Human Chorionic Gonadotropin (HCG) - An Ineffective Approach to Treating Obesity, January 2013

Human Chorionic Gonadotropin (HCG) - An Ineffective Approach to Treating Obesity, January 2013

TOS’ Position: We conclude that the scientific evidence does not support the use of HCG for the treatment of obesity. This position is in agreement with the U.S. FDA. The Obesity Society is committed to advocating the use of therapies for the treatment of obesity that are evidence-based and rejects those that have been shown to be ineffective.

History: In 1901, Froelich reported the case of a boy with hypogonadism due to a pituitary tumor who was obese and had not gone through puberty (1). Subsequently, clinical use of human chorionic gonadotropin (HCG) to induce puberty in boys with Froelich’s syndrome was noticed to result in a change in fat distribution (2). A. T. W. Simeons was a respected scientist and known for his work in tropical medicine. Simeons later became interested in obesity and his use of HCG was influenced by the effect of HCG on fat distribution in boys with delayed puberty (Froelich Syndrome) (2). Simeons, through empirical observations, developed a method of treating obesity which he reported in Lancet in 1954 (3). Simeons’ program consisted of injecting intramuscularly 125 units of HCG per day, obtained from the urine of pregnant women, six days a week for six weeks along with a of 500 kcal/d diet consisting of lean meat, leafy vegetables, unsweetened dry crisp bread (rusk), fruit, salt and fluids. He claimed that those on this program lost 20 to 30 pounds over the course of six weeks. He attributed to his HCG program four characteristics; rapid weight loss, no feelings of weakness, no feelings of hunger and loss of fat from the parts of the body where it normally remains the longest (stomach, hips, thighs and upper arms).

The Science: Recent data supports the hypothalamus , rather than the pituitary, as the dominant organ controlling food intake and energy expenditure. However, the Simeons’ Program for the treatment of obesity became very popular and clinics specializing in the program became popular and profitable for the physicians that ran them. In response to this popular therapy there were sixteen double blind trials of HCG for the treatment done, mostly in the 1970’s. Many studies were criticized for not adhering to Simeon’s directions exactly, but one of these trials did follow the Simeon program and randomized twenty subjects to HCG and twenty to placebo (4). The HCG group lost 8.8kg which was not different than the saline placebo but consistent with the weight loss seen by Simeon. There were no differences in hunger, mood, or localized body measurements as had been claimed by Simeon.

A meta-analysis of eight uncontrolled and sixteen controlled trials of HCG for the treatment of obesity was published in 1995 (5). Of the 12 studies scoring more than 50 out of 100 points for methodological quality, all were controlled studies and only one concluded that HCG was a useful adjunct to weight loss. The authors concluded that there was no scientific evidence that HCG was effective in the treatment of obesity, nor did it bring about a feeling of well-being, cause fat redistribution, or reduce hunger.

Safety: Although the dose of HCG used in the Simeon obesity treatment program may be at placebo levels, it is unclear whether HCG for weight loss could be associated with safety concerns. HCG in relatively low doses does have effects on the human endometrium (6), and the effect of a human pregnancy hormone in males is also of some concern, particularly with regard to adverse effects on prostate and male breast tissue (7,8). In addition, the quality, dose, and composition of “HCG” used by many HCG weight loss clinics are unknown.

Summary: As a consequence of the evidence summarized above, the United States Food and Drug Administration (FDA) has mandated the following warning on the HCG package insert: “HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or “normal” distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.” Unfortunately, in spite of the clear evidence and the FDA warning, recent popular books and a well-known television physician have touted the efficacy of HCG for weight loss, leading to a resurgence of clinics offering this ineffective treatment to obese patients.

References

  1. Fröhlich A. Ein Fall von tumor der hypophysis cerebri ohne akromegalie. Wiener klinische Rundschau, 1901, 15: 833-836; 906-908.
  2. Gusman HA. Chorionic gonadotropin in obesity, further clinical observations. Am J Clin Nutr. 1969;22(6):686-95
  3. Simeons ATW. The action of chorionic gonadotrophin in the obese. Lancet. 1954;267(6845):946-7.
  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;127:461-3.
  5. Lijesen GKS, Theeuwen I, Assendefft WJJ, VanDerWal G. The effect of human chorionic gonadotroopin (HCG) in the treatment of obesity by measn of the Simeons therapy: a criteria-based meta-analysis. Br J Clin Pharmacol. 1995;40:237-43.
  6. Fanchin R, Peltier E, Frydman R, de Ziegler D. Human chorionic gonadotropin: does it affect human endometrial morphology in vivo? Semin Reprod Med 2001; 19: 31–35.
  7. Tao YX, Bao S, Ackermann DM, Lei ZM, Rao CV. Expression of luteinizing hormone/human chorionic gonadotropin receptor gene in benign prostatic hyperplasia and in prostate carcinoma in humans. Biol Reprod 1997; 56: 67–72.
  8. Carlson HE, Kane P, Lei ZM, Li X, Rao CV. Presence of luteinizing hormone/human chorionic gonadotropin receptors in male breast tissues. J Clin Endocrinol Metab 2004; 89: 4119–4123.