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Editor's Memo: FDA Removes Homeopathic HCG; Helps Legitimate Use In Pain Treatment

January/February 2012

Early last month, the FDA took action against seven companies marketing over-the-counter human chorionic gonadotropin (HCG) products that were labeled “homeopathic” for weight loss.1 As most physicians know, HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions. The FDA took its action in order to keep non-approved formulations of HCG from being marketed online and in retail outlets.

The fraudulent claim that was cited by the FDA in its action was that homeopathic HCG, when combined with a 500-calorie diet, produces weight loss. The FDA and the Federal Trade Commission contend this is fraudulent advertising, because there is no proof that HCG independent of a low-calorie diet produces weight loss. The action taken by the FDA was supported by the American Society of Bariatric Physicians, the national weight loss society of physicians.

I support this action by the FDA because pharmaceutical-grade HCG fills a needed adjunctive role in pain management. Fraudulent claims about weight loss hurt legitimate medical practice. In pain management, our menu of therapeutic agents is short, and we need natural hormones to assist in some special clinical situations.

The use of HCG has great value in chronic pain management because of its basic physiologic properties. It is called “human chorionic gonadotropin” because it was originally believed to be produced only in the placenta during pregnancy. The public consequently often believes that it is only a “fertility drug.” Science has discovered, however, that HCG is produced in the pituitary of men and women of all ages.2,3

Chemically, it is made up of two amino acid subunits labeled a and b. One unit contains amino acid sequences that are identical to follicle-stimulating hormone, luteinizing hormone, and thyroid-stimulating hormone.2,3 Consequently, HCG stimulates the gonads, adrenal glands, and thyroid to secrete a number of hormones, including testosterone. The other subunit of HCG is an anabolic agent. It increases cyclic adenosine monophosphate (cAMP) and nitric oxide (NO).4 cAMP is known to be a critical element in tissue production, and NO is known to increase blood flow. There are HCG receptors throughout the body, including in the central nervous system (CNS).5,6 Animal studies show that it has considerable neurogenic properties.7

Pain practitioners will find HCG particularly useful in patients with central pain, as these patients develop significant hormonal deficiencies and have a need to regenerate CNS tissue. In my practice, I use HCG as an adjunct to standard pain management that is accompanied by hormonal testing for pituitary-adrenal-gonadal deficiencies; physician supervision is recommended when prescribed.

Below are key points that summarize HCG’s use in pain practice, which clearly separates its use from that advertised by the makers of homeopathic HCG.

  • No claims of pain cure are made. HCG in pain practice is an adjunct to standard therapy when hormonal deficiencies are apparent.
  • Unquantifiable dosages such as “homeopathic” are not acceptable, as we must know the precise dosages of every medication we prescribe. After all, a patient with chronic pain may be concomitantly taking multiple agents (eg, opioids, neuropathic compounds, and anti-inflammatory drugs), and we must constantly monitor for effectiveness, side effects, and interactions.
  • As a highly active hormonal substance, HCG must be prescribed and monitored by a physician and not sold for self-help purposes.
  • A 500-calorie diet is inappropriate in the vast majority of patients with chronic pain, as some are malnourished and even in a catabolic state because of poor dietary habits.
  • One of the labeled indications for HCG is hypogonadism. Low serum testosterone levels are common in male and female pain patients who take opioids and other agents. Unfortunately, severe pain, per se, as well as many of our pharmaceutical agents cause pituitary insufficiencies and require hormonal replacement.
  • Any physician can use a marketed pharmaceutical off-label as long as he or she does not make any public claim or advertise about off-label use. Advising the patient that the pharmaceutical is being used in an off-label manner is recommended. Be it clearly stated here that there is no claim of pain cure for HCG or that it is a substitute for standard pain treatment measures.

Note from Dr. Tennant

An Onus on Diagnostics in 2012
There is the long-held belief that pain can’t be measured. This reality led to the establishment of the fifth vital sign and the ubiquitous Visual Analog Scale to signal the severity of a person’s pain. While pain, per se, may not yet be quantifiable, diagnostic testing of the causes and results of pain are fast emerging. To this end, 2012 will definitely be a banner year for utilization of a wide variety of diagnostic tests. Clinically, the most needed assessment will help differentiate peripheral from central pain. Other diagnostic needs are to identify the legitimate pain patient who is injured or disabled and to reject the abuser and malingerer.

This issue of Practical Pain Management starts our year with a number of diagnostic articles, and more will come as the year progresses. Michael R. Clark, MD, MPH, MBA, et al describe a plethora of assessments for depression, disability, and function; Gabriel E. Sella, MD, introduces saliva testing for drugs of abuse; and Joshua Gunn, PhD, educates us on interpreting benzodiazepine metabolism. I have also authored an article recommending cortisol screening for chronic pain patients as a biologic marker to determine pain severity and the need for aggressive treatment measures.

The new knowledge about central pain calls for a new diagnostic armamentarium. When peripheral pain transforms to central pain, the process includes microglia activation, central nervous system (CNS) inflammation, cellular destruction, sympathetic discharge, and hormonal and immunologic abnormalities. It’s time we begin to look at such simple diagnostic tests as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), blood pressure, pulse rate, and depression scales with a more enlightened view. We now must consider that abnormalities found using these diagnostic tools may indicate CNS inflammation and central pain. Somewhere along the way in our careers we’ve heard a wise old sage say something like, “Diagnosis, diagnosis, diagnosis. If you can make a diagnosis, you can always figure out something to do.” Right now we are starting to make some astute diagnoses.

Last updated on: April 15, 2015
First published on: January 1, 2012