THE SAFETY OF CAPSULES CONTAINING LACTIC ACID BACILLI

Results & Discussion

Dr.Thomas Paraidathathu and Lee Seng Hup
Pharmacy Department, Faculty of Allied Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur

RESULTS
In the acute toxicity studies, there was a significant decrease as compared to controls in the ALT levels of the rats fed with OM-X capsules. However, no dose related effects were observed.

There was no significant differences in ALT levels between rats in the control group and treatment groups in the sub-acute studies.

No differences were observed in ALT levels of rats between any of the group in both the acute as well as subacute toxicity studies.

No differences were observed in serum urea levels of rats between any of the groups in both the acute as well as the subacute toxicity studies.

The ratio of weight of kidney and liver to body weight was not different between all groups of rats in both the acute as well as the subacute toxicity studies.

In the acute toxicity studies, there was a trend towards a decrease in body weight in the rats in the treatment groups as compared to rats in the control group.

In the subacute studies, however, the trend towards an increase in the body weight of the rats in the treatment groups as compared to the control rats, after 7 days of treatment. However, these differences were not statistically significant.

There were some changes in the fur of the animals fed the higher doses of the product. Diarrhoea was seen in the rats fed with corn oil aloe (controls) after the first day of feeding.

DISCUSSION
The sales of health supplements was still recently on the increase. Consumers with extra cash to spend did not mind spending a little extra on health supplements "hoping" that they would help to keep them healthy. Another reason for the popularity of health supplements was that they were considered as 'natural" and therefore safer than the synthetic drugs and vitamins. This opinion stems from a belief that all things chemical or synthetic are toxic and harmful. Such generalisation is not safe because some of the most toxic substances are 'natural, such as botulinum toxin and aflatoxin.

Products containing lactic acid bacteria have been available for a long time. Initially they were home-produced products, but, more recently they have been made into pharmaceutical dosage forms such as capsule. One such product is OM-X capsule which contains a mixture of minerals, vitamins, herbs and live lactic acid bacteria.

The product is approved by the Ministry of Health as health supplement. Among the effects that have been reported for the products include action against MRSA, restoration of gut flora, treatment of hypercholesterolemia, hepatic encephalopathy and gut infections. There have anecdotal reports of patients, in certain instances, taking more than a few capsules a day. Being a 'natural' product, the possible toxicity of the product is often not considered especially since the ingredients have been part of our native foods. However, large numbers of live bacteria in a capsule can have different effects from the amounts found in foods and so it is important to study the toxicity of these products.

Our results show that there is no significant toxicity of OM-X capsules in rats, even at the extremely high doses that were used. While an increase in the levels of hepatic enzymes ALT and AST are indicators of liver damage, a reduction in the levels of activity of these enzymes do not necessarily mean a beneficial effect on the liver. The absence of any effect on serum urea levels indicates that there may not be any toxic effect on the kidney. These results taken together with an absence of changes seen in the ratio of kidney and liver weight to body weight as compared to controls indicates an absence of toxicity in the kidney and liver.

The rats in the treatment groups as compared to control rats showed a reduction in the body weight in the acute toxicity studies, while they increased in body weight in subacute toxicity studies, this trend may indicate that in the first day of feeding with the contents of OM-X capsules the rats may not have eaten as well as the controls, but, with repeated feeding an adaptation was made, such that after 7 days they were eating as well as the controls.

The results of this study show that, for the parameters that were studied, products containing live lactic acid bacteria, such as OM-X capsule, do not produce toxicity in Sprague_Dawley rats.

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