SUMMARY
A controlled study in 50 cases of infective hepatitis was carried out with an indigenous drug Liv.52 and conventional therapy like B-complex and corticosteroids. The cases were divided into two groups of 25 cases each, those treated with Liv.52 being the test group while the other 25 on B-complex and corticosteroids alone served as control. The evaluation of therapy in each group was done from the clinical standpoint as well as by liver function tests like serum bilirubin, serum alkaline phosphatase, thymol turbidity, S.G.P.T. and S.G.O.T. and histological studies, initially, after 4 weeks and 8 weeks of treatment respectively. The overall result showed that the addition of Liv.52 is much more effective than B-complex and corticosteroids administered alone. Liv.52 brings about early clinical improvement as well as promotes rapid and highly significant biochemical as well as histological improvement in infective hepatitis cases. Attempts have been made to explain the multi-faceted improvements on the basis of the multi-pronged action of Liv.52.
Infective hepatitis accounts for nearly 90% of all jaundice cases in our country. The mode of infection is oro-faecal. It thrives in congested and insanitary conditions so rampant in our country. Besides, nutritional deficiencies increase the susceptibility of liver cells to necrosis. The resulting complications of hepatic failure and coma or the post-hepatic cirrhosis with its ultimate fatality, appear quite frequently in our country and constitute a major therapeutic challenge. No such drug has been found to have a specific curative action in this disease process. It has become necessary, therefore, to use drugs having poly-directional actions such as B-complex and corticosteroids.
Liv.52 is an indigenous product having many Ayurvedic constituents. Each tablet of Liv.52 contains: Capparis spinosa, Cichorium intybus, Solanum nigrum, Terminalia arjuna, Cassia occidentalis, Achillea millefolium, Tamarix gallica and Mandur bhasma.
Many actions such as anabolic, choleretic, stomachic, diuretic and aperient have been attributed to Liv.52. (Sule et al, 1956; Murkibhavi and Sheth, 1957; Karandikar et al, 1963; Captain and Syed, 1966; Joglekar and Leevy, 1970). Liv.52 has undergone extensive clinical trials in liver disorders like infective hepatitis and cirrhosis of the liver, and encouraging results have been claimed (Mathur, 1957). Experimental studies carried out on mice (Joglekar et al. 1963) and dogs (Murkibhavi et al. 1957) and in rats (Karandikar et al. 1963), have shown its efficacy in acute hepatic toxicity, thereby, suggesting its protective action on the hepatic parenchyma. The drug has also been claimed to stimulate cellular growth in the presence of hepatotoxins and necrosing substances (Prasad, G.C., 1974).
The present study was undertaken to evaluate the efficacy of Liv.52 in infective hepatitis, in the light of these highly encouraging claims by various authors.
MATERIAL AND METHODS
A total of 50 patients of infective hepatitis of varying age groups admitted to the medical wards of Darbhanga Medical College Hospital were selected for study. These cases were divided into two groups of 25 each. One group was put on Liv.52, six tablets in divided doses along with B-complex and corticosteroids daily while the other group was treated with B-complex and corticosteroids alone and served as control. The cases, on admission, underwent thorough clinical examination and routine laboratory investigations like total and differential count of white blood cells, stool examination, urine examination. Specialist investigations like serum bilirubin, serum alkaline phosphatase, thymol turbidity, S.G.P.T. and S.G.O.T. estimations were also performed initially in order to assess derangement in liver functions. These were repeated after 4 weeks and 8 weeks of treatment to determine the degree of improvements in both the groups.
Ten cases in each group were subjected to histopathological studies initially and then after 4 weeks and after 8 weeks of treatment. The efficacy of the treatment was judged by the amelioration in subjective symptoms and objective signs as well as the degree of improvement in various liver function tests as also in the histopathology.
OBSERVATIONS AND RESULTS
Of the 50 cases, 34 were males and 16 were females of ages ranging from 15 to 65 years. The majority (40%) were in the age group of 26 to 35 years (Table I). Of the various manifestations, jaundice and dark-coloured urine were present in all the cases, while other symptoms like anorexia, nausea, vomiting, constipation, abdominal pain, diarrhoea, pruritus, bleeding, fever, etc. were found in varying degrees (Table II and III).
Table I: Showing age and sex of patients with infective hepatitis |
Sl. No. |
Age group |
No. of cases |
Total No. of cases |
Male |
Female |
Control |
Liv.52 |
Control |
Liv.52 |
1. |
15-25 |
4 |
3 |
2 |
2 |
11 |
2. |
26-35 |
9 |
5 |
2 |
4 |
20 |
3. |
36-45 |
4 |
2 |
1 |
3 |
10 |
4. |
46-55 |
1 |
2 |
1 |
1 |
5 |
5. |
56-65 |
2 |
2 |
— |
— |
4 |
Table II: Showing degree of jaundice in infective hepatitis |
Sl. No. |
Jaundice |
Total No. of cases |
Control |
Liv.52 |
1. |
Mild |
23 |
14 |
9 |
2. |
Moderate |
18 |
8 |
10 |
3. |
Severe |
9 |
3 |
6 |
Table III: Showing comparative improvements in symptomatology in the Control and Liv.52 groups |
Sl. No. |
Symptoms |
Control |
Liv.52 |
Initial |
After |
Initial |
After |
1. |
Jaundice |
25 |
12 |
25 |
4 |
2. |
Loss of appetite |
22 |
9 |
23 |
6 |
3. |
Loss of weight |
22 |
15 |
20 |
6 |
4. |
Abdominal pain |
19 |
6 |
16 |
3 |
5. |
Nausea |
9 |
5 |
11 |
3 |
6. |
Vomiting |
5 |
6 |
3 |
3 |
7. |
Constipation |
16 |
4 |
12 |
3 |
8. |
Epigastric discomfort |
23 |
10 |
25 |
2 |
9. |
Fever |
5 |
5 |
3 |
3 |
10. |
Malaise |
6 |
6 |
4 |
2 |
11. |
Pruritus |
6 |
7 |
3 |
4 |
12. |
Bleeding |
0 |
0 |
1 |
0 |
13. |
Yellow-coloured urine |
25 |
20 |
25 |
23 |
14. |
Restlessness |
2 |
10 |
2 |
0 |
15. |
Precoma |
0 |
0 |
1 |
0 |
16. |
Diarrhoea |
4 |
4 |
2 |
2 |