Liv.52 trial in Infective Hepatitis
Mehrotra, M.P., M.D. (Luck.), F.R.C.P. (Edin.), F.C.C.P., F.A.C.C., F.I.C.A. (U.S.A.), Professor of Clinical Medicine, S.N. Medical College, Agra, India, Dinesh Chandra Mathur, M.B., Research Fellow, India.
Table III: Showing clinical improvement in symptoms |
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Symptoms |
Group I: 35 cases treated with Liv.52 |
Group II: 15 cases control group |
Anorexia |
Within 7 days |
More than 9 days |
Pain in the abdomen |
2 days |
4 days |
Nausea |
3 days |
7 days |
Fever |
2 days |
7 days |
Vomiting |
3 days |
More than 7 days |
Sense of well-being |
Within 3 days |
More than a week |
Various biochemical values at the time of admission and during the treatment, of the two groups, are given in Tables IV to VI.
Table IV: Showing the comparative evaluation of serum bilirubin improvement (Bilirubin level less than 2. mg.%) |
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No. of days |
Group I 35 patients No. of % |
Group II 15 patients No. of cases |
7 days |
8 or 229% |
2 or 13.3% |
14 days |
19 or 54.3% |
4 or 26.% |
21 days |
6 or 17.1% |
5 or 33.3% |
More than 21 days |
2 or 5.7% |
4 or 26.6% |
Table V: Comparative evaluation of serum alkaline phosphatase improvement less than 13 KA units |
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No. of days |
Group I No. of patients |
Group II No. of patients |
7 days |
8 or 22.8% |
2 or 13.3% |
14 days |
16 or 45.7% |
3 or 20.0% |
21 days |
10 or 28.6% |
9 or 60.0% |
More than 21 days |
1 or 2.9% |
1 or 6.7% |
EFFICACY OF THE DRUG
1. Jaundice: In 65.7% (23 patients of Group I) jaundice disappeared within 14 days as against the control group of 46.6%.
2. Loss of appetite: The appetite was improved within 7 days in Group I, while it took 9 days in Group II.
3. Pain in the abdomen: In most patients pain in the abdomen was relieved within two days with Liv.52 while in Group II it took four days or more.
4. Nausea: Nausea was another major complaint of the patients (48%) and most of them had anorexia and aversion for food. In 88% this symptom disappeared within 3 days in Group I, but in Group II patients nausea continued for more than a week.
5. Fever: Fever subsided in 2 days in Group I, but took about a week for Group II patients, to shed the fever.
6. Lassitude, weakness and fatiguability: Ten per cent of the patients, had these symptoms during the disease process. Weakness and fatiguability got ameliorated within a week after the start of treatment. All the patients treated with Liv.52 tablets reported a sense of well-being in 3 days’ time.
7. Vomiting: In Group I patients, vomiting stopped in 3 days but lasted for a week in Group II patients.
8. Serum bilirubin: In 27 patients of Group I, the serum bilirubin level was less than 2 mg% as compared to only 6 patients in the control group, within 14 days.
9. Alkaline phosphatase: In the group of patients treated with Liv.52, alkaline phosphatase level reverted to normal (less than 13 KA units) in 24 or 68.8% as compared to only 5 or 33.3% in the control group, within 14 days (see Table V, above).
10. Zinc sulphate turbidity: In Group I patients zinc sulphate turbidity returned to normal in 21 or 60% within 14 days whereas in the control group only 83.3% showed this change (see Table VI).
DISCUSSION
Liv.52 is an indigenous drug and has been tried in various hepatic disorders. In the present series this drug was used to treat patients with infective hepatitis. The results of the clinical trial showed that Liv.52 is effective in the treatment of patients suffering from infective hepatitis. Clinical evaluation has also shown that there is marked improvement within a week in relieving symptoms like pain in the abdomen, vomiting and anorexia. Improvement in appetite and a sense of well-being were marked features in the patients treated with Liv.52 tablets. Similar observations have been reported also by Athavale (1966) and Sule et al (1968). This improvement is probably due to hepatic stimulation which was also claimed by Joglekar and Leevy (1970), Joglekar et al (1963), Karandikar et al (1963) and Sule et al (1968).
It may be noted that in patients with infective hepatitis the serum bilirubin levels remained high for a long time after the jaundice had subsided, which is due to intrahepatic cholestasis (Bockus, 1966) but in the group of patients treated with Liv.52 the serum bilirubin returned to near normal in 76.8% of the patients indicating that cholestasis was greatly relieved by reducing the intrahepatic oedema.
High levels of alkaline phosphatase which were present in 86.4% of the patients returned to normal in 68% within 14 days also indicating the relief of intrahepatic cholestasis.
In the present series, zinc sulphate turbidity which indicates the serum gamma globulin levels and hepatocellular necrosis, also returned to normal in 60% of the patients indicating that the drug helps in the regeneration of the hepatic cells, damaged during the disease process and prevents further necrosis of the cells. No patient in the present series treated with Liv.52 has reported till now with relapse of the jaundice and no side-effect of toxicity was met with during this study.
The mechanism of action of this drug seems to be by improved liver function and all observations, clinical, biochemical and histopathological researches may, with advantage, be directed to it.
SUMMARY:
Fifty cases of infective hepatitis were studied in this controlled trial. Marked improvement in the symptoms like nausea, vomiting, anorexia, pain in the abdomen were observed within 3 days. Biochemically two patients showed rapid improvement in this series. Serum bilirubin in 78.8%, alkaline phosphatase in 68.8% and zinc sulphate turbidity in 60% returned to normal within 14 days of treatment.
No side effect, or toxicity was noted during the study and no patient returned to hospital with relapse of the jaundice.
REFERENCES
1. Athavale, V.B. (1966) – Probe, 6: 12.
2. Bockus, H.L. (1966) – Gastroenterology, Vol. III, Second Hd., W.B. Saunders Company, Philadelphia and London.
3. Joglekar, G.V. and Leevy, C.M., (1970) – Jour. Ind. Med. Prof., 12: 7480.
4. Joglekar, G.V. et al (1963) – Acta Pharmacol. et toxicol., 20: 73.
5. Karandikar, S.M. et al (1963) – Acta Pharmacol. et toxicol., 20: 274.
6. Mathur, P.S. (1957) – Current Medical Practice, 2: 107.
7. Sherlock, S., (1961) – Diseases of Liver and Biliary System, Ed. Oxford, 279.
8. Sheth, S.C. et al (1960) – Indian Jour. of Paediatrics, 149: 202.
9. Sule, C.R. et al (1968) – Jour. Ind. Med. Prof., 14: 6391.
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