Arena Has Submitted for FDA Approval for Lorcaserin

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.

Posted in Breaking News, General, Obesity Drugs, Obesity Treatment, Overweight Treatment |

HCG Treatment for Obesity – HCG and Weight Loss

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:

1. Do not follow the Simeons method for weight loss.
2. Do not follow the Simeons diet.
3. Do not use HCG for weight loss.

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.

Posted in Breaking News, Did You Know?, General, Obesity Drugs, Obesity Treatment, Overweight Treatment | 16 Comments