Chapter 10
Medical Treatments: Prescription Drugs and Surgery
Science . . . never solves a problem without creating ten more.
—GEORGE BERNARD SHAW
By now, you probably realize that there really is no magic pill, medication, or surgery that will allow you to eat unhealthy, fatty, sugary, or starchy foods to your heart’s content while you still lose weight or maintain healthy weight loss. There are, however, some medications and surgeries that may, if dietary and lifestyle changes fail, help with weight loss. But these drugs and surgeries carry varying degrees of risk and side effects, so it’s important to be aware of the pros and cons. Ultimately, even with surgery or a weight-loss drug, you will still need to eat well, change your lifestyle, control your diet, and in some cases completely transform the way you eat if you want to lose weight with these interventions and keep it off.
THE HCG PROTOCOL
Human chorionic gonadotropin, or HCG, is a hormone that is normally produced in large quantities in a pregnant woman’s body. In fact, a home pregnancy test is testing for the presence of HCG in the urine to confirm pregnancy. In a pregnant woman, one of the functions of HCG is to mobilize the burning of fat to ensure that energy is provided to the developing fetus and protect the pregnancy, even if the mother is facing a situation of starvation or is only able to get limited calories. As a medication, HCG is used at fairly high doses as a fertility treatment for women.
For weight loss, HCG is used in minute concentrations along with a very low-calorie diet as a way to shift the hypothalamus and trigger fat-burning. The combination of HCG and a very low-calorie diet is sometimes referred to as the HCG protocol or the HCG diet, or in some cases as the Simeons diet, after British physician Dr. A.T.W. Simeons, the doctor who first proposed it as a weight-loss method in 1954. It’s occasionally referred to as the Pounds and Inches Diet after Dr. Simeons’ book, which was titled Pounds and Inches: A New Approach to Obesity.
The theory is that the HCG is triggering the burn-off of stored fat and allows for weight loss without the normal side effects of a low-calorie diet, such as hunger, irritability, headaches, weakness, reduced muscle mass, or reduced metabolism. HCG is thought to work in a number of different ways:
• HCG causes the hypothalamus to trigger fat to move out of storage and become available for use as immediate energy. The combination of the released stored energy plus the energy from the low-calorie diet add up to several thousand calories a day of energy available for daily function. But, since much of the calories are coming from stored fat, weight is lost, and in particular body fat.
• HCG prevents the metabolism from dropping, despite being on a very low-calorie diet. The normal response to a very low-calorie diet is for the metabolism to become less efficient, which can cause fatigue and stall weight loss. The theory is that the HCG circumvents this mechanism with the hypothalamus and keeps metabolism at a stable level.
• Because HCG focuses weight loss preferentially on fat areas, muscle mass is theoretically less likely to be lost.
• After weight loss on HCG, hypothalamic balance is restored, and leptin and insulin resistance may also be reduced, making it easier to continue losing weight, or maintain weight loss.
• For patients who have been yo-yo dieters or on very low-calorie diets, hypothalamic dysfunction that has slowed metabolism or reduced their caloric needs may be reversed, and the metabolism returns to a more normal function.
Hormone expert and holistic gynecologist Sara Gottfried, MD, explains the theory behind HCG:
We are programmed to be in balance, and we’re born that way, looking for homeostasis, but we have all these archaic systems, such as insulin and leptin systems, that can work against us when managing our weight. I’ve been interested in how we can reset the hypothalamus, remodel it so that it is appropriately interpreting signals from the thyroid and from leptin, For me, that is the greatest excitement for HCG. We don’t totally understand how this works mechanistically, but we believe it remodels the hypothalamus, makes it more responsive to the thyroid, and shifts the body toward burning rather than storing fat.
Cardiac surgeon and hormone expert Dr. Rob Carlson has been prescribing HCG for more than six years and has seen hundreds of patients successfully lose up to fifty pounds during a course of HCG. Says Dr. Carlson:
Reduced-calorie diets often leave patients feeling exhausted and hungry. Coupled with a slow improvement in reshaping of their body, they quickly grow tired of the dieting process and fall back into old habits. In overweight people, HCG seems to work by making available permanently stored supplies of fat, as well as making it possible to adhere to the low-calorie diet. I’ve found that HCG allows patients to lose weight, preferentially from primary fat stores—double chins, protruding stomachs, and fat around the thighs are often the first to go—but also to control their appetite and reduce the “blah” feeling you get when dieting.
I also had an opportunity to speak with Dutch physician Dirk Van Lith, MD. Dr. Van Lith is a leading European proponent of HCG and author of a book on the topic. According to Dr. Van Lith, we have three kinds of fat:
Type 1 is a sort of packing material for the organs (kidneys, heart, etc.). Type 2 is a reserve of fuel, which the body can freely draw upon and distribute as needed around the body. Type 3 is the fat locked away around hips, thighs, and abdomen, which is entirely abnormal and causes obesity. Most weight-loss programs target type 1 and 2 fat, and type 3 fat is lost only as a last resort. The HCG protocol targets type 3 fat.
The Controversy
The use of HCG as part of a specific weight-loss protocol is a controversial approach.
One of the problems facing the HCG protocol is a major image problem. The HCG protocol gained visibility and public attention after pitchman Kevin Trudeau mentioned it in his book The Weight Loss Cure “They” Don’t Want You to Know About. Trudeau is a notorious huckster, using late-night infomercials to sell various books promising natural cures, magical solutions for debt, and schemes to make money.
Not only does Trudeau have no health training, credentials, or background, but some of the health information he peddles in his books and websites is truly bizarre. For example, Trudeau asserts that AIDS is a made-up hoax and that sunscreen causes cancer. In connection with his promotional activities Trudeau is also a convicted felon, having served two years in prison for a larceny conviction related to the fraudulent use of credit cards. He has also been successfully sued a number of times by the Federal Trade Commission for fraud.
So pretty much anything Kevin Trudeau discusses is, understandably, tainted. The problem is that sometimes, in the midst of all his hucksterism, Kevin Trudeau actually does—perhaps by pure accident—manage to mix in some legitimate information, including recommendations regarding organic foods, calcium supplementation, and other commonsense ideas.
Because of Trudeau’s support for HCG, some practitioners categorically dismiss HCG for weight loss, writing it off as “snake oil” or placebo. At the same time, there are practitioners who have been using HCG successfully with their patients for years, long before Trudeau came on the scene. And now, increasing numbers of legitimate practitioners, including physicians, hormone experts, and some bariatric (weight loss) physicians, are rediscovering HCG, and using it successfully themselves or with patients. Even the American Society of Bariatric Physicians includes panels and sessions on the HCG debate in its annual meetings, and recognizes that there are different positions among its members regarding the use and effectiveness of HCG.
Dr. Van Lith feels comfortable with the safety of HCG. “In twenty years,” he says, “I have not seen one single side effect. Heart patients, diabetics, metabolic syndrome, thyroid patients—they all lose weight, and many have unsuccessfully tried everything else before.”
Criticisms of the HCG Protocol
The main criticism of the HCG protocol is, frankly, that it’s ineffective.
Critics of the HCG protocol point to research studies that have found that HCG is no more effective than placebo, and say that the effects of the diet are due to being on a very low-calorie diet of 500 to 600 calories a day, not the HCG.
There are some vague criticisms about whether HCG is safe, but typically, the concerns cite side effects that are associated with use of HCG for fertility. High-dose HCG for fertility treatments can result in ovarian hyperstimulation and rupture of ovarian cysts, among other side effects. The doses used for fertility treatment, however, are typically 5,000–10,000 IU, much higher than the 125 IU a day used in the HCG protocol.
Some critics suggest that the HCG protocol is a ketogenic diet, and what’s happening is that the limited carbohydrates in the diet are sending the body into a state called ketosis, where appetite typically is suppressed. Stored fat is burned during ketosis, but there are concerns that over time, ketosis can increase the risk of kidney stones and gallstones.
Some critics say that the HCG protocol works only because it’s a very low-calorie diet that is supervised and overseen by a practitioner, and that oversight by medical professionals is what is ensuring greater success.
Some practitioners have also suggested to me that one of the key reasons people lose weight on the HCG diet is not the HCG, but the fact that many people on the diet eat no starches whatsoever and are effectively on a gluten-free diet, sometimes for the first time in their lives. They attribute weight loss to the combination of eliminating gluten from the diet along with the low number of calories, not necessarily the HCG.
It’s also important to note that while HCG is prescribed for and has FDA approval as a fertility treatment, its use as a weight-loss treatment is considered an “off-label” use, and the FDA requires physicians to advise patients that HCG has not been demonstrated to be an effective treatment for weight loss.
Does HCG Work?
So the question is, despite the criticism, does HCG work?
If you ask some people who have followed the HCG protocol, they will say yes. I’ve heard from dozens of thyroid patients who have done a forty-day course of HCG and lost fifteen, twenty, even as much as forty pounds.
I’ll start with my own case. I did a forty-day course of prescription injectable HCG, along with the very low-calorie diet, and lost seventeen pounds. The weight I lost was almost all from the belly and waist area. I was not hungry on the diet, and I felt energetic. I had no difficulty staying on the diet. The injections were not painful at all. I saw steady weight loss throughout the cycle. And what was surprising to me was that even after the maintenance period and returning to a regular eating pattern, rather than the usual creep back up the scale, the weight I’d lost stayed off. In fact, the HCG seemed to reset my metabolic set point, the weight at which my body tended to want to maintain itself.
While treated for hypothyroidism, Michael went from 155 pounds and a 26-inch waist to 255 pounds and a 46-inch waist:
I took the HCG shots for forty-five days and followed the diet and I lost about thirty-five pounds. I continued the diet but with an increased caloric intake to about 1,500 calories a day. I found that the low-carbohydrate, low-fat diet worked for me. I am now at 197 pounds and a 36-inch waist. It may not work for all, but it worked for me.
Mari, a thyroid patient, went from 115 pounds to 290 over several years and several pregnancies.
I had apnea, reflux, untreatable constipation, fourteen-day periods, prediabetes, unexplainable joint pain, muscle aches, and sinus problems. At forty-four years old, I was still looking for some viable way to lose weight. A friend of mine used HCG to lose 160 pounds, so I did three months of sublingual HCG. I lost thirty pounds, but the stress of the very low-calorie diet caused my reverse T3 to elevate. My hair fell out, and I gained six pounds of water weight. Fortunately, I changed to Cytomel, since natural thyroid meds were so rare. This was a good thing! I lost the water, my hair grew back, and I continued on to lose another twelve pounds, following Atkins. From that experience and from Atkins, I learned to count carbs and keep a fairly ketogenic diet, which keeps my weight stable and keeps me from retaining a lot of water.
With hypothyroidism and inadequate treatment from doctors, the five-foot-nine McMillan went from 140 pounds in his thirties to 298 pounds in his forties:
I started to ask doctors what was wrong with me. They told me I was depressed and gave me Prozac. They told me I had brain fog because I did not get enough sleep. I went through six doctors in seven years. Finally, once I had my thyroid somewhat in check, I went to see my naturopath about how I might lose more weight. My naturopath suggested I would be a good candidate for HCG. She explained what it was, and I read as much as I could about it. I purchased the drops and went on my way with my modified blood type diet and HCG. I followed the protocol to the letter and I am proud to say that I lost twenty pounds in forty days and I have not felt this good in ten years. I was on maintenance for three weeks, and I lost another five pounds.
I spoke with a number of physicians who are increasingly using HCG with patients who are unable to lose weight with traditional diet and exercise approaches.
So if we have some patient evidence-based medicine that shows that HCG works, and practitioners who prescribe HCG because they see it work with their patients, why don’t we have research to back it up?
The truth is, one journal study showed greater weight loss with less hunger on HCG versus placebo. But a number of other studies have shown that HCG plus a low-calorie diet does not result in greater weight loss compared to the same diet without HCG.
HCG proponents explain this in part by pointing out that the studies have not looked at fat composition or body shape, and say that the key is that HCG-treated patients lose more body fat from the right places—versus muscle and fat from the wrong places—when compared to those not taking HCG.
Is that enough of an excuse? I don’t know. I’ll admit that while the theories behind why the HCG protocol works make sense, there is little proven research to back it up. Part of that may be due to the fact that HCG is not patentable. Large-scale studies are rarely undertaken to evaluate drugs that can’t be profitably mass-produced by a drug manufacturer.
The HCG Protocol
Generally, the HCG protocol is very simple. The concept is that you follow a twenty- or forty-day cycle of using HCG, along with a very low-calorie diet composed of very specific foods, allowing you to lose a substantial amount of fat, primarily from areas of the body that have excess fat deposits.
While simple, proponents caution that HCG protocol needs to be followed very carefully. You can’t take HCG and eat anything you want, or go above the calorie limits. The diet is specifically designed, at around 500–600 calories, to work with the HCG to achieve the results. According to practitioners working with the HCG protocol, the average weight loss on a forty-day course of HCG is anywhere from fifteen to thirty-five pounds.
Most practitioners who oversee the HCG protocol with patients follow a multiphase approach:
• On days 1 and 2, HCG is taken, but food is not restricted, and in fact, high-fat and higher-calorie foods are encouraged. If HCG is injected, one dose is taken in the morning; when sublingual or intranasal HCG is used, typically morning and evening doses are used.
• On day 3, the actual low-calorie diet begins, and it is followed until day 39.
• On days 40, 41, and 42, no HCG is taken, but the low-calorie diet is followed.
The foods eaten on the HCG protocol are very limited. Lunch on the HCG protocol includes the following:
• Protein: One 100 gram (3½ ounces, weighed raw) serving of protein, grilled or boiled without extra fat. Proteins can include veal, beef, chicken breast, fresh whitefish, lobster, crab, or shrimp. Remove all visible fat before cooking.
• Vegetables: One serving of spinach, chard, chicory, beet greens, green salad, tomatoes, celery, fennel, onions, red radishes, cucumbers, asparagus, or cabbage.
• Starch: One thin breadstick (Italian grissini) or one melba toast.
• Fruit: One apple, one orange, half a grapefruit, or a handful of strawberries.
Dinner is the same four choices as lunch. The fruit or breadsticks can be eaten in the morning as breakfast, or as snacks. But do not eat more than a serving of protein, vegetable, breadstick, and fruit in one meal. Also required daily is at least 2 liters of water per day.
In addition, the following are allowed:
• The juice of one lemon daily
• Seasonings: salt, pepper, vinegar, mustard powder, garlic, sweet basil, parsley, thyme, marjoram
• Tea or coffee in any quantity without sugar
• 1 tablespoon milk in every twenty-four-hour period
• Saccharin or stevia for sweetening as needed
Prohibited on the HCG protocol are salmon, eel, tuna, herring, and dried or pickled fish. No oil, butter, or dressing is permitted.
Some practitioners recommend following Dr. Simeon’s original protocol, which prohibits use of all medicines and cosmetics. Other practitioners seem less concerned about medicines and cosmetics, and patients continue to take any prescribed medications and use the normal toiletries and cosmetics while on the HCG protocol.
HCG is not used while menstruating, but the diet is continued, and HCG is resumed when the menstrual period stops.
There’s no recommendation to stop exercising on HCG, and most HCG protocols recommend some form of physical activity to help reset the body’s weight set point.
For his patients, Dr. Van Lith recommends a slightly modified protocol. He has patients follow the high-calorie approach with HCG on days 1 and 2.
New in my routine is that, after the normal high-calorie diet on days 1 and 2, I have them stop eating on day 3, and instead take a big spoon of castor oil only. On Day 4, I recommend they take Epsom salts, to clean the body and triggers some detoxification. I then have then start on day 5 with the very low-calorie diet. I’ve found that this detoxification process is more effective for many patients.
Dr. Van Lith adds an unripe green pear and a thin slice of watermelon to the fruit offerings. He says that if hungry, you can eat celery, cucumber, leek, or radish at any time and in any quantity during the day. He also said that you can add celery, cucumber, leek, or radish to the main vegetable at any meal if desired. Dr. Van Lith adds Wasa crackers as an option in lieu of breadsticks and melba toast. Finally, Dr. Van Lith has his HCG patients take a serving of psyllium husk every morning, to promote regularity.
Dr. Van Lith does caution, however, that thyroid patients must remember to wait at least an hour after taking their thyroid medication to take the psyllium, and he urges having thyroid levels rechecked periodically when using a fiber supplement, to ensure the medication is being absorbed.
Maintenance and Repeat Cycles
Three days after the last dose of HCG, the low-calorie diet is stopped. At this point, for three weeks calories are not controlled, but dieters are urged to avoid processed carbohydrates, starches, and sugar in any form.
After three weeks, you can add in small amounts of carbohydrates, but you weigh yourself daily and adjust your diet accordingly. If you have an increase of more than two pounds from your final weight, you do what’s known as a “steak day.” This means skipping breakfast and lunch and eating a big steak and a big apple or tomato for dinner.
Typically, those who want to do multiple cycles of HCG need to wait six to eight weeks between cycles, to allow for HCG to get out of the system and restore sensitivity to the drug.
According to Dr. Van Lith, about 75 percent of his patients have little to no difficulty maintaining their weight after following the HCG protocol. But Dr. Van Lith has some specific recommendations regarding weight maintenance after the HCG protocol.
I tell my clients that whenever they eat any processed carbohydrates, they should take a big spoon of psyllium. This functions as a carbohydrate blocker. So if you are eating white rice, for example, adding psyllium gives it the glycemic profile of brown rice.
At the same time, he also recommends that to counteract the effects of hydrogenated fats or unhealthy oils, flaxseed oil should be a regular part of the diet.
In the morning, you can put it in muesli, oatmeal, or a drink. In the afternoon, drizzle it on an avocado or a hard-boiled egg. And in the evening, mix it into a salad.
Just for Thyroid Patients
For thyroid patients, Dr. Van Lith recommends emphasizing protein in the diet versus carbohydrates. And, according to Dr. Van Lith, thyroid patients do tend to lose weight more slowly on HCG. But he has found that switching to natural desiccated thyroid can help.
For thyroid patients, I only use natural thyroid, because I have found that synthetic T4 inhibits the HCG, and you get better results with natural thyroid. If patients tend to lose 12 kilos [26 pounds] in six weeks, a typical hypothyroid patient might lose 10 kilos [22 pounds]. But once they’ve started on natural desiccated thyroid, I find they are more likely to lose 11–12 kilos [24–26 pounds] on the next course of HCG.
Should You Try HCG?
Ideally, if you are following an HCG protocol, it should be a medically supervised, prescription HCG program. Do not be tempted by do-it-yourself or over-the-counter HCG programs. That means you should have a consultation with a medical professional before you start, and use a form of HCG prescribed for you.
While some practitioners have told me that they’re actually surprised to see that homeopathic HCG has worked with some of their patients, if you want to actually follow the HCG protocol, you should consult with a physician for prescription HCG.
Dr. Rick Ferris, a naturopathic physician and pharmacist, has successfully overseen many patients following the HCG protocol.
There are different forms of prescription HCG—injectable, intranasal spray, topical, sublingual, even nonprescription homeopathic HCG—but I prefer the injectable and sublingual forms. One of the key issues for me is supervision. With the over-the-counter products, you are not being mentored appropriately, and you don’t have medical supervision, which can make a key difference.
The injectable HCG seems to be favored by most of the practitioners I interviewed. Dr. Van Lith, who works with both injectable and sublingual prescription HCG, prefers a custom-compounded injectable HCG he formulated. He feels that it may be more effective, and patients won’t forget to take a nighttime dose, a problem that can arise with the sublingual HCG.
Dr. Rob Carlson also prefers HCG by injection:
I prefer the injectable approach, using an 0.3 cc syringe and an 8 mm, 31 gauge needle, injected subcutaneously [right underneath the skin] into the tummy fat. These needles are incredibly small, and therefore generate minimal discomfort. I believe another mechanism of why this diet is effective is that if you are going to be committed to injecting yourself daily for twenty-one, twenty-six, or forty-two days, then you are also probably committed to following the diet.
A topical cream form has been developed, but the HCG molecule is quite large and topical absorption of the HCG is not optimal, and may require high doses several times a day to achieve adequate absorption. There is a sublingual HCG that is sprayed or dropped underneath the tongue. The absorption is, however, variable and a substantially higher dose is required to achieve an adequate dose of the HCG in the bloodstream. Pills are not an option, because HCG cannot survive in the acidic environment of the stomach and be properly metabolized by the liver. A relatively new modality is potentially promising: a rapidly dissolving HCG tablet that is not swallowed but allowed to dissolve in the mouth and absorbed through the venous plexus underneath the tongue. This has a higher absorption than the sublingual spray, and because it is absorbed so well it is only taken once a day.
If you are intimidated by needles, keep in mind that the needles used for HCG injections are usually very small, very thin insulin needles used by diabetics for daily injections. If you’ve never injected yourself, see a health care practitioner for a lesson in how to safely administer an injection. If you are worried about the pain of an injection, note that if you have any abdominal fat—a “muffin top”—that’s a particularly painless place for injections. (I speak from experience!) I can tell you that the injections did not hurt in the slightest. In fact, I barely even felt them. Dr. Van Lith provides his patients who use injectable HCG with a syringe used by children with diabetes. According to Dr. Van Lith, “Most people can’t even feel the 3 mm needle, and there is no risk of it going into the abdominal cavity.”
Some people should not use the HCG protocol, and different practitioners have different guidelines. Generally, women who are pregnant or nursing should not use HCG. Some practitioners will prescribe HCG for type 2 diabetics but not for insulin-dependent diabetics. Others rule out anyone with heart disease, current cancer, or history of cancer. Some physicians also rule out anyone with gallstones, a history of gout, epilepsy, or kidney disease. Be sure that you provide accurate information about your medical history to the practitioner overseeing your HCG protocol.
More Information
In the Resources section and at my website ThyroidDietRevolution.com, I have more information and links to several reliable and reputable sources who can work with thyroid patients on the HCG protocol.
PRESCRIPTION WEIGHT-LOSS DRUGS
Prescription weight-loss drugs may help jump-start weight loss after a long plateau, but they are not going to return you to a healthy weight and keep you there for life. Ultimately, you still need to figure out how to rebalance your metabolism, optimize your thyroid, incorporate an exercise program, and determine what combination and quantities of protein, carbohydrates, and fats allow you to function your best and maintain a healthy weight.
But if you could benefit from a weight-loss drug, here is a look at the very limited number of prescription drugs available. Note that some of these drugs are being sold online by unscrupulous companies that require minimal health information and no medical examination. You should not purchase diet drugs this way, particularly because there are a variety of potential side effects that can be dangerous. Your health needs to be thoroughly evaluated before you are prescribed diet drugs, and your response to the drugs must be monitored on an ongoing basis by a physician. If you order drugs directly, you are bypassing this important, even lifesaving step.
Orlistat (Xenical, Alli)
Orlistat, made by Roche Laboratories, is known by the brand names Xenical and Alli. Orlistat is a lipase inhibitor—that is, a fat blocker. It has been available by prescription as Xenical in the United States since 1999, and at a lower dose it has been available over the counter under the name Alli since 2007.
Orlistat blocks the absorption of about one-third of the fat ingested in a meal. Absorption is prevented in the small intestine, where orlistat stops the enzyme lipase from digesting fat. The fat then goes through the system undigested. Orlistat’s most common side effects are oily discharge from the anus and loose stools, which usually occur when people eat more than 30 grams of fat a day. Orlistat, therefore, trains people to eat a healthier, lower-fat diet because of the looming possibility of intestinal discomfort and oily stools if they stray from the low-fat diet.
Overall, orlistat works in about a third of patients. It appears to help some people lose weight (ten to fifteen pounds, typically over a year or longer), lowers cholesterol levels, and lowers concentrations of glucose and insulin. It can also help people make a lifestyle change to a low-fat diet.
A study of approximately five hundred type 2 diabetes patients treated with the antidiabetes drug metformin and placed on a mildly reduced-calorie diet were also given either orlistat or a placebo. Another study looked at approximately five hundred type 2 diabetic overweight and obese patients receiving insulin on a reduced-calorie diet, who were divided into orlistat and placebo groups. In both studies, patients taking orlistat lost more weight than those taking the placebo. This study also showed that taking orlistat was “associated with a significantly greater improvement in control of blood sugar levels,” to the extent that some orlistat participants were able to decrease or discontinue their diabetes medications.
Weight loss is usually temporary if patients go off the drug without further dietary modification. Patients need to follow dietary guidelines on fat intake (less than 30 percent of total daily calories from fat) very carefully to reduce the risk of unpleasant side effects. The fat intake should be divided among three meals. A multivitamin is recommended to counter the loss of some fat-soluble vitamins. Studies showed that levels of vitamins A, D, E, and beta-carotene were lower in patients taking orlistat compared to placebo. More common side effects include an oily spotting on underpants, gas with discharge, an urgent need to have a bowel movement, oily or fatty stools, an increased number of bowel movements, an inability to control bowel movements, orange or brown oil in the stool, and headache. Less common side effects are allergic reactions, which may include an outbreak of hives anywhere on the body, swelling of the throat, shortness of breath, and swelling of the lips and tongue. Menstrual irregularities, back pain, and upper respiratory infections were also mentioned by some participants in clinical trials.
Orlistat should not be taken or should be monitored very carefully among people with difficulty absorbing nutrients from food, gallbladder problems, kidney stones, diabetes, anorexia, bulimia, or sensitivity to any chemical component of orlistat. If people are taking other weight-loss medications or cyclosporine, they may not be able to take orlistat, or their physician may prescribe a lower dose than usual. Orlistat is not to be taken during pregnancy.
Some patients have found that the oily stools and anal leakage side effects are troublesome, particularly in the early weeks, and describe intestinal gas and irritable bowel syndrome, with alternating diarrhea and constipation, as a constant concern while taking the drug.
Orlistat may not be especially suitable for thyroid patients, as it can negatively affect the absorption of thyroid medication. This is a particular concern for thyroid cancer survivors, who need to ensure stable dosage and absorption of thyroid medication as part of their effort to prevent cancer recurrence.
Xenical and Alli tend to be expensive, running from $45 to $375 per month depending on the dose.
Phentermine (Adipex-P, Ionamin, Fastin)
Phentermine is the generic name for an appetite-suppressant drug that goes by the brand names Adipex-P, Ionamin, and Fastin. Phentermine has been on the market in the United States since 1959.
In 1999 phentermine was pulled from the market in the European Union, but it is still available in the United States. Phentermine may sound familiar because it was the “phen” in the huge fen-phen scandal of the late 1990s. The “fen” parts—fenfluramine (Pondimin) and dexfenfluramine (Redux) were pulled from the market after patients taking the fen-phen combination experienced heart valve damage and symptoms of primary pulmonary hypertension, which is sometimes fatal. Lawsuits were filed against the manufacturer of Pondimin and Redux, and the FDA started warning people about the heart condition in the summer of 1997.
Phentermine stimulates the central nervous system like an amphetamine, increasing heart rate and blood pressure and decreasing appetite. Phentermine is intended for short-term use only because the body will grow accustomed to the increased stimulation, and the dose of phentermine will lose effectiveness over time.
Phentermine reportedly does not cause as many jittery feelings as benzphetamine (discussed later). For those with sensitive stomachs who cannot tolerate the Adipex-P immediate-release dose, Ionamin is set in a resin that takes longer to dissolve.
One 2000 review of all placebo-controlled trials since 1960 about antiobesity pharmacotherapy lasting thirty-six to fifty-two weeks found that weight loss attributable to the drug was 8.1 percent, or 17.4 pounds, for those receiving phentermine, which was greater than statistics for sibutramine, orlistat, or diethylpropion (discussed later).
Note, however, that according to the National Institutes of Health, guidelines now suggest that phentermine not be taken for more than three to six weeks. It’s not clear if there is much potential for weight loss in this short a period.
Phentermine can be physically and psychologically addictive. Common side effects include elevated blood pressure, primary pulmonary hypertension, regurgitant cardiac valvular disease, heart palpitations, rapid heart rate, dry mouth, unpleasant taste, diarrhea, constipation, urticaria (hives), impotence, changes in libido, dizziness, blurred vision, difficulty breathing, shortness of breath, restlessness, headache, and insomnia. Less commonly, some people taking phentermine have reported hallucinations, abnormal behavior, and confusion.
Phentermine is not to be taken if moderately high or high blood pressure exists. For diabetics, insulin requirements may need to be altered, and phentermine may decrease the hypotensive effect of guanethidine. Effects of phentermine on cancer, fertility, pregnancy, children, and nursing mothers have not been determined.
Phentermine should not be taken by people who have hardening of the arteries, heart disease, moderate to high blood pressure, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, agitated states, or a history of drug abuse, or during or within fourteen days of the administration of monoamine oxidase inhibitors (hypertensive crisis may result), or if taking a tricyclic antidepressant.
Phentermine is potentially extremely dangerous when used in combination with fenfluramine or dexfenfluramine. This combination may result in primary pulmonary hypertension, which is high blood pressure (caused by the artery getting smaller in diameter) in the main artery of the lungs that carries blood from the heart. The increased pressure within the pulmonary arteries overworks the right side of the heart. The heart then works harder to overcome the increased blood-flow resistance created by the abnormally high pressure in the pulmonary arteries. The right side of the heart can become enlarged, and if the disease progresses, it can result in congestive heart failure. Symptoms of primary pulmonary hypertension include shortness of breath (particularly during exercise), chest pain, and fainting.
While this drug is readily available without prescription on the Internet, it is not advisable to purchase or take this drug unless under a physician’s supervision.
Generic phentermine can run from approximately $40 a month up to as much as $75 a month for a brand-name product.
This is the only diet drug I have taken, but only as part of the phen-fen combination in the 1990s, for around four months. While I am lucky to have escaped the permanent damage suffered by some people who took these drugs in combination, I never lost any weight on phen-fen.
There’s another reason that thyroid patients probably do not want to take phentermine. Studies have shown that the drug can actually cause a reduction in T3 and an increase in reverse T3. The researchers described it as “a pattern of serum thyroid hormones similar to that observed in resting patients on a total fast.”
Benzphetamine (Didrex)
Benzphetamine, one of the first diet drugs on the market, is also known by the brand name Didrex. Benzphetamine is a stimulant that is an anorectic—that is, it acts as an appetite suppressant. The drug has been available in the United States since 1959.
By stimulating the central nervous system, increasing heart rate, and decreasing appetite, the drug has the potential to help with weight loss. Benzphetamine is considered most useful for those who have changed their eating patterns and lost weight but have hit a plateau. It is best given in a long-acting form and requires careful oversight by a physician.
The drug is habit-forming and has considerable potential for addiction. It should only be used short-term (a few weeks at a time) because the body builds up tolerance. Some side effects include heart palpitations, irregular heartbeat, elevated blood pressure, feeling overstimulated, restlessness, insomnia if taken late in the day, tremors, nervousness, sweating, headaches, dizziness, dry mouth, unpleasant taste, nausea, diarrhea, allergic reactions (hives), and changes in libido. Less common side effects include psychological disturbances (hallucinations, confusion), heart damage, depression or withdrawal symptoms after discontinuing benzphetamine, and impotence.
Benzphetamine should not be taken by anyone who has a history of heart disease, hardening of the arterial walls, moderate to severe hypertension, sensitivity to amphetamines, hyperthyroidism, glaucoma, anxiety, or a history of drug abuse, or by those taking monoamine oxidase inhibitors or other central nervous system stimulants. Benzphetamine should not be taken during pregnancy. It should not be taken in combination with guanethidine, tricyclic antidepressants, amphetamines, urinary alkalinizing agents, or urinary acidifying agents.
The typical monthly cost for benzphetamine is approximately $40 to $160 per month.
Diethylpropion (Tenuate)
Diethylpropion—brand name Tenuate—is an appetite-suppressant drug that has been available since the 1960s. The drug is a central nervous system stimulant that curbs appetite and increases heart rate and blood pressure. Diethylpropion has been shown to be effective in helping with weight loss over short periods of time without significant amphetaminelike side effects. Diethylpropion has been on the market a long time with no major problems, although the class of anorectic diet drugs is under more scrutiny now for heart-related problems because of the fen-phen incidents.
Since diethylpropion is an older diet drug, the less expensive generic form is available. Although few long-term studies were done when diethylpropion was first introduced in the late 1960s as a diet drug, there have been no major problems associated with the drug.
Diethylpropion can be habit-forming, so it can only be taken for short periods of time (a few weeks), then the patient must stay off the drug for a few weeks. Side effects may include slightly increased heart rate and blood pressure, sleeplessness, restlessness, dry mouth, nervousness, headache, diarrhea, constipation, and changes in libido. Less common side effects include irregular heartbeat, insomnia, impotence, and allergic reactions.
People with heart disease, high blood pressure, hardening of the arteries, anxiety problems, epilepsy or seizure disorder, or diabetes, or those who have taken monoamine oxidase inhibitors, should be careful taking diethylpropion and need to inform their physician of such conditions. People taking monoamine oxidase inhibitors should not take diethylpropion until they have been off the MAOI for at least fourteen days. Pregnant women should not take diethylpropion. Due to unpredictable episodes of dizziness or restlessness, people should be careful when driving and operating heavy machinery. People taking insulin, guanethidine, and tricyclic antidepressants should inform their doctor because the dosage of these drugs or of diethylpropion may need to be adjusted.
The drug runs approximately $30 a month for the generic, up to $50 for a brand-name prescription.
Phendimetrazine (Bontril, Plegine, Prelu-2)
Phendimetrazine, known by the brand names Bontril, Plegine, and Prelu-2, is an appetite suppressant that has been available in the United States since the late 1960s. It is a central nervous system stimulant that curbs appetite and increases heart rate and blood pressure. Studies have shown that phendimetrazine can be an effective appetite suppressant.
There is potential for abuse or dependence on this drug, since it is related to amphetamines. Tolerance also typically develops in a few weeks, and phendimetrazine is no longer effective at that point.
Side effects may include slightly increased heart rate and blood pressure, sleeplessness, restlessness, dry mouth, nervousness, headache, diarrhea, constipation, increase in urinary frequency, and changes in libido. Less common side effects include irregular heartbeat, insomnia, blurred vision, stomach pain, and impotence.
The drug was pulled from the market in the European Union in 1999. While phendimetrazine is still available in the United States, it carries heavy warnings about heart problems, because, as a stimulant diet drug, there are concerns that it may have serious or even fatal side effects like those seen with the popular but now banned combination of fenfluramine and phentermine (fen-phen).
People with hardening of the arteries, heart disease, moderate to severe pulmonary hypertension, high blood pressure, hyperthyroidism, glaucoma, anxiety, or a history of drug abuse should not take phendimetrazine. Use with other central nervous system stimulants is contraindicated. People with mild hypertension should be cautioned. Diabetics may need to adjust their insulin requirements while taking phendimetrazine.
There is also a danger in a large dosage or overdose, which can cause unusual restlessness, confusion, belligerence, hallucinations, and panic states. Fatigue and depression usually follow the central nervous system stimulation. Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Poisoning may result in convulsions, coma, and death.
The drug runs from $20 to $50 a month, depending on brand and dosage.
Topiramate (Topamax)
Topiramate (brand name Topamax) is an antiepileptic drug approved in October 1998. Topiramate helps control seizures by altering chemical impulses in the brain. In 2002, researchers began to publish studies about using topiramate for weight loss.
In one study about the weight changes in patients during clinical trials for topiramate, researchers found that a daily dose of 200 mg resulted in a 5 percent or greater weight loss in 28 percent of the patients; 57 percent of those treated with 800 mg/day lost that amount of weight. The amount of weight lost was proportional to baseline body weight; therefore, the higher the initial body weight, the more weight the patients lost. Interestingly, those who took valproic acid, an anticonvulsant (brand name Depakote), prior to participating in the topiramate clinical trial lost even more weight.
Other studies have shown that topiramate may have applications as a treatment for binge-eating disorders.
The monthly cost for topiramate runs from $60 to $200, depending on dosage.
BUPROPION-NALTREXONE COMBINATION THERAPY
Some physicians are combining the antiaddiction and immune-modulating drug naltrexone with the antidepressant bupropion as an off-label treatment for weight loss. “Off-label” means that the use is not FDA-approved to date. It is legal for physicians to prescribe medications for off-label use. (It is prohibited, however, for drug manufacturers to promote off-label use of medications.)
Naltrexone is sometimes known by the brand name Revia, and bupropion is perhaps best known as Wellbutrin. The combination of the two drugs appears to boost weight loss by changing the workings of the body’s central nervous system. Drug manufacturers are studying an experimental medication, Contrave, that combines the two in one pill.
Kent Holtorf, MD, is a physician who has been using these drugs together as an adjunct to weight loss:
I’ve found that the antidepressant Wellbutrin (bupropion) does not work well for weight loss. A combination of Wellbutrin and low-dose naltrexone is, however, having some surprisingly good results. Typically, we have the patients on 300 mg of Wellbutrin-SR twice a day, along with an increasing dose of naltrexone, typically 10, up to 20, and then to 30. At a lower dose, for example 4.5 mg daily, it helps as an immune modulator, and at higher doses it seems to help with weight, cravings, and the set point.
While the combination of bupropion and naltrexone is generally well tolerated, some patients complain of sleepiness or nausea. The two medications can run upward of $250 per month.
METFORMIN (GLUCOPHAGE)
Metformin (brand name Glucophage) is an oral drug used to treat type 2 diabetes. Metformin helps decrease the amount of glucose absorbed from food and the amount of glucose produced by the liver. Metformin also increases responsiveness to insulin. It is sold under other trade names as well, including Riomet, Fortamet, Glumetza, Obimet, Dianben, Diabex, and Diaformin.
Several studies have shown that metformin may help nondiabetics lose weight by reducing hunger and by helping sensitize the body to insulin. In one study, about 80 percent of women who took metformin and adhered to a controlled-carbohydrate diet lost 10 percent of their starting weight in a year.
Some physicians suggest that metformin can work best in patients who are closely following a low-glycemic diet that does not spike blood sugar, and when a dosage of metformin is taken three times daily a few minutes before each meal.
Metformin is not recommended in anyone who has kidney, lung, and liver disease, and some forms of heart disease, based on the risk of a rare but serious complication called lactic acidosis.
The main side effects are nausea, upset stomach, and diarrhea, and a risk of hypoglycemic symptoms such as shakiness and dizziness.
While the implications are not clear, thyroid patients should be aware that several studies have shown that metformin suppresses TSH levels. One study found that a number of patients who were hypothyroid and on metformin had suppression of TSH to levels below normal, but without any signs of hyperthyroidism, and no change in free T4 or free T3 indicative of a change in circulating thyroid hormone. Another study found that metformin may be associated with a significant drop in TSH levels. Thyroid patients and practitioners should keep this effect of metformin in mind when evaluating thyroid therapy. It’s also another reason why TSH alone can not be considered a reliable gauge for thyroid function, and free T4 and free T3 levels should be run regularly as well.
Metformin in a generic form can run $20 to $40 a month; the brand name drug can run $60 to $100 a month, depending on the dose.
Note that there are anecdotal reports that some patients do not respond to generic metformin, but do respond to the Glucophage brand specifically.
INJECTABLE DIABETES DRUGS
Several drugs used to treat diabetes are now being used by some practitioners as off-label treatments for weight loss and obesity, particularly in patients who are insulin-resistant or leptin-resistant and may be classified as prediabetic.
These drugs typically come as liquid in a prefilled pen that is used to inject under the skin of the abdomen or upper arm, and are usually injected several times daily before or with meals, depending on the drug.
• Byetta (exenatide). Byetta helps stimulate the pancreas to secrete insulin when blood sugar levels are high. It also slows the emptying of the stomach and reduces appetite.
• Symlin (pramlintide). Symlin is an antihyperglycemic medication that helps slow the movement of food through the stomach, which prevents blood sugar from rising too high after a meal. Symlin may also decrease appetite.
• Victoza (liraglutide). Studies suggest that Victoza helps control blood sugar by increasing insulin secretion, delaying gastric stomach emptying, and suppressing the secretion of glucagon.
Risks and Side Effects
These medications can cause side effects, including hypoglycemia (low blood sugar), which can cause shakiness, dizziness, sweating, weakness, pale skin, and even loss of consciousness, among other symptoms. In some cases, elevated blood sugar can occur, and may cause symptoms such as shortness of breath, breath that smells fruity, and unconsciousness. These symptoms require immediate medical intervention.
There have been problems with Byetta in people who have any kidney problems or history of pancreatitis. The FDA has also indicated that there may be concerns about an increased risk of thyroid cancer in Byetta and Victoza, and while the link hasn’t been clearly established in humans, animal studies have shown a connection.
Byetta is more associated with general side effects than the other medications. While all these drugs have been reported to produce some stomach upset and other associated symptoms, users of Byetta typically report more of the gastrointestinal side effects, including acid stomach, diarrhea, indigestion, nausea, and vomiting, especially when first starting the medication.
Dr. Kent Holtorf prescribes these medications for weight loss as part of his practice:
The biggest side effect is nausea, which occurs in about 25 percent of patients. Most of the time it is mild and diminishes with continued use, but a few patients will not be able to tolerate it. For Byetta, I recommend starting with a 5 mcg injection before meals. Some patients start with half a shot for the first few days (only pushing the plunger halfway). The nausea in some people can be due to an increased production of stomach acid, so Zantac (ranitidine) or a proton pump inhibitor drug—like Prilosec (omeprazole), Prevacid (lansoprazole), or Nexium (esomeprazole) for example—can be helpful. Nausea is less commonly a side effect of Symlin compared to Byetta, so it’s preferable for some patients. For Symlin, the optimal dose is 120 mcg three times per day.
Should You Consider an Injectable Diabetes Medication?
Whether or not to use one of these medications for weight loss is a decision you and your practitioner will need to make. Here are some considerations.
First, will it work for you? According to Dr. Holtorf, you are more likely to have better results if you have demonstrable leptin or insulin resistance, as evidenced by elevated leptin levels or elevated fasting glucose levels.
While none of these drugs are approved by the FDA for weight loss, Symlin in particular is being studied in people without diabetes. One six-week trial of Symlin reported in the American Journal of Physiology—Endocrinology and Metabolism found that obese patients who injected Symlin three times daily before each meal lost an average of four and a half pounds, compared to a control group that injected placebo and lost no weight. The study subjects also reported feeling full despite eating less.
I’ve talked with several thyroid patients who have lost twenty to thirty pounds in several months taking Byetta or Symlin. Kelly had an excellent experience:
Nothing I was doing was working weightwise, and I have a history of diabetes in my family, so at 190 pounds, I was terrified that I was on my way to being diabetic. I was a bit freaked out at the idea of injecting myself, but the little pen actually is easy and I barely felt it. I felt kind of green the first few days, but I was able to tolerate it, and it was, truly, the first time in years that the scale started to move. I was able to lose twenty-five pounds in three months, and I continue to lose a few pounds a month while eating a healthy diet. This is phenomenal for me, as usually I have to suffer for weeks just to lose a pound. Even better, my blood sugar level is now normal. At some point, my doctor will wean me off the Symlin, and hopefully my blood sugar and weight will stabilize at a lower weight.
Joanne tried Byetta for weight loss but had a different experience.
I have high leptin levels and am slightly insulin-resistant, so my doctor and I thought a trial of the Byetta would be reasonable. I started at the lowest dose and was very committed to making this work. But I wasn’t able to tolerate the side effects at all. I felt exhausted all the time I was on it. I was nauseous every single day while on Byetta, and I threw up so much, I felt like the drug was making me a drug-induced bulimic, to be honest. I put up with this for two months, and despite being really careful on my diet and constant vomiting, I couldn’t believe that I only lost four pounds. It wasn’t worth it to me to stay on the medication.
While an occasional patient like Kelly has reported dramatic weight loss, and some have significant side effects like Joanne, those who tolerate these medications should not expect dramatic weight loss. Many patients using them off-label are reporting modest weight loss at best.
Second, what about the inconvenience of injections? Says Dr. Holtorf:
Taking a subcutaneous shot several times a day can be problematic, but when patients have great results it is worth it for most. Some people are concerned that the medications require refrigeration, but it’s usually not necessary, as these medications are very stable at normal daytime temperatures. So it’s not a problem to keep it in your purse or in the desk drawer.
Third, there is the issue of side effects and risks. These medications do frequently have side effects that can range from temporarily uncomfortable to thoroughly intolerable. It’s also important to keep in mind the increasing concerns on the part of regulators regarding the potential thyroid risks posed by Byetta and Victoza.
Finally, a key consideration is cost. Symlin, Byetta, and Victoza are quite expensive, and when prescribed off-label are usually not reimbursed by insurance companies. A thirty-day supply of these drugs can run $250 to $400 or more, depending on the dosage.
For some patients, however, one of these medications may be the key to breaking a plateau or starting a successful effort to finally lose weight gained after a period of hormonal imbalance. The objective is not to remain on these medications forever, but rather, to lose weight, help lower the leptin and insulin resistance, and then go off the medication at a point where the weight, metabolism, and hormonal balance will make it easier to maintain the weight loss or allow for continued weight loss.
WEIGHT-LOSS DRUGS IN DEVELOPMENT
One thing to be encouraged about is that since there are so many overweight, frustrated people in the world, finding solutions has become a major priority for the scientific community. Tremendous research efforts are looking at various weight-loss drugs and approaches, and many new developments and drugs are in the works. Here is a brief look at some of the things you’re likely to hear about in the future.
Contrave
Contrave was mentioned earlier, and is the manufactured drug that combines naltrexone (Revia) and bupropion (Wellbutrin). In preliminary studies, the combination drug has helped users drop an average of 5 percent of body weight over a yearlong clinical trial. In the study, half of those who took the highest dose of naltrexone lost 5 percent of their weight or more, compared to only 16 percent of those taking placebos. Contrave does have side effects, however. One in three participants had nausea, and participants complained of other side effects including headache, constipation, dizziness, vomiting, and dry mouth. Half of the study participants dropped out before completing a year of treatment.
Empatic
Empatic is an experimental drug that combines the antidepressant bupropion with the anticonvulsant drug zonisamide. It is in the process of testing but has shown a fairly substantial weight-loss effect. One study found that participants who took the drug daily for sixteen weeks lost an average of nearly thirteen pounds, compared with about two pounds in patients taking placebo pills.
Nastech PYY Nasal Spray
Another product that is in the testing phase is a nasal spray that delivers peptide YY (PYY) for the treatment of obesity. PYY is a hormone naturally produced by the stomach in relation to the calorie content of a meal. According to results from various studies, obese or nonobese patients given a ninety-minute intravenous infusion of PYY consumed on average 30 percent fewer calories. All the people studied experienced a significant decrease in their overall twenty-four-hour calorie intake. Furthermore, obese patients were observed to have lower levels of circulating PYY. Therefore, increasing levels of PYY may be an effective therapeutic strategy in treating obesity, and the nasal formula has been shown to deliver sufficient amounts of PYY for therapeutic value. Studies are still ongoing.
WEIGHT-LOSS SURGERY
There are a number of surgical procedures currently being performed as treatments for obesity in those who are significantly overweight. In the last decade, bariatric surgery has become the second most common abdominal operation in the United States.
In this section, you’ll find a review of some of the more common procedures as well as the newer approaches gaining popularity. We’ll also take a look at the pros and cons, and the relevance and safety for thyroid patients.
Gastric Bypass (Roux-en-Y) Surgery
Gastric bypass is also known as Roux-en-Y (pronounced “roo-on-why”) or Roux-en-Y gastric bypass (RYGB). RYGB surgery can be done in two ways: via an open incision, or laparoscopically, meaning that the surgeon inserts the surgical instruments, including a light and tiny camera, through a small incision. In RYGB surgery, the stomach is divided—often using staples—and only a small pouch, initially capable of holding only a small amount of food, about one ounce, is left to connect to the small intestine. Because the stomach is smaller, one feels full on far less food, and since food bypasses the duodenum, fat absorption is also reduced.
Gastric Sleeve Surgery
Gastric sleeve surgery is also called a sleeve gastrectomy and vertical sleeve gastrectomy. In this surgery, the stomach is divided into a smaller section—typically about 20 percent of its total volume—and that section is then separated from the rest (often with staples) and left connected to the small intestine. This procedure can be done via open incision or laparoscopy. When compared to traditional gastric bypass, studies show that patients tend to be more satisfied and lose more weight with the Roux-en-Y procedure versus gastric sleeve, though both are generally considered similarly effective.
A new variation on gastric sleeve surgery, known as trans-oral gastroplasty (TOGa), is in clinical trials, but will likely become a popular option. TOGa surgery is performed endoscopically, through the mouth, and does not involve an incision. A flexible endoscopic tube is inserted so the surgeon can see the procedure, and a small, remote-control surgical device is also inserted, which can push certain parts of the stomach out of the way, suck certain parts of the stomach into itself with a vacuum method, and staple sections together to form the “sleeve” that limits the amount of food that can enter the stomach at any one time. The rest of the stomach is still present.
Gastric Banding or Laparoscopic Gastric Banding (Lap-Band)
Gastric banding involves the placement of an adjustable silicone band near the top (esophagus end) of the stomach, creating a smaller stomach pouch and a narrow passage into the larger remaining portion of the stomach. In this procedure, the food intake is restricted, but the normal digestive process is not changed. The small passage delays the emptying of food from the pouch and causes a feeling of fullness. A port is placed on the outside of the patient’s abdomen for the surgeon to use in adjusting the size of the band, which can be tightened or loosened over time to change the size of the passage; initially the pouch holds about 1 ounce of food and later expands to 2 to 3 ounces. The surgery is done with an open incision, or in some cases is done laparoscopically, in which case it’s called laparoscopic gastric banding (LAGB, or lap-band surgery). Gastric banding is sometimes used as a follow-up surgery when patients fail to lose weight after a traditional gastric bypass.
A note about laparoscopy: For any weight-loss surgeries, while laparoscopy is often preferred due to faster recuperation time, surgeons may choose not to use this technique for patients who have had abdominal surgery in the past and therefore have scar tissue that can interfere with the surgery. In some cases, surgeons also may choose open incision versus laparoscopy for patients who have severe heart and lung disease, and for those who weigh more than 350 pounds.
Other Procedures
Less commonly performed are surgical procedures that reduce nutrient absorption by bypassing larger portions of the digestive tract. These include:
• Bileopancreatic diversion, in which a considerable portion of the stomach is removed, and the small section remaining is connected to the final section of the small intestine, bypassing most of the small intestine. Weight is lost because most of the calories and nutrients are directed into the colon and not absorbed.
• Bileopancreatic diversion with duodenal switch, in which a larger portion of the stomach is left intact, including the pyloric valve, and the duodenum and small intestine are both divided near this valve. This form of surgery is sometimes used in patients who have a very high body mass index, over 50—a level referred to as “super-obese”—as those patients have a failure rate of some 40 percent after traditional Roux-en-Y surgery.
Who is Eligible for Bariatric Surgery?
Typically, according to the National Institutes of Health, the American Medical Association, and bariatric physicians, bariatric surgical procedures are only considered for people who are considered severely obese. This is defined as being one hundred pounds overweight or having a body mass index greater than 40. In some cases, a patient may be considered eligible for bariatric surgery if he or she has a BMI of 35 or more and is experiencing serious obesity-related health conditions, such as high blood pressure, heart disease, diabetes, sleep apnea, or degenerative joint disease.
Effectiveness
The popularity of bariatric surgery has grown because the surgery, and in particular the RYGB surgery, has demonstrable results, including:
• Average excess weight loss that is usually higher than with purely restrictive dietary procedures
• One year after surgery, a typical weight loss averaging approximately 75 percent of excess body weight
• Continued weight loss, as studies have shown that as long as ten years postsurgery, a large majority of patients maintain 50 to 60 percent of excess body weight loss
• Improvement or resolution of major health conditions, including back pain, sleep apnea, high blood pressure, diabetes, and depression, in almost all patients
Generally, studies have shown that patients tend to be most satisfied and lose the most weight with the traditional RYGB procedure. It has the longest history and is the most studied, and many bariatric surgeons consider it to be the basic, most reliable surgical method for weight loss. RYGB is the most frequently performed bariatric surgery in the United States.
In terms of effectiveness, there are many studies that show that the body weight lost at one year postsurgery is considerably greater for RYGB versus gastric banding. One study showed that approximately 75 percent of excess body weight is typically lost after RYGB and diabetes fully resolved in 78 percent of patients, versus 48 percent of excess weight lost and 50 percent resolution of diabetes after laparoscopic adjustable gastric banding.
In one pilot study of the TOGa procedure, forty-seven people who weighed on average 120 pounds more than their ideal body weight had the procedure, and after six months, the subjects had lost more than a third of their excess body weight. By twelve months, their excess weight loss averaged almost 40 percent. This is less than the traditional gastric bypass, but the TOGa endoscopic procedure—as compared to laparoscopic or open surgery—is associated with quicker recovery, shortened hospital stay, decreased complications, and no incision or scarring.
Research has shown that patients who have an extremely high body mass index (over 70) do best with an open incision gastric bypass versus laparoscopy.
Complications and Problems
No weight-loss surgery should be undertaken lightly, and the decision to have bariatric surgery is one that a patient needs to make in conjunction with a knowledgeable bariatric expert. It generally should be a decision that is made only after a comprehensive nonsurgical effort to lose weight has been unsuccessful.
All bariatric surgeries have risks, and rare but serious complications of any surgery include bleeding, infection, reactions to the anesthesia, and blood clots in the legs.
The most serious problems, however, including infection and even death, are most common after RYGB surgery compared to the other surgeries. Substantially fewer immediate complications in the short term are associated with sleeve gastrectomy, laparoscopic band procedures, and endoscopic procedures.
One serious complication is gastric leakage, in which there is a leak at the staple line and stomach contents leak into the abdomen. This is dangerous because the acid can eat away other organs; an additional surgery may be required to correct the problem, along with a lengthy recuperation. Gastric leakage is more common after sleeve gastrectomy than other procedures.
Another complication is “dumping syndrome,” whereby stomach contents are passed rapidly into the small intestine. This can be triggered by too much sugar or larger amounts of food. Dumping syndrome can cause malnutrition, and is also very uncomfortable, causing nausea, vomiting, weakness, sweating, faintness, and diarrhea.
Almost a third of patients develop nutritional deficiencies after bariatric surgery, because the body is less able to absorb iron, calcium, and other nutrients efficiently. Nutritional deficiencies can specifically lead to iron deficiency anemia, chronic anemia, osteoporosis, and other bone problems stemming from low calcium.
While gastric banding surgery tends to have a lower complication rate than gastric bypass—with shorter hospitalization and faster recovery—it does carry with it a longer-term risk for band erosion or migration, which can cause infection or ineffectiveness and require additional surgery to reposition, revise, replace, or remove the gastric band entirely. Some experts estimate that as many as half of all patients ultimately require subsequent surgeries.
There are other possible complications as well:
• The success of the procedure can be reduced substantially if even slightly increased amounts of food are eaten and the stomach pouch is stretched. This requires another surgery to repair it.
• The opening between the stomach pouch and the small intestine may get narrower, which can require corrective surgery.
• Gallstones and gallbladder attacks, which occur more often when you lose weight quickly. It’s estimated that up to 30 percent of patients develop gallstones after bariatric surgery.
• An incisional hernia (a bulging of tissue through the site of the incision). This is more common when an open procedure is done.
• Kidney stones.
• Gastritis (inflamed stomach lining) or heartburn.
• Ulcers, including bleeding stomach ulcers.
• Vomiting from eating more than the stomach pouch can hold.
• Breakdown of staple lines (band and staples fall apart, reversing the procedure).
• Low blood sugar (hypoglycemia).
• Chronic dehydration.
The Future of Bariatric Surgery
A number of newer procedures are being tested or on the horizon in the area of bariatric surgery, including:
• Natural orifice transluminal endoscopic surgery (NOTES). Besides the TOGa procedure, we can expect to see more use of the mouth and other orifices for incisionless gastric surgery.
• Restorative obesity surgery, endolumenal (ROSE). If stomach stretching has resulted in weight gain after gastric bypass, this incisionless endoscopic surgery can restore the stomach pouch back to its original postsurgery proportions.
• Intragastric balloon. This is a balloon that is implanted endoscopically in the stomach area to reduce the size of the stomach and therefore create a sensation of fullness. Some balloons are fixed in size, but the more recent development is an adjustable valve that allows doctors to increase or decrease the balloon’s size with saline or air through an endoscopy procedure on an as-needed basis. At present, the balloons being tested are only left in for six months, but some studies are being done on balloons being left in for as long as a year or more. In one study that lasted for fifteen months, patients lost 10 percent or more of their body weight in a four-to-six-month period with the balloon.
• Intragastric injection of botulinum toxin. This slows the emptying of the stomach and creates a feeling of fullness.
• Gastrointestinal neuromodulation. The idea is that some kind of microchip or device would be implanted to stimulate the vagus nerve, mimicking a feeling of fullness and suppressing appetite.
Especially for Thyroid Patients
In consulting with a number of bariatric surgeons, there do not appear to be any specific warnings against any bariatric surgery techniques for thyroid patients. Most agreed, however, that no patient should undergo any weight-loss surgery until the thyroid hormone level is normal. Bariatric surgery should only be performed after normalization of thyroid levels if weight remains a problem and the patient meets the criteria for a bariatric surgical intervention.
Some surgeons have indicated that Crohn’s disease, an autoimmune condition, is a contraindication for bariatric surgery. Also, anyone who has a history of chronic, long-term steroid use may not be eligible for bariatric procedures.
There are few studies that look at the results of bariatric surgery in patients with hypothyroidism, or autoimmune Hashimoto’s disease specifically, though more studies in this vein would be helpful to have as part of the decision-making process for patients. One study did look at the results of RYGB surgery in twenty morbidly obese hypothyroid patients. Among those studied, one patient died as a result of the surgery, and four others had serious complications. The remaining fifteen patients experienced weight loss as well as what is referred to as “improvement in thyroid function.”
Another study looked at eighty-six patients who underwent gastric bypass or adjustable gastric banding. The patients were not on thyroid treatment—though their mean TSH level was measured at 4.5, a level considered subclinically hypothyroid by some physicians. The mean body mass index of the patients went from 49 to 32 after surgery, and this was associated with a mean reduction in the TSH level from 4.5 to 1.9.
Interestingly, one 2008 study from the journal Obesity Surgery looked at twenty morbidly obese women with hypothyroidism who were on thyroid replacement therapy. After RYGB surgery, the hypothyroidism resolved in 25 percent of the women, improved in 10 percent of the patients, was unchanged in 40 percent, and worsened in 25 percent of the patients; the ones whose hypothyroidism worsened all had autoimmune Hashimoto’s disease. The researchers have concluded that hypothyroidism appears to improve in the majority of morbidly obese patients who undergo RYGB surgery, except for those whose thyroid disease is autoimmune in nature. Bariatric experts consulted were not concerned regarding this one small study, however, suggesting that a worsening of hypothyroidism—as defined by a need for an increased dosage of medication—may be due to poor absorption of the medication and is likely to be offset by the benefits of the weight loss.
Feedback from thyroid patients who have had bariatric surgery suggests that their results tend to mirror the success and complication rates of the general population. However, some patients’ comments indicated that their weight-loss postsurgery was slower than that of others who did not have a thyroid condition, or that their loss plateaued earlier and at a point when a smaller overall percentage of body weight had been lost.
Keep in mind that if you have any sort of bariatric surgery, you should:
1. Ensure that your thyroid function is optimized before surgery.
2. Be sure that you will be allowed to take your thyroid medication while hospitalized. (Some patients find that it’s easier—and less expensive—to bring their own medication from home.)
3. Get thyroid levels retested frequently after surgery, to evaluate any changes in your absorption or thyroid requirements. If you have substantial weight loss, your need for thyroid medication may drop, so retesting is especially important.
Choosing a Surgeon and Hospital
If you decide to investigate bariatric surgery, keep in mind that a number of research studies have shown that the best results are likely with surgeons and hospitals that do substantial numbers of bariatric surgeries a year. Some guidelines suggest that you choose only hospitals that do at least one hundred weight-loss surgeries a year. One study found that low-volume surgeons and hospitals have double the complication rate compared to surgeons and hospitals that do a high volume of bariatric surgeries. Also make sure that your surgeon is a board-certified bariatric surgeon.
For additional reference, a list of some of the top bariatric surgeons and hospitals is online at the website for the book, ThyroidDietRevolution.com.
LIPOSUCTION
The liposuction technique was invented by Italian surgeons in 1974. In recent years, liposuction has not been used in attempts to remove large amounts of fat but rather to “sculpt” body parts. Liposuction is usually performed in patients who have lost all the weight they can, or who have areas of the body that are especially resistant to fat loss. Areas such as thighs, buttocks, and the abdomen are common for liposuction.
Long-term weight loss is never a goal or result of liposuction. But I’m including it here because thyroid patients regularly ask if liposuction is safe for them, and some patients who have already lost weight are interested in spot reduction of stubborn areas.
Certain preexisting conditions need to be specifically evaluated before any of the several types of liposuction is performed, and may make a patient ineligible for liposuction. These include:
• History of heart problems (heart attack)
• High blood pressure
• Diabetes
• Allergic reactions to medications
• Pulmonary problems (shortness of breath, air pockets in bloodstream)
• Allergies (antibiotics, asthma, surgical prep)
• Smoking, alcohol, or drug use
Tumescent Liposuction (Fluid Injection)
Tumescent liposuction is the most common type of liposuction. It involves injecting a large amount of medicated solution into the areas before the fat is removed. The fluid is a mixture of local anesthetic, a drug that contracts blood vessels (epinephrine), and a salt solution. The lidocaine in the mixture helps to numb the area during and after surgery, and may be the only anesthesia needed for the procedure. The epinephrine in the solution helps reduce the loss of blood, the amount of bruising, and the amount of swelling from the surgery. The salt solution allows the fat to be removed more easily, and it is suctioned out along with the fat. This type of liposuction generally takes longer to perform than other types.
Super-Wet Technique
The super-wet technique is similar to tumescent liposuction, except that less fluid is used during the surgery. This technique takes less time; however, it often requires intravenous sedation or general anesthesia.
Ultrasound-Assisted Liposuction
Ultrasound-assisted liposuction (UAL) is a technique used in the United States since 1996. In UAL, ultrasonic vibrations are used to liquefy fat cells. After the cells are liquefied, they can be vacuumed out. UAL can be done in two ways: externally (above the surface of the skin with a special emitter) or internally (below the surface of the skin with a small heated cannula). This technique may help remove fat from denser, more fibrous areas of the body, such as the upper back. UAL is often used together with the tumescent technique, in follow-up (secondary) procedures, or for greater precision.
Laser Liposuction
Laser liposuction is a newer technique and is done as an outpatient procedure, often under local anesthesia (or light sedation if more fat removal is involved). In laser liposuction, the fat, heated by lasers, becomes softer and easier to remove. Fluid—a mixture of saline and local anesthetic—is then inserted under the skin in the area to be treated. Proponents of laser liposuction claim that the heat of the laser stimulates the production of collagen, which improves appearance of the skin and results in less bruising. Critics say that the procedure has all the risks of traditional liposuction plus the additional risk of skin burns from the laser and added cost.
Risks and Side Effects
As with any surgery, liposuction has risks from anesthesia, pulmonary embolism, infection, organ damage, and, for UAL surgery, burns. There are various reports that put the risk of death from liposuction at about 3 deaths for every 100,000 liposuction procedures.
One of the key downsides to liposuction is that up to 20 percent of liposuction patients wind up with lumps, texture changes, and asymmetry (referred to as fat fibrosis and necrosis) after the procedure. In some cases, additional surgery is required to address these issues.
Some patients have brown discoloration of skin in the area that has had the liposuction procedure. Up to 6 percent of patients report problems with nerves—resulting in a pins-and-needles feeling and other neurological symptoms—as a result of liposuction.
Ultimately, when fat cells are removed by liposuction, they do not grow back. But if you gain weight, the fat goes to remaining fat cells, which can result in asymmetrical distribution of fat.
Plastic surgeons consulted did not have any particular concerns regarding liposuction in general for thyroid patients. Some experts have suggested that laser liposuction techniques may be less effective for people with hypothyroidism, due to a slowdown in the body’s ability to process the liquefied fat.