles, I’ve exchanged e-mails with world-class experts on both sides and I’ve heard the best that alternative medicine has to say for itself. The fact that our discussion made you think but didn’t make me think tells me that I have read what you have about alternative medicine and you have not read what I have about alternative medicine, pseudoscience, critical thinking and the psychology of how people deceive themselves.

I’m surprised to see you relying on testimonials and “what works for you” in alternative medicine, just as I would be surprised to see you depend on a friend’s opinion when choosing a car instead of checking out sources such as consumer reports and comparative statistics on reliability, safety, repair history and customer satisfaction. It strikes me as comparable to reading the first three names on a class roster and assuming the class is all women because the first three names happened to be women; you don’t get good statistics if your sample size is too small. I don’t imagine you depend on testimonials when deciding whom to vote for; I suspect you rely more on things like the candidate’s platform, his actions in office, and his voting history.

Small children believe in the tooth fairy. It “works” for them, because they get money every time they put a tooth under their pillow. But as they get older, they usually want to know the “truth.” I asked a gullible friend what she would think of me if I told her I still believed in the tooth fairy. She said, “I’d think that was sweet.” I don’t think it would be sweet, I think it would be pitiful. No matter how satisfying a false belief may be, I prefer the truth.

Some people have the philosophy that they can create their own reality; some prefer wishful thinking, random trial and error, and intuition to rational thinking and testing. The scientific method leads to one consensus answer; all other methods lead to several different, conflicting answers. I have come to believe that the scientific method, while imperfect, is the only valid tool for understanding reality. I like nothing better than changing my mind, because it means I was mistaken and I have been able to correct my mistake. Just as I gave up the tooth fairy, I have given up a whole slew of things, from the reliability of memory to ESP, because my original beliefs were contradicted by the evidence I found.

To rely on testimonials and to not wonder how things work or what science says about them is like having a set of the Encyclopedia Britannica and using it only to press flowers. Our brains are capable of much more and I think it is far more satisfying to use them to look at information that challenges our preconceptions and increases our knowledge.

I do my utmost to keep an open mind, but not so open that my brains fall out. I’m ready to accept any alternative treatment as soon as it is supported by convincing evidence (by the standards of the scientific method). I won’t argue with you about alternative medicine any more, but I do hope you will read some of the arguments from the other side.

For Further Information

• Spontaneous Remission and the Placebo Effect
• Why Bogus Therapies Often Seem to Work
• Common Questions about Science and “Alternative” Health Methods
• Why Extraordinary Claims Demand Extraordinary Proof
• How Quackery Sells

_______________________

Dr. Hall is a retired family practitioner and Air Force colonel who resides in Puyallup, Washington

This article was posted on March 12, 2004.

An evaluation of Dr. John Upledger’s craniosacral therapy illustrates an exercise proposed

for skeptics to develop critical thinking and a better understanding of human psychology

Harriet A. Hall, M.D.

After reading some particularly egregious nonsense, you have probably asked yourself; “How could anyone in his right mind believe that?” There is an answer to your question. In. fact, the person who believes the nonsense will usually provide the answer himself if you give him half a chance. Go to the source. Read the believer’s account of how he came to believe. He will probably give a clear enough description that you can see where he went wrong. It will give you an insight into human. psychology. It will probably ais he very entertaining. Here is an example of how it works.

I recently heard of craniosacral therapy. It is a method some osteopathic physicians use to restore health by adjusting the bones of the skull and sacrum. Anatomists can demonstrate that the skull bones are fused together in adulthood and cannot move. Other fallacies inherent in the therapy are too numerous to list: craniosacral therapy is totally implausible and has been thoroughly debunked elsewhere.

So how could anyone in his right mind believe in it? To find out, I went to the horse’s mouth. My local library had a book entitled Your Inner Physician and You: CranioSacral Therapy and SomatoEmotional Release, by Dr. John E. Upledger, who is a major proponent of craniosacral therapy. I decided to read his account with as open a mind as I could summon, and give him a fair chance to convince me.

He describes his eureka moment. He was assisting a neurosurgeon by holding the dura (membrane surrounding the brain and spinal cord) steady while the surgeon removed a calcified plaque. He wasn’t doing a very good job of holding still. The surgeon complained. Most of us would have thought our own muscles were at fault; however, Upledger observed that the dura was fluctuating up and down at about ten cycles per minute, overcoming his attempts to hold it still. Nobody had ever observed this before.

He hypothesized that this “craniosacral rhythm” was intrin-sic to human health. Since the cerebrospinal fluid within the dura is in a closed space, the skull bones must move in and out to accommodate the rhythmic changes. The nervous system controls the rest of the body, so if the bones are not moving freely, nerve conduction might be abnormal and health might suffer. Perhaps he had found the basic cause of all disease.

He tried mobilizing the cranial bones through hands-on manipulation, and convinced himself he could feel the bones move one-sixteenth of an inch or more. Patients with autism, seizures, cerebral palsy, headaches, dyslexia, colic, asthma, and other diseases reported dramatic improvement. He found that well people treated with monthly adjustments reported more energy, felt happier, and were sick less often.

He felt he had achieved a glimpse into the “core.” He states, “I’m not quite sure as yet what the core is all about, but I do know that at times the craniosacral system feels like the entrée into the deepest region of the patient’s (and my own) total being. I’m not quite sure as yet what the ‘total being’ is all about, but it feels like the craniosacral system is where it all comes together, whatever it is.”

So far, he had failed to convince me. It seems obvious that he had experienced an illusion (ideomotor activity; as experienced by Ouija boarders and water witchers). His false perception was reinforced when patients seemed to respond to treatment (perhaps from placebo effect, suggestion, hypnosis, a wish to agree with the doctor, the natural tendency of symptoms to improve with time, hands-on massage therapy, or whatever). I found his claims implausible and unbelievable.

This was bad enough, but then he really got carried away.

He thought he had found a “cure-all,” but apparently it wasn’t enough to cure all, since he proceeded to add other treatments to his armamentarium. He discovered tissue memory he found his hands “almost moving by themselves” to certain areas of the patient’s body that seemed to contain some sort of memory of an old injury. He could feel heat and pulsations: under his hands these increased, then decreased until the sensations seemed to stop. At that point the patient’s pain would subside. The patient sometimes felt an emotion (fear, anger) and at that time or later might remember a forgotten injury.

He proceeded to discover energy cysts (energy from an injury supposedly forms a ball deep in the tissues and stays there until released), somatoemotional release (touching the patient and giving permission allows old traumatic memories to surface and ventilate), and healing energy (which he transmits from the fingers of one hand to the other hand through the patient’s body). Next he tried hypnosis. He regressed a patient to age two days, where she remembered her grandmother saying she should never have been born; insight caused her symptoms to disappear. He asked to talk to a patient’s Inner Physician, who would explain the cause of the illness. One Inner Physician appeared to the patient in the form of a seagull and asked to be addressed as “Mermaid.” (I am not making this up.)

He found that combinations of therapies worked even better than one at a time. Multiple hands with multiple therapists got results logarithmically faster. He tried therapy in float tanks: it worked wonders. He tried swimming with dolphins: multiple therapists surrounded the patient and were told to silently encourage the dolphins’ freedom of choice, and to think that the dolphins were at least equal to them in knowledge and skill, and probably superior. (Perhaps this was true.) Dolphins spontaneously came up and touched the therapist’s back to relieve the patient’s symptoms. In one case, they reduced a leg-length discrepancy from three inches to one inch. At the same time the therapists’ own skills were enhanced in “some non-conscious way.”

Onward and upward, enthusiasm undaunted, he tried sound therapy for an orchestra conductor. Hearing a cello play a concert “A” tone caused back pain; “G” relieved upper and lower back pain, while “B” worked only for his upper back.

He would try anything his intuition suggested to him. He sensed that a patient had excess energy, so he grounded the patient’s big toe to a drainpipe with copper wire, and-lo and behold-it worked! He successfully applied the same therapy to a woman with sympathetic reflex dystrophy who was in so much pain she would scream when the therapist’s hand came within three inches of her body (!?). He had her husband connect her to the kitchen sink at home with a thirty-foot copper grounding wire so she could get around the house. (My hus-band says this sounds like a reasonable way to control a wife, but he may be prejudiced.)

Upledger never reports a failure. Everything seems to work for him. With that kind of reinforcement, how could he doubt? He is an intelligent and educated man and is admirable in many ways. You have to respect his creativity, imagination, and the courage to try unorthodox things in defiance of traditional medical education. New ideas should be encouraged: eventually some will lead to breakthroughs. It is obvious that he believes he has helped patients and patients believe they have been helped.

If the skull bones really could move as much as one-sixteenth of an inch, it would be easy enough to measure and prove it. Unfortunately, Upledger is so convinced his treatments work that he has no motivation to prove the effect is real. He wants to keep on truckin’ and to “spread the word.” He doesn’t pause to reflect that if his hypotheses were demon-strated to be true, it would be a major scientific discovery worthy of a Nobel Prize. He doesn’t stop to think that he is subjecting his patients’ money, time, health, and perhaps even their lives to unproven treatments.

Evolution has given the human mind a great ability and desire to find patterns everywhere and the motivation to seek explanations. If we can’t find meaning, we will invent it. If something seems to work once, we will repeat it with the expectation that it might work again. We have a tendency to jump to conclusions because there is a survival value to deciding quickly. We rely strongly on personal testimonials, because until recently (in an evolutionary sense) that’s all we had to go by. As any magician knows, our senses are prey to many kinds of illusions. Illusory perceptions allow us to accomplish things we couldn’t otherwise do; for instance, our brains fill in the blind spot in our visual field. All these traits were instrumental in our developmental success as a species.

Every one of us can be fooled, so don’t cast any stones. Be skeptical of weird ideas, but go to the source and listen carefully and sympathetically. Approach it as a case study of self-deception. Try to pinpoint where logic went wrong. You might learn how to better avoid making mistakes yourself, and you just might have a few laughs in the process. Just remember, you’re not laughing at an individual; you’re appreciating the humor in the very human failings we all share.

Further Reading

• Barrett S. Bizarre therapy leads to patient’s death. Quackwatch, July 6, 2003.
• Barrett S. Craniosacral therapy. Quackwatch, revised March 26, 2003, revised September 22, 2002.
• Barrett S. Massage therapy: Riddled with quackery. Quackwatch, Sept 22, 2002.
• Barrett S, Jarvis WT (eds.). The Health Robbers: A Close Look at Quackery in America. Buffalo, New York: Prometheus Books, 1993.
• Hartman SE, Norton JM. Interexaminer reliability and cranial osteopathy. Scientific Review of Alternative Medicine 6(1):23-34, 2002.
• Homola S. Inside Chiropractic: A Patient’s Guide. Amherst, New York: Prometheus Books, 1999.
• Upledger J. Your Inner Physician and You: CranioSacral Therapy and SomatoEmotional Release. Berkeley, California: North Atlantic Books, 1997.

_________________

Dr. Hall is a retired family practitioner and Air Force colonel who resides in Puyallup, Washington. This article was first published in May/June 2003 issue of Skeptical Inquirer.

Quackwatch Home Page

This article was posted on July 6, 2003.

Several hundred practitioners, mostly chiropractors, are offering a simple paper-and-pencil test that they say can tell how your brain is functioning [1]. They call it “blind spot mapping,” “brain function testing,” “brain mapping,” or “cortical mapping.” They claim that this test can detect an enlarged blind spot in one eye, that the enlarged blind spot reflects a malfunction in the brain, and that they can shrink the blind spot back to normal by manipulating the neck on the same side. Some chiropractors see this as the long-awaited proof that spinal manipulation affects more than just the musculoskeletal system. A typical ad [2] reads:

Note the wording: if you have undetected problems, you “will [not “may”] suffer future neurological breakdown.” Other ads imply that selective spinal manipulation based on blind-spot testing is effective in treating ADHD, balance problems, learning disability, pain, eye problems, etc. This chiropractor chooses not to identify himself in his ads, providing only a phone number. At least one major chiropractic organization has an ethics policy prohibiting “blind” ads such as this.

What is the Blind Spot?

Every eye has a blind spot where the optic nerve enters the eye and where photoreceptors are absent. We normally do not notice this because the brain fills in the missing information. The brain can give us the illusion of an uninterrupted visual field, but it cannot change the size of the blind spot because the area where photoreceptors are absent is a fixed anatomical feature. Diseases of the retina can cause photoreceptors to malfunction, which may cause an apparent enlargement of the anatomical blind spot or the appearance of additional blind spots at other locations. In the illustration to the right, the black spot to the right is a normal blind spot; the central black ring is a field defect (scotoma) caused by a disease.

How is Blind Spot Mapping Done?

You can easily do your own test at home. Tape a sheet of paper to the wall and make a small mark at eye level. From about a foot away, fixate on the mark with one eye while covering the other eye. Take a small target (the researchers used a red dot on a plastic extender, but you can use any small target you can see easily) and slowly move it horizontally from the mark to the edge of the paper. At some point, the target will disappear from view, and then it will reappear. You have now located the left and right borders of the blind spot. By returning to the blind spot and moving the target out in other directions, you can map its other dimensions by marking the paper at the points where the target seems to reappear. Your finished map will look something like this:

You will probably notice that this is not a very precise test, and results may vary depending on the size of the target, the lighting, whether you are wearing glasses, how slowly you move the target, how patient you are, whether your head moves, and how reliably you manage to stay fixated on the central mark. Scientists prefer to test visual fields with standardized instruments to minimize such possible sources of error.

Ophthalmologists regularly map the visual fields, including the blind spot, to follow patients with glaucoma and to diagnose other diseases. They rarely find that the blind spot is enlarged on one side, and when they do they can almost always find retinal disease to explain it. Chiropractors are claiming to find an enlarged blind spot in almost everyone. Something is wrong here.

Where’s the Evidence?

Brain function testing by blind spot mapping has been reported in only one published study [3]. The author, Frederick R. Carrick, D.C., Ph.D., heads the Carrick Institute for Graduate Studies where he teaches clinical neurology to chiropractors. Carrick has also served for several years as president of the ACA Council on Neurology.

Carrick’s report states that 500 volunteers who were taking postgraduate neurology courses were tested and all were found to have a significantly enlarged blind spot in one eye, averaging about 50% larger in diameter than the blind spot on the normal side.

Since nonelderly people chosen at random should not have abormally enlarged blind spots, the logical next step would have been to compare the pencil-and-paper test to standardized tests to see if something was wrong with the measurement method. If Carrick had taken their temperatures, for example, and found that all were above 105 degrees F., he probably would have thought to check the accuracy of his thermometer. But instead of checking the accuracy of his initial tests, he manipulated each volunteer’s neck on the side of the enlarged blind spot, remeasured the spots, and reported that they were no longer enlarged. He concluded that (a) the blind spot must represent brain function or hemisphericity in the cerebral cortex or it wouldn’t have changed after manipulation, and (b) manipulation must affect brain function or the blind spot would not have changed. Neither conclusion is warranted, and the reasoning is circular.

The study has additional flaws, several of which have been pointed out by other chiropractors in letters to the journal’s editor [4-10].

Blind spot mapping is also described on the Web site of Bio-Kinetics, a “total body-brain integration system.” [11] Bio-Kinetics utilizes a patented device called the New-Stim Stimulator, a spring-loaded mallet that delivers a 4-ounce to 5-pound thrust to a 3/8 inch area over the spine in lieu of manual manipulation. Its practitioners use blind spot testing, electrocephagraph [sic] tests, structure balance tests, and surface electromyography to evaluate their patients’ progress. The Web site’s proprietors state that they have done blind spot testing on thousands of people and found less than 1% to be normal.

It is hard to imagine how 99% of people who seek treatment for a variety of problems could have an identical abnormal test result. The normal range for most tests is determined by testing a large normal population, graphing the values obtained (which usually form a bell-shaped curve), and cutting off the extreme ends (beyond 2 standard deviations). They claim the New-Stim is 95% effective in restoring the blind spot to its normal size, but they provide no other assessment of clinical results. Their proposed explanations for how the test may work are fanciful and not consistent with the known facts of neuroanatomy. For instance, it was suggested than nerve impulses from the spine are summated with impulses from the eye in the thalamus and the resultant integrated signal goes from there to the optic area of the cerebral cortex.[3] This hypothesis would require the presence of pathways that are not known to exist [4], and even if they did, a difference in signal strength could not change the size of the blind spot.

The Bio-Kinetics Web site shows a lack of understanding of basic principles.

• It states, “The larger the blind spot the less peripheral vision we have.” (The blind spot is located about halfway between the center and the periphery of the visual field and has no significant effect on peripheral vision because the same area is visible from the other eye).
• It claims that if the blind spot “is smaller than a nickel or quarter, it indicates that the brain is being over stimulated from input somewhere in the body.” This is ridiculous because the blind spot can never be smaller than the optic disc, and no stimulation from anywhere in the body can make it so.
• It confuses the blind spot in the eye with the blind spot outside your car when you are driving. But the driving-related “blind spot” is not a visual defect. It occurs because the rear-view mirror can’t be positioned so that the driver has an unobstructed view of everything behind and alongside of the car.
• It describes “blind spots” as large as a dinner plate; but that situation would be more than just a blind spot, it would qualify as a blind eye, even if some far peripheral vision remained. Only the most optimistic practitioner would hope to restore such an eye to normal vision by a tap on the neck. Moreover, anyone with such a defect would be blind and know it without blind-spot testing.

Another chiropractor who was one of Carrick’s students has stated:

Realize that if you have a large blind spot in your left eye compared to your right eye you cannot perceive vision as well from that left eye and you will have to tilt your head to compensate for this. The changes in head position have major effects on body mechanics. Patients that have a large blind spot often remark that they have a tendency to walk into walls or worse, end up in your office because they were involved in an auto accident because they didn’t see the other car coming [12].

The above statement is not supported by the scientific literature related to either chiropractic care or to vision [13]. It is also illogical if you remember that the invisible area of each blind spot is visible to the other eye.

James Randi Educational Foundation has a standing offer of $1,000,000 to anyone who can demonstrate the existence of the paranormal under controlled conditions to eliminate the possibility of either deliberate trickery or self-delusion. He directly contacted Carrick and personally offered him the prize if he could demonstrate that his blind spot test worked. Carrick refused [14]..

The Bottom Line

Blind-spot testing is worthless. It does not reflect brain function, and it does not validate claims of chiropractors that manipulation affects the brain.

References

1. Carrick FR. Personal communication to Harriet Hall, M.D., Dec 26, 2002.
2. Burns D. The News Tribune, Tacoma WA, Dec 31, 2002.
3. Carrick FR. Changes in brain function after manipulation of the cervical spine. Journal of Manipulative and Physiological Therapeutics 20:529-545, 1997.
4. Seaman D. Letter to the editor. Journal of Manipulative and Physiological Therapeutics 21:295-6, 1998.
5. Troyanovich S and others. Letter to the editor. Journal of Manipulative and Physiological Therapeutics 21:297-99, 1998.
6. Noone P. Letter to the editor. Journal of Manipulative and Physiological Therapeutics 21:302-3, 1998.
7. Henry G. Letter to the editor. Journal of Manipulative and Physiological Therapeutics 21:303-4, 1998.
8. Turk D. Letter to the editor. Journal of Manipulative and Physiological Therapeutics 21:497, 1998.
9. Meyer J. Letter to the editor. Journal of Manipulative and Physiological Therapeutics 21:498, 1998.
10. Ahadpour A. Letter to the editor. Journal of Manipulative and Physiological Therapeutics 21:495, 1998.
11. Frequently asked questions. Bio-Kinetics Health Systems Web site, accessed Dec 31, 2002.
12. Burdorf M. Blind spots and chiropractic: Chiropractic adjustments have a direct effect on brain function. Archived Web site, dated Jan 20, 1998.
13. Seaman D. Philosophy and science versus dogmatism in the practice of chiropractic, accessed Dec 31, 2002.
14. Carrick FR, Randi J. E-mail correspondence, Jan 15-16, 2003.

__________________

Dr. Hall is a retired family practitioner and Air Force colonel who resides in Puyallup, Washington.

This page was posted on March 2, 2003.