Archives Decides At Last Minute Not to Publish a Scheduled Paper 6

Here’s something I’ve never seen: 12 minutes before the scheduled publication of a paper the journal publishing the paper announced that it had “made the decision not to publish” the paper. Here’s what happened:

Last Thursday the JAMA/Archives media team issued a press package to  accredited media about several articles scheduled for publication in Archives of Internal Medicine on Monday (today) at 4 PM ET. The package included a press release (see below) about an article, “Stress Reduction in the Secondary Prevention of Cardiovascular Disease: A Randomized Controlled Trial of Transcendental Meditation and Health Education in African Americans.” The first author was Robert Schneider, MD, from the Maharishi University of Management, Maharishi Vedic City, Iowa. Co-authors from the same institution were: Maxwell Rainforth PhD, Sanford Nidich. EdD, Carolyn Gaylord-King, PhD, John Salerno, PhD, and Charles Alexander, PhD. Two other authors, Clarence Grim and Theodore Kotchen are from the Medical College of Wisconsin in Milwaukee.

Today (Monday), at 3:48 PM ET, 12 minutes before the scheduled publication of the paper, the following message appeared in my inbox:

Subject: Important Notice from Archives of Internal Medicine — Please Open Immediately!

The editorial office of the Archives of Internal Medicine has made the decision not to publish,  “Stress Reduction in the Secondary Prevention of Cardiovascular Disease: A Randomized Controlled Trial of Transcendental Meditation and Health Education in African Americans,” by Schneider et al, and the accompanying Commentary by Mehta and Bairey Merz that was to post Online First at 3 PM central time today.

The decision is to allow time for review and statistical analysis of additional data not included in the original paper that the authors provided less than 24 hours before posting. We apologize for the short notice, but hope you will understand and not run your stories on this study today.

Sincerely,

JAMA/Archives Media Relations

Without more information it’s difficult to comment at this point, but I strongly suspect that we will hear more about this story in the future. It should be noted that the study was funded by the NHLBI. In addition, the same study was presented at the AHA Scientific Sessions in 2009. The first author, Robert Schneider, is the Dean of the College of Maharishi Consciousness Based Health Care at Maharishi University of Management and Director of the Institute for Natural Medicine and Prevention, which is funded by the NIH’s National Center for Complementary and Alternative Medicine. Schneider is a specialist in clinical hypertension and has published extensively, including papers in the American Journal of Cardiology, Stroke, and Hypertension.

[Update: the NCCAM has written to inform me that it "does not currently fund research at Maharishi University of Management; we last provided grant funding to the institution in FY 2004." The information in the article was taken directly from the website linked above.]

For more on this story see my next post.

Here is the press release that was issued by JAMA/Archives last Thursday:

Stress Reduction Approach May Help Reduce Risk of Cardiovascular Events in African-American Patients With Cardiovascular Disease

CHICAGO – A stress reduction approach using meditation techniques in African-American patients who have coronary heart disease (CHD) appears to reduce the risk of death, myocardial infarction (heart attack) and stroke, and also is associated with reduced blood pressure and stress levels, according to a report published Online First today in Archives of Internal Medicine, one of the JAMA/Archives journals.

According to background information in the article, cardiovascular disease (CVD) is the leading cause of death in the United States and worldwide. The authors note that African Americans have higher rates of CVD-related illness and death, and that psychosocial stress might be a contributing factor. “The disparity in CVD in African Americans may be related, at least in part, to high levels of psychosocial and environmental stress,” they write.

Robert H. Schneider, M.D., from the Maharishi University of Management, Maharishi Vedic City, Iowa, and colleagues investigated the effect of stress reduction with the Transcendental Meditation (TM) program, in 201 African American patients with CHD. The clinical portion of the study was conducted at the Medical College of Wisconsin, Milwaukee. The researchers theorized that the effects of a stress reduction intervention would help reduce CVD risk factors and perhaps prevent CVD-related morbidity and mortality. Between 1998 and 2007, study participants either engaged in meditation techniques for 20 minutes twice per day, or spent the same amount of time practicing other heart-healthy lifestyle behaviors that they were taught in a cardiovascular health education program.

The researchers found that the group practicing meditation had a lower risk, compared with the control group, of experiencing the combined endpoint of cardiovascular events that included myocardial infarction or stroke, or death. This group also experienced a reduction in systolic blood pressure of, on average, 4.9 mm Hg (millimeters of mercury) more than the control group. Participants who entered the study with high blood pressure or high stress levels were more likely to have a lower risk of CVD-related illness and death if they were in the meditation group, versus the health education group.

The authors point out that in addition to a reduction in clinical endpoints, participants who practiced meditation techniques were more likely to experience less stress and anger. Those who adhered most closely to the protocol for meditation frequency and length had greater risk reduction. “The results of this trial placed in the context of other studies in the field suggest that the TM program is feasible and efficacious to clinically implement in patients with CHD for prevention of CVD clinical events and associated risk factors,” the researchers conclude. “These clinical data along with cost-effectiveness data have implications for the role of behavioral intervention in prevention-oriented cardiovascular practice and policy.”
(Arch Intern Med. Published online June 27, 2011. doi:10.1001/archinternmed.2011.310. Available pre-embargo to the media at http://www.jamamedia.org.)

Editor’s Note: This study was funded by a grant from the National Institutes of Health, National Heart, Lung and Blood Institute. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Commentary: Stressing Stress Relief

An accompanying commentary discusses the role that psychosocial stress may play in CVD, and the relevance of the findings from the study by Schneider and colleagues. Besides aggravating the effects of other pathophysiologic risk factors, the article states, psychosocial stress may contribute to injury of the lining of the blood vessel wall and to early atherosclerosis. “Accordingly, interventions that address psychosocial stress offer new therapeutic opportunities to ameliorate CHD morbidity and mortality,” write Puja K. Mehta, M.D. and C. Noel Bairey Merz, M.D., both from Cedars-Sinai Medical Center in Los Angeles.

Although the study by Schneider and colleagues improved some measures of stress and anger in the intervention group, they point out, it did not seem to affect other measures. For example, the level of depression was not significantly different between the treatment and control groups. This, apparently, is in concordance with other research which has not shown that stress reduction can reduce major adverse events by mitigating depression, isolation and lack of social support.

Still, Mehta and Bairey Merz note, the meditation practice studied by Schneider and colleagues appeared to benefit patients with CHD, offering “new hope for the beleaguered area of psychosocial stress intervention for improving health outcomes in our over 13 million women and men with established CHD in the United States.” They urge further research into how these methods can best help patients. “Secondary prevention guidelines should include psychosocial stress interventions demonstrated to reduce morbidity and mortality,” they add. “Cardiac rehabilitation programs should reinvigorate their psychosocial screening and treatment options.”
(Arch Intern Med. Published online June 27, 2011. 2011;doi:10.1001/archinternmed.2011.300. Available pre-embargo to the media at http://www.jamamedia.org.)

Editor’s Note: This work was supported by the National Center for Complementary and Alternative Medicine, the National Institutes of Health General Clinical Research Center, the National Center for Research Resources, the Women’s Guild of Cedars-Sinai Medical Center, the Edythe L. Broad Women’s Heart Research Fellowship and the Barbra Streisand Women’s Cardiovascular Research and Education Program at Cedars-Sinai Medical Center. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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6 comments

  1. Pingback: New Concerns Raised About Withdrawn Archives Meditation Paper « CardioBrief

  2. RE: NCCAM update

    Although the last NCCAM funding for TM was 2004, regular NIH funding has continued right to the present.

    The National Institutes of Health has granted more than $24 million over the past 20 years to study the effects of the Transcendental Meditation program on cardiovascular disease. The following is a summary of findings of the published research as well as a listing of universities where recent studies have been conducted.

    Reduced Metabolic Syndrome (American Medical Association’s Archives of Internal Medicine, June 2006)
    This 16-week, randomized, placebo-controlled clinical trial of 103 coronary heart patients found Transcendental Meditation improved blood pressure and insulin resistance components of the metabolic syndrome as well as cardiac autonomic nervous system tone compared with a control group receiving health education. These results suggest that TM may modulate the physiological response to stress and improve coronary heart disease risk factors.

    Extended Longevity (American Journal of Cardiology, May 2005)
    This study was a first-of-its-kind long-term, randomized trial. It evaluated the death rates of 202 men and women, average age 71, who had mildly elevated blood pressure. Subjects in the study participated in the Transcendental Meditation program; behavioral techniques, such as mindfulness or progressive muscle relaxation; or health education. The study tracked subjects for up to 18 years. The study found that the Transcendental Meditation technique reduced death rates by 23%.

    Reduced Blood Pressure and Reduced Use of Hypertensive Medication (American Journal of Hypertension, January 2005)
    This long-term, clinical trial evaluated 150 men and women, average age 49, with stage I hypertension (average blood pressure 142/95 mm Hg). Blood pressure in the Transcendental Meditation group reduced by nearly 6 mm diastolic pressure and 3 mm systolic pressure. In contrast, blood pressure in the progressive muscle relaxation group and conventional health education classes reduced by 3 mm diastolic pressure, with no change in systolic pressure. Use of hypertensive medication was also found to significantly decrease in the TM group in comparison with controls.

    Reduced Blood Pressure in At-risk Teens (American Journal of Hypertension, April, 2004) This $1.5M, four-year, randomized, controlled study found that adolescents at risk for heart disease experienced decreased blood pressure as a result of the daily practice of Transcendental Meditation.

    Reduced Atherosclerosis (American Journal of Cardiology, April 2002)
    This study found that subjects with multiple risk factors for cardiovascular disease substantially reduced atherosclerosis through a multi-modality treatment program derived from a traditional medicine that included the daily practice of Transcendental Meditation. In the study, 57 adults were randomly assigned into three treatment groups. After one year, the ceratoid intima-media thickness decreased significantly more in the subjects who were randomly assigned to the TM group.

    Reduced Thickening of Coronary Arteries (Stroke, March 2000)
    A study found that the daily practice of the TM technique reduced the thickening of coronary arteries in hypertensive adults, thereby decreasing the risk of heart attack and stroke. After 6 to 9 months, carotid intima-media thickness decreased in the TM group as compared to matched control subjects. This reduction was similar to that achieved by lipid-lowering drugs and extensive lifestyle changes.

    Reduced Constriction of Blood Vessels(Psychosomatic Medicine, July 1999 and January 1999)
    A study of middle-aged adults reported that the TM technique reduced blood pressure by reducing constriction of the blood vessels (vasoconstriction), thereby decreasing the risk of heart disease. A separately published study on adolescents with high normal blood pressure found that randomly assigned subjects who practiced the TM technique exhibited greater decreases in resting blood pressure, vascular resistance, and stress reactivity from pre-to post-treatment, compared to controls.

    Reduced Blood Pressure(International Journal of Neuroscience, January 1997)
    Findings from a controlled study showed a significant reduction in ambulatory diastolic blood pressure in subjects regularly practicing the TM technique, compared to controls.

    Reduced Myocardial Eschemia (American Journal of Cardiology, May 1996)
    Study found that the TM program significantly reduced myocardial eschemia in coronary artery disease patients after eight months of practice.

    Reduced Blood Pressure: Comparisons with Other Procedures(Hypertension—the American Heart Association’s journal—November 1995 and August 1996)
    Clinical studies of older African Americans found that the TM program was 1) as effective as antihypertensive drugs in reducing blood pressure, 2) twice as effective as progressive muscle relaxation in lowering hypertension, and, 3) significantly effective in reducing blood pressure for both men and women in all five major risk categories including obesity, high alcohol use, low exercise levels, psychological stress and high salt intake.

    Update on NIH-funded research on Transcendental Meditation

    Cedars-Sinai Hospital, Los Angeles
    The effects of Transcendental Meditation on cardiovascular disease in coronary heart disease patients with metabolic syndrome

    Published in the American Medical Association’s Archives of Internal Medicine, July 2006

    Howard University School of Medicine, Washington, D.C.
    Morehouse School of Medicine, Atlanta
    The effects of Transcendental Meditation in older African American women at risk for heart disease
    Findings presented at the annual meeting of the American College of Cardiology, March 2006

    Charles R. Drew University of Medicine and Science, Los Angeles
    (1) A study on the mechanisms of atherosclerosis—the effects of Transcendental Meditation on the sympathetic nervous system and the functioning of the arterial endothelium in African Americans; and (2) The effects of Transcendental Meditation on carotid atherosclerosis
    Published in the American Heart Association’s Stroke

    University of California, Irvine
    The effects of Transcendental Meditation on brain functioning, stress, and pain as shown by magnetic resonance imaging (MRI)
    Published in Neuroreport, August 2006

    The Medical College of Wisconsin, Milwaukee
    (1) The effects of Transcendental Meditation on the prevention of hypertension in African Americans; and (2) The effects of Transcendental Meditation on morbidity and mortality in African Americans with heart disease
    Update: The NIH recently awarded another $2 million to continue the study for another four years (for a total of 8 years)

    University of Iowa
    The effects of the multimodality approach of TM and Ayurvedic medicine on coronary disease
    Findings presented at the annual meeting of the American College of Cardiology, March 2006

    University of Pennsylvania
    The effects of Transcendental Meditation on congestive heart failure
    Submitted for publication

    University of Hawaii
    The effects of Transcendental Meditation in slowing hardening of the arteries in older, high-risk native Hawaiians
    Submitted for publication

    —————-
    NIH awarded grant of $8 million to Maharishi University of Management to establish first research center in US for natural preventive medicine for minorities. (September, 1999)
    The Center for Natural Medicine and Prevention will study effectiveness of TM program and antioxidant herbal preparations (such as Maharishi Amrit Kalash) in treating and preventing cardiovascular disease in African Americans and other high-risk groups. Research will also include other serious chronic diseases.

    NIH also gave $1.8 million to a project studying stress reduction and atherosclerotic cardiovascular disease (CVD) in African Americans.
    Project directed by Dr. Robert Schneider and scientists at major Los Angeles medical center.

  3. I’ve not kept up with more recent TM research, but here are two more NIH funded studies, both from 2007.

    Reduced Blood Pressure (Current Hypertension Reports, December 2007) 

    This meta-analysis of 17 published studies from the medical literature (selected from over 100 published studies for their careful experimental design utilizing randomized controlled trials) reported on the effects of stress reduction techniques on elevated blood pressure in about 1000 subjects total.  The treatments employed included simple biofeedback, relaxation-assisted biofeedback, progressive muscle relaxation, stress management training, and the Transcendental Meditation program.  The results of statistical analyses showed that none of the first 4 treatment approaches demonstrated statistically significant reductions in elevated blood pressure, while the Transcendental Meditation program showed both significant clinical and statistical reductions in blood pressure.

    Improved Quality of Life for Congestive Heart Failure Patients (Ethnicity and Disease, March 2007)

    This study examined the effects of conventional health education and the practice of the Transcendental Meditation technique on measures of heart failure severity and quality of life in a randomized controlled trial of twenty-three older African American men and women with congestive heart failure (CHF). The results indicate that the use of the TM technique may be effective in improving the quality of life and functional capacity of heart failure patients. Full Article

  4. Pingback: 2011 in Review: Rivaroxaban, Sapien, Mark Midei, Conflicts of Interest, and Much More

  5. Pingback: Mysterious Disappearing Paper Finally Reappears In Another Journal « CardioBrief

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