hCG Hormone Diet
Pharmacist regularly field questions about weight loss programs. Most develop some degree of familiarity with many of the popular diet programs, in order to redirect customers from some of the more harmful plans and approaches. Recently, a pharmacist friend of mine was asked about how to best to manage a “plateau” on the hCG diet. He admitted that he never knew it was being dispensed for weight loss purposes. He mentioned that he frequently dispensed human chorionic gonadotropin (hCG), and knew of its use for the treatment of infertility, where it promotes ovulation. But weight loss? He confessed that he couldn’t think of a mechanism for how hCG could promote weight loss. So, he approached me (his biology/nutrition based friend) to see if I were willing to investigate this weight loss method for him. After some digging, I found a long, rich vein of pseudoscience that dates back decades, but was this method safe and effective?
The Background: hCG is comprised of 244 amino acids. It is produced in large amounts in a pregnant woman’s placenta, extracted from her urine. Actually, its presence in urine signifies a positive pregnancy test. Historically, hCG is used, in part, for the treatment of infertility in females to help induce ovulation. Its use as a weight loss adjunct has roots that date back to the 1950s, when British physician A.T.W Simeons announced case studies of weight loss in patients given hCG. He combined a reduction diet (500 kcal per day) with daily injections of the pregnancy hormone human chorionic gonadotropin (hCG) (125 IU i.m.). According to Simeons the patient should not lose more weight during a 4-to-6 weeks' diet than without hCG, but the injections should facilitate to maintain the diet and to lose body weight at specific parts of the body (e.g. hip, belly, and thigh).
This is an example of the 500 calorie diet plan recommended by Simeon: Breakfast: | Tea or coffee in any quantity without sugar. Only one tablespoonful of milk allowed in 24 hours. Saccharin or Stevia may be used. | Lunch: | 1. 100 grams of veal, beef, chicken breast, fresh white fish, lobster, crab, or shrimp. All visible fat must be carefully removed before cooking, and the meat must be weighed raw. It must be boiled or grilled without additional fat. Salmon, eel, tuna, herring, dried or pickled fish are not allowed. The chicken breast must be removed from the bird.2. 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.3. One breadstick or one Melba toast.4. An apple, orange, or a handful of strawberries or one-half grapefruit. | Dinner : | The same four choices as lunch (above.) |

Drinks and Seasonings permitted on the hCG Diet based on Dr Simeons original hcg diet protocol as written in Pounds and Inches:
The juice of one lemon daily is allowed for all purposes.
Salt, pepper, vinegar, mustard powder, garlic, sweet basil, parsley, thyme, marjoram, etc., may be used for seasoning, but no oil, butter or dressing.
Tea, coffee, plain water, or mineral water (2 liters of water per day is recommended) are the only drinks allowed, but they may be taken in any quantity and at all times.
The fruit or the breadstick may be eaten between meals instead of with lunch or dinner, but not more than four items listed for lunch and dinner may be eaten at one meal.
No medicines or cosmetics other than lipstick, eyebrow pencil and powder may be used without special permission.
After his first publication on the diet, various studies conducted with male and female patients analyzed the effectiveness of the diet. Ten of these studies showed positive and another ten studies reported negative results with regard to hCG-related weight reduction. Two of these studies with positive results were double-blind studies (hCG vs. placebo). Most of them were reports on therapeutical experiences and were not controlled studies. According to these reports the body proportions normalized and the feeling of hunger was tolerable. Four out of 10 studies with negative results were controlled studies (hCG vs. control without hCG), whereas 6 were double-blind studies. These studies showed a significant weight reduction during dieting, but no differences between treatment groups in respect of body weight, body proportions and feeling of hunger. In recent publications describing mostly well-documented double-blind studies; authors largely reject hCG administration in dieting stating, “Supporters of the hCG diet must prove the efficacy of this method in controlled studies according to prescribed federal standards. Until then the opinion this panel is still valid, that hCG is ineffective in dieting and should not be used.” Simeon’s promising data continued to fail to be replicated in later studies, and interest in the injections as a diet plan seemed to deservedly fade.
Then, in 2007, the diet leapt back into consciousness when telemarketer and convicted felon, Kevin Trudeau released a book called “The Weight Loss Cure, What THEY Don’t Want You To Know”, which included enough information about the hCG (Simeons diet) to again create interest in Dr. ATW Simeons original work. Shortly thereafter, a few ‘pioneer’ Professional Clinics in the US began offering hCG for weight loss. As more people started reading “The Weight Loss Cure” and interest stirred again, the general public became eager to find a ‘cure’ to weight loss and began doctoring themselves because they couldn’t find Doctors offering the HCG Diet. Trudeau proclaimed the truth was being 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.
Current evidence
Numerous studies dating back to the 1970’s and their conclusions are consistent and persuasive today: 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 endorse the use of hCG for weight loss. There are however several medical journals that have published studies and evidence stating categorically that hCG does not work.
American Society of Bariatric Physicians 2009:
“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.” Conclusions state that they do not recommend the hCG diet for weight loss. They do not recommend hCG for weight loss.
The J. Clin. Pharmacol. 1995 September; 40(3): 237–243.
The effect of human chorionic gonadotropin (HCG) in the treatment of obesity by means of the Simeons therapy: a criteria-based meta-analysis.
This study was conducted to assess if there is any scientific ground for the use of human chorionic gonadotropin (HCG) as adjunctive therapy in the treatment of obesity. This study analyzed 24 previous publications on hCG for weight loss and used computer aided tracing and citation tracking. The 24 studies were scored based on their quality and methodology.
Conclusions are that there is no scientific evidence that HCG is effective in the treatment of obesity. In addition they state that hCG does not promote fat redistribution nor does it reduce hunger or create a feeling of well being.
W. V. Med. J. 2011 Jan-Feb; 107(1):12:
“There they go again”–hCG and weight loss.
The increased demand of hCG has led to shortages and increased expense for the legitimate use of hCG for endocrinological and fertility disorders. This article quotes Fienberg and Hiatt stating: “What is unacceptable is to persist in demonstrably ineffective practices either because we fail to collect systematic information about the effects of our actions or because we establish and respond to inappropriate incentives.”
Conclusions are that systemic information has been obtained and has shown lack of benefit from the use of this therapy for weight loss. The persistence and promotion of this treatment is unacceptable.
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.”
Over the past several years a flurry of non-prescription (i.e., over-the-counter) hCG products have appeared on the market, including “homeopathic” hCG. If truth be told, hCG is a protein that would be digested if consumed orally. But scientific logic 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 in December of 2011, when it began to pull all unapproved hCG products completely off the market. This has put the supplement industry into the position 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.”
Finally in 2012, the FDA and Federal Trade Commission issued warning letters to seven companies marketing over-the-counter hCG products labeled as “homeopathic” for weight loss. The letters warned the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the products.
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?
In conclusion, there is overwhelming evidence on the side the hCG diet. After extensive research, there is no doubt in my mind that this diet is not effective. This is only the least of my concern regarding the diet. Exposing yourself to a rigorous 500 calorie per day diet is completely unhealthy and I would never recommend it. The FDA mentions several potential side effects from the calorie restriction such as gallstone formation, electrolyte imbalance, and arrhythmias (irregular heartbeats). The neurological consequences are not mentioned but most definitely exist. I can’t imagine a person being able to concentrate and perform their daily activities with such a diet. The daily recommended caloric intake for an adult is over 1800 calories a day. If a person looses weight during this diet it is due to the near starvation calorie intake scheme that they expose themselves to and not the daily hCG application. Several reputable studies have been performed on the effectiveness of hCG in weight loss. These studies all conclude that hCG is not better than placebo for weight loss. Evidence also shows that hCG is not effective as a hunger suppressant, or for fat redistribution. The following concluding statement from one of the largest and most comprehensive studies on hCG sums up the findings that I passed on to my pharmacist friend:
“We conclude that there is no scientific evidence that HCG causes weight-loss, a redistribution of fat, and staves off hunger or induces a feeling of well-being. Therefore, the use of HCG should be regarded as an inappropriate therapy for weight reduction, particularly because HCG is obtained from the urine of pregnant women who donate their urine idealistically in the belief that it will be used to treat an entirely different condition, namely infertility. Pharmacists and physicians should be alert on the use of HCG for Simeon’s therapy. The results of this meta-analysis support a firm standpoint against this improper indication. Restraints on physicians practicing this therapy can be based on our findings.”

References:

G. K. Sabine, 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 Pharmacology 1995; 40: 237-243

American Society of Bariatric Physicians 2009: hCG Position Paper

Toffle, Roger, “There they go again” — hCG and Weight Loss,”MDW. V. Med. J. 2011 Jan -Feb; 10, Vol 107, No1

HDI Health, www.hcgdietinfo.com/HCG-Diet-Products.htm7(1):12

Zelman, Kathleen, The Truth about hCG for Weight Loss, www.webmd.com
Riskind, Arlyn, Endocrine Experts Agree with FDA that hCG Diet is Unproven and Potentially Harmful, The Endocrine Society, press release, 2009

Katz, David,’ hCG Diet for Weight Loss?’ The Huffington Post, January, 2011