Complementary

1
Complementary Alternative Approachesto
Menopause and Post-Menopausal Health
National Center for Complementary and Alternative
Medicine, NIH, HHS
NIH Scientific Workshop Menopausal Hormone
Therapy October 23-24, 2002
2
Self-Reported Use of CAM SWAN Baseline Cohort
Embargoed until 10/28/02, 4pm AJPH
Percent
Hispanic
Chinese
Japanese
SWAN, 1995-1997 N3300
African Am
Caucasian
3
Sources of Phytoestrogens
Black Cohosh
Red Clover
Soybeans
Hops
4
Alternatives to Hormone Therapies The Evidence

• Small clinical trials - indicated that some CAM
  products may relieve menopausal symptoms
• Basic studies - identified agents, such as soy
  isoflavones, that are estrogenic and other
  products that may exert progestational or
  anti-steroidogenic activities
• Long-term studies - none conducted yet to
  determine whether these products are effective or
  safer than conventional hormone therapies

5
Botanical Products in Medical Research

• Issues Affecting Choice of Products for Study
• Identifying appropriate parts, species, and
  cultivars of plant
• Optimizing growing and harvesting conditions
• Selecting whole extract or a specific fraction
• Establishing method of extraction,
  product standardization, and purity
• Defining formulation, dose, and length of
  administration

6
Womens Health An NCCAM Area of Emphasis

• Some current research projects
• Supporting Phase I - II clinical trials of black
  cohosh and red clover
• Studying how soy consumption influences
  menopausal symptoms in Japanese women
• Examining herbal-drug interactions
• Examining effects of isoflavones on bone density
  and breast cancer
• Assessing the interactions between soybean
  phytochemicals and tamoxifen in breast cancer

7
Future Research Objectives for Industry,
Government, and Academia

• Delineate more fully the quality of life
  problems imposed by menopause
• Prepare well-characterized and standardized
  products for research studies
• Define chemical constituents, mechanisms, and
  pharmacology
• Conduct dose-ranging studies

8
Future Research Objectives for Industry,
Government, and Academia

• Clinical trials to determine efficacy for
  menopausal symptoms and quality of life
• Lab and clinical studies of the safety in women
  with hormone-sensitive cancers
• Large collaborative trials to study long-term
  activity and safety in products proven to be
  reliably effective