Daniel O. Belluscio MD
Leonor E. Ripamonte MD
Additional information can be requested at:
Dr. Daniel Belluscio
The oral hCG Research Clinic
To assess the
validity of the hypothesis that hCG
(Human Choriogonadotropin) mobilizes fat from deposits of fat, the authors designed a Double Blind
Study performed on obese volunteers.
The result of this study suggests that oral
administration of hCG , in the course of a Very-Low-Calorie Diet (VLCD),
significantly decreases the total amount of subcutaneous body fat from
specific deposits of fat. Since an increased amount of body fat is responsible for the
genesis and maintenance of obesity, the authors suggest that hCG may be
useful for obesity treatment.
Both Placebo and hCG-treated patients were managed with the same Very Low Calorie Diet.
hCG-treated volunteers lost more body fat than their Placebo counterparts.
Keywords: Obesity, obesidad, weight gain, weight loss, adipose tissue, fat, tejido
graso, grasa, dieta, dietas, ganancia de peso, hipercolesterolemia, hypercholesterolemia,
food, weight regain, obesity drugs, anti-obesity, alimentacion, BMI.
About forty years ago, a
Physician published in the publication The Lancet, an unusual approach to
the treatment of obesity (33,34). It
consisted in the administration of small amounts of hCG (Human
substance secreted by the human placenta, to obese patients who were
also put on a Very Low Calorie
Diet (500 Kcal/day). He stated that obese individuals lost fat
from fat deposits, felt better during treatment and improved the shape
of their bodies.
The method was used, and misused, for about twenty years, until a series
of tests (blind and open) led to the conclusion that this approach to obesity rendered the same results
concerning weight loss both in Placebo and hCG-treated patients.(2,7, 14,15,
26, 32, 35,36,41).
Recent investigations demonstrate conclusively that it is possible to lose a great amount
of weight at the expense of lean (instead of fat) tissue. Consequently, an important issue
in any weight reduction program is knowing whether patients are losing lean
body mass instead of fat.
Since no assessment of the fat to lean weight loss ratio was performed in those
previous studies and, in our experience hCG has a metabolic action on fat masses, we have designed a new
Research Protocol comprising parameters not included in previous studies.
All patients were Caucasic, ages ranging from 23 to 73 y.o (group P: 41 ± 13; group G1: 42 ± 12; group G2: 41 ± 14), a range of heights of 1,62 cm. to 1,81 cm., and overweight ranging from 25 to 49,9 on BMI
Since there were no published reports on the oral use of hCG, group G2 was administered twice the dose of G1, to assess if hCG concentration may affect obtained
The pharmacist prepared two types of vials: one containing saline solution
(Na Cl 0,9% w/v), and the other containing a diluted and
buffered solution of standardized hCG .
Vials were randomly labeled, each number corresponding to a patient. The pharmacist kept the codes in a sealed
envelope. They were opened after completing the protocol.
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Test parameters are as follows:
A. Laboratory blood tests before (day 0) and after the study.
B. Subcutaneous weekly fat content assessments performed on different
body areas (Skinfold thickness test), using a
Lange (Cambridge,Mass) skinfold Caliper
- Tricipital region
- Anterior axillary line
- Lateral thoracic region
- Supraumbilical region
- Infraumbilical region
- Inner thigh, 8
cm. below the pubic area.
- Areas above and
below the patella.
C. Body Impedance, assessed with a Maltron (UK) portable device.
D. Subcutaneous fat on different body areas , assessed by a portable Ultrasound
device (Keiko Ind., Japan).
Selected areas were:
- Tricipital region
- Inner thigh, 8
cm. below the pubic area.
- Areas above and
below the patella.
E. Body circumference
reduction in the course of the study. The following areas were
measured with a metric tape measure:
- Abdominal region
level of the navel)
- Hips (maximum
- Thighs (8 cm. below the pubic
- Suprapatellar border
F. Irritability score
during the treatment period, assessed through answers to a questionnaire
sent to the volunteers weekly.
Assessments B,C,D and E were performed by the same observer throughout the study
thus avoiding differences between individuals.
The study period lasted
five weeks. At the end of the study, the envelope containing the codes for every patient
were opened, and data collected were submitted to statistical
For data analysis the
following procedures were performed:
- Data were input into
filed in ASCII format.
- Analyses of frequency,
standard deviations, and standard errors.
- Variance, covariance and
multiple regression analyses.
thickness - Drug
When comparing the obtained results before and after the study period, significant differences between
Placebo and hCG treated volunteers were observed:
- For Dose 1:
1.Supraumbilical skinfold: F=2.24 p< 0.05
- For dose 2:
1. Supraumbilical skinfold: F=2.43 p<0.05
2. Infraumbilical fold: F= 8.99 p< 0.0001
3. Internal aspect of thighs: F=3.33 p< 0.01
4. Subscapular: F=4.22 p< 0.002
thickness- Groups comparison
From the groups that
received the active component, five volunteers did not complete the five
weeks course of treatment, and three failed to attend at least one control
session: Total eight patients.
Of the group that received the placebo, three patients did not complete the last two
and two failed to attend the last one. Total : 5 cases.
Analysis of data collected shows significant differences in the results
of the following skinfold thickness tests between placebo and hCG-
- Supraumbilical: p< 0.04
- Infraumbilical: p< 0.004
- Internal aspect of
- Suprapatellar: p< 0.005
- Tricipital: p< 0.08
- Axillary anterior
III. Ultrasound assessment
evaluations of subcutaneous adipose tissue from different groups
revealed the following data:
- Inner thigh:
fat and lean mass, impedanciomethry.
Impedance and body
circumference measures revealed no statistically significant differences in weight loss, total fat and lean mass.
answered a questionnaire concerning their mood during the treatment period. The following
statistical differences were observed between the responses received from hCG and
- hCG-treated patients felt in a better the treatment: p < 0.03 at the 3rd. treatment week and p < 0.01 at
- Sleep quality, regarding amount of hours and quality was
improved : p <
0.06, at the 3rd. week of treatment.
- In a regular discussion with any member of the family they
accepted more openly pt differences on opinions
reagrding the subject discussed: p< 0.01, at the
5th. treatment week.
- They were less irritable:
p<0.001 at the 4th. treatment week.
- They were better able
to cope when things did not go as they expected: p<0.05.
- They were less prone
to quarrel for petty reasons: p<0.05.
- They were less prone to episodes
of irritability : p< 0.005 at the 4th. week.
The hCG protocol for the
treatment of obesity has been loved and hated for the last 40 years. In 1974, the FDA banned the use
of hCG in the US based on a series of studies maintaining that weight loss was
similar both in the Placebo and hCG-treated groups. Our study
corroborates those previous findings.(2,7, 14,15, 26, 32, 35,36,41).
However, all the the reports on the
subject of hCG and obesity are not negative: studies from Asher
WL, Harper HW, Bradley
R, et al., Vallini
A, et al, Veilleux
H, et al., suggest that hCG exerts a lipid-mobilizing action.
studies based their conclusions on the fact that weight loss was similar both in hCG and
Placebo treated patients. But weight on a scale is only one of the tools suitable to
describe obesity: A more accurate description recently coined is that obesity is the
accumulation of body fat above predefined standards.
If obesity can be defined
as an excess of body fat, then it follows that any pharmacological intervention on the
disease should assess whether the drug in question can mobilize fat from fat
According to our preliminary study, hCG oral administration decreases the amount of body
fat from certain body regions to a statistically significant level.
This is the first study published on the oral use of hCG for the
treatment of obesity.
This hCG metabolic action has been previously suggested by the studies of
R, Fried GH., Scaffidi
H, et al., Yanagihara
Y. , Yanagihara
Therefore, it seems that hCG can accelerate fat mobilization from certain fat
deposits in the
course of a weight reduction program including a Very Low Calorie Diet (VLCD).
Subcutaneous adipose tissue reduction could be accomplished by
lipogenesis inhibition at the level of the fat cell membrane (see : adipose tissue metabolism).
Since administered hCG acumulates at the hypothalamic region, we speculated that hCG
metabolic actions could be exerted through the release of a lipolytic substance located in
What is the
significance of this finding within the context of obesity?
Adipose tissue reduction
should be the goal in any weight reduction program, rather than appetite or
anxiety reduction. This study suggests that the oral use of hCG helps to mobilize fat from
certain fat deposits, but poses several as yet unsolved questions:
- Why was circumference
reduction similar in both groups while the hCG treated group significantly
decreased the amount of subcutaneous body fat? Our hypothesis is
that they gained total body
water and/or lean mass.
- Why did hCG treated volunteers not lose more weight despite
a significant reduction in subcutaneous
fat?. We have
no explanation for these data.
In our opinion,
further studies should be performed to ascertain the unresolved issues in this
We followed patients for a 8 mo. following treatment. A preliminary
conclusion can be drawn: At 8 mo. post-treatment, more of the hCG-treated patients maintained their
weight reduction that their placebo-treated counterparts (p< 0.003).
No side effects were
reported with the oral use of hCG.
We suspect that only a fraction of hCG is absorbed, and this fraction might be
responsible for the metabolic activity we have observed in our patients.
Since hCG contains IR beta-endorphin (17),
we hypothesize that the improvement in our volunteers' daily mood might be related to
ß-endorphinergic activity at hypothalamic level. When hCG-treated volunteers where
compared to the placebo-treated group regarding their mood during the treatment, the former were less
irritable, felt in a better mood throughout the treatment, and their
were significantly decreased.
According to previous studies, subcutaneous adipose tissue reduction could be
accomplished by an inhibition of lipogenesis at the level of the adipocyte membrane
adipose tissue metabolism). Since administered hCG accumulates at the
hypothalamic region, we speculated that hCG metabolic actions could be exerted through the
release of a lipolytic substance located in that area. hCG has no direct
action upon fat cells.
As a result of
accelerated subcutaneous fat mobilization, body
contour shows a more pleasant aesthetic appearance.