Position Paper Regarding HCG Injections Along with a Very Low Calorie Diet for Weight Loss
by Dr. Kathryn Retzler
Portland, Oregon
The "HCG Diet" has become popular over the last few years due to the
accessibility of the Internet and advertising by clinics that perform
the protocol. I've read ATW Simeons protocol "Pounds and Inches: a New
Approach to Obesity" several times. The paper is intriguing in terms of
Simeons' theories about weight gain and the role of hypothalamic
dysfunction in prevention of weight loss. It's also bold Simeons claims
that the protocol is easy to follow and uniformly effective in
suppressing appetite, elevating mood, and enabling "abnormal", stubborn
fat to be lost. He also states that HCG resets the hypothalamus to
prevent lost weight from being regained. "Pounds and Inches" is
available from several sources on the Internet. If you're interested,
you can order a copy of Simeons' paper describing his protocol published
in 1954 from the Lancet.[1]
HCG or "human chorionic gonadotropin" is a hormone produced during
pregnancy. It's also produced by tumors in women (hydatidiform mole) and
men (testicular cancer). HCG injections are used medically since part
of its molecular structure mimics luteinizing hormone (LH). HCG
injections (in dosages ranging from 1000 to 2000 units, 2-3 times per
week) are used to increase testosterone production in men with low
testosterone who want to preserve fertility. HCG injections (5,000 to
10,000 units) are sometimes used in women to induce ovulation.
Simeons protocol uses minute dosages of HCG (125 units), 6-7 days per
week for 23 to 40 days, along with a very low calorie (VLC) diet of 500
calories per day. Since HCG does share some of its molecular structure
with LH and thyroid stimulating hormone (TSH), theoretically, it may
increase testosterone production, ovulation and progesterone production,
or release of thyroid hormone. It may also cause excess stimulation of
the ovary and ovarian cysts. However, the dosage used is very small and
these effects are unlikely. A VLC diet (with or without HCG) can
precipitate gallstones (since it's very low in fat), and may cause
symptoms of toxicity (since fat tissue stores toxins).
Research regarding HCG injections and weight loss is nearly all negative.
In other words, most trials where patients received either HCG
injections or placebo and followed identical VLC diets, show no
difference in amount of weight lost, type of weight lost, hunger level,
or mood. A summary of published studies follows this paper.
No study that I've read has looked at long-term maintenance of weight
lost with the HCG protocol. Randomized controlled trials of VLC diets
show a large variation in regain of initial weight loss percentage.
Participants in these trial regained 7-122% of initial weight lost by
one year, and 26-121% by 5 years. [2]Active follow-up weight maintenance
programs that include behavior therapy, nutritional education, and
exercise are more effective at improving weight maintenance.
It would be worthwhile to perform a clinical trial to see if
participants following the HCG protocol are more successful at
maintaining weight loss than VLC diet alone. Simeons claims patients who
follow his protocol maintain weight loss 60-70% of the time, although I
don't think he published data to back up this claim.
I've spoken to many patients who've followed the HCG protocol with
great success they've lost significant amounts of weight, claim not to
have been hungry, and had an increased sense of well-being. Many of
these people have sustained their weight loss, many have not. I've
personally gone through Simeons protocol, documenting all calories
consumed as well as calories burned (by wearing a Bodybugg). I also
measured my fat and muscle percentage before and after the diet using
bioelectrical impedance analysis. I lost 12 pounds and 4% body fat
during the 23 day protocol. I was extremely hungry throughout the entire
protocol, although I did exercise every day. Some proponents of the
protocol recommend not exercising, although this seems like bad advice
given the overwhelming health benefits of regular exercise. I've also
undergone a VLC diet, documenting all calories consumed and burned,
without using HCG injections. I lost a similar percentage of excess
weight.
My position on the HCG protocol for weight loss is that I do
not think it's harmful. I also don't think it has any effect over
placebo. I do not discount the power of any placebo. The
placebo response is really a measure of the power of the self-healing
ability. Many people are willing to follow a VLC diet if they inject
themselves or take oral HCG since they believe the HCG will suppress
their appetite and help them lose weight. I do believe that physicians
who perform this protocol should disclose the negative research
regarding HCG benefits to patients. I also believe it is ignorant of
them at best, and unethical at worst, to prescribe a substance and
oftentimes, charge high fees, for a product or protocol thathas shownno
benefitover placebo.
Note that since 1975, the FDA requires the following information to
be given with any HCG advertised or promoted for weight loss:
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.
If you are interested in following the HCG protocol, I think you
should be informed about the research regarding HCG and weight loss. You
should also make sure your physician is aware of your current health
status before you follow any VLC diet, and that causes of abnormal
weight gain (e.g., hypothyroidism, hypogonadism, Cushing's, and other
endocrine problems) have been ruled out. Before going on any VLC diet,
I'd also recommend undergoing a detox program that supports Phase I and
Phase II liver function. Make sure you don't have pre-existing
gallstones, liver, or kidney disease. If you're using insulin for
diabetes management, you must make sure your dosage is adjusted based on
blood sugar levels, and that you don't develop ketoacidosis, which can
be fatal.
If you do undergo a VLC diet (with our without HCG) you owe it to yourself to change the factors that caused you to become overweight in the first place:
improve your overall diet and nutrition knowledge, honestly evaluate
causes of emotional eating, decrease stress, and increase exercise
frequency and intensityotherwise, the chance of you gaining back the
weight you've lost is nearly 100%.
I welcome comments or questions regarding my position. In addition,
if you're aware of any research using the HCG protocol that I have not
listed here, or if you believe my conclusions are incorrect, please
contact me: drretzler@hormonesynergy.com.
Kathryn Retzler, ND
www.hormonesynergy.com
Summary of Research and Articles RE: HCG Injections & VLC Diet for Weight Loss
Note: Dr. Simeons does not state that HCG alone accomplishes weight
loss; rather, he states patients treated with HCG will not be hungry or
tired, will lose a different kind of weight ("abnormal fat" that is
difficult to lose), and will experience an increased sense of
well-being. He also claims that weight lost is unlikely to be regained
("60-70%" of patients keep weight off) due to a resetting of the
hypothalamus.
Positive Papers:
Asher W, Harper H. Effect of human chorionic gonadotrophin on weight loss, hunger, and feeling of well-being. Am J Clin Nutr. 1973;26(2):211-8.
This study is a well-designed, randomized, double-blind trial of 40
women receiving HCG or placebo at an HCG treatment clinic (Harold
Harper, MD). All followed a 500 to 550 kcal diet; 20 received 125 IU HCG
six days per week for 6 weeks (36 injections); 20 received placebo
injections six days per week (36 injections). Mean age of the HCG group
was 37.8 years; placebo group 38.4 years. Results: Mean weight loss
(HCG: 19.96 +/- 1.63 lbs; placebo: 11.05 +/- 1.29 lbs) and percentage of
starting weight lost (HCG: 11.47%; placebo: 6.77%) were greater in the
HCG group than the placebo group. Fourteen patients lost 15 lbs or more
in the HCG group; 5 lost 15 lbs or more in the placebo group.
Hunger was decreased (HCG: 76.6% of daily responses indicated little
or no hunger; placebo group 48.7% of daily responses indicated little or
no hunger). Feeling of well being was greater in the HCG group (HCG:
86.5% indicated they felt "good" to "excellent"; placebo: 70% said they
felt "good" to "excellent"). Blood pressure was not significantly
different between the two groups. Interestingly, Dr. Harper's patients
who received placebo injections lost more weight on average than either
the HCG or placebo patients of 4 other physicians. The authors
concluded, "Therefore, HCG used in a casual program of weight reduction,
as it is often used in a general practice, is of no value," meaning
that the very low calorie diet is the critical element leading to weight
loss.
Gusman H. Chorionic gonadotropin in obesity. Further clinical observations. Am J Clin Nutr. 1969;22:686.
This paper is not a study but rather an article regarding Dr.
Gusman's personal success treating "well over 2,500 patients of both
sexes, aged 15 to 75" with Simeons' HCG protocol. Gusman studied with
A.T.W. Simeons at his clinic in Rome. In this article, Gusman discusses
Simeons' concept of obesity, namely, that it is a "definite metabolic
disorder, much as is diabetes, caused by a breakdown of a regulating
mechanism located in the...hypothalamus." He call this "the
fat-regulating center."
Gusman explains that fat cells in the obese differ from normal fat
cells in that they're more numerous and larger. These "overstuffed" fat
cells metabolize glucose less efficiently than normal fat cells. Normal
fat tissue serves two functions: structural material (to protect organs
and blood vessels) and fuel storage. Abnormal fat tissue is also a
potential reserve for fuel, but is not immediately available in
nutritional emergencies. Only after the normal fat reserves are
exhausted will the body use abnormal fat. Severe calorie restriction
leads to exhaustion of normal fat reserves before abnormal fat is used,
and the patient will be weak and hungry "while the ugly fat deposits of
which he originally wished to rid himself have hardly been reduced. At
this point, the patient often becomes depressed and frustrated, and the
diet is abandoned."
The only type of "nutritional emergency" where all types of fat cells
are immediately useable is during pregnancy. Simeons suggests it's HCG
that brings about changes in the hypothalamus preventing obesity during
pregnancy.
Gusman compiled records from 450 of his patients receiving either 3
or 6 week treatment. He makes the following observations: 1) 90% of
patients were able to reduce their weight, 2) 60-70% reached their
desired normal weight, 3) "a majority" claimed this regiment was the
easiest and most successful to follow, 4) "many" who regained some or
all of their weight claimed they kept their weight off longer than
previously, and didn't mind returning for treatment, 5)"nearly all
patients" experienced "euphoria" in spite of marked low intake of food,
and 6) the markedly obese had the most satisfying results.
Lebon P. Treatment of overweight patients with chorionic gonadotropin. J Am Geriat Soc. 1966;14:116.
Lebon P. Action of chorionic gonadotrophin in the obese. Lancet. 1961;2:268.
Simeons AT. The action of chorionic gonadotrophin in the obese. Lancet. 1954 Nov 6;267(6845):946-7.
Stuart C. The action of chorionic gonadotophin in the obese. Lancet. 1961;278(7196):268-9.
Negative studies:
Bosch B, Venter I, Stewart RI, et al. Human chorionic gonadotrophin and weight loss. A double-blind, placebo-controlled trial. S Afr Med J. 1990;77(4):185-9.
This study was a double-blind, placebo-controlled trial comparing HCG
injections with placebo for weight loss. 40 obese women (body mass
index greater than 30 kg/m2) were placed on the same diet supplying
5,000 kJ per day and received daily injections of saline or HCG, 6 days a
week for 6 weeks. A psychological profile, hunger level, body
circumferences, fasting blood sample, and food records were obtained at
the start and end of the study, while body weight was measured weekly.
Results: Subjects receiving HCG injections showed no advantages over
those on placebo in respect to any of the variables recorded.
Furthermore, weight loss on the diet was similar to that on severely
restricted intake. The authors conclude, "There is no rationale for the
use of HCG injections in the treatment of obesity."
Craig L, Ray R, Waxler S, et al. Chorionic gonadotropin in the treatment of obese women. Am J Clin Nutr. 1963;12:230-234.
This study was a double-blind, placebo-controlled trial evaluating
the effectiveness of the Simeon method using HCG vs. placebo, and a 550
calorie per day diet. 20 obese women were treated for forty days.
Results: all subjects but one lost weight, but the losses were small and
not uniform, suggesting varied adherence to the diet. The basal
metabolic rate was increased in four HCG subjects and two control
subjects.
Greenway FL, Bray GA. Human chorionic gonadotrophin (HCG) in
the treatment of obesity: a critical assessment of the Simeons method. West J Med. 1977;127(6);461-3.
This study was a double-blind, placebo control trial using HCG
injections or placebo to test weight loss, hunger level, mood, and
localized (spot) reduction while adhering to a VLC diet. Results: Weight
loss was identical between the two groups, and there was no evidence
for differential effects on hunger, mood or localized body measurements.
The authors conclude, "Placebo injections, therefore, appear to be as
effective as HCG in the treatment of obesity."
Lijesen S, Theeuwen I, Assendelft W, et al. The effect of
human chorionic gonadotropin (HCG) in the treatment of obesity by means
of the Simeons therapy: a criteria-based meta-analysis. Br J Clin Pharmacol 1995;40:237-243.
This paper was a meta-analysis of eight uncontrolled and 16
controlled trials measuring the effect of HCG in the treatment of
obesity. The trials were scored for quality and methods (based on four
main categories: study population, interventions, measurement of effect,
and data presentation and analysis) and the main conclusion of
author(s) with regard to weight-loss, fat-redistribution, hunger, and
feeling of well-being. Methodological scores ranged from 16 to 73 points
(maximum score 100), suggesting that most studies were of poor
methodological quality. Of the 12 studies scoring 50 or more points, one
reported that HCG was a useful adjunct. The studies scoring 50 or more
points were all controlled. The authors 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."
Miller R, Schneiderman LJ. A clinical study of the use of human chorionic gonadotrophin in weight reduction. J Fam Pract 1977 Mar;4(3):554-8.
This study was a double-blind, crossover trial using saline or HCG
injections, along with a VLC diet. There was also no significant
difference in mood, hunger, or missed injections, and no apparent
difference in adherence to diet when the two agents were compared. In
contrast, a significant difference was found in the ability of subjects
to lose weight in the first four weeks of the study in contrast with the
second four weeks, no matter which agent was used. Thus, the initiation
of a new therapeutic program, even using an inert agent, has a
temporary benefit--a manifestation both of placebo effect and the
Hawthorne effect.
Rabe T, Richter S, Kiesel L, Runnebaum B. [Risk-benefit analysis of a hCG-500 kcal reducing diet (cura romana) in females]. Geburtshilfe Frauenheilkd. 1987 May;47(5):297-307.
The British physician A.T.W. Simeons described in 1954 a new method
for dieting. He combined a reduction diet (500 kcal per day) with daily
injections of the pregnancy hormone human chorionic gonadotropin (hCG)
(125 IU i.m.). According to Simeons the patient should not lose more
weight during a 4-to-6 weeks' diet than without hCG, but the injections
should facilitate to maintain the diet and to lose body weight at
specific parts of the body (e.g. hip, belly, thigh). After the first
publication various studies conducted with male and female patients
analyzed the efficacy of the "Cura romana". 10 of these studies showed
positive and another 10 studies negative results with regard to
hCG-related weight reduction. Two of these studies with positive results
were double-blind studies (hCG vs. placebo). Most of them were reports
on therapeutical experiences and were not controlled studies. According
to these reports the body proportions normalized and the feeling of
hunger was to
lerable. Four out of 10 studies with negative results were controlled
studies (hCG vs. control without hCG), whereas 6 were double-blind
studies. These studies showed a significant weight reduction during
dieting, but no differences between treatment groups in respect to body
weight, body proportions and feeling of hunger. One of them is the only
German study conducted by Rabe et al. in 1981 in which 82 randomised
premenopausal volunteers had been dieting either with hCG or without hCG
injections. In recent publications describing mostly well-documented
double-blind studies, authors largely reject hCG administration in
dieting. Supporters of the hCG diet must prove the efficacy of this
method in controlled studies according to the German Drug Law. Until
then the opinion of the German steroid toxicology panel is still valid,
that hCG is ineffective in dieting and should not be used.
Shetty KR, Kalkhoff RK. Human chorionic gonadotropin (HCG) treatment of obesity. Arch Intern Med. 1977 Feb;137(2):151-5.
This study compared six hospitalized obese women given 125 IU of
human chorionic gonadotropin (HCG) intramuscularly daily for 30 days
with five obese women who received injections of dilutent only
(placebo). Patients consumed identical, 500-calorie per day diets for
the same period. Although the number of patients was small, the study is
significant since patient diets and all injections were monitored
closely in a hospital setting. Results: Mean weight loss in the
HCG-treated group was nearly identical to that achieved by women given
the placebo. Reduction of triceps skinfold thickness or circumferential
body measurements of the chest, waist, hips, and thighs were not
different. Patterns of change of a variety of plasma and urine
substrates, electrolytes, and hormones were similar in the two groups
and consistent with semistarvation and weight loss. The authors
concluded," These results indicate that HCG has no effects on chemical
and hormonal parameters measured and offe
rs no advantage over calorie restriction in promoting weight loss."
Stein MR, Julis RE, Peck CC, et al. Ineffectiveness of human chorionic gonadotrophin in weight reduction: a double blind study. Am J Clin Nutr. 1976;29(0):940-8.
This study was a well-designed, randomized, double-blind trial of 51
women receiving HCG or placebo for 32 days (28 injections), along with a
500 to 550 kcal/day diet. The study was designed to duplicate the
Asher-Harper study (above). Each patient was given the same diet (the
one prescribed in the Asher-Harper study), was weighed daily Monday
through Saturday and was counseled by one of the investigators who
administered the injections. Results: There was no statistically
significant difference in the means of the two groups in number of
injections received, weight loss (HCG: 15.79 lbs; placebo: 15.52 lbs),
percent of weight loss (HCG: 9.48%; placebo: 9.25%), hip and waist
circumference, weight loss per injections, or in hunger ratings. The
authors concluded, "HCG does not appear to enhance the effectiveness of a
rigidly imposed regimen for weight reduction."
Young RL, Fuchs RJ, Woltjen MJ. Chorionic gonadotrophin in weight control. A double-blind crossover study. JAMA. 1976;236(22):2495.
202 patients participated in a double-blind, randomized, cross-over
study of the effectiveness of human chorionic gonadotropin (HCG) vs.
placebo in a weight reduction program. Serial measurements were made of
weight, skin-fold thickness, dropout rates, reasons for dropping out,
and patient subjective response. Results: There was no statistically
significant difference between those receiving HCG vs. placebo during
any phase of this study.
An additional interesting study:
Sohar E. A forty-day-550 calorie diet in the treatment of obese outpatients. Am J Clin Nutr. 1959;7:514-518.
The purpose of this paper was to present a method of producing rapid
weight reduction in obese patients. This study looked at forty-five
patients who started fifty-three courses of 550-calorie diet, consisting
of two meals prescribed in detail. Patients were told what to eat
(Simeon diet) and were not told calorie content. 39 patients were given
HCG injections (125 units), 14 others received daily injections of
saline. Patients were told that weight reduction would be due to the
diet but that injections would help curb appetite. The authors assumed
from the start that HCG was ineffective in terms of weight reduction.
Injections were given for "psychological reasons only" since patients
were assured they would curb appetite.
The authors state that the diet Simeon prescribed is successful
because average daily weight loss is high due to the very low calories
consumed. Patients are more likely to stick to the diet due to time
limitation i.e., they know the diet will only last 40 days. They state
that "the vast majority of patients are willing to suffer for forty days
for the reward of losing the predicted and attainable amount of 20
pounds." The author also surmises that success is due to the fact that
food is prescribed, not calories. This eliminates the estimating that
usually goes on with calorie counting. In other words, most patients do
not weigh or measure food and do not record calories properly. Sohar
recommends not advising patients in terms of calories, but to prescribe
meals in detail.
Another reason Sohar gives for success of the diet is that only two
meals per day are prescribed; therefore, contact with food is minimized.
Lastly, activity level is unrestricted, "enabling all obese people,
most of whom are housewives, to reduce." Sohar points out that his
paper, as well as Simeon's work, proves that obese patients can lead a
normal life performing moderate work on 500 to 600 calories per day.
1] Simeons AT. The action of chorionic gonadotrophin in the obese. Lancet. 1954 Nov 6;267(6845):946-7.
[2] Saris W. Very-low-calorie diets and sustained weight loss. Obesity Research. 2001;Suppl 4:295S-301S.
