Studies with Liv.52 in the Treatment of Infective Hepatitis, Chronic Active Hepatitis and Cirrhosis of the Liver
Prof. Mandal, J.N., M.B. (Cal.), D.C.H. (Lond.), F.R.C.P. (Edin.), Professor - Director
and Roy, B.K., M.D. (Cal.), Senior House Physician to Professor-Director, Department of Medicine, Medical College and Hospital, Calcutta, India.
Liv.52 in chronic active hepatitis and cirrhosis
INTRODUCTION
Amongst the wide spectrum of liver diseases prevalent all over the world, incidence of Infective Hepatitis, Chronic Active Hepatitis and Cirrhosis of the Liver comprises a very large group which is responsible for a high rate of mortality and morbidity amongst the population at large all over India. Various causes have been ascribed to the significantly higher morbidity and mortality from this group of diseases in our country and also in other underdeveloped and developing countries. Amongst them, under nutrition and/or malnutrition, specially protein malnutrition, widely prevalent infections, particularly viral infections, liver injuries caused by parasitic infections, and recognised or unrecognised toxins etc. have been considered important factors in explaining the higher incidence, a more severe course, and a rather unsatisfactory prognosis in this group of diseases. While the aetiology in certain clinical entities of the group e.g. viral hepatitis, post-hepatitis cirrhosis etc. has been well recognised and well established and this has helped clinicians towards a better understanding of the disease process, certain entities of the clinical spectrum still remain ill-understood, in spite of extensive studies of the conditions. Mostly the aetiology of these conditions still remains a matter of conjecture, rather than a scientific truth, e.g. juvenile cirrhosis of India, classical portal cirrhosis etc.
The other important aspect of the problem regarding this group of diseases is the relatively unsatisfactory response to therapy and prognosis. This remains so in spite of the spectacular progress made during last 3-4 decades in the therapy of other diseases, infective or otherwise. Though one entity of the group, viz. Infective (Viral) Hepatitis is more or less a self-limiting disease, mostly resolving itself in 4-6 weeks’ time, the others of the group tend to be relentlessly progressive either ending fatally, or leading to morbidity over a prolonged period. Even in case of the first category viz. Viral hepatitis, though the prognosis is stated as excellent in most of the advanced countries, in India it is a common experience that the disease runs a more prolonged course, some times severe and fulminant, leading to hepatic failure, and the mortality from the disease is not insignificant. Moreover, many cases are left behind with a stage of chronic and more prolonged activity (cholestatic hepatitis, chronic active hepatitis etc) which ultimately may lead to post-hepatitis cirrhosis, following a progressive course and with resultant morbidity and mortality. Since there is no specific treatment for the conditions until now, the therapeutic regimen followed in these cases up to the present moment is by and large symptomatic and at best palliative. Different regimens have been tried at different times by different authorities and institutions, not without controversial arguments in favour of or against a particular regimen and the available literature is replete with claims and counterclaims. In spite of the not-too-happy a situation, attempts are perpetually being made to find out some effective therapy for the conditions. A better than before understanding of the aetiopathogenesis and progress of the disease, both pathological and clinico-biochemical, has encouraged workers in different parts of India and abroad to renew and augment the search for a better remedy for these conditions than was available until a few years back. Unfortunately, no “Specific” treatment for these conditions has been available till date, and clinicians and others concerned have to be satisfied with the best sort of symptomatic and palliative regimen available, along with the much needed reassurance and explanation of the situation to the unfortunate sufferers from the diseases.
To be an ideal remedy in the aforesaid disease states, it must at least fulfil the following criteria, viz. (1) the remedy must be able to control the infection or counter the noxious and injurious elements, if these are aetiological factors, (2) it should be able to protect the liver parenchyma from the ravages of the factors in (1), (3) it should enable the healing process of the damaged parenchyma of the liver to revert to a structurally normal or near normal state, (4) it must help the liver parenchymal cells to regain their multifarious functional capabilities to normal or as near normal as possible, (5) by virtue of the above effects, it should be able to prevent complications, short-term or long-term, leading to mortality and morbidity. Unfortunately, virtually all of the therapeutic schedules followed at present still lag far behind the above ideals in many respects.
During the last decade and a half, an indigenous proprietary preparation “Liv.52” marketed by The Himalaya Drug Co., for the therapy of different liver diseases, has been claimed by the manufacturers to have properties which to some extent fulfil and approach the ideal requirements of a remedy of this nature. During the same time, a good number of clinicians and allied workers in the field have tried the preparation in liver diseases of different types. Their results, both by the clinical and biochemical parameters, as also in pathological and long-term prognostic aspect, have been recorded mostly in Indian medical literature1-12.
The preparation is claimed to possess the following major properties:
(i) Hepatic stimulant and choleretic, leading to increased functional efficiency.
(ii) Protects the hepatic parenchyma against the effect of toxi-infective noxious agents.
(iii) Accelerates cellular metabolic activity and promotes regeneration of damaged liver cells.
Also it is claimed to be a good appetiser, stimulator of haemopoiesis and a pronounced anabolic agent.
Different workers have recorded their observations by different parameters, and on the whole, the main theme harped upon by most of the workers in the available literature on the use of the remedy has been on the lines that the preparation has a definite beneficial effect on the liver diseases. Since there is no truly “specific” remedy available for the conditions, the preparation has been considered a definite advance towards palliative therapy and effective control of mortality and morbidity in our population from the ravages of the diseases.
In consideration of the foregoing facts, and bearing in mind the claims and at times counterclaims about the efficacy of the preparation in different liver diseases, it was decided to observe for ourselves in the Department of Medicine, Medical College, Calcutta the claimed efficacy or otherwise of the preparation by conducting a controlled trial in the commonly available case material of the group viz. (i) Acute Infective (Viral) Hepatitis, (ii) Chronic Active Hepatitis and (iii) Cirrhosis of the Liver.
The full requirements of the preparation for the trial were supplied by The Himalaya Drug Co. The preparation Liv.52 is available in three forms, viz. drops, syrup and tablets.
COMPOSITION
Each Liv.52 tablet contains: Capparis spinosa 65 mg Cichorium intybus 65 mg Solanum nigrum 32 mg Cassia occidentalis 16 mg Terminalia arjuna 32 mg Achilla millefolium 16 mg Tamarix gallica 16 mg Mandur bhasma 33 mg
Processed in Eclipta alba, Phyllanthus niruri, Boerhaavia diffusa, Tinospora cordifolia, Berberis aristata, Raphanus sativus, Phyllanthus emblica, Plumbago zeylanica, Embelia ribes, Terminalia chebula, Fumaria officinalis.
MATERIAL AND METHODS
The trial was started in the Medical College and Hospital, Calcutta in the month of June 1974, after receiving permission from local authorities and from the Drugs Controller, Directorate General of Health Services, India. The trial was conducted from June 1974 to August 1977. During this period 165 (one hundred sixty five) patients were included initially in the trials. Children below 10 years were excluded. Patients were selected both from Indoor and Outdoor Section of the Hospital. Sixty one patients were excluded from the final analysis, 44 for the lack of proper follow-up and 17 due to death from hepatic coma within 24-72 hours of admission. Of the remaining one hundred four cases who could be followed up, seventy three patients were on Liv.52 and 31 patients belonged to Control Group. The number of cases in each category is given in Table I.
Amongst the wide spectrum of liver diseases prevalent all over the world, incidence of Infective Hepatitis, Chronic Active Hepatitis and Cirrhosis of the Liver comprises a very large group which is responsible for a high rate of mortality and morbidity amongst the population at large all over India. Various causes have been ascribed to the significantly higher morbidity and mortality from this group of diseases in our country and also in other underdeveloped and developing countries. Amongst them, under nutrition and/or malnutrition, specially protein malnutrition, widely prevalent infections, particularly viral infections, liver injuries caused by parasitic infections, and recognised or unrecognised toxins etc. have been considered important factors in explaining the higher incidence, a more severe course, and a rather unsatisfactory prognosis in this group of diseases. While the aetiology in certain clinical entities of the group e.g. viral hepatitis, post-hepatitis cirrhosis etc. has been well recognised and well established and this has helped clinicians towards a better understanding of the disease process, certain entities of the clinical spectrum still remain ill-understood, in spite of extensive studies of the conditions. Mostly the aetiology of these conditions still remains a matter of conjecture, rather than a scientific truth, e.g. juvenile cirrhosis of India, classical portal cirrhosis etc.
The other important aspect of the problem regarding this group of diseases is the relatively unsatisfactory response to therapy and prognosis. This remains so in spite of the spectacular progress made during last 3-4 decades in the therapy of other diseases, infective or otherwise. Though one entity of the group, viz. Infective (Viral) Hepatitis is more or less a self-limiting disease, mostly resolving itself in 4-6 weeks’ time, the others of the group tend to be relentlessly progressive either ending fatally, or leading to morbidity over a prolonged period. Even in case of the first category viz. Viral hepatitis, though the prognosis is stated as excellent in most of the advanced countries, in India it is a common experience that the disease runs a more prolonged course, some times severe and fulminant, leading to hepatic failure, and the mortality from the disease is not insignificant. Moreover, many cases are left behind with a stage of chronic and more prolonged activity (cholestatic hepatitis, chronic active hepatitis etc) which ultimately may lead to post-hepatitis cirrhosis, following a progressive course and with resultant morbidity and mortality. Since there is no specific treatment for the conditions until now, the therapeutic regimen followed in these cases up to the present moment is by and large symptomatic and at best palliative. Different regimens have been tried at different times by different authorities and institutions, not without controversial arguments in favour of or against a particular regimen and the available literature is replete with claims and counterclaims. In spite of the not-too-happy a situation, attempts are perpetually being made to find out some effective therapy for the conditions. A better than before understanding of the aetiopathogenesis and progress of the disease, both pathological and clinico-biochemical, has encouraged workers in different parts of India and abroad to renew and augment the search for a better remedy for these conditions than was available until a few years back. Unfortunately, no “Specific” treatment for these conditions has been available till date, and clinicians and others concerned have to be satisfied with the best sort of symptomatic and palliative regimen available, along with the much needed reassurance and explanation of the situation to the unfortunate sufferers from the diseases.
To be an ideal remedy in the aforesaid disease states, it must at least fulfil the following criteria, viz. (1) the remedy must be able to control the infection or counter the noxious and injurious elements, if these are aetiological factors, (2) it should be able to protect the liver parenchyma from the ravages of the factors in (1), (3) it should enable the healing process of the damaged parenchyma of the liver to revert to a structurally normal or near normal state, (4) it must help the liver parenchymal cells to regain their multifarious functional capabilities to normal or as near normal as possible, (5) by virtue of the above effects, it should be able to prevent complications, short-term or long-term, leading to mortality and morbidity. Unfortunately, virtually all of the therapeutic schedules followed at present still lag far behind the above ideals in many respects.
During the last decade and a half, an indigenous proprietary preparation “Liv.52” marketed by The Himalaya Drug Co., for the therapy of different liver diseases, has been claimed by the manufacturers to have properties which to some extent fulfil and approach the ideal requirements of a remedy of this nature. During the same time, a good number of clinicians and allied workers in the field have tried the preparation in liver diseases of different types. Their results, both by the clinical and biochemical parameters, as also in pathological and long-term prognostic aspect, have been recorded mostly in Indian medical literature1-12.
The preparation is claimed to possess the following major properties:
(i) Hepatic stimulant and choleretic, leading to increased functional efficiency.
(ii) Protects the hepatic parenchyma against the effect of toxi-infective noxious agents.
(iii) Accelerates cellular metabolic activity and promotes regeneration of damaged liver cells.
Also it is claimed to be a good appetiser, stimulator of haemopoiesis and a pronounced anabolic agent.
Different workers have recorded their observations by different parameters, and on the whole, the main theme harped upon by most of the workers in the available literature on the use of the remedy has been on the lines that the preparation has a definite beneficial effect on the liver diseases. Since there is no truly “specific” remedy available for the conditions, the preparation has been considered a definite advance towards palliative therapy and effective control of mortality and morbidity in our population from the ravages of the diseases.
In consideration of the foregoing facts, and bearing in mind the claims and at times counterclaims about the efficacy of the preparation in different liver diseases, it was decided to observe for ourselves in the Department of Medicine, Medical College, Calcutta the claimed efficacy or otherwise of the preparation by conducting a controlled trial in the commonly available case material of the group viz. (i) Acute Infective (Viral) Hepatitis, (ii) Chronic Active Hepatitis and (iii) Cirrhosis of the Liver.
The full requirements of the preparation for the trial were supplied by The Himalaya Drug Co. The preparation Liv.52 is available in three forms, viz. drops, syrup and tablets.
COMPOSITION
Each Liv.52 tablet contains: Capparis spinosa 65 mg Cichorium intybus 65 mg Solanum nigrum 32 mg Cassia occidentalis 16 mg Terminalia arjuna 32 mg Achilla millefolium 16 mg Tamarix gallica 16 mg Mandur bhasma 33 mg
Processed in Eclipta alba, Phyllanthus niruri, Boerhaavia diffusa, Tinospora cordifolia, Berberis aristata, Raphanus sativus, Phyllanthus emblica, Plumbago zeylanica, Embelia ribes, Terminalia chebula, Fumaria officinalis.
MATERIAL AND METHODS
The trial was started in the Medical College and Hospital, Calcutta in the month of June 1974, after receiving permission from local authorities and from the Drugs Controller, Directorate General of Health Services, India. The trial was conducted from June 1974 to August 1977. During this period 165 (one hundred sixty five) patients were included initially in the trials. Children below 10 years were excluded. Patients were selected both from Indoor and Outdoor Section of the Hospital. Sixty one patients were excluded from the final analysis, 44 for the lack of proper follow-up and 17 due to death from hepatic coma within 24-72 hours of admission. Of the remaining one hundred four cases who could be followed up, seventy three patients were on Liv.52 and 31 patients belonged to Control Group. The number of cases in each category is given in Table I.
| Table I:Categories of liver disease studied | |||
| Liv.52 group | Control group | ||
| (a) | Infective Hepatitis | 30 | 15 |
| (b) | Chronic Active Hepatitis | 24 | 8 |
| (c) | Cirrhosis | 19 | 8 |
| 73 | 31 | ||
| Table II: Age distribution | |||||||||
| Liv.52 group | Control group | ||||||||
| 10-30 years | 31-45 years | 46-60 years & above | Total | 10-30 years | 31-45 years | 46-60 years & above | Total | ||
| (a) | Infective hepatitis | 20 | 7 | 3 | 30 | 9 | 5 | 1 | 15 |
| (b) | Chronic active hepatitis | 10 | 12 | 2 | 24 | 3 | 5 | 0 | 8 |
| (c) | Cirrhosis | 3 | 8 | 8 | 19 | 2 | 3 | 3 | 8 |
| 33 | 27 | 13 | 73 | 14 | 13 | 4 | 31 | ||
| Table III: Sex distribution | |||||||
| Liv.52 group | Control group | ||||||
| Male | Female | Total | Male | Female | Total | ||
| (a) | Infective hepatitis | 22 | 8 | 30 | 10 | 5 | 15 |
| (b) | Chronic active hepatitis | 16 | 8 | 24 | 5 | 3 | 8 |
| (c) | Cirrhosis | 14 | 5 | 19 | 6 | 2 | 8 |
| 52 | 21 | 73 | 21 | 10 | 31 | ||
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