صفحه 1:
www.tabaye.ir
صفحه 2:
An Overview of Ephedra
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صفحه 3:
on ۱۱۵۳۷ ۰7۱۷6635 دوع
Notice CBS News- 12/31/2003
The FDA's Latest Scapegoat:
Ephedra Idaho Observer -1/2004
FDA's Ephedra Ban Takes Effect
Web MD Medical News -4/12/2004
“We have a tremendous burden of proof in
order to take supplements off of the
market. We crossed the t’s and dotted the
i’s so that the ephedra ban should stand up
in court.”
Human Services Secretary Tommy Thompson
صفحه 4:
News...
FDA Ban on Ephedra Overtu . ,
Ss
Seattle Times -4/15/200!-~
FDA Wants Ephedra Ban Re
CBS News -5/9/2006
Chinese Point Finger and Laugh at Stupid
Americans
“We've had this stuff for like 5000 years. The
Americans get it for a few decades and screw it all
up. Morons.”
Zhou Li Quing- spokesperson for the Chinese Herbal Safety Committee -
12/03/2003
صفحه 5:
Ephedra
Ephedraceae sinica
« An evergreen shrub PHENTLPROPANDLAMINE
native to central 0 امبعسيره برع ل
Asia — بل cH, 4
= Predominant active یا نزو
alkaloid- ephedrine /
= Other active 6 on
1 alkaloids include: Sh
A pseudoephedrine سد =
norephedrine سسمو()
norpseudoephedrine لا
OH CH,
صفحه 6:
Traditional Uses of ephedra (ma
Quang)... from
dried, comminuted
branches
= Used for ~5000 yrs.
by practitioners of
traditional Chinese
medicine (TCM) to
treat asthma, flu, and
nasal congestion
= Combined with other
herbs to enhance or
decrease effects
صفحه 7:
1887- Ephedrine first isolated by Japanese chemist,
N. Nagai
1920’s- Series of studies on ephedrine’s
pharmacological properties leads to synthetic
production
1927- Widely used as a nasal decongestant, central
nervous system stimulant, and to treat bronchial
asthma
1950’s- Many reports of side effects such as t blood
pressure and t heart rate lead pharmaceutical
companies to switch to pseudoephedrine
صفحه 8:
Physiological Effects
Strong stimulant- enhances the release of
norepinephrine (NE) from sympathetic nerve
endings (see handout)
Has f, and f, agonist activity>relaxes bronchial
muscles
Has a, a,, 6,, and B, adrenergic activity—leads to
less desirable effects such as 7 blood pressure, T
heart rate, and nervousness
To compensate, the body releases adenosine and
prostaglandin (PG) which inhibit the release of
NE
صفحه 9:
Physiological Effects
» Caffeine and aspirin may c=
inhibit and/or reduce the ۱
effects of adenosine and = a
PG continued NE ==
activation
1 pecs” stack
ephedrine alkaloids (ma
huang)
caffeine (Gaurana, Bissey
Nut, Kola)
aspirin/salicin (Willow Bark
extract)
صفحه 10:
Reported Benefits
* Increased weight loss due to
thermogenic effect
* Enhanced athletic performance
* Increased energy
* 3 billion servings sold during 1999
12 million people using
ephedra
صفحه 11:
Adverse Effects
Dizziness, tremors, irregular heart rate
myocardial infarctions, strokes
May induce psychological dependence
1993-2003- FDA documented 2,277 adverse event
reports (AER) concerning cardiovascular,
neurological and psychiatric effects (~1% of total?)
Type ‘A’ AE- directly related to the
pharmacological actions of the active ingredient
Type ‘B’ AE- rare and difficult to separate from
pre-existing conditions; cause/effect hard to prove
صفحه 12:
Sound the Alarm
™ 1990s- Government and herbal agencies a.
to decrease intake (warning labels, dosage limits,
prohibit combination with caffeine...)
™ 2003- RAND report published
® April 12, 2004- FDA's Final Rule
effective>banning the sale of dietary supplements
containing ephedra (didn’t apply to use in TCM)
9 April 2005- Ban overturned in Utah federal
court for doses < 10 mg; sent back to FDA to
determine safe and dangerous levels
صفحه 13:
Efficacy and Safety of Ephedra and
Ephedrine for Weight Loss and
Athletic Performance:
* PerformedlMébearmalyeesn California
Evidence-based Practice Center-RAND
* Published in Journal of American
Medical Association on March 23,
2003
صفحه 14:
Efficacy and Safety of Ephedra and Ephedrine for Weight Loss
and Athletic Performance: A meta-analysis. JAMA(2003)289:12
Objective: Assess the efficacy and safety of ephedra and
ephedrine used for weight loss and enhanced athletic
performance
Data Sources: Searched 9 databases (including
unpublished trials and non-English documents) for any related
studies; adverse events (AE) reported to the FDA included
Study Selection: Controlled trials for weight loss (min. 8
week follow-up) or athletic performance (no min. follow-up);
case report for adverse events included if:
1)strong evidence ephedra taken within 24 hrs. prior to event
2)alternative explanations were ruled out
-of 530 screened articles, 52 controlled trials and 65 case
reports included in AE analysis
-of > 18,000 other case reports screened, 284 reviewed in
detail
صفحه 15:
Efficacy and Safety of Ephedra and Ephedrine for Weight Loss
and Athletic Performance: A meta-analysis. JAMA(2003)289:12
" Data Extraction:
= Trials identified independently by 2 reviewers
= Case reports reviewed with explicit and implicit
methods
Data Synthesis: و
No trials of ephedra and athletic performance
found that met criteria
= Safety data yielded estimates of 2.2- to 3.6-fold
increases in odds of psychiatric, autonomic, or GI
symptoms, and heart palpitations
= Insufficient data for conclusions about AE at a
rate les than 1.0 per thousand.
= Majority of case reports insufficiently documented
صفحه 16:
Efficacy and Safety of Ephedra and Ephedrine for Weight Loss
and Athletic Performance: A meta-analysis. JAMA(2003)289:12
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صفحه 17:
Efficacy and Safety of Ephedra and Ephedrine for Weight Loss
and Athletic Performance: A meta-analysis. JAMA(2003)289:12
" Conclusions:
"Ephedrine and ephedra promote
modest short-term weight loss (~0.9
kg/mo > than placebo)
"No data regarding long-term weight
loss
"Insufficient evidence to support use for
athletic performance
"Use with caffeine is associated with
increased risk of psychiatric,
autonomic, or gastrointestinal
صفحه 18:
Content versus label
claims in ephedra-
containing dietary
supplements
- BJ Gurley, SF Gardner, and MA Hubbard
- American Journal of Health-System
Pharmacy(2000) 57:10
صفحه 19:
Content versus label claims in ephedra-containing dietary
supplements (abstract). Am J of Health-System Pharmacy
(2000) 57:10
" Specific Aim: ‘lo determine the content
of ephedra alkaloids in herbal dietary
supplements containing ephedra (ma
huang).
" Study Design: The contents of
ephedrine, pseudoephedrine,
methylephedrine, norephedrine, and
norpseudoephedrine were measured in
20 ephedra-containing supplements using
high-performance liquid chromatography
صفحه 20:
Content versus label claims in ephedra-containing dietary
supplements (abstract). Am J of Health-System Pharmacy
(2000) 57:10
" Results:
" total alkaloid content varied
considerably (0.0-18.5 mg/dosage
unit)
" Observed significant lot-to-lot
variations in alkaloid content for 4
products
= 10 supplements exhibited
discrepancies between the label claim
for alkaloid content and the actual
alkaloid content in excess of 20%
صفحه 21:
Content versus label claims in ephedra-containing dietary
supplements (abstract). Am J of Health-System Pharmacy
(2000) 57:10
SUPPLEMENT FACTS
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Conclusion: “Assay of 20
ephedra-containing dietary
supplements showed that
alkaloid content often
differed markedly from
label claims and was
inconsistent between 2 lots
of some products.”
صفحه 22:
Recommendations
Slight t short-term wt.loss
Athletic enhancement?
TIT adverse events
Dosage level?
Thus...
" High cost/benefit
ratio
" Official positions
=
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2)
4)
صفحه 23:
Summary
= Market forces
© Conventional
sales
= Internet Sales
"Is it legal?
= TCM
= Still under
appeal
صفحه 24:
The End... not