Complementary and Alternative Medicine in Chronic Liver Disease

August 22-24, 1999
Natcher Conference Center, NIH

The aims of the workshop are:
1. To assess the current knowledge of Complementary and Alternative Medicine (CAM) for chronic liver diseases, focusing on the available scientific evidence for efficacy and safety.
2. To identify and prioritize research needs that will more fully define the potential for efficacy and the safety of CAM for treatment or amelioration of liver diseases.

AGENDA

AUGUST 22, 1999 (1:00-5:30PM)

Session I: CAM and Chronic Liver Diseases: Introduction and Definitions

Chair: Leonard Seeff, MD

1:00-1:15 Welcome and Introduction Leonard Seeff, MD
NIDDK, NIH
1:15-1:35 Overview of Center for Complementary &
Alternative Medicine (CAM)
Richard Nahin, MPH, PhD
NCCAM, NIH
1:35-1:55 Spectrum of Botanicals and Herbal Supplements Edward Croom, PhD
University of Mississippi
1:55-2:15 Epidemiology of CAM in Clinical Practice David Eisenberg, MD
Beth Israel Deaconess Medical Center,
Harvard Medical School, Boston
2:15-2:45 Discussion
2:45-3:00 Break
3:00-3:20 Spectrum of Liver Disease and Treatment
Strategies (Hepatocellular & Cholestatic)
Karen Lindsay, MD
USC
3:20-3:40 Use of CAM by Patients in Liver Diseases Clinics Doris Strader, MD
VAMC Washington
3:40-4:00 CAM and Chronic Liver Disease:
View of the Practitioner
Andrew L. Rubman, ND
University of Bridgeport, Southbury Clinic
4:00-4:20 Regulation of CAM: Role of the FDA Freddie Ann Hoffman, MD
FDA
4:20-5:00 Discussion

AUGUST 22, 1999 (6:30-9:30 PM ), Marriott Hotel, 5151 Pooks Hill Rd., Bethesda, MD

Complimentary and Alternative Medicine in Liver Diseases: Meet the Experts Forum

A forum for individuals to meet and question experts in the field of alternative medicine regarding informed choices for treatment strategies, co-sponsored by the American Liver Foundation and Hepatitis International Foundation

Panel Expertise
David Eisenberg, MD,
Beth Israel Deaconess Hospital
Epidemiology of CAM
Andrew L. Rubman, ND, Southbury Clinic Naturopathic Medicine
Freddie Ann Hoffman, MD, FDA Federal Regulatory Issues
Bruce Bacon, MD, St. Louis University Liver Disease
Anna MacIntosh, PhD, ND, Nat'l. Coll. Naturopathic Med Naturopathic Medicine
Thomas Schiano, MD, Albert Einstein College of Medicine Liver Toxicity
Moderator: Jay Hoofnagle, MD, NIDDK, NIH Liver Disease

Agenda
6:30-6:40- Welcome, Introductions Jay Hoofnagle, MD
6:40-6:50- Opening Statement, ALF Alan P. Brownstein, MPH
6:50-7:00- Opening Statement, HFI Thelma King Thiel
7:00-8:00- HFI sponsored Guests
8:00-8:15- break
8:15-9:15 ALF sponsored Guests
9:15-9:30- Summary and Conclusions Jay Hoofnagle, MD

Monday, August 23, 1999

Session 2: Design of Outcome Research

Chair: Bruce Bacon, MD

8:30-8:50 Methods and Statistical Considerations in
Designing Controlled Clinical Trials for Therapy
Elizabeth Wright, PhD
New England Research Institute, Boston
8:50-9:10 Lessons From Controlled Clinical Trials in CAM
Implications for the Study of Liver Diseases
Wayne Jonas, MD
USUHS
9:10-9:30 Special Consideration in Alternative Medicine
Clinical Trials and the Placebo Effect
Ted Kaptchuk, OMD
Beth Israel Hospital, Boston
9:30-9:50 Clinical Trial Outcome Measures for Hepatitis Anna MacIntosh, PhD, ND
National College of Naturopathic Medicine
9:50-10:15 Discussion
10:15-10:45 Break

Session 3: Liver Disease and CAM

Chair: Jay Hoofnagle, MD

10:45-11:15 Silymarin (Milk Thistle) and Liver Disease Peter Ferenci, MD
Department of GI/Hepatology University of Vienna
11:15-11:35 Therapeutic Evaluation of Hepatitis Remedies:
The Usefulness of Ethnomedical Focusing
Techniques
Memory Elvin-Lewis
Washington University
11:35-12:00 Discussion
12:00-1:00 Lunch and Posters (Lunch Provided)
1:00-1:20 Herbal Medicine 861 has Direct Antiproliferative
Effects on Hepatic Stellate Cells
Bruce Bacon, MD
St. Louis University
1:20-1:40 Glycyrrhizin Mark Zern, MD
Thomas Jefferson Hospital
1:40-2:00 Long Term Effect of Sho-saiko-to (TJ-9) on the
Levels of markers for Hepatic Fibrinogenesis
In Chronic Hepatitis C
Hiromasa Ishii, MD
Keio University, Japan
2:00-2:20 Immune modulation, CAM and Liver Disease Craig McClain, MD
University of Kentucky
2:20-2:40 Discussion
2:40-3:00 Break

Session 4: Spectrum of Botanicals for Use in Liver Diseases

Chair: Freddie Ann Hoffman, MD

3:00-3:20 Botanicals and Formulations: Practical Solutions Ed Alstat RPh, ND
Eclectic Institute, Inc.
3:20-3:40 IND's for Botanicals and Formulations Floyd Leaders, PhD
Bethesda
3:40-4:00 US Pharmacopeia and CAM Srini Srinivasan, PhD
Dietary Supplement Division
4:00-4:30 Discussion
4:30 Posters and Reception

August 24, 1999

Session 5: Cultural-Based Use of Botanicals in Liver Disease

Chair: John C. Chah, PhD

8:30-8:50 Experimental and Clinical Study on
Inhibition and Reversion of Liver
Fibrosis with Integrated Chinese
And Western Medicine
Baoen Wang, MD
Beijing Friendship Hospital
Capital University of Medical
Sciences
8:50-9:10 Clinical and Pharmacological Studies
on Liver Diseases by Kampo Herbal
Medicine in Japan
Jong-Chol Cyong, PhD
Graduate School of Medicine
University of Tokyo
9:10-9:30 Antiviral Activity of Aucubin
Derived from Traditional Chinese
Herbs in HepG2, Woodchucks
And Humans Infected with HBV
Il Moo Chang, PhD
National Products Research Institute
Seoul National University
9:30-9:50 New Evidence for the Rationale of
Systemic Therapy with Proteolytic
Enzymes and L-Ornitin Aspartate
In Liver Disease
Ralf Kleef, MD
German Medical Boards for
Complementary Medicine
9:50-10:10 Recent Advances in Liver Diseases
in Ayuvedic Medicine
Shri K. Mishra, MD, PhD
University of Southern California School of Medicine
10:10-10:30 Dietary Botanical Supplements with
Antiviral and Antiinflammatory Properties
Used in the Treatment of Liver Disorders
In Traditional African Medicine
Dr. Maurice Iwu, PhD
Bioresources Development and
Conservation Programme, Nigeria
10:30-10:45 Discussion
10:45-11:20 Break & Snack

Session 6: Adverse Effects, Hepatotoxicity, and Quality Control

Chair: Jim Lewis, PhD

11:20-11:40 Toxicity of Herbal Products, Excluding
Liver Toxicity, by Organ System
Mary Palmer, MD
11:40-12:00 Hepatotoxicity of Herbs and Other
Botanicals
Thomas Schiano,MD
Mount Sinai
12:00-12:20 Reporting of Adverse Effects: The FDA
Perspective
Lori Love, MD PhD
FDA
12:20-12:40 Adverse Effects of Botanicals: The CDC
Experience
Rossanne Philen, MD, MS
CDC
12:40-1:00 Quality Control and Quality Assurance
of Botanicals
Yuan-yuan Chiu, PhD
FDA
1:00-1:30 Discussion
1:30-1:45 Summary Jay Hoofnagle, MD
NIDDK

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