By Dr. Ed Hendricks on December 22, 2009
Arena Pharmaceuticals announced today that the company has submitted their application to the US Food and Drug Administration (FDA) for marketing approval for Lorcaserin, Arena’s internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The press release indicated the submission is based on an extensive data package from lorcaserin’s clinical development program that includes 18 clinical trials totaling 8,576 patients.
Now the waiting begins to see if the FDA will approve this novel drug.
By Dr. Ed Hendricks on December 20, 2009
History
Human Chorionic Gonadotropin (HCG) is a hormone normally secreted by the trophoblastic cells of the placenta during pregnancy. It was first described as a treatment for obesity in conjunction with a very low calorie diet by Dr. A. Simeons in 1954 [1]. The Simeons method consisted of a rigid diet of about 500 calories per day combined with 125 units of HCG injected six days per week for 8 weeks. For each of the two meals permitted daily, patients were instructed to select one item from each of four food groups, protein, vegetable, bread, and fruit. For protein servings patients were told to select from the following list: 3.5 ounces of meat, 3.75 ounces of fish, 4 ounces of Hoop cheese, or 6 egg whites. The latter two choices were to be selected occasionally [2]. The protein intake on the Simeons diet therefore ranged from about 45 to 50 grams per day. The Simeons method was very popular in the 1970s and advocates claimed that the method had numerous advantages including rapid weight loss with minimal hunger, no weakness, and dramatic loss of fat in the stomach, hips, thighs, and upper arms.
The method was wildly popular in the early 1970s; there were HCG weight loss clinics in every city in the U.S. After a series of clinical trials disputing the effectiveness of the Simeons method it fell from favor, but popular demand for HCG in the treatment of obesity has recently resurfaced in the United States. At the time the Simeons method was popular only HCG for injection was available. Sublingual HCG tablets were developed relatively recently. Perhaps this is one reason the method has resurfaced.
Discussion
Although there were a few early studies in agreement with Simeons recommendations [2-3], a number of subsequent studies produced evidence that the HCG in the Simeons method was ineffectual and that the weight loss was entirely due to the diet [4-7]. A meta-analysis review in 1995 of prior studies concluded that there is no scientific evidence that HCG is effective in the treatment of obesity [8]. The meta-analysis found insufficient evidence supporting the claims that HCG is effective in altering fat-distribution, hunger reduction or in inducing a feeling of well-being. The authors stated “…the use of HCG should be regarded as an inappropriate therapy for weight reduction…” In the authors’opinion, “Pharmacists and physicians should be alert on the use of HCG for Simeons therapy. The results of this meta-analysis supports a firm standpoint against this improper indication. Restraints on physicians practicing this therapy can be based on our findings.” PubMed and Google Scholar searches (on December 2, 2009) revealed no favorable reports on the Simeons method since the 1966 report by Lebon [3].
The diet employed in the Simeons method provides a daily protein intake below that recommended by the RDA for most patients. Although the caloric intake of the Simeons diet is similar to that of an early (prior to about 1985) VLCD, but the protein intake is much lower than that prescribed for VLCDs in current use. Indeed, in the last few years several well-known researchers have produced very convincing evidence that most adults benefit from protein intakes well above the minimum RDA and intakes more than double the minimum RDA improve weight loss during caloric restriction diets [9-10]. A further criticism of the Simeons diet is that the amounts of protein per serving recommended do not reach 30 grams, the threshold dose required for initiation of muscle protein synthesis [11-14]. In view of these recent advances in nutrition science, the Simeons diet is severely deficient in protein.
Recent studies indicate that HCG injections in men, especially men with testosterone deficiency, can produce a slight gain in muscle mass, thought to be due to rises in testosterone levels [15]. The doses in the latter study were 250 units twice weekly. However, no studies have been reported of muscle mass changes in patients before and after weight loss with the Simeons method. Therefore one cannot assume that weight loss with the Simeons method will result in a net gain in muscle mass. Rather, loss of muscle mass can be expected. There are no reports in the medical literature regarding the effectiveness of sublingual HCG.
Summary:
Numerous clinical trials have shown HCG to be ineffectual in producing weight loss. HCG injections can induce a slight increase in muscle mass in androgen-deficient males. The daily protein intake in the Simeons diet is set at about 40% of what we advise with our diets. The last favorable report of the Simeons method was in 1966, 43 years ago, at a time when scientific knowledge of protein requirements was rudimentary. All of the medical reports since 1966 reject both the use of HCG and the protein-deficient Simenons diet. Patients who are treated with the Simeons method lose weight because the diet is a protein-deficient starvation diet in which the patient loses muscle mass. Neither HCG infections nor sublingual HCG accelerates weight loss. The Simeons method is harmful since it promotes loss of muscle mass.
Recommendations:
References:
1. Simeons A. The action of chorionic gonadotropin in the obese. Lancet 1954; 2: 946-947.
2. Asher WL, Harper HW. Effect of human chorionic gonadotrophin on weight loss, hunger, and feeling of well-being. Am J Clin Nutr 1973; 26: 211-218.
3. Lebon P. Treatment of overweight patients with gonadotropin: follow-up study. J Am Geriat Soc 1966; 14: 116-125.
4. Greenway FL, Bray GA. Human chorionic gonadotropin (HCG) in the treatment of obesity: a critical assessment of the Simeons method. West J Med 1977; 127: 461-463. PMCID: 1237915.
5. Stein M, Julis R, Peck C, Hinshaw W, Sawicki J, Deller J, Jr. Ineffectiveness of human chorionic gonadotropin in weight reduction: a double-blind study. Am J Clin Nutr 1976; 29: 940-948.
6. Young RL, Fuchs RJ, Woltjen MJ. Chorionic Gonadotropin in Weight Control: A Double-Blind Crossover Study. JAMA 1976; 236: 2495-2497.
7. Bosch B, Venter I, Stewart RI, Bertram SR. Human chorionic gonadotrophin and weight loss. A double-blind, placebo-controlled trial. S Afr Med J 1990; 77: 185-189.
8. Lijesen GK, Theeuwen I, Assendelft WJ, Van Der Wal G. The effect of human chorionic gonadotropin (HCG) in the treatment of obesity by means of the Simeons therapy: a criteria-based meta-analysis. British journal of clinical pharmacology 1995; 40: 237-243. PMCID: 1365103.
9. Layman D. Dietary guidelines should reflect new understandings about adult protein needs. Nutrition & metabolism 2009; 6: 12.
10. Layman DK. Protein quantity and quality at levels above the RDA improves adult weight loss. J Am Coll Nutr 2004; 23: 631S-636S.
11. Paddon-Jones D, Rasmussen BB. Dietary protein recommendations and the prevention of sarcopenia. Curr Opin Clin Nutr Metab Care 2009; 12: 86-90.
12. Paddon-Jones D, Short KR, Campbell WW, Volpi E, Wolfe RR. Role of dietary protein in the sarcopenia of aging. Am J Clin Nutr 2008; 87: 1562S-1566.
13. Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr 2008; 87: 1558S-1561.
14. Symons TB, Sheffield-Moore M, Wolfe RR, Paddon-Jones D. A moderate serving of high-quality protein maximally stimulates skeletal muscle protein synthesis in young and elderly subjects. J Am Diet Assoc 2009; 109: 1582-1586.
15. Liu PY, Wishart SM, Handelsman DJ. A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Recombinant Human Chorionic Gonadotropin on Muscle Strength and Physical Function and Activity in Older Men with Partial Age-Related Androgen Deficiency. J Clin Endocrinol Metab 2002; 87: 3125-3135.
By Paula Hendricks - Nutritionist on December 4, 2009
PRODUCTS & SPECIALS
FROM THE DOCTOR You Want to Take my Blood Pressure Again?
Why so many? Beginning in November, the medical assistants have been taking 2-3 blood pressure readings per patient visit. Many of you are asking, “Why did we start doing this?” Well, there are several reasons. First, many patients are nervous when they first arrive at the office, and many have been rushing to make their appointment on time, or are anxious about their weigh-in. In these situations, the first blood pressure reading may be higher than normal. A second reading a few minutes later is often lower. Second, averaging two (or more) blood pressure readings is now the recommended standard of practice for measuring blood pressure in a physician’s office. Our own research has confirmed that a single blood pressure reading is sometimes inaccurate and misleading.
What do the blood pressure numbers mean and what should they be? The higher (systolic) number represents the pressure while the heart contracts to pump blood throughout the body. The lower number (diastolic) represents the pressure when the heart relaxes between beats. Review the chart below to determine your blood pressure category.
| BLOOD PRESSURE CATEGORY |
SYSTOLIC mmHg |
DIASTOLIC mmHg |
| Normal |
<120 |
<80 |
| Prehypertension |
120-139 |
80-89 |
| Hypertension, Stage 1 |
140-159 |
90-99 |
| Hypertension, Stage 2 |
≥160 |
≥100 |
Currently, the experts recommend lifestyle changes and/or weight loss as the only treatment for prehypertension. Patients with Stage 1 or Stage 2 hypertension are typically advised to make lifestyle changes, lose weight, and take anti-hypertensive medications. Untreated elevations in blood pressure are associated with higher mortality. It is now well-known that reducing blood pressure to normal levels extends life-span. This is the major reason a more accurate blood pressure measurement is important for your health.
What change should you expect with weight loss? If your blood pressure is above normal, you should begin to see a decrease in blood pressure with just a few pounds of weight loss. This is true even if you are already on medications to control hypertension. If your blood pressure is normal, less than 120/80 to begin with, you may see only a slight decrease in blood pressure. Of course if your blood pressure goes down with weight loss, it will go right back up if you regain the weight lost. An exercise program will also help to lower your blood pressure. Blood pressures for everyone tend to rise gradually as the years go by so if weight loss lowers your blood pressure, it may go back up with the passage of time even though you maintain your weight loss. If your blood pressure remains above normal, even with weight loss and exercise, we may recommend starting a blood pressure medication.
What about blood pressure medications? If you are on blood pressure medications, you may be able to reduce the dose or discontinue your medications entirely with weight loss. If you begin to experience lightheadedness or dizziness, it may mean your medication dosage should be adjusted. As with any medical concern, always discuss with your practitioner.
FROM THE NUTRITIONIST
By Paula Hendricks - Nutritionist on December 4, 2009
Appetizers for the Holidays – Skip the chips and dip, cookies, and other snacking pitfalls. Make it simple this year with great-tasting and beautiful presentations for your holiday appetizers that are both healthy and full of flavor. Your guests will love them andso will the host when you bring your beautiful dish to your next holiday event. Picturesof these recipes are available in the office.
| Caprese Salad – Such a simple, elegant appetizer! Slice tomatoes, the best tasting you can find in the winter, and cut again in half. In the deli section, buy either fresh cow or buffalo mozzarella. Rinse the cheese and slice into small bite-sized rounds. Layer an appetizer plate alternating with tomatoes and cheese. Cut some fresh basil into small strips and sprinkle over tomatoes. Drizzle some high quality olive oil over the dish, grind some fresh cracked pepper on top, and a sprinkle some kosher or sea salt to finish. | Cucumber Canapes – Top cucumbers with some fresh crabmeat (or imitation crab) that is tossed with a mixture of mayonnaise and Greek-style plain yogurt. Add some salt, pepper and fresh dill weed. Add a little mayonnaise-yogurt swirl to the finished product and sprinkle some capers around plate. Place crab atop fresh endive leaves instead of cucumbers for a different look and taste. Very light and refreshing appetizer. | ||
| Tomato Slices and Chopped Cheese – Slice firm tomatoes into thin rounds; half each round and place on a plate. Cut some hard gouda cheese into tiny bite-size pieces, or other firm cheese of your choice. In separate bowl, mix olive oil, lemon juice and some Italian herb seasoning. Drizzle over the tomato and cheese plate. Top with some fresh chives.
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Shrimp atop Endive – Another elegant presentation. Put bay shrimp in bowl and toss with olive oil, dill weed, minced garlic, lemon juice and a little Dijon mustard. Cut off the end of the endive and discard any brownish leaves. Arrange endive leaves on a platter and add about 1 tablespoon of the shrimp to each leaf. | ||
| Prosciutto and Melon Tasters – Slice honeydew or other melon into small bite-size slivers and put on a plate. Cut prosciutto into manageable bite-size pieces and layer on top of melon. Sprinkle with some fresh shredded parmesan. Delicious.
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Deli Plate – Buy a salami stick (look for a reduced-fat brand), peel off outer layer and cut into thin slices. Further cut the slices into little wedges and place the pieces on a plate. Top with fresh parmesan wedges and add some mini deli pickles to the presentation.
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Happy holidays and happy entertaining!
By Paula Hendricks - Nutritionist on December 3, 2009
Think 30!
Protein intake is your Key to effective weight loss. A daily optimum protein intake of at least 30 grams for breakfast, lunch and dinner allows you to maintain good health while you lose weight. In addition to helping with weight loss, protein helps build and repair body tissues including muscle, major organs and collagen, keeps hair, skin, bones and nails healthy, regulates body processes including digestion and metabolism, and forms hormones, enzymes, and immune system antibodies to help your body function properly. Need any more reasons to think 30?
Use the following list of approximate 30 gram protein choices to meet your Daily Target Protein Intake. Always follow the plan outlined specifically for you.
*Protein grams in food products vary. Always read the nutritional labels and weigh your servings to ensure you are getting the right amount. We recommend purchasing a food scale.
How does the Hendricks family prepare 30 Gram Protein Meals?
Here is a list of some of our weekly favorites:
* Shrimp Cocktail: Chop one celery stick into small bite-sized pieces. Place in small bowl and add 6 oz bay shrimp. Mix together. For the sauce, mix together 1 tsp. mayonnaise, 1 tsp. Greek-style yogurt, 1 tsp. horseradish, 2 T. salsa, and 1 T. low sugar ketchup, and a dash of garlic salt. Add sauce to shrimp and serve chilled. Looks elegant served on butter leaf lettuce cups.
* Vegetable Scramble: In mixing bowl, whip 2 whole eggs, one egg white, a dash of garlic salt and pepper. Add to the eggs 1/2 cup chopped vegetables (zucchini, red peppers, onion) and 1/6 of an avocado. In a non-stick pan over medium heat, melt a tiny bit of butter and pour the egg mixture in. Scramble until eggs are almost set. Add 2 ounces shredded reduced fat cheddar cheese; mix. Place on plate and top with 2 T. salsa if desired.
*Lemony Chicken Cesar Salad: For the marinade, mix the juice of 1/2 of a lemon, 1 T. olive oil, 1 minced garlic, and a dash of salt and pepper. Pour marinade over one 4.5 oz boneless skinless chicken breast and let sit for 10-15 minutes. Grill in a non-stick pan until cooked, about 4 minutes on each side. Cut chicken into strips and lay over a bed of Romaine lettuce. Drizzle 1-2 T. of creamy dressing (see Salad Dressing hand-out) and sprinkle salad with some freshly grated Parmesan cheese. Add a couple anchovies if you like.
* Filet Mignon over Greens: Sprinkle salt and pepper on one petite filet (4.5 ounces) and rub in a little olive oil. In a hot skillet, grill filet on one side for 2 minutes, flip and grill for 2 minutes, and repeat until meat is cooked to your liking. Saute 2 cups of raw spinach in 1 T. olive oil and seasoning of your choice. Place spinach on plate and top with the cooked filet. *
* Omelet with Canadian Bacon: In a mixing bowl, whip two whole eggs, one egg white, 2 ounces chopped Canadian bacon, salt and pepper. In a non-stick pan over medium heat, milt a tiny bit of butter and pour the egg mixture in pan. Cook until almost set. Add 1 ounce shredded reduced fat cheddar cheese. Fold egg in half to form an omelet. Slide omelet onto a plate.
* Tzatziki (Greek Yogurt and Cucumber): In a single serving bowl, put 1 1/3 cup Greek-style thick plain yogurt (ck label to ensure 30 grams). Add 1/2 cup finely chopped English cucumber, 1 small minced garlic clove, 1 tsp. fresh lemon juice, and salt. Mix. Drizzle 1 T. olive oil and sprinkle some dried mint leaves on top of yogurt.
* Deli Meat Roll-Ups: Take approximately 6 oz of your favorite lean deli meat (ck label to ensure 30 grams) and put on a plate. For the sauce, add 1 tsp. mayonnaise, 1 tsp. Greek-style plain yogurt, and 2 tsp. Dijon mustard together and mix together. Spread the sauce on each piece of deli meat and roll up. Add a little crunch and roll some chopped lettuce in each roll.
* Cheesy Lasagna: Mix together 1/2 cup low-fat cottage cheese, 1/2 cup low sugar marinara or spaghetti sauce, and 1/2 cup canned mushrooms (drained). Heat in microwave-safe bowl on medium for about 2 minutes. Add 1/2 cup shredded reduced fat hard cheese (Kraft brand). Mix and serve warm.
Contact our non–surgical weight loss clinic, which serves Sacramento, Roseville, and surrounding areas, to schedule an appointment.
2310 Professional Dr., St. 200
Roseville, California 95661
Phone:916.773.1191
Fax: 916.773.0498
click for map & directions
2621 Capitol Ave.
Sacramento, California 95816
Phone: 916.551.1999
Fax: 916.551.1998
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