Remission of Varicose Ulcers with Systemic Medicine

Oxford Journals “Journals of Evidence-based Complementary and Alternative Medicine” (eCam)
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Remission of Varicose Ulcers with Systemic Medicine
Olalde J.A. (a), Magarici M. (b), Amendola F. (c), del Castillo O. (d) De Arriba, C (e).

(a) Founder of Systemic Medicine. President of Adaptógenos Educational Medical Centers.
(b) Medical Director of Adaptógenos Educational Medical Centers (CMA), Caracas, Venezuela.
(c) Assistant Doctor, Medical Direction of Adaptógenos Educational Medical Centers.
(d) Engineer, Methodology and Statistics, Assistant, Adaptógenos Educational Medical Centers.
(e) Assistant Chemist, Medical Direction, Adaptógenos Educational Medical Centers.

Summary

The effects of an herbal combination formulated under the principles of Systemic Medicine were evaluated in 129 patients diagnosed with varicose ulcer, in a retrospective, multicentric, descriptive study of two years. Improvement in the ulcerous lesions was observed in 79% of the cases and remission was observed in the other 21% of the patients who received Systemic Treatment during a period of just two months. In all the cases a significant increase in Quality of Life was observed. There was evidence that treatment with Systemic Medicine produces a significant improvement of the most frequent symptoms (cramps, pain and edema) for p<0.0001. The tolerance to the treatment was excellent. The patients who were assessed received treatment only by oral administration. It is to be expected that local treatment of varicose ulcers, utilized in conjunction with systemic treatment, including antibiotics in the cases where they are required, will significantly improve the therapeutic effectiveness of this treatment.

I. Introduction.

Varicose ulcers correspond to lesions with loss of substance that settle on skin damaged by a dermatitis caused by a venous hypertension, which constitutes the main complication of chronic venous insufficiency. They are also known as stasis ulcers.
They constitute the final level of chronic venous insufficiency, according to all the classifications, and they are the most frequent vascular ulcers. Once triggered, they tend, like all chronic ulcers, to have an insidious evolution, with healing difficulty, severe effects on the surrounding skin and frequent recidivism.
Age is a risk factor to consider, since they appear more frequently after the age of 60. The typical characteristics of venous ulcers in general are:
• Pulsing.
• Variable size, from very little to very extensive, on occasion surrounding completely the lower extremity.
• They can be single or multiple with a tendency to join; they may be bilateral, being more visible in the leg which has more varicose veins.
• Usually, they are round or oval, but sometimes they are irregular.
• The borders are raised, of a red-violet color, bright on occasion. When they become chronic, the borders are paler and harder.
• The bottom of the ulcer depends on its condition and on its chronicity; generally, it is red because of the congestion, although it can be yellowish in case of (blank). There can be purulent secretion as a sign of a secondary infection. When its cure is favoured, abundant granulation tissue is observed.
• In terms of pain, it is also variable. Some ulcers are moderately painful, others are not, but some can be extremely painful when they are infected.
• The most frequent location is the middle perimalleolar area, or also the internal lateral region of the lower third of the leg (internal supramalleolar zone).
Varicose ulcers produce deterioration of the quality of life and have a negative effect on every day activities. These patients have high work absenteeism and are generally off sick, besides being large consumers of health resources, since the care associated to the treatment is frequently long.
One of the clinical treatments of varicose ulcers is the compressive dressing of the leg and the use of dressings that favor healing. However, since they don’t eliminate the cause that produces the ulcers, with time said lesions can reappear.
Also, there is surgical treatment, whether by means of open surgery (which is an aggressive procedure) or by endoscopic surgery. This technique is more innovative, but it has a few limitations, such as access to the veins in the ankles, where more than 30% of the ulcers are located.

Since April 2002, the Adaptógeno Educational Medical Centers and Units use a herbal combination formulated according to the following principles:

Fig. 1

Stimulation of Energy, Organization and Intelligence in the triangle of Health.

a) Stimulation of the Energy Axis.

Leuzea carthamoides: its active principles are phytosteroids of the family of ecdysone, and which activate the synthesis of enzymes that participate in the mitochondrial synthesis of ATP, which hydrolisis generates energy (4).

b) Stimulation of the Intelligence Axis.

Harpagophytum procumbens: its active principles – Iridoid Glycosides and Phytosterols – inhibit cyclooxygenase and Thromboxane synthetase, reducing the production of Prostaglandin E2 and of TXA2. This reduces the inflammatory processes of the varicose ulcer and the formation of platelet thrombus. (5,6).

c) Stimulation of the Organization Axis.

Ruscus aculeatus: the principal active substances are two steroid saponins: ruscogenine and neoruscogenine. These substances inhibit significantly the increase of the permeability caused by mediators of the inflammatory responses, such as bradiquinine, leucotriene B4 and Histamine. (7-12-53).
In addition, they have an anti-elastase activity, part of the enzymatic system that participates in the degradation of perivascular structural components (57). This action contributes to explain its usefulness in the treatment of patients with chronic venous insufficiency.
On the other hand, the active principles of this plant have vein-constrictive effects. This effect seems to be mediated by the calcium or by the direct activation of the alpha-1 and alpha-2 adrenergic receptors. (7,17,18).
Clinical studies prove the benefits of this plant in cases of venous insufficiency. (19,20).

II. Materials and Methods.

A descriptive, retrospective analysis was made to a series of cases of patients diagnosed with varicose ulcer, who attended the Adaptógeno Medical Centers and Units all over the country, during the period between April 2002 and July 2004.
The data to be evaluated were obtained from the clinical histories filed in each one of the Medical Centers. Said information was entered into a database previously designed for the purpose of analyzing variables of clinical-therapeutical interest.
The study included all patients with a diagnosis of varicose ulcer, of both sexes, of all ages, who were treated in the Adaptógeno Medical Centers and Units, and who declared having fulfilled the treatment prescribed by Systemic Doctors during a period of two months.
During their first consultations in Adaptógeno Medical Centers, the patients declared having received conventional treatment, without any satisfactory response. After starting the treatment prescribed by the doctors specialized in Systemic Medicine, these patients only fulfilled the herbal treatment, with the exception of a few cases (14%) in which antibiotic-therapy was also prescribed due to an infection caused by the lesion.
The clinical histories of those patiens who did not go back for subsequent appointments or who did not fulfill the treatment prescribed were excluded.
To assess the effectiveness of the treatment, the ulcers were classified according to their size, in small (< 4 cm), medium (4-8 cm) and large (> 8 cm).
The following variables were analyzed:
1. Number of patients diagnosed with varicose ulcer.
2. Percentage of patients with varicose ulcers, according to their size (small, medium or large).
3. Percentage of patients with improvement of most frequently referred symptoms (pain and cramps in the lower extremities).
4. Evolution of the ulcerous lesions, taking into account the reduction of the size of the ulcer, aspect of the lesion (necrotic tissue, granulation tissue and amount of exudate).
5. Average time in which the ulcers healed completely.
6. Percentage of patients with undesirable effects as a result of the treatment.
7. Changes in the quality of life described by patients, according to Grogono-Woodgate’s Index of quality of life. (21).

III. Results.

129 patients were included in this study.

Classification of patients with varicose ulcers.

The group with small varicose ulcers predominated with 47.3% of the cases, followed by the group with medium varicose ulcers with 28.7%, and in the third place, the group with small ulcers with 24%.
Improvement of the symptoms after the treatment.
The variation in the number of patients who had symptoms (cramps, pain and edema), independently of the size of the ulcers, is shown in figures 2, 3 and 4, respectively.

Fig 2.

In relation to the total number of patients who expressed having had cramps, there was evidence of an improvement of 71.4% (10 patients)

Fig 3.

From the total number of patients who expressed having had pain at the beginning of the treatment, 46 (78%) said that said symptom disappeared. The square-Chi calculated for this sample was of 44.02; therefore, it is possible to affirm that the treatment of varicose ulcers based on the principles of Systemic Medicine produces a significant improvement of pain for p<0.0001.

Fig 4.

After the treatment with Systemic Medicine, there was evidence of the disappearance of the edema in 88.7% of the patients who expressed having had the symptom at the beginning of the treatment. The square-Chi* calculated for this group of patients was of 53.02; therefore, it is possible to affirm that the significant reduction of the edema is due to the treatment with Systemic Medicine, for p<0.000

There is evidence of a significant improvement of the symptoms in the patients, independently of the size of the ulcers.

Improvement of the ulcers after the treatment

An improvement in the Quality of Life was observed in 81.3% of the patients who received systemic treatment.

Undesirable Effects

Only mild dyspepsia, which did not cause the suspension of the treatment, was observed in one patient.

IV. Discussion and Conclusions:

In this analysis of a number of cases of 129 patients diagnosed with varicose ulcer and who received Systemic Treatment during a period of two months, a remarkable improvement of the size and characteristics of the lesions was observed in 79% of the cases.
Remission of the lesions was observed in 21.7% of the cases, in just two months of treatment. It is possible to suppose that, if the treatment had been continued during a longer period of time, the cicatrization of the lesions could have been achieved in all the patients.
It was evidenced that treatment with Systemic Medicine produces a significant improvement of the most frequent symptoms (cramps, pain and edema) for p<0.0001.
Our patients received treatment only by oral administration. We infer that local treatment of varicose ulcers, utilized in conjunction with systemic treatment, including antibiotics in the cases where they are required, will significantly improve the therapeutic effectiveness of this treatment.
The Quality of Life improved significantly in both groups of patients (81.3%) and the tolerance to the treatment was excellent.
The systemic formula used in this study is in the procedure of registration of intellectual property. For this reason, Adaptógeno Educational Medical Center has only mentioned 3 plants from the ones used in this disease, together with their scientific references. Any person who wants to know the complete systemic formula may formally request it to the institution.

V. References

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