Pyatigorsk

RESEARCH REPORT

Use of ENDONORM® when treating Hypothyroidism
Endocrinology program

Supervisor of studies: Mishagin V.A., MD, Prof.
Specialist in charge of the section: Akhkunbekova N.K., Senior research associate, Ph.D. in medicine

 Relevance

Hypothyroidism is a state conditioned by a long-lasting stable deficiency of thyroid hormones, encountered (according to WHO) in 19 of every 1000 women and in 1 of every 1000 men. Despite (удалено) its prevalence, hypothyroidism can long remain undiscovered. This is partially due to the fact that this abnormality has a gradual onset and nonspecific symptoms which initially are considered to be the result of defatigation, other diseases, and pregnancy. In typical cases patients describe their condition as asthenia. All metabolic processes in the body slow down in patients with hypothyroidism. In response to thyroid hormones deficiency, energy is produced with less intensity, which leads to temperature decrease and chilling. Another presentation of subclinical hypothyroidism can be liability to frequent infections, which is due to the lack of stimulating effect of thyroid hormones on the immune system. Often enough, hypothyroidism can result in sterility.

In 99% of cases, hypothyroidism is a result of affection of the thyroid gland itself. Thyroid gland disorders which can cause hypothyroidism are hypothyrosis (goiter), thyroadenitis, nodular and multinodular goiter. Hypothyroidism can also result from thyroid resection, radiation injury of thyroid gland, and thyrostatic therapy.

By now there’s only one treatment known so far – thyroid hormones replacement therapy (L-thyroxine, euthyrox, thyreotom etc.), which is to be received for life. All efforts to stimulate thyroid hormones production have been ineffective. However, in the 19^th century thyroid gland disorders used to be treated with cinquefoil tincture. Based on this, we (удалено) started treating hypothyroidism with ENDONORM® which contains cinquefoil extract. Beside cinquefoil, ENDONORM® contains extracts of bur beggar-ticks, licorice, laminaria pulvis, which have anti-inflammatory effect and eliminate iodine deficiency.

Research objective

To determine the functional condition of thyroid gland in patients with hypothyroidism of various genesis before and after ENDONORM® therapy.

Research task

1. To study the effect of ENDONORM® on the thyroid gland at different stages of treatment.
2. To study the effect of the preparation on the hormonal status of the patients with the abnormality in question.
3. To make a comparative evaluation of the therapy’s effectiveness in the cohorts under observation having hypothyroidism of different genesis and degree of disorder manifestation.

Phenomena under study: the possibility of curing hypothyroidism.

Subject of research – 59 patients with thyroid gland hypofunction of different genesis.

Working procedure

All the patients underwent ultrasound investigation of the thyroid gland with colored Doppler mapping, enzyme multiplied immunoassay of the blood serum with an estimation of thyroid stimulating hormone of the pituitary (TSH), triiodothyronine (T3), free thyroxine (T4 free), anti-thyroglobulin autoantibodies, thyroperoxidase antibodies, thyroglobulin before and after ENDONORM® therapy (before the therapy, 4 weeks after the start of the therapy and after the end of the therapy), fine-needle aspiration puncture biopsy was performed for cause under ultrasonic control.

Treatment technique.

Patients took ENDONORM® according to the traditional schedule – 1 cap three times a day, 10 minutes before meals, during two months with a 10 days break period. A 2-course therapy was held.

Equipment used

Automated immunoenzymometric analyzer «Stat Fax» (USA), enzyme immunoassay kits «ADALTS» (USA), ultrasonic scanner «Aloka SSD 5500» (Japan), automated puncture needles «MaxiSell» (Denmark).

Research findings and their originality

59 patients were observed (18 men and 41 women) at the age of 20 to 50 years, who have been previously receiving thyroxine preparation replacement therapy. The patients were divided into three groups:

1. Patients with autoimmune hypothyroidism (31),

2. Patients with goiter (10),

3. Patients with post surgical hypothyroidism (18).

Ultrasound investigation made before the therapy showed thyroid glad volume restriction in patients of groups 1 and 3. In patients of group 2, the thyroid glad volume was larger than normal (12 to 25 ml in men, 10 to 18 ml in women). In the time course, the thyroid gland was increased by 2 times in patients of groups 1 and 3, and in group 2, it almost came to its normal size (table 1).

Table 1.

Thyroid gland size values in patients who received ENDONORM® therapy (cm³), (М±m)

In diagnosing hypothyroidism accompanied with thyroid gland node formation all patients underwent fine-needle biopsy of the nodes. Cytological screening made for these patients allowed to reveal colloid goiter with different degree of thyrocites proliferation or autoimmune thyroiditis (Hashimoto’s thyroiditis). Changes in thyroid gland node size are shown in table 2.
In patients with autoimmune thyroiditis the size of pseudonodular formations decreased 3 times and a tendency to decrease was noted during further observations. In cases of recurrent nodular colloid goiter, the node size decreased 2 times, and 4 months after the end of the therapy it decreased 5 times, as compared to its size before treatment.

Table 2.

Change in the size of nodular formations in patients who received ENDONORM® therapy (cm3), (М±m)

Representative results have been received during the examination of the thyroid hormones (table 3). TSH level, which was considerably higher than the normal values before the start of ENDONORM® therapy, (3 weeks before the therapy started the patients stopped taking thyroid hormone preparations) was kept down in the course of treatment to slightly above the norm in patients with autoimmune hypothyroidism, while in patients with goiter it came to normal value and in patients with postsurgical hypothyroidism it came to modestly exceeding the norm.

Before the treatment, concentration of triiodothyronine in the blood serum in patients with autoimmune hypothyroidism was below the normal level, in patients with goiter it was slightly above the normal level, and in patients with postsurgical hypothyroidism it was considerably below the normal level. In the course of treatment, the level of triiodothyronine in patients with autoimmune hypothyroidism increased considerably, in patients with endemic hypothyroidism it slightly decreased, and so it did in patients with postsurgical hypothyroidism.

Before the treatment, concentration of free thyroxine in patients with autoimmune hypothyroidism was at the normal level, in patients with endemic hypothyroidism it was slightly below the normal level and in patients with postsurgical hypothyroidism it was also slightly below the normal level. In the course of ENDONORM® therapy, the level of free thyroxine increased and came to normal level in patients of all groups.

Before the treatment, concentration of thyroglobuline and thyroperoxidase antibodies showed classical values: above the norm in patients with autoimmune hypothyroidism and normal in patients with endemic and postsurgical thyroid gland hypofunction. In the course of treatment, the level of antibodies in patients with autoimmune thyroiditis was considerably decreased though it did not come to its normal value.

Concentration of thyroglobulin in the blood serum of patients with autoimmune thyroiditis and postsurgical hypothyroidism was not above the normal level and in patients with endemic hypothyroidism it was modestly above the norm. In the course of treatment the level of thyroglobulin decreased to normal values in patients of this group and in patients of other groups thyroglobulin concentration did not vary perceptibly.

Table 3.

Hormonal status indices during ENDONORM® treatment (IU/ml, nmol/l), (М± m)

Based on the analyze of the obtained data, we can safely speak of effectiveness of ENDONORM® for cases of hypothyroidism of different genesis. In future, it is planned to continue the research work aimed at studying the long-term results of the test described above and at observing the patients in the monitored groups.

References

1. Endocrinology. /Under the editorship of. N. Lavin Мoscow, 1999
2. Troshina E.A., Aleksandrova G.F., Abdulkhabirova F. et al. Hypotyroidism syndrome during internship. Textbook of methodics for doctors. Moscow 2003
3. Fadeev V.V., Melnichenko G.A. Hypotyroidism: Guidebook for doctors. Moscow 2004
4. Braverman L. Diseases of the thyroid. Humana Press, 1997.

Chief endocrinologist of the Federal State Institution «Pyatigorsk State Resort Medicine scientific research institute of the Federal Medical and Biological Agency of Russia»,
  Doctor of Medicine, professor Mishagin V.A.