LiverHope
Volume 2, Issue 11 November 2000
LiverHope
Volume 2, Issue 11 November 2000
I’ve
just been diagnosed with Hepatitis C!
Now what?
-
Attend LiverHope Too -
November
19th, 2000
In This Issue
Calendar............................................................................................. 1
Chinese Medicine............................................................................. 1
Acupuncture For
Acute and Chronic Pain................................... 2
NIH Center Backs
Research Into Alternative Therapies............ 2
Fatigue Associated
With Chronic Hepatitis C............................. 3
FDA Advisory Panel
Recommends Approval of Hoffmann-LaRoche's Viral Load Test 4
Participation
Invited for Hazelden Foundation Hepatitis C Group 5
Donations Needed
for Transplant Fund....................................... 5
What it Does Chinese medicine is a complete medical system that has diagnosed, treated, and prevented illness for over twenty-three centuries. While it can remedy ailments and alter states of mind, Chinese medicine can also enhance recuperative power, immunity, and the capacity for pleasure, work, and creativity.
How It Thinks Within Chinese cosmology, all of creation is born from the marriage of two polar principles, Yin and Yang: Earth and Heaven, winter and summer, night and day, cold and hot, wet and dry, inner and outer, body and mind. Harmony of this union means health, good weather, and good fortune, while disharmony leads to disease, disaster, and bad luck. The strategy of Chinese medicine is to restore harmony.
Each human being is seen as a world in miniature, a garden in which doctor and patient together strive to cultivate health. Every person has a unique terrain to be mapped, a resilient yet sensitive ecology to be maintained. Like a gardener uses irrigation and compost to grow robust plants, the doctor uses acupuncture, herbs, and food to recover and sustain health.
Acupuncture For Acute and Chronic Pain
Pain management is the most widely investigated use of acupuncture (Birch et al, 1996). The explosion of interest in acupuncture in the West, triggered by James Reston’s article in the New York Times and Richard Nixon’s trip to China in the early 1970s, focused almost entirely on the use of the needles to produce analgesia. Not only were numerous clinical trials conducted, but also many studies investigated the mechanisms by which acupuncture alleviates pain. The initial progress in explaining its analgesic action in Western scientific terms provided a measure of credibility for acupuncture within the biomedical community. But it also had the inappropriate effect of keeping clinical testing of acupuncture largely within the framework of the drug model. Slow in coming were the realizations that, in many of the clinical trials for pain, what were designed as “placebo acupuncture” treatments were causing significant non-placebo effects, and that needling of supposed non-points (“irrelevant acupuncture”) as a sham control were often producing effects intermediate between placebo responses and effects of true needling. Attention to the design of clinical trials of acupuncture has only recently begun to receive the necessary attention to insure that it is tested by methods that on the one hand are rigorous enough to satisfy scientific standards, while on the other do not distort the diagnostic and treatment principles that are unique to this therapeutic tradition.
Some of the best-designed and most clinically promising studies in the use of acupuncture for relief of acute and chronic pain are summarized in this article. These studies, that reflect the wide range of pain conditions for which acupuncture has been effectively applied, are grouped by condition treated. The groupings include headache, facial, dental, neck and low-back pain, tennis elbow, osteoarthritis, renal colic, dysmenorrhea, fibromyalgia, athletic injury, endoscopy-associated pain and post-surgical pain. In a number of the clinical trials, acupuncture proved as good or better than current standard care (e.g., Junnila, 1982; Ahonen et al, 1983; Johansson et al, 1991) and usually without the side effects commonly associated with the standard therapies (e.g., Wang et al, 1992; Hesse et al, 1994).
The cumulative evidence suggests that acupuncture represents a therapeutically beneficial, cost-effective treatment option for a broad spectrum of acute and chronic pain conditions. Patients unwilling to accept, unable to tolerate, or non-responsive to standard therapies for pain management, should especially be offered the opportunity to receive an adequate course of acupuncture treatment for their conditions.
NIH Center Backs Research Into Alternative Therapies
CRYSTAL CITY, Va., Jun 13 (Reuters Health) - Dr. Stephen Straus, the director of the National Center for Complementary and Alternative Medicine, said Saturday that practitioners have to start proving scientifically that alternative therapies work. Straus also noted that his agency has been given $70 million this fiscal year to help fund such studies.
"Our job, in fact, is to make a science out of complementary and alternative medicine," said Straus, speaking to the estimated 1,200 attendees of the Comprehensive Cancer Care 2000 meeting.
He described an ambitious agenda for the National Center, a division of the National Institutes of Health (NIH). A wide-ranging program is needed to begin addressing which complementary and alternative (CAM) practices work, and which don't, Straus said, noting that more Americans are using CAM. And, he said, "there is good reason to believe that some of these practices are effective."
He also said more insurers were paying for practices such as chiropractic, acupuncture and massage, but for the wrong reasons. Their decisions have been based on public pressure and state mandates--not science, Straus said.
The National Center is funding centers of excellence around the country, which will conduct early safety and efficacy studies, determine how therapies work, and teach CAM practitioners how to do more rigorous scientific research. Centers funded so far include ones that will focus on cancer, asthma, arthritis, pediatrics, addiction, chiropractic, aging, and cranio-facial health.
Centers on botanicals are also being funded, said Straus. These centers are crucial because they will research how herbal products work, what are the active and inactive ingredients, and find ways to standardize preparations so they can reliably be used in clinical trials. Nonstandard herbal formulas are a concern, said Straus, noting that many off-the-shelf remedies contain the wrong parts of plants or may be adulterated, or have no expiration date.
He said most Americans don't seem to care. "Americans buy botanicals like they buy wine--if the label looks pretty and it's expensive, they buy it," Straus commented.
The National Center's most ambitious effort currently is funding five large clinical trials: St. John's wort to treat depression, which is completing enrollment this week; acupuncture for osteoarthritis pain; glucosamine/chondroitin sulfate for arthritis; shark cartilage for non-small cell lung cancer; and the largest study ever of dementia, a 3,000-patient trial of ginkgo biloba in people aged 75 and over.
That study will cost $16 million and run four years, Straus said.
The agency also hopes to increase funding of studies at its NIH campus and grants to individual investigators with promising early studies, he said.
In cancer, the National Center will be getting input on promising new research to fund from its 15-member Cancer Advisory Panel on Complementary and Alternative Medicine.
Copyright © 2000 Reuters Limited.
Fatigue Associated With Chronic Hepatitis C
Many people with chronic hepatitis C develop severe fatigue that seems to be out of proportion to their general condition. The degree of fatigue does not appear to be related to the activity of the chronic hepatitis.
In people with chronic hepatitis C, fatigue can be the main symptom, and is often the only symptom. It is a major determinant of their quality of life.
Accordingly, it is important to determine the cause of fatigue, because such information will facilitate the development of effective treatments.
A major problem in studying the effectiveness of new treatments for fatigue is that it is a perception and, consequently, subjective (one person's opinion). Therefore, fatigue is difficult to measure. Attempts are being made to overcome this problem by developing scales or scores of fatigue that employ objective criteria (things that are measurable). To establish the effectiveness of a new therapy for fatigue it is necessary to compare the effects of a treatment and a placebo (dummy treatment) on an objective assessment of fatigue. In such a trial patients would be assigned to receive the treatment or placebo by chance with both the physician and the patient being unaware of the nature of their medication until the study has ended.
In addressing the problem of fatigue, peripheral fatigue should be distinguished from central fatigue.
Peripheral fatigue occurs during prolonged exercise in working muscles and is unlikely to be particularly relevant to the fatigue experienced by most patients with chronic hepatitis C.
Central fatigue, on the other hand, occurs as a consequence of changes in the brain. The question arises whether altered function of the brain in patients with chronic hepatitis C contributes to fatigue.
Accumulating evidence suggests that certain complications of chronic liver disease are associated with altered transmission of nerve impulses in the brain.
For example, pruritus (itching), which may complicate chronic hepatitis C, is associated with increased transmission of nerve impulses triggered by opioids (the body's own substances that have morphine-like effects), and poor concentration and sleepiness (which may occur as a late complication of chronic hepatitis C). Pruritus is also associated with increased suppression of the activity of neurons (brain cells) as a consequence of enhanced inhibitory effects of the simple amino acid GABA (gamma-aminobutyric acid) on transmission of nerve impulses.
Increased transmission of nerve impulses triggered by opioids in chronic hepatitis C may affect transmission of nerve impulses triggered by substances other than opioids. One of these additional substances that trigger nerve impulses is serotonin (5-hydroxytryptamine, 5-HT). Indeed, relief of itching in patients with chronic liver disease has been reported following administration of ondansetron into an arm vein. Ondansetron counteracts some of the nerve impulses triggered by serotonin by occupying a subtype of receptors for serotonin that are found on certain neurons. This finding suggests that this complication of chronic hepatitis C (itching) is associated with increased transmission of nerve impulses triggered by serotonin.
Thus, altered transmission in serotonin pathways may occur in chronic hepatitis C and may contribute to behavioral complications of this disease that may include fatigue. Accordingly, it is necessary to consider whether altered transmission of nerve impulses in serotonin pathways could contribute to fatigue associated with chronic hepatitis C. Three reports in the medical literature suggest that this could be the case.
First, the time that active male athletes could exercise on a bicycle for measuring exercise was significantly less after the administration of paroxetine (a drug that increases transmission of nerve impulses triggered by serotonin), than after administration of a placebo. Extraneous effects of paroxetine on body functions could not explain the results. Paroxetine, which is used to treat depression, acts centrally on the brain.
The authors of the study concluded that there might be "a central (brain) component to fatigue which is mediated by the activity of serotoninergic neurons (brain cells triggered to transmit nerve impulses by serotonin)".
Second, in studies involving rats, fatigue during extended periods of exercise was reported to be related to indices of transmission of nerve impulses in the brain triggered by serotonin.
Last, a woman with chronic hepatitis C and profound fatigue was reported to become completely free from excessive fatigue when treated long-term with ondansetron 4 mg twice daily. While taking the drug she was able to work more efficiently and for longer hours.
The results of these three studies suggest that altered transmission of nerve impulses triggered by serotonin contributes to (central) fatigue originating in the brain. In particular, the findings in the case study suggest that altered transmission of nerve impulses triggered by serotonin - in neuronal pathways in the brain on which a specific subtype of serotonin receptors are located - contributes to the profound fatigue that commonly occurs in patients with chronic hepatitis C. Excessive fatigue associated with chronic hepatitis C may be amenable to effective treatment with drugs that act specifically on the serotonin system in the brain and alter transmission of nerve impulses triggered by serotonin. A controlled trial of oral ondansetron therapy for fatigue in patients with another chronic liver disease, primary biliary cirrhosis, has been initiated in Toronto, Canada.
Dr E. Anthony Jones is from the Department of Gastrointestinal and Liver Diseases, Academic Medical Center, Amsterdam, The Netherlands.
FDA Advisory Panel Recommends Approval of Hoffmann-LaRoche's Viral Load Test
The U.S. Food and Drug Administration's (FDA) Advisory Panel recommended FDA approval for Roche's qualitative viral load test - Version 2.0 of Amplicor and COBAS Amplicor HCV Test, version 2. The panel also recommended that a warning label be included because certain uncommon genotypes would not be detected by the tests and that heparin (a organic compound that prevents blood clotting) may lead to a false-positive test result (a test that indicates that a disease is not present when in fact it is).
If approved, this would be the first FDA approved test to measure the hepatitis C virus.
There are two types of viral load tests - 'qualitative' and 'quantitative'. Qualitative measures the presence of virus while 'quantitative' measures the amount of virus. Roche has developed both tests, but has only submitted their 'qualitative' test to the FDA for approval. Roche is expected to submit their 'quantitative' viral load test to the FDA later this year.
Currently, there are two types of viral load tests commonly used but have not been approved by the FDA:
1. Polymerase Chain Reaction or PCR measures the amount of HCV in your blood. These tests are very sensitive and can measure viral load down to less than 100 virus particles per milliliter of blood.
2. Branched-Chain DNA Assay - a method that is easier (and cheaper) to apply to a large number of samples, but only measures viral load above 200,000 viral particles per milliliter of blood.
The HCV viral load tests that are currently used have also been controversial because the results vary depending on the way the sample blood is handled and stored. Furthermore, results may vary from lab to lab. These tests are considered experimental and therefore may not be covered by some insurance companies. FDA approval would practically guarantee reimbursement by insurance companies.
Another benefit of an FDA approved viral load test is that it will be standardized and reported in international units, which will make it easier to compare results from different types of tests.
The value of the quantitative test for HCV is questionable since the amount of virus detected does not correlate with disease progression. However, this test is considered important for measuring virus before, during, and after treatment with interferon or interferon and ribavirin.
A low viral load prior to treatment may 'predict' a better response and most doctors believe that if you do not go 'undetectable' (clear or eliminate HCV) within 3 months, individuals are unlikely to clear the virus while on treatment. And if you clear the virus on treatment and remain virus free for one year, the chances are extremely good that you have cleared the virus for good.
Participation Invited for Hazelden Foundation
Hepatitis C Group
Hazelden Mental Health Services is developing a free, six-week therapy group to assist chemically dependent individuals who also have hepatitis C. The program will integrate the Twelve Steps of AA and other therapeutic components that have proven successful in managing this chronic illness.
The group consists of six, two-hour sessions at the Hazelden Mental Health Clinic located at Fellowship Club in St. Paul. The group will be offered on Mondays beginning November 13 at 6:30 pm and will meet weekly through December 18. Participants are required to have one year of continuous recovery with a diagnosis of hepatitis C. Participants are expected to attend all six sessions and offer suggestions to Hazelden to help in the development of future groups. If you are interested in further information or participating in this group, please call Bob Ackley at (651) 213-4242. Potential participants will be interviewed by Hazelden Mental Health Services to insure that the group meets the individual’s needs. Participation is limited to eight individuals.
Hazelden Mental Health Services also offers recovery sensitive outpatient therapy to chemically dependent individuals and their families. Mental Health Services can be accessed at three locations: Center City, St. Paul and Plymouth. Hazelden Foundation is a nonprofit organization specializing in building recovery in the lives of individuals, families and communities affected by alcohol, drug dependency and other related illnesses. For more information on Hazelden, please call 1-800-257-7800 or visit www.hazelden.org.
Donations Needed for Transplant Fund
Pat Buchanan is accepting donations of items that can be auctioned on eBay.
The proceeds from these auctions will be donated to Pat Davis’ transplant fund. Any item, new or used, from china to clothing, can be auctioned. Pat Davis is one of the people with Hepatitis C who is such a great source of support for everyone with this disease. I can think of no one else who is as deserving of a new liver. Her insurance will not cover the entire cost, so fundraising is being organized on her behalf. If you can donate any items for auction, it would be greatly appreciated. Cash donations are also welcome and are fully tax deductible by law. Donations will be accepted at any of our meetings or by mail.
Thanks for helping.
LiverHope Support Group Helen Clark & Pat Buchanan Co-Facilitators Email: info@liverhope.com Fax: (763)
566-0589 Website: www.liverhope.com Helen: (952)
933-0932 - helen@liverhope.com Pat: (763) 566-3839 - pat@liverhope.com
16807 Canterbury Drive
Minnetonka, MN 55345-2621
Voicemail: (763)
780-0108
1 Ulrich Beyendorff has been the Clinic Supervisor at the Alternative
Medicine Clinic, Department of Medicine, Hennepin County Medical Center since
1992. He is a Co-Principal Investigator
of a NIH Office of Alternative Medicine sponsored research project on the
investigation of Chinese Herbal Medicine in the treatment of Hepatitis C. Uli
and Dr. Jeffrey Albrecht are performing the first human trials of an herbal
formula thought to lessen the severity of Hepatitis C symptoms. Uli received his Chinese Medicine training
in San Francisco and China. Uli is a
Licensed Acupuncturist, State of Minnesota and has received both a Diplomate in
Acupuncture and a Diplomate in Chinese Herbology from the National Commission
for the Certification of Acupuncturists, Washington, DC. His focus is on the treatment of fatigue,
OB-GYN, and Gastroenterology including liver diseases.