Medical Weight Loss Training provides you with our FREE Medical Weight Loss Certification Training Manual. Please contact us for your complete online training for Physicians, Physician Assistants (PA), Nurse Practitioners (NP) and Registered Nurses (RN).
How to start a medically supervised weight loss clinic: a Beginner’s Guide to Prescription Medications.
Are you a healthcare provider looking to enhance your approach to weight loss management? Have you ever wondered if there’s a more comprehensive and effective strategy to help your patients achieve lasting results? If so, it’s time to explore the world of comprehensive medical weight loss training protocols. This article is your gateway to unlocking a new level of expertise and understanding in the realm of weight management. Discover how integrating evidence-based practices and advanced training can revolutionize your ability to guide patients toward their weight loss goals. Read on to elevate your expertise and transform patient outcomes.
Introduction to Obesity
Obesity is defined as body mass index (BMI), which is a ratio of weight and height, greater than 30 kg/m2. BMI between 25 and 30 kg/m2 is considered overweight. An obese individual has amassed fat to the degree that it has multiple negative health effects, as it increases the likelihood of hypertension, diabetes, heart disease, specific cancers and various other diseases.
Pathophysiology
Leptin, ghrelin, and other mediators are involved in regulation of appetite, adipose tissue storage, and insulin resistance. Leptin signals the level of fat storage in the body. Produced by adipose tissue, leptin increases appetite when storage levels are low and decreases appetite when storage levels are high. Most obese individuals are categorized as leptin resistant and administration of leptin does not correct obesity in most patients. Ghrelin triggers an increase in appetite when the stomach is empty and is produced by the stomach. Both control appetite on the hypothalamus. Any deficiency or resistance along this pathway may contribute to obesity.
Causes
Anecdotal belief suggested that obesity was due to low metabolism, as obese people ate little, but gained weight. Research seems to indicate otherwise, as an obese individual typically has greater energy usage to maintain their increased BMI.
The major cause of obesity is excess consumption of food and inadequate physical activity. It is a simple math equation of input minus output. Additional causes of obesity can be attributed to genetics, medical or psychiatric illness. Many other social influences contribute to the cause ranging from access to fast food, insufficient sleep, higher age of maternal pregnancy, and amount of automobile usage.
Diet
Since 1971, the average caloric increase is 335 calories per day in women and 168 calories per day in men. The primary source of the extra calories is due to sweetened beverages and potato chips. In addition, consumption of fast food meals quadrupled from 1971-2000. Within the same time frame, the obesity rate in the USA increased from 14% to 30%. Clinical tests also prove that obese patients consistently under-report their food consumption when compared to normal BMI patients. The national calorie consumption averages are 2800 calories per day for males, and 1800 calories per day for females. The average person reports 30% – 40% less consumption than what one actually consumes in a day.
The average dinner plate has gotten larger in the past 50 years. Eating out has increased 200% from 1975 to 1997. A larger portion is also served in restaurants. While intake of fruits and vegetable serving is higher, up to 17% of all vegetable intake is due to potatoes in French fries. Cheese consumption is up, but due to pizzas and cheeseburgers.
Lifestyle
Automotive transportation, labor saving technology, and television have resulted in an increase in sedentary lifestyles. Up to 60% of the world’s population gets insufficient exercise.
Lack of sleep is associated with weight gain as less than 7 hours of sleep resulted in an increased risk of obesity. Less than 6 hours of sleep increased the risk to 27%. Children aged 6 -12 who got less than 10 hours of sleep a night showed 3.5 times greater incidence of obesity than those who got 12 hours of sleep. It is believed that sleep deprivation leads to increased insulin, cortisol and ghrelin, and decreased growth hormone and leptin. The current recommendation is that adults receive at least 7 hours of sleep, 8 hours optimally.
Genes
There is no evidence of a Mendelian pattern of inheritance. Adoption studies show that there is stronger correlation with biological siblings than with half siblings. Also, adopted children had BMI that correlated with the biological parent’s than with adopted parents. Genes may play a role as research has shown that when food is abundant, genes controlling metabolism and appetite predispose a patient to become obese. Several rare genetic syndromes also cause obesity (Prader-Willi, Cohen, etc.).
Medical and psychiatric illnesses
Along with genetic causes, various congenital and acquired conditions such as Cushing’s syndrome, hypothyroidism, and other psychiatric disorders can contribute to obesity. Medications, such as insulin, antipsychotics, antidepressants, steroids, hormones, can also cause weight gains.
BMI
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. It is calculated by dividing the patient’s weight by the square of the patient’s height.
BMI = kg/meters2
BMI = pounds * 703 / inches2
| BMI | Classification |
| <18.5 | Underweight |
| 18.5 – 24.9 | Normal Weight |
| 25 – 29.9 | Overweight |
| 30 – 34.9 | Class I Obesity |
| 35-39.9 | Class II Obesity |
| >40 | Class III Obesity |
Various online calculators and tools exist to simplify this formula for your office.
Health Effects
As one of the leading causes of preventable deaths, average life expectancy is reduced by six to seven years for obese patients. Severe obesity (BMI > 40) can reduce life expectancy by up to 10 years.
CDC states that overweight and obesity increases the risk of the following diseases.
- Coronary heart disease
- Type 2 diabetes
- Cancers (endometrial, breast, and colon)
- Hypertension (high blood pressure)
- Dyslipidemia (for example, high total cholesterol or high levels of triglycerides)
- Stroke
- Liver and Gallbladder disease
- Sleep apnea and respiratory problems
- Osteoarthritis (a degeneration of cartilage and its underlying bone within a joint)
- Gynecological problems (abnormal menses, infertility)
Epidemiology
Prior to the 20th century, obesity was rare. The WHO in 2005 estimated that at least 400 million adults worldwide (10%) were obese. WHO predicts that obesity will overtake malnutrition and infectious disease as the most significant cause of poor health. Obesity rates are rising even among poorer, developing countries.
Society
It is estimated that Americans spent $60.9 billion on weight loss. Obese workers had higher rates of absenteeism and disability leaves. This increases cost for employers, while receiving decreased productivity. Therefore, obese people are less likely to be hired for a job and receive fewer promotions. Obese children are frequent targets of bullies.
A fat acceptance movement has started with organizations like National Association to Advance Fat Acceptance and International Size Acceptance Association. However, obesity has not yet received the same type of support as the civil rights movement.
Benefit of weight loss
The Framingham heart study shows that weight loss resulted in lower blood pressure and lipid profiles. Studies have shown up to 20% reduction in mortality due to weight loss. Risk is lowered in obese patients with hypertension, dyslipidemia and diabetes.
Management of Obesity
Assessment of your patient begins with a thorough history and physical. The patient’s weight history should be reviewed, even from childhood. Any prior weight loss attempts should be discussed and analyzed as to their source of failure. Current medication history is important as many of the drugs cause weight gain as its side effect. Complete social history is important, discussing prior drug addiction, alcohol consumption and smoking history.
Psychotropic agents
Antidepressant drugs (tricyclic antidepressants, monoamine oxidase inhibitors)
Antipsychotic drugs
Lithium
Anticonvulsant agents
Valproic acid (Depakene)
Carbamazepine (Tegretol)
Steroid hormones
Corticosteroids
Estrogen, progesterone, testosterone or other anabolic/androgenic steroids
Insulin and most oral hypoglycemic agents
Based on clinical research, we know that obese patients typically have unrealistic goals. An obese patient, who initially weighed 218 pounds, described their final weight of 135 pounds (38%) as their dream goal, 150 pounds (31%) as being happy, and 163 pounds (25%) as being acceptable, but 180 pounds (17%) as disappointing. Therefore, it is important to manage your patient’s expectations and engage in a realistic discussion prior to their treatment. Remind your patients that besides weight loss, the goals should include improved self-esteem, stamina and health. A 500 daily calorie deficit will result in 26 pounds weight loss within 6 months. Using safe weight loss methods, they can lose 10% of their body weight over 6 months. On average, patients can expect 8% weight loss over 12 months. When looking at long term numbers, it is important to look at maintenance. Rapid initial weight loss typically does not translate into long term weight loss maintenance.
Behavioral Strategies
Successful management of the obese patient involves multiple behavioral strategies, such as self-monitoring, stimulus control, cognitive restructuring, stress management, and social support.
Self-Monitoring
Food diaries (listing calories, fat grams and food groups) , physical activity logs, and weight measurements are essential to creating awareness. Consistently, research has proven that self-monitoring is associated with improved treatment outcome. Patients report that it is one of the most helpful tools in their treatment. However, research shows that more obese patients do not accurately self-record their diet intake.
Stimulus Control
Patients should identify cues that increase patient’s overeating and inactivity. For example, if the patient noticed that they are eating snack foods while watching TV, they might benefit from only eating snacks at the kitchen table or just removing snack foods from the house.
Cognitive Restructuring
Cognitive restructuring identifies automatic thoughts which can be a negative view of one’s self or an unrealistic view of their weight loss expectation. Many obese patients have low self-esteem and unrealistic views about how much weight loss is possible. A research study found that patient’s expectations were typically greater than what was realistic. Most patients in this study lost 10% of their body weight and were disappointed with the results.
Stress Management
Stress reduction techniques are designed to distract the patient from the stress and to prevent stress related issues. Stress has been shown to be one of the primary predictors of overeating and relapse back into weight gain.
Social Support
Social support from family, community-based programs, or involvement in other social activities have shown to increase success of losing weight and maintaining weight loss. These programs do not need to be focused on weight loss. Peer support has shown to help patients become more self-confident, deal with stress, and develop new interpersonal skills.
Effectiveness of Behavior Modification
The use of multiple strategies is associated with greater weight loss. Drop-out rate is generally low. Many studies show an average weight loss of 1 pound per week and 17.6 pounds over about 20 weeks. Behavioral treatments typically last 20 weeks, and at 10 months after the treatment termination, most patients were able to maintain about 2/3 of their initial weight loss.
Assessing Treatment Outcome
Successful treatment should not only be limited to weight loss. Improvements on metabolic profile, comorbidity, physical activity, self-esteem and psychological status, and quality of life should also be measured. Methods for measuring and maintaining these outcomes should be incorporated into the patient’s program.
Exercise
While the American Heart Association recommends a minimum of 30 minutes of moderate exercise 5 days per week, the Labor Department states that only 16% of Americans exercised on an average day. CDC states that fewer than 2 in 10 Americans get the recommended exercise recommendation. Exercise causes muscle to burn energy from fat and glycogen storage. As muscle mass increases, stamina and intensity increases. Then, the muscle becomes efficient at burning fat.
Exercise is shown to be more beneficial in weight loss maintenance than initial weight loss. Only 9% of the study population could maintain the weight loss without continuing or increasing their exercise routine. Research shows that a dose response curve exists where very intense exercise leads to greater weight loss. A meta-analysis shows that while using exercise alone leads to weight loss, combination with dieting showed a greater weight loss. Also, a single bout of exercise will increase a person’s basal metabolic rate by 5% -15% for up to 48 hours. While resistance training is better at increasing lean muscle mass and increasing the metabolic rate, aerobic exercise is better at generating immediate weight loss.
Various barriers prevent your patients from exercising (job, finances, time, stigma, etc.). Altering one’s daily routine, such as taking the stairs instead of the elevator or bicycling to work, has shown to be effective in burning calories. A pedometer is also useful for counseling your patients and setting daily step goals. Initial goal of 120 minutes of exercise per week is recommended (minimum of 200 minutes per week is recommended). At least 20 minutes of exercise was required to trigger the metabolic response of fat burning, muscle development and appetite suppression.
Surgery
Bariatric surgery is considered by many to be the most effective treatment. It is associated with long term weight loss and decreased mortality. However, the cost and potential complications limit its widespread use. In 2009, up to 350,000 Americans underwent this operation. This is significantly higher from 63,000 in 2002.
Typically, surgery is recommended for the severely obese (BMI > 40) who failed traditional methods and pharmacological intervention. Variable surgical options are available, but the two most common are gastric banding (reducing the volume of the stomach to create early satiety) and gastric bypass (reducing the surface area of the bowel to reduce absorption).
Bariatric surgery produces long term weight loss, as one study showed 14% to 25% weight loss at 10 years and 29% decrease in mortality. Postoperative complications are common ranging from infection, DVT, hemorrhage, hernia, bowel obstruction, leakage, dumping syndrome, to nutritional deficiencies. Complications ranged from 10% to 20%. A study shows that after one year, gastric bypass procedures show 30% more weight loss than gastric banding procedures.
Diet
Most clinical practice guidelines recommend dieting and exercising. Dieting typically results in short term weight loss. Long term weight loss typically requires lifestyle modification. Even then, success rates range from 2% – 20%.
Many types of diets and dietary recommendations exist on the market. Diets are generally divided into four categories:
Low Calories
Very Low Calories
Low Fat
Low Carb
A meta-analysis in the New England Journal of Medicine found no difference between the three main types of diet (low fat, low carb, low cal). At two years, all three forms of the diet resulted in 2 – 4 kg weight loss in all studies. Very low calorie diet falls outside of the three main types of diet. Due to the numerous side effects and dangers associated with this diet, close monitoring by a physician is highly recommended.
Low Calorie Diet (LCD)
Overview
Low Calorie Diet is simply what you’d expect from dieting: low calories. The goal of this type of diet is to maintain an energy deficit of 500 – 1,000 calories per day. This results in weight loss of 0.5 kg (1.1 lb) to 1 kg (2.2 lbs) per week. Calorie restriction without malnutrition has been shown to improve age-related health diseases and to slow the aging process in animals and fungi. Human studies are still ongoing.
Efficacy
A NIH study of 34 randomized controlled trials determined that LCDs lowered body weight by 8% in the short term over 3 – 12 months.
Treatment Protocol
Most diets can be considered low calorie diets as they mostly function to reduce daily caloric intake. DASH (Dietary Approaches to Stop Hypertension) by NIH and Weight Watchers are examples of LCD.
Safety / Side Effect
As with all diets, consultation with a physician is recommended. Several studies revealed loss of muscle mass and muscle strength as well as loss of bone in the hip and spine.
Very Low Calorie Diet (VLCD)
Overview
Very low calorie diet is a diet of 800 calories per day or less. VLCDs are usually commercially prepared formulated, liquid meals that contain all the essential protein, fat, vitamins, and minerals. Consumption of carbohydrates is optional. However, small amounts of carbohydrate consumption will prevent ketosis, diuresis, and electrolyte abnormality.
Efficacy
The VLCD is prescribed on a case to case basis for rapid weight loss (about 1.5 to 2.5 kilograms or 3 to 5 pounds per week) in patients with Body Mass Index of 30 and above, for an average total weight loss of 44 pounds over 12 weeks. The health care provider can recommend the diet to a patient with BMI between 27 and 30 if the medical complications the patient has due to overweight present serious health risk
A study in 1997 showed that short term use of VLCD was more effective than mild calorie restriction in improving glycemic control and promoting substantial weight loss.
Numerous clinical trials have shown VLCD to be highly effective in about 80 percent of outpatients and give an average weight loss of 2 kg/week which is comparable to that seen in complete starvation.
Treatment Protocol
Studies recommend staying under 800 calories per day with protein intake of about 40-55 g/day without carbohydrates, and about 25-30 g/day when carbohydrates (30-45 g/day) are consumed. Mixtures of meal replacement products, such as bars, shakes, or manufactured meals may be used. Some researchers state that VLCD should not be followed longer than 4 weeks. If necessary, a second or third VLCD can be attempted by the patient with a 2 month interval on a well-balanced low calorie diet.
A sample diet plan is as follows:
Breakfast: Any amount of tea or coffee, no sugar (green tea recommended), only one tablespoonful of milk.
Lunch:
1. 100 grams (3.5 oz) of boiled or grilled meat or fish (No salmon or tuna) without fat or oil.
2. One type of following vegetables: cabbage, tomatoes, celery, onions, asparagus, spinach, beets, cucumbers
3. One small breadstick or hard toast.
4. One apple, orange, or one-half cup of strawberries (No bananas)
Dinner: Same as Lunch
Grapefruit diet is a type of VLCD where grapefruit is included with every meal
12 days on – 2 days off
Breakfast
1/2 Grapefruit
2 Eggs & 2 Slices Bacon
Lunch
1/2 Grapefruit
Meat
Vegetable
Dinner
1/2 Grapefruit
Meat
Vegetable
Safety / Side Effect
VLCD should be undertaken by an obese patient under medical supervision whose health risk is greater than any risk of the diet itself. Many patients report minor side effects such as constipation, weakness, nausea and diarrhea. Dietary fiber is recommended to reduce some of these minor side effects and reduce hunger.
Sudden deaths, ventricular arrhythmias and QT interval prolongation have been documented in VLCD. During 1977 and 1978, during or shortly after a VLCD, 17 obese adult Americans died suddenly of ventricular arrhythmias. Cause may be due to mineral (calcium, copper, potassium, magnesium) deficiencies due to the diet. A careful overview of the EKG prior to this diet is mandatory.
Although gallstones are common in obese patients, they are more common after rapid weight loss. Gallstones form due to decreased contraction of bile by the gallbladder. It is unclear if the diet is responsible for the gallstone formation or the amount of weight loss.
Contraindications for VLCD
Cardiac, Renal, Liver or Gallbladder disease
Pregnancy
Psychiatric Illness
Substance Abuse
Conclusion
VLCD is shown to cause rapid weight loss, but has limited long term success. In the long term maintenance of weight loss, VLCD is no more effective than modest diet restriction of 1200 – 1500 cal diets.
VLCD vs LCD
Meta-analysis shows that VLCD achieves rapid weight loss compared to LCD. However, VLCD did not produce greater long-term weight losses than LCD. One notable difference was found in a study that showed that VLCD resulted in significantly larger decreases in food craving at the end of the 5th week, compared to LCD. However, the study concluded that food craving diminishes with calorie restriction.
hCG Diet
Overview
The popular hCG diet utilizes the principles of VLCD with hormone therapy. Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing embryo and the placenta during pregnancy. Luteinizing Hormone (LH), also known as Gonadotropin-releasing hormone (GnRH), is produced in the pituitary gland and has similar structure and properties as hCG.
Dr. Albert Simeon, a British Endocrinologist, formed his hypothesis based on two groups of patients: pregnant women in India and children with Froelich’s Syndrome.
The pregnant women in India were on a low calorie diet due to their poverty. He noted that pregnant women lose fat rather than lean muscle. His theory was that hCG produced by the fetus was programming the body to consume adipose tissue in order to support the pregnancy. Froelich’s Syndrome, which is a syndrome that is a result of decreased levels in LH from the hypothalamus, causes obesity, growth and sexual retardation. Suboptimal level of LH in the hypothalamus, which contains the brain’s hunger center, is associated with increased food intake. When Dr. Simeon treated his patients with low doses of hCG, he noted that his patients also lost fat. Dr. Simeons started to use daily hCG injections in combination with a Very Low Calories Diet (VLCD) on his patients who wanted to lose fat without losing any muscle. He claimed that patients will achieve the following: “a) lose weight quickly, b) not feel weak, c) not be hungry, and d) lose fat from those parts of the body where it tends to remain longest during normal dieting (i.e. stomach, hips, thighs, upper arms).”
The current theory maintains that hCG injection is a hypothalamic appetite suppressant. It also has an adipocyte effect, as lipolysis is enhanced on a VLCD diet while preserving lean muscle. Exercise is not needed to lose fat, and some practitioners advocate against exercising while on this diet.
Efficacy
The efficacy of the hCG diet is of great controversy. Journal of the American Medical Association and the American Journal of Clinical Nutrition issued a warning saying that hCG is neither safe nor effective as a weight-loss aid. A meta-analysis study in 1995 has found that “there is no scientific evidence that HCG is effective in the treatment of obesity; it does not bring about weight-loss or fat-redistribution, nor does it reduce hunger or induce a feeling of well-being.” It further concluded “that the effect of the Simeons therapy can be attributed to a diet of 500 kcal, but that the HCG has no specific effect”. However, the meta-analysis did state that one of the study “claimed effect of HCG is that patients no longer feel hungry and/or find it easier to keep to the diet because they feel good about it.”
A small retrospective study in 2010 that reached statistical significance showed that “sublingual hCG appeared to be significantly better in weight loss than a similar meal replacement diet.” A recent study in 2011 on older men with androgen deficiency concluded that “3 months of treatment with twice weekly r-hCG demonstrates sustained androgenic effects on hormones and muscle mass.”
The FDA has required the labeling and advertising of hCG to state the following:
“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.”
Its proponents will state that hCG enhances compliance as it reduces side effects of VLCD and increases the patient’s basal metabolic rate. Many practitioners will state that a patient on this diet will lose 1 to 2 lbs per day without feeling hungry, lose weight proportionally, and feel a sense of well-being.
Treatment Protocol
Dr. Simeon’s protocol requires 26 days. Every day, 125 IU of hCG is injected subcutaneously next to the belly button or intramuscularly elsewhere. hCG is available in various forms: injectable (125IU), nose spray (250IU) or oral (500IU) through a compounding pharmacy.
The following dietary recommendations are given to the patient.
Day 1 and 2
Patients are allowed to eat to capacity.
Day 3 – 23
Begin the 500 calories diet for 21 days.
Days 24 – 26
Stop hCG injections after 24 injections. hCG may stay within the patient’s body for 3 days. Continue the 500 calories diet until day 26.
After 30 days off of hCG protocol, the treatment protocol may be repeated one additional time.
Dietary restrictions
All foods are allowed except starch and sweet fruits. Sample meal is explained in the VLCD section.
Multivitamin and multimineral supplementation is highly recommended.
Most health providers use 600 – 900 calories for daily restriction, rather than the strict 500 calories.
The Simeon protocol is attached with the training packet provided.
Safety / Side Effect
Side effects recorded include irregular menstruation, anaphylaxis, edema, migraine headaches, and pregnancy (fertility increases). This is contraindicated in patients with multiple systemic diseases, COPD, Asthma, PCOS, fibroid, endometriosis, breast cancer, CHF, gout and seizure disorder.
Conclusion
The controversy around the hCG diet is ever present. Even while a meta-analysis study has found that “there is no scientific evidence that hCG is effective in the treatment of obesity,” hCG weight loss centers are opening up across the US. Also, there are legions of hCG patients who claimed that the diet was miraculous and that they did not feel hungry at all. Physicians will report anecdotal stories of weight loss success and breakthrough results. Currently, there are reports of new research papers coming out in support of hCG diet which will further ignite the controversy.
Due to the hCG buzz, the homeopathic industry also came out with their homeopathic hCG. The United States FDA stated in 2011 that this product is illegal and fraudulent. There is no evidence that oral, over-the-counter hCG products are effective weight loss supplements. Furthermore, hCG is a peptide hormone, which would easily be degraded by gastric enzymes rendering them ineffective.
Low Fat Diet
Overview
As the name suggests, this diet consists of low levels of saturated fat and cholesterol with high intake of whole grain, vegetable and fruits, moderate intake of nuts and low fat diary, and low intake of meats and sodium. Fat gets bad press, but is needed for good health. Fat supplies energy and fatty acids. Fat soluble vitamins such as A, D, E, and K are essential.
Efficacy
The benefit of this diet is also under debate. Many sources recommend this type of diet as it reduces the risk of coronary heart disease and stroke in women. A study in JAMA challenged the prior belief that a low fat diet lowered the risk of breast cancer. A Cochrane review in 2002 stated that low fat diets were no more effective than other diets in achieving long lasting effects.
Treatment Protocol
The American Heart Association recommends that 20% – 30% of the calories should be from fat, with less than 10% from saturated fat. An average American consumes 35% of the calories from fat and ingests 12% of saturated fat. Key to limiting fat is reducing meat and dairy with saturated fats, fried foods and margarines with trans-fat, and corn oil with polyunsaturated fatty acid.
Safety / Side Effect
It is essential that a dieter does not cut out essential fatty acids and numerous vitamins that are missed in a low fat diet. Also, a dieter may cut out fat, but increase their carbohydrate intake. “Bad carbs,” such as corn syrup, can replace the fat that is not consumed.
Pritikin Diet
Overview
Nathan Pritikin was diagnosed with heart disease in his early forties. He created a diet that focuses on taking food straight from nature in the form of various nuts, beans, legumes and other unprocessed foods. The Pritikin Diet is based on a very-low-fat, low-sodium, high-fiber diet and exercise to decrease the risk of coronary heart disease.
Efficacy
Many studies analyzing the Pritikin diets have found the diet showed improvement in most coronary heart disease risk factors: body mass index, blood pressure, serum glucose, cholesterol, and serum triglyceride. A meta-analysis on diabetics found that 74% on oral medications were free of drugs and 44% on insulin were free of insulin after three weeks of the program.
Treatment Protocol
The focus of the Pritikin Diet is to focus back to the roots of nutrition, where only unprocessed food was available. Amounts of food consumed were also much smaller than the large plate portions we find today in homes and restaurants. This diet advocates food amounts that would have been true to their description of sustenance, to sustain life, at one time and would not contribute to obesity. The Pritikin Diet allows for many small portions of unprocessed foods. It does not provide room for foods that are high in fat or calorie content as well as those far removed from nature.
On this diet, up to six meals per day are permitted. Daily fat content is only ten percent, which may make dieting a little difficult at times. It focuses mostly on vegetables, grains and fruits.
At the Pritikin Program, all subjects are treated with a comprehensive diet and exercise program. The diet consisted of 10%–15% of calories from fat, 15%–20% from protein (primarily from plants but also from seafood), and 65%–75% from carbohydrates (comprising whole grains, vegetables, and fruits), and contained about 40 g/1000 kcal of fiber. Salt was limited to <1500 mg/d and cholesterol to <100 mg/d. Alcohol, tobacco products, and caffeinated beverages were not allowed. Subjects also received instruction for a personalized exercise program (outdoor walking plus daily exercise classes) for a
total of 45–60 minutes of aerobic exercise performed to achieve a heart rate of 70%–85% of maximal heart rate.
Safety / Side Effects
One of the main issues from the Pritikin diet is that the dieters gain the weight back, because very few people have the amount of time for meal preparation. Vitamins may become deficient due to an insufficient amount of fats in the diet, causing problems in the skin and nervous system. Also, a 1000 to 1200 calories diet with 10% of fat may be sustainable for the short term but difficult in the long-term.
Low Carbohydrate
Overview
Low carb diets restrict carbohydrates, such as bread and pasta, and are replaced by foods that contain a higher amount of proteins and fats, such as meat, fish, cheese and nuts, and other foods low in carbohydrates, such as vegetables. Various books and diets have been developed with this principle, such as The Doctor’s Quick Weight Loss Diet, Atkins Diet Revolution, Stone Age diet, and the glycemic index.
The scientific principle of the low carbohydrate diet is to lower the level of insulin secretion by the pancreas. High carbohydrate diet causes beta cells in the pancreas to release insulin. Low carbohydrate diets release less insulin, which leads to a longer state of ketosis and the body uses stored fat as a source of glucose.
Most low carb diets recommend levels less than 20 grams of “net carbs” per day (one slice of white bread has 15 grams of carbs). USDA recommends a daily carbohydrate intake ranging between 225 and 325 g a day based on a 2,000-calorie diet.
Efficacy
A study in JAMA concluded that concluded “In this study, premenopausal overweight and obese women assigned to follow the Atkins diet, which had the lowest carbohydrate intake, lost more weight and experienced more favorable overall metabolic effects at 12 months than women assigned to follow the Zone, Ornish, or LEARN diets.” A meta-analysis study concluded that “low-carbohydrate, non-energy-restricted diets appear to be at least as effective as low-fat, energy-restricted diets in inducing weight loss for up to 1 year.” A 2008 review found that low carb/high protein diets were more effective at 6 months and are as effective at 1 year at weight loss and reducing cardiovascular risk factors when compared to low fat diets. However, a 2001 scientific review in Obesity Research concluded that a low carb dieter’s initial advantage in weight loss was largely due to water loss.
Treatment Protocol
Low carbohydrate diets differ in the specific amounts of carb intake, levels of other food ingested, and exceptions to the rules. However, most agree that processed sugar should be eliminated or reduced. Most diets restrict carbohydrate intake to 20 grams to 60 grams per day.
Safety / Side Effect
Many of the critics of the low carbohydrate diet are concerned about hypoglycemia and ketosis, which should not be confused with ketoacidosis. Some experts view prolonged ketosis as potentially dangerous causing liver damage, heart disease and other health problems. A 2004 study in Annals of Internal Medicine states that minor adverse effects such as diarrhea, weakness, rashes and muscle cramps were more frequent in low-carbohydrate diet groups. Specifics of the safety and side effects will be evaluated when we look at the Atkins diet.
Atkins Diet
Overview
When Dr. Atkins first introduced his diet in 1972, it was revolutionary as he placed high emphasis on decreasing a patient’s carbohydrate intake rather than the usual emphasis on decreasing a patient’s fat intake. Typically, carbohydrate levels less than 50 to 100 grams per day trigger ketosis. Due to the low insulin level, ketosis lipolysis occurs and stored fat cells are transferred and used for energy.
Efficacy
Dr. Atkins and in many studies state that up to 15 pounds weight loss within the initial two weeks of dieting can be achieved. Some of this weight loss is due to diuresis due to ketosis. In many short term studies, the Atkins diet was effective over the traditional low fat diets. Some studies tout its benefits in individuals with diabetes, coronary artery disease, seizures, and certain types of cancers. A 2005 study in JAMA tested patients on four different diets: the Atkins diet, the Dean Ornish diet, the Zone diet and Weight Watcher’s diet. After continuous medical observation for one year the study concluded that there was no significant difference between any of the four diets.
Treatment Protocol
There are four phases for this diet. Aside from phase 1, moving from one phase to another depends on the progress of the patient rather than a strict calendar.
Phase 1 is called Induction, as it induces the body to burn fat rather than carbohydrates. For two weeks, the dieter will eliminate all processed carbs from the diet, eat only carbs that are rich with nutrient and fiber content, and is allowed unlimited consumption of fats and protein. Only 20 grams of carbohydrates (USDA ~ 300 grams), such as vegetables and whole grains, are allowed per day. Multi-Vitamin pills and omega-three-fatty acid supplements are recommended during this time. This is the phase that most patients report the largest weight loss, as one can lose 5 – 10 lbs per week.
Phase 2 is called Ongoing Weight Loss, and up to 60 grams of nutritional value carbohydrates may be added (5 grams increase per day). Weight loss in this phase will be slower. This phase is recommended until the patient is within 10 lbs of their ideal weight.
Phase 3 is the Pre-Maintenance Phase and allows the dieter to eat an increased variety of food. Carbohydrate intake may increase by 10 grams per week. As in phase 2, the weight loss in phase 3 is slower.
Phase 4, the Lifetime Maintenance Phase, provides your patients with a diet maintenance plan for life. It encourages the dieter to determine his or her individual threshold for carbohydrate consumption. In this phase, a cardio-intensive exercise program is added, advocating a minimum of twenty minutes three times a week to the optimal thirty minutes five or six times per week.
Safety / Side Effect
The Atkins diet is surrounded by controversy. Critics have pointed out increases in cholesterol levels due to high saturated fat intake, substandard daily vitamin levels, and increases in risk of colon cancer in patients on the Atkins diet. Patients have complained of headaches or withdrawal type symptoms when they quit eating carbohydrates. Other potential risks include kidney failure, gout, gallstones, kidney stones, cancer, osteoporosis, dehydration, and dietary deficiencies. A long term study in The New England Journal of Medicine found that women eating more protein from vegetable sources, rather than animal sources, had lower risk of heart disease.
South Beach Diet
Overview
The South Beach diet was created by Dr. Agatston who believed that low fat diets were not working, because patients were simply replacing fat with carbohydrate. He also believed that diets like the Atkins diet lead to too few carbohydrates, too much fat and too little fiber in one’s diet.
Efficacy
Several small scale studies showed favorable results to the diet. An average of 8 to 13 pounds were lost within the fourteen days of phase one. During phase 2, 1 to 2 pounds of weight was lost. A 2009 study showed that reduction in low-density lipoprotein cholesterol and apolipoprotein B levels were observed after the South Beach whereas it was not observed in the Atkins Diet.
Treatment Protocol
The South Beach diet differentiates between “good carbs” and “bad carbs.” Bad carbs included heavily refined sugars and grain, and good carbs were relatively unprocessed foods such as vegetables, beans, and whole grains. Using the principle of glycemic index developed by Dr. Jenkins, carbohydrate sources are considered “good” if they have a low glycemic index. Dr. Agatston also differentiated between “good fats” vs “bad fats.” The South Beach diet emphasized replacing foods rich in trans-fats and saturated fats with unsaturated fats and omega-3 fatty acid. This emphasized replacing red meat and poultry with lean meats, nuts, and oily fish. A small amount of alcohol was also allowed in this diet.
The South Beach Diet is divided into three phases. In phase 1, for two weeks, the dieter must eliminate all sugars, processed sugars, fruits and high glycemic vegetables. This helps to eliminate the insulin spike and therefore, the hunger cycle. Phase 2, introduces most fruits, whole grain, and vegetables. Phase 3 is the maintenance period that lasts for life. There are no forbidden foods, but the dieter is expected to understand the principle and live accordingly.
Safety / Side Effect
The safety issues are similar to the Atkins diet, but the South Beach diet is considered safer, due to the differentiation between good or bad carbs and fats. However, there has been a case report of ketoacidosis of a patient who was on the South Beach diet.
Medical Managed Plan
There are many types of plans available in the commercial market. They vary from franchises, protocol centric programs, physician office meal programs, to office based physician plans.
Nationwide Centers
Medi-Weightloss Clinics
Patients come in once a week for monitoring and once a month check-ups and lab work. Counseling is performed by physician assistants or nurse practitioners. Medication is dispensed in house. Online resources and fitness programs are available to patients. This franchise nationwide program has three phases:
- Acute weight loss: 500 – 600 calories/day with high protein, 2 servings of vegetables or 1 fruit and 1 vegetable + appetite suppressant
- Short term maintenance: raise the calorie levels and wean off suppressants
- Wellness: emphasis on exercise, support and skills to keep the weight off
Cost
$268 for the initial consultation, lab work, EKG, and start kit/medication.
$70 per week for prescription drugs, vitamin injection and counseling.
$20 – $40/ month additional for vitamins, supplements and colon cleanser.
Center for Medical Weight Loss
www.centerformedicalweightloss.com
Started in Long Island by Dr. Kaplan, the Center for Medical Weight Loss has expanded nationwide. Physicians get a territory to operate under the center’s brand. Access to new clinical studies and research, seminar training and advertising support is offered by CMWL.
Patients are started on a low calorie diet (800 – 1200/day) with nutritional bars, hot soups, snack foods and shakes produced by the company. Prescriptions (such as phentermine) are also used. Weekly appointments are tapered off when the patient achieves progress. Counseling of behavior modification and lifestyle changes are emphasized.
Cost
Varies.
Some charge $19 for an initial consultation. Fees range from $75 to $650 per month, depending on the patient’s need and location. Monthly price typically includes weekly counseling, check-up, food, and medication.
Physicians Weight Loss Center
Founded in 1979, PWLC is one of the oldest nationwide chains. They have several systems of weight loss based on the goals of the patient. Patients are offered daily visits for the first two weeks, then three times per week for the rest of the program. Variety options from regular food, meal replacement with Medifast, to nutritional supplements are available to the patient. Prescription medication is used by PWLC.
Cost
Depends on the system that the patient signs up for. For the original PWLC diet, there is the $199 registration fee, plus cost of EKG and blood work, plus $58/week for products and supplements.
Registered Dietician vs. Nutritionists
Both specialists use a variety of techniques focused on an individualized program (body, diet, medication, exercise, and lifestyle analysis; diet and lifestyle plan) to achieve weight loss for their patients. However, nutritionists do not possess a medical degree. Registered Dieticians require a 4 year degree and a mandatory internship, and typically work in more medical environments.
Cost
RD spends up to an hour per session and can charge $75 – $195 for initial consult and $65 for follow ups.
Nutritionists also spend up to an hour per session and charge $40 – $85 per hour.
Office Based Physician Weight Loss
Many physicians have added weight loss to their primary practice to help their obese patients and to increase their income. Some physicians have developed their own program, based on current dietary guidelines. Some have teamed up with a local nutritionist, registered dietitian or a fitness gym. Analysts estimate that only about 5% of the physicians are substantially involved in offering a weight loss program to their patients. Obesity is still not thoroughly taught in medical schools or in residencies.
Cost
Physicians will typically charge from $100 – $250 for the initial consultation. This can be billed to the insurance company, while some charge patients out of pocket. It should be noted that most insurance companies do not cover diet plans. At least a monthly follow up and lab tests are recommended. When it comes to prescription drugs, there are two types of practices: dispensing and non-dispensing. A practice that dispenses medication from the office gains extra income. This comes with additional requirements that we recommend that you check with your state board about becoming a licensed dispenser of pharmaceutical drugs.
The criticism about individual office-based weight loss practices come from lack of structure. Many physicians will add weight loss as a “cash cow.” Many offices will only provide initial screening exams, a prescription and a diet recommendation. Many offices do not have a support counseling staff in the office and will refer patients out. In addition, most offices do not offer exercise programs. Patients are left with an incomplete weight loss package as they lack that additional support that is crucial to the patient’s success. Therefore, nationwide franchise weight loss centers are better organized and provide a more comprehensive weight loss package.
Weight Loss Companies
Weight Watchers
Weight Watchers recently had a make-over as they dropped their traditional point system and introduced Points Plus. In the old point system, dieters used them to eat whatever they liked, but with the new system, the goal is to use the points more wisely by eating foods rich in protein and fiber. In addition, dieters get unlimited quantities of fresh fruits and non-starchy vegetables. Points Plus still maintains that all the food ingested fits within the calorie allowance. Dieters have access to the online database, mobile phone app or a Points calculator. Weight Watchers still recommends that calories stay below 1200 per day. They also offer online access and nationwide meetings.
Weight Watchers claims that their dieters who attended their meetings lost three times more weight than those that dieted on their own. However, there was no study cited to back up this claim. A 2005 JAMA study comparing Atkins, Ornish, Weight Watchers, and Zone concluded that “Each popular diet modestly reduced body weight and several cardiac risk factors at 1 year. Overall dietary adherence rates were low, although increased adherence was associated with greater weight loss and cardiac risk factor reductions for each diet group.”
Nutrisystem
Nutrisystem is based on home delivery of portion controlled, low glycemic meal plans of breakfast, lunch, dinner and desserts/snacks. Using a diet of 1200 calories per day for women and 1500 calories for men, the patient will lose 1 – 2 pounds per week. Approximately 57%, 23%, and 20% of calories come from carbohydrate, protein, and fat. A vegetarian program is also offered. Behavioral support is offered online and via telephone. 28 days’ worth of meals start at $279.99 ($30 more for men). The patients still need to purchase additional grocery foods, such as fruit, vegetable, and dairy.
A few studies show greater compliance and weight loss than dieting alone, with up to 25% – 60% more at 3 to 12 months. Patients were more satisfied due to convenience. The company has been criticized because its prepackaged foods do not create a lifestyle change once the plan stops. In 2011, they started offering “transitions” plans, where they allow customers to select partial programs.
Medication
Anti-obesity medications attempt to alter appetite, metabolism, or absorption of calories. Due to the side effects and addiction profile of some drugs, medications should be individualized and prescribed when the risk of obesity outweighs the potential risks of the drugs.
History
Weight loss attempts are described as far back as 2nd century AD, where a Greek physician prescribed laxatives, along with heat, massage and exercise. In the 1920s thyroid hormone was used on obese patients with some effects, but they also had hyperthyroidism as a side effect. Dinitrophenol was introduced in 1933, which uncoupled oxidative phosphorylation in the mitochondria to produce heat instead of ATP. This was discontinued due to side effects including fatal hyperthermia. Amphetamine was also used in the 1930s, which was later banned by the FDA due to the increasing number of deaths. Fen-phen was approved in 1959, but in 1997 was removed due to evidence that it causes valvular heart disease. Ephedra was another stimulant that was subsequently removed from the US market due to concern of strokes and deaths.
It is important to treat obesity as a chronic disease without a cure. Currently, no safe or effective treatment exists for rapid and long term weight loss. Most experts recommend losing 1 to 2 pounds per week. Behavioral therapy, exercise and dietary modifications are the three main pillars of successful weight loss maintenance. However, the rate of relapse back into obesity is high. Therefore, various pharmacologic options are used as adjuncts to traditional weight loss programs.
Finally, there are many off-label uses of drugs (synthroid, metformin, Prozac, etc.) that physicians use to treat obesity. Most of these drugs are not included in this presentation as they lack good clinical evidence of significant results.
Caution
Typically, anyone with any of the following symptoms should be excluded from using pharmaceutical agents: severe systemic illnesses, psychiatric illness, hypertension, cardiac disease, pregnancy, breast feeding, aged under 18 or above 50, and any drug to drug interactions.
Appetite Suppressants
Two classes of anorectic drugs are currently available: noradrenergic and the serotonergic agents. Norepinephrine, serotonin and dopamine are neurotransmitters in the hypothalamus (the appetite center), which is thought to play a role in energy intake, energy expenditure, substrate utilization, and adipose storage.
Noradrenergic Agents
Phentermine is the most commonly prescribed appetite suppressant currently in the US market. Fen-Phen was a drug that combined fenfluramine with phentermine. This drug was pulled from the US market due to it causing valvular heart disease. Phentermine continues to be sold as a single weight loss agent. Phentermine is structurally similar to amphetamine, which makes it a DEA schedule IV drug, and affects the noradrenergic neurotransmission.
In clinical trials, the use of phentermine alone resulted in significant weight loss when compared with placebo. At the end of 36 weeks, 13% weight loss was achieved.
Typical dose ranges from 30mg to 37.5mg per day. Typically, usage should be limited to a maximum of 8 to 12 weeks, as many studies show a tolerance. Another study looked at intermittent dosing, one month on and one month off, and saw that the intermittent treatment was just as effective. Typically, patients will start off with half of the 37.5mg tablet, once per day in the morning before breakfast. Patients can take a half tablet in the evening, if night appetite suppression is needed (insomnia can become a problem). Patients can increase to one whole tablet in the morning if tolerance is reached.
The most common side effects include insomnia, dry mouth, heartburn, decreased sex drive, headache, nervousness and irritability. Palpitations, tachycardia and hypertension may occur. Phentermine should not be taken by persons with symptomatic cardiovascular disease, moderate to severe hypertension hyperthyroidism, glaucoma, agitated states, advanced arteriosclerosis, or a history of drug abuse. Please see the package insert for full description.
Diethylpropion is another noradrenergic appetite suppressant that is used. The mechanism of action and side effect profile is similar to phentermine. The starting dose is 25mg three times a day, before meals for up to 8 to 12 weeks. In a clinical trial, diethylpropion at 75mg per day, after 6 months, patients saw a 12.3% body weight loss vs placebo (2.8%).
Serotonergic Agents
The serotonergic drugs act on the hypothalamus to decrease satiety by partially inhibiting the reuptake of serotonin and releasing serotonin into the synaptic cleft.
Fluoxetine (Prozac) was thought to be a promising solution to obesity, but weight loss has not been consistent among subjects in clinical trials. A three month study failed to show benefit over placebo. However, at 20 weeks, significantly greater weight loss was achieved. Unfortunately, after one year, weight loss between the two groups was not different. Fluoxetine continues to be used by some physicians as an off-label use.
Adrenergic/Serotonergic Agents
Sibutramine (Meridia) is an adrenergic/serotonergic agent approved by the FDA in 1997 for use in the management of obesity. Initially tested as an antidepressant, patients in the sibutramine group lost weight that was dose dependent. Sibutramine inhibits monoamine uptake, suppressing appetite in a fashion similar to SSRIs. Also, sibutramine may also stimulate thermogenesis by activating the beta3-system in adipose tissue. It does not stimulate the secretion of serotonin.
Sibutramine has been withdrawn from the market due to low efficacy and raised risk of heart attack and stroke.
Phen-pro (phentermine 30mg –Prozac 20mg) is another combination drug that is used off-label for weight loss. Similar to sibutramine, it is believed that phen-pro causes increased norepinephrine and serotonin activity in the hypothalamus to reduce hunger. However, this combination is poorly studied and lacks good medical research to be recommended.
Thermogenic Agents
There is no drug that is available in the US market currently. However, a combination of ephedrine and caffeine exists, which has anorectic and thermogenic properties. Ephedrine causes the release of norepinephrine, which affects food intake, and enhances thermogenesis. Caffeine, an adenosine antagonist, reduces the breakdown of norepinephrine within the synaptic junction, which enhances the effects of ephedrine. Studies showed that ephedrine (20 mg) with caffeine (200 mg or two to three cups of caffeinated coffee) taken three times daily was found to be more effective than placebo or either drugs alone. Side effects, such as tremor, insomnia and dizziness, were transient after eight weeks of treatment and comparable with placebo effects. Although clinically effective, the risk of cardiac complications limits its clinical use.
Thyroid hormone also increases the metabolic rate, but it causes unwanted side effects such as tachycardia and is associated with increased protein loss. It has not been recommended as a weight loss medication, because its effect on weight loss is minimal.
Digestive Inhibitors
Orlistat (Xenical), the first lipase inhibitor approved by the FDA in 1998 for treatment of obesity, is an irreversible inhibitor of gastric and pancreatic lipases and prevents the absorption of 30 percent of fat. Orlistat inhibits enzymes from breaking down triglycerides into free fatty acids. Therefore, triglycerides, cholesterol and lipid soluble vitamins are poorly absorbed and excreted in the feces.
Orlistat is approved for patients with a BMI of at least 30 kg per m2 or in patients with hypertension, diabetes or dyslipidemia with a BMI of greater than 27 kg per m2
In a one year double-blind, placebo controlled study, weight loss ranged from 3 to 4 kg (6.6 to 8.8 lb) with 120 mg of orlistat three times a day versus placebo. Patients regained about 2 kg (4.4 lb) during the second year of orlistat versus placebo. Studies have also shown weight loss of 8.5 percent at one year compared with 5.4 percent for placebo Improvements in blood pressure, cholesterol levels, glucose and insulin measurements were recorded, but the difference was not clinically significant.
Side effects include flatus, steatorrhea, fecal incontinence and oily spotting. These effects are more significant in patients eating a high-fat diet. Changes in coagulation parameters in patients being treated with warfarin (Coumadin) occur, because of decreased vitamin K absorption. One study showed that concentrations of fat-soluble vitamins were lower in orlistat patients than in the placebo group, but the numbers remained within the reference range. Also, in 2010, FDA issued a warning about severe liver injuries related to orlistat.
Metformin
Metformin has been shown to result in weight loss in diabetics and patients with polycystic ovary syndrome. A meta-analysis showed that only 2 of the 9 studies showed a small reduction in waist to hip ratio. They concluded that “insufficient evidence exists for the use of metformin as treatment of overweight or obese adults who do not have diabetes mellitus or polycystic ovary syndrome.”
Orlistat
Orlistat or Xenical was the first lipase inhibitor approved by the FDA in 1998. The treatment of obesity, which is an irreversible inhibitor of gastric and pancreatic lipase and prevents the absorption of up to 30% of fat. Orlistat inhibits enzymes from breaking down triglyceride into free fatty acids. Therefore, triglycerides, cholesterol, lipid soluble vitamins are poorly absorbed and excreted in the feces. Orlistat is approved for patients with a BMI of at least 30 kilograms per meter square, or in patients with hypertension, diabetes, dyslipidemia, with a BMI greater than 27 kilograms per meter square in a one year double blind placebo controlled study.
Weight loss ranged from three to four kilograms or 6.6 to 8.8 pounds with hundred and 20 milligrams of Orlistat stat three times a day versus placebo. Patient regained about two kilograms for 4.4 pounds during the second year of Orlistat stat versus placebo. Studies have also shown weight loss of 8.5% at one year compared with 5.4% for placebo.
Improvements in blood pressure, cholesterol, glucose, insulin measures were also recorded, but the difference was not clinically significant. Side effects include diarrhea, fecal incontinence, and oil spotting. These effects are more significant in patients eating a high fat diet. Changes in coagulation parameters in patients being treated on warfarin occur because of decreased vitamin K absorption. One study showed that concentrations of fat soluble vitamins were lower in Orlistat patients than in the placebo group, but the numbers remained within the reference range. Also, in 2010, FDA issued a warning about severe liver injuries related to Orlistat.
Lorcaserin
Lorcaserin, marketed as Belviq, acts as a selective serotonin 2C receptor agonist in the hypothalamus to reduce appetite and promote weight loss. A study showed that treatment with Lorcaserin led to significant weight loss compared to placebo, with 47.5% of patients achieving at least 5% weight loss at 1 year compared to 20.3% in the placebo group.
The adverse events are headaches, URIs, nasopharyngitis, sinusitis, and nausea. This is a schedule four DEA controlled drug due to its hallucinogenic properties. A meta-analysis concluded that Lorcaserin treatment did not increase the risk of major adverse cardiovascular events in patients with obesity or overweight. However, it is essential to note that Lorcaserin was withdrawn from the market due to concerns about potential tumor development in laboratory rats.
Phentermine/Topiramate
Phentermine/topiramate, marketed as Qsymia, is a combination medication that targets both appetite suppression (phentermine) and seizure control (topiramate). A randomized controlled trial demonstrated the effectiveness of Phentermine/Topiramate in achieving weight loss. The study found that patients receiving the highest dose of Phentermine/Topiramate (15 mg phentermine/92 mg topiramate) achieved an average weight loss of 10.9% after 1 year, compared to 1.6% in the placebo group.
Safety concerns related to Phentermine/Topiramate have been raised, particularly regarding its potential impact on cardiovascular health. It should be noted that the European Union (EU) has denied approval of this drug due to concerns regarding potential heart and psychiatric side effects.
Bupropion/Naltrexone
Contrave combines bupropion, an antidepressant, and naltrexone, an opioid antagonist. It works by affecting the hypothalamus and the mesolimbic dopamine circuit, which is the reward pathway involved in food cravings. The FDA has approved Contrave as an adjunct to diet and exercise for chronic weight management in patients with a BMI greater than 30 or greater than 27 with comorbidities.
Research studies have shown a weight loss range of 5-15% after one year of treatment with Contrave. However, researchers found a slightly higher incidence of psychiatric adverse events in the Contrave group compared to placebo. It is crucial for healthcare providers to closely monitor patients for any signs of mood or behavior changes while on Contrave treatment. It should also be noted that bupropion, an antidepressant component of Contrave, carries a boxed warning due to an increased risk of suicidal ideation and behavior in patients.
Alternative Treatments
Alternative Supplements
A survey in 1998 found that 7% of adults used an OTC weight loss supplement. Retail sales are in the billions each year. When counseling your patients, understanding the evidence for the efficacy, safety, and quality of these supplements becomes essential. It is impossible to cover all the supplements as more than hundreds of commercially available combinations exist. Currently, no weight loss supplement has met the criteria for recommended use by the FDA. Ephedra-caffeine combination had some evidence to support its efficacy, but the FDA later banned it due to reports of adverse side effects.
Advising your patients on using alternative treatment is difficult. Many times, patients will speak to you with anecdotal evidence of its success. Our responsibility should be to encourage our patients to stop taking supplements that are known to cause harm, educate the dangers of using unknown supplements, and monitor the patients closely if they choose to continue taking their alternative supplements.
Thermogenic Formulas
These are also known as fat burners. These supplements aim to temporarily increase metabolism and energy. Patients also use them to provide energy boost prior to their exercise session.
Ephedra and Caffeine
Ephedra sinica, Ma huang in Chinese, is a sympathomimetic and is believed to be a thermogenic agent. A meta-analysis showed a 1kg per month more weight loss using this supplement versus placebo. However, no long term data exists. Side effects of psychiatric, cardiovascular, and gastrointestinal symptoms, including hypertension, stroke, seizure and deaths prompted FDA to ban the sales in the US.
Green Tea Extract
A catechin, called epigallocatechin gallate (EGCG), when combined with caffeine, was shown to elevate metabolism beyond that of caffeine alone. While it is also a good source of antioxidants, it lacks medical research to justify its use.
Blood Sugar Regulators
These compounds are believed to keep your body sensitive to insulin.
Chromium
Chromium is believed to play a role in carbohydrate and lipid metabolism, because chromium deficiency is associated with hyperglycemia, hyperinsulinemia, hypertriglyceridemia, and low levels of HDL. The Results of three randomized controlled trials failed to show any difference in weight loss. Reports of rhabdomyolysis and renal failure have been reported in high doses (more than 1000 mcg).
Ginseng
Data suggests that ginseng improves glucose tolerance and plays a role in carbohydrate metabolism. However, no clinical trials have shown statistical weight loss when compared to placebo.
Early Satiety
GLUCOMANNAN, PSYLLIUM, AND GUAR GUM
These soluble fiber, theoretically, could absorb water in the gut and expand causing early satiety and lower consumption. Guar gum, which can swell 10 to 20 times its size in the GI tract, has not shown to be beneficial in a meta-analysis. Glucomannan was proven to show weight loss in a small study, but banned in some countries due to incidence of GI obstructions. A study with psyllium showed that glucose and lipid parameters improved significantly, but there was no difference in weight loss. It is thought that these agents can help decrease the GI side effects of Orlistat.
Fat Metabolism
HYDROXYCITRIC ACID
Hydroxycitric acid (HCA) has been found to decrease fatty acid synthesis. Randomized controlled trials failed to show any difference in BMI.
CONJUGATED LINOLEIC ACID
Conjugated linoleic acid (CLA) has been found to reduce fat deposition in obese mice, possibly through increased fat oxidation and decreased triglyceride uptake. A 12 week randomized controlled trial showed no change in BMI.
LICORICE, PYRUVATE, VITAMIN B5, AND L-CARNITINE
A small study found fat mass loss using licorice, but side effects of pseudoaldosteronism , hypertension, and hypokalemia have limited its recommendation. Pyruvate, the end product of glucose metabolism, was associated with weight loss, but the trial had a very limited sample size. Vitamin B5 and L-carnitine is postulated to help in weight loss, but no human trials support this.
Fat Inhibitor
CHITOSAN
Chitosan, a fiber derived from the shells of shrimp, crab and lobster, is a positively charged polymer that is believed to bind negatively charged fat molecules within the intestinal lumen and prevent fat absorption. A meta-analysis showed a greater mean weight reduction for chitosan (3.3 kg [7 lb, 4 oz]) over placebo, but the method was in question. Other randomized controlled trials failed to show any weight loss difference.
Appetite Suppressant
Hoodia Gordonii
Hoodia has been long used by the indigenous population of Southern Africa as an appetite suppressant when making long hunting trips in the Kalahari Desert. Extract, known as P57, is believed to affect the hypothalamus to suppress appetite. Live hoodia seems to have the best effect. However, randomized clinical trials are still lacking. Safety issues are still unknown.
Lipotropics
Lipotropic Injection
Lipotropic agents play an important role in lipid/fat metabolism. Choline emulsifies cholesterol so that it doesn’t stick to arterial walls during transport. Also, choline functions as a methyl donor in the liver and aids in detoxification. Inositol metabolizes fat and cholesterol, and aids in transportation and redistribution of body fat. Methionine has lipotropic properties similar to choline. While these agents are not vitamins, as they are readily synthesized by the body, there is theoretical belief that providing extra doses of lipotropic compounds will aid in faster fat metabolism by the body.
These lipotropic injections are combined with various vitamins that are necessary in metabolism of fats and carbohydrates. B12 is considered an important part of a weight loss program, due to its role in fatty acid synthesis and energy production. Lipotropic injections have not been a subject of any substantial randomized controlled trials.
Holistic Approach
Acupuncture
Weight loss is not one of acupuncture’s traditional goals. It is unclear as to its role in weight loss. Acupuncture may help you relax, which is useful if your patients eat because they are stressed or depressed. Most of the studies evaluating acupuncture and weight loss are limited by short duration, inadequate placebo controls and non-standardized treatment. Few controlled trials do offer positive results though. Acupuncture may be a potentially useful adjunct in weight loss, but it still needs more careful study.
Mindfulness and Meditation
Mindfulness is a nonjudgmental method of giving attention to the present moment.
Mindfulness encourages the practitioner to eat only when hungry to avoid eating purely out of habit. It encourages the opposite of eating on the run, where one is disconnected from the body’s response as one is eating. This all prevents eating when one is not hungry and stopping when full.
Meditation is about focusing your attention on your breath, thoughts and feelings. People use it to deal with anxiety, stress, pain, sleep problems, depression, and to feel better.
Research indicates that mindfulness and meditation can be a good behavioral modification in combination with diet and exercise.
Hypnosis
Combining hypnotic suggestions with other behavioral methods can help a person make lifestyle changes. According to the Mayo Clinic, studies have shown an average of 6 pounds of weight loss through hypnosis. However, the research is still scarce.
Prayer
Faith-based weight loss books such as The Hallelujah Diet, and The Prayer Diet have become popular. They suggest that people are mistaking spiritual hunger with physical hunger. These books encourage people to turn to God for their emotional pains rather than food. These approaches typically include a support group as well. There are no good clinical studies to support this approach. However, a recent meta-analysis “indicated small, but significant, effect sizes for the use of intercessory prayer.”
Medical Weight Loss Protocol Options
You have several options of starting a medical weight loss facility. The easiest option is to join a nationwide chain. This comes at a price as there will be additional fees to your practice (franchising a zone, advertising, material, support products, etc.) or require a profit sharing agreement. You can explore our list of vendors listed in the training packet for a list of companies that you can contact.
Running your own independent weight loss clinic is also a possibility. If you have an existing practice where your patients know and trust you, then you are one step ahead of the competition. Being a physician gives you another advantage in that you can prescribe medications to your patients. Non-medical weight loss programs are limited to diet, behavior modification and exercise.
A combination of full medical evaluation, EKG, lab, diet plan, exercise plan, behavior modification, nutritional counseling, and/or medication is recommended. Below are a few of the medical weight loss option that is available to add to your practice:
Using an existing Diet Plan
You can use a commercially available diet plan, such as Weight Watchers, Medifast or Nutrisystem and provide medical supervision as an adjunct. Using these meal replacement plans eliminate the need to formulate your own diet plan. The physician’s primary role would be to evaluate your patient for complications, behavioral support, and prescription assistance to aid in weight management. A study in the Lancet indicated that when overweight patients were referred to Weight Watchers by their doctor, in a 12 month period, they lost more than twice as much weight when compared to the patients who only received standard care from their physician.
Use a physician managed diet plan:
Most diet plans should be medically approved by a physician, but the very low calorie diet and ketosis diet should be closely monitored. This is due to high risk of severe complications and rarely death.
Create your own diet plan:
Based on your medical knowledge, you can also develop your own diet plan.
The 7 inch plate diet is based on a popular book the 9 Inch Diet. A typical meal plan for lunch would be the following:
Using a 7 inch plate, divide your plan accordingly: section 1 = ½ plate, section 2 = ¼ plate, and section 3 = ¼ plate
- Section 1 for Vegetable/Fruit (Broccoli, green beans, carrots, mushroom, tomatoes, cauliflower, spinach, peppers, greens, salad greens)
- Section 2 for meat (Lean Cuts), fish, or poultry. No fried foods, but if you are frying then use canola or olive oil
- Section 3 for starch (Bread, rolls, rice, crackers, cooked grain, starchy vegetables such as potatoes, corn, winter squash, dry cooked beans, dry peas, lentils)
- 8 oz glass of low fat milk
- A piece of fruit
Exercise
The easiest option would be to enroll your patients in a gym or an exercise program and monitor your patient’s compliance. This is not always what patients want. While weight loss is attainable without a formal exercise program, we know from research that exercise is essential to maintaining a patient’s weight loss.
While a variety of exercise program options exists, a simple exercise or “movement plan” that has worked for a variety of experts is a pedometer. This is an easy measure that can be written into the daily log and be translated into total calories expended. The goal is 10,000 steps a day. This is roughly equivalent to 30 minutes of continuous walking. Your patient will wear the pedometer for a few days to see how many steps your normal activity is. (Most inactive people take only 2000 to 4000 steps per day.) Every two to three days, your patient will add 500 steps until your patient reaches 15,000 to 20,000 steps per day.
Behavior Modification
Many behavior modification plans exist. Below is a sample from UCSF weight management program:
Dispensing Controlled Medication
Dispensing prescription medication comes with regulations and responsibility. Due to narcotic “pill mills” that have popped up across the US, the states and DEA have become more vigilant on monitoring the activities of the prescribing and dispensing physician licenses. We recommend the following:
Current up to date DEA registration with correct address
Rights to prescribe category III and IV drugs
Check your state licensing body for regulations regarding weight loss controlled substances: Some have rules about what can be used, documentation needed, and time of use restrictions.
United States Code (USC) Controlled Substances Act has detailed rules and restriction from the DEA http://www.deadiversion.usdoj.gov/21cfr/21usc/index.html
Drugs must be kept in a locked container
Keep a written prescription for the drug and keep it within the patient’s chart.
Written log of the medication dispensed should be kept with patient’s name, address, medication, quantity, lot # and signature on the prescription label.
Inventory and the log should exist for at least 2 years.
Patient information label: One stays in the log book, and the second goes on the medication bottle. Label contains name and date, medication, instruction, lot #
Dispensing bottle: child proof container
Vendors: Buy from reputable vendors and keep all shipment records and receipts.
Do not dispense any medication if you have not seen the patient. Check with your state if you need to be onsite with direct supervision for your staff to dispense the medication. Do not refill over the telephone. Zero tolerance for “lost” medication.
Business Models
In all business models, the initial consultation is required. They should either be done by a physician, diet expert, or qualified sales manager. The initial medical visit should include the following: complete medical history and physical, diet history (including eating habits, sleep, environmental factors, stressors, and exercise), vitals including weight and BMI, Laboratory (fasting glucose, lipid profile, thyroid profile, comprehensive metabolic, CBC, and UA), and an EKG.
Example 1
Meal replacement
Consider meal replacement or a dedicated diet for a patient with a BMI greater than 30. Use companies that offer meal replacement to physicians only (Medigenics, Progressive Labs). Companies like Medifast used to offer meals only to physicians, but now allow online ordering. You can also consider private labeling your own line of meal replacement and nutritional supplements. Most companies will have instructions for patients to follow when you dispense one month supply of meal replacements. While many meals are shakes, bars, or cookies, consider mixing them to give the patients a variety.
On the follow up visit, patients should meet with a dietician or a nutritional specialist to help add one regular meal to their meal replacement plan and discuss their exercise routine. By the third or sixth month, the patient should be completely off the meal replacement or using them only for their breakfast. You may consider using prescription medication as you start to add normal meals or observe patients regaining their weight.
Example 2
Medication only
These patients usually have a BMI between 25 and 30 and do not need a meal replacement or a focused diet. Dispense the first 4 weeks of medication. Follow up in 4 weeks for additional medication and evaluation, with earlier follow up for those needing additional laboratory or blood pressure monitoring. Refer your patient out to the local dietician or counselor for emotional and behavioral support and monitoring. This method requires minimal staff training and new hires.
A variation of this plan is allowing a dietician or nutritionist to come into your office on certain days of the week. These days can be “diet” days where the additional support staff can collect his/her fees for service from the patient or the insurance company. The dietician can either pay your office a flat rate or a percentage depending on the finance arrangements.
Start Up and Marketing
It doesn’t matter how excellent your weight loss program is, if nobody knows anything about it. You can spend a lot of time understanding the literature on weight loss, developing a program and training your staff, but it will be fruitless if you can’t get the word out. Using keywords such as “medical weight loss“, “physician supervised” or “doctor managed” will help you stand out from the non-medical weight loss companies.
Developing a business structure that fits your practice, business partner relationship or medical malpractice requirements are important subjects that you need to discuss and plan ahead.
Will you open up a new practice, add on to your practice, or devote one or two days a week to seeing patients primarily for weight loss?
Are you going to hire an ancillary support staff, like a nutritionist, or will you train your current staff? How will you train your staff?
Are local dieticians, nutritionists, health clubs or personal trainers interested in a joint partnership?
Do you have a business plan and a cash flow plan for building this business?
What are your marketing strategies? What is your online advertising plan? Website? Email marketing?
In setting up your pricing, you should ideally call your competitors and send in a secret shopper. Your secret shopper should find out the fees for the plan, additional fees (follow up, lab, supplements, medication, etc.), hours of operation (evening hours), insurance billing, support classes (group or evening classes) and type of additional support provided.
Offering the following products for sale will add additional income to your practice per patient:
Phentermine adds around $20 each month
Meal replacement adds around $30 – $60 each month
Supplement adds $20 – $40 each month
hCG program adds $100 – $400 each month
All the profit numbers vary with your local competition and your cost for the products purchased.
Starting up a business and marketing are subjects that can require a four year degree in a college. We have tried to condense the crucial information into an online seminar. For more information on start-up and marketing, we recommend you sign up and learn on www.cosmeticmedicalconsulting.com
Medically supervised weight loss certification training online
For more information, contact us at email@MedicalWeightLossTraining.com or call us at (212) 470-8059 TODAY!
BONUS
Semaglutide Protocol for Effective Medical Weight Loss
Tirzepatide Protocol as Weight Loss Treatment
