Clinical studies

Outline of the thigh and knee in obese women after therapy with *TRITERPEN®

PROF. DR. CLAUDIA FILOZOF

Summary
Four obese women (age: 45 + – 1.3 years, BMI 35 + – 2.7) were treated with low-calorie diet (910 kcal) and 15 local treatment sessions with *TRITERPEN® in one of its members and placebo in another in a double-blind study. The outline of the thigh and knee was evaluated. The thigh treated with active formula lost significantly more than the one treated with placebo. There is a tendency in the same direction in the outline of the knee treated with active formula but without reaching statistical significance. No adverse effects were observed to induce cessation of treatment.
We conclude that the formula studied was useful in reducing thigh.

*TRITERPEN®

Introduction

Obesity is defined as excess of body fat (1). However, the location of this excess is very important not only in the relationship with associated metabolic complications (2), but also in therapeutic response (3). The excess of abdominal fat, mainly perivisceral location showed association with glucid intolerance, noninsulin-dependent diabetes, hypertension, dyslipoproteinemias (4). The femur-gluteus fat excess has shown no association with metabolic complications. Studies in adipose tissues also showed regional differences in the response to lipolytic stimuli (5). The excess of fat of femur-gluteus location is more resistant to lipolysis and this is due to the higher proportion of antilipolytic Alpha2 receptors (6) and the hyperplastic characteristics of this adipose tissue (7). The aim of this study was to evaluate in a double-blind study the effect of *TRITERPEN® in reducing the perimeter of the thigh and knee. The *TRITERPEN® formula includes: a thermo-active principle, plant extracts (from asian hidrocotile, vareque vesicular and hedera Helix), hydrolyzed cartilage and vitamin E.

Material and Methods

We studied 4 woman patients 45 + – 1.3 years of age and body mass index (BMI) 35 + – 2.7. All of them made a 918 kcal diet (carbohydrates: 124 g, protein: 43 g) and attended the consultation with a frequency of 3 times a week for 5 weeks of the intervention. Weight and height were measured with a standard balance and BMI was calculated using the formula weight / height squared. The thigh perimeter was measured at the level of maximum circumference below gluteus fold. The measurement was performed with the patient’s weight on the limb to be measured (8). There were 3 measurements each time and took the average value. The perimeter of the knee was measured at 1 cm. Above the top of the kneecap.
At each visit, we administered a magnesium sulfate solution 700mosm / 1, a vial containing the concentrated product and the emulsion *TRITERPEN® in one of the members and the same concentration of magnesium sulfate with placebo cream and blister the other side. Both the member with the active product and the member with the placebo were covered with plastic bands for 30 minutes. Patients received a bottle of emulsion with the active product or placebo and were instructed to apply it to each member in their home address (placebo-active).

Results

The 4 women completed the study. All lost more cm in the thigh active than in the placebo (table 1, Figure 1). The mean difference between placebo and active product were studied with Student’s test (p = 0.03). On the perimeter of the knee only one patient lost the same amount of cm in the treated limb with active versus placebo. The remaining 3 lost more cm over the perimeter of the knee treated with the active ingredient (Table 2, Figure 2). However, the mean difference was not significant in this case.

Table 1: Changes in thigh perimeters pre and post-treatment

  Initial
Active
Thigh
Final
Active
Thigh
Initial
Placebo
Thigh
Final
Placebo
Thigh
Mean 72,76 70,3 72,25 71,4
DS 4,2 3,7 4,3 3,7
Initial-final Active difference: 2.4 + - 1.1
                                               P = 0.03
Initial-final Placebo difference: 0.9 + - 0.8

Figure 1: The difference in cm lost, thigh treated with active formula versus placebo after 15 sessions (p = 0.03)

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Table 2: Changes in thigh perimeters pre and post-treatment

  Initial
Active
Knee
Final
Active
Knee
Initial
Placebo
Knee
Final
Placebo
Knee
Mean 53,8 50,4 53,8 51,1
DS 6,4 4,7 6,1 4,3
Initial-final Active difference: 3.4 + - 2.2
                                               NS
Initial-final Placebo difference: 2.6 + - 2

As adverse effects were found only flushing of the skin in the treated area in one of the patients that not required cessation of therapy.

Figure 2: Difference in cm lost, knee treated with active formula versus placebo after 15 sessions.
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Clinical Cases

Localized Obesity

ant2     des2
Before After

Initiation of Treatment: 09/12/97
Sex: Female
Age: 56 End of Treatment: 04/04/98


Cellulite and Localized Obesity

ant1     des1
Before After

Initiation of Treatment: 12/03/98
Sex: Femenino
Age: 36 End of Treatment: 10/07/98

Discussion

We know the difficulty of reducing femur-gluteus fat with comprehensive measures of antiobesity treatment (9). However, it is reported that beta adrenergic stimulation and Alpha2 inhibition allow local reductions of excess fat (10).
It is possible that the reduction of the outline observed in these patients is due to the action of vesicular vareque, to which had been attributed xanthine characteristics. It is known the effect of xanthines in lipolysis by increasing cAMP (11).
Another possible explanation may relate to thermo principle, which favors the drainage to a reduction of the outline, but not due to lipolysis.
However, the low number of patients studied allows only bounded conclusions.
Given the significant reduction of the outline in the limbs treated with active drug, it would be interesting to conduct a larger study, discriminating the individual effect of each of the components of the formula in reducing the local perimeter.

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