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The HCG Diet: Yet another ineffective quick fix diet plan and supplement

I contribute biweekly to Science-Based Medicine and could easily devote every post to writing about weight loss supplements, and never run out of topics. As soon as one quick fix falls out of favour, another inevitably replaces it. Some wax and wane in popularity. And pharmacies don’t help the situation. I cringe every time I walk down the aisle where weight loss products and kits are located. Detox? Hoodia? The “fat blaster”?  Here are pharmacists, well educated and perfectly positioned to provide good advice to consumers, but standing behind a wall of boxes with ridiculous weight loss promises.  Yet pharmacists tell me that these products are not only sought out by customers, but they actually sell well. It’s a lost opportunity to provide good advice, and consumers pay the price.

Perhaps because consumers associate these products with pharmacies, I get regular questions about weight loss programs. I end up developing some degree of familiarity with many of them, if only to be able to credibly redirect away from some of the more harmful plans and approaches. It’s that philosophy that I used recently when I was asked about how to best to manage a “plateau” on the HCG diet. I’d never dispensed human chorionic gonadotropin (HCG) before, but knew of its use for the treatment of infertility, where it promotes egg release. But weight loss? I couldn’t think of a mechanism for how HCG could promote weight loss. So I did some digging, and found a long, rich vein of pseudoscience that dates back decades.

HCG is a hormone secreted by the placenta during pregnancy.  Its use as a weight loss adjunct has roots that date back to the 1950s, when Italian physican ATW Simeons announced [PDF] case studies of weight loss in patients given HCG injection and placed on very low calorie diets — about 500 kcal/day. Simeons’ data failed to be replicated in later studies, and interest seemed to deservedly fade. The diet leapt back into consciousness when telemarketer and convicted felon Kevin Trudeau started promoting the diet again in 2007, claiming the TRUTH had been suppressed by the American Medical Association and the FDA. Since then, HCG (also called the Simeons method) has been on a bit of tear, and it’s currently enjoying a resurgence of popularity.

The Evidence

With HCG, we’re not facing a situation of unproven efficacy. Rather, there’s good evidence to demonstrate that it does not have any meaningful effect.  Multiple studies and meta-analyses have evaluated the HCG diet and found no evidence that HCG injections offer any incremental benefit. The studies date go way back to the 1970s [PDF], and their conclusions are consistent and persuasive: The weight loss effect on the HCG diet is due to the dramatic calorie reduction, and the HCG has no measurable effect on weight loss. Not surprisingly, there are no medical associations that I could find that endorse the use of HCG for weight loss. The American Society of Bariatric Physicians warns,

Numerous clinical trials have shown HCG to be ineffectual in producing weight loss. HCG injections can induce a slight increase in muscle mass in androgen-deficient males. The diet used in the Simeons method provides a lower protein intake than is advisable in view of current knowledge and practice. There are few medical literature reports favorable to the Simeons method; the overwhelming majority of medical reports are critical of it. Physicians employing either the HCG or the diet recommended by Simeons may expose themselves to criticism from other physicians, from insurers, or from government bodies.

So does the HCG Diet Work?

Any weight loss from the HCG diet is actually due to the dramatic calorie restriction required as part of the diet plans — in some cases, as low as 500 calories per day. This near-starvation diet is dramatically below appropriate levels for weight loss or maintenance, and escalates the risk of malnutrition if prolonged. Even if it wasn’t immediately harmful, a 500kcal diet is simply unsustainable. Weight maintenance is the real challenge with obesity.

HCG injections are not innocuous. It may be teratogenic (cause birth defects) in pregnant women. Reported side effects include headache, fatigue, irritability, restlessness, ovarian overstimulation, ascites, and edema.

Regulatory status

The FDA has long maintained that HCG is ineffective for weight loss and in the 1970’s mandated this warning with all HCG diet advertisements:

HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or “normal” distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.

What’s appeared over the past several years have been  non-prescription (i.e., over-the-counter) HCG products, including “homeopathic” HCG which if you follow the absurd principles of homeopathy, should cause weight gain, not loss. Moreover, HCG is a protein that would be digested if consumed orally. But scientific cogency isn’t a necessary component of a good sales pitch, and you’ll see homeopathic versions sold widely. The FDA noted this and took action this past December, when it began to pull all unapproved HCG products completely off the market.  This has put the supplement industry into the positon of creating “HCG-free” versions of their products become infused with “radionics” where the HCG “energy” is transferred to vitamins or amino acids. The FDA emphasizes in its warnings that all non-prescription versions of HCG are fraudulent and ineffective, as non-prescription HCG does not exist.  Even “homeopathic” HCG is prohibited:

“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions.”

The FDA even notes that the infamous Quack Miranda warning is insufficient warning to consumers, when it comes to HCG:

We recognize that a number of pages on your website contain a disclaimer stating that the products are not intended to diagnose, treat, cure, or prevent any disease. However, notwithstanding this disclaimer, the claims made on your website for “HCG Fusion 30″ and “HCG Fusion 43″ clearly demonstrate that these products are drugs as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because they are intended to affect the structure or any function of the body.

The Alternative Universe

The lack of evidence for HCG, and the explicit FDA warnings haven’t stopped a thriving business model among those that promote alternatives to science-based medicine. In the United States, for example, a naturopath has formed the “HCG Diet Council” and is collecting anecdotes from providers and users as part of their “standardized research program” of both HCG and homeopathic HCG. “Does the FDA Want to Keep America Fat?” the council asks. In Canada,  naturopaths at the Northern Centre for Integrative Medicine thumb their nose at the evidence, and Health Canada’s warning:

HCG (Human Chorionic Gonadotrophin) is authorized in Canada only for treatment of women with infertility, and only in an injectable form. There is no scientific evidence that the use of HCG either by mouth (as drops under the tongue, as advertised on the Internet) or as a self-administered injection, could promote weight loss.

NCIM honors the intent of Health Canada’s statement, which is protective in nature. Health Canada’s statement does not address the more substantive issue, which is the significant risk of not taking action to reduce your weight and risking future illness. The NCIM HCG Rx+ weight loss intervention cannot make any guarantees, it nevertheless provides a time-tested approach to weight loss that is physician supervised and individually monitored for safety and effectiveness.

And NCIM doesn’t honour the intent of the statement at all. It notes that the prescription it provides for HCG injections may be covered by private drug insurance.

And a post on HCG can’t neglect it’s biggest television promoter after Kevin Trudeau: Dr. Oz, who having recommended against the HCG diet, turned around and subsequently promoted it on his show, prompting obesity specialist Dr. Yoni Freedhoff to ask “Dr. Oz — so corrupted by fame he even sells himself out?

Conclusion

There’s no persuasive evidence that HCG injections has any meaningful effects on weight loss. And “homeopathic” HCG is quite literally, nothing. If the HCG diet shows one thing at all, it’s the tenacity of an idea once it’s been planted. Despite warnings by researchers, health professionals, and regulators since at least 1976 about the lack of evidence for HCG as a weight loss adjunct, it continues to attract attention and new users, now promoted by naturopaths and television personalities that are indifferent to the evidence. It’s gratifying to see a regulator (the FDA in this case) take off the gloves with supplement vendors and other purveyors of HCG pseudoscience. When it comes to weight loss there are no quick fixes.

 

Posted in: Health Fraud, Herbs & Supplements, Naturopathy, Pharmaceuticals

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