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March 18, 1999

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Indian proves Ayurvedic drug's efficacy against hepatitis B

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Shobha Warrier in Madras

Four per cent of the Indian population goes around with the hepatitis B virus in the blood. That's 40 million people out there who are capable of transmitting the virus to others, through blood transfusions, needles, exchange of body fluids, sexual intercourse etc.

It's even more infectious than even the infamous HIV virus, scoring a 33 per cent on an 'infectivity' rate against HIV's 0.3 per cent.

There is a vaccine against hepatitis B virus available but there aren't many Indians who earn enough to buy it. And so, though 82 countries have listed the vaccine on their routine infant immunisation programme, India hasn't. It can't.

And if you already have the virus, the vaccine is of no help. You have to opt for other drugs.

India is bracketed in the intermediate zone as far as the spread of the disease is concerned -- between two and seven per cent of the population -- and is expected to soon enter the senior league, the highly prevalent zone (8-20 per cent).

Now in Kerala, an Ayurvedic medicine, an extract from a plant locally termed keezharnelli, has been used for centuries to treat jaundice. Now an Indian scientist, after a series of clinical and scientific tests, has concluded that the plant extract can indeed cure hepatitis B. The resultant medicine is expected to hit the national and international market soon.

Dr S P Thiagarajan, professor and head of the department of microbiology at the Madras University's Dr A L Mudaliar Institute of Post Graduate Medical Sciences, began doing his Ph D research work on the plant in 1979 because he had heard stories of the plant's medicinal powers. And that was when hepatitis B was spreading alarmingly in India. The university has already patented keezharnelli, Phyllanthus amarus.

Of the five hepatitis viruses, Hepatitis A, B, C, D and E, A and E are water borne and, therefore, spread less easily. But hepatitis B, C, and D are very dangerous and can be passed on through blood transfusion, injections, needles, body fluids, sexual intercourse, etc, in a fashion reminiscent of the HIV virus.

These three viruses not only produce acute jaundice but also lead to chronic liver diseases like liver sclerosis and liver cancer.

Carriers may show no symptoms but they still can pass on the virus. And just because they have no signs of the disease does not mean they cannot be affected. For, after several years of carrying the virus, they can develop liver cancer or liver sclerosis.

In the developed countries, even in the seventies, it was mandatory to test the donated blood for hepatitis B. But that is still not true of India.

"We wanted to look at the treatment offered by Ayurveda scientifically and find out if this plant extract has any scientifically provable inactivating property against this virus," said Dr.Thiagarajan.

Dr.Thiagarajan had sent in his paper in 1979 to the Indian Journal of Medical Research for publication. He says he "felt dejected earlier because people who should have supported me didn't do so... I had to wait two years to get my first article published in the Indian Journal of Medical Research.

I got acceptance and support only after international scientists, particularly Nobel laureate Dr.Baruch Blumberg, accepted it. [Dr.Blumberg got the Nobel Prize for discovering the Hepatitis B virus. He, along with Irving Millman, also invented the hepatitis B vaccine]. Yes, now things have changed. In recent years, I've been getting a lot of support."

Dr Blumberg also showed interest in collaborative work. And so they began testing the plant extract in animal models for acute and chronic toxicological studies. These tests are essential and obligatory before the drug is tried on humans.

Finally, they gave the extract to patients with acute jaundice and compared the result with other Ayurvedic preparations available commercially and the conventional treatment opted for in modern medicine, wherein patients are given only vitamins and other supporting medication.

The results of two weeks of this treatment showed that the group treated with the keezharnelli capsule were normal, by clinical, virological and biochemical standards. They also found that the hepatitis B virus was absent in 80 per cent of the treated patients. They also learnt that the extract worked best on patients with hepatitis A and B.

Dr.Blumberg and his group did a clinical study in the USA on woodchucks infected with the woodchuck hepatitis B virus, which is quite similar to the human variety. The woodchucks too were cured.

Now Dr Thiagarajan and his collaborators in the USA under Dr Blumberg decided to try treating the carriers. They conducted a double blind clinical trials -- which means neither the subjects nor the researchers knew which subjects were receiving medication -- on two groups of carriers. One group was treated with keezharnelli capsules and the other with placebos.

The result showed that 59 per cent of the carriers treated with keezharnelli capsule were purged of the virus while just four per cent of the placebo group lost the virus. They jointly published the result in a London journal in 1988, drawing attention from scientists worldwide. Now they have about 28 published about 28 papers publications on the plant extract.

Soon after their paper was published, another landmark test trial was conducted at the Scottish Centre for Infection and Environmental Health in Glasgow. Tests were conducted on Scottish carriers who had been carrying the virus for between five and 12 years. They were undergoing treatment with interferon -- proteins produced by infected cells that inhibit the virus reproducing and spreading -- and lamivudine -- known to be effective in reducing the damaging effect of chronic hepatitis B on the liver. When they were treated with keezharnelli, the result showed that 35 per cent of the carriers were cured.

The most important discovery was that the virus did not reappear even four years after the withdrawal of treatment. The virus reappeared immediately after medication was withdrawn in cases where interferon and lamivudine were used. In addition, these drugs were expensive and had serious side effects, unlike keezharnelli.

Dr Thiagarajan recommends three capsules of 500 mg each per day for severe cases of hepatitis B, and three 500 mg capsules per day for six months for asymptomatic carriers. Those with severe liver diseases may have to consume the medicine for a year. He expects the capsule to be in the Indian market by the end of the year.

"This is a major breakthrough because this is one plant which has been scientifically evaluated in our country and is accepted the world over. In India, there is a wealth of information available in the traditional Ayurveda and Siddha branches of medicine. But the problem is we have not bothered to study them scientifically."

According to him, Indian scientists have to show what the Ayurvedic and Siddha physicians felt in the language of modern science for it to be acceptable.

"I'm positive that the 21st century will be the century of traditional medicines." According to Dr Thiagarajan, "We have to do scientific studies at the earliest and patent plants without delay. The next one year is going to be very crucial."

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