BOGUS CLAIMS FOR WEIGHT LOSS PRODUCTS: NO MAGIC BULLET!

                                   

   The consumer is constantly bombarded with claims of magical breakthroughs aimed to counteract a variety of real or perceived maladies, ranging from obesity, depression, sexual under-performance, pains, and a host of others. Probably the most prevalent of these claims is the promise of substantial weight loss without the inconvenience of calorie restriction. The real aim of all these scams, however, is to separate you from your money. The ads are often supported by a “dignitary”, ranging from a sports hero (possessing no background in health science) to a physician such as the celebrated Dr. Oz (who often misuses his knowledge). In the effort to bolster the various claims, individuals—functioning as shills—provide testimonials to support the purported benefits of a given product.

   Although I could have chosen from many examples, let’s take a look at three popular products touted to promote weight loss—without purposeful dieting—and explore the real facts.

    Example number one: Saffron extract. Dr. Oz has recently revealed a “miracle appetite suppressant that will shrink your belly fat in no time.” The product he is touting is called Satiereal extract, a patented saffron extract product produced by Inoreal, Ltd. (France). The reality: The only scientific study available on this product was published in 2010, in which 61 mildly overweight women (age 25-45) were tested. They were blindly divided into a treated group, receiving this product, and a placebo group, given an identical pill with no active ingredient. Over the course of 8 weeks, the treated group lost an average of 2 lbs versus no change in the placebo group. Although the promotions state that there are no side effects of this agent, the study actually noted that 16% of this group experienced at least “mild” unfavorable effects that included nausea, diarrhea and gastro-esophageal reflux (heartburn), perhaps, in themselves, able to curb one’s appetite. Possible fluid loss, a potential confounder, was also unaccounted for. The supposed reason for the weight reduction: less snacking and easier satiation. Unfortunately this study was sponsored by the maker of the product, introducing potential conflicts of interest.  Even if these results were accurate, the numbers are small, and for real validity they need to be repeated elsewhere and extended to populations including very obese females and males of all ages and continued for longer periods beyond eight weeks. After studying prices, I concluded that the average daily cost for saffron extract (2 capsules) approximates one dollar. This means that if you are lucky enough to equal the claimed 2 lb weight loss in eight weeks (a highly tenuous assumption), you would be paying about $30 for each pound lost—not a very good bargain and definitely not a “miracle” breakthrough!

   Conclusion: If you buy, you are wasting your money. Try locking up you snack sources or keeping them out of sight!

Hydroxycut is a brand of dietary supplement that is marketed as an aid to weight loss. Originally developed and marketed by MuscleTech Corp., now defunct, the product was sold to Iovate Health Sciences in 2003-2004 but the latter company continues to use MuscleTech as a brand to market Hydroxycut. By 2009, about 15% of Americans were taking dietary supplements for weight loss, and Hydroxycut was the biggest seller, with about a million units sold each year. Average cost per person—about $1.35 daily.

     Iovate Health Sciences was forced by the U.S. Food and Drug Adminishtration (FDA)  in 2004 to reformulate Hydroxycut to eliminate ephedra, a dangerous component. In 2009 this agency again issued a warning to consumers to stop using Hydroxycut products, due to 23 reports of serious health problems associated with its the use, including at least one death, and users were advised to destroy any product that they may possess. The warning stated “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk. Consumers who have these products are urged to stop using them.” Following the FDA warning, the manufacturer agreed to recall the products.

    After the 2009 recall, Hydroxycut was again reformulated and placed back on sale, and presumably the only ingredient left from prior formulations was caffeine. Providing false reassurance to the consumer, Hydroxycut is sold at conventional retailers, online retailers, and through direct television marketing. Like virtually all dietary supplements, published studies demonstrating scientific evidence of its effectiveness and safety are flimsy and riddled with conflicts of interest, or lacking altogether. Compounding the farce, Hydroxycut had been promoted as being created and endorsed by doctors. Television advertisements for Hydroxycut featured a medical resident in training, although reporters were unable to locate him after Hydroxycut was removed from the market in 2009.

As of 2013, the primary ingredients in the product line include Lady’s mantle extract, Wild olive extract, Komijn extract, Caffeine Anhydrous (1,3,7-Trimethylxanthine) supplying 200 Mg of caffeine, Wild mint extract and, in some products, Green coffee bean extract. Also supposedly included is Garcinia Cambogia, or Hydroxycitric Acid, (see below) Despite the reformulation, these substances (except for caffeine and hydroxycitric acid) have been poorly studied and might still be harmful. Side effects continue to include liver failure (requiring liver transplantation in some cases), rhabdomyolysis (extensive muscle breakdown), and one death of a 19-year-old man. Another case published in 2013 reported on a patient who developed ulcerative colitis with repeated exacerbations each time after ingesting Hydroxycut Hardcore.

    Providing an advertising bonanza for the Iovate company, in March 2013 racecar driver Tony Kanaan piloted the winning No. 11 Hydroxycut IndyCar at the Indianapolis 500 and was planning to use this car in 8 other events at the 2013 IndyCar Championship series. 

    In my opinion, these Hydroxycut events provide evidence that the FDA, although having limited success in warnings and recalls, should have greater power over dietary supplements. This is unlikely to occur, given so much clamor against government agencies. Unfortunately, weight-loss supplements manufacturers care far less about their products’ safety and efficacy than they do about expanding and protecting their bottom lines.

    Needless to say, this is another product to avoid!

Garcinia Extract (Hydroxycitric Acid)

 

    Recently, Dr. Oz described Garcinia Cambogia as; “The Holy Grail of Weight Loss”. Citing clinical studies, Oz emphasized that this “dual action fat burner” could be the magic ingredient that helps you lose weight, “even without diet or exercise!”

     But what are the facts?  This product, containing the presumed active ingredient, hydroxycitric acid, has been, to some extent, studied scientifically, and the results are, at best, disappointing. A recent pooled analysis of several studies, published in 2011§, disclosed the following: Of twenty-three reported trials they included twelve that were sufficiently well conducted to meet scientific standards. Only nine of these trials provided data suitable for statistical analysis. Although the analysis revealed a small, statistically significant difference in weight loss favoring hydroxycitric acid over placebo, gastrointestinal adverse events were twice as common in the treated group compared with placebo in one included study. These authors concluded that the controlled trials suggest that Garcinia extracts/HCA can cause minor short-term weight loss. The authors cautioned, however, about the acceptance of even this interpretation, for three studies with small sample sizes seemed to have influenced the overall analytic result in favor of Hydroxycitric Acid over placebo. If these three trials were excluded, the analysis showed no effect on weight reduction. Moreover, the largest and most rigorously controlled trial they reviewed disclosed no significant difference in weight loss between Hydroxycitric Acid and placebo.

    So, even if Garcinia Extract has any effect—which is highly doubtful—the magnitude of the effect is small, amounting to an average of less than two pounds. In order to resolve any remaining questions, however, these researchers indicated the need for future trials that should be more rigorous and better reported.

   Conclusion: In each of the three examples cited above, the consumer is tipped off by the closing disclaimer:  “These statements have not been evaluated by the US Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.” This commonly appearing statement provides the closest thing to a guarantee that you’re getting ripped off with a useless product!



§ J Obes. 2011; 2011: 509038.


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SNAKE OIL: THE SAGA CONTINUES

               27SJPMJJ99       

                     MISLEADING ADS FOR “HEALTH” PRODUCTS

  The consumer is constantly bombarded with claims of magical breakthroughs aimed to counteract a variety of real or perceived maladies, ranging from obesity, depression, sexual underperformance, pains, and a host of others. Their real aim, however, is to separate you from your money. The ads are often supported by a “dignitary”, ranging from a sports hero (possessing no background in health science) to a physician such as the celebrated Dr. Oz (who often misuses his knowledge). In the effort to bolster these claims, individuals—functioning as shills—provide testimonials to support the purported benefits of a given product.

   Although I could have chosen from many examples, let’s take a look at four recently promoted products and explore the real facts.

    Example number one: Saffron extract. Dr. Oz has recently revealed a “miracle appetite suppressant that will shrink your belly fat in no time.” The product he is touting is called Satiereal extract, a patented saffron extract product produced by Inoreal, Ltd. (France). The reality: The only scientific study available on this product was published in 2010, in which 61 mildly overweight women (age 25-45) were tested. They were blindly divided into a treated group, receiving this product, and a placebo group, given an identical pill with no active ingredient. Over the course of 8 weeks, the treated group lost an average of 2 lbs versus no change in the placebo group. Although the promotions state that there are no side effects of this agent, the study actually noted that 16% of this group experienced at least “mild” unfavorable effects that included nausea, diarrhea and gastro-esophageal reflux (heartburn), perhaps, in themselves, able to curb one’s appetite. Possible fluid loss, a potential confounder, was also unaccounted for. The supposed reason for the weight reduction: less snacking and easier satiation. Unfortunately this study was sponsored by the maker of the product, introducing potential conflicts of interest.  Even if these results were accurate, the numbers are small, and for real validity they need to be repeated elsewhere and extended to populations including very obese females and males of all ages and continued for longer periods beyond eight weeks. After studying prices, I concluded that the average daily cost for saffron extract (2 capsules) approximates one dollar. This means that if you are lucky enough to equal the claimed 2 lb loss in eight weeks (a highly tenuous assumption), you would be paying about $30 for each pound lost—not a very good bargain and definitely not a “miracle” breakthrough!

   Conclusion: If you buy, you are wasting your money. Try locking up you snack sources or keeping them out of sight!

   Example number 2: Super Beta Prostate.  Referring to this product, Joe Theismann, the former football star, says “Throughout my career in football, I’ve seen some major game-changing moments. The same goes for my own life—like when I realized the reason I was going to the bathroom so much during the day and getting up in the middle of the night to go was due to my prostate! Now that was a game changer!”

    What are the facts? β-sitosterol is the ingredient in this product alleged to be effective in promoting function of the prostate gland (located at the base of the bladder and often accounting for slowing urine flow). Alone and in combination with similar plant sterols, β-sitosterol reduces blood levels of cholesterol, and is sometimes used in treating elevated levels of this substance by inhibiting cholesterol absorption in the intestine. While this substance is useful in prevention and control of cardiovascular disease, one small study conducted in Europe suggested that urine flow was enhanced in those taking medicinal form of this plant sterol, and thus it has been touted for benign prostatic hyperplasia (BPH) in that continent. Nevertheless, even if proven to be effective in prostate conditions (which is doubtful), this substance is widely distributed in the plant kingdom and found in such sources as pecans, avocados, pumpkin seeds, cashews, fruit, rice bran, wheat germ, corn oils, soybeans. and others. This presents one with a veritable cafeteria of nutritious and cheaper ingredients with which to fend off cardiovascular and prostate(?) conditions.

   Conclusion: I would choose a diet that includes these latter components. Nothing more need be said.

 

Example number 3: Lipogen PS Plus. This product was touted recently in a large newspaper article, seemingly presented as a report on “Heath and Wellness”—but marked by an inconspicuous and tiny label “Advertisement.” It stated that a “simple pill” provides you with a means to “teach your brain how to remember again.” The ad goes on to state further that “researchers have identified the importance of a remarkable compound called phosphatidylserine, the key ingredient of Lipogen PS Plus, purported to eliminate those pesky “senior moments” that plague individuals of almost any age, somewhat more common in the elderly.

    But what are the facts? In an extensive search of the scientific literature, I encountered no acceptable evidence that phosphatidylserine (alone or in combination with anything else) produced any benefit to memory retention or function. In one limited test for safety, this product seemed free of significant side effects, and as a result, the FDA apparently acknowledged that feature and agreed that it was safe as a nutritional supplement, but there is no acknowledgment of a beneficial effect on brain function. Nevertheless, the ad went on to state that their product is the “ONLY health supplement with a FDA qualified health claim.” Despite apparent “approval” by the FDA, the ad goes on contradict itself by providing at the end the usual disclaimer for useless products: “These statements have not been evaluated by the US Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.”

   So there you have it in a nutshell. Another useless—or at best unproven—product designed to fleece the unsuspecting customer!      

 

Example number 4: Hydroxycut is a brand of dietary supplements that is marketed as another aid to weight loss. Originally developed and marketed by MuscleTech Corp., now defunct, the product was sold to Iovate Health Sciences in 2003-2004 but the latter company continues to use MuscleTech as a brand to market Hydroxycut. By 2009, about 15% of Americans were taking dietary supplements for weight loss, and Hydroxycut was the biggest seller, with about a million units sold each year. Average cost per person—about $1.35 daily.

     Iovate Health Sciences was forced by the U.S. Food and Drug Adminishtration (FDA)  in 2004 to reformulate Hydroxycut to eliminate ephedra, a dangerous component. In 2009 this agency again issued a warning to consumers to stop using Hydroxycut products, due to 23 reports of serious health problems associated with its the use, including at least one death, and users were advised to destroy any product that they may possess. The warning stated “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk. Consumers who have these products are urged to stop using them.” Following the FDA warning, the manufacturer agreed to recall the products.

    After the 2009 recall, Hydroxycut was again reformulated and placed back on sale, and presumably the only ingredient left from prior formulations was caffeine. Providing false reassurance to the consumer, Hydroxycut is sold at conventional retailers, online retailers, and through direct television marketing. Like virtually all dietary supplements, published studies demonstrating scientific evidence of its effectiveness and safety are flimsy and riddled with conflicts of interest, or lacking altogether. Compounding the farce, Hydroxycut had been promoted as being created and endorsed by doctors. Television advertisements for Hydroxycut featured a medical resident, although reporters were unable to locate him after Hydroxycut was removed from the market in 2009.

As of 2013, the primary ingredients in the product line include Lady’s mantle extract, Wild olive extract, Komijn extract, Caffeine Anhydrous (1,3,7-Trimethylxanthine) supplying 200 Mg of caffeine, Wild mint extract and, in some products, Green coffee bean extract. Despite the reformulation, these substances (except for caffeine) have been poorly studied and might still be harmful. Side effects continue to include liver failure (requiring liver transplantation in some cases), rhabdomyolysis (extensive muscle breakdown), and one death of a 19-year-old man. Another case published in 2013 reported on a patient who developed ulcerative colitis with repeated exacerbations each time after ingesting Hydroxycut Hardcore.

    Providing an advertising bonanza for the Iovate company, in March 2013 racecar driver Tony Kanaan piloted the winning No. 11 Hydroxycut IndyCar at the Indianapolis 500 and is planning to use this car in 8 other events at the 2013 IndyCar Championship series. 

    In my opinion, these Hydroxycut events provide evidence that the FDA, although having limited success in warnings and recalls, is in need of greater power over dietary supplements. This is unlikely to occur, given so much clamor against government agencies. Unfortunately, weight-loss supplements manufacturers care far less about their products’ safety and efficacy than they do about expanding and protecting their bottom lines.

    Needless to say, this is another product to avoid!

   Conclusion: In all the examples cited above, the consumer is tipped off by that closing disclaimer already noted, which I repeat:  “These statements have not been evaluated by the US Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.” This commonly appearing statement provides the closest thing to a guarantee that you’re getting ripped off with a useless product!

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