Christine Goertz

Effect of Disodium EDTA Chelation Regimen on Cardiovascular Events in Patients With Previous Myocardial Infarction The TACT Randomized Trial

IMPORTANCE Chelation therapy with disodium EDTA has been used for more than 50 years to treat atherosclerosis without proof of efficacy. OBJECTIVE To determine if an EDTA-based chelation regimen reduces cardiovascular events. DESIGN, SETTING, AND PARTICIPANTS Double-blind, placebo-controlled, 2 × 2 factorial randomized trial enrolling 1708 patients aged 50 years or older who had experienced a myocardial infarction (MI) at least 6 weeks prior and had serum creatinine levels of 2.0 mg/dL or less. Participants were recruited at 134 US and Canadian sites. Enrollment began in September 2003 and follow-up took place until October 2011 (median, 55 months). Two hundred eighty-nine patients (17% of total; n=115 in the EDTA group and n=174 in the placebo group) withdrew consent during the trial. INTERVENTIONS Patients were randomized to receive 40 infusions of a 500-mL chelation solution (3 g of disodium EDTA, 7 g of ascorbate, B vitamins, electrolytes, procaine, and heparin) (n=839) vs placebo (n=869) and an oral vitamin-mineral regimen vs an oral placebo. Infusions were administered weekly for 30 weeks, followed by 10 infusions 2 to 8 weeks apart. Fifteen percent discontinued infusions (n=38 [16%] in the chelation group and n=41 [15%] in the placebo group) because of adverse events. MAIN OUTCOME MEASURES The prespecified primary end point was a composite of total mortality, recurrent MI, stroke, coronary revascularization, or hospitalization for angina. This report describes the intention-to-treat comparison of EDTA chelation vs placebo. To account for multiple interim analyses, the significance threshold required at the final analysis was P = .036. RESULTS Qualifying previous MIs occurred a median of 4.6 years before enrollment. Median age was 65 years, 18% were female, 9% were nonwhite, and 31% were diabetic. The primary end point occurred in 222 (26%) of the chelation group and 261 (30%) of the placebo group (hazard ratio [HR], 0.82 [95% CI, 0.69-0.99]; P = .035). There was no effect on total mortality (chelation: 87 deaths [10%]; placebo, 93 deaths [11%]; HR, 0.93 [95% CI, 0.70-1.25]; P = .64), but the study was not powered for this comparison. The effect of EDTA chelation on the components of the primary end point other than death was of similar magnitude as its overall effect (MI: chelation, 6%; placebo, 8%; HR, 0.77 [95% CI, 0.54-1.11]; stroke: chelation, 1.2%; placebo, 1.5%; HR, 0.77 [95% CI, 0.34-1.76]; coronary revascularization: chelation, 15%; placebo, 18%; HR, 0.81 [95% CI, 0.64-1.02]; hospitalization for angina: chelation, 1.6%; placebo, 2.1%; HR, 0.72 [95% CI, 0.35-1.47]). Sensitivity analyses examining the effect of patient dropout and treatment adherence did not alter the results. CONCLUSIONS AND RELEVANCE Among stable patients with a history of MI, use of an intravenous chelation regimen with disodium EDTA, compared with placebo, modestly reduced the risk of adverse cardiovascular outcomes, many of which were revascularization procedures. These 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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00044213.

Auricular Acupuncture in the Treatment of Acute Pain Syndromes: A Pilot Study

This pilot study used a randomized controlled clinical trial design to compare the effects of standard emergency medical care to auricular acupuncture plus standard emergency medical care in patients with acute pain syndromes. Eighty-seven active duty military personnel and their dependents with a diagnosis of acute pain completed the study, which was conducted in the emergency room (ER) at Malcolm Grow Medical Center, Andrews Air Force Base, Maryland. The primary outcome measure was change in pain level from baseline, as measured by the Numerical Rating Scale. Participants in the acupuncture group experienced a 23% reduction in pain before leaving the ER, while average pain levels in participants in the standard medical care group remained basically unchanged. (p < 0.0005). However, both groups experienced a similar reduction in pain 24 hours following treatment in the ER. More research is needed to elucidate treatment effects and to determine mechanisms.

Patient-centered outcomes of high-velocity, low-amplitude spinal manipulation for low back pain: A systematic review

Low back pain (LBP) is a well-recognized public health problem with no clear gold standard medical approach to treatment. Thus, those with LBP frequently turn to treatments such as spinal manipulation (SM). Many clinical trials have been conducted to evaluate the efficacy or effectiveness of SM for LBP. The primary objective of this paper was to describe the current literature on patient-centered outcomes following a specific type of commonly used SM, high-velocity low-amplitude (HVLA), in patients with LBP. A systematic search strategy was used to capture all LBP clinical trials of HVLA using our predefined patient-centered outcomes: visual analogue scale, numerical pain rating scale, Roland-Morris Disability Questionnaire, and the Oswestry Low Back Pain Disability Index. Of the 1294 articles identified by our search, 38 met our eligibility criteria. Like previous SM for LBP systematic reviews, this review shows a small but consistent treatment effect at least as large as that seen in other conservative methods of care. The heterogeneity and inconsistency in reporting within the studies reviewed makes it difficult to draw definitive conclusions. Future SM studies for LBP would benefit if some of these issues were addressed by the scientific community before further research in this area is conducted.

Natural products and chronic hepatitis C virus.

Background: Chronic hepatitis C virus (HCV) infection is a significant public health problem, with a worldwide prevalence of approximately 170 million. The standard of care for chronic HCV, a combination of α‐interferon (IFN) and ribavirin, is only 50% effective, has serious side effects, and can be prohibitively expensive for low‐income countries with a high prevalence of HCV. Many patients use natural products, including those who are not eligible for IFN/ribavirin, cannot afford treatment, or fail to respond to IFN.

Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study.

Study Design. Randomized controlled trial. Objective. To assess changes in pain levels and physical functioning in response to standard medical care (SMC) versus SMC plus chiropractic manipulative therapy (CMT) for the treatment of low back pain (LBP) among 18 to 35-year-old active-duty military personnel. Summary of Background Data. LBP is common, costly, and a significant cause of long-term sick leave and work loss. Many different interventions are available, but there exists no consensus on the best approach. One intervention often used is manipulative therapy. Current evidence from randomized controlled trials demonstrates that manipulative therapy may be as effective as other conservative treatments of LBP, but its appropriate role in the healthcare delivery system has not been established. Methods. Prospective, 2-arm randomized controlled trial pilot study comparing SMC plus CMT with only SMC. The primary outcome measures were changes in back-related pain on the numerical rating scale and physical functioning at 4 weeks on the Roland-Morris Disability Questionnaire and back pain functional scale (BPFS). Results. Mean Roland-Morris Disability Questionnaire scores decreased in both groups during the course of the study, but adjusted mean scores were significantly better in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). Mean numerical rating scale pain scores were also significantly better in the group that received CMT. Adjusted mean back pain functional scale scores were significantly higher (improved) in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). Conclusion. The results of this trial suggest that CMT in conjunction with SMC offers a significant advantage for decreasing pain and improving physical functioning when compared with only standard care, for men and women between 18 and 35 years of age with acute LBP.

Design of the Trial to Assess Chelation Therapy (TACT).

TACT is an National Institutes of Health-sponsored, randomized, double-blind, placebo-controlled, 2 × 2 factorial clinical trial testing the benefits and risks of 40 infusions of a multicomponent disodium EDTA chelation solution compared with placebo and of an oral, high-dose multivitamin and mineral supplement. TACT has randomized and will follow up 1,708 patients for an average of approximately 4 years. The primary end point is a composite of all-cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. A 900-patient substudy will examine quality-of-life outcomes. The trial is designed to have >85% power to detect a 25% relative reduction in the primary end point for each treatment factor. Enrollment began in September 2003 and was completed in October 2010.

Oral High-Dose Multivitamins and Minerals After Myocardial Infarction: A Randomized Trial

BACKGROUND Whether high-dose multivitamins are effective for secondary prevention of atherosclerotic disease is unknown. OBJECTIVE To assess whether oral multivitamins reduce cardiovascular events and are safe. DESIGN Double-blind, placebo-controlled, 2 x 2 factorial, multicenter, randomized trial. (ClinicalTrials.gov: NCT00044213) SETTING: 134 U.S. and Canadian academic and clinical sites. PATIENTS 1708 patients aged 50 years or older who had myocardial infarction (MI) at least 6 weeks earlier and had serum creatinine levels of 176.8 mol/L (2.0 mg/dL) or less. INTERVENTION Patients were randomly assigned to an oral, 28-component, high-dose multivitamin and multimineral mixture or placebo. MEASUREMENTS The primary end point was time to total death, recurrent MI, stroke, coronary revascularization, or hospitalization for angina. RESULTS The median age was 65 years, and 18% of patients were women. The qualifying MI occurred a median of 4.6 years (interquartile range [IQR], 1.6 to 9.2 years) before enrollment. Median follow-up was 55 months (IQR, 26 to 60 months). Patients received vitamins for a median of 31 months (IQR, 13 to 59 months) in the vitamin group and 35 months (IQR, 13 to 60 months) in the placebo group (P = 0.65). Totals of 645 (76%) and 646 (76%) patients in the vitamin and placebo groups, respectively, completed at least 1 year of oral therapy (P = 0.98), and 400 (47%) and 426 (50%) patients, respectively, completed at least 3 years (P = 0.23). Totals of 394 (46%) and 390 (46%) patients in the vitamin and placebo groups, respectively, discontinued the vitamin regimen (P = 0.67), and 17% of patients withdrew from the study. The primary end point occurred in 230 (27%) patients in the vitamin group and 253 (30%) in the placebo group (hazard ratio, 0.89 [95% CI, 0.75 to 1.07]; P = 0.21). No evidence suggested harm from vitamin therapy in any category of adverse events. LIMITATION There was considerable nonadherence and withdrawal, limiting the ability to draw firm conclusions (particularly about safety). CONCLUSION High-dose oral multivitamins and multiminerals did not statistically significantly reduce cardiovascular events in patients after MI who received standard medications. However, this conclusion is tempered by the nonadherence rate. PRIMARY FUNDING SOURCE National Institutes of Health.

Military Report More Complementary and Alternative Medicine Use than Civilians

OBJECTIVES The study objective was to estimate complementary and alternative medicine (CAM) use among active duty military and compare data with civilian use. DESIGN A global survey on CAM use in the 12 previous months was conducted. Final participants (16,146) were stratified by gender, service, region, and pay grade. Analysis included prevalence of CAM use, demographic and lifestyle characteristics. RESULTS Approximately 45% of respondents reported using at least one type of CAM therapy. Most commonly used therapies were as follows: prayer for ones own health (24.4%), massage therapy (14.1%), and relaxation techniques (10.8%). After exclusion of prayer for ones own health, adjusting to the 2000 U.S. census, overall CAM use in the military (44.5%) was higher than that in comparable civilian surveys (36.0% and 38.3%). CONCLUSIONS Military personnel reported using three CAM stress-reduction therapies at 2.5-7 times the rate of civilians. Among the military, high utilization of CAM practices that reduce stress may serve as markers for practitioners assessing an individuals health and well-being.

The association of complementary and alternative medicine use and health care expenditures for back and neck problems

Background:Health care costs associated with use of complementary and alternative medicine (CAM) by patients with spine problems have not been studied in a national sample. Objectives:To estimate the total and spine-specific medical expenditures among CAM and non-CAM users with spine problems. Research Design:Analysis of the 2002–2008 Medical Expenditure Panel Survey. Subjects:Adults (above 17 y) with self-reported neck and back problems who did or did not use CAM services. Measures:Survey-weighted generalized linear regression and propensity matching to examine expenditure differences between CAM users and non-CAM users while controlling for patient, socioeconomic, and health characteristics. Results:A total of 12,036 respondents with spine problems were included, including 4306 (35.8%) CAM users (40.8% in weighted sample). CAM users had significantly better self-reported health, education, and comorbidity compared with non-CAM users. Adjusted annual medical costs among CAM users was

Randomized Effectiveness Trial of a Brief Course of Acupuncture for Posttraumatic Stress Disorder

424 lower (95% confidence interval: