Friday, October 30, 2009

Oral contraceptives and adverse birth outcomes

It has been suggested that the use of oral contra­ceptives near to the time of conception may be as­sociated with an increased risk of some congenital anomalies. Now a study using Canadian data has indicated that oral contraceptive use at this time may increase the risk of low birthweight and pre-term birth.

The study included 1,540 pregnant women who had used oral contraceptives within 3 months of their last menstrual period and 6,108 controls unexposed to oral contraceptives. Oral contracep­tive use within 30 days before the last menstrual period significantly increased the risk of very low birthweight (<1,500 g) 3.2-fold, of low birthweight (<2,500 g) by 93% and of preterm birth (<37 weeks) by 61%. Oral contraceptive use during the period 31–90 days before the last menstrual period did not increase these risks.

Use of oral contraceptives in the month be­fore the last menstrual period increases the risks of low birthweight and preterm birth.

Chen X-K, et al. Recent oral contraceptive use and adverse birth outcomes. Eur J Obstet Gynecol Reprod Biol 2009;144:40–43.
http://www.mims.com/Page.aspx?menuid=RecentHL&RecentHeaderID=351

Wednesday, October 28, 2009

Contrary to Common Belief, Women Feel Same Heart-Attack Symptoms as Men

From Heartwire
Reed Miller

October 27, 2009 (Edmonton, Alberta) — Women are as likely as men to feel chest pain or other typical heart-attack symptoms, a study presented October 26, 2009 here at the Canadian Cardiovascular Congress shows [1].

In the study, presented by critical-care nurse Martha Mackay (University of British Columbia School of Nursing, Vancouver), 305 patients (39.7% women, average age 64) undergoing a nonemergent PCI were asked a series of open-ended questions about their sensations and experience while the angioplasty balloon was creating an ECG-evident ischemia.

Women and men were equally likely to report chest discomfort or other "typical" symptoms of acute coronary syndrome, regardless of ischemic status. However, women were significantly more likely to report nonchest discomfort such as pain in the neck, jaw, and throat. Older patients were more likely to report chest or throat discomfort. Patients who had undergone a PCI before were more likely to report jaw pain, and prior MI and older age increased the likelihood of neck pain.

Countering Common Misperceptions

Even as professional organizations such as the American Heart Association (AHA) have made a major push to make women aware of their risk for cardiovascular disease, the perception that women's heart-attack symptoms are different from men's persists. Recent retrospective research--subject to recall bias and the usual problems associated with reliance on written medical records--has suggested that this perception is misguided, so Mackay and her colleagues chose to conduct this study because the question "hadn't really been settled."

To rectify the methodological issues of the previous research, Mackay's group developed their questions for the study subjects carefully to ensure they weren't influencing them to report a particular symptom. For example, they did not tell the patients they were studying ACS symptoms but instead told them they were researching patients' overall experience during PCI.

The study underlines the importance of public-education campaigns aimed at women such as the AHA's Go Red for Women campaign or the Heart Truth campaign run by the Heart and Stroke Foundation in Canada, Mackay said.

The study also suggests a need for new protocols and tools that will help health providers get a better understanding of patients' symptoms. Patients may not say they are feeling chest pain if another pain is more dominant. So providers must ask questions that elicit a more complete description of the patient's symptoms in order to make an accurate diagnosis, she explained.

Monday, October 26, 2009

Exercise Improves Fatigue in Cancer Patients on Chemotherapy

From Medscape Medical News

News Author: Zosia Chustecka
CME Author: Désirée Lie, MD, MSEd

October 21, 2009 — A supervised exercise program significantly improved fatigue in cancer patients undergoing chemotherapy, according to a study published online October 13 in the British Medical Journal.

The study also found significant improvements in vitality, aerobic capacity, muscular strength, physical and functional activity, and emotional well-being. However, there was no improvement in quality of life.

"The effect size of the improvement in fatigue (0.33) suggests a small to medium clinically important change," say the researchers, headed by Lis Adamsen, PhD, professor of clinical nursing at the Copenhagen University Hospital in Denmark. This is in contrast to some previous studies that found only a small or no effect.

The researchers suggest that the larger effect on fatigue seen in their study was due to several elements of their exercise program, including the high-intensity training.

"Doctors may encourage patients to exercise, but the exercise must be supervised," Dr. Adamsen told Medscape Oncology. In addition, for patients who are undergoing chemotherapy, there must be "specific inclusion criteria and screening procedures" in place to prevent adverse reactions, she added.

For example, 1 participant in this study who had a brain tumor experienced a grade 3 seizure after cardiovascular training. "We must therefore advise patients with brain tumors or brain metastases not to participate in high-intensity exercise interventions," the researchers note.

Nine Hours of Training Each Week

The study involved 269 patients with a variety of different cancers being treated at 2 Copenhagen university hospitals. There was a broad range of diagnoses and disease statuses, the researchers note. There were 27 patients with ovarian cancer, 28 with hematological malignancies, and 15 with testicular cancer; the remainder had cancer affecting the esophagus, brain, cervix, pharynx, pancreas, or stomach.

All of the patients were receiving chemotherapy, either as treatment for advanced disease or as adjuvant therapy, and there was a wide range of regimens in use.

Half of the patients were randomly assigned to the exercise program, which was supervised by trained nurse specialists and physiotherapists. It lasted for 6 weeks and involved 9 hours of training each week. The patients had to follow the program exactly; they could not pick and choose the activities they preferred, the researchers note. "The intervention was offered as a package and must be viewed as an entity [in which] each component has a role in the outcomes," they explain.

On Mondays, Wednesdays, and Fridays, there was a high-intensity physical training session lasting 90 minutes, followed by 30 minutes of relaxation training. The high-intensity session involved resistance training on machines, such as leg and chest presses, and cardiovascular training on a stationary exercise bike. On Tuesdays, there was a body awareness training session (which included stretching and exercises based on yoga and Pilates) lasting 90 minutes, followed by 30 minutes of relaxation training. On Mondays and Fridays, patients had 30 minutes of massage, which could include scar tissue massage and venous pump massage.

Larger Effect on Fatigue Than Seen in Previous Studies

Fatigue was the primary outcome, and was measured on a scale of 0 to 100. In this study, it was the most frequently reported symptom and, at baseline, 65% of study participants reported a fatigue level greater than that of the general population (mean score, 21), and 29% of participants reported severe fatigue (mean score, >60).

After 6 weeks on the exercise program, the patients who participated reported a significant improvement in fatigue, with ratings falling by an average of 6.6 points (P = .02; size effect, 0.33). The researchers note that this size effect could be clinically important. Although the intervention reduced fatigue, the mean score for these patients was 34.6, which is still higher than that for the general population.

This reduction in fatigue is greater than has been seen in previous studies, the researchers note. A meta-analysis of several studies (Cancer Epidemiol Biomarkers Prev. 2005;14:1588-1595) found an effect size of only 0.13, which may be "too small to be clinically meaningful," they write. In addition, 2 recent studies of moderate exercise in women with breast cancer who were receiving adjuvant therapy found no significant improvement in fatigue (BMJ. 2007;334:517-520; J Clin Oncol. 2007;25:4396-4404).

When asked about the differences between the results from the latest study and those from previous studies, Dr. Adamsen suggested that her team found a larger effect on fatigue because the exercise program they used involved high-volume training (9 hours per week) and because it involved a combination of high- and low-intensity elements.

The researchers believe that this is the first study to incorporate a high-intensity design; none of those mentioned in a review of 26 studies of exercise in cancer patients did (J Clin Oncol. 2005:23:899-909).

We found a reduction in fatigue that we consider to be of importance to the patients' daily lives.
"We found a reduction in fatigue that we consider to be of importance to the patients' daily lives, even though no change was seen in the global health status/quality of life," the researchers conclude.

"Being diagnosed with cancer and exposed to chemotherapy disrupts the patient's life, affecting physiological and psychological functioning and contributing to negative effects on global health status/quality of life," they point out. "Improvements in this measure may have been too ambitious a goal in this short-term clinical trial."

The researchers have disclosed no relevant financial relationships.

BMJ. 2009;339:b3410. Abstract

Thursday, October 22, 2009

Herpes Zoster Attacks Increase Stroke Risk By 30%

From Medscape Medical News CME
News Author: Susan Jeffrey
CME Author: Désirée Lie, MD, MSEd

October 20, 2009 — A new epidemiological study suggests that the risk for stroke, both ischemic and hemorrhagic, is increased by 30% after a herpes zoster attack. The risk is even higher, about 4-fold, if the attack involves the eye (herpes zoster ophthalmicus).

Herpes zoster infection, also known as shingles, has been shown in other studies to be associated with an increased risk for stroke, the researchers, with lead author Jiunn-Horng Kang, MD, from the Department of Physical Medicine and Rehabilitation and chair of the Sleep Physiological Lab at Taipei Medical University Hospital in Taiwan, point out. Their study is the first attempt to their knowledge to look at the exact risk and frequency of stroke after herpes zoster attacks.

There is still no established therapy to prevent herpes zoster vasculopathy and associated stroke, Dr. Kang told Medscape Neurology. Early antiviral medication could have an important role, he noted, but this role still needs to be studied.

"From the practical view, physicians should be aware of the potential elevated risk of stroke when they care [for] patients with acute herpes zoster attack," he said. "Furthermore, [careful] monitoring and management of the preexisting risk factors for stroke such as hypertension, hyperlipidemia, and diabetic mellitus could be helpful to reduce the risk for stroke."

The report was published online October 8 and will appear in the November issue of Stroke.

Large- and Small-Vessel VZV Vasculopathy

Primary varicella zoster virus (VZV) infection usually affects children and causes varicella or chicken pox, the researchers note. Although some children can have serious complications, varicella is usually benign and transient. The VZV then becomes inactive, sequestered in the sensory and autonomic ganglia. By mechanisms that are not entirely clear, the researchers note, spontaneous reactivation of VZV causes lesions with painful vesicles known as herpes zoster or shingles.

There have been numerous reports linking VZV vasculopathy and stroke syndrome after zoster attacks since the 1970s, the authors write, and VZV is the only recognized human virus able to replicate in cerebral arteries. "It is hypothesized to spread along the nerve fibers to the blood vessels, where it induces further inflammatory and thrombotic responses," Dr. Kang and colleagues note.

VZV vasculopathy can affect both the large and small vessels. In large-vessel VZV vasculopathy, vessels are damaged by inflammation induced by the virus, which can result in stroke. Small-vessel VZV vasculopathy, in contrast, can manifest as nonspecific symptoms including fever, headache, seizures, weakness, consciousness disturbances, and cognitive impairments, known as small-vessel encephalitis.

"To our knowledge, despite many case reports of conditions associated with VZV vasculopathy, large sample data regarding the exact frequency and risk of stroke occurring postherpes zoster attack are still lacking," the authors write.

In this study, the researchers used a data set released by the Taiwan National Health Research Institute in 2006, a representative sample of enrollees in Taiwan's National Health Insurance program. For this analysis, they identified a total of 7760 patients who received treatment for herpes zoster between 1997 and 2001 and matched them with 23,280 randomly selected subjects. The researchers then calculated the 1-year stroke-free survival for patients who received treatment for herpes zoster and for control subjects.

During the 1-year follow up, a total of 439 strokes occurred, 133 among those treated for herpes zoster (1.71%) and 306 from the control group (1.31%). The log rank test showed that those treated for herpes zoster had a significantly lower stroke-free survival rate (P < .001).

The risk for stroke after herpes zoster was increased by 31% compared with that for control patients and increased more than 4-fold for herpes zoster ophthalmicus.

http://cme.medscape.com/viewarticle/710960?sssdmh=dm1.546207&src=nldne&uac=71630FV


NOTES: Protect your child from chickenpox with the vaccine to be given at 15months and 4 1/2 year of age. If the unvaccinated child is known to have contact with a case of chickenpox or zoster, he should be vaccinated within 24 hours for maximal protection.

Wednesday, October 7, 2009

Oxygen Therapy Relieves Headache Pain in the ED, Cuts Length of Stay, Drug Use

From Reuters Health Information

By Marilyn Larkin

NEW YORK (Reuters Health) Oct 05 - Giving high-flow oxygen therapy for 15 minutes to emergency department patients with headaches provides rapid relief and reduces hospital stays, use of CT scans, and headache pharmacotherapy, according to a pilot study.

Dr. Boris Veysman of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School reported the results on Monday at the annual meeting of the American College of Emergency Physicians in Boston.

"Very often, when a patient comes to the emergency department with one complaint being headache, they're uncomfortable and symptomatic and they have to wait for a workup before anyone can determine the cause. A diagnosis may not even be made in the emergency department," Dr. Veysman told Reuters Health. "So we approached it from a different perspective and asked, 'What if therapy were the first thing you did (for a headache) before attempting to find a cause?' And so we tried giving oxygen therapy, because it's so widespread and safe."

In the placebo-controlled study, 17 patients were randomized to 100% oxygen at 15 L/min for 15 minutes; 14 received high flow air for 15 minutes; and 17 received no intervention prior to standard treatment. Headache intensity was assessed using a 10-point visual analog scale.

Median times to relief were significantly shorter for patients treated with oxygen (40 minutes) compared with those treated with high flow air (110 minutes) or nothing (120 minutes). Median length of stay was also significantly shorter for patients treated with oxygen (57.5 minutes) than for those treated with air (210 minutes) or nothing (180 minutes).

In addition, CT scans were ordered less frequently: for four of 17 patients (24%) who received oxygen; 11 of 14 (79%) who received air; and eight of 17 (47%) who got nothing.

Medication was given to 29% of those who received oxygen, 86% of those who received air, and 82% of those who received no treatment.

Headache intensity was significantly reduced at both 15 minutes and 30 minutes after initiation of treatment, with patients treated with oxygen realizing the greatest reductions.

"It was a small study, and our results are preliminary," Dr. Veysman stressed. "But the medical community is starting to recognize that it's important to treat discomfort even when you don't know what's causing it, as long as you feel confident the treatment won't make the patient worse. In this case, we found more relief with oxygen than with placebo, although the fact that the headache goes away doesn't necessarily mean the patient can go home."

Bayer Sued for Prostate Cancer Claims About Selenium in Multivitamin

From Medscape Medical News
Nick Mulcahy

October 6, 2009 — A consumer advocacy and industry watchdog group has filed suit against Bayer for claiming that an ingredient, selenium, in its One A Day Men's Health Formula multivitamin product might reduce the risk for prostate cancer.

The lawsuit was filed in the Superior Court of California in San Francisco, according to the filers, the Center for Science in the Public Interest (CSPI) of Washington, DC.

"Bayer has run radio ads that say their product may reduce the risk of prostate cancer. The packaging says the same. Even after the Selenium and Vitamin E Cancer Prevention Trial (SELECT) showed that selenium did not prevent prostate cancer, they continued to run TV ads that referred to a prostate health benefit," David Schardt, MS, senior nutritionist at CSPI, told Medscape Oncology.

Mr. Schardt explained that the company has never received approval from the US Food and Drug Administration (FDA) to make a specific prostate cancer claim.

He also said that any claim about prostate issues was an indirect reference to prostate cancer because selenium has never been shown to have any benefit for benign prostatic hyperplasia.

Bayer was allowed to make a "qualified claim" that "selenium may reduce the risk of certain cancers" on the basis of guidance from the FDA, said Mr. Schardt, but was not allowed to make a claim about prostate cancer.

Large Trial Showed No Benefit
Selenium has been promoted as potentially offering protection against prostate cancer by many different health supplement companies, but last year a large trial showed no benefit, and more recently, a smaller trial suggested that selenium is harmful if prostate cancer is already present.

SELECT is the 35,000-patient trial that found that neither selenium nor vitamin E, taken alone or together, prevented prostate cancer after 5 years of use, as reported by Medscape Oncology. In October 2008, the trial's Data and Safety Monitoring Committee made the decision to stop the use of the supplements.

A Bayer spokesperson told Medscape Oncology in an email that the FDA's guidance on the qualified health claim about selenium changed earlier this year. The company is now "in the process of revising the packaging and promotional materials for its One A Day Men's and One A Day Men's 50+ [Advantage products] to exclude reference to the qualified health claim regarding the relationship between selenium intake [and] the reduced risk for certain cancers."

The main support for FDA's earlier qualified claim about selenium was "data relating to prostate cancer," the email noted.

There have been a number of studies suggesting that selenium protected against prostate cancer, including the Nutritional Prevention Cancer Trial, a skin cancer study that incidentally revealed prostate cancer data (JAMA.1996;276;1957-1963). However, SELECT has been called the "definitive" trial on the subject by SELECT author and investigator Larry Baker, MD, from the University of Michigan in Ann Arbor.

Packaging and Ads Refer to Prostate Benefit

Although the company says that it is revising its promotional materials, a One A Day Men's Health Formula package bought today in Philadelphia by Medscape Oncology suggests a possible prostate cancer benefit.

Emerging research suggests Selenium may reduce the risk of prostate cancer.
"Did you know that prostate cancer is the most frequently diagnosed in men and that emerging research suggests Selenium may reduce the risk of prostate cancer?" says the label. "One A Day Men's Health Formula is a complete multivitamin plus key nutrients including Selenium to support a healthy prostate."

The packaging also includes the disclaimer that the "product is not intended to diagnose, treat, cure, or prevent any disease."

A One A Day radio ad with a prostate cancer claim is posted on the CSPI site; the date of the airing is not specified. The site also has a link to a TV ad for One A Day that refers to the benefits of selenium for prostate health.

Before filing its lawsuit, the CSPI filed a complaint in June 2009 with the FDA over the prostate cancer claim on One A Day Men's Health Formula labelling.

"The claim that the selenium in One A Day Men's Health Formula reduces the risk of prostate cancer gives the product the status of an unapproved drug, and is therefore illegal," according to a CSPI press statement.

Also in June, the CSPI urged the FDA to seize stockpiles of the men's vitamin.

The impetus behind the drastic recommendation was a new study on selenium and prostate cancer that suggested potential harm, according to a CSPI press statement.

In that study, researchers from the Dana-Farber Cancer Institute in Boston, Massachusetts, found that a high level of selenium in the blood was associated with a slightly elevated risk for aggressive prostate cancer in men who have the disease.

"If you already have prostate cancer, it may be a bad thing to take selenium,
" the senior author of the study told Medscape Oncology at the time.

Major League Baseball and One A Day

One A Day Men's Health Formula multivitamin has also been associated with prostate cancer through a charitable campaign with Major League Baseball (MLB).

"The main promotional platform with baseball is the 'One A Day Men's Strikeout Prostate Cancer Challenge,' in which One A Day and MLB combine to donate $10 to the Prostate Cancer Foundation for every strikeout thrown throughout the regular season and the playoffs," an MLB spokesperson told Medscape Oncology in an email.

The One A Day Web site features the campaign but also notes that the product is "not intended to prevent or treat prostate cancer."

Although nothing about the fundraising campaign is illegal, in June 2009, the CSPI encouraged both MLB and the Prostate Cancer Foundation to drop their ties to One A Day and Bayer because of the misleading advertising.

The CSPI estimates that the charitable contributions from this program with MLB should be around $350,000.

According to an article published October 1 in the New York Times , One A Day Men's Health Formula had sales of $23.3 million for the 52 weeks ending September 6. The source of the figure was Information Resources, a market research firm.

Bayer and Other Claims Issues

Bayer will be in big trouble if they are found to be in violation of the law.
"Bayer will be in big trouble if they are found to be in violation of the law," said Mr. Schardt about the prostate cancer claims. In 2007, the company signed a court order to not misrepresent any of their multivitamins, he explained.

This followed an action that resulted in Bayer paying a $3.2 million fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice over weight-loss claims made in connection with another One A Day product, according to a CSPI press statement.

Bayer is also running a $20-million corrective advertising campaign about its birth control pill Yaz under the order of the FDA and a number of state attorneys general, according to the same press statement.