This new section of U.S. Medicine will bring to our readers highlights from the peer-reviewed literature and clinical trials of topics that are of most universal interest to the readers of this multidisciplinary magazine. While it is virtually impossible to address the needs of every specialist in every issue, our editors are committed to reviewing the most topical and relevant studies in journals that you may not receive. We welcome your input on this new section, please visit us at www.usmedicine.com to express your opinion.

Women’s Health

NIAID Launches H1N1 Influenza Vaccine Trial in Pregnant Women

The first trial testing a candidate 2009 H1N1 influenza vaccine in pregnant women was launched recently by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial is being conducted through the NIAID-funded national network of Vaccine and Treatment Evaluation Units (VTEUs).

“Women are at higher risk of developing severe illness if they become infected with influenza virus while pregnant, which is why they are strongly encouraged to receive the seasonal influenza vaccine every year,” says NIAID Director Anthony S. Fauci, MD. “Data indicate that pregnant women are at higher risk for complications from the 2009 H1N1 influenza virus as well, so this trial will provide critical information for public health planning.” Dr Fauci added, “The American public has shown once again its remarkable willingness to step up and help during an emergency. The interest in this trial has been extraordinary, and participating medical centers expect to fill all the available slots for volunteers soon.”

Up to 120 women 18 to 39 years of age who are in their second or third trimester (14 to 34 weeks) of pregnancy will be enrolled into this initial trial. Volunteers will receive 15 micrograms or 30 micrograms of a candidate 2009 H1N1 influenza vaccine manufactured by Sanofi Pasteur. All women will receive an initial injection and a second injection 21 days later. Safety data will be collected and assessed continuously throughout the trial by the study investigators and by an independent safety monitoring committee. Study investigators will take blood samples to determine how the immune system responds to the vaccine (for example, by producing antibodies) at set time points before and following each injection. Cord blood will also be collected to measure maternal antibodies transferred to the infants through the placenta.

Because the vaccine contains inactivated virus, it is impossible to become infected with the 2009 H1N1 influenza virus by receiving this vaccine. The vaccine contains no thimerosal, a preservative, or adjuvant added to some vaccines to improve the body’s response to vaccine.The design of this trial in pregnant women is patterned after clinical trials that opened in August through NIAID’s VTEU network. Those trials are testing the same vaccine in various groups of healthy individuals, including adults, the elderly, and children. The candidate vaccine is also being tested in pregnant women because they represent a population whom public health officials have recommended to receive a licensed 2009 H1N1 influenza vaccine when it becomes available this fall.

Guided imagery for military sexual trauma-related posttraumatic stress disorder (PTSD)

Military sexual trauma (MST) is a significant women’s mental health issue. There is a crucial need for effective therapies for MST-related posttraumatic stress disorder (PTSD) that are well-tolerated and can be flexibly administered in a variety of treatment settings. Guided imagery is a novel, transportable intervention technique that meets these requirements and warrants research in PTSD. The proposed study will be a randomized controlled trial of the Guided Imagery for Trauma (GIFT) intervention for women veterans with MST-related PTSD. This minimal contact intervention is designed to increase coping, affect management and relaxation skills, and to fostering more positive images and beliefs associated with surviving trauma. The feasibility and tolerability of GIFT have already been demonstrated in an open-label pilot of 15 women veterans with MST-related PTSD, with very promising initial results.

The primary aims of this study are: (1) To determine the efficacy of the GIFT intervention for women veterans with MST-related PTSD, (2) To determine the effects of GIFT on mental health and health services utilization, and neurobiological outcomes, and (3) To identify predictors of GIFT treatment outcomes.

The research plan will consist of a 12-week randomized, controlled trial of GIFT in 38 women veterans with MST-related PTSD. Half will be randomly assigned to GIFT and half to a music control group. GIFT includes a pretreatment orientation and midpoint consultation session with a clinician facilitator, a guided imagery audio, daily self-monitoring of audio use, and weekly telephone coaching calls with the facilitator. The music control condition is designed to control for all nonspecific aspects of GIFT and matches the GIFT protocol in all ways but the two specific “ingredients” through which GIFT is hypothesized to have its effect: (1) the guided imagery audio, and (2) the facilitator’s help in structuring and focusing use of the guided imagery audio. Thus, the key differences between the two groups are that controls will receive an audio of the relaxing background music used on the guided imagery audio, but not the guided imagery exercises, and controls’ contacts with the facilitator is limited to psychoeducational information and general support, and will not include help in structuring and focusing use of the audio, which is a key component of GIFT.

This study is currently recruiting participants.

Cardiology

No significant cardiovascular differences should exist between liberal and restrictive blood transfusion strategies in surgical hip repair patients. Patients undergoing hip fracture repair surgery may become anemic after surgery and require blood transfusions. Patients treated by a restrictive transfusion strategy had no significant differences in cardiovascular outcomes compared to similar patients treated with a liberal blood transfusion strategy, according to late-breaking clinical findings from Jeffrey L. Carson, MD, of the University of Medicine and Dentistry of New Jersey’s Robert Wood Johnson Medical School in New Brunswick, NJ.

The study involved 2,016 patients, primarily women (75%), with a mean age of 81, who had surgery to repair a hip fracture. Some patients received transfusions as soon as their hemoglobin levels fell below 10 g/dL. Other patients were given blood transfusions only when symptomatic, or if their hemoglobin levels dropped below 8 g/dL, a more restrictive strategy.

For patients in the liberal transfusion strategy group, 4.3% of patients had a heart attack, unstable angina, or died in the hospital, whereas 5.2% of patients on the restrictive transfusion arm had either a heart attack, unstable angina, or died in the hospital, a difference that was not statistically significant. Although anemia occurs in most patients with hip fracture, many of whom are women, the data emerging from the analysis of this study indicate that transfusion in the absence of symptoms is not always required. The appropriate use of blood transfusions assures more efficient use of the nation’s blood supply.

Air pollution impacts blood-vessel health. A study of atherosclerosis (MESA) and air pollution confirms that air pollution appears to have short-and long-term ill effects on the health and resiliency of blood vessels. The researchers used ultrasound-guided measurements of blood-vessel diameter and responsiveness in 3,501 people participating in the ongoing MESA study, a long-term population-based study of ethnically diverse Americans in six urban US regions. The researchers recorded air pollution levels in these locales the day before the blood vessel measurements were taken and estimated annual exposure to fine particulate air pollution. The results link long-term exposure to air pollution with both forearm-artery narrowing and a reduced ability of these arteries to adjust to normal changes in blood flow. In contrast, short-term exposure to air pollution only appeared to affect artery-narrowing. The study suggests that both types of changes may be early cardiovascular disease risk factors affected by the environment.

Fat deposits near the heart are linked to clogged arteries. Along with abdominal fat, fat deposits near the heart itself (pericardial fat), have been associated with cardiovascular disease, diabetes, and metabolic syndrome. Metabolic syndrome is the name for a group of risk factors linked to excess weight and obesity that increase the risk of heart disease, diabetes, and stroke. Researchers discovered that pericardial fat alone was associated with clogged arteries (detected by magnetic resonance imaging), independent of other known risk factors such as high blood pressure and smoking. The results suggest that pericardial fat may be involved in the development of atherosclerosis, or hardening of the arteries. The study involved 94 male participants in the ongoing Multi-Ethnic Study of Atherosclerosis (MESA) study, a long-term population-based study of ethnically diverse Americans in six urban US regions.

Combination of physician and patient intervention best lowers blood pressure. Despite widely publicized hypertension treatment guidelines for physicians and lifestyle recommendations for patients, blood pressure control rates remain low. Researchers from Duke University who conducted the Hypertension Improvement Project (HIP) tested physician and patient intervention methods in community-based primary care clinics. A total of 32 physicians and 574 patients participated in the study. Physician intervention techniques included Internet-based training (before patient intervention began), followed by self-monitoring and quarterly feedback reports for 18 months.

Patient intervention practices included 20 weekly group counseling sessions focused on weight loss, a hypertension-controlling diet, exercise, and reduced sodium intake, followed by 12 brief monthly phone contacts. After six months, those who received both physician and patient intervention methods experienced the largest impact with a decrease in systolic blood pressure of 9.7 mmHg. The systolic blood pressure of those patients who received only physician intervention decreased 5.3 mmHg, while the systolic blood pressure of those who had only patient intervention decreased 7.1 mmHg. However, the added benefit of the combined intervention did not persist 12 months after the period of intense patient intervention. Notably, at 18 months, more than 70% of patients were at goal blood pressure in all study groups (compared with approximately 60% ). Future research should focus on increasing the magnitude of the effect in each individual component, and sustainability of the interaction between an informed patient and a proactive practice team.

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