Current Research Projects:
Comprehensive National Intravenous Vitamin C Cases Repository
The database that we are creating would be a repository of data on intravenous high-dose Vitamin C administration as an adjunctive treatment for patients with cancer. Many practitioners in the U.S. administer this form of treatment, however, there is little data available on its effectiveness as cancer treatment, including its effectiveness for certain kinds or different stages of cancer. The database would serve as the single data bank accumulating the data from different physicians for comprehensive analysis. We hope that this future analysis would, primarily, elucidate whether this treatment has a positive effect for cancer patients and warrant a further structured study or a clinical trial. Also, the analysis of combined data would compare the effectiveness of different protocols that are being used by the practitioners to identify the best practices which maximize the benefits for the patients.
We developed a blueprint for the information to be included into the database, and we are open to suggestions. We plan to gather retrospective patient cases and then continue to collect information in a prospective manner. Since one of our primary goals is to collect statistically powerful amount of data to make a decision on feasibility of a clinical trial, we plan to continue prospective collection of information until a well informed decision can be made. We have the support of the National Cancer Institute in helping us to set up this repository.
Reiki Share Program for Elderly Residents and Staff of an Assisted Living Facility
Elderly people living in independent or assisted-living facilities frequently suffer from multiple chronic diseases. Reiki has been previously reported to induce sense of calmness, decrease anxiety and improve wellbeing when used for patients in various medical settings. The objective of this study was to assess the feasibility of conducting Reiki training and Reiki Share program among the elderly, and to measure the effect of Reiki therapy on the quality of life and heart rate variability of elderly residents and staff members at The Residences at Thomas Circle, a retirement community in downtown Washington D.C. Our results indicate that Reiki Share program is easy to implement in these settings, and that the majority of participating residents and staff find it beneficial and express the desire to continue such a program. We are currently looking for funding to conduct Phase II of this study to assess the effects of Reiki program on the quality of life among the residents and the staff. Please visit the Effectiveness of Reiki on Quality of Life of Elderly Residents and Staff of a Retirement Community – Phase II trial description in our For Prospective Collaborators section.
Trial to Assess Chelation Therapy for Cardiovascular Disease (TACT) Project Completed
Reviewed by Dr. Kogan
GW CIM has participated as one of clinical sites for the NIH TACT trial, Effect of Disodium EDTA Chelation Regimen on Cardiovascular Events in Patients With Previous Myocardial Infarction. The long awaited results of the study have been published in the Journal of American Medical Association (JAMA). This large trial involved over 1,700 patients and was sponsored by the National Insitutes of Health (NIH). The pre-specified primary endpoint was a composite of total mortality, recurrent myocardial infarction (MI), stroke, coronary revascularization, or hospitalization for angina. The EDTA chelation therapy reduced the risk of primary endpoint by 18%, and the result was statistically significant. The side effects were similar between EDTA and the placebo.
Over 80% of the participants in the trial were men, and the average age was 65 years. Over 30% of patients had diabetes, over 80% had high cholesterol, and almost 70% suffered from a high blood pressure. Median patients’ body mass index (BMI)was 30, which falls into the obese category. Also, over 80% of patients have had a past revascularization procedure, such as CABG or coronary stenting. In addition, nearly all patients were receiving the best available medical treatment for existing coronary artery disease. Over 90% of patients were taking Aspirin, Plavix, or Coumadin, over 70% of patients were on statins or B-blockers, and over 60% of patients were on ACE Inhibitor or ARB. So, how clinically relevant is the 18% demonstrated risk reduction? I’ll answer it with the quote from the study: “An 18% relative treatment effect is within the range of effects that have been considered clinically important in prior trials, such as the use of clopidogrel (Plavix) for patients with acute coronary syndromes.” Due to a large number of patients in the trial, authors performed subgroup analyses, and there were two important findings. Patients with diabetes had 39% risk reduction, and patients who had myocardial infarction in anterior portion of the heart (remind you, all patients in this trial had history of a heart attack) had 37% risk reduction.
While the study did not have enough power to make these results definitive, it identifies the groups of patients who have the maximum potential to benefit from future studies.
This study provides the best current evaluation of the EDTA chelation therapy, although translating the findings into clinical practice is not easy. The trial had several methodological issues that have drawn a lot of criticism. The authors conclusion was that the “results provide evidence to guide further research but are not sufficient to support the routine use of chelation therapy for treatment of patients who have had an MI.” Despite all the fire that the study generated, a few things are clear. Patients with preexisting cardiovascular disease who have seriously considered doing this therapy and have been waiting for the study results will likely proceed with the search for physicians who will administer it. Clinics that have been doing chelation therapy will use the results to support what they do. Insurance companies will not offer coverage for this therapy any time soon. So, does this study change anything? Hopefully, we will see more chelation studies to clarify a potential role of chelation in prevention of cardiovascular events, especially in patients with preexisting diabetes and anterior MIs.
To review the abstract of the trial please visit: http://jama.jamanetwork.com/
Association between Patient Improvement and the Number of Visits to an Integrative Medical Center
The principal aims of this study were: 1) To see if there is a correlation between change in medical symptom questionnaire (MSQ) score (as a measure of quality of life) and a number of treatments received by a patient at the Center. 2) To ascertain the demographic characteristics of the patient population of the Center. 3) To describe the medical practices at the center. The research was performed by analyzing medical records. The results demonstrated that many complex and chronically ill patients presenting to the Center have improved over a period of time. Despite a trend, no statistically significant association was found between patients’ improvement and the number of visits to the Center. The results suggest that multiple confounding factors such as the nature of a medical condition, patients’ expectations, the type of therapeutic treatment received at the Center, and other factors need to be further investigated.