Effect of Liv52, A Herbal Preparation, on Absorption and Metabolism of Ethanol in Humans
Chauhan, B.L. and Kulkarni, R.D., M.D., R & D Centre, The Himalaya Drug Co., Bombay, India.ABSTRACT
In 8 social drinkers the effect of a single dose of Liv.52 or placebo on ethanol absorption has been studied after ingestion of 30 ml whisky in 5 min. The t½ absorption with Liv.52 was 3.62 min., significantly less than after placebo, 6.29 min. The peak concentration after Liv.52 (49.9 mg/100 ml) was significantly higher than with placebo (40.5 mg/100 ml).
Whisky 120 ml consumed by regular alcohol users in 1h, before and following 15 days of Liv.52 treatment produced significantly higher ethanol levels at 2, 3 and 4 h and significantly lower acetaldehyde levels at 3 and 4 h after Liv.52 treatment.
Liv.52 enhanced the rate of absorption of ethanol and rapidly reduced acetaldehyde levels, which may explain its hepatoprotective effect on ethanol-induced liver damage.
INTRODUCTION
Chronic alcohol consumption is a prime cause of liver disease.1,2 Present evidence indicates that acetaldehyde, the intermediate metabolite of ethanol, is directly injurious to liver.3,4 Significantly higher levels of acetaldehyde in blood are reported after ethanol ingestion by chronic alcohol users as compared to non-alcoholics, as a result of a primary reduction in hepatic acetaldehyde dehydrogenase activity.5,6 Acetaldehyde via its covalent binding to hepatic proteins may be the critical event leading to liver injury.4
Hepatoprotective agents of herbal origin have been available on the Indian market for many years and are regularly prescribed by physicians. Liv.52, a herbal formulation based on Ayurvedic principles, contains a number of hepatoprotective ingredients which are known to protect the liver from damage produced by toxic substances, including alcohol.8-11
Using 131I-labelled Rose Bengal and a whole body linear scanner body segment counter, Harshe et al, demonstrated reversible depression of liver function, even after a single episode of social drinking and the protective effect of Liv.52 (Harshe et al., 1978, unpublished data).
The present study was designed to examine the effect of Liv.52 on the absorption and metabolism of ethanol in moderate and occasional drinkers.
MATERIAL AND METHODS
Twenty-five healthy male subjects with a mean age of 36.7 (±2.95) y and mean weight of 59.2 (±1.72) kg., volunteered for the study. After ascertaining the history of alcohol intake they were classified as occasional, mild, moderate or chronic alcohol users12. Their informed written consent was obtained.
Study of ethanol absorption
Eight mild to moderate drinkers, whose alcohol consumption was from 10 to 20 units/week, were enrolled in the trial to study the effect of a single dose of Liv.52 on the absorption of ethanol.13 On the first occasion, subjects received 6 tablets of placebo and on the second occasion after 3 days, 6 tablets of Liv.52 at 08.00h whilst fasting. Two h later and after collection of a fasting blood sample, 75 proof Peter Scot Whisky 30 ml, containing 44.8% v/v ethanol, was given with 70 ml chilled soda, to be consumed over 5 min. Further blood samples were collected 2, 5, 10, 15, 20, 30, 40, 60, 90 and 120 minutes after alcohol ingestion. Blood samples were immediately processed for ethanol estimation by a modified GC method.14 The method was validated by doing 10 replicates of the assay. The coefficient of variation was less than 3%.
Study of ethanol metabolism
The effect of Liv.52 on ethanol metabolism was studied in 17 subjects. Nine were moderate alcohol users who had consumed more than 20 units/week for more than 5 years and 8 were occasional drinkers.
Ethanol metabolism was checked by estimating the blood ethanol and acetaldehyde levels. In the fasting state, after the `0’ hour blood collection, each subject consumed 60 ml Peter Scot whisky with 100 ml soda and 3 cubes of ice in 30 minutes, at 09.00 h. The next portion of 60 ml whisky was consumed over the next 30 minutes, i.e., between 09.30 and 10.00 h. Blood was sampled at 1 h, i.e., at the end of alcohol consumption and hourly thereafter for 6 h. A standard lunch was allowed at 12 noon. Blood samples were immediately processed for ethanol and acetaldehyde assay.
All subjects then took Liv.52, 3 tablets b.i.d. for 14 days, and on Day 15 ethanol metabolism was again studied by the same procedure.
RESULTS The effect of a single dose of Liv.52 on ethanol absorption in mild to moderate alcohol users is depicted in Table 1.
Table 1 : Mean Cmax tmax area under plasma concentration (AUC) and t½ absorption of ethanol following ingestion of 30 ml whisky and effect of single dose of Liv.52 |
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Treatment |
Cmax |
tmax |
AUC mg. 100 ml min 0-120 min. |
t½ min |
Placebo |
40.5* ±3.99 |
17.5 ±0.94 |
2330 ±255 |
6.29* ±0.89 |
Liv.52 |
49.9* ±2.31 |
12.1 ±1.9 |
2330 ±249 |
3.62* ±0.54 |
Mean (SEM). Unpaired t test. * p<0.05 |
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Refference: http://www.himalayahealthcare.com/pdf_files/liv191.pdf
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