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UTILITY OF AN ORAL PRESENTATION OF hCG (human Choriogonadotropin) FOR THE MANAGEMENT OF OBESITY.
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CONTENTS
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DISCUSSION
Concerning hCG and its utility for the management of obesity, this study
introduces two new aspects, and adds new data for a third:
I) This is the first report assessing variables not included in previous
reports
(37,50,68,88);
II) We report a new administration route for hCG management of obesity,
the oral approach, which has never been reported before;
III) We have detected mood changes in hCG treated patients, regarding a
better confrontation of daily emotionally conflicting situations.
These assertions will be separately discussed:
I) Skinfold thickness (SKF) and Tetrapolar Bioelectric Impedance (TBI)
records.
Both approaches have been extensively discussed in the literature. It was shown that the correlation between the values obtained with the two methods to be linear and highly significant for both sexes
(41,54,55,75,81,82).
There is general agreement that skinfolds calipers are particularly useful in the clinical setting
(9,10,15,16,36,39,40,55,65,76,81,82), particularly in view of the fact that measurement of subcutaneous body fat at different body sites is becoming increasingly important for the characterization of risk of certain disease states
(55).
When comparing skinfolds assessments to body circumference estimates, despite some data suggests that the latter approach appears to be more sensitive in the determination of subcutaneous body fat
(52), this procedure is in our opinion subjected to clinical variables
(bloating syndrome after a meal, premenstrual water retention, etc.) that may affect negatively on the final estimates
results.
Also, when comparing SKF to body contour assessments, some data suggests that the pattern of fat thickness body distribution measured over a number of specific sites by one method of measurement is unlikely to be duplicated by of the other method on the same individual
(39,40).
Adipose tissue patterns show great variability, indicating the importance of using skinfold caliper readings from a variety of different anatomic sites including upper
limbs, lower limbs and trunk (30).
According to the above conclusions from several authors (13,24,59,61,72,73), we would like to suggest that former studies on hCG and obesity lacked of sufficient data to accurately estimate modifications of adipose tissue distribution in tested
volunteers. Consequently we designed the study to assess as many as possible variables.
As far as our study concerns, we subjected each volunteer enrolled in the trial to four bioelectrical
impedance, eight anthropometrical plus nine SKF evaluations. Performing this multiple site
determinations, our results indicate that specific SKF are highly responsive to hCG pharmacological intervention
(upper and lower umbilical).
The greater response was obtained in those regions where the corresponding circumference assessments resulted in nearly significant or significant decreases through the trial period
(see waist and abdomen records in Fig. 2 and the above detailed description of statistical results for the effect of the
interaction).
II) Oral hCG might be an alternative therapeutic administration route.
No data appears on the scientific literature regarding an oral administration of hCG in
humans. But results from this study suggest hCG may be used by the
sublingual-enteral route. Despite plasmatic ß-hCG remained undetectable both in Placebo and hCG groups throughout the
study, an oral administration of hCG proved to possess therapeutic
activity.
Since commercial preparations of hCG contains ß-endorphin (see below), it may be tempting to hypothesize that this pentapeptide might account for the pharmacological activity observed on mood stability in the course of the
Protocol.
III) Volunteers treated with hCG coped better with daily irritating
situations.
As can be seen on
Figure 5, hCG-treated groups handled better their irritability, their mood at
home, and were less prone to episodes of extreme nervousness capable of provoking violent discussions . Several reports proposed hCG might be used for the treatment of psychoses or neurosis (29,61,24). Our study appears to corroborate these
proposals.
To conclude, this study poses several still unanswered questions:
1. hCG plasmatic levels. We have tested all volunteers, screening for the b-hCG in plasma. Concentrations were undetectable in all cases.
Therefore, which hCG fraction is responsible for the pharmacological activity observed in our
study?. hCG molecular size (alpha chain -14,500 KD; beta chain -22,200
KD) makes highly improbable that the entire molecule has been absorbed. Our hypothesis is that only a fraction of the entire hCG molecule is absorbed through this administration route .
2. hCG and lipid metabolism. We do not know precisely how hCG acts on adipose tissue
metabolism. However, some reports (31,83,84,85 ) suggest hCG possesses a metabolic activity on adipose tissue (i.e. decrease
lipogenesis). These actions are not directly exerted upon
adipocytes, since fat cell membranes have no receptors for hCG (31).
3. hCG and mood. A stable mood and lack of attrition characterized the
hCG-treated group.
It is well known that VLCD's are associated with mood changes, particularly attrition
(78) during the dieting
period. In one study, disinhibition and hunger were significantly related to anxiety and depression while restraint was not
(43,44). A study concluded that elevated levels of anxiety persist in female patients throughout a VLCD course of treatment
(44).
Also many patients complain about fatigue in the course of a VLCD (4).
Conversely, our data suggests that hCG-treated volunteers rather improved their attitude towards their
environment, in the sense of an enhanced well-being, less irritability and lack of fatigue.
Since commercial preparations of hCG contains
b-endorphin (38) and this neuropeptide has been demonstrated to affect the function of
limbic-emotional circuits (5,21,27,57), we hypothesized that the
b-endorphin fraction present in commercial preparations of hCG might account for the activity observed regarding mood control.
Additional studies remain to be performed to test the validity of this
hypothesis.
CONCLUSIONS
1. Female obese volunteers participating in a double blind study, and submitted to the administration of an oral presentation of hCG plus a
VLCD, decreased specific body circumferences and skinfold thickness from conspicuous body areas more efficiently than Placebo+VLCD
-treated subjects.
Since a significant fat proportion from total body fat is subcutaneously located (50 to 65
percent, depending on sex and fat distribution), this hCG metabolic activity would result in a reduction of the total body fat
mass, the main cause for obesity. We suggested that the combination of a VLCD and oral hCG could not only trigger clinically significant changes in subcutaneous fat stores but simultaneously decrease body weight and modelate body
contour.
2. hCG oral administration proved to be a safe and effective procedure on obese treated
volunteers. No side effects were observed in the course of the study. There are no reports in the literature regarding this administration route to compare our
findings.
3. Compared to placebo treated subjects, volunteers managed with an oral administration of hCG coped more efficiently with daily irritating
situations, were in a better mood, and handled home conflicts without stepping up family
discussions.
This study appears to contradict former conclusions on the issue of hCG and
obesity. We attribute those differences to a different approach, including variables not assessed in former
publications.
