Carsil Silymarin Clinical Studies!

Clinical use of Carsil

Carsil Max (Silymarin) hard capsules 30 x 110 mg<

Carsil is appropriate in patients with liver steatosis, chronic hepatitis, hepatic cirrhosis, toxic metabolic liver damage, liver adipose degeneration, but also as a hepatoprotective agent in case of administration of liver-loading substances.

The judgment of the effect of the liver therapeutic agents is rather problematic. On the one hand due to the substantial spontaneous inter-individual fluctuations of the course of the disease, and on the other - because the comparisons among the cohorts of patients are difficult, as the same clinical and histological picture may be the result of totally different ethiopathogenetic prerequisites.

Carsil in hcronic liver diseases (CLD)

H. Brailsky et al performed a comparative clinical study of Carsil and Legalon.

The study was carried out as an open clinical trial on inpatients and outpatients. After a preliminary diagnostic appraisal based on clinical, laboratory-biochemical and instrumental methods, the patients were assigned to the respective groups, as follows:

First group: mild liver damage - chronic persisting hepatitis (CPH) and liver steatosis (LS):

Second group: chronic active hepatitis (CAH):

Third group: hepatic cirrhosis (HC).

The definite assignment of the patients to the individual groups was done on the basis of the results of the histomorphological investigation and the laparoscopy. The patients were randomly assigned to the groups with Carsil and Legalon therapy, after the diagnostic clarification and the order of admission to the clinic.

Table A indicates the data about the effect on the clinical symptoms in the aggregate group of chronic liver diseases (CLD) treated with Carsil. Table B shows the data about the effect on the clinical symptoms in the aggregate group of chronic liver diseases (CLD) treated with Legalon.

Symptom Table A. Effect on the clinical symptoms in patients with CLD, after Carsil therapy Table B. Effect on the clinical symptoms in patients with CLD, after Legalon therapy
  (% of patients with effect) (% of patients with effect)
Pain 54.16 66.50
Feeling of weight 68.96 27.20
Upper dyspeptic syndrome 47.36 44.45
Lower dyspeptic syndrome 33.33 50.00
Pruritus 40.00 50.00
Dark urine 40.00 57.14
Raspberry tongue 20.00 14.28
Coated tongue 55.50 0.00
Icterus 33.33 50.00
Palmar erythema 0.00 37.50
Telangiectases 8.30 25.00>
Hepatomegaly 2.85 5.25
Splenomegaly 9.67 0.70
Acholia 0.00
Weight loss 60.00
Impotence 20.00

Table A and B indicate that the subjective symptoms of pain and weight in the right hypochondrium, the upper and lower dyspeptic syndrome, the pruritus and dark urine were best influenced after Carsil and Legalon therapy. Some of the above symptoms improved in more than half of the patients. The icterus was less affected. A week or no change of the incidence of the objective signs, such as liver raspberry tongue, telangiectasis, hepato-, and splenomegaly, occurred after both drugs. The reduction in terms of the degree of the hepato- and splenomegaly under the influence of the therapy deserves attention.

The administration of Carsil is indicated in liver damage of mild and moderate degree: liver steatosis and chronic persisting hepatitis.

No contraindications for administration of Carsil exist also in advanced liver damage, where it can be included as a basic medication.

In 1977 Z. Krustev at al. performed a comparative clinical trial of Carsil and Legalon on CLD patients in order to study the change in the clinical, morphological and laboratory parameters.

An open trial was carried out to compare the Bulgarian Carsil brand with the Legalon brand of Madaus (Germany). Initially, the inpatients received 210 mg Carsil or Legalon each for 20-25 days (bed regimen and liver diet prescribed). They continued the therapy as outpatients until the third month, with various labor regiments assigned according to the severity of the liver disease. No other hepatoprotective agents or immunostimulants were given to the patients. Administration of antibiotics (4 cases), antihypertensive agents (7 cases) and other symptomatic medication was necessary in some of the cases. An active selection was done of 18 patients pairs with the same clinical diagnosis, liver disease etiology, analogous degree of the liver damage judged by a primary blind diagnostic liver biopsy. A relative selection was also done, according to comorbid diseases, sex and age.

The feeling of pain and weight in the right hypohondrium, the change of the urine color, the upper and the lower dyspeptic complaints, the cutaneous signs of liver damage, the icterus and the menstrual disorders were recorded in order to evaluate the clinical effect of the therapy. In 3 out of the 18 patients, no detectable base-line clinical signs of liver damage were recorded, with the exception of the hepatomegaly (evaluated ultrasonographically). Therefore, the results of the clinical effect in 15 patient pairs only are reported. No negative dynamics of the above clinical signs was observed in any of the patients. A good clinical effect was recorded in half of the patients treated with Carsil and Legalon for 3 months. A better clinical effect of the Legalon therapy was observed in 5 pairs, and of the Carsil therapy - in 3 pairs, while in 7 pairs (p>0.10) the effect had the same direction. No effect of the therapy was observed predominantly in patients with a more severe liver damage.

In the group of the chronic liver disease patients, no significant differences between both drugs were found in terms of the clinical signs of liver damage (Table 1). The ultrasonography-detected liver changes (Figure 1), the parameters of protein synthesis (Table 2), of cytolysis (Table 3), of cholestasis and immune response (Table 4), as well as in terms of the histological findings of a parenchymal and mezenchymal liver damage (Table 5).

Table 1. Clinical effect of the therapy with Carsil and Legalon

Drug

Patients
  Improved No change Aggravated
  20 days 90 days 20 days 90 days 20 days 90 days
Carsil 7 8 8 7 0 0
Legalon 9 9 6 6 0 0
p >0.10

Figure 1. Ultrasonographic dynamic examination of the liver and spleen of patients on Carsil and Legalon (3 months)

10
9

Legalon

8

Carsil

7
6

Carsil

Legalon

5
4

Carsil

3

Legalon

2
1
1st group of patients - Improved

2nd group patients - Unchanged

3rd group of patients - Aggravated


Table 2. Change of the protein synthesis parameters - 90th day

Parameter Product t-test for paired data
n xd ±Sxd t p< p=
Albumin g/l Carsil 18 -0.56 ±1.32 0.42 0.30
Legalon 18> 3.13 ± 1.56 2.01 0.10 0.10
SChE U/L Carsil 12 67 ± 346 0.19 0.62
Legalon 12 191 ± 369 0.52 0.27
Cholesterol mmol/L Carsil 18 0.34 ± 0.34 0.99 0.50
Legalon 18 0.52 ± 0.53 0.98 0.19
Prothrombin consumption index Carsil 18 1.86 ± 1.79 1.04 0.27
Legalon 18 4.43 ± 4.50 0.98 0.15
C - Carsil; L - Legalon

Table 3. Change of the cytolysis parameters - 90th day

Parameter Product t-test for paired data
n xd ±Sxd t p< p=
ASAT U/L Carsil 18 -19.11 ± 11.82 1.62 0.15
Legalon 18 -17.81 ± 8.44 2.099 0.10 0.046
ALAT U/L Carsil 12 -19.17 ± 10.42 1.84 0.10 0.09
Legalon 12 -19.83 ± 7.48 2.59 0.02 0.01
C - Carsil; L - Legalon

Table 4. Change of the cholestasis parameters - 20th day

Parameter Product t-test for paired data
n xd ±Sxd t p=
Total bilirubin Carsil 6 2 9 0.145
Legalon 11 5 2 0.105
Conjugated bilirubin Carsil 10 4 3 0.09
Legalon 11 3 4 0.029
ALP Carsil 8 2 6 0.55
Legalon 5 3 9 0.363
Gamma - GTP Carsil 9 2 5 0.033
Legalon 7 4 7 0.274
C - Carsil ; L - Legalon

Table 5. Change of histology picture after Carsil and Legalon therapy

Parameter Product Improved Unchanged Worsened Patients total
Parenchyma Carsil 3 7 4 14
Legalon 4 1 4 9
Mesenchyma Carsil 5 9 0 14
Legalon 1 7 1 9
Total Carsil

6 6 2 14
Legalon

4 1 4 9
C - Carsil; L - Legalon

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