African Countries That Received More Intensive Assistance From AIDS Relief Program Show Greater Decline in Death Rate

Posted May 11, 2012 by sscadmin

EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, MAY 15, 2012

Media Advisory: To contact Eran Bendavid, M.D., M.S., call Ruthann Richter at 650-725-8047 or email richter1@stanford.edu. To contact editorial author Ezekiel J. Emanuel, M.D., Ph.D., call Holly Auer at 215-349-5659 or email holly.auer@uphs.upenn.edu.

CHICAGO – Between 2004 and 2008, all-cause adult mortality declined more in African countries in which the AIDS relief program PEPFAR operated more intensively, according to a study in the May 16 issue of JAMA, a theme issue on Global Health.

“The effect of global health initiatives on population health is uncertain. Between 2003 and 2008, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the largest initiative ever devoted to a single disease, operated intensively in 12 African focus countries,” according to background information in the article. PEPFAR has targeted the rapidly expanding human immunodeficiency virus (HIV) epidemic with a coordinated effort to increase HIV treatment, prevention, and care. PEPFAR scaled up the delivery of expanded antiretroviral therapy (ART) and supported large-scale prevention efforts. The initiative’s effect on all-cause adult mortality has not been known.

Eran Bendavid, M.D., M.S., of Stanford University, Stanford, Calif., and colleagues examined the relationship between PEPFAR’s implementation and trends in adult mortality. Using person-level data from the Demographic and Health Surveys (DHS), the researchers conducted cross-country and within-country analyses of adult mortality (annual probability of death per 1,000 adults between 15 and 59 years old) and PEPFAR activities. Across countries, adult mortality was compared in 9 African focus countries (Ethiopia, Kenya, Mozambique, Namibia, Nigeria, Rwanda, Tanzania, Uganda, and Zambia) with adult mortality in 18 African nonfocus countries from 1998 to 2008.

The study included data on 1,538,612 African adults collected from 41 surveys conducted in 27 countries between 1998 and 2008. During this time period, 60,303 deaths were captured in the DHS used in this study. Analysis of the data indicated relatively greater mortality declines among adults living in focus countries between 2004 and 2008, with mortality in the focus countries declining from 8.30 per 1,000 adults in 2003 to 4.10 per 1,000 in 2008. The mortality trends in nonfocus countries did not show a similar decline during the study period (from 8.5 in 2003 to 6.9 in 2008). After adjustments for country-level and personal characteristics, the odds of all-cause death was lower in the focus countries.

The authors also examined district-level data for Tanzania and Rwanda. High and low PEPFAR activity districts had similar populations, but program intensity was significantly different between the groups. Adults in Tanzania living in the regions with above-median (midpoint) PEPFAR intensity had a lower odds of mortality compared with adults living in regions with below-median intensity; in Rwanda, the similar comparison also revealed a lower odds of mortality for adults living in the regions with above-median PEPFAR intensity.

The researchers also found that, using the results for each focus country and generalizing to the size of each country’s adult population, an estimated total of 740,914 all-cause adult deaths were averted between 2004 and 2008 in association with PEPFAR. In comparison, PEPFAR was associated with an estimated 631,338 HIV-specific deaths averted during the same period.

“In conclusion, we provide new evidence suggesting that reductions in all- cause adult mortality were greater in PEPFAR’s focus countries relative to the nonfocus countries over the time period from 2004 through 2008. Our analysis suggests an association of PEPFAR with these improvements in population health,” the authors write.

(JAMA. 2012;307[19]:2060-2067. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Please Note: For this study, there will be multimedia content available, including the JAMA Report video, embedded and downloadable video, audio files, text, documents, and related links. This content will be available at 3 p.m. CT Tuesday, May 15 at this link.

Editorial: PEPFAR and Maximizing the Effects of Global Health Assistance

In an accompanying editorial, Ezekiel J. Emanuel, M.D., Ph.D., of the University of Pennsylvania, Philadelphia, writes that the “article by Bendavid et al is welcome news in helping to document the even greater benefits of PEPFAR not only on HIV/AIDS but on overall mortality in countries.”

“However, the further question that must be asked by ethically responsible people and policy makers becomes: Is PEPFAR worth it? Many other global health programs are improving the health of poor people worldwide but are not funded anywhere near the level of PEPFAR. The fundamental ethical, economic, and policy question is not whether PEPFAR is doing good, but rather whether other programs would do even more good in terms of saving life and improving health. Clearly, besides treatment for HIV/AIDS, there are other highly effective and lower-cost interventions for the world’s poor.”

(JAMA. 2012;307[19]:2097-2099. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Emanuel reported receiving payment for speaking engagements unrelated to this work.

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Prenatal Micronutrient, Food Supplementation Intervention in Bangladesh Decreases Child Mortality Rate

Posted May 11, 2012 by sscadmin

EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, MAY 15, 2012

Media Advisory: To contact Lars Ake Persson, M.D., Ph.D., email lars-ake.persson@kbh.uu.se. To contact editorial co-author Robert E. Black, M.D., M.P.H., call Tim Parsons at 410-955-7619 or email tmparson@jhsph.edu.

CHICAGO – Pregnant women in poor communities in Bangladesh who received multiple micronutrients, including iron and folic acid combined with early food supplementation, had substantially improved survival of their newborns, compared to women in a standard program that included usual food supplementation, according to a study in the May 16 issue of JAMA, a theme issue on Global Health.

“Maternal and child undernutrition is estimated to be the underlying cause of 3.5 million annual deaths and 35 percent of the total disease burden in children younger than 5 years. The potential long-term consequences of nutritional imbalance or insult in fetal or early life also include cognitive impairment and chronic diseases in adulthood. Effective child nutrition interventions are available to reduce stunting, prevent consequences of micronutrient deficiencies, and improve survival. The knowledge base is weaker regarding prenatal nutrition interventions of benefit for mother and offspring,” according to background information in the article. “The proportion of malnourished mothers and children remains high in many areas of the world, especially in South Asia, where more than one-quarter of newborns have a low weight.”

Lars Ake Persson, M.D., Ph.D., of Uppsala University, Uppsala, Sweden, and colleagues conducted a study (the MINIMat trial) to examine whether a prenatal multiple micronutrient supplementation (MMS), as well as an early invitation to a daily food supplementation, would increase maternal hemoglobin level at 30 weeks’ gestation, birth weight, and infant survival, and that a combination of these interventions (early invitation with MMS) would further improve these outcomes. The randomized trial, conducted in Matlab, Bangladesh, included 4,436 pregnant women who were recruited between November 2001 and October 2003, with follow-up until June 2009. One-third of the women were illiterate and one-fifth experienced occasional or constant deficit in their perceived income-expenditure status.

Participants were randomized into 6 groups; a double-masked supplementation with capsules of 30 mg of iron and 400 μg of folic acid, 60 mg of iron and 400 μg of folic acid, or MMS containing a daily allowance of 15 micronutrients, including 30 mg of iron and 400 μg of folic acid, was combined with food supplementation randomized to either early invitation (9 weeks’ gestation) or usual invitation (20 weeks’ gestation).

There were 3,625 live births out of 4,436 pregnancies. The average birth weight among 3,267 single-birth infants was 2,694 grams (5.9 lbs.). Overall, 31 percent of newborns weighed less than 2,500 g (5.5 lbs.). There was no significant difference in birth weight among treatment groups, and no main-effect differences between food groups or among micronutrient groups. The researchers found that infants in the early invitation with MMS group had a lower risk of death, with a mortality rate of 16.8 per 1,000 live births vs. 44.1 per 1,000 live births for usual invitation with 60 mg of iron and 400 μg of folic acid. The early invitation with MMS group had an under 5-year mortality rate of 18 per 1,000 live births (54 per 1,000 live births for usual invitation with 60 mg of iron and 400 μg of folic acid). Usual care invitation with MMS had the highest infant mortality rate (47.1 per 1,000 live births).

Adjusted maternal hemoglobin level at 30 weeks’ gestation was 115.0 g/L, with no significant differences among micronutrient groups. Women in the early invitation group had a small (0.9 g/L) but statistically significant lower hemoglobin level concentration than those in the usual invitation group.

“Scientists and policymakers have recommended replacing the current iron-folic acid supplements with MMS in the package of health and nutrition interventions delivered to pregnant women to improve size at birth and child growth and development. Other studies have questioned this view based on the limited size of the effect on birth weight and the absence of positive effect on fetal and neonatal survival. The MINIMat trial provides evidence that mortality of the offspring was reduced if multiple micronutrients were combined with a balanced protein-energy supplementation that began early in pregnancy,” the researchers conclude.

(JAMA. 2012;307[19]:2050-2059. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Food, Micronutrients, and Birth Outcomes

In an accompanying editorial, Parul Christian, Dr.P.H., M.Sc., and Robert E. Black, M.D., M.P.H., of the Johns Hopkins Bloomberg School of Public Health, Baltimore, write that results from one country, such as in this study, “may not be applicable in other settings for a number of reasons, including variable maternal prepregnancy status, levels of macronutrient and micronutrient deficiencies, and antenatal [before birth] and delivery care availability.”

“Several nutrition programs in Asia and Africa have long targeted pregnant and lactating women in large-scale food supplementation programs, such as the one ongoing in Bangladesh when this trial was conducted. Coverage rates in these programs are known to be generally low and women are normally identified late in pregnancy. Further research on the timing of nutritional interventions including prior to and early and late in pregnancy is needed to examine their efficacy and safety both for survival and other long-term developmental consequences.”

(JAMA. 2012;307[19]:2094-2096. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: Both authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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Also Appearing in This Week’s JAMA Theme Issue on Global Health

Posted May 11, 2012 by sscadmin

Prevalence of Girl Child Marriage Decreases in South Asia

Girl child marriage (i.e., < 18 years of age) affects more than 10 million girls globally each year and is linked to maternal and infant morbidities (e.g., delivery complications, low birth weight) and an increased risk of death. Half (46 percent) of child marriages occur in South Asia. Anita Raj, Ph.D., M.S., of the

University of California, San Diego, and colleagues conducted a study to assess whether the prevalence of girl child marriage has changed over the past 2 decades in 4 South Asian nations (Bangladesh, India, Nepal, and Pakistan) with a girl child marriage prevalence of 20 percent or greater.

As reported in a Research Letter, the authors found that the prevalence of girl child marriage decreased in all countries from 1991-1994 to 2005-2007. Significant relative reductions occurred in marriage of girls prior to age 14 years across all 4 nations. Little or no change over time was seen in marriage of 16- to 17-year-old adolescent girls for any nation except Bangladesh, where such marriages increased by 35.7 percent. “Reductions in girl child marriage in South Asia have occurred but are largely attributable to success delaying marriage among younger but not older adolescent girls. Improvements in education of girls and increasing rural to urban migration may have supported these reductions, but many schools graduate students at the 10th standard (about 15-16 years), maintaining vulnerability to early marriage for 16- to 17-year-old girls.”

(JAMA. 2012;307[19]:2027-2029. Available pre-embargo to the media at www.jamamedia.org)

A Framework Convention on Global Health – Health for All, Justice for All

In a Special Communication, Lawrence O. Gostin, J.D., of the Georgetown University Law Center, Washington, D.C., writes that “health inequalities represent perhaps the most consequential global health challenge and yet they persist despite increased funding and innovative programs.”

A global coalition of civil society and academics—the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI)— has formed an international campaign to advocate for a Framework Convention on Global Health (FCGH). Recently endorsed by the UN Secretary-General, the FCGH would re-imagine global governance for health. Mr. Gostin examines the key modalities of an FCGH to illustrate how it would improve health and reduce inequalities. “The modalities would include defining national responsibilities for the population’s health; defining international responsibilities for reliable, sustainable funding; setting global health priorities; coordinating fragmented activities; reshaping global governance for health; and providing strong global health leadership through the World Health Organization.”

(JAMA. 2012;307[19]:2087-2092. Available pre-embargo to the media at www.jamamedia.org)

Viewpoints in This Week’s JAMA

Primary Health Care in Low-Income Countries – Building on Recent Achievements

Jeffrey D. Sachs, Ph.D., of Columbia University, New York, discusses the advances and challenges of providing health care in low-income countries.

“The dozen years since the adoption of the Millennium Development Goals have been a period of great achievement and advances in public health in the poorest countries. The cynics and naysayers were proven wrong. Ancient scourges such as malaria and newer ones such as AIDS can be controlled, even in the poorest places. Now is the time to redouble efforts to ensure that the gains of the past decade are pushed forward to become lasting triumphs.”

(JAMA. 2012;307[19]:2031-2032. Available pre-embargo to the media at www.jamamedia.org)

Policy Making With Health Equity at Its Heart

Michael G. Marmot, F.R.C.P., of University College London, examines the importance of putting health equity – defined as the systematic inequalities in health between social groups that are deemed to be avoidable by reasonable means – at the heart of all policy making, nationally and globally.

“When governments cut social expenditures, the effect is greatest on those at the lower end of the social hierarchy, those who are most dependent on cash and in-kind government expenditures. It should be of the highest priority to ensure that government policies do not unfairly increase avoidable health inequalities. What applies to policies of governments should also apply to global decision making whether on trade, overseas development assistance, or financial flows—put health equity at the heart of all policy making.”

(JAMA. 2012;307[19]:2033-2034. Available pre-embargo to the media at www.jamamedia.org)

Achieving Equity in Global Health – So Near and Yet So Far

Zulfiqar A. Bhutta, F.R.C.P.C.H., Ph.D., of Aga Khan University, Karachi, Pakistan, and K. Srinath Reddy, M.D., D.M., (Card), of the Public Health Foundation of India, New Delhi, write that “few issues have generated as much passion and imagination over the last few decades as the challenge of global health. From major studies on the global burden of disease to the recognition of the global epidemic of human immunodeficiency virus, AIDS, and tuberculosis, health has been center stage of the global development debate.”

The authors discuss the needs of several major global health issues and cite initiatives that have experienced positive outcomes in certain areas of public health.

(JAMA. 2012;307[19]:2035-2036. Available pre-embargo to the media at www.jamamedia.org)

Noncommunicable Diseases – A Global Health Crisis in a New World Order

Shannon L. Marrero, B.A., of Brown University, Providence, R.I., and colleagues write that in September 2011, the United Nations General Assembly (UNGA) held a High-Level Meeting on the Prevention and Control of Non-communicable Diseases. It is only the second time in history that the UNGA convened a high-level meeting in response to a global health crisis. The authors discuss the outcomes and aftermath of the high-level meeting and affirm that the previously unrecognized non-communicable diseases (NCDs) epidemic has at last acquired a voice.

“The NCDs—cardiovascular disease, chronic respiratory disease, diabetes, and cancers—are the dominant public health challenge of the 21st century. Left unattended, NCDs compromise the Millennium Development Goals, thwart the eradication of poverty, and undercut economic growth.”

(JAMA. 2012;307[19]:2037-2038. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: Please see the articles for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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Considerable Prevalence of Both Malaria and Sexually Transmitted/Reproductive Tract Infections Exist Among Pregnant Women in Sub-Saharan Africa

Posted May 11, 2012 by sscadmin

EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, MAY 15, 2012
Media Advisory: To contact R. Matthew Chico, M.P.H., email Katie Steels at katie.steels@lshtm.ac.uk or call +44 (0)20-7927-2802.

CHICAGO – A review of studies reporting estimates of the prevalence of sexually transmitted infections/reproductive tract infections (STIs/RTIs) and malaria over the past 20 years suggests that a considerable burden of malaria and STIs/RTIs exists among pregnant women attending antenatal (before birth) facilities in sub-Saharan Africa, according to a review and meta-analysis of previous studies published in the May 16 issue of JAMA, a theme issue on Global Health.

“There are 880,000 stillbirths and 1.2 million neonatal deaths each year in sub-Saharan Africa. Low birth weight (< 2.5 kg [5.5 lbs.]), attributable to intrauterine growth retardation, preterm delivery, or both, is the leading risk factor for neonatal mortality. Intrauterine infection is implicated in stillbirth and is associated with 25 percent to 40 percent of preterm births. Sexually transmitted infections and reproductive tract infections and malaria are associated with adverse birth outcomes, but both may be mitigated with preventive or presumptive treatment or by repeated screening and treatment throughout the antenatal period. The extent to which either approach may be beneficial depends on the underlying prevalence of STIs/RTIs and malaria in pregnancy,” according to background information in the article.

R. Matthew Chico, M.P.H., of the London School of Hygiene and Tropical Medicine, London, and colleagues conducted a systematic review and meta-analysis to provide estimates for the dual prevalence of STIs/RTIs and malaria in pregnancy among women in sub-Saharan Africa. The researchers conducted a search for studies reporting malaria, syphilis, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, or bacterial vaginosis among pregnant women attending antenatal care facilities in sub-Saharan Africa. A total of 171 studies, which were conducted from 1990-2011, were identified that met inclusion criteria.

The studies included 340,904 women. The researchers found that the pooled prevalence estimates among studies in East and Southern Africa were: syphilis, 4.5 percent (n = 8,346 positive diagnoses), N gonorrhoeae, 3.7 percent (n = 626), C trachomatis, 6.9 percent (n = 350), T vaginalis, 29.1 percent (n = 5,502), bacterial vaginosis, 50.8 percent (n = 4,280), peripheral malaria, 32.0 percent (n = 11,688), and placental malaria, 25.8 percent (n = 1,388).

“West and Central Africa prevalence estimates were as follows: syphilis, 3.5 percent (n = 851), N gonorrhoeae, 2.7 percent (n = 73), C trachomatis, 6.1 percent (n = 357), T vaginalis, 17.8 percent (n = 822), bacterial vaginosis, 37.6 percent (n = 1,208), peripheral malaria, 38.2 percent (n = 12,242), and placental malaria, 39.9 percent (n = 4,658),” the authors write.

“The dual prevalence of malaria and STIs/RTIs is evident among pregnant women who attend antenatal facilities in sub-Saharan Africa. As malaria control and elimination efforts are brought to scale, the relative contribution of STIs/RTIs to adverse birth outcomes most likely will increase proportionately. Coinfection prevalence estimates for malaria and STIs/RTIs need to be established and routinely reported. Rigorous studies using molecular diagnostic methods are needed to characterize more accurately the prevalence of these infections and their clinical consequences. Clinical trials are needed to compare birth outcomes, operational feasibility/acceptability, and cost-effectiveness of intermittent preventive treatment during pregnancy (IPTp) with azithromycin-based combination therapy against an approach of integrated screening and treatment for malaria and STIs/RTIs,” the researchers conclude.
(JAMA. 2012;307[19]:2079-2086. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Mr. Chico reports having previously received funding as part of 2 studies co-financed by Pfizer and the Medicines for Malaria Venture that are investigating the use of azithromycin plus chloroquine in IPTp. No other disclosures were reported.

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Archives of Internal Medicine Study Highlights

Posted May 11, 2012 by sscadmin

Asymptomatic patients who undergo treadmill exercise echocardiography (ExE) after coronary revascularization may be identified as being at high risk but those patients do not appear to have more favorable outcomes with repeated revascularization (Online First, see news release below).

A small clinical trial reported by investigators from Japan suggests that acupuncture appears to be associated with improvement of dyspnea (labored breathing) on exertion, in patients with chronic obstructive pulmonary disease (COPD) (Online First, see news release below).

Feeding tubes do not appear to be associated with prevention or improved healing of pressure ulcers in a study of nursing home residents with advanced cognitive impairment, including 1,124 with a feeding tube and no evidence of a pressure ulcer, and 461 with a feeding tube and having a pressure ulcer.

A review of medical malpractice claims closed between 2002 and 2005 that involved some defense costs suggests that 55.2 percent resulted in litigation, ranging from 46.7 percent for claims against anesthesiologists to 62.6 percent for claims against obstetricians and gynecologists, according to the results reported in a research letter (Online First).

Treatment with the beneficial bacteria Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 in postmenopausal women with recurrent urinary tract infections (UTIs) did not meet the noninferiority criteria in the prevention of UTIs when compared with the antibiotic trimethoprim-sulfamethoxazole in a randomized noninferiority trial. However, the development of antibiotic resistance was lower with the use of lactobacilli.

According to a research letter reporting a study of hospitalization trends for atrial fibrillation (AF, an irregular heart beat) in Australia over a 15-year period compared with the cardiovascular conditions of myocardial infarction (MI, heart attack) and heart failure (HF), there has been an increase in the number of hospitalizations for AF of 203 percent (7.9 percent annually). In comparison, the number of hospitalizations for MI increased 79 percent (4.5 percent annually) and HF hospitalizations increased 17 percent (0.7 percent annually).

(Arch Intern Med. 2012; doi:10.1001/archinternmed.2012.1355; doi:10.1001/archinternmed.2012.1233; 172[9]:697-701; doi:10.1001/archinternmed.2012.1416; 172[9]:704-712; 172[9]739-740. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: Please see the articles for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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Acupuncture Appears Associated with Improvement in Patients with Chronic Obstructive Pulmonary Disease

Posted May 11, 2012 by sscadmin

EMBARGOED FOR RELEASE: 10 A.M. (CT), MONDAY, MAY 14, 2012

Media Advisory: To contact author Masao Suzuki, L.Ac, Ph.D., email masuzuki@meiji-u.ac.jp. To contact corresponding commentary author George T. Lewith, M.A., M.D., F.R.C.P., M.R.C.G.P, email gl3@southampton.ac.uk.

CHICAGO – According to a small clinical trial reported by investigators from Japan, acupuncture appears to be associated with improvement of dyspnea (labored breathing) on exertion, in patients with chronic obstructive pulmonary disease (COPD), according to a study published Online First by Archives of Internal Medicine, a JAMA Network publication.

The management of dyspnea is an important target in the treatment of COPD, a common respiratory disease characterized by irreversible airflow limitation. COPD is predicted to be the third leading cause of death worldwide by 2020, according to the study background.

Masao Suzuki, L.Ac., Ph.D., of Kyoto University and Meiji University of Integrative Medicine, Kyoto, Japan, and colleagues conducted a randomized controlled trial from July 2006 through March 2009. A total of 68 patients diagnosed with COPD participated, and 34 were assigned to a real acupuncture group for 12 weeks, plus daily medication. The other 34 were assigned to a placebo acupuncture group in which the needles were blunt (and appeared to, but did not enter the skin). The primary measure was the evaluation of a six-minute walk test on a Borg scale where 0 meant “breathing very well, barely breathless” and 10 signified “severely breathless.”

“We demonstrated clinically relevant improvements in DOE [dyspnea on exertion] (Borg scale), nutrition status (including BMI), airflow obstruction, exercise capacity and health-related quality of life after three months of acupuncture treatment,” the authors note.

After 12 weeks of treatment, the Borg scale score after the six-minute walk test improved from 5.5 to 1.9 in the real acupuncture group. No improvement was seen in the Borg scale score in the placebo acupuncture group before and after treatment (4.2 and 4.6, respectively), according to the study results.

“Randomized trials with larger sample sizes and longer-term interventions with follow-up evaluations are necessary to confirm the usefulness of acupuncture in COPD treatment,” the authors conclude.

(Arch Intern Med. Published online May 14, 2012. doi:10.1001/archinternmed.2012.1233. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: The trial was funded by the Grants-in-Aid for scientific research from the Japan Society of Acupuncture and Moxibustion (JSAM). Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Invited Commentary: Reevaluating Acupuncture Research Methods

In an invited commentary, George T. Lewith, M.A., M.D., F.R.C.P., M.R.C.G.P, and Mike Thomas, Ph.D., F.R.C.P., of the University of Southampton, Hampshire, England, write: “Where does this study lead us? The authors note that acupuncture must be used in addition to conventional care, and although this is undoubtedly correct, it may have significant economic implications.”

They continue: “Evaluating traditional interventions, such as acupuncture, that are widely available has many implications, including the fact that best practice and dose response have rarely been evaluated scientifically as would be the case for a new pharmaceutical agent.”

“This study points to an important potential role for acupuncture in COPD management. These findings demand larger but equally methodologically rigorous confirmatory studies if we are to consider integrating this approach into our management strategy,” they conclude.

(Arch Intern Med. Published online May 14, 2012. doi:10.1001/archinternmed.2012.1674. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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Study Examines Exercise Testing in Asymptomatic Patients After Coronary Revascularization

Posted May 11, 2012 by sscadmin

EMBARGOED FOR RELEASE: 10 A.M. (CT), MONDAY, MAY 14, 2012

Media Advisory: To contact corresponding author Thomas H. Marwick, M.D., Ph.D., M.P.H., call Tora Vinci at 216-444-2412 or email vinciv@ccf.org. To contact commentary author Mark J. Eisenberg, M.D., M.P.H., call Allison Flynn at 514-398-7698 or email allison.j.flynn@mcgill.ca.

CHICAGO – Asymptomatic patients who undergo treadmill exercise echocardiography (ExE) after coronary revascularization may be identified as being at high risk but those patients do not appear to have more favorable outcomes with repeated revascularization, according to a report published Online First by Archives of Internal Medicine, a JAMA Network publication. The article is part of the journal’s Less is More series.

Cardiac events and recurrent ischemia (a temporary shortage of oxygen caused by impaired blood flow; identified in the study as new or worsening cardiac wall motion abnormality shown on the echocardiogram) are common after revascularization procedures, both percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG).

Guidelines of the American College of Cardiology/American Heart Association recommend evaluation with stress imaging tests, including ExE, in symptomatic patients after revascularization, but evaluating asymptomatic patients “is more controversial,” the authors note in the study background.

“Testing is considered inappropriate early after PCI (<2 years) and CABG (<5 years), but the justification for these cutoffs is ill defined,” the study notes.

Serge C. Harb, M.D., and colleagues at the Cleveland Clinic Heart and Vascular Institute, Ohio, examined the effectiveness of testing asymptomatic patients early and late postrevascularization. Their observational study was conducted with data from asymptomatic patients with a history of PCI or CABG who were referred for ExE at the Cleveland Clinic from January 2000 through November 2010.

ExE was performed in 2,105 asymptomatic patients (average age 64; 310 were women; 845 [40 percent] had a history of myocardial infarction [heart attack]; 1,143 [54 percent] had undergone PCI and 962 [46 percent] had undergone CABG an average of 4.1 years before the ExE).

Ischemia was detected in 262 patients and 88 of them underwent repeated revascularization. A total of 97 patients died over an average followup period of 5.7 years, and death was associated with ischemia in groups tested both early (less than two years after PCI or less than five years after CABG) and late (two or more years after PCI, or five or more years after CABG), according to the study results. The main predictor of outcome appeared to be exercise capacity, “suggesting that risk evaluation could be obtained from a standard exercise test rather than exercise echocardiography,” the authors note.

“In conclusion, the results of this study suggest that asymptomatic patients who undergo treadmill ExE after coronary revascularization may be identified as being at high risk but do not seem to have more favorable outcomes with RVs [repeated revascularization],” the authors conclude. “Given the very large population of post-PCI and post-CABG patients, careful consideration is warranted before the screening of asymptomatic patients is considered appropriate at any stage after revascularization.”

(Arch Intern Med. Published online May 14, 2012. doi:10.1001/archinternmed.2012.1355. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Invited Commentary: Is Routine Stress Testing Worth the Effort in Asymptomatic Patients After Coronary Revascularization?

In an invited commentary, Mark J. Eisenberg, M.D., M.P.H., of McGill University, Montreal, Canada, writes: “A strategy of routine periodic stress testing in asymptomatic patients following coronary revascularization is associated with high rates of resource utilization and high costs. Most positive test results using such a strategy will be false-positives and will lead to further testing and additional angiographic procedures.”

Eisenberg continues: “Despite the fact that current evidence discourages the use of routine testing, this strategy is still commonly observed in practice. Thus, the time has arrived for a large, well-controlled trial randomizing asymptomatic patients postrevascularization to routine periodic stress testing vs. conservative management.”

“Until well-supported data become available supporting such a strategy, routine testing in asymptomatic patients is probably not worth the effort,” Eisenberg concludes.

(Arch Intern Med. Published online May 14, 2012. doi:10.1001/archinternmed.2012.1910. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: Dr. Eisenberg is a national investigator of the Quebec Fund for Health Research. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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Flu Vaccination Reminder Via Text Messaging Appears to Improve Rate of Vaccination Among Low-Income Children and Adolescents

Posted May 8, 2012 by

EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, APRIL 24, 2012

Media Advisory: To contact Melissa S. Stockwell, M.D., M.P.H., call Karin Eskenazi at 212-305-3900 or email ket2116@columbia.edu; or call Stephanie Berger at 212-305-4372 or email sb2247@columbia.edu. To contact editorial co-author William G. Adams, M.D., call Jenny Eriksen Leary at 617-638-6841 or email jenny.eriksen@bmc.org.

CHICAGO – A text messaging intervention with education-related messages sent to parents increased influenza vaccination coverage compared with usual care in a traditionally hard-to-reach, low-income, urban, minority population of children and adolescents, although coverage overall remained low, according to a study in the April 25 issue of JAMA.

“Timely vaccination is the cornerstone of influenza prevention through vaccination of susceptible populations before illness becomes epidemic in communities. The effectiveness of the influenza vaccine in children and adolescents ranges from 66 percent to 95 percent, depending on age, vaccine type, and season,” according to background information in the article. Children and adolescents ages 6 months to 18 years are at increased risk for influenza illness and death, and influenza is one of the most common causes of hospitalization in children and adolescents. Influenza vaccine coverage nationally remains low; only 51 percent of those ages 6 months to 17 years were vaccinated in the 2010-2011 season according to parental report. “Coverage is lower in low-income populations who are at higher risk of influenza spread due to crowded living conditions,” the authors write. “Traditional vaccine reminders have had a limited effect on low-income populations; however, text messaging is a novel, scalable approach to promote influenza vaccination.”

Melissa S. Stockwell, M.D., M.P.H., of Columbia University, New York, and colleagues evaluated the effect of targeted text messages for low-income, urban parents to promote influenza vaccine receipt among children and adolescents. The randomized controlled trial included 9,213 children and adolescents ages 6 months to 18 years who were receiving care at 4 community-based clinics in the United States during the 2010-2011 influenza season. Of the 9,213 children and adolescents, 7,574 had not received influenza vaccine prior to the intervention start date and were included in the primary analysis. Parents of children assigned to the intervention received up to 5 weekly immunization registry-linked text messages providing educational information and instructions regarding Saturday clinics. Both the intervention and usual care groups received the usual care, an automated telephone reminder, and access to informational flyers posted at the study sites.

The children and adolescents in the study were primarily minority, 88 percent were publicly insured, and 58 percent were from Spanish-speaking families. As of March 31, 2011, a higher proportion of children and adolescents in the intervention group (43.6 percent) compared with the usual care group (39.9 percent) received the influenza vaccine. Of all children and adolescents vaccinated by this date, 93.9 percent of the intervention group were vaccinated outside of the Saturday clinics compared with 97.2 percent of the usual care group.

At the cohort-based fall review date, 27.1 percent of the intervention group vs. 22.8 percent of the usual care group had received influenza vaccine.

The authors note that the intervention effect was greater in a subgroup analysis accounting for delivery of text messages, lending support to the inference that text messaging was effective in promoting the behavioral changes leading to increased vaccination. “Using text messaging (especially when linked with electronic health records [EHRs] or registries) to identify and notify large patient populations in need of vaccination could be an efficient means for improving influenza vaccination rates in adults as well as children and adolescents.”

Text messaging to increase vaccination coverage has numerous strengths, the authors write. “It can reach large populations, and for vaccines like influenza recommended for the majority of the population, even small increases in vaccination rates can lead to large numbers of protected individuals. It may also be cost-effective. Once the system is set up, the only variable cost is the sending of the text messages, which, even using commercial platforms, usually cost pennies per message. Therefore, depending on the size of the population, even amortizing upfront and monitoring costs, text messaging is inexpensive on a per individual basis.”

“Underlying vaccination coverage overall remained low, as they do nationally, and further studies are recommended to identify ways to maximize the potential of text messaging,” the researchers conclude.

(JAMA. 2012;307[16]:1702-1708. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: This study was supported by a grant from the Maternal and Child Health Bureau, Health Resources and Services Administration, Department of Health and Human Services. The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Editorial: Text Messaging – A New Tool for Improving Preventive Services

Peter G. Szilagyi, M.D., M.P.H., of the University of Rochester School of Medicine and Dentistry, Rochester, New York, and William G. Adams, M.D., of the Boston University School of Medicine, Boston, write in an accompanying editorial that the “study by Stockwell et al is a modest step forward in an important area of public health.”

“Modest steps are the norm when complex behaviors and systems are targeted such as receipt of preventive services. Nonetheless, these systems have substantial potential, particularly when the technologies are tailored to individual patients and families, delivered in an actionable way, and driven toward important health behaviors. There can be little doubt that in the next decade there will be an increasing use of such systems and their application to additional services. As recently as 10 years ago, e-mailing patients was considered novel and text messaging did not exist. Within the next few years, the novel findings presented in this study will also become a routine component of the complex system of health care delivery.”

(JAMA. 2012;307[16]:1748-1749. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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Botox Injections Associated With Only Modest Benefit for Chronic Daily Headaches and Chronic Migraine Headaches

Posted May 8, 2012 by

EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, APRIL 24, 2012

Media Advisory: To contact Jeffrey L. Jackson, M.D., M.P.H., call Maureen Mack at 414-955-4744 or email mmack@mcw.edu.

CHICAGO – Although botulinum toxin A (“Botox”) injections are U.S. Food and Drug Administration approved for preventive treatment for chronic migraines, a review and analysis of previous studies finds a small to modest benefit for patients with chronic migraine headaches and chronic daily headaches, although botox injections were not associated with greater benefit than placebo for preventing episodic migraine or chronic tension-type headaches, according to an article in the April 25 issue of JAMA.

“Migraine and tension-type headaches are common. Although up to 42 percent of adults experience tension-type headaches sometime in their life, most do not seek medical advice. Migraines are less common, with a worldwide prevalence between 8 percent and 18 percent, but are associated with greater disability. Migraine headaches are responsible for $1 billion in medical costs and $16 billion in lost productivity per year in the United States alone,” according to background information in the article. Botulinum toxin A injections were first proposed as headache treatment when it was observed that patients with chronic headaches receiving cosmetic botulinum injections experienced headache improvement, prompting several case series that suggested benefit. However, the medical literature on botulinum effectiveness for headaches has been mixed.

Jeffrey L. Jackson, M.D., M.P.H., of the Medical College of Wisconsin, Milwaukee, and colleagues performed a review and meta-analysis to assess the association of botulinum toxin A with reducing headache frequency when used for preventive treatment of migraine, tension, or chronic daily headaches in adults. For the study, headaches were categorized as episodic (less than 15 headaches per month) or chronic (15 or more headaches per month) migraine and episodic or chronic daily or tension headaches. The researchers identified 27 randomized placebo-controlled trials that included 5,313 study participants and 4 randomized comparisons with other medications that met study inclusion criteria.

Pooled analyses of the data suggested that botulinum toxin A was associated with fewer headaches per month among patients with chronic daily headaches (1,115 patients, -2.06 headaches per month) and among patients with chronic migraine headaches (1,508 patients, -2.30 headaches per month). There was no significant association between use of botulinum toxin A and reduction in the number of episodic migraine (1,838 patients, 0.05 headaches per month) or chronic tension-type headaches (675 patients, -1.43 headaches per month).

Compared with placebo, botulinum toxin A was associated with a greater frequency of blepharoptosis (drooping of the upper eyelid), skin tightness, paresthesias (a prickly, tingling sensation), neck stiffness, muscle weakness, and neck pain.

In the 4 trials that compared botulinum toxin A with other treatment modalities, botulinum toxin A was not associated with reduction in headache frequency compared with topiramate (1.4 headaches per month) or amitriptyline (2.1 headaches per month) for prophylaxis against chronic migraine headaches. “Botulinum toxin A was not associated with a reduction in headache frequency vs. valproate in a study of patients with chronic and episodic migraines (0.84 headaches per month) or in a study of patients with episodic migraines (0.3 headaches per month). Botulinum toxin A was associated with a greater reduction in average headache severity than methylprednisolone in a single trial among patients experiencing chronic tension-type headaches (-2.5 headaches per month),” the authors write.

“Our analyses suggest that botulinum toxin A may be associated with improvement in the frequency of chronic migraine and chronic daily headaches, but not with improvement in the frequency of episodic migraine, chronic tension-type headaches, or episodic tension-type headaches. However, the association of botulinum toxin A with clinical benefit was small. Botulinum toxin A was associated with a reduction in the number of headaches per month from 19.5 to 17.2 for chronic migraine and from 17.5 to 15.4 for chronic daily headaches.”

(JAMA. 2012;307[16]:1736-1745. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Neither Dr. Jackson nor Dr. Kuriyama has any conflicts to disclose. Although Dr. Hayashino has accepted speaker fees from a number of pharmaceutical firms, none of these manufacture botulinum toxin A.

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