Four years ago my client who I’ll call Shane explained his frustration. He’d tried everything and was considering the hCG diet—priced at the time at $300 per week of participation, 4-6 weeks. He said it could be bought locally and self-administered…
More than just a skeptic, by then I’d helped many individuals “recover” from this diet, individuals whose health declined, weight returned and now had new health problems. That said, just because I attract a group for whom a regimen doesn’t work doesn’t necessarily mean it is bad—we’re all different—but there sure have been a lot of folks… I kept my knee-jerk reaction to myself and promised Shane I’d review the scientific literature. That’s only fair. My article “hCG Diet. Weight Loss Miracle? Diet Scam?” came from that review of science.
A month later, at our Anchorage Women’s show booth, I learned that a local doctor recently bought an hCG franchise and was promoting free talks through our public library—complete with franchise-provided literature claiming “hCG melts fat,” “hCG prevents muscle wasting,” “hCG helps stabilize moods during fast weight loss…” With all this promotion, and the fact that two-thirds of us are obese, quite a number of people began to ask me for my opinion.
Luckily, I’d done my homework. So when Kara approached me with her friend’s suggestion that she too try the hCG diet, I was prepared. Kara also kindly allowed me to borrow her friend’s program manual and I bought the program’s cookbook so I could analyze the diet component.
Just yesterday, in my Weight Loss and the Low Fat Lies class, one of my new class-mates brought up the subject of the Human Chorionic Gonadotropin (hCG) diet. It’s being promoted locally, again.
Remember, I’m a research scientist of 30+ years with dozens of published results papers from clinical trials I’ve personally designed, obtained appropriate approvals (yes, studies on people have rules), collected data, analyzed, and published on normal channels—including peer review by others who also are experts on the subject. Scientific method is there for a reason—and while the language of health science may be foreign to most, I was raised in that country and speak it fluently.
What does the 500-calorie diet look like?
The hCG diet is basically this: Eat 500 Calories per day from specific foods, inject yourself with a shot of HCG each day for 6 weeks, absolutely no fat—not even from cosmetics—no exercise. Websites, books and blogs claim the hCG (allegedly) “resets” your metabolism and helps you not to be hungry.
It isn’t easy:
- No breakfast except water, tea or coffee;
- lunch is 100 grams of meat protein with all fat removed, one type of vegetable only to be chosen from the following: spinach, chard, chicory, beet-greens, green salad, tomatoes, celery, fennel, onions, red radishes, cucumbers, asparagus, cabbage; one breadstick or Melba toast; one apple, orange, or a handful of strawberries or one-half grapefruit.
- Dinner is same as lunch.
Period. Strictly.
For 4-6 weeks.
What is hCG anyway?
Human Chorionic Gonadotropin, or hCG, is a very small protein (like most hormones) produced in large amounts in a pregnant woman’s placenta. This is the hormone that turns your pregnancy test to positive (and it is also made by some cancers and is used to detect those).
Originally, for medical use the hormone was extracted from the urine of pregnant women. It has two FDA-approved medical uses: 1. treatment of infertility in women—to help induce ovulation—and, at much lower doses, 2. given to low-testosterone boys when their testicles have not dropped down into the scrotum normally. This can be caused by a pituitary gland disorder. hCG can be biochemically converted into testosterone. Doctors can legally prescribe medications “off label” meaning for uses beyond those approved and listed “on” the label.
What is the US FDA and US Trade commission stance on hCG?
Not everything is reviewed by the FDA; sometimes that isn’t necessary or even gets in the way. But in the case of hCG, on several occasions the FDA has reviewed whether or not there was enough data to support advertising claims. Based on review of existing science, in 1975 the FDA determined the use of hCG for weight loss to be fraudulent and requires labels for hCG to state:
“hCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION. 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.”
In 1976, the FTC ordered the Simeon Management Corporation, Simeon Weight Clinics Foundation, Bariatrics Management Corporation, C.M. Norcal, Inc., and hCG Weight Clinics Foundation and their officers to stop claiming that their hCG-based programs were safe, effective, and/or approved by the FDA for weight-control.
Homeopathic hCG began being used around 2008 by many Naturopathic Professionals as an alternative to hCG prescription injections. As of December 6, 2011, and after reviewing the evidence, the United States FDA has prohibited the sale of “homeopathic” and over-the-counter hCG diet products and declared them fraudulent and illegal. There is a reason for this.
Since the FDA bases decisions on available research, let’s look at the quality of the hCG diet scientific evidence:
Step one—propose a theory to explain a new observation: In 1954 A.T. Simeons, a doctor specializing in hormones, published The action of chorionic gonadotrophin in the obese in the medical journal Lancet. This article discusses his theory that hCG injection causes rapid mobilization of body fat stores and induced feelings of well-being. NO actual study was performed—these were just ideas based on his observation that boys being given hCG for pituitary disorders also slimmed down.
A healthy pituitary gland secretes at least eight different hormones that control other parts of the endocrine system, namely the thyroid gland, adrenal glands, ovaries, and testes. Pituitary hormones get these organs making more or less of their own hormones, like thyroid hormone, adrenaline, and others involved in energy use, growth, sexual function, inflammation and more. The pituitary gland is immensely important to your health balance.
Based on these observations, Simeons theorized that hCG reduced the weakness and hunger of very low calorie diets (500kcal/day) and that hCG treatment could be used to prevent the protein wasting and vitamin deficiencies which are a frequent side-effect of such low caloric intake.
Any idea how hCG might accomplish these claims? Only that it influences pituitary hormones—some of which have to do with energy use and growth. Finding out how belongs on the scientific “to do” list.
Any idea if it will work on most people? Any unwanted side effects? Unknown in 1954, that’s where clinical trials come in starting with safety studies.
So far so good.
Step two—conduct actual research: The research gradient starts with understanding safety and then weighing possible benefits against adverse effects, including other approaches already understood and considered safe:
- Usually the original observation is explored with a small trial of willing and well-informed study subjects who are monitored mostly for safety.
- If the approach looks fairly safe, then larger studies are done to characterize the benefits and continue to monitor and characterize side effects—Does it work for everyone or what portion? Are there certain sorts of people it won’t help? What sorts of unwanted and potentially harmful effects are caused? Studies may or may not include comparing the therapy to alternate therapies (e.g. people who do just the diet alone if testing hCG itself, or who follow a different protocol entirely).
- For most drugs and therapies, any encouraging findings in #2 are further explored in large numbers of people following a controlled clinical protocol where the new procedure is compared to existing treatments or no treatment.
Of course research depends on everyone following the same protocol. To that end, Simeons’ codified his very low calorie diet in detail—down to the exact levels of proteins (stripped of fat) needed daily and exactly which other foods (mostly vegetables and some fruit) could be eaten with those proteins.
This exact combination of injectable hCG and very precise, very low calorie, mostly protein diet is known as the Simeons protocol. Ideally, the package of evidence compiled in steps #1-3 and following Simeons’ protocol is then submitted to the FDA requesting approval of this drug for this new use—only after this can the drug label can now list weight loss as a use for hCG.
But Simeons didn’t follow scientific sequence; in 1967 he privately published his consumer book Pounds & Inches: A New Approach to Obesity. His theories and observations remained largely untested. Weight loss diet books are top sellers—both bogus and research-based alike easily sell by the millions given only a good publisher. And a book by a doctor carries with it authority and perceived expertise, whether or not there has ever been any research to back it up. The scientific community, not Simeons, responded by conducting actual research to see if hCG actually resulted in claims made by the book: weight loss, fewer cravings, less muscle wasting, or some benefit given the known side effects (see below).
Because the release of this book spurred many to try the Simeons hCG protocol; the last four decades have seen many carefully designed studies on how hCG works, or if it even does.
Step three—publish all research findings, good or bad, using the peer-review system of professional medical and scientific journals:
This way, anyone, anywhere can access the scientific findings including the actual data and use that to draw their own conclusions. Quality medical journals are indexed in the US National Library of Medicine and available online to review by anyone, anywhere in the world. Yes, there are inherent biases; studies with “no results” tend to remain unpublished, but overall this is a good system.
By “peer review” is meant having a panel of experts in that subject review the proposed publication and make sure the conclusions the author states are supported by the actual work the author did—sometimes peers see things, they may even request new analyses of the data to check possible alternate explanations—or suggest the next idea to test or… this system is helpful to the quality of the final publication.
A 1976 paper published in the peer-reviewed Journal of the American Medical Association performed a rigorously controlled, double-blind crossover study examining the effects of hCG on weight loss on 200 obese individuals undergoing very low calorie diets. This double-blind study, where neither the patient nor the physician knows who is receiving hCG or a placebo showed… the envelope please?
- Both groups lost a significant amount of weight (not surprising given subjects were only consuming 500 kcal/day), however there was no difference in weight loss between the hCG and placebo treatments.
- Because Dr. Simeons claimed that hCG preserves muscle mass while reducing fat, these researchers also tested that: There was no difference in fat loss between the hCG and placebo treatments, an outcome conveniently ignored by all the pro-hCG blogs and internet sites.
With more studies, the evidence became clear: the vast preponderance of studies examining the effectiveness of hCG in the treatment of obesity found absolutely no effect. Of twelve carefully designed and controlled studies completed by 1995, in only one group—40 “very motivated” female participants—did the hCG side lose slightly more weight than the placebo control. In 1995, Lijesen and team summarized all the hCG results data to date: It’s a technical read with the findings here.
The research also shows some serious health problems associated with the hCG diet protocol—specifically:
- hCG stimulates ovulation and can cause multiple pregnancies,
- hCG alters the hormones released by the pituitary gland in ways that remain largely unstudied,
- hCG can lead to a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition,
- hCG promotes hormone-related cancers (such as prostate, pancreatic, ovarian…) and increases risk in those predisposed,
- using hCG during pregnancy can cause birth defects in the baby,
- hCG can cause early puberty in young boys,
- hCG can cause depression, fatigue, irritability, and other unwanted emotions,
- hCG can cause water weight gain.
Step four—continue to consider new explanations; retest ideas when there is new data.
And Step 5—if new evidence, get that new data reviewed by the FDA (riskier side effect profiles than originally documented will remove drugs from the market; old patents or existing medications may receive FDA approval for new uses based on the new testing).
Around 2008, a non-drug version of hCG became available, as a homeopathic remedy. Most homeopathic remedies are classified as drugs that can be marketed without FDA approval in the United States and can be sold over the counter (OTC), online through lay people, in multilevel marketing, through non-MD experts like NDs, DCs, Health Coaches… a license to prescribe medications is not required. BUT the FDA is responsible to ensure that OTC remedies and vitamins are uncontaminated, have the ingredients in them they say they do, and are honestly labelled. Unlike dietary supplements, homeopathic packaging can include claims about treating specific conditions, as long as they are “self-limiting” or short-term, like sprains, colds, or allergies.
The FDA relies on an independent industry organization, the Homeopathic Pharmacopoeia Convention of the United States, to determine what counts as a homeopathic drug. Substances are tested by trained homeopaths to determine how they affect healthy subjects at various concentrations, the results are documented and with this “proving” can be added to a document known as the Homeopathic Pharmacopoeia of the United States—a list of substances now 1295 items long.
An important omission: a search for homeopathic hCG in the National Library of Medicine returns: NO ITEMS FOUND. Not a single study or paper on homeopathic hCG has ever gone through traditional evidence-gathering and publication steps—although, to be fair, this isn’t required for OTC products. But…
Another important omission: homeopathic hCG in the Homeopathic Pharmacopoeia? NOT LISTED. Therefore, the FDA takes the position that homeopathic hCG claims are fraudulent and, therefore, sales of products making those claims are illegal.
If the evidence clearly suggests that hCG is completely useless in the treatment of obesity, why is hCG so popular?
If a product is so good, why not just do the research and contribute to our understanding of it?
Circumventing science through consumer books and late-night talk shows:
Unfortunately for all of us, the highly emotional and desirable weight loss outcome with the ease of drops or tablets brings about an explosion of websites that smack of weight loss gimmickry—promises of obesity “cures” and “30 pounds in three weeks…” often laced with “doctor approved” and “as seen on…”
Enter stage left Kevin Trudeau’s 2007 consumer book “The Weight Loss Cure They Don’t Want You to Know About.” For those of you who don’t know Kevin Trudeau from late-night infomercials, in 2008 he was fined $5 million and banned from making infomercials for 3 years due to the false promises used to sell this book (and make millions); in 2014 Trudeau was sentenced to 10 years in prison for violating the first ban and continuing to make false claims promoting his “how to lose weight hunger-free,” 500 calorie diets, injectable hormones and other promises. Watch the excellent piece by 20/20 here.
Of course, with this level of promotion and the convenience of sublingual homeopathic drops and tablets (no injections!), more and more people sought hCG with the emotional promises of a quick fix. Enter science again; more results studies (see here) more attempts to answer whether hCG affects adipose tissue or fat cells (see here) more negative results for hCG.
But does it end? No, Enter Dr. Emma and Dr. Oz—more talk shows.
In 2012 a Dr. Emma appears on the Dr. Oz show claiming to have done no less than four clinical trials “proving” her new hCG protocol where one isn’t limited to 500 calories. The “creator of Dr. Emma’s hCG protocol” peppers her talk with statements like “There have not been any trials published in over 20 years. My trial is the first to show the difference in body composition between HCG and placebo.” The problem is, I can’t find her trial or her supposedly published papers.
Something smells wrong. A search in the National Library of Medicine returns NO ITEMS FOUND. Searching the clinical trials database produces, NO ITEMS FOUND—I can find none of this work published anywhere on the internet so I (and others) can see what she did. Not one single paper found its way to the normal scientific channels, through peer review, published… I even wrote requesting same: NO ITEMS SENT. Yet Dr. Emma claims:
- Measuring homeopathic hCG on “hundreds of people between 2010-11, patients using an oral form of HCG (drops or pellets) had no detectable HCG in the bloodstream. I concluded that HCG is unable to be absorbed by mouth.” Not surprising since most oral hCG is homeopathic—meaning it works on a resonance principle and rarely has much of the original compound in it. In other words, it shouldn’t be detected. But since this paper isn’t published anywhere, no one can see what she did.
- That her program doesn’t require the very low calories of Dr. Simeons’ method, but it still is an extremely restricted diet of portion control, counting, and careful choices.
- That the weight loss in each group is similar. “The striking difference is that the hCG group lost only 2 pounds of muscle, but the placebo group lost 5 pounds of muscle. Therefore, hCG causes a different type of weight loss.” Folks, given the earlier extremely well-done studies that showed just the opposite—this is surely news and should be contributed to scientific journals by now (her talk: 2012; I’m writing this in 2015). I want to know how many people are included? How did she choose them? Since she modified Dr. Simeons’ diet, could that explain it? NO ITEMS FOUND.
- That she proudly presented her studies at the October 2012 meeting of the American Society of Bariatric Physicians and got them to change their position statement.
What does the bariatric (obesity & weight loss) profession think?
Several physician boards have discussed the evidence and created negative position statements regarding hCG itself, the very low calorie diet, and the combination of the two with regard to weight loss. Although as seen on Dr. Oz, Dr. Emma claims she presented her findings to the bariatric board in 2012, as of September 2015, the quite readable American Society of Bariatric Physicians statement concludes:
“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…
“It is the position of the American Society of Bariatric Physicians that:
“1. The Simeons method for weight loss is not recommended.
“2. The Simeons diet is not recommended.
“3. The use of HCG for weight loss is not recommended.”
Is hCG appropriate for weight loss?
The hCG groups themselves state: “Not without the very low calorie protocol. hCG is only useful in burning fat and increasing metabolism if the 500 calorie protocol is followed. “If you administer hCG without properly following the 500 kcal diet, there is a high risk you’ll gain even more fat!”
Is it the 500 calories, high protein restrictive diet that works? Or the hCG itself?
Many, many people swear by this diet. You probably have friends who have used it. So why do people claim they are not hungry? And can it really burn fat without wasting muscle?
There is an alternate explanation: the decrease in hunger emphasized in hCG promotions is likely from the emphasis on more protein intake and/or carbohydrate restriction. This shifts the body into ketosis (burning stored fat for energy). Ketogenic dietary plans are associated with diminished hunger sensation—it may have nothing to do with the hCG. This may even explain the Dr. Emma findings based on hints given about her diet (she sells her plans). Despite her promise of no longer needing to stay at 500 calories, the diet itself is just as disciplined with daily food journals and specific meals.
More on that alternate fat loss explanation: Recently, science showed that fat intake does not stop fat burning nor does it trigger fat storage except when overall calories from fat are well above what the body needs to burn. During weight loss, getting enough protein and calories from the right foods protects muscle from being lost.
What science also recently showed is that when fat is combined with carbohydrates, the rise in blood sugar forces the body to burn the carbohydrate calories (or store them as fat) and ignore the fat consumed (and store it as fat). Very few carbohydrates are allowed on the Simeons very-low-calorie and the Emma low-calorie plans. Limiting carbohydrates results in more of a pure fat loss, which causes a shrinking in inches and size of clothing… isn’t that what we want?
What to do?
We all want to rid ourselves of the excess fat we know is horribly bad for our health, is caused by and in turn causes inflammation, upsets organ balance, stores harmful chemicals, and makes dozens of hormones—many of which keep the body in an inflammatory state.
Besides, it doesn’t look the way we want to look.
Most weight loss programs don’t work because they are designed wrong—Lean Cuisine and Weight Watchers emphasize low calories not quality—and most of the calories come from carbohydrates which will eventually create sugar handling problems. These are not nourishing foods but they appeal to our desire for simple because they come in a box or a bar.
There is a ton of food prep on the hCG diet; it takes time and discipline to follow it. Why not take the time and discipline to follow a healthier plan?
The very low calorie hCG diet component is an unhealthy restriction. Why not just shift the sorts of foods you eat to those that ignite your fat burning?
The regimen includes questionable use of a powerful hormone. This concerns me—we should not mess with our delicate balance of hormones without knowing exactly what is happening.
There is weekly support because you have to go into the prescribing doctor’s office for re-exams (and rightly so given the hormone and low calorie diet safety profiles), for which they charge you about $2-300 each visit. There are less costly and safer programs where you can get great information. Join my next Group Program. We have fun and get the job done! Or hire someone you enjoy and who can guide you.
If you are motivated and can be disciplined, the Paleo diet, is an excellent ketogenic diet as long as you ignore the rather thick “desert” sections or questionable ingredients (they do sell cookbooks, but truly are inflammatory). Here’s a good one. Or try the original Atkins diet (yes it has many published studies).
But please skip the $1200 hCG programs. Enough said.
References
Asher WL, Harper HW. Effect of human chorionic gonadotrophin on weight loss, hunger, and feeling of well-being. Am J Clin Nutr. 1973 Feb;26(2):211–218
Gibson AA, et al., Do ketogenic diets really suppress appetite? A systematic review and meta-analysis. Obes Rev. 2015 Jan;16(1):64-76. doi: 10.1111/obr.12230. Epub 2014 Nov 17.
Goodbar NH, et al., Effect of the human chorionic gonadotropin diet on patient outcomes. Ann Pharmacother. 2013 May;47(5):e23. doi: 10.1345/aph.1R755. Epub 2013 Apr 19.
Johnstone AM, et al., Effects of a high-protein ketogenic diet on hunger, appetite, and weight loss in obese men feeding ad libitum. Am J Clin Nutr. 2008 Jan;87(1):44-55.
Lijesen GK, et al., The effect of human chorionic gonadotropin (hCG) in the treatment of obesity by means of the Simeons therapy: a criteria-based meta-analysis. Br J Clin Pharmacol. 1995;40:237–243.
Mikirova NA, et al., Effect of Weight Reduction on Cardiovascular Risk Factors and CD34-positive Cells in Circulation. Int J Med Sci. 2011; 8(6): 445–452. Published online 2011 Aug 1 PMCID: PMC3156990
Simeons AT, The action of chorionic gonadotrophin in the obese. Lancet. 1954 Nov 6; 267(6845):946-7.
Tunc, E, Immunohistochemical and ultrastructural changes in rat fat tissue related to the local hCG injection. Eur Rev Med Pharmacol Sci 2013; 17 (22): 3103-3110
Young RL, Fuchs RJ, Woltjen MJ. Chorionic gonadotropin in weight control. A double-blind crossover study. JAMA. 1976 Nov 29;236(22):2495-7.
