Chelation Therapy For Vascular Disease

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Chelation Therapy For Vascular Disease

• Ong Mei Lin FRCP, FESC,FACC
• Gleneagles Medical Centre
• Penang

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Background
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EDTA
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CHELATION THERAPY

• EDTA is a man made amino acid, first synthesized
  in Germany in the 1930s.
• The word comes from the term chelate, from the
  Greek chele which refers to the claw like
  structure of the chemical Ethylenediaminetetraacet
  ic acid (EDTA)
• With this claw, EDTA binds divalent and
  trivalent ions to form a stable ring structure.

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CHELATION THERAPY

• EDTA is water soluble and only chelates metallic
  ions that are dissolved in water
• It binds lead, iron, mercury, copper, aluminium,
  nickel, cobalt, magnesium, zinc,cadmium,
  manganese, and calcium.
• Chelation therapy involves multiple infusions of
  EDTA to chelate these cations.
• The chelated metal ions are then excreted in the
  urine.
• Additional vitamins and mineral supplements are
  often given concomitantly

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Method
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CHELATION THERAPY

• PROTOCOL (Am Coll of Advancement in Medicine)
• Intravenous infusion of 500-1,000 ml of a
  solution containing
• 50 mg Disodium EDTA/kg body weight
• Heparin
• Magnesium chloride
• A local anaesthetic
• Several B vitamins
• 4-20 gm of Vitamin C
• Infused slowly over 3.5 4 hours, 1 - 3 x a week

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CHELATION THERAPY

• No of treatments to achieve optimal therapeutic
  benefit said to range from 20 ( minimum) , 30 (
  usually needed) or 40 (not uncommon) to as many
  as 100 or more
• Full benefit does not normally occur for up to 3
  months after a series is completed
• Follow up treatments may be once or twice
  monthly for long term maintenance, to sustain
  improvement and to prevent recurrences of
  symptoms.

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CHELATION THERAPY

• Lifestyle modification
• - stress reduction
• - caffeine avoidance
• - alcohol limitation
• - smoking cessation
• - exercise and nutritional counseling
• Is encouraged as part of the complete
• therapeutic program

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Mechanisms of action Hypotheses

• Calcium removal from plaque
• Other Hypotheses
• PTH and plaque decalcification
• Free radical scavenging/ antioxidant
• Cell membrane stabilization
• Arterial dilatation
• Prevent plaque rupture (by inhibition of MMP)

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A Alternative to CABG?
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CHELATION THERAPY

• IS IT EFFECTIVE?
• IS IT SAFE?

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CHELATION THERAPY

• EVIDENCE FOR ITS EFFECTIVENESS
• Published data (Uncontrolled Trials and
• Case Reports)
• Randomized controlled Trials

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Uncontrolled studies and case reports
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Uncontrolled studies and case reports
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Uncontrolled studies and case reports
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CHELATION THERAPY

• EVIDENCE FOR ITS EFFECTIVENESS
• Published data (Uncontrolled Trials and
• Case Reports)
• Randomized controlled Trials

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Controlled Clinical Trials
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Chelation Therapy for Ischemic Heart Disease. A
Randomised Controlled TrialKnudtson ML et al.
JAMA 2002

• Study Question Does chelation therapy with EDTA
  impact exercise ischemia or quality of life in
  stable CAD?
• Method Double blind randomised controlled trial
  of EDTA in 84 patients with CAD and stable angina
  and optimal medical therapy, with at least 1 mm
  ST depression

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Chelation Therapy for Ischaemic Heart Disease
(PATCH)
84 Randomised
43 Placebo
41 EDTA
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Chelation Therapy for Ischemic Heart Disease
(PATCH)

• Treatment Protocol Patients were randomly
  assigned to receive 40mg/kg EDTA chelation
  therapy or placebo for 3 hours/treatment, 2X
  weekly for 15 weeks and once/month for 3 months.
  Patients in both groups took oral multivitamins
• Main Outcome Measure Change from baseline to 27
  week follow-up in time to ischemia (1 mm ST
  depression)

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Chelation Therapy for Ischemic Heart Disease
(PATCH)

• Results
• 39 patients in each group completed the protocol.
  
• 1 chelation patient had treatment discontinued
  for a transient rise in creatinine
• Equal improvement in time to ischemia in both
  groups
• Exercise capacity and quality of life scores
  improved similarly in both groups

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Chelation Therapy for Ischaemic Heart Disease
(PATCH)

• Conclusion
• Based on time to ischemia, exercise capacity,
  and quality of life measurements, there is no
  evidence to support a beneficial effect of
  chelation therapy in patients with ischemic heart
  disease, stable angina and a positive treadmill
  test for ischemia
• 
  JAMA. 2002

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CHELATION THERAPY

• EVIDENCE FOR ITS EFFECTIVENESS
• Trial to Assess Chelation Therapy ( TACT)
• Multicenter, randomized double blind trial
• 2372 patients age 50 years and older who have
  had
• an MI
• Begin recruitment March 2003
• Time to complete 5 years
• nccam.nih.gov

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CHELATION THERAPY

• EVIDENCE FOR ITS EFFECTIVENESS
• Trial to Assess Chelation Therapy ( TACT)
• 100 research sites in USA
• 30 wkly IV treatments then 10 more given 2X/mth
  
• Patients also given high dose vitamins
• Collaboration between National Center for
  Complementary and Alternative Medicine (NCCAM)
  and the NHLBI

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CHELATION THERAPY

• IS IT EFFECTIVE?
• IS IT SAFE?

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Side Effects Major

• Renal failure
• Bone marrow depression
• Hypo/hypertension
• Fits
• Arrhythmias
• Respiratory arrest
• Death (Mangee, Med J Aust 1985)

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Side Effects Minor

• Thrombophlebitis (50)
• Pain at injection site (23)
• Fatigue (23)
• Tetany (10)
• Nausea/Vomiting (10)
• Allergy (3)
• Up to 50 drop out rate
• Prabha Am H J
  2002

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Statements
American Heart Association finds no
scientific evidence to demonstrate any benefit of
this form of therapy. Furthermore, employment of
this form of unproven treatment may deprive
patients of the well established benefits
attendant to the many other valuable methods of
treating these diseases. National Heart,
Lung and Blood Institute, NIH there has been
no scientific evidence of such benefit and
there is scientific evidence of no benefit
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Statemants

• American College of Cardiology
• there is insufficient evidence to justify
  the application of chelation therapy for
  atherosclerosis on a clinical basis. At this time
  chelation therapy should only be applied under an
  investigational protocol.

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Thank You