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Human chorionic gonadotropin
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=== HCG diet === British endocrinologist [[Albert T. W. Simeons]] proposed HCG as an adjunct to an ultra-low-calorie weight-loss diet (fewer than 500 calories).<ref name="isbn0-615-42755-3">{{cite book | vauthors = Simeons AT | title = Pounds & Inches: A New Approach To Obesity | publisher = Popular Publishing | year = 2010 | isbn = 978-0-615-42755-3}}</ref> Simeons, while studying pregnant women in India on a calorie-deficient diet, and obese boys with pituitary issues ([[Frölich's syndrome]]) treated with low-dose HCG, observed that both lost fat rather than lean (muscle) tissue.<ref name="isbn0-615-42755-3" /> He reasoned that HCG must be programming the [[hypothalamus]] to do this in the former cases in order to protect the developing fetus by promoting mobilization and consumption of ''abnormal'', ''excessive'' [[adipose]] deposits. Simeons in 1954 published a book entitled ''Pounds and Inches'', designed to combat obesity. Simeons, practicing at Salvator Mundi International Hospital in Rome, Italy, recommended low-dose daily HCG injections (125 IU) in combination with a customized ultra-low-calorie (500 cal/day, high-protein, low-carbohydrate/fat) diet, which was supposed to result in a loss of adipose tissue without loss of lean tissue.<ref name="isbn0-615-42755-3" /> Other researchers did not find the same results when attempting experiments to confirm Simeons' conclusions, and in 1976 in response to complaints the FDA required Simeons and others to include the following disclaimer on all advertisements:<ref>''In the Matter of Simeon Management Corp.'' (Fed. Trade Comm'n, 1976) 87 F.T.C. 1184; affirmed by ''Simeon Management Corp. v. FTC'' (9th Cir. 1978) 579 F.2d 1137, 49 ALR-Fed 1.</ref> {{quotation|These weight reduction treatments include the injection of HCG, a drug which has not been approved by the Food and Drug Administration as safe and effective in the treatment of obesity or weight control. There is no substantial evidence that HCG 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-restrictive diets.|1976 FDA-mandated disclaimer for HCG diet advertisements}} There was a resurgence of interest in the "HCG diet" following promotion by [[Kevin Trudeau]], who was banned from making HCG diet weight-loss claims by the U.S. [[Federal Trade Commission]] in 2008, and eventually jailed over such claims.<ref name="FTC 2008/10">{{cite web | url = http://www.ftc.gov/opa/2008/10/trudeau.shtm | title = Kevin Trudeau Banned from Infomercials For Three Years, Ordered to Pay More Than $5 Million for False Claims About Weight-Loss Book | date = 6 October 2008 | publisher = Federal Trade Commission | quote = ''FTC v. Trudeau'' (7th Cir., 2009) 579 F.3d 754 remanded (N.D.Ill., 2010) 708 F.Supp.2d 711, affirmed (7th Cir. 2011) 662 F.3d 947, certiorari denied (Oct. 9, 2012) _U.S._, 133 S.Ct. 426, 184 L.Ed.2d 257; and a ten-year prison sentence for violating a court order, ''U.S. v. Trudeau'' (N.D.Ill., Jan. 29, 2014) 2014 u.s.dist. LEXIS 10717, 2014 WL 321373. }}</ref><ref>{{cite journal | vauthors = Bell CB | title = The Curious Case of Kevin Trudeau, King Catch Me If You Can. | journal = Mississippi Law Journal | date = 2009 | volume = 79 | pages = 1043 | url = http://heinonline.org/HOL/Page?handle=hein.journals/mislj79&div=44&g_sent=1&collection=journals#1053 }}</ref> A 1976 study in the [[American Journal of Clinical Nutrition]]<ref name="pmid786001">{{cite journal | vauthors = Stein MR, Julis RE, Peck CC, Hinshaw W, Sawicki JE, Deller JJ | title = Ineffectiveness of human chorionic gonadotropin in weight reduction: a double-blind study | journal = The American Journal of Clinical Nutrition | volume = 29 | issue = 9 | pages = 940–948 | date = September 1976 | pmid = 786001 | doi = 10.1093/ajcn/29.9.940 | doi-access = free }}</ref> concluded that HCG is not more effective as a weight-loss aid than dietary restriction alone.<ref name="urlHCG Worthless as Weight-Loss Aid">{{cite web | url = http://www.dietscam.org/reports/hcg.shtml | title = HCG Worthless as Weight-Loss Aid | vauthors = Barrett S | work = Diet Scam Watch | publisher = dietscam.org | access-date = 2009-02-03 | archive-date = 2009-01-20 | archive-url = https://web.archive.org/web/20090120183842/http://dietscam.org/reports/hcg.shtml | url-status = dead }}</ref> A 1995 meta analysis found that studies supporting HCG for weight loss were of poor methodological quality and concluded that "there is no scientific evidence that HCG is effective in the treatment of obesity; it does not bring about weight-loss or fat-redistribution, nor does it reduce hunger or induce a feeling of well-being".<ref name="pmid8527285">{{cite journal | vauthors = Lijesen GK, Theeuwen I, Assendelft WJ, Van Der Wal G | title = The effect of human chorionic gonadotropin (HCG) in the treatment of obesity by means of the Simeons therapy: a criteria-based meta-analysis | journal = British Journal of Clinical Pharmacology | volume = 40 | issue = 3 | pages = 237–243 | date = September 1995 | pmid = 8527285 | pmc = 1365103 | doi = 10.1111/j.1365-2125.1995.tb05779.x }}</ref> On November 15, 2016, the [[American Medical Association]] (AMA) passed policy that "The use of human chorionic gonadotropin (HCG) for weight loss is inappropriate."<ref>{{Cite news|url=https://globenewswire.com/news-release/2016/11/15/890309/10166002/en/Obesity-Medicine-Association-Applauds-American-Medical-Association-s-Decision-to-Adopt-New-Anti-HCG-Policy.html|title=Obesity Medicine Association Applauds American Medical Association's Decision to Adopt New Anti-HCG Policy|date=15 November 2016 | publisher = Obesity Medicine Association | via = GlobeNewswire News Room|language=en-US|access-date=2016-11-16}}</ref> {{quotation|There is no scientific evidence that HCG is effective in the treatment of obesity. 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 support a firm standpoint against this improper indication. Restraints on physicians practicing this therapy can be based on our findings."| American Society of Bariatric Physicians'<ref name="ASBP" /> commentary on Lijesen et al. (1995)<ref name="pmid8527285" />}} According to the American Society of Bariatric Physicians, no new clinical trials have been published since the definitive 1995 meta-analysis.<ref name="ASBP">{{cite web | url = http://www.asbp.org/resources/uploads/files/HCG%20Position%20Statement.pdf | work = American Society of Bariatric Physicians | archive-url = https://web.archive.org/web/20120511014611/http://www.asbp.org/resources/uploads/files/HCG%20Position%20Statement.pdf | archive-date=2012-05-11 | title = Position statement on HCG diet }}</ref> The scientific consensus is that any weight loss reported by individuals on an "HCG diet" may be attributed entirely to the fact that such diets prescribe calorie intake of between 500 and 1,000 calories per day, substantially below recommended levels for an adult, to the point that this may risk health effects associated with malnutrition.<ref>{{cite web | url = http://www.mayoclinic.com/health/hcg-diet/AN02091 | title = Does the HCG diet work — and is it safe? | work = [[Mayo Clinic]] }}</ref> ====Homeopathic HCG for weight control==== Controversy about, and shortages<ref name="urlBulletin">{{cite web | url = http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=382 | title = Chorionic Gonadotropin (Human) Injection Shortage | date = 2010-10-13 | work = Bulletin | publisher = American Society of Health-System Pharmacists | access-date = 2010-10-23 | archive-date = 2011-09-19 | archive-url = https://web.archive.org/web/20110919004921/http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=382 | url-status = dead }}</ref> of, injected HCG for weight loss have led to substantial Internet promotion of "[[homeopathy|homeopathic]] HCG" for weight control. The ingredients in these products are often obscure, but if prepared from true HCG via homeopathic dilution, they contain either no HCG at all or only trace amounts. Moreover, it is highly unlikely that oral HCG is bioavailable due to the fact that digestive protease enzymes and hepatic metabolism renders peptide-based molecules (such as insulin and human growth hormone) biologically inert. HCG can likely only enter the bloodstream through injection.{{cn|date=September 2023}} The United States [[Food and Drug Administration]] has stated that over-the-counter products containing HCG are fraudulent and ineffective for weight loss. They are also not protected as homeopathic drugs and have been deemed illegal substances.<ref name="urlHCG weight-loss products are fraudulent, FDA says - USATODAY.com">{{cite web | url = https://www.usatoday.com/yourlife/fitness/weight-loss-challenge/2011-01-24-hcgdiet24_ST_N.htm?loc=interstitialskip | title = HCG weight-loss products are fraudulent, FDA says - USATODAY.com | vauthors = Hellmich N | date = 2011-01-23 | publisher = USA Today | access-date = 2011-02-03 }}</ref> HCG is classified as a prescription drug in the United States and it has not been approved for over-the-counter sales by the FDA as a weight loss product or for any other purposes, and therefore neither HCG in its pure form nor any preparations containing HCG may be sold legally in the country except by prescription.<ref name="MedPage20111206" /> In December 2011, FDA and FTC started to take actions to pull unapproved HCG products from the market.<ref name="MedPage20111206" /> In the aftermath, some suppliers started to switch to "hormone-free" versions of their weight loss products, where the hormone is replaced with an unproven mixture of free amino acids<ref>{{cite news|url=http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2012/03/08/prweb9258422.DTL|title=Hormone-Free HCG Drops are Quickly Replacing Homeopathic Counterparts|newspaper=San Francisco Chronicle|date=March 9, 2012}}</ref> or where [[radionics]] is used to transfer the "energy" to the final product.{{cn|date=September 2023}} {{As of|2011|12|6|df=US}}, the United States [[Food and Drug Administration]] has prohibited the sale of [[homeopathy|homeopathic]] and [[over-the-counter drug|over-the-counter]] hCG [[dieting|diet]] products and declared them [[fraud|fraudelent]] and banned.<ref name="MedPage20111206">{{cite news | vauthors = Gever J | date=December 6, 2011 |title=FDA Yanks HCG Weight Loss Agents from Market |url=http://www.medpagetoday.com/ProductAlert/OTC/30042?pfc=101&spc=230 |publisher=[[MedPage Today]] |access-date=December 7, 2011}}</ref><ref>{{cite web |url=https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm |archive-url=https://web.archive.org/web/20111208151744/http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm |url-status=dead |archive-date=December 8, 2011 |title=HCG Diet Products Are Illegal |publisher=FDA |date=December 6, 2011}}</ref><ref>{{cite press release |title=FDA, FTC act to remove 'homeopathic' HCG weight loss products from the market |publisher=FDA |date=6 December 2011 |url=https://www.ftc.gov/system/files/attachments/press-releases/ftc-charges-hcg-marketer-deceptive-advertising/fda_hcg_products_press_release_12-6-11.pdf |access-date=5 January 2021}}</ref>
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