Clinical treatment with Tribestan in women with climacteric syndrome

Dr. Pavleta Tabakova, Dr. Mitko Dimitrov, Dr. Bozihdar Tashkov (Head Physician), Director Of Studies: Prof. Dr. S. Dokumov)

Climacterium is a complicated biological process with versatile symptoms associated with the gradual dying out of the hormonal activity of ovaries on the background of a general aging of the female organism.

Climacterium is a psychological process with duration from two to more years, most often at the age of 40-55. The visible manifestation is the cessation of menstruation - advancing of menopause. The initial period of gradual dying out of ovarian function, known as premenopause is with various duration in individual women.

A disorder of the cyclic activity of hypothalamic-hypophyseal axis with predomination of parasympathicus occurs on the background of age readjustment of the central nervous system. Various neuro-vegetative symptoms, neuro-psychic disorders, metabolic changes etc. are observed during climacterium. Hypothalamic reactivity is intensified leading to the increase of the production of hypophysiotropic hormones.

The ovulatory activity of ovaries declines and the receptive function versus hormones partially fades. The reduced production of ovarian hormones leads to a compensatory effect (growth) of gonadotrophic hormones. On its part, that however is the cause of hyperthyroidism, virilization, acromegalic manifestations etc.

Climacterium advances with several phases:

  1. Hypoluteinic
  2. Hyperesterogenic preclimacterium
  3. Hypoesterogenic-hypergonadotropic
  4. Afollicular - with light reduction of gonadotrophic hormones but still higher than the normal values.

The clinical symptoms of that age of the woman are neuro-vegetative, neuro-physical, cardiovascular, endocrine, metabolic changes in hepatic function, disturbances in locomotor apparatus, miction disturbances, weight gain, etc. In some of the women, the above mentioned phenomena proceed particularly aggravated and in fact they are the object of the present study. Among them, the group of the so-called postcastration climacterium is rather special - abatement phenomena, occurring after surgical removal of ovaries due to various reasons.

In 1984, during the studies of Tribestan effect on females with anovulatory disturbances, we came across a favorable effect of the product on trial both on females in postcastration and on females in natural climacterium. That was a reasonable ground to propose the testing the effect of Tribestan (Pharmachim) on a greater number of females with climacteric syndrome.

Materials and methods

The product on trial, TRIBESTAN (Pharmachim) was provided by NIHFI as filmtablets of 250 mg. It contains a natural product obtained from the above-the-ground part of the plant Tribulus terrestris, with the predominating content of steroid saponins of furostanol type, with prevailing quantity of protodioscine. Additionally, sufficient quantities of placebo tablets were also provided.

Administration Schedule

  • Variety 1 - 3 x 2 tablets, 20 days and reduction of the dose with one tablet every 4-5 days up to 2 x 2 tablets, 3 x 1 tablet and 2 x 1 tablet - always strictly individual.
  • Variety 2 - 2 x 2 tablets - 30 days with reduction every 4-5 days up to 2 x 1 tablet.
  • Variety 3 - 3 x 1 tablet, uninterruptedly and for a long time.

Clinical Groups. The object of the present study were 50 females with data about natural and postcastration climacteric syndrome. A pilot study on another 12 females was carried out in 1984. In 46 of 50 females (92%), treatment with placebo, 2 tablets three times daily for 15-20-30 days, was initiated immediately after making the diagnosis and the manifestation degree of the clinical symptoms.

After recording the status at the end of placebo period, Tribestan treatment was initiated according to the above schedules.

Parameters for observation and evaluation. The final result from the treatment was classified according to the clinical picture: complete elimination of the climacteric complaints; abrupt reduction of the complaints and no effect on the complaints. That classification was possible on the base of periodical follow up of a series of subjective, objective clinical and paraclinical parameters:

  • changes in neurovegetative and neuropsychic complaints - intensity and frequency of hot flashes, sweat, depression, overexcitation, easy fatigability, apathy, etc.
  • changes in cardiovascular system - changes in pulse, blood pressure, oppression in heart region, palpitation, tachycardia and/or extrasystoles, etc.
  • changes as pruritus, miction disturbances.
  • characteristics of the stage of climacterium according to estrogen-progesterone level, evaluated by vaginal hormonal cystosmears.
  • blood count
  • blood sugar profile
  • ultrasound diagnosis
  • radioimmunological control of the level of gonadotrophic and steroid hormones - FSH, LH, prolactine, progesterone, testosterone, E 2.
  • changes in libido sexualis.

Conclusion

The option of the research, based on the experience from the treatment of 50 patients with natural and postoperative climacterium during that experiment, as well as on the data from the previous pilot study on another 12 women with the same clinical picture is that Tribestan (Pharmachim) can successfully be used in the treatment of climacteric syndrome in females, both natural or postcastration. The absence of any adverse effects, the ready tolerance and its excellent effect makes it a desired agent for the treatment of all patients with similar complaints.

It should be stressed here that the effect is gradually attained within a rather long period of time by a rather great number of tablets. Furthermore, a maintenance therapy for about 2 - 2.5 years is necessary.

That means that each woman should pay 600 levs for the provision of the necessary number of Tribestan tablets. With consideration given to the fact that a great part of the women will prefer the considerably cheaper hormonal depot-agents, the attention of the manufacturer should be drawn either on the price of the product or on the dose of the active principle in one tablet.

Dr. Palveta Tabakova, Dr. Mitko Dimitrov (Head Physician), Dr. Bozhidar Tashkov, Director of Studies: Prof. Dr. S. Dokumov)

Effect of Tribestam diring menopause

(Dr. P. P. Tabakova et al.)

Radioimmunoassays

Hormone Tribestan treatment No. Limit of confidence
(Mean +/- 1.96 SEM)
E2 Before
After
42
40
0.10 ÷ 0.22
0.20 ÷ 0.54
Prg Before
After
32
34
5.00 ÷ 10.30
4.14 ÷ 7.44
Tst Before
After
41
45
1.15 ÷ 1.74
0.96 ÷ 1.30
FSN Before
After
46
42
51.38 ÷ 72.34
42.30 ÷ 59.74
LH Before
After
42
43
32.45 ÷ 46.05
29.62 ÷ 38.88
Prl Before
After
42
37
265.20 ÷ 378.20
200.60 ÷ 267.60

Distribution of patients by level of progesterone/estrogen according to hormonal cytological examinations

Level Number of Patients Percentage
High 7 14
Normal 1 2
Low 6 12
Very low 16 32

 Total

30* 100

* 20 patients without cytological examination

Distribution of patients by the maintenance dose of Tribestan


Maintenance dose (tabl/day) Number of patients Percentage
2 x 1 27 55.1
3 x 1 14 28.6
2 x 2 8 16.3
Total 49* 100

* 1 patient without effect

Total effective dose of Tribestan

Dose(tabl/day) No Total effective dose
Mean Limit of confidence
Mean +/- 1.96 SEM
3 x 1 7 68.6 53.0 84.2
2 x 2 13 115.4 93.7 137.1
3 x 2 30 141.5 113.7 169.3

Distribution of patients by the total effective dose of Tribestan

Total number of patients Initial dose (tablets/day)
3 x 1 2 x 2 3 x 2 Total
No % No % No % No %
<60 2 4 - - - - 2 4
60-100 5 10 5 10 8 16 18 36
110-180 - - 7 14 18 36 25 50
190-220 - - 1 2 1 2 2 4
>220 - - - - 3 6 3 6

Distribution of patients by duration of placebo treatment


Duration of treatment (days) Number of patients Percentage
0 4 8.0
14 6 12.0
15-20 32 64.0
21-30 8 16.0
  Total 50 100

Distribution of patients by type libido sexualis

Type of libido sexualis Number of patients Percentage
Normal 2 4.0
Low 20 40.0
Very low 28 56.0
Total 50 100

Distribution of patients by incidence of some symptoms before Tribestan treatment

Symptoms Number of patients Percentage
Head waves 50 100
Perspiration 39 78
Depression 27 54
Hyperexcitation 22 44
Tenseness 18 36
Sense of heaviness in the heart region 30 60
RR-changes 11 22
ECG-changes 8 16

Distribution of patients by duration of menopause

Duration of menopause (months) Number of patients Percentage

<12

19 38.0

12-35

16 32.0

36-50

7 14.0

>60

8 16.0

 Total

50 100.0

Distribution of patients by type of menopause

Type of menopause Number of patients Percentage
Natural 26 52.0
Postoperative 24 48.0

 Total

50 100.0

Distribution of patients by age

Age group (years) Number of patients Percentage

30-34

1 2.0

35-39

3 6.0

40-44

8 16.0

45-49

19 38.0

50-54

13 26.0

55-59

4 8.0

60+

2 4.0

 Total

50 100.0

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