Obesity and the negative consequences of that disease process have significantly increased in the U.S. over the last few decades. In fact, since 2008 there has not been a single state in the U.S. where the obesity rate declined. In more than 16 states, the percentage of obese adults increased and the rate of obesity in children ages 10 to 17 is continuing to dramatically increase. (Sources: Trust for America’s Health and Robert Wood Foundation and Obesity Data from Centers for Disease Control and Prevention (CDC). The traditional approach of the U.S. medical system is to tell patients “eat less and exercise more.” This is initially good advice, however, it falls far short of what is needed to lower and reverse the rate of obesity.

In an effort to address the obesity epidemic, pharmaceutical companies are trying to find the magic pill for weight loss, fad diets come and go, and alternative approaches have evolved, including surgeries developed specifically for weight loss. Each of these approaches has significant side effects and others are simply dangerous. Worse, unscrupulous individuals and companies take advantage of the increased desire of our society to find a way to lose weight.

There are multiple different approaches and tools to weight loss that are safe and useful. Some of these approaches are misunderstood. One of those approaches is the Dr. Simeons hCG Protocol.

Developed in the 1950’s, Dr. Simeons Protocol, published in the medical journal The Lancet , was designed to improve the obese patient’s metabolism thus allowing for weight loss. When a patient practiced improved habits it was found that the weight loss was generally maintained. The protocol worked. After Dr. Simeons died in 1970, the protocol nearly disappeared with him. Though interest in the hCG Protocol has waxed and waned over the years, it has found recent resurgence.

The basics of the protocol involve using a protein hormone called human Chorionic Gonadotropin (hCG), which is produced in high amounts during pregnancy to allow the fetus to survive. HCG medication requires a physician’s prescription. The actual medication is stored in a powder form and needs to be reconstituted and refrigerated for use. Once reconstituted and properly refrigerated its shelf life is about 60 days. Although there are oral pill forms that can be stored at room temperature, they are not as effective as the injectable form, in my experience.

In the protocol, hCG is used once each day and is combined with a strict, very low calorie diet (VLCD) of 500 to 700 calories. The hCG acts as an appetite suppressant and allows for the body to tap into and utilize the stored fat as a source of energy and nutrition. This is where the controversy begins. Consuming only 500 calories a day? Pregnancy hormone? Who can really live on 500 to 700 calories a day and why would anyone take a pregnancy hormone to lose weight? Over the years research has been incomplete and studies have not been definitive. And everyone, from lay people to health experts, has his or her own opinions about the legitimacy of the hCG Protocol.

My humble opinion is that first, this is NOT a cure or final solution for weight loss. The hCG Protocol is not for everyone and it is not a diet to follow as a way to manage weight for life. It is, however, an effective tool that can be used for some individuals to improve their metabolism, lose weight, and help work towards finding a change that improves their overall health in the long run.

When I first was exposed to the protocol I did not like the idea of the “diet.” In my initial evaluation of it, I applied my knowledge of strict very low calorie diets and their significant issues such as muscle wasting, weakness, low energy levels and potential for a general starvation state. In fact, my first description of the protocol used the words “stupid, bad, gross negligence, and downright dangerous.” All that stood out for me was “hCG” and “500 calorie diet.” I would have stopped right there in my understanding of the protocol had it not been for the successful experience of a family member who wanted to do a second round of the hCG Protocol to continue her pursuit in achieving her ultimate health goal. My response to her request for the hCG was an emphatic “NO!” Her reply to my “expert” opinion as to how dangerous it was: “It worked and I never felt better while I was on it AND I kept off the weight I lost!” She then continued to tell me about other people she knew who did well while on it.

Only because she insisted on doing it anyway and planned on going to the original provider for the hCG did I decide to research the protocol further. I was fearful for her safety and wanted to be ready for the issues I “knew” she was going to develop. I even purchased the Kevin Trudeau book, The Obesity Cure , which promotes the hCG Protocol for weight loss and had been touted at that time. Reading the book only reinforced my original negative opinion of the “hCG Diet.” My opinion was further supported by the nonsensical miscellaneous items it touted as “requirements.” I realized that book was not about the actual protocol, but about selling junk. However, I could not deny the number of individuals who said they did well on the program.

I spent more time researching and found some small studies that questioned the effectiveness of the protocol and others that supported it. I did not find, however, and this is important, one single study that showed long-term harm from the protocol nor did I find any case studies with negative outcomes. I decided then to conduct my own case studies with multiple types of patients: women, men, smokers, non-smokers, diabetics, old, young, etc. I did some basic pre- and post-protocol laboratory analysis. What I found was the exact opposite of what I expected to happen. No starving states, hunger not an issue, incredible weight loss without the negative issues I had anticipated. Average weight loss was about 0.5 pounds a day over a period of 39-49 days, depending upon the individual and their response to the diet. Some lost significantly more and others a little less. Men did notably better than women.

There were caveats. I noted that there had to be a real commitment to the protocol; if there were any food issues, underlying psychiatric issues, or lack of social/family support, then there was a higher failure rate, as would be the case with any weight loss program. There were some side effects such as hair loss, constipation and, the most common, dry skin, despite increased water intake. All were rare and reversible.

Many individuals continued to lose weight after they completed the protocol and began a regular diet. I attributed this to an overall improvement in the participant’s general metabolism. Individuals had a number of positive side effects such as improved taste of food, improved general metabolic functional blood panels, and persistent improved overall metabolic function. There were some interesting and positive surprises. This included reversal of diabetes and pre-diabetes states, improved thyroid function (one case of a temporary hyperthyroid state that stopped once the hCG Protocol was finished), no hunger, no starving states, enough energy to work out at any level, and overall persistent weight loss after the protocol ended.

Following these results, I began to offer the hCG Protocol formally to my patients. I remained selective in offering it to patients who were committed, had more than 10 pounds to lose, more than 28 percent body fat percentage, social support, no undiagnosed underlying metabolic pathology (diabetes, hypothyroid, cancers or history of cancer of any type, kidney dysfunction, seizure disorder, etc). Over the following months, I modified the protocol and my selection process. This has been a continuing dynamic endeavor. In the last four years that I have provided the protocol, I have not found one single long-term negative side effect. Not one. There have been some anecdotal temporary side effects of hair loss, hunger without starvation, dry skin, and constipation, as I previously mentioned. A few patients have gone into an actual starving state, which is easily recognized and remedied. The reasons for that vary widely and will be addressed later in a more detailed paper.

Yes, patients do fail on the hCG Protocol. The number one cause of failure is non-compliance – patients just not following the protocol for one reason or another. Other reasons include overpowering cravings for food. Not hunger, but actual cravings or a Pavlov-like desire to eat. I attributed the cause for the few patients that have gone into an actual starvation state to incorrect dose for that individual, antibodies to the hCG, and undiagnosed underlying metabolic issues, among other reasons. Despite these infrequent issues, I have not yet found one single long-term negative effect from this weight loss program.

The bottom line: lack of good long-term studies and the persistent influx of misinformation passed around by experts with good intentions, but poor input and lack of knowledge have resulted in a widespread misunderstanding of the hCG Protocol.

There are a great deal of opinions, from patients to providers, on the effectiveness and safety of the hCG Protocol. Unfortunately, many of these opinions are based on biases resulting from their limited knowledge of VLCD and of the awareness of hCG as a pregnancy hormone and fertility medication. The so-called experts begin to feed on each other’s opinions and thus the cycle of baseless “expert” opinion is perpetuated. This baseless opinion grows and becomes “standard of care.” The Food and Drug Administration (FDA), directors of medical centers, and individual experts all feed into this dynamic, which then spill over directly into policies. For example, certain malpractice insurance companies will discriminate against physicians who provide the legitimate hCG Protocol and will not cover their malpractice. Yet these same insurance companies will cover procedures that have actual death rates. The media perpetuates this misinformation with quick snippets of statements stating that the hCG Protocol is bad medicine. This type of misinformation creates an impenetrable cloud masking the truth behind the treatment, and ultimately impedes the legitimate treatment of those who can benefit.

There continue to be multiple pseudo hCG weight loss programs being marketed to the general public that exploit the positive outcomes of the original Dr. Simeons hCG Protocol. One afternoon recently at a local mall, I found eight different over-the-counter “HCG PROTOCOL WEIGHT LOSS” diets. Of course, none were the actual hCG hormone. I’ve seen ads in papers or on the Internet and entire billboards with seductive women touting “hCG Diets” you can buy online or through 1-800 numbers. Creative marketing and labeling using the letters “hcg” and even Dr. Simeons’ name and protocol in their directions and inserts mislead the public. Many of these products contain the usual ingredients found in over-the-counter weight loss supplements: caffeine, argentine, green tea, guanine, etc. None include the actual hCG hormone. Words such as “analogue, hcg booster, hcg stimulator, pituitary stimulator,” etc., again mislead the consumer. Worse, some even claim to be “homeopathic hCG.” There is no such actual homeopathic form noted in the list of homeopathic remedies published in the Homeopathic Pharmacopoeia or the Homeopathic Medicine Index .

Unfortunately, providers are getting much of their negative feedback from individuals using these pseudo hCG diets and not the actual protocol. They assume that the actual hCG Protocol is being used, note the negative side effects or failed attempts in losing weight, and establish their negative opinions. Then they pass it on. This contributes to the circle of consistent misinformation.

Even the popular Dr. Oz initially considered the protocol in a very negative light. His opinion changed as a result of further investigation by his research team, although he remains appropriately cautious. The bottom line: We need more studies. After being around for more than 50 years, the hCG Protocol has shown no documented long-term negative issues. It is not for everyone, and requires the usual counseling, lifestyle changes, medical evaluation and follow-up. Patient selection for compliance must occur. If a patient travels a lot, has small children in the home, does not have spousal or family support, or has an underlying psychological issue with eating or food, then the protocol will be more difficult for them to follow. It is absolutely necessary to spend some time researching to find a legitimate provider who understands how to utilize the protocol in a patient’s specific setting.

For Dr. Simeons’ hCG Protocol to work, post-protocol procedures must be individualized and guided by a team consisting of the patient’s social support network and physician. Myths about the diet are perpetuated by physicians, providers and nutritionists who do not have the practical experience with the protocol. Research is limited. However, I do believe the hCG Protocol, when administered under a doctor’s supervision, is an effective and safe method of weight loss and metabolism improvement for individuals who otherwise cannot lose weight.