Taco Bell removes green onions (AP)

E. coli probe also focuses on produce - Bridgewate...

Taco Bell removes green onions (AP)

Jamba Juice issues warning in Southwest (AP)

Taco Bell to Reopen Restaurants After - Washington...

Taco Bell to Reopen Restaurants After - Washington...

Jamba Juice issues warning in Southwest (AP)

New York first city to oust evil oils - The Age

Taco Bell to Reopen Restaurants After - Washington...

New York Bans Most Trans Fats in Restaurants - New...

Archives

February 2006

March 2006

April 2006

May 2006

August 2006

September 2006

October 2006

November 2006

December 2006

Current Posts

Search

Google

Powered by Blogger

Wednesday, April 12, 2006

News Flash

Estrogen-Only Pills Increase Blood Clot Risk
A new government study links estrogen-only pills with an increased risk of blood clots in healthy women past menopause, but the risk was not as much as supplements that also contain progestin. "Unfortunately, the list just keeps growing. Almost everything we look at is a negative effect, except for relief of symptoms in women who have severe symptoms," said Dr. J. David Curb, the lead author of the estrogen-only study.
Abortion Pill Did Not Kill Woman: FDA
Food and Drug Administration officials say they have ruled out the abortion pill RU-486 in one of two deaths in women who have taken the drug. The second remains under investigation. Four other women have died of a rare but deadly infection after undergoing pill-triggered abortions. All four of those women tested positive for Clostridium sordellii, a common but rarely fatal bacterium. The FDA has warned doctors to watch for infection by the bacterium, though the drug mifepristone has not been proven to be the cause of death in any of those cases.
Contact Lens Solution Eyed in Fungus Outbreak
The makers of a contact lens solution has voluntarily stopped shipment of the product after federal health officials linked it to a fungal eye infection that can cause temporary blindness. The CDC is investigating 109 reports of Fusarium keratitis infection across 17 states since 2005. Officials said it was too early to determine if the solution was the cause of the infection, while both the FDA and the CDC continue to investigate a growing number of reports of eye infection caused by fungus.
Breakthrough in Lupus Research
A breakthrough procedure offers new hope to those suffering from lupus. Dr. Richard Burt of Northwestern Memorial Hospital is pioneering new research that uses a patient's own stem cells to treat extremely severe cases of lupus and other autoimmune diseases. "We bring the patient in, and we give them chemo to destroy their immune system," Dr. Burt said. "And then right after the chemotherapy, we infuse the stems cells to make a brand-new immune system."
Scientist Develop Laser that 'Melts Fat'
For the first time, a laser is being developed by scientists using selected wavelengths to heat up fat in the body without harming the overlying skin, which is then broken down and excreted by the body. Experts believe it could be used to treat heart disease, cellulite, and acne. "We can envision a fat-seeking laser, and we're heading down that path now," said Professor Rox Anderson, a dermatologist at the Massachusetts General Hospital.

 

Vasectomy Not Always an Instant Fix

Miranda Hitti

 

April 7, 2006 -- A vasectomy can take months to take full effect, but many men skip follow-up tests that check the vasectomy's success, a new study shows.

A vasectomy is a permanent sterilization procedure for men. Doctors cut the vas deferens, which are tubes in the male reproductive system that carry sperm. A vasectomy prevents sperm from being transported out of the testes, but it doesn't affect a man's orgasm or ejaculation. It also doesn't prevent sexually transmitted diseases.

While vasectomy almost always works, success isn't necessarily instant. That's why doctors ask men to get follow-up tests. Until those tests show success, patients and their female partners need to use another form of birth control to avoid pregnancy.

No Clue About Success

The new study, published in BJU International, included 436 men who got vasectomies at The Cleveland Clinic.

The men were told to submit two semen samples two months after vasectomy and again a month later. If those samples contained sperm, the men were to submit semen samples monthly until they had gotten two consecutive negative tests.

A quarter of the men didn't do their two-month test, and only 21% followed the full instructions to get two back-to-back negative tests, the study shows.

The no-shows for the two-month test "had no idea whether the procedure was successful or if their partner could still become pregnant," researcher Nivedita Dhar, MD, says in a news release. Dhar is the chief urology resident of The Cleveland Clinic's Glickman Urological Institute.

Patients' Results

In patients who followed the testing rules, vasectomy was eventually judged successful in all but one man, the study shows.

Two months after vasectomy, sperm were found in a quarter of the semen samples that were submitted. Most of those sperm were rare and nonmotile, meaning they were few in number and couldn't move on their own.

But three samples showed rare motile sperm, which can move. A man who submitted one of those samples later got a second vasectomy, which worked.

Three months after vasectomy, half of all patients submitted semen samples, 9% of which contained sperm. Three patients whose semen samples showed no sperm at two months showed rare, nonmotile sperm in the three-month check. Those three men all had sperm-free semen samples four and five months after vasectomy.

It's "impossible," Dhar says, to know if and when the vasectomies succeeded in the patients who didn't submit semen samples.

Fewer Tests, Better Compliance?

Dhar and colleagues suggest simplifying the follow-up process to encourage more men to get follow-up tests after vasectomy.

"Provided patients have been adequately counseled, we think that one negative semen analysis at three months or one with rare, nonmotile sperm at two months may be adequate to determine the success of vasectomy," the researchers write.


SOURCES: Dhar, N. BJU International, April 2006; vol 97: pp 773-76. WebMD Medical Reference provided in collaboration with The Cleveland Clinic: "Sexual Health: Your Guide to Birth Control: Sterilization." News release, The Cleveland Clinic.

Reviewed by Louise Chang

 

Active or Passive Smoking May Be Linked to Glucose Intolerance

News Author: Laurie Barclay, MD

 

April 10, 2006 — Both active and passive smoking increase the risk of developing glucose intolerance, according to the results of a prospective cohort study reported in the April 6 Online First issue of the BMJ.

"Smoking has been linked to impaired response to glucose tolerance tests and insulin resistance," write Thomas K. Houston, MD, from the Birmingham Veterans Affairs Medical Center in Alabama, and colleagues. "Although smoking cessation can result in modest weight gain, smoking is related to a more unhealthy distribution of upper body weight and greater waist:hip ratio. Smoking has also been associated with risk of chronic pancreatitis and pancreatic cancer, suggesting that tobacco smoke may be directly toxic to the pancreas."

The Coronary Artery Risk Development In young Adults (CARDIA) study began in 1985 to 1986 with recruitment of black and white men and women aged 18 to 30 years with no glucose intolerance at baseline. Participants were 1386 current smokers, 621 previous smokers, 1452 never smokers with reported exposure to secondhand smoke (validated by serum cotinine concentrations, 1 - 15 ng/mL), and 1113 never smokers with no exposure to secondhand smoke. The primary endpoint was time to development of glucose intolerance (glucose, >/= 100 mg/dL or taking antidiabetic drugs) during 15 years of follow-up.

At baseline, median age was 25 years, 55% of participants were women, and 50% were African American. During follow-up, glucose intolerance developed in 16.7% of participants. There was a graded association between smoking exposure and the incidence of glucose intolerance during the 15-year follow-up, which was 21.8% for smokers, 17.2% for never smokers with passive smoke exposure, 14.4% for previous smokers, and 11.5% for never smokers with no passive smoke exposure.

After adjustment for multiple baseline sociodemographic, biological, and behavioral factors, risk was still higher in current smokers (hazard ratio [HR], 1.65, 95% confidence interval [CI], 1.27 - 2.13) and never smokers with passive smoke exposure (HR, 1.35; 95% CI, 1.06 - 1.71) than in never smokers without passive smoke exposure. However, risk in previous smokers was similar to that in never smokers without passive smoke exposure.

"We found that tobacco exposure is associated with the development of glucose intolerance over a 15 year period, with a dose-response effect apparent," the authors write. "These findings support a role of both active and passive smoking in the development of glucose intolerance in young adulthood."

Study limitations include potential residual confounding, observational nature, and recruitment of African Americans and white people from 4 US urban areas, limiting generalizability.

"Importantly, we identified passive tobacco exposure in never smokers as a new risk factor for glucose intolerance," the authors conclude. "If confirmed by further research, these findings provide further documentation of the deleterious effects of tobacco smoking, and policy makers may use them as additional justification to reduce exposure to passive smoke."

Omega-3 Fatty Acid Supplements May Help Relieve Neck, Low Back Pain

News Author: Laurie Barclay, MD

 

April 10, 2006 — Omega-3 fatty acid supplements may be effective for relieving neck and low back pain, according to the results of a short-term trial reported in the April issue of Surgical Neurology.

"The use of nonsteroidal anti-inflammatory drugs (NSAIDs) is a well-established effective therapy for both acute and chronic nonspecific neck and back pain," write Joseph Charles Maroon, MD, and Jeffrey W. Bost, PAC, from the University of Pittsburgh Medical Center in Pennsylvania. "Extreme complications, including gastric ulcers, bleeding, myocardial infarction, and even deaths, are associated with their use. An alternative treatment with fewer side effects that also reduces the inflammatory response and thereby reduces pain is believed to be omega-3 essential fatty acids (EFAs) found in fish oil."

From March to June 2004, 250 patients evaluated by a neurosurgeon and found to have nonsurgical neck or back pain were asked to take a total of 1200 mg/day of omega-3 EFAs (eicosapentaenoic acid [EPA] and decosahexaenoic acid [DHA]) found in fish oil supplements. Approximately 1 month after starting the supplement, these patients were sent a questionnaire.

Of the 250 patients, 125 returned the questionnaire. Average duration of fish oil therapy at the time of returning the questionnaire was 75 days. Dosage of EFAs was 1200 mg in 78% and 2400 mg in 22%. Reported benefits were discontinuation of prescription NSAIDs in 59% of patients, improvement in overall pain in 60%, improvement in joint pain in 60%, and satisfaction with the level of improvement in 80%. There were no significant adverse effects reported, and 88% stated they would continue to take the fish oil supplements.

"Our results mirror other controlled studies that compared ibuprofen and omega-3 EFAs demonstrating equivalent effect in reducing arthritic pain," the authors write. "Omega-3 EFA fish oil supplements appear to be a safer alternative to NSAIDs for treatment of nonsurgical neck or back pain in this selective group."

Study limitations include retrospective, non–placebo-controlled survey design; variability in underlying patient pathology; and lack of long-term follow-up.

"That close to two thirds of patients could discontinue NSAIDs is certainly provocative, especially given the recent FDA [Food and Drug Administration] warnings regarding their complications," the authors write. "The effectiveness of omega-3 EFAs in rheumatoid and some cases of osteoarthritis has been demonstrated. Appropriately designed studies are needed to confirm the effectiveness of omega-3 EFA for pain relief in discogenic pain."

Frequent Tanning May Be Addictive

News Author: Laurie Barclay, MD

 

April 3, 2006 — Frequent tanning is addictive, according to the results of a small, randomized study reported in the April issue of the Journal of the American Academy of Dermatology.

"We had previously shown that ultraviolet light has an effect on mood that tanners value," lead author Mandeep Kaur, MD, from Wake Forest University School of Medicine in Winston-Salem, North Carolina, said in a news release. "Now, in this small study, we've shown that some tanners actually experience withdrawal symptoms when the 'feel-good' chemicals are blocked."

The authors note that frequent tanners overwhelmingly prefer UV-emitting beds to non–UV-emitting tanning beds, even when their choice is blinded. Frequent tanning has features of an addictive behavior, which may be mediated by induction of cutaneous endorphins by UV light.

The investigators tested whether opioid antagonism blocks the potential reinforcing effect of indoor tanning in 8 frequent tanners, defined as those who tan 8 to 15 times a month or more than necessary to maintain a tan; and in 8 infrequent tanner control subjects who used tanning beds no more than 12 times a year.

Opioid blockade reduced UV preference in frequent tanners. With naltrexone administration, 4 of 8 frequent tanners, but no infrequent tanners, had withdrawal-like symptoms.

The major study limitation is the small sample size, leading the authors to recommend further studies.

"The finding was unexpected and is consistent with the hypothesis that frequent tanning may be driven in part by a mild dependence on opioids, most likely endorphins," says senior author Steven Feldman, MD, PhD, also from Wake Forest. "The nausea and jitteriness induced by the medication are consistent with symptoms of mild opiate withdrawal."

The National Institutes of Health partly funded this study, along with Galderma Laboratories, LP, and the Wake Forest University Women's Health Center of Excellence. The authors have disclosed no relevant financial disclosures.

 

High Levels of Vitamin D, Calcium May Lower Type 2 Diabetes Risk

NEW YORK (Reuters Health) Apr 04 - Women with high intakes of vitamin D and calcium appear to have a lower risk of type 2 diabetes, according to Boston-based researchers.

Dr. Anastassios G. Pittas, of Tufts-New England Medical Center and colleagues evaluated data for 83,779 women enrolled in the Nurses' Health Study. The women had no history of diabetes, cardiovascular disease or cancer at baseline. Vitamin D and calcium intake from foods and from supplements were evaluated every 2 to 4 years. The results of the study are published in the March issue of Diabetes Care.

A total of 4843 incident cases of diabetes were documented over 20 years of follow-up. The mean daily cumulative intakes of vitamin D and calcium in these women were 309 IU and 867 mg, respectively.

"Based on the latest guidelines set by the Institute of Medicine, only 3% of women in our cohort had adequate vitamin D intake, and only 24% had adequate calcium intake," Dr. Pittas's group reports.

Total vitamin D intake was not significantly associated with type 2 diabetes after adjusting for multiple potential confounders, but there was a 13% lower risk of diabetes among women in the highest versus the lowest category of vitamin D intake from supplements (p = 0.04).

Women with the highest versus total calcium had a 21% lower risk of diabetes than those with the lowest intakes (p < 0.01). The risk was 18% lower among women in the highest versus the lowest category of calcium intake from supplements (p < 0.001).

The lowest risk of diabetes was observed among women with the highest combined intakes of calcium and vitamin D compared with those with the lowest.

The mechanism by which vitamin D affects diabetes risk is unclear. Insulin resistance and impaired pancreatic beta-cell function have been linked with vitamin D insufficiency. "These observations together with the finding of vitamin D receptors in beta-cells and the finding of impaired insulin secretory capacity in mice lacking a functional vitamin D receptor indicate an important role for vitamin D in regulating beta-cell function," the researchers report.

The mechanism by which calcium may affect the risk of diabetes is also unclear. "Abnormal regulation of intracellular calcium affecting both insulin sensitivity and insulin release has been suggested as a potential mechanism to explain the putative association between calcium insufficiency and risk of diabetes."


Reuters Health Information 2006. © 2006 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

News Flash

Body Fat? It's in the Genes
The actions of 3 specific genes determine how many fat cells you have and how they are distributed, researchers say. The findings come from doctors at Harvard's Joslin Diabetes Center and the University of Leipzig, Germany. Using new gene-chip technology and fat samples from nearly 200 people, they identified 3 multiple developmental genes that are important in the early development of the embryo, and play a major role in body pattern, face formation, and skeletal development. Some scientists believe environmental factors affect gene activity, but Harvard Professor C. Ronald Khan, MD, says it's too soon to know whether people can change what their fat genes dictate.
When Antacids Aren't Enough
Incidence of an esophageal disease called adenocarcinoma have jumped six fold in the last 30 years and doctors now suspect that chronic heartburn may be driving the nation's fastest-increasing form of cancer. Doctors now are warning people who have had severe gastric esophageal reflux disease, or GERD, for many years not to keep popping over-the-counter acid blockers instead of seeing a doctor. "One of the big problems is if you wait until it produces symptoms, it's almost impossible to cure," says Dr. Kenneth DeVault, a professor of medicine at the Mayo Clinic in Jacksonville, Fla.
Statins May Aid in Heart Valve Disease
Long thought to be the result of wear and tear, heart valve disease now appears to be caused by a potentially reversible chronic inflammatory process, according to Dr. Nalini Rajamannan in an online report published by the Journal of American College of Cardiology. "Our findings open the door to the idea that medical therapies such as statins may be able to play a role in preventing or slowing the process, and curtailing the need for surgery," Dr. Rajamannan said.
Cholesterol Linked to Prostate Cancer
Italian researchers now believe that cholesterol may be used by the body to produce male hormones which have been linked to prostate cancer, according to a study published in the Annals of Oncology. The findings are based on evidence from a study of 2,745 men which found that men with prostate cancer were 50% more likely to have had high cholesterol levels. Those diagnosed with prostate cancer before the age of 50 and after the age of 65 were as much as 80% more likely to have had high cholesterol. Other experts said study findings were plausible, but disputed the hormone theory.

Estrogen HRT: No Breast Cancer Risk

Daniel DeNoon

 

April 11, 2006 -- After hysterectomy, estrogen-only hormone therapy does not increase a woman's risk of breast cancer.

That's the word from the final analysis of the estrogen-only arm of the Women's Health Initiative (WHI) study. The trial was stopped early because it linked hormone therapy to increased risk of stroke, with no reduction in heart-disease risk.

The study had two arms. Menopausal women with an intact uterus received estrogen plus progestin or an inactive placebo. That's because estrogen alone increases a woman's risk of uterine cancer. Women who had undergone hysterectomy, however, received estrogen-only hormone therapy or placebo.

The average five-year breast cancer risk estimates were similar between the estrogen-plus-progestin group and the estrogen-only group.

Could this be true? Stanford researcher Marcia L. Stefanick, PhD, chairwoman of the WHI steering committee, led a team that took a detailed look at the estrogen-only data. Stefanick's report appears in the April 12 issue of The Journal of the American Medical Association.

"The major finding is no increased risk of breast cancer in women taking just estrogen," Stefanick tells WebMD. "There is a tendency for decreased risk of breast cancer, but it is not statistically significant. This means it would be inappropriate simply to say estrogen alone decreases breast cancer."

Stefanick says estrogen may be safer for some women than for others.

"Women at lower initial risk of breast cancer seem to be the ones who have even lower risk if they go on estrogen," she says. "Women with a higher risk of breast cancer seem to have even higher risk with estrogen."

HRT Risk Overblown?

Stefanick says there are big differences between treating women who have had a hysterectomy and women with an intact uterus. And there are big differences between estrogen-only hormone therapy and estrogen-plus-progestin therapy.

"The media always talk about 'hormones do this' or 'hormones do that,'" Stefanick says. "What we are clear on is estrogen plus progestin does one thing in one group, and estrogen alone does something very different in a different group. We cannot say it is all about progestin. But we can say progestin plus estrogen gives a really different outcome than just estrogen."

The study results are very reassuring to Hugh Taylor, MD, associate chief for research in the obstetrics, gynecology, and reproductive sciences department at Yale University. Taylor spoke at a news conference organized by Wyeth, which makes Premarin and Prempro, the hormones tested in the WHI study. Taylor has received speakers' fees from Wyeth, but has no financial interest in the company. Wyeth is a WebMD sponsor.

Controversy Continues

"Women have been on a roller coaster ride. That ride is over," Taylor says. "For women with hysterectomy, the evidence is clear: Estrogen is safe for them. There is no breast cancer risk for estrogen alone. This has been the No. 1 fear keeping women from using estrogen for their menopausal symptoms."

While the study did not consistently find an overall reduction in breast cancer, the women on estrogen-only therapy did have significantly fewer cases of the most common kind of breast cancer -- ductal cancer.

"What was significantly decreased was ductal cancer, the most common form, a real reduction by almost 30% in the most common kind of breast cancer," Taylor says.

What about women who have not had a hysterectomy?

"As we see more detailed results from the WHI, we see there are some reassuring findings for women without hysterectomy," Taylor says. "In terms of heart disease, in younger women there is no increased risk. Ongoing studies with newly menopausal women are suggesting a benefit even with combined estrogen/progestin treatment. There was increased risk of breast cancer, but this number was very small. On balance, the risks of estrogen plus progestin are very low."

That's a controversial opinion. Boston University epidemiologist Lynn Rosenberg, ScD, recently analyzed data from a study of more than 23,000 black women. Reporting in the April 10 issue of the Archives of Internal Medicine, she finds that women who used hormone therapy -- even estrogen alone -- had a higher risk of breast cancer than women who never used hormone therapy.

"In my view, the weight of evidence would make me very suspicious of estrogen alone," Rosenberg tells WebMD. "It seems absolutely certain that estrogen plus progestin increases the risk of breast cancer, particularly if you take if for a long time."

Doctors currently prescribe hormone therapy for women who need help with the symptoms of menopause. Taylor says every woman with these symptoms is a candidate for this treatment, unless they have a high risk of breast cancer or a clotting disorder.

"The paradigm of treating menopause symptoms with the lowest effective dose of hormone therapy, for the shortest period necessary, is very sensible," Taylor says.


SOURCES: Stefanick, M.L. The Journal of the American Medical Association, April 12, 2006; vol 295: pp 1647-1657. Marcia L. Stefanick, PhD, professor of medicine, Stanford University School of Medicine; chairwoman, Women's Health Initiative steering committee. Wyeth news conference with Hugh Taylor, MD, associate professor and associate chief for research, department of obstetrics, gynecology & reproductive sciences, Yale University; and William T. Creasman, MD, professor of obstetrics and gynecology, Medical University of South Carolina. Lynn Rosenberg, ScD, professor epidemiology, Boston University.

Reviewed by Louise Chang

Low-Fat, High-Carbohydrate Diet May Not Cause Postmenopausal Women to Gain Weight

News Author: Laurie Barclay, MD

 

Jan. 4, 2006 — A low-fat eating pattern emphasizing fruits, vegetables, and grains does not result in weight gain in postmenopausal women, according to an interim report from the Women's Health Initiative (WHI) Dietary Modification Trial reported in the January 4 issue of JAMA.

"Obesity in the United States has increased dramatically during the past several decades," write Barbara V. Howard, PhD, from MedStar Research Institute in Washington, DC, and colleagues. "There is debate about optimum calorie balance for prevention of weight gain, and proponents of some low-carbohydrate diet regimens have suggested that the increasing obesity may be attributed, in part, to low-fat, high-carbohydrate diets."

In this long-term, low-fat diet trial for which the primary end points were breast and colorectal cancer, 48,835 postmenopausal US women of diverse backgrounds and ethnicities were enrolled between 1993 and 1998 and randomized to a dietary intervention (40%) or control group (60%).

The dietary intervention included group and individual sessions to promote decreased fat intake and increased consumption of vegetables, fruits, and grains, but it did not include weight loss or caloric restriction goals. The control group received diet-related educational materials. The primary endpoint was change in body weight from baseline to follow-up. This analysis includes data from a mean follow-up of 7.5 years, through August 31, 2004.

Compared with the control group, women in the intervention group lost weight in the first year (mean, 2.2 kg; P < .001) and maintained lower weight (difference, 1.9 kg; P < .001 at 1 year and 0.4 kg; P = .01 at 7.5 years). Even when stratified by age, ethnicity, or body mass index (BMI), women in the intervention group showed no tendency toward weight gain. In either group, weight loss was greatest among women who decreased their percentage of energy from fat. A similar but lesser trend was seen with increases in vegetable and fruit servings. There was a nonsignificant trend toward weight loss with increasing intake of fiber.

"A low-fat eating pattern does not result in weight gain in postmenopausal women," the authors write. "This large randomized trial demonstrates that dietary recommendations for reducing fat and replacing it with vegetables, fruits, and grains do not increase body weight, which implies that guidelines that restrict fat intake and advocate increases in complex carbohydrates have not been a contributing factor to the weight gain that has been occurring in the United States throughout the past several decades."

Study limitations include low representation of nonwhites; inclusion only of postmenopausal women aged 50 to 79 years, although the researchers purport that the data are likely generalizable to younger persons and to both sexes; exclusion of women reporting less than 32% fat intake at baseline; biased nature of self-reported food intake; inability to separate carbohydrate intake into the percentage of sugar or simple vs complex carbohydrate; inability to evaluate the potential effects of changes in caloric intake; and possible overestimate of the baseline percentage of energy from fat.

The National Heart, Lung, and Blood Institute funded this study. Dr. Howard has disclosed various relevant financial relationships with Merck, the Egg Nutrition Council, General Mills, Pfizer, and Schering-Plough.

In an accompanying editorial, Michael L. Dansinger, MD, MS, and Ernst J. Schaefer, MD, from Tufts University Human Nutrition Research Center in Boston, Massachusetts, call this a "landmark study... [because the] trial provide[d] a unique opportunity to examine long-term effects of an ad libitum low-fat dietary pattern on body weight and the relationship between weight changes and specific changes in dietary components." However, they continue to describe that the findings on long-term weight change are "somewhat underwhelming." Again, total weight loss at 1 year for the intervention group was only 2.2 kg with a 1.9-kg difference between the intervention and control groups at 1 year and only a 0.4-kg difference after 7.5 years of follow-up.

The editorialists suggest that the dietary intervention should have included the goal of weight reduction. They also stress that weight loss for an individual will not occur without physical activity and belief (by physician and patient) in lifestyle change, regardless of the dietary intervention applied. Citing their own study, published in the January 5, 2005, issue of JAMA, they explain that better adherence leads to better results.

"Much more work needs to be done on the obesity front, including a concerted collective effort focused on developing reliable methods of facilitating high long-term adherence levels to substantial lifestyle efforts — specifically calorie-reduced eating patterns and much more exercise," Drs. Dansinger and Schaefer write. "That is something on which health advocates and popular diet proponents can agree."

 

Childhood Pneumococcal Vaccination Cuts Disease Rates in Young Infants

NEW YORK (Reuters Health) Apr 11 - Since the introduction of a heptavalent pneumococcal conjugate vaccine (PCV7) in 2000 and its recommendation for all children 2-23 months old, rates of invasive pneumococcal disease among young infants have declined, new research suggests.

Previous reports have linked PCV7 use with a drop in IPD rates among children younger than 2 years of age. However, it was unclear if childhood PCV7 immunization reduced disease rates among infants who were too young to receive PCV7 themselves, namely those who were just a few months old.

In the present study, reported in the Journal of the American Medical Association for April 12, Dr. Katherine A. Poehling, from Vanderbilt University School of Medicine in Nashville, and colleagues assessed IPD rates among infants, 0 to 90 days of age, before and after the introduction of PC7V.

In the eight states studied, 89 cases of IPD occurred before PCV7 introduction and 57 occurred afterward. The bulk of these cases - 64% -- involved isolated bacteremia.

With the introduction of PCV7, the average rate of IPD among young infants fell 40% from 11.8 to 7.2 cases per 100,000 live births. The reduction was most pronounced for black infants, falling from 17.1 to 5.3 cases per 100,000 live births (p = 0.001). By contrast, the decline seen among white infants was not statistically significant.

Use of PCV7 was associated with a drop in rates of PCV7-serotype isolates, but seemed to have no effect on rates of non-PCV7 serotypes.

"Our data provide further evidence that PCV7 has resulted in herd immunity because neonates and young infants have had a significant decrease in IPD rates, although they are too young to receive a full series of PCV7," the authors conclude.

 


Reuters Health Information 2006. © 2006 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

 

Pap Abnormalities in Adolescents Require Cautious Management

NEW YORK (Reuters Health) Apr 12 - Adolescents with abnormal cervical cytology screening results should be treated less aggressively than adult women, the American College of Obstetricians and Gynecologists (ACOG) recommends.

ACOG issued its committee opinion on evaluating and treating abnormal cervical cytology in adolescents, in the April issue of Obstetrics & Gynecology. In many cases, the authors write, monitoring is more appropriate than more invasive treatment, given that cervical intraepithelial neoplasia (CIN) grades 1 and 2 typically regress in adolescents, and that "surgical excision or destruction of cervical tissue in a nulliparous adolescent may be detrimental to future fertility and cervical competency."

Although treatment for atypical squamous cells of undetermined significance with high-risk human papillomavirus warrants immediate colposcopy in adult women, according to ACOG, the college recommends a repeat Pap at six and 12 months or a high-risk HPV test only, for adolescents. If test results remain abnormal, colposcopy should be performed.

For low-grade squamous epithelial lesions in adolescents, ACOG also recommends a repeat Pap test at six and 12 months or a high-risk HPV test at 12 months rather than immediate colposcopy. And for CIN 2, the committee recommends close follow-up at four to six month intervals with cytology or colposcopy, while noting that follow-up without treatment is not recommended for noncompliant patients.

All other recommendations for adolescents are the same as for adult women.

ACOG also recommends that cervical cancer screening be initiated in adolescents three years after sexual activity begins, but before age 21, while a patient's risk of future non-compliance and of contracting HPV infection should also be considered. "Obtaining a complete and accurate sexual history, therefore, is critical," the committee, states.

They add that clinicians also should consider issues of confidentiality and parental consent when colposcopy or other more invasive treatment is required for adolescents.


Reuters Health Information 2006. © 2006 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Brain Imaging Predicts Treatment Success in Depressed Patients

By Will Boggs, MD

NEW YORK (Reuters Health) Apr 12 - Functional MRI can be used to predict which patients with unipolar depression will respond to cognitive behavior therapy (CBT), according to a report in the April issue of the American Journal of Psychiatry.

"By examining brain function before treatment," Dr. Greg J. Siegle from the University of Pittsburgh School of Medicine told Reuters Health, "it may be possible to give cognitive therapy to just those patients for whom it is most likely to be effective, thereby improving treatment rates and decreasing patient burden."

Dr. Siegle and colleagues performed functional MRI on 14 unmedicated depressed patients and 21 comparison subjects who had never been depressed. This was done during performance of a task sensitive to sustained emotional information processing. The investigators repeated testing of the depressed patients after 16 sessions of CBT.

The team found that low sustained reactivity in the subgenual cingulate cortex to negative words was strongly associated with a reduction in depression after CBT. High sustained reactivity to negative words in a region of the right amygdala was also associated with improved treatment response.

"Depression," continued Dr. Siegle, "often involves increased automatic reactions to emotional situations and decreased regulation of emotional responses, This study suggests that cognitive therapy, which helps people to react differently to emotional situations and thoughts, may be particularly useful for depressed people who have brain correlates of these characteristics."

Dr. Siegle went on to say that he and his colleagues are conducting a larger study to investigate "whether the same mechanisms which predict response to CBT change upon recovery. In addition, we are looking forward to performing similar studies with patients who are receiving medications."


Reuters Health Information 2006. © 2006 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

HPV Vaccine May Be Safe and Protective

News Author: Laurie Barclay, MD

 

April 11, 2006 — Human papillomavirus (HPV) vaccine is highly immunogenic and safe and offers protection for up to 4.5 years, according to follow-up results of a randomized study published in the April 6 Early Online Publication issue of The Lancet.

"These findings set the stage for the widescale adoption of HPV vaccination for prevention of cervical cancer," lead author Diane M. Harper, MD, from Dartmouth Medical School in Lebanon, NH, said in a news release.

The authors note that effective vaccination against HPV 16 and HPV 18 to prevent cervical cancer requires a high degree of sustained protection against infection and precancerous lesions.

To evaluate the long-term efficacy, immunogenicity, and safety of a bivalent HPV-16/18 L1 virus-like particle AS04 vaccine, the investigators did a follow-up study of their multicenter, double-blind, randomized, placebo-controlled trial reported in 2004. The sample included 393 women who originally received all three 0.5-mL doses of bivalent HPV-16/18 virus-like particle AS04 vaccine, and 383 women who received placebo.

During the extended follow-up phase, more than 98% seropositivity was maintained for HPV-16/18 antibodies. The vaccine had significant efficacy against HPV-16 and HPV-18 endpoints, including incident infection (96.9%; 95% confidence interval [CI], 81.3 - 99.9); persistent infection: 6-month definition, 94.3% (95% CI, 63.2 - 99.9); 12-month definition, 100% (95% CI, 33.6 - 100).

Combined analysis of the initial efficacy and extended follow-up showed a vaccine efficacy of 100% (95% CI, 42.4 - 100) against cervical intraepithelial neoplasia lesions associated with vaccine types. However, there was also broad protection against cytohistologic outcomes beyond that anticipated for HPV-16/18, and protection against incident infection with HPV 45 and HPV 31. Safety profile was good over the long term.

"Up to 4.5 years, the HPV-16/18 L1 virus-like particle AS04 vaccine is highly immunogenic and safe, and induces a high degree of protection against HPV-16/18 infection and associated cervical lesions," the authors write. "There is also evidence of cross protection."

The main study limitation is the few observations of cervical intraepithelial neoplasia in the extended follow-up phase, which may reflect the time required to develop true persistent high-grade cervical dysplasia.

GlaxoSmithKline Biologicals funded and coordinated this study, and employs 4 of its authors. Several other authors have disclosed various financial relationships with GlaxoSmithKline Biologicals, Merck & Co, 3M, Pfizer, Roche, and/or Schering.

 

Tuesday, April 11, 2006

News Flash

Rise in Autism Tied to Better Diagnosis
The number of children classified as mentally retarded or as learning disabled by special education programs has declined in tandem with the rise in autism cases between 1994 and 2003, according to a study in the journal Pediatrics. The results suggests that the past decade's rise in autism cases was largely a labeling issue, and is not evidence of an epidemic but reflects better diagnosis of autism by schools.
Kidney Stone Treatment Has Risks
A recent study found that patients who underwent lithotripsy to eradicate kidney stones developed diabetes at almost 4 times the rate of those whose kidney stones were treated by other methods. The report published in The Journal of Urology also found those who underwent the shock wave treatment increased their likelihood of developing high blood pressure by 50% compared to groups treated by other methods.
Balloon Sinuplasty Offers New Hope for Sinusitis
A radically new treatment to relieve sinusitis, called balloon sinuplasty, uses small balloons, much like the ones used to open clogged arteries, to open the sinus cavity of those suffering from blocked passageways. The soft, malleable bones in the sinus are actually fractured by the inflated balloon, leaving the sinus open once the balloons are deflated and withdrawn. "It allows for no incisions or cutting. There's no bruising or swelling," said Dr. Howard Levine of the Cleveland Nasal/Sinus Center.
You Are What You Drink?
Researcher shows that beverages now account for 21% of the total calories consumed by Americans, up from 16% during the 1970's. Michael Jacobson, executive director of the Center for Science in the Public Interest, calls liquid calories "invisible" and leave people hungrier than food does. Many people don't realize the effect of their liquid choices, says Leslie Kaul, a registered dietician with the American Dietetic Association, citing one client who consumed 1,000 calories of cranberry juice a day, thinking she was making a healthier choice than soda.

 

Long-term Dietary Intervention May Reduce Risk for Insulin Resistance in Children

News Author: Laurie Barclay, MD

 

April 7, 2006 — Long-term, biannual dietary intervention reduces risk for insulin resistance in 9-year-old children, according to the results of a randomized study reported in the April issue of Diabetes Care.

"Insulin resistance, defined as an inadequate metabolic response to plasma insulin at normal concentrations, is promoted by obesity and high intake of saturated fat, and up to 30% of overweight or obese individuals develop insulin resistance," write Tuuli Kaitosaari, MD, from the University of Turku in Finland, and colleagues from the Special Turku Coronary Risk Factor Intervention Project for Children (STRIP) study. "Preventing obesity and sedentary lifestyle and supporting a healthy lifestyle are important preventive measures, particularly if started in childhood."

In this study, healthy 7-month-old infants (n = 1062) were randomized to the intervention (n = 540) and control groups (n = 522). The intervention consisted of biannual individualized counseling sessions for each child's family, aimed at minimizing children's exposure to known environmental risk factors for atherosclerosis. At 9 years of age in a random subgroup of 78 intervention children and 89 control children, a homeostasis model assessment of insulin resistance (HOMA-IR) index, serum lipids, blood pressure, and weight for height were determined.

Compared with the control children, the intervention children consumed less total fat (P = .002) and saturated fat (P < .0001) and had a lower HOMA-IR index (P = .02). Saturated fat intake was significantly correlated with HOMA-IR. Multivariate analyses revealed that the study group, but not saturated fat intake or other determinants of HOMA-IR (serum triglyceride concentration, weight for height, and systolic blood pressure), was significantly associated with HOMA-IR.

"This suggests that the beneficial effect of intervention on insulin sensitivity was largely, but not fully, explained by the decrease in saturated fat intake," the authors write. "The long-term biannual dietary intervention decreases the intake of total and saturated fat and has a positive effect on insulin resistance index in 9-year-old children."

The authors suggest that development of insulin resistance and possibly also atherosclerosis may be delayed or prevented by introducing relevant dietary and lifestyle habits in early childhood.

"Further follow-up studies with continuing counseling sessions in our trial will show whether the observed beneficial effects of intervention will continue over puberty into early adulthood," the authors conclude.

The Juho Vainio Foundation; the Yrjö Jahnsson Foundation; the Finnish Cardiac Research Foundation; the Foundation for Pediatric Research, Finland; the Academy of Finland; the Sigrid Juselius Foundation; the Turku University Foundation; the Finnish Cultural Foundation, City of Turku; EVO funds of Turku University Central Hospital; and the Raisio Group Research Foundation supported this study.

The costs of publication of this article were defrayed in part by the payment of page charges, mandating that the article must therefore be marked "advertisement."

 

Vitamins E and C Plus Ibuprofen May Protect Against Alzheimer's

By Karla Gale

NEW YORK (Reuters Health) Apr 07 - For patients at high risk of Alzheimer's disease, taking a combination of vitamins E and C plus ibuprofen significantly reduces their risk, results of a longitudinal study suggest.

"We found that for people at low risk, taking vitamin C and E alone is sufficient to further reduce their risk. But for those with apolipoprotein epsilon-4 (APOE-epsilon-4) alleles, the combination exerts a synergistic benefit," Dr. Majid Fotuhi told Reuters Health.

Dr. Fotuhi, from Johns Hopkins University in Baltimore, and his associates prospectively followed nearly 5000 elderly residents of Cache County in Utah for 8 years, taking into account their regular consumption of vitamins C and E, ibuprofen, or a combination of the three. Dr. Fotuhi reported the findings at the American Academy of Neurology's 58th Annual Meeting here in San Diego.

They identified 127 subjects who regularly consumed all three agents. Results showed that this group exhibited significantly less decline in Modified Mini-Mental State Exam scores. After adjusting for age, gender, APOE genotype, hypertension, cholesterol, stroke, coronary artery bypass surgery, and MI, those who used all three agents performed better than non-users by approximately 1 point every 2 years.

"With this approach, we've advanced a 2-point attack on the cascade of events that leads to Alzheimer's disease pathology," Dr. Fotuhi said. "On the one hand, we reduce inflammation (with vitamins E and C), and on the other hand, we reduce the amount of amyloid in the brain (with ibuprofen), the substrate that causes inflammation."

As noted, APOE-epsilon-4 carriers experienced the greatest benefit from the triple-combination treatment. According to the researchers' presentation, this subset of patients in their late 60s or 70s exhibited no decline in cognitive function during the 8-year follow-up when they took all three agents. Subjects who took just one of these agents had worsening memory over time.

"So if patients seem to be at high risk, such as having several family members with Alzheimer's disease or with early memory loss, they are likely to benefit the most from the triple-combination therapy," the researcher said.

As to what dose of ibuprofen to use, Dr. Fotuhi urges caution, since the drug is associated with gastric ulcers. He recommends a dose no higher than 100 mg/day.

He is so encouraged by these findings that he has patented a combination pill containing vitamins A and E, ibuprofen, and "a small amount of omega-3 fatty acid."



Reuters Health Information 2006. © 2006 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Secondhand Smoke Tied to Diabetes?

Miranda Hitti

 

April 6, 2006 -- For the first time, researchers report a possible link between secondhand smoke and glucose intolerance.

The study, published in BMJ Online First, doesn't prove that secondhand smoke causes glucose intolerance. But it does show an association between tobacco exposure -- including nonsmokers exposed to secondhand smoke -- and glucose intolerance.

Thomas Houston, MD, MPH, of Alabama's Birmingham Veterans Affairs Medical Center, helped conduct the study. He and his colleagues studied more than 4,600 young blacks and whites for 15 years.

Current cigarette smokers were most likely to develop glucose intolerance, which was defined as having diabetes or impaired fasting glucose (blood sugar). Having impaired fasting glucose is also referred to as prediabetes. Nonsmokers reporting secondhand-smoke exposure came in second, followed by former smokers. Nonsmokers without secondhand-smoke exposure were least likely to develop glucose intolerance, the study shows.

About the Participants

The group was equally split between blacks and whites. Fifty-five percent were women.

Participants had enrolled in a larger study on heart health. They lived in four cities: Chicago; Minneapolis; Birmingham, Ala.; and Oakland, Calif.

When the study started, participants were 18-30 years old and didn't have glucose intolerance. They got an initial checkup lasting four or five hours and were interviewed about smoking.

The group included 1,386 current smokers, 621 former smokers, 1,452 smokers who reported secondhand-smoke exposure, and 1,113 nonsmokers who reported no secondhand-smoke exposure. To try to make sure that nonsmokers really weren't smokers, the researchers checked participants' blood for a marker of nicotine.

Participants got follow-up interviews by telephone every year. They were also scheduled for in-person checkups two, five, seven, 10, and 15 years into the study.

Other Influences

The researchers gathered lots of other information about participants, including diet habits, waist-to-hip ratio, blood pressure, alcohol use, physical activity, income, and education.

Those factors might affect a person's risk of developing glucose intolerance and varied among participants. For instance, current smokers had lower education and consumed more fat and alcohol than nonsmokers with no secondhand-smoke exposure.

The researchers took those and other factors into account. The study's main findings didn't change, but Houston's team doesn't rule out other possible influences, since observational studies can't prove cause and effect.

The findings should be checked in other groups of people, write Houston and colleagues. They note mixed results in other studies on tobacco exposure and diabetes risk.


SOURCES: Houston, T. BMJ Online First, April 7, 2006. News release, BMJ.

Reviewed by Louise Chang

 

Saturday, April 08, 2006

News Flash

FDA Approves Skin Patch for ADHD
The Food and Drug Administration announced the approval of the first skin patch to treat attention deficit hyperactivity disorder in children. The patch contains methyphenidate, the same stimulant that is in Ritalin and is designed to be worn for 9 hours. In December, an FDA panel voted to recommend the patch's label encourage its use only as an alternative treatment for kids ages 6 to 12 for whom taking pills is too difficult.
Britain Confirms 1st Case of Bird Flu
Government officials say a dead swan found in Scotland has tested positive for the A(H5N1) viral strain of bird flu. The native mute swan was discovered 8 days ago in the small costal town of Fife, northeast of Edinburgh. Officials emphasize that there is no immediate danger to humans and there is not yet any danger to the poultry supply, but have established a 1.8 mile protection zone around the location where the dead swan was found to prevent the movement of poultry in and out of the area.
BP Drug Holds Promise for Marfan Syndrome
New research is sparking hope that a popular blood-pressure medication might also protect those with Marfan syndrome against fatal aneurysms. According to a study published in the journal Science, the drug Cozaar worked so well in mice that the government is about to test it in babies and children with Marfan syndrome, a genetic disease of the connective tissues that could cause weakening of the aorta. "We're now talking about the ability to prevent rather than attenuate or respond to manifestations of this disease," said Dr. Harry Dietz, the lead researcher at John Hopkins University. The work may also point to new ways to prevent more common aortic aneurysms.
Anti-depressant Linked to Stillbirth: Study
A study published in the American Journal of Obstetrics and Gynaecology found the use of selective serotonin reuptake inhibitors during pregnancy may increase the risk of having a stillborn baby. Researchers found women using SSRIs were twice as likely to have a stillbirth, and were also more likely to have premature and low-birth weight babies.

 

Obesity Linked to Lower Risk of Cardiac Death in CAD

NEW YORK (Reuters Health) Apr 06 - Obese patients with coronary artery disease (CAD) who have normal myocardial perfusion on single-photon emission computed tomography (MPS) have a lower risk of death from cardiac causes that their leaner counterparts.

A prospective study of 4720 patients with known CAD and 10,019 patients with suspected CAD, conducted by Dr. Daniel S. Berman, of Cedars-Sinai Medical Center in Los Angeles, and colleagues assessed the relationship between body mass index and the prognostic value of MPS.

Obese, overweight and normal weight patients with or without known CAD and a normal MPS had similar rates of cardiac deaths, less than 1% annually.

Obese and overweight patients with known CAD and an abnormal MPS had a lower risk of cardiac death than their normal-weight counterparts. Normal-weight patients with low ejection fractions also had the highest rate of cardiac death.

Dr. Berman's team found that body mass index was not predictive of cardiac death in patients with suspected CAD, but it was an independent inverse predictor of cardiac death in patients with known CAD. This relationship was especially strong in women, those with a low ejection fraction, abnormal MPS and adenosine stress.

The results are published in the April 4th issue of the Journal of the American College of Cardiology.

Reuters Health Information 2006. © 2006 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Short Sleep Duration May Be a Risk Factor for Hypertension

News Author: Laurie Barclay, MD

April 6, 2006 — Sleeping less than 6 hours per night increases the risk for hypertension, according to the results of a longitudinal study reported in the April 3 Online First issue of Hypertension.

"Depriving healthy subjects of sleep has been shown to acutely increase blood pressure and sympathetic nervous system activity," write James E. Gangwisch, MD, from the College of Physicians and Surgeons at Columbia University in New York, NY, and colleagues. "Prolonged short sleep durations could lead to hypertension through extended exposure to raised 24-hour blood pressure and heart rate, elevated sympathetic nervous system activity, and increased salt retention. Such forces could lead to structural adaptations and the entrainment of the cardiovascular system to operate at an elevated pressure equilibrium."

The investigators conducted longitudinal analyses of the first National Health and Nutrition Examination Survey (n = 4810), using Cox proportional hazards models and controlling for covariates. During the 8- to 10-year follow-up period between 1982 and 1992, there were 647 cases of hypertension, determined by physician diagnosis, hospital record, or cause of death.

In subjects between the ages of 32 and 59 years, sleep durations of less than 6 hours per night were associated with more than double the risk for hypertension (hazard ratio, 2.10; 95% confidence interval [CI], 1.58 - 2.79). Controlling for potential confounding variables only partially reduced this relationship. The increased risk continued to be significant after controlling for obesity and diabetes, consistent with the hypothesis that these variables would act as partial mediators.

"Short sleep duration could, therefore, be a significant risk factor for hypertension," the authors write. "Further research is needed to investigate the biological mechanisms that link short sleep duration and high blood pressure. If short sleep duration functions to increase blood pressure, then interventions that increase the amount and quality of sleep could potentially serve as treatments and as primary preventative measures for hypertension."

Study limitations include relatively low sample size for older subjects; inability to determine whether short self-reported sleep durations indicated sleep deprivation or normal variability between individuals in required sleep durations; inability to rule out reverse causation or uncontrolled confounders; use of self-reported sleep durations; lack of repeated measures of sleep duration; possible underdiagnosis of hypertension; possible bias arising from loss to follow-up; and missing data on baseline risk variables.

"In results from the National Sleep Foundation 2002 Sleep in America Poll, not getting enough sleep was associated with irritability, impatience, pessimism, and feeling tired and stressed," the authors point out. "It would seem that these feelings and emotional states would function to lessen one's resolve and willpower to follow dietary or exercise regimens that would be protective against hypertension."

 

Cancer Vaccine Works Long Term

Salynn Boyles

 

April 5, 2006 -- A vaccine targeting the sexually-transmitted virus that can cause cervical cancer was still protecting women who got it after more than four years, researchers reported Wednesday.

The findings represent the longest follow-up yet of an experimental human papillomavirus (HPV) vaccine, which has the potential to dramatically lower deaths from cervical cancer.

Two such vaccines are poised to hit the market in the U.S. pending approval by the FDA. The agency is expected to rule on Merck's vaccine -- called Gardasil -- early in June.

A spokesman for GlaxoSmithKline tells WebMD that the company plans to seek FDA approval for its HPV vaccine -- Cervarix -- by the end of the year.

"With fast-track status, if all goes well, we could have [approval] within six months," says Phillippe Monteyne, who heads global vaccine development for the company.

100% Protection

The study included 800 women who were vaccinated with either three doses of Cervarix or a placebo.

In November 2004, researchers reported that the vaccine was 100% effective in preventing persistent infection with the two HPV strains that cause about 70% of cervical cancers -- HPV-16 and HPV-18.

In a follow-up, published in the latest issue of The Lancet, they reported that the women given the vaccine continued to be protected four and a half years after receiving the last dose of the vaccine.

The women were also protected against two other HPV strains that have also been associated with cervical cancer -- HPV 45 and HPV 31. This cross-protection occurred even though the vaccine was not designed to target these strains.

About half a million cases of cervical cancer are diagnosed worldwide each year, and an estimated 280,000 women -- mostly in developing countries -- die from the disease.

Researchers estimate that if all eligible women got the vaccine, it would reduce the worldwide incidence of cervical cancer by almost 70%.

"This is a very exciting time," says Diane M. Harper, MD, MPH, who led the study team. "We haven't had an advance like this in cancer care or in women's health for 50 years. This has tremendous potential."

Unanswered Questions

There are still many unanswered questions, most notably who will get the vaccine, when they will be vaccinated, and which vaccine they will get.

The GlaxoSmithKline vaccine protects against cervical cancer alone, while the Merck vaccine also targets two HPV viruses that cause genital warts.

But Harper says her findings suggest that the GlaxoSmithKline vaccine may protect women against cervical cancer longer than its competitor.

Harper directs the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School's Norris Cotton Cancer Center. The study was funded by GlaxoSmithKline, but she says she has also done research on the Merck vaccine. GlaxoSmithKline and Merck are WebMD sponsors.

"I'm not trying to pick a fight and say one vaccine is better than the other," she says. "These are both good vaccines, but it is clear that there are real differences between them."

If, as expected, the FDA approves the Merck vaccine in early June, the CDC's Advisory Committee on Immunization Practices is expected to weigh in on who should be vaccinated at its meeting later that month.

It may recommend that preteen girls be given the vaccine, or it may recommend the vaccine for girls in their teens.

HPV infection rates peak among women in their late teens and very early 20s, Harper says.

"Stay tuned for June," American Cancer Society Director of Breast and Gynecological Cancer Debbie Saslow, PhD, tells WebMD. "There are a lot of groups interested in having a voice in how this vaccine is used."

Some conservative groups have been vocally opposed to the vaccine, arguing that it could undermine efforts to discourage sex among teens.

Saslow says other conservative groups have expressed support for the vaccine, although they don't want it to be among the immunizations that schools require.

The Developing World

Immunization strategies for nonindustrialized countries, where 80% of cervical cancer deaths occur, remain to be determined.

In the U.S, the vaccine is expected to cost between $200 and $300 for a three-dose series, although the companies have not said how much they will charge, according to Saslow.

Projections are that without the vaccine, cervical cancer deaths in the developing world will rise dramatically in the coming decades.

The Bill and Melinda Gates Foundation has pledged $50 million for the prevention of cervical cancer in the coming decades, but it is not clear how big a role vaccination will play in its efforts.


SOURCES: Harper, D.M. The Lancet, April 6, 2006; vol 367: online edition. Diane M. Harper, MD, MPH, director, gynecologic cancer prevention research group, Norris Cotton Cancer Center, Dartmouth Medical School, Lebanon, N.H. Debbie Saslow, PhD, director of breast and gynecological cancer, American Cancer Society. Phillippe Monteyne, head of global vaccine development, GlaxoSmithKline. WebMD: "Vaccine May Prevent Cervical Cancer."

News Flash

FDA Approves Skin Patch for ADHD
The Food and Drug Administration announced the approval of the first skin patch to treat attention deficit hyperactivity disorder in children. The patch contains methyphenidate, the same stimulant that is in Ritalin and is designed to be worn for 9 hours. In December, an FDA panel voted to recommend the patch's label encourage its use only as an alternative treatment for kids ages 6 to 12 for whom taking pills is too difficult.
Britain Confirms 1st Case of Bird Flu
Government officials say a dead swan found in Scotland has tested positive for the A(H5N1) viral strain of bird flu. The native mute swan was discovered 8 days ago in the small costal town of Fife, northeast of Edinburgh. Officials emphasize that there is no immediate danger to humans and there is not yet any danger to the poultry supply, but have established a 1.8 mile protection zone around the location where the dead swan was found to prevent the movement of poultry in and out of the area.
BP Drug Holds Promise for Marfan Syndrome
New research is sparking hope that a popular blood-pressure medication might also protect those with Marfan syndrome against fatal aneurysms. According to a study published in the journal Science, the drug Cozaar worked so well in mice that the government is about to test it in babies and children with Marfan syndrome, a genetic disease of the connective tissues that could cause weakening of the aorta. "We're now talking about the ability to prevent rather than attenuate or respond to manifestations of this disease," said Dr. Harry Dietz, the lead researcher at John Hopkins University. The work may also point to new ways to prevent more common aortic aneurysms.
Anti-depressant Linked to Stillbirth: Study
A study published in the American Journal of Obstetrics and Gynaecology found the use of selective serotonin reuptake inhibitors during pregnancy may increase the risk of having a stillborn baby. Researchers found women using SSRIs were twice as likely to have a stillbirth, and were also more likely to have premature and low-birth weight babies.

 

Obesity Linked to Lower Risk of Cardiac Death in CAD

NEW YORK (Reuters Health) Apr 06 - Obese patients with coronary artery disease (CAD) who have normal myocardial perfusion on single-photon emission computed tomography (MPS) have a lower risk of death from cardiac causes that their leaner counterparts.

A prospective study of 4720 patients with known CAD and 10,019 patients with suspected CAD, conducted by Dr. Daniel S. Berman, of Cedars-Sinai Medical Center in Los Angeles, and colleagues assessed the relationship between body mass index and the prognostic value of MPS.

Obese, overweight and normal weight patients with or without known CAD and a normal MPS had similar rates of cardiac deaths, less than 1% annually.

Obese and overweight patients with known CAD and an abnormal MPS had a lower risk of cardiac death than their normal-weight counterparts. Normal-weight patients with low ejection fractions also had the highest rate of cardiac death.

Dr. Berman's team found that body mass index was not predictive of cardiac death in patients with suspected CAD, but it was an independent inverse predictor of cardiac death in patients with known CAD. This relationship was especially strong in women, those with a low ejection fraction, abnormal MPS and adenosine stress.

The results are published in the April 4th issue of the Journal of the American College of Cardiology.

Reuters Health Information 2006. © 2006 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Short Sleep Duration May Be a Risk Factor for Hypertension

News Author: Laurie Barclay, MD

April 6, 2006 — Sleeping less than 6 hours per night increases the risk for hypertension, according to the results of a longitudinal study reported in the April 3 Online First issue of Hypertension.

"Depriving healthy subjects of sleep has been shown to acutely increase blood pressure and sympathetic nervous system activity," write James E. Gangwisch, MD, from the College of Physicians and Surgeons at Columbia University in New York, NY, and colleagues. "Prolonged short sleep durations could lead to hypertension through extended exposure to raised 24-hour blood pressure and heart rate, elevated sympathetic nervous system activity, and increased salt retention. Such forces could lead to structural adaptations and the entrainment of the cardiovascular system to operate at an elevated pressure equilibrium."

The investigators conducted longitudinal analyses of the first National Health and Nutrition Examination Survey (n = 4810), using Cox proportional hazards models and controlling for covariates. During the 8- to 10-year follow-up period between 1982 and 1992, there were 647 cases of hypertension, determined by physician diagnosis, hospital record, or cause of death.

In subjects between the ages of 32 and 59 years, sleep durations of less than 6 hours per night were associated with more than double the risk for hypertension (hazard ratio, 2.10; 95% confidence interval [CI], 1.58 - 2.79). Controlling for potential confounding variables only partially reduced this relationship. The increased risk continued to be significant after controlling for obesity and diabetes, consistent with the hypothesis that these variables would act as partial mediators.

"Short sleep duration could, therefore, be a significant risk factor for hypertension," the authors write. "Further research is needed to investigate the biological mechanisms that link short sleep duration and high blood pressure. If short sleep duration functions to increase blood pressure, then interventions that increase the amount and quality of sleep could potentially serve as treatments and as primary preventative measures for hypertension."

Study limitations include relatively low sample size for older subjects; inability to determine whether short self-reported sleep durations indicated sleep deprivation or normal variability between individuals in required sleep durations; inability to rule out reverse causation or uncontrolled confounders; use of self-reported sleep durations; lack of repeated measures of sleep duration; possible underdiagnosis of hypertension; possible bias arising from loss to follow-up; and missing data on baseline risk variables.

"In results from the National Sleep Foundation 2002 Sleep in America Poll, not getting enough sleep was associated with irritability, impatience, pessimism, and feeling tired and stressed," the authors point out. "It would seem that these feelings and emotional states would function to lessen one's resolve and willpower to follow dietary or exercise regimens that would be protective against hypertension."

 

Cancer Vaccine Works Long Term

Salynn Boyles

 

April 5, 2006 -- A vaccine targeting the sexually-transmitted virus that can cause cervical cancer was still protecting women who got it after more than four years, researchers reported Wednesday.

The findings represent the longest follow-up yet of an experimental human papillomavirus (HPV) vaccine, which has the potential to dramatically lower deaths from cervical cancer.

Two such vaccines are poised to hit the market in the U.S. pending approval by the FDA. The agency is expected to rule on Merck's vaccine -- called Gardasil -- early in June.

A spokesman for GlaxoSmithKline tells WebMD that the company plans to seek FDA approval for its HPV vaccine -- Cervarix -- by the end of the year.

"With fast-track status, if all goes well, we could have [approval] within six months," says Phillippe Monteyne, who heads global vaccine development for the company.

100% Protection

The study included 800 women who were vaccinated with either three doses of Cervarix or a placebo.

In November 2004, researchers reported that the vaccine was 100% effective in preventing persistent infection with the two HPV strains that cause about 70% of cervical cancers -- HPV-16 and HPV-18.

In a follow-up, published in the latest issue of The Lancet, they reported that the women given the vaccine continued to be protected four and a half years after receiving the last dose of the vaccine.

The women were also protected against two other HPV strains that have also been associated with cervical cancer -- HPV 45 and HPV 31. This cross-protection occurred even though the vaccine was not designed to target these strains.

About half a million cases of cervical cancer are diagnosed worldwide each year, and an estimated 280,000 women -- mostly in developing countries -- die from the disease.

Researchers estimate that if all eligible women got the vaccine, it would reduce the worldwide incidence of cervical cancer by almost 70%.

"This is a very exciting time," says Diane M. Harper, MD, MPH, who led the study team. "We haven't had an advance like this in cancer care or in women's health for 50 years. This has tremendous potential."

Unanswered Questions

There are still many unanswered questions, most notably who will get the vaccine, when they will be vaccinated, and which vaccine they will get.

The GlaxoSmithKline vaccine protects against cervical cancer alone, while the Merck vaccine also targets two HPV viruses that cause genital warts.

But Harper says her findings suggest that the GlaxoSmithKline vaccine may protect women against cervical cancer longer than its competitor.

Harper directs the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School's Norris Cotton Cancer Center. The study was funded by GlaxoSmithKline, but she says she has also done research on the Merck vaccine. GlaxoSmithKline and Merck are WebMD sponsors.

"I'm not trying to pick a fight and say one vaccine is better than the other," she says. "These are both good vaccines, but it is clear that there are real differences between them."

If, as expected, the FDA approves the Merck vaccine in early June, the CDC's Advisory Committee on Immunization Practices is expected to weigh in on who should be vaccinated at its meeting later that month.

It may recommend that preteen girls be given the vaccine, or it may recommend the vaccine for girls in their teens.

HPV infection rates peak among women in their late teens and very early 20s, Harper says.

"Stay tuned for June," American Cancer Society Director of Breast and Gynecological Cancer Debbie Saslow, PhD, tells WebMD. "There are a lot of groups interested in having a voice in how this vaccine is used."

Some conservative groups have been vocally opposed to the vaccine, arguing that it could undermine efforts to discourage sex among teens.

Saslow says other conservative groups have expressed support for the vaccine, although they don't want it to be among the immunizations that schools require.

The Developing World

Immunization strategies for nonindustrialized countries, where 80% of cervical cancer deaths occur, remain to be determined.

In the U.S, the vaccine is expected to cost between $200 and $300 for a three-dose series, although the companies have not said how much they will charge, according to Saslow.

Projections are that without the vaccine, cervical cancer deaths in the developing world will rise dramatically in the coming decades.

The Bill and Melinda Gates Foundation has pledged $50 million for the prevention of cervical cancer in the coming decades, but it is not clear how big a role vaccination will play in its efforts.


SOURCES: Harper, D.M. The Lancet, April 6, 2006; vol 367: online edition. Diane M. Harper, MD, MPH, director, gynecologic cancer prevention research group, Norris Cotton Cancer Center, Dartmouth Medical School, Lebanon, N.H. Debbie Saslow, PhD, director of breast and gynecological cancer, American Cancer Society. Phillippe Monteyne, head of global vaccine development, GlaxoSmithKline. WebMD: "Vaccine May Prevent Cervical Cancer."

Friday, April 07, 2006

News Flash

Cooking Chicken Kills Bird Flu Virus
A government panel advises cooking chicken until it reaches an internal temperature of at least 165 degrees in order to destroy viruses and bacteria that may be contained in poultry. "It's not in response directly to avian influenza, but so many people right now are concerned about bird flu and wonder if poultry will be safe to eat," said Richard Raymond, the Centers' for Disease Control and Prevention undersecretary for food safety.
Stay Skinny, Stay Young?
Researchers have shown that people who follow a strict low-calorie diet--consuming as little as 890 calories a day-- can decrease DNA damage linked with aging. Calorie restriction also slowed their metabolism, and decreased insulin levels, factors thought to be associated with longevity. The findings are preliminary and longer-term research is needed to determine whether such changes can meaningfully extend people's lives.
Hygiene Hypothesis' Holds True for Tots: Study
The "hygiene hypothesis" holds that when babies are exposed to germs, it helps them to fight allergies and asthma later in life. Indeed, some experts believe that too much cleanliness might be a contributing factor to the dramatic increase in allergy sufferers. In a recent study, Dr. Dennis Ownby at the Medical College of Georgia found that babies in households with multiple pets have fewer allergies at age 6 or 7 not just to animals, but also to ragweed, grass, and dust mites. And while studies of babies in day care have found these children to have more infections early in life, they have fewer allergies and less wheezing as they age than do their peers, Dr. Ownby said.
Tips on Eating Before Exercising
Past studies have shown that exercising on an empty tank does burn slightly more calories, but because people become fatigued faster their workouts tend to be shorter. Other experts point out that the practice lowers blood pressure, causing ravenous hunger that would lead most people to eat more that they would otherwise. Recommendation? A small piece of fruit will provide just enough energy for a more intense workout.

 

Don't Ignore Migraines in Teenagers

April 5, 2006 (San Diego) -- If your teenager constantly complains of a headache, don't write it off as an excuse to skip a day of school or avoid the day's chores, Florida researchers advise.

A nationwide study of 18,714 adolescents aged 12 to 19 shows that migraine headaches in teenagers are common, disabling, and substantially undertreated.

"If your adolescent has a headache, they more than likely are really having a headache," says researcher Paul Winner, MD, director of the Palm Beach Headache Clinic and professor of neurology, Nova Southeastern University, Fort Lauderdale, Fla. "Headaches are causing a lot of disability in the nation's youths."

Findings of a nationwide survey not only show that a large number of adolescents have migraine headaches, but they aren't receiving appropriate treatment for those debilitating headaches. The results were presented at the American Academy of Neurology (AAN) 58th annual meeting.

The study found that for a one-year period, 5% of boys and 7.7% of girls reported frequent migraines.

Migraine Medications

About 60% of those with migraines were using only over-the-counter medications to alleviate the symptoms. Only 17% used prescriptions drugs for migraines and 22% used both prescription and over-the-counter medication.

Almost one-third of adolescents with migraines met the criteria of severity and frequency of headache for taking medications to prevent migraines; even so, the majority was not receiving those medications.

Thirty-one percent met the criteria to warrant preventive therapy. Yet of those who met the criteria for preventive therapy, only 19% had used preventive medicine previously and only 10.6% were current users.

"There was a lot more disability than what we expected," Winner tells WebMD. "The fact that 31% of these kids were eligible for preventive care is enormous. That represents a lot of pain, suffering, and loss of school and family activities."

Increasing Frequency of Migraines

The study sent out questionnaires to 120,000 households that were representative of the U.S. population. Surveys were returned by 77,879 households that yielded data on 18,714 adolescents. Migraine cases were established by national guidelines on headache criteria. Migraine sufferers who were candidates for preventive therapy were determined by an expert panel of neurologists using AAN guidelines.

The researchers found that the frequency of migraine headaches among adolescent sufferers continued to "rapidly" increase. "The child initially might have one or two headaches a month and then a couple of years later have 10 or 15 headaches a month," Winner says. "They seem to transition quickly. These kids need help."

The study also showed that girls starting at age 14 and both male and female adolescents from poorer families earning less than $22,500 annually had higher rates of migraine headaches, according to Winner.

Advice for Parents

Winner advises parents of children with frequent headaches to seek help from their doctors and that adolescents talk with their parents and doctors about frequent headaches. "The child needs to know that it isn't normal to have a really severe headache," he says. "That is not a normal state."

Migraine headaches are less common in childhood and reach higher levels in adulthood, so the percentage of adolescents with migraines isn't surprising, notes J.D. Bartleson, MD, associate professor of neurology, Mayo Clinic College of Medicine.

"What is more surprising is that migraine headaches in adolescents are underrecognized and undertreated," Bartleson tells WebMD.

Bartleson says there needs to be better public awareness that both acute symptomatic and preventive treatment is available for migraine headaches.


SOURCES: American Academy of Neurology 58th annual meeting, San Diego, April 1-8, 2006. Paul Winner, MD, director, Palm Beach Headache Clinic; professor of neurology, Nova Southeastern University, Fort Lauderdale, Fla. J.D. Bartleson, MD, associate professor of neurology, Mayo Clinic College of Medicine.

Bed Rest May Not Be Helpful for Threatened Miscarriage

Laurie Barclay, MD

 

April 5, 2006 — An opinion piece in the March 24 issue of The New York Times highlights a controversial issue in obstetrics: the value of bed rest for threatened miscarriage. Although this intervention is widely prescribed, evidence of its efficacy is limited or absent, and some experts suggest that there may be deleterious effects.

"There is no evidence that bed rest is beneficial for preserving the pregnancy in cases of threatened miscarriage," American College of Obstetrics and Gynecology fellow Robert L. Goldenberg, MD, a professor of obstetrics and gynecology at the University of Alabama at Birmingham, told Medscape. "I tell my patients to do whatever they feel more comfortable with, whether it be rest or continuing their usual activities."

Part of the problem in determining the value, if any, of bed rest in this situation is the difficulty in carrying out well-designed, methodologically sound research, according to Alexandros Sotiriadis, MD, a PhD researcher in obstetrics and gynecology at the University Hospital of Ioannina in Greece.

"Bed rest for threatened miscarriage has been used empirically in the past, when a 'detachment' of the fetus was held responsible for miscarriage or threatened miscarriage," Dr. Sotiriadis told Medscape. "This approach is currently criticized as our insight into the pathophysiology of miscarriage has improved, and it has become clear that there is lack of evidence to support the [efficacy] of bed rest in this condition."

In many cases of threatened miscarriage the causes are nonreversible, for example, those due to chromosomal abnormality, and bed rest would not be expected to have any effect. Because of the small proportion of cases of threatened miscarriage eventually resulting in actual miscarriage, statistically convincing research would require several hundreds of participants to detect small differences attributed to bed rest. Karyotype analysis in cases of miscarriage would also be essential in this setting, Dr. Sotiriadis said. After excluding those cases in which miscarriage was inevitable because of chromosomal abnormalities, the effect of bed rest would likely be so small
that the number of patients needed to treat to prevent 1 miscarriage would be too great in terms of cost-effectiveness.

"Antepartum bed rest treatment is based on 2 assumptions: that bed rest treatment is (1) effective and (2) safe — ie, has no major adverse effects," Judith A. Maloni, PhD, RN, FAAN, a professor at the Frances Payne Bolton School of Nursing at Case Western Reserve University in
Cleveland, Ohio, told Medscape. "There is no evidence for the first assumption, and there is increasing research to support that bed rest has major adverse effects for the mother and possibly for the fetus/infant."

Two small randomized controlled trials (RCTs) from the early 1990s showed overall lack of effect. In one of these studies, 61 women with viable pregnancies and vaginal bleeding at less than 8 gestational weeks were randomized to receive injections of human chorionic gonadotropin, injections of placebo, or bed rest. Abortion rates were 30%, 48%, and 75%, respectively (Int J Fertil Menopausal Stud 1993;38:160-165).

In addition, because Cochrane reviews rely primarily on data from RCTs, they have rated antepartum bed rest to prevent threatened miscarriage as a "form of care unlikely to be beneficial." Evidence from current RCTs shows no significant difference in maternal-fetal outcomes for women with twin and triplet gestations treated with hospital bed rest and those allowed to ambulate at home (Cochrane database, 2004).

"At one time bed rest was thought to be effective, but this conclusion was based on the results of older studies (not RCTs) that had serious methodologic flaws such as, for example, failure to exclude fetal and neonatal deaths from congenital anomalies that were incompatible with life," Dr. Maloni said. "In contrast, one recent study indicates that vigorous leisure activity during pregnancy, especially during the second trimester, is associated with a reduced risk of preterm birth." (Epidemiology. 2002;13[6]:653-659).

A retrospective study of 226 women showed that 16% of 146 women prescribed bed rest for threatened abortion eventually miscarried compared with 20% of women not prescribed bed rest (P = .41; Minerva Ginecol. 2001;53:337-340). However, in an observational cohort study of 230 women with threatened miscarriage and subchorionic hematoma, 9.9% who complied with recommended bed rest miscarried compared with 23.3% of women who continued their usual activities (P = .03; Isr Med Assoc J. 2003;5:422-424).

"In our practice some physicians do nothing, some prescribe bed rest for several days, and some also add vaginal progesterone," Avi Ben-Haroush, MD, an obstetrician/gynecologist at Rabin Medical Center in Petach-Tikva, Israel, and lead author of the last-mentioned study, told Medscape. "It is well acknowledged that these measures are empiric with no real evidence."

Two decades ago, 96% of general practitioners in the United Kingdom prescribed bed rest for heavy bleeding in early pregnancy (BMJ. 1987;295:583-586). A study published by Dr. Maloni in 1998 (J Women's Health. 1998;7(3):351-358) showed that about 90% of obstetricians prescribed some form of bed rest or activity restriction during the second and third trimester to prevent preterm birth in women with preterm labor, preterm rupture of membranes, placenta previa, or multiple gestation.

"Currently, it is my observation that physicians are now using bed rest somewhat less," Dr. Maloni said. "They now rarely prescribe complete bed rest in the hospital (not allowed out of bed to toilet) but continue to prescribe bed rest with bathroom privileges in varying degrees. They have also tended to shift the site of bed rest from the hospital to the home."

Across the United States, prescription of bed rest is somewhat inconsistent, according to Dr. Maloni. Some practices and hospitals rarely use antepartum bed rest and others advise very strict bed rest.

"Abstinence from an active environment for a few days may make some patients feel safer, and therefore psychologically better," said Dr. Sotiriadis, who recently wrote a review of this subject (BMJ. 2004;329:152-155). "Yet again, immobilization would not help even in this setting, as it would only make the patients feel ill and probably responsible for the [potentially adverse] outcome."

Dr. Maloni pointed out that there are some women with symptoms of preterm labor, such as contractions with cervical dilatation, who may need to reduce excessive or intense activity during pregnancy. Examples of such activity might include running, aerobics, or physically demanding employment.

"These women may benefit from reducing some of this activity," Dr. Maloni said. "But this does not mean that they should go on bed rest during their pregnancy. This is my clinical impression, but the idea needs to be tested by research."

Apart from the lack of evidence supporting the efficacy of antepartum bed rest for threatened abortion, there are potentially adverse effects to consider. Muscle atrophy and cardiovascular deconditioning are well documented effects of bed rest in men and nonpregnant women. Dr. Maloni and colleagues have written extensively about the physical and psychological effects of bed rest on pregnant women and even in their offspring. Antepartum symptoms may include musculoskeletal and cardiovascular deconditioning, sleep disturbances, and other changes in circadian rhythms. Additional problems may include insufficient weight gain and low birth weights.

"The effects vary by the severity of activity restriction and length of bed rest," Dr. Maloni said. "Bathroom privileges do not offset the side effects of bed rest. Psychosocial adverse effects include increased depression, stress, and family functioning difficulties."

In Dr. Maloni's longitudinal study of 106 postpartum women who had a singleton high-risk pregnancy and were treated with antepartum bed rest, duration of maternal bed rest was significantly correlated with the number of symptoms at postpartum weeks 1, 2, 4, 5, and 6.
(J Obstet Gynecol Neonatal Nurs. 2005;34[2]:163-171). At 6 weeks, at least 40% of women continued to report fatigue, mood changes, tenseness, difficulty concentrating, back muscle soreness, dry skin, and headache.

However, Dr. Ben-Haroush said that "there are no reported adverse effects for bed rest in [threatened abortion]," and according to Dr. Sotiriadis, direct evidence regarding adverse effects of bed rest in threatened miscarriage is "quite limited." Both of these experts agree that pregnancy is associated with a hypercoagulable state. "Immobilization, especially strict and/or prolonged, can predispose to thromboembolic events," Dr. Sotiriadis pointed out.

Experts interviewed by Medscape recommend RCTs to evaluate the effects of bed rest in women with vaginal bleeding and viable pregnancy in the first trimester, preterm labor, placenta previa, and preterm rupture of membranes. Dr. Maloni also suggested additional research replication regarding the adverse effects of bed rest on maternal weight gain, infant birth weight, and maternal bone density antepartum and postpartum.

While awaiting the results of such studies, Dr. Maloni encouraged women to get a second opinion from a high-risk perinatologist or maternal-fetal medicine specialist about whether bed rest is needed and, if so, the degree of activity restriction that should occur. Women opting for bed rest should ask their obstetrician about postpartum physical therapy referral for a systematic assessment of cardiovascular and musculoskeletal weakness, and to obtain a specific planned program of supervised rehabilitation to address the deconditioning effects of bed rest, she said.

"I think this common obstetric practice should be discontinued until RCT evidence is produced to support that bed rest treatment improves fetal and maternal outcome," Dr. Maloni concluded. "If physicians do not discontinue the practice, then they should order a planned program of postpartum rehabilitation for postpartum women. Early discharge should be reconsidered in light of the adverse side effects that extend into the postpartum recovery period."

Dr. Sotiriadis suggested that physicians have a thorough discussion with the patient and her partner to explain the events and mechanisms underlying threatened miscarriage, and that they offer continuous support, ideally by a dedicated healthcare professional or early pregnancy unit.

"There cannot be evidence-based guidelines [concerning the use of bed rest for threatened abortion] as there is lack of evidence," Dr. Sotiriadis concluded.

Drs. Ben-Haroush, Maloni, Rosenberg, and Sotiriadis report no relevant financial relationships.

Reviewed by Gary D. Vogin, MD



Laurie Barclay, MD is a freelance writer for Medscape.

http://eclinic.blogspot.com