Research & Treatment News
January 17, 2006
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A May 2005 review of clinical studies which casts doubt on milk thistle's value has recently been re-released into the press. Alternatively, an extensive amount of research supports the continued usage of this herb at higher dosages.
Researchers of the Cochrane Review examined 13 randomized, clinical trials assessing the impact of silymarin (the extract of milk thistle) on liver disease. It is important to note that a current search of silymarin clinical studies on Medline.com results in 846 entries. According to the National Institutes of Health and hundreds of in-vitro studies, silymarin demonstrates a marked hepato-protective effect. In addition to concluding that milk thistle is perfectly safe, the researchers in this Cochrane Collection Review also concede that studies using higher dosages are required to accurately determine silymarin's effect on liver function.
Those concerned with optimal liver protection should look for the following characteristics in a quality milk thistle product:
* A high dosage
* A delivery system which enhances absorption
* Use of the most beneficial constituent of silymarin
Medical researchers concur that silybin, which comprises 50 percent of silymarin, is responsible for the majority of milk thistle's liver-protective qualities. While the standard dose of silymarin is 420 mg per day, higher dosages of the more specific form, silybin, demonstrate correspondingly higher levels of liver protection. Furthermore, when silybin is in a phytosome complex, liver cells can absorb 8 to 10 times more than a standard preparation. The daily recommended dosage of UltraThistle provides 1,080 mg of silybin phytosome, far exceeding the levels of bio-available milk thistle used in this scientific review. For more information on UltraThistle, visit www.UltraThistle.com.
The article below urges researchers to conduct studies with higher dosages of milk thistle extract.
Milk Thistle Does Not Lower Mortality in Liver Diseases, Best Studies Find
By Lise Stevens, Contributing Writer
Health Behavior News Service
Milk thistle, a widely used alternative medicine, is not proven effective in lowering mortality in alcoholic or hepatitis B or C liver disease, according to a systematic review of current evidence.
While some studies found that liver-related mortality may be significantly reduced in patients treated with milk thistle, these findings were not duplicated in the higher quality clinical trials.
However, milk thistle was found safe to use with no serious side effects and with participants perceiving improvement in symptoms — although no more than with placebo.
Dr. Andrea Rambaldi, visiting researcher at the of the Centre for Clinical Intervention Research at Copenhagen University Hospital, led a team that reviewed 13 randomized clinical trials involving 915 patients who were treated with milk thistle or its extracts.
Participants had acute or chronic alcoholic liver cirrhosis, liver fibrosis, hepatitis and/or steatosis, and viral-induced liver disease (hepatitis B and/or hepatitis C). Patients with rarer specific forms of liver disease were excluded.
All the trials compared the efficacy of milk thistle or any milk thistle constituent versus placebo or no intervention in patients with liver disease. “There is no evidence supporting or refuting milk thistle for alcoholic and/or hepatitis B or C virus liver diseases,” the authors found.
The review appears in the most recent issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
According to the Centers for Disease Control and Prevention, 170 million people worldwide are infected with hepatitis C, and 2 billion are infected with hepatitis B. While a vaccine exists to prevent hepatitis B, there is no vaccine for hepatitis C.
Although the virus can be cleared in a handful of patients, many strains are resistant to treatment. Drug therapies that focus on long-term suppression of the virus are expensive, and many patients develop a resistance. The current gold standard treatment, which combines injections of interferon and ribavirin, has serious side effects and is hard for patients to tolerate.
With lack of effective treatment for liver disease, researchers have been looking for alternative therapies that curb symptoms with minimum adverse effects on patients.
Milk thistle and its extracts have been used since the time of ancient Greece for medicinal purposes, are currently widely used in Europe for liver disease, and are readily available in the United States at alternative medicine outlets and outdoor markets.
G. Thomas Strickland, M.D., Ph.D., professor at the University of Maryland School of Medicine, has been studying the role of silymarin, an extract of milk thistle, in preventing complications of chronic hepatitis virus infection. Strickland says that the exact mechanism of action of silymarin is unclear.
A problem with current trials, according to Dr. Strickland, is that the dose of silymarin administered, typically 140 mg three times daily, is too low. “I would certainly double it,” he says, “especially since at the current dose we’re not seeing any improvement in acute viral or chronic hepatitis, and we’ve shown that silymarin is totally safe.”
“ The problem is, there is no cure for viral hepatitis except bed rest and diet, and treatments like silymarin are worth pursuing,” Strickland says, calling for more research funding.
“ We should consider doing randomized clinical trials with higher doses of silymarin,” Dr. Rambaldi concurs.
According to the National Center for Complementary and Alternative Medicine , a part of the National Institutes of Health, studies in laboratory animals suggest that silymarin may benefit the liver by promoting the growth of certain types of liver cells, demonstrating a protective effect, fighting oxidation (a chemical process that damages cells) and inhibiting inflammation.
In their review, Dr. Rambaldi and colleagues conclude, “Milk thistle could potentially affect alcoholic and/or hepatitis B or C virus liver diseases. Therefore, large-scale randomized clinical trials on milk thistle for alcoholic and/or hepatitis B or C liver diseases versus placebo may be needed.”
- Rambaldi A, Jacobs BP, Iaquinto G, Gluud C. Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases. The Cochrane Database of Systematic Reviews 2005, Issue 2.
Posted by Editors at 4:37 PM --- Printer-friendly version
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The start of the New Year was accompanied by the European Patent Office granting a patent for a rapid HCV test. Now that the technology is here, let's hope the test proves accurate, with high levels of selectivity and specificity.
MedMira Granted Hepatitis C Patent in Europe
Patent Further Protects MedMira's Diagnostic Technology
HALIFAX, Jan. 3 /PRNewswire-FirstCall/ - MedMira Inc., ("MedMira") (TSX Venture: MIR, NASDAQ: MMIRF) the global market leader in premium rapid diagnostic solutions, announced today that it has been granted a patent for the HCV Mosaic Antigen by the European Patent Office. This is the company's first major patent on its rapid diagnostic technology in Europe, and paves the way for the world's first combination HIV and Hepatitis C instant rapid test.
Hepatitis C (HCV) impacts over 170 million people worldwide according to the World Health Organization, which also indicates over 40% of individuals with HIV are co-infected with HCV. A combination rapid HIV/HCV test can play a critical role in patient outcomes.
Patent No. EP 1328 811 B1 will ensure that MedMira's rapid HCV diagnostic technology is protected as it is brought to market in Europe. The patented technology is a key component in MedMira's rapid HCV tests and HIV/HCV combination tests slated for market entry in 2007.
"We are very pleased to receive this patent for our groundbreaking technology," said Hermes Chan, president and COO of MedMira, and principal inventor of the HCV Mosaic Antigen. "Considerable R&D efforts were dedicated to developing this technology in the past years. Protecting this valuable diagnostic solution through the patent process was an important step in bringing the complete line of rapid HCV diagnostic products to the European market."
The HCV Mosaic Antigen is a highly immunoreactive mosaic antigen composition containing a plurality of different antigenic peptides encoded from the core region of the HCV genome. The granted patent also describes a test kit utilizing the antigen, and a method for its use for the purpose of detecting antibodies to HCV in a test sample.
About MedMira
MedMira is the leading global manufacturer and marketer of in vitro flow-through rapid diagnostic tests. MedMira's tests provide reliable, rapid diagnosis in just 3 minutes for the detection of human antibodies in human serum, plasma or whole blood for diseases such as HIV and hepatitis C. The United States FDA and the SFDA in the People's Republic of China have approved MedMira's Reveal(TM) G2 and MiraWell(R) rapid HIV tests, respectively.
MedMira's Reveal(R) G2 and MiraWell(R) rapid HIV tests are currently used in clinical laboratories, hospitals, and clinics where professional counselling and patient treatment are immediately available.
The MiraCare(TM) Rapid HIV Antibody Test, MedMira's over-the-counter (OTC) product, is available in pharmacies throughout Hong Kong and Macao Special Administrative Regions, in the People's Republic of China.
MedMira delivers rapid diagnostic solutions to healthcare communities around the globe. Its corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada with a representative office in Guilin, China.
This news release contains forward-looking statements, which involve risk and uncertainties and reflect the company's current expectation regarding future events. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For more information visit MedMira's website at http://www.medmira.com.
Posted by Editors at 11:28 AM --- Printer-friendly version
January 9, 2006
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While GlobeImmune's therapeutic vaccine for Hepatitis C is only in Phase Ib of clinical trials, their focus on immunity to the Hepatitis C virus is fascinating. GI-5005 is based on tarmogens being potent activators of antigen-specific immune responses against disease.
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection
This study is currently recruiting patients.
Verified by GlobeImmune July 2005
Sponsored by: GlobeImmune
Information provided by: GlobeImmune
ClinicalTrials.gov Identifier: NCT00124215
Purpose:
The GI-5005 therapeutic vaccine or placebo will be injected under the skin of hepatitis C virus (HCV) subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections.
| Condition | Intervention | Phase |
| Hepatitis C | Vaccine: GI-5005 | Phase I |
MedlinePlus related topics: Hepatitis C
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1 Double-Blind, Placebo Controlled, Dose-Escalation, Multi-Center Therapeutic Trial of the Safety, Immunogenicity, and Efficacy of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, in Patients With Chronic Hepatitis C Infection
Further study details as provided by GlobeImmune: GI-5005 targets two HCV antigens which are highly conserved, abundant and essential for virus replication. GI-5005 has demonstrated robust activity in preclinical models of HCV. Because the body’s response to Tarmogens resembles successful natural immunity to the hepatitis C virus, the Company believes that the GI-5005 Tarmogen may represent a successful approach to treating this difficult disease. The Company initiated a Phase 1b trial at five US centers for GI-5005 in July 2005.
Expected Total Enrollment: 48
Study start: June 2005
Eligibility:
Ages Eligible for Study: 18 Years and above
Genders Eligible for Study: Both Criteria
Inclusion Criteria:
• Patients with chronic hepatitis C virus infection including treatment naive subjects as well as subjects who are partial responders and relapsers to prior interferon therapy
• >18 years of age
• Negative skin test for hypersensitivity to saccharomyces cerevisiae.
Exclusion Criteria:
• Non-responders to previous interferon treatments
• Cirrhosis
• HCV treatment within 3 months
• Hepatitis B infection
• HIV infection
Location and Contact Information:
Please refer to this study by ClinicalTrials.gov identifier NCT00124215
John Ferraro 720-859-4134
California
Huntington Medical Research Institutes, Pasadena, California, 91105, United States; Recruiting
Ruth Co 626-397-5825
Myron Tong, M.D., Principal Investigator
Colorado
University of Colorado Health Sciences Center, Denver, Colorado, 80262, United States; Recruiting
Jennifer DeSanto 303-315-1128
Gregory Everson, M.D., Principal Investigator
Florida
University of Miami, Miami, Florida, 33136, United States; Recruiting
Angelique Brown 305-243-2184
Eugene Schiff, M.D., Principal Investigator
Illinois
University of Chicago, Chicago, Illinois, 60637, United States; Recruiting
Katie Wherity 773-702-4477
Helen Te, M.D., Principal Investigator
Donald Jensen, M.D., Sub-Investigator
New York
Weill Medical College of Cornell University, New York City, New York, 10021, United States; Recruiting
Mary Ahern 212-746-2115
Ira Jacobson, M.D., Principal Investigator
More Information:
Sponsor's website: http://www.globeimmune.com
Study ID Numbers: GI-5005-01
Last Updated: December 8, 2005
Record first received: July 25, 2005
ClinicalTrials.gov Identifier: NCT00124215
Health Authority: United States: Food and Drug Administration
Posted by Editors at 2:23 PM --- Printer-friendly version
