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Monday, 7 June 2004 05:30 PM GMT
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A German study which appeared in last month's Digestive Disease
Week (DDW 2004), Louisiana shows over 40% response rates.
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Hepatitis C patients may respond to a combination of green tomatoes
and mistletoe extracts when
interferon fails according to a German study which appeared in last
month's Digestive Disease Week (DDW 2004), Louisiana.
Harald Matthes, MD, medical director and chief of the Department of
Gastroenterology at Havelhohe Hospital for Anthroposophically Extended
Medicine in Berlin, Germany, presented the findings on May 16th at
Digestive Disease Week 2004 (DDW).
He found that treatment with a mix of herbs that includes extracts of mistletoe and
green tomato may lead to a sustained response in patients with hepatitis
C (HCV) for whom treatment with pegylated interferon–alpha has failed or
is contraindicated.
Hepatitis C
Hepatitis C is a disease featuring inflammation of the liver due to
infection with hepatitis C virus. Hepatitis C infects an estimated 170
million persons worldwide and 4 million persons in the United States.
Currently, the preferred treatment is pegylated interferon together with ribavirin.
Studies have shown sustained cure rates of 75% or better in people with
genotypes 2 or 3 HCV (which is easier to treat) and about 50% in those
with genotype 1.
The new combination
Mistletoes are parasitic plants with a root-like system imbedded in
their host to extract food and water. The extracts used were mistletoe extract (Viscum album), and oral extracts of green tomato (Solanum
lycopersicum) and Hepatodoron (Fragaria vesca and Tritis vinifer).
The mistletoe extract is thought to activate CD4 T helper–1 cells to induce an HCV–specific immune
response, and the Hepatodoron stimulates liver regeneration.
The green tomato contains alkaloids that induce apoptosis through the
caspase 8 pathway. This is important because HCV blocks heaptocyte
apoptosis, which is required to clear infected cells from the liver.
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Study details
Study objectives
The objective of the current German study is to achieve HCV-RNA-PCR
negativity after 1 or 2 years of treatment and 6 months of follow up,
documentation of side effects, fibrosis -parameter (PIIIP) and the
quantitative course of HCV-RNA-PCR.
Up to now, 85 patients with chronic hepatitis C (> 6 months) with
increased transaminases and positive HCV-RNA-PCR values have been
included. 43 patients had a liver biopsy before therapy; 27 patients
failed interferon therapy. Genotype was determined in all patients.
Initially mistletoe was administered 3 times per week subcutaneously;
concomitantly, Hepatodoron 3 x 2 tablets were given. After 14 days
Solanum lycopersicum Herba D3-4 tablets were applied. Duration of
therapy was 12 (78 patients) - 24 months (64 patients).
Results
78 of 85 patients terminated the therapy. 14 patients (18%) were
HCV-RNA-PCR negative after 12 months. After 24 months 20 patients (25%)
showed a sustained response. 44 patients (56%) were non-responders. No
essential side effects were observed.
Transaminases and PIIIP-values decreased significantly during therapy
(p<0,05). Virus load did not decrease continuously but in those patients
with HCV-RNA-PCR negativity it decreased below the limit of detection,
independent of the initial level. 2 patients had shown a so-called
'break through' phenomenon.
After 12 months, 18% were complete responders, 49% were partial
responders and 33% were nonresponders. After 1 more year of treatment
and an additional 6 months' follow–up, the corresponding rates were 44%,
28% and 28%.
Promising outlook
The advantage of mistletoe therapy is the absence of side effects and
its cost effectiveness.
About 60% of patients exhibited local responses to the injection, but
otherwise adverse events were mild and uncommon. Mistletoe is used in
the treatment of about 60 percent of cancer patients in Germany, so its
safety profile is well established.
The researchers estimate that the cost to treat each patient who
achieves a complete and sustained response is $5,600 with the herbal
extracts, compared with $28,000 for interferon therapy. However, some
experts cautioned mistletoe treatment could induce heaptocyte apoptosis, which could be quite
dangerous for patients with an impaired hepatic reserve.
In the US subcutaneous injections of mistletoe are considered a drug rather
than a dietary substance, and have not been approved by the FDA.
Digestive Disease Week is jointly sponsored by the American
Association for the Study of Liver Diseases, the American
Gastroenterological Association, the American Society for
gastrointestinal Endoscopy, and the Society for Surgery of the
Alimentary Tract.
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