Trial of Liv.52 in Infectious Hepatitis in Children in Goa

Harish Mazumdar, M.B., F.A.A.P. (U.S.A.), Professor and Head of the Department, and Mira Mazumdar, M.B.,B.S., F.A.A.P. (U.S.A.), Research Officer, Department of Paediatrics, Goa Medical College, Panaji, Goa.

INTRODUCTION

Infectious hepatitis produces an acute inflammation of the liver which, though mild and self limiting in many cases, often runs an acute fulminating and fatal course or results in severe, chronic and irreparable hepatic damage. In India the infection seems to be more severe and its complications more frequent than in the affluent countries, probably due to malnutrition. No satisfactory specific treatment is yet available for this infection. Liv.52* has been reported by many workers1,2,3 to be effective in the treatment of infectious hepatitis by decreasing its morbidity and the duration of jaundice as well as improving the appetite and preventing complications. Its effect on liver cell regeneration and protection against hepatotoxicity has also been described by many workers4,5,6. A trial was conducted in the Department of Paediatrics, Goa Medical College from July 1971 to June 1974 to assess the effects of this drug in cases of infectious hepatitis in children. The trial group of patients comprised of 50 consecutive cases admitted to the Children's Ward. The control group also had 50 children who had been likewise consecutively treated as inpatients in the ward from January 1967 to June 1971. The controls were adequately well matched with the trial group in their ages, sex, socio-economic background and severity of the condition. At the end of the trial a careful comparative evaluation was made of the results in the two groups. This paper outlines our findings.

MATERIAL AND METHODS

There were 50 children of the trial group (Table I) ranging in age from 5 months to twelve years, comprising of 30 males and 20 females. A very careful history and physical findings were recorded. Table II shows the clinical manifestations on admission in both groups of patients.

Table I: Age incidence (1967-1974) No. of patients Control Trial Total 0-3 9 13 22 3-6 21 19 40 6-9 10 6 16 9-12 10 12 22

*Each ml of Liv.52 drops contains: Extracts of: Capparis spinosa 17 mg Cichorium intybus 17 mg Solanum nigrum 8 mg Cassia occidentalis 4 mg Terminalia arjuna 8 mg Achillea millefolium 4 mg Tamarix gallica 4 mg Prepared in the juices and decoctions of various hepatic stimulants.

Table II: Manifestation on admission
No. of cases
Control					Trial on Liv.52			Total
Fever			35			40			75
Anorexia			27			24			51
Nausea and/or vomiting			12			14			26
Abdominal pain			10			8			18
Dark urine			15			27			42
Light or clay coloured stools			–			6			6
Oedema			3			1			4
Pruritus			–			1			1
Constipation			2			1			3
Diarrhoea			–			1			1
Drowsiness and pre-coma			2			1			3
Jaundice	Nil		–			3			3
Mild				32			31			63
Moderate				12			10			22
Severe				6			6			12
Enlarged Liver	Upto 3 cm		45			34			79
More than 3 cm				5			16			21
Tender				26			24			50
Firm				5			8			13
Enlarged spleen			15			12			27

Since 1967, we have routinely investigated liver function tests in cases of hepatitis on admission and again at weekly or two weekly intervals depending on clinical improvement. The same schedule ws followed during the trial. The results of the tests in both groups, showing the figures on admission and after two weeks, are detailed in Table III. In both groups there were a number of patients who, for considerations other than medical, had to be sent home within two weeks of admission. They, however, followed the treatment at home and returned for their tests when required. Out of 50 patients in the control group 4 died within one week of admission. The admission L.F.T. data of these 4 patients are included (in Table III in the "Before" column) in order to give a comprehensive picture of all the patients. They are excluded from calculation of results. In every case the following investigations were done on admission: peripheral hemogram, estimations of serum bilirubin, total proteins, albumin, globulin, glutamic pyruvic transaminase, alkaline phosphatase, zinc turbidity as well as prothrombin time, urinalysis and stool examination.

Table III: Liver function tests before and after treatment
Test						No. of patients
Control													Trial on Liv.52
Before					After*			Before					After
Serum bilirubin in mg%			1-2			14			18		18	45
2-5		27		28			21			5
5		9		0			11			0
Serum total proteins in g%			4			4			0		2	0
4.1-4.5		16		0			2			0
4.6-5.0		8		0			15			2
5.1-5.5		9		9			7			11
5.6-6.0		3		8			10			17
6.0		10		29			14			20
Serum albumin in g%			2			8			0		3	0
2.1-2.5		14		12			8			0
2.6-3.0		21		29			24			25
3.1-3.5		2		0			9			10
3.6-4.0		0		0			5			12
4.0		5		5			1			3
SGPT in IU			40			9			14		11	39
40-100		28		32			21			11
100-260		13		0			18			0
Alkaline phosphatase in K.A.U.			14			4			9		16	32
14		46		37			34			18
Zinc turbidity units			6			9			0		10	38
6		41		46			40			12
Prothrombin time			Normal			30			37		26	50
Raised		20		9			24			0
Urine: Bile Salts, Pigments, Urobilinogen			Present			22			1		22	0
Absent		28		45			28			50
* 4 patients in the control group died within 2 weeks of admission

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