Q: Dr. Gannage, what is your experience with chelation therapy?
A: I have been using chelation therapy as an alternative modality in my medical practice since 1999. I trained through the American College for Advancement in Medicine (ACAM), which is the world leader in physician training. ACAM’s protocol for administering the treatments is the standard by which all others are measured. The protocol considers safety, monitoring, appropriate dosing and scheduling of lab work, and how to mitigate risks related to the intravenous chelation treatments. Practitioners applying chelation treatments need to be well versed in these areas.
Q: What is Chelation Therapy?
A: Chelation therapy refers to the administration of a drug, in this case EDTA, for purposes of removing heavy metals from the body. The ACAM protocol calls for mixing the EDTA with ascorbic acid (Vitamin C), some B vitamins, and minerals. The mixture is delivered as an infusion i.e. directly into a vein. For cardiovascular disease, chelation treatments are considered investigational and unproven by conventional medicine. ACAM generally proposes 30 to 40 chelation treatments for cardiovascular patients.
Q: What is TACT?
A: TACT is an acronym for the Trial to Assess Chelation Therapy. It is a clinical research study sponsored by the National Insititutes of Health. The study is designed to answer the following question: what are the benefits of intravenous EDTA chelation therapy in patients with known coronary heart disease. Physicians, including myself, have research sites where patients can enroll and be included in the study. There are 120 research sites in the U.S. and Canada. There is no charge to participate.
Q: Is the study attempting to answer any other questions?
A: Yes, the study is also evaluating the effectiveness of high dose antioxidants (versus placebo). It will assess if high-dose antioxidants have any clinical benefit to patients with heart disease.
Q: Who is eligible to participate?
A: Patients are eligible if they are over the age of 50 and have had a previous heart attack, more than 6 weeks prior to enrollment. Participants must be non-smokers for at least 3 months and not have had received many chelation treatments in the preceding 5 years. Blood pressure must be less than 160/100. There are other screening criteria related to certain lab parameters and state of health.
Q: What is the Study Design?
A: TACT is a randomized trial using both chelation therapy and placebo. Neither the trial participant nor the investigators, including myself and my staff, are aware of which type of infusion the participant is randomly selected to receive. The same procedure is in place for the oral supplements. Randomized, placebo-controlled, double blind studies are considered the gold standard in medical research.
Q: What is required of participants during the research study?
A: The initial screening process begins with time allotted for reading and signing a consent form at the office. This is called informed consent, within which all elements of the study are outlined. Screening includes a medical history and baseline lab work. Documentation related to a previous heart attack has been collected and is reviewed. Once enrolled, infusions (i.e. the study product delivered through a vein) are administered at the research site once per week for 30 total treatments in the first phase. Subsequently, 10 treatments are administered 2 to 8 weeks apart. Participants are required to take low dose vitamins throughout the trial. Lab testing is conducted according to the study schedule, and enrollees report any symptoms or problems to the Site Coordinator or Investigator at each visit. The infusions are administered over 3 hours.
As mentioned, all participants take one capsule of low dose vitamin and mineral per day. All subjects also take 6 additional capsules – half receive high dose antioxidants, while the other half receive placebo capsules. Compliance and accountability have to be ensured.
Q: Sounds like a challenging study for participants. Why include placebo?
A: Yes, the effort required by participants (and investigators) is significant. This is an important study. Placebo is required to give statistical strength to the study answer, i.e. the results will have more meaning because a placebo group is included. Placebo controlled studies are considered the best form of research by the medical community, and NIH studies are very highly regarded. Change in public policy and mainstream attitudes toward a treatment depend on these types of trials.
Bear in mind that, because of the study design, 75% of participants will receive some form of treatment throughout the study – chelation therapy, high dose antioxidants or both.
Q: When does the trial begin?
A: TACT was launched in the U.S. in 2003 as a 5-year study. In the past month the study received approval by Canadian authorities for research sites in this country. The first participant in Canada received this country’s first treatment in my office at the beginning of March 2007. We are actively and currently screening patients who call the office.
Q: How can one receive more information about TACT?
A: My office telephone number is (905) 294-2335 at 300 Main St N, Markham, ON, L3P 1Y8 and online at www.Integrative-Medicine.ca. I am considered a Site Investigator. The Principal Investigator, Dr G. Lamas, is an esteemed cardiovascular researcher located in Miami at the Mount Sinai Medical Center. Contact information in Florida (the Clinical Coordinating Center) is: (305) 674-2162, or e-mail .(JavaScript must be enabled to view this email address). Further information, including a list of research sites, is available at http://nccam.nih.gov/chelation.
Editor’s Note:
Other physicians in the GTA who are site investigators participating in the TACT study include:
Dr. Paul Jaconello, MD
751 Pape Avenue, Ste. 201
Toronto 416-463-2911
Dr. S. Bergman, MD
Longevity Healthy Aging
1670 Dufferin St., Ste. 205
(St. Clair & Dufferin)
Toronto 416-652-9862 or 1-866-YOUNG-86 or log on to the website
Dr. Fred Hui, MD has 3 trial sites:
1) 421 Bloor St. E., suite 202, Toronto 416-920-4200.
2) 18 Wynford Dr. Suite 313, Toronto 416-443-0811
3) 566 Bryne Drive, Barrie, Ontario 705-721-1969
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