A double blind trial with Liv.52 in acute viral hepatitis was carried out in the Department of Gastroenterology, Osmania General Hospital, Hyderabad. Liv.52 is an indigenous compound (The Himalaya Drug Co.) useful in the management of viral hepatitis.
At present there is no specific drug available for the management of viral hepatitis which can ameliorate the symptoms and enhance recovery. Steroids, which enjoyed a prime position as the mainstay in the management of this condition in the past, have been shown to have no material effect on the recovery time, even though there was an initial rapid fall in the bilirubin levels. On the other hand, a high incidence of relapse and chronicity has been observed (Blum et al 1969).
Liv.52, whose composition is shown in Table I, has been claimed to be very effective protecting the liver, during experiments with animals on exposure to various hepatotoxic agents (Joglekar et al 1963), (Joglekar and Leevy 1970). A number of clinical trials have been conducted with this preparation in acute viral hepatitis and many of them have observed that this product has brought about rapid amelioration of symptoms (Ramalingam et al 1971-Gupta et al 1972).
Table I: Composition of Liv.52 tablets |
Capparis spinosa |
65 mg |
Cichorium intybus |
65 mg |
Solanum nigrum |
32 mg |
Cassia occidentalis |
16 mg |
Terminalia arjuna |
32 mg |
Achillea millefolium |
16 mg |
Tamarix gallica |
16 mg |
Mandur bhasma |
33 mg |
(Prepared in the juices and decoctions of various hepatic stimulants) |
MATERIAL AND METHODS
Fifty consecutive patients admitted to our Department, suffering from viral hepatitis were included in this trial. They were alternately allotted to one of the two groups, Group 'A' and Group 'B'. The diagnosis of viral hepatitis was based on clinical and biochemical features. Patients in whom there was a rapid deterioration and who lapsed into coma were excluded from this study. The response to treatment was recorded carefully at weekly intervals and liver function tests were also carried out at weekly intervals till the patients showed total biochemical recovery. No histological criteria were used. Patients in Groups 'A' were given Tab. 'A' and patients in Group 'B' received Tab. 'B' both in a dosage of 2 tabs/three times daily. Any side effects to the drug therapy were noted. In addition, all the patients were given complete bed rest. Supportive therapy with Glucose and B-Complex were given when necessary.
RESULTS AND DISCUSSION
The age and sex distribution in the two groups 'A' and 'B' are shown in Table II below:
Table II: Showing the age distribution in group 'A' and 'B' |
Age in years |
Group–A |
Group–B |
11-20 |
4 |
9 |
21-30 |
9 |
4 |
31-40 |
4 |
7 |
41-50 |
6 |
2 |
51-60 |
2 |
3 |
Most of the cases were seen in the second to fourth decade of life; there was a male predominance in both groups.
On admission, the presenting symptoms were similar in both groups-namely, loss of appetite, high-coloured urine, jaundice, vomiting, fever and itching in a few cases. The period of symptomatology prior to admission varied from 4-10 days and averaged about 6 days in both groups. Physical signs on admission were one of the icterus with mild to moderate Hepatomegaly in both groups. There were no signs of hepatocellular failure.
In this trial, there were no drop-outs due to cases lapsing into hepatic coma. Liver Function Tests on admission are given in Table-III below for Group A and B.