The Science Behind “Lose Up to 30 Pounds in 30 Days”

The Simeon Protocol.

The following is a revised version of our study published in the American Journal of Bariatric Medicine. The study involved 140 patients treated with the Simeon Protocol and the prescription pregnancy hormone recommended by Dr. Simeon.

A Retrospective Analysis of 140 Patients Treated with hormones and a Calorie Restricted Diet in accordance with the Simeon Protocol. By Joseph Feste, M.D., and Mike Clark, PhD. of NBH Lifetime Health.

INTRODUCTION

Obesity continues to be a public health concern in the United States and throughout the world. In the United States, obesity prevalence doubled among adults between 1980 and 2004. Obesity is associated with an increased risk of several conditions, including diabetes mellitus, cardiovascular disease, hypertension, certain cancers, and with an increased risk of disability and a modestly elevated risk of all-cause mortality.

Although obesity is a consequence of complex factors including an increase in the consumption of calories and a decrease in physical activity, the prevalence of obesity is influenced by environmental factors. In the United States, foods are inexpensive and widely available. In addition, food portion sizes have increased and individuals are eating out of the home more often. On the other hand, opportunities for physical activity may have decreased. The Center for Disease control reported that about 65% of American adults (or about 100 million) are either overweight or obese. This epidemic of obesity affects almost all age groups; approximately 18% of adolescents ranging from 12 to 19 years are obese and approximately 20% of children ranging from 6 to 11 years are obese.

Management of the complications of obesity in the United States costs about 100 billion dollars per year, with about 50 billion dollars being spent on healthcare services. This amount equals approximately 6% of the total federal health sector budget. Obesity also yields loss of productivity which costs the federal government around four billion dollars yearly. Each year approximately four billion dollars are spent on weight loss services and products.

In spite of this recognized “epidemic,” one diet that seems to result in significant weight loss for thousands if not hundreds of thousands of people, is maligned by the FDA, by Attorneys General in some states, by many physicians and by “experts” who appear on TV to criticize its use and warn of potential dangers. Yet, the use of the Prescription Weight Loss Hormone diet continues to gain in popularity both by individuals and by an increasing number of medical clinics offering such treatment programs.

It is  important to note that the Hormone involved for  weight loss is a prescription item and that it can only be prescribed by a physician as an off-label use after consultation with  the physician and a  determination by the physician that its use if proper for a particular individual.

HISTORY AND BACKGROUND OF THE USE OF A PRESCRIPTION HORMONE IN  MEDICAL WEIGHT LOSS PROGRAMS.

The Hormone produced by pregnant women, named herein for convenience purposes as the Prescription Weight Loss Hormone,” was first discovered in 1927 in the urine of pregnant women by Ascheim and Zondek. Since then, thousands of articles have been published regarding its action on gonads. Dr. TW. Simeons, a British physician, published the first known report on Prescription Weight Loss Hormone and obesity in 1954 in The Lancet. After its publication, the Prescription Weight Loss Hormone was advocated for several years as a useful approach to obesity. Studies published to date have been in conflict as to the benefit of Prescription Weight

Loss Hormone as an adjunct to VLCDs (very low calorie diets).

One recent public examination of the use of thePrescription Weight Loss Hormone to treat obesity was addressed by two physicians who reviewed their analysis in presentations at the ASBP course. One physician, Dr. David Bryman, concluded “sublingual [Prescription Weight Loss Hormone] appeared to be significantly better in weight loss than a similar meal replacement diet of comparable protein and calorie composition.” A second physician, Dr. G. Michael Steelman, conducted a study comparing the effects of injectable [Prescription Weight Loss Hormone] and sublingual [Prescription Weight Loss Hormone] on weight loss. He used the 500-calorie diet (Simeon’s Diet) modified by increasing the recommended protein intake from seven ounces to 10-14 ounces.

A second study by Steelman showed that weight loss in patients on Prescription Weight Loss Hormone and this diet could be attributed to the loss of adipose tissue alone. He concluded, “More scientific data is needed before a recommendation can be made regarding the .use of [Prescription Weight Loss Hormone] in the treatment of obesity and that the use of [Prescription Weight Loss Hormone] and a very low calorie diet (VLCD) should be conducted by a physician with special training and expertise in their use.” Dr. Steelman also concluded that: [Prescription Weight Loss Hormone] + VLCD is effective, that it may just act as a placebo, but that possible mechanisms exist to explain it having a benefit, that no harm from [Prescription Weight Loss Hormone] has been shown in studies at doses used, that negative studies are flawed (too), and that the published studies are not comparable and of questionable reliability in meta analysis.

A study by Belluscio, et aI, found that female obese volunteers participating in a double blind study who submitted to the administration of a sublingual presentation of Prescription Weight Loss Hormone plus a VLCD, decreased specific body Circumferences and skin-fold thickness from conspicuous body areas more efficiently than Placebo+VLCD-treated subjects.’ The study suggested that the combination of a VLCD and oral Prescription Weight Loss Hormone could not only trigger clinically significant changes in body weight, but simultaneously modulate body contour.

Dr. Bryman recently reported findings from a small pilot study where he found that patients on a modified [Prescription Weight Loss Hormone] diet lost significantly more weight than those on an isocaloric meal replacement plan, with an average of 19.84 ± 6.2 Ibs. In six weeks for the Prescription Weight Loss Hormone group. The meal replacement patients lost 14.75 ± 4.7 Ibs. The average decrease in BMl in the Prescription Weight Loss Hormone group was 3.18 ± 0.8 and in the meal replacement group, 2.48 ± 0.8. The loss of lean body mass based on serial measurements using a bio-impedance scale was 1.47 ± 7.3 Ibs. in the Prescription Weight Loss Hormone group and 0.84 ± 8.21bs in the meal replacement group. This difference was not considered to be statistically significant.

METHODS AND MATERIALS

At the authors’ clinic, 140 patients were randomly selected from patients who completed a 43-day calorie restricted diet with pharmaceutical grade, prescription injectable Prescription Weight Loss Hormone. The 140 patients included 40 men and 100 women of various ages. The diet followed a 500 calorie per day protocol and included a daily injection of 200 units of Prescription Weight Loss Hormone into the abdominal or lateral thigh fat for 40 days using a standard one cc syringe. The patients injected themselves at home after being shown how to inject. The Prescription Weight Loss Hormone was kept refrigerated at the homes or offices of the patients.

Data gathered from the beginning and ending body composition measurements of the patients were recorded in an Excel spreadsheet. Patients were also asked throughout the program if they experienced hunger during the program.

All patients were medically supervised and were encouraged to make a weekly visit to the medical clinic to check their progress and record their weight. Each week, the patients received an injection containing methionine, insoitol, choline, and vitamins B1, B5, B6, and B12. Most patients included two protein drinks per day in their meal plans as a substitute for some of the protein in the meals or as an additional protein supplement as described below.

The protein drinks (Nutritional Resources, Grovetown, Ga.) contained 15 grams of protein and three grams of carbohydrate each. Patients were advised to also include the proteins listed in the protocol for their meals. The first two days of the 43 day program involved “loading days” where the patients were encouraged to eat every three hours during waking hours or at least to eat heavily for two days. No restrictions were placed on what they ate although fat was encouraged. The belief here was that the loading days would help maximize fat mobilization and prevent hunger during the program. On days three to 43, the patients followed the 500-calorie diet and injected Prescription Weight Loss Hormone daily in the morning as per the protocol given to all patients. They were advised to do only moderate to light exercise. lf they had a particularly stressful day or if they worked long hours on a particular day or days, they were advised to add 100 to 150 calories, preferably protein.

We documented and analyzed the results obtained using tile Prescription Weight Loss Hormone 43 day diet protocol on weight loss, changes in Body Mass Index (BJvII), changes in Basal Metabolic Rate (BMR), change ill percent of body fat (% BF), net fat control, and lean body muscle control (LBM). Beginning and ending measurements were taken using the Inbody 230 Body Composition Machine (BioSpace, Los Angeles, Calif.)

RESULTS

We found both men and women lost weight and fat (Figure 1-2), with the majority of the weight loss coming from fat (Table I). The average weight loss in men was 30.87 Ibs. and included an average body fat loss of 26.10 Ibs. (Table I). Of the total weight loss, the average male dieter lost approximately 84.54% fat and their BMI decreased 4.61 kg/l1l. The average weight loss of women was 21.93 Ibs. and included an average body fat loss of 16.04 Ibs (Table I). Of the total weight loss, the average female dieter lost approximately 73.14% fat and their BMI decreased
3.71 kg/m. Figure 3 shows that there was very little or no change in BMR following the intervention. The intervention led to a slight decrease in percent body fat in both males and females (Figure 4).

Most patients reported no hunger and many reported that they sometimes had difficulty eating the 500 calories. If the patient reported hunger, they generally were advised to add 100 calories to 150 calories each day, preferably in the form of protein. This resolved the hunger issue for most patients. Some required a reduction in their exercise (over exercising) as they were exceeding the moderate to light recommendation.

SUMMARY

We have reported one of the largest series of the use of the Prescription Weight Loss Hormone with a calorie restricted diet program in the literature to date. The results have demonstrated that the Prescription Weight Loss Hormone, in combination with a calorie restricted diet, suppresses the appetite and results in minimal decreases in lean body mass and in the Basal Metabolic Rate. Also, we demonstrate again that the “Prescription Weight Loss Hormone Diet” results in significant fat loss in a short time period. It should be noted, however, that there was no control group in this study, and therefore the results should be taken with caution since we cannot prove that Prescription Weight Loss Hormone has a greater effect than a placebo injection and VLCD would on any of these parameters.

We do agree with other authors that this diet must be done in a medical setting under strict supervision by physicians knowledgeable about the use of VLCD (very low calorie diet). The Prescription Hormone typically does not cause significant side effects. Women, when they ovulate, produce about 5,000 to 10,000 units of Luteinizing Hormone(LH) every month (LH and Prescription Weight Loss Hormone share a common alpha subunit and might be expected to produce similar adverse effects).

Moreover, the Prescription Weight Loss Hormone is also produced by the placenta to support pregnancy. The levels in pregnancy will reach as high as 100-150,000 units before delivery. Regardless of what some TV reports have stated, we have not seen evidence presented to link heart disease, cancer, or blood clots, to the Prescription Weight Loss Hormone diet. In fact, pregnant women do not get these “side effects” from their significantly elevated Prescription Weight Loss Hormone levels.

Further, pregnancy is not considered a “disease state” (as stated by one TV commentator) but a natural condition. The real concern is that the VLCD, which is an essential part of the Prescription Weight Loss Hormone Diet, can lead to health issues, particularly if the patient already has health issues or the physician is untrained in proper utilization of such diets. Many overweight and obese patients have health issues. This is why proper monitoring is essential (our patients come in weekly for their checkups and have lab testing, blood pressure readings and body compositions). We monitor their protein intake and often will increase protein calories when appropriate. The Prescription Weight Loss Hormone diet is not a magic cure nor is it the best diet for all patients. However, in the majority of the cases, when properly conducted in a medical setting, it can be a safe and effective weight loss approach.

ABOUT THE AUTHORS

Joseph Feste, MD, FACOG, AACS, AACG is the Medical Director of NBH Lifetime Health in Austin, Texas. Dr. Feste was a Clinical Associate Professor in the Department of Ob/Gyn at the Baylor College of Medicine. He earned his MD degree fr0111 Baylor College of Medicine in Houston, Texas and received a BA degree from the University of Texas, EI Paso.

Mike Clark, MBA, JD, PhD is the Director of Education and Research for NBH Lifetime Health and the Lifetime Health Weight Loss & Hormone Centers. Mr. Clark has been an ASBP member since 2010 and has certificates in the fields of Mesotherapy, Endermologie, Lasers and Intense Pulse Light. He has attended numerous bioidentical seminars over the past 12 years and is a member of A4M. Mr. Clark earned his MBA from Portland State University, JD from Columbia University and PhD from Clayton College.