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This Calgary local news story is somewhat disturbing. Not disturbing in the same way that CTV Calgary News presented a homeopathic remedy as a viable method of treating food allergies (which the ‘patient’ – read: son-who-has-a-sucker-for-a-mother – was unlikely to have had in the first place) without any input from the evidence-based medical community whatsoever to explain why this ‘treatment’ can not be differentiated from quackery. That was one of the most irresponsible and unethical pieces of journalism (I use the term very loosely) I have ever witnessed. You can read more about that debacle here.

No. This story carried by Global TV Calgary News was actually quite good and I give full marks to Shane Jones for his professional journalistic skills. Some people might see this and only see the weight loss and not listen to what sound science has to say on the matter, but there’s only so far we can go before personal responsibility for actions kicks in.

The subject of the segue was the so-called hCG diet (it can be viewed here, and begins at the 33′ 40″ mark). hCG – short for human chorionic gonadotropin – is a glycoprotein hormone released during pregnancy that prevents the disintegration of the corpus luteum of the ovary, thereby maintaining progesterone production. This is critical since progesterone is involved in the menstrual cycle and maintaining its production extends the luteal phase of the cycle. In other words, it’s what stops menstruation during pregnancy.

The claim that hCG can aid in weight loss was first made by endocrinologist A.T. Simeons1-3. In India, Simeons studied pregnant women on a calorie-deficient diet and young boys with Frolich’s syndrome treated with low-dosage hCG. Frolich’s syndrome is a disorder (primarily affecting males) in which the levels of the neurohormone GnRH are low and regulation of food intake (regulated by the hypothalamus in the brain) is disrupted, resulting in increased apetite leading to obesity.

Simeons claimed that both pregnant women with a calorie-restricted diet and sufferers of Frolich’s syndrome lost weight due a rediction in body fat and not lean muscle (something very desirable in a weight loss regimen) and reasoned that hCG must be acting on the hypothalamus to reduce apetite. Simeons recommended daily low-dose injections of hCG (125 IU) combined with a very low-calorie diet (500 cal/day, high protein/low fat content).

While not an unreasonable hypothesis, it was thus only a hypothesis and in need of testing before being introduced as a standard of care therapy for obesity. So, what does Science have to say regarding the efficacy of Simeons’ protocol? In a word, “balderdash”4-11. A meta-analysis12 showed that of 12 articles published in peer-reviewed journals that were worthy of consideration (assessed from study population, interventions, measurement of effect, and data presentation and analysis), only one showed any usefulness of hCG with regard to weight-loss, fat-redistribution, hunger, and feeling of well-being.

The problem is that every single randomized double-blinded clinical trial (the only acceptable way to assess the efficacy of any therapy) has demonstrated that this protocol is absolutely indistinguishable from those on the same diet, but given saline in lieu of hCG. As one journal entry stated, it is “a manifestation both of placebo effect and the Hawthorne effect.” The Hawthorn effect is the name given to a curious phenomenon wherein the subjects of a study improve or modify their behavior being experimentally measured simply in response to the fact that they are being studied. This is not quite the same as the placebo effect, but it is related. The placebo and Hawthorn effects are exactly those kinds of confounders which randomized double-blinded trials are designed to eliminate. Because of this, people self-reporting improvement are data that are completely useless and can not be considered when trying to determine the efficacy of a therapy.

But does this knowledge that a therapy has been tested for efficacy and found to be wanting by the medical research community end claims that Simeons’ protocol is an effective weight loss program? Of course not. We humans like to think we are rational, but reason and logic are learned behaviors that must be consciously applied, and everyone is subject to irrational behaviors being chosen over rational ones. There are also those who latch onto claims simply because claims are being made that they would like to be true. We are seeing this with the so-called ‘liberation therapy’ for MS. People want the claims to be true and so are primed to expect improvements when they use a treatment. But wanting them to be true doesn’t make them true, and this is exactly why assessing therapeutic strategies are done with both subject and experimenter are blinded as to whether the subject receives the actual drug, and thus makes a comparison between control and drug groups valid. Subjects in these studies wanted hCG to reduce their apetite when on severely calorie-restricted diets and so did report that hunger was decreased, whether they were given hCG or saline. If each group knew what they were getting – whether told by or unwittingly picked up from the experimenter – comparing the two groups might show a false positive effect where hCG produced more weight loss with less hunger.

Even though the claims made by proponents of the cHG diet have been falsified, this does not stop unscrupulous hawkster taking advantage of people wanting to lose weight and their trust. Among those that picked up on Simeons’ claims are the likes of Kevin Trudeau. Yes… THAT Kevin Trudeau. The same Kevin Trudeau that has no medical training, though he posed as one to commit larceny. (Well, neither do I, but I am published in the medical research literature and know a helluva lot more about assessing claims in a scientific manner.) The same Kevin Trudeau that was fined $500,000 by the FTC for fraudulent claims in his “Mega Memory System” and other infomercials, again for $2M due to fraudulent claims that his coral calcium elixir could cure cancer. The same Kevin Trudeau that was arrested earlier this year for attempting to influence the judge hearing the case against him for misleading claims made in infomercials plugging his bood, The Weight Loss Cure ‘They’ Don’t Want You to Know About. This is one thing I wish Global News had picked up on. Trudeau is shameless in promoting potentially-harmful nonsense for financial gain.

Just look at the title of the book, The Weight Loss Cure ‘They’ Don’t Want You to Know About. It has such a conspiratorial tone, and everyone loves a conspiracy. But what conspiracy would there be? Who is the “They”? Medical practitioners who treat obesity? I don’t think so. It’s not likely that if the Simeons protocol works there would suddenly be no obese people to treat. Indeed, the medical community would stand to gain from having a magic bullet for weight loss. Prescribing lifestyle changes doesn’t bring in much cash. The truth is that there is no conspiracy. It’s a manufacturcy that is designed specifically to excite people’s imagination that he is fearlessly and altruistically leaking some deep dark secret closely held by the medical community. Nothing could be farther from the truth. The claim the hCG reduces apetite, allowing very low caloric diets has been tested and the claim has fails these tests numerous times. The hypothesis has long since been discarded by the medical community. It’s done.

Of course, people do lose weight while on this regimine. After pointing out that hCG has not been approved as a weight loss drug in either the US or Canada, Dr. Suttorp echoed my first though about the hCG regimine: “It’s the 500 calories a day that is actually creating the weight loss.” Word. The average daily calorie requirement for women is 2000 cal/day and for men 2500 cal/day. A ballorina might take in 800 cal/day, in my opinion a pretty good standard for unhealthy diets. The Simeons protocol goes beyond this by almost 40%. Without changes in lifestyle, weight regain after ending such severe calorie-restricted diets is pretty much inevitable. The key may be to control the action of apetite hormones such as leptin, ghrelin and insulin. A recent study has shown that rebounders have higher levels of leptin than those that do not regain weight13.

Very low calorie diets (under 800 cal/day) are really starvation diets that cause the body to rely on ketone metabolism for producing glucose. They can have adverse effects, including increased incidence of gout, the formation of gallstones and produce electrolyte imbalances, and are not a good method of sustained weight loss in the treatment of obesity14.

But the long and the short of this: people on this diet are paying $125-300 for a six-week supply of hCG when the part that is causing all of the weight loss – the caloric restriction – is completely free, albeit not a means to weight loss any doctor would or should advocate. What we are witnessing is a result of the a need for immediate gratification- I want to lose weight, and don’t want to have to work for it and I want it now. But life doesn’t work that way. Lifestyle changes are far more successful in losing weight without the regain which is only available through a balanced diet and exercise. I’ve been a member of Weight Watchers for a while now, and it is a program that teaches people to make food choices that reduce caloric intake, are higher in fibre and lower in fat. I highly recommend this program and others like it. I would advise (but not being a nutritionist I would take my advice given outside my expertise with a grain of salt, of course) avoiding those programs which get you to buy their food. It’s not possible to learn anything from that, making long-term success in keeping the weight off less likely. But for goodness sake, avoid having anything to do with this hCG crap! This diet is no less an urban legend (no matter that people unwittingly carry out the actions of the legend, a process known as “ostension”) than the one in which green M&Ms are an aphrodesiac.

References

  1. Simeons AT. The action of chorionic gonadotrophin in the obese. Lancet. 1954 Nov 6;267(6845):946-7.
  2. Simeons AT. Chronic gonadotrophin in the treatment of obese women. Am J Clin Nutr. 1963 Sep;13:197-8.
  3. Simeons AT. Chronic gonadotrophin in the treatment of obesity. Am J Clin Nutr. 1964 Sep;15:188-90.
  4. Miller R, Schneiderman LJ. A clinical study of the use of human chorionic gonadotrophin in weight reduction.
    J Fam Pract. 1977 Mar;4(3):445-8.
  5. Miller R, Schneiderman LJ. Human chorionic gonadotrophin and weight loss. A double-blind, placebo-controlled trial. S Afr Med J. 1990 Feb 17;77(4):185-9.
  6. Kotsuji F, Kubo M, Takeuchi Y, Tominaga T. Alternate-day GnRH therapy for ovarian hypofunction induced by weight loss: treatment of six patients who remained amenorrhoeic after weight gain. Clin Endocrinol (Oxf). 1993 Dec;39(6):641-8.
  7. Stein MR, Julis RE, Peck CC, Hinshaw W, Sawicki JE, Deller JJ Jr. Ineffectiveness of human chorionic gonadotropin in weight reduction: a double-blind study. Am J Clin Nutr. 1976 Sep;29(9):940-8.
  8. Miller R, Schneiderman LJ. A clinical study of the use of human chorionic gonadotrophin in weight reduction. J Fam Pract. 1977 Mar;4(3):445-8.
  9. Shetty KR, Kalkhoff RK. Human chorionic gonadotropin (HCG) treatment of obesity. Arch Intern Med. 1977 Feb;137(2):151-5.
  10. Young RL, Fuchs RJ, Woltjen MJ. Chorionic gonadotropin in weight control. A double-blind crossover study. JAMA. 1976 Nov 29;236(22):2495-7.
  11. Birmingham CL, Smith KC. Human chorionic gonadotropin is of no value in the management of obesity. Can Med Assoc J. 1983 May 15;128(10):1156-7.
  12. Lijesen GK, Theeuwen I, Assendelft WJ, Van Der Wal G. 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 Sep;40(3):237-43.
  13. Crujeiras AB, Goyenechea E, Abete I, Lage M, Carreira MC, Martínez JA, Casanueva FF. Weight Regain after a Diet-Induced Loss Is Predicted by Higher Baseline Leptin and Lower Ghrelin Plasma Levels. J Clin Endocrinol Metab. 2010 Aug 18. [Epub ahead of print]
  14. Very low-calorie diets. National Task Force on the Prevention and Treatment of Obesity, National Institutes of Health. JAMA. 1993 Aug 25;270(8):967-74.
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