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Women still left out of much medical research

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Your sex matters when it comes to your health, yet women may still be an afterthought in research studies.

Despite policies and grant requirements to include females in research studies, many researchers still don’t analyze their data by sex, a new study found. If researchers don’t look at their results by sex, it’s impossible to know if diseases, drugs or vaccines might impact each sex differently.

“Sex influences health and disease in multiple organ systems. It’s not just related to the reproductive tract. By not considering by sex in research, it’s a harm to women’s health,” said study author Nicole Woitowich.

“We need this information. Right now, we’re trying to put a puzzle together and we don’t have all the pieces. By including both sexes in research, we can improve the health of all people,” she explained. Woitowich is the associate director of the Women’s Health Research Institute at Northwestern University Feinberg School of Medicine, in Chicago.

Why does this make such a difference? Woitowich noted that in a recent study of a type of brain tumor where researchers analyzed their data by sex, they found differences in the response to treatment by sex.

Kathryn Schubert, president and CEO of the Society for Women’s Health Research, said, “Women need to be included in studies. When you think about diseases that affect women and men, like cardiovascular disease, symptoms may be different by sex, treatment may be different. If you haven’t thought about the differences between males and females in your research, it’s almost not worth it. You have to include the other half of the population.”

Schubert’s organization notes that 90 percent of women with sleep apnea aren’t diagnosed because their symptoms may differ from men’s. And 80 percent of people with osteoporosis are women.

Erin Mulcahy Stein, executive director of Maria Shriver’s Women’s Alzheimer’s Movement, pointed out that two-thirds of people with Alzheimer’s disease are women, making it important to understand what role sex plays in that condition.

Many diseases strike women differently

“Women have at least three or four life stages that men don’t have — menstruation, pregnancy, perimenopause and menopause — and all of these can affect how a disease develops in women. If we don’t have full understanding of these stages because we’ve left out 51 percent of the population, there’s a real risk there that we might miss something. We’ve seen it in heart disease when women were dropping dead of heart attacks because doctors thought women would have symptoms the same way men did with crushing chest pain, but that’s not how women present with the disease,” Stein said.

And, she explained, there are similar differences with Alzheimer’s. Women performed better on tests that were used to diagnose Alzheimer’s for many years, which meant they were diagnosed later. Now, those tests have been adjusted to account for those sex differences.

Historically, women were left out of research because researchers were concerned that the variability of female hormones — due to menstruation — might affect study results.

Woitowich said, “It was assumed that there was no difference between males and females outside of the reproductive tract, and it was just easier and cheaper to use one set of animals in research, and those tended to be male.”

And, she noted that it wasn’t until 2016 that basic science researchers were required to use animals of both sexes in research to get grants from the U.S. National Institutes of Health (NIH).

The current research included more than 700 studies from nine areas of biological research. The investigators looked at whether studies used male, female or both sexes, and whether or not they reported and analyzed the data by sex.

The good news is that more studies were including both male and female subjects — just 28 percent had both males and females in 2009 compared to 49 percent in 2019. Despite that increase in inclusion, the researchers didn’t find an increase in the number of studies that analyzed their data by sex during that time.

Only 4 percent of the published studies provided a reason why they didn’t use both sexes or why they didn’t separate the data by sex. Of those that provided a reason, many said it was to limit the influence of female hormones.

Scientists break out results by sex

In some cases, researchers also failed to detail how many males or females were studied. This is a big problem if another research team is trying to replicate the study’s findings, Woitowich said.

“One of the things I found most worrisome was that close to one-third of those who used both males and females didn’t report the numbers of each sex. The ability to repeat studies is so important. And, if I don’t have that information when I repeat the study and I get a different result, that leaves me confused,” she said.

So what can be done to change this? Woitowich said the NIH took the first step in 2016 by requiring scientists to consider both sexes.

“But that’s not the whole solution. In this study, the literature was all peer-reviewed. Editors of journals need to require information on sex. And, other funders besides the NIH need to make inclusion of both sexes a requirement, or if you’re studying just one sex, explain why. If you are including both sexes, describe why you’re not doing sex-based analysis,” she said.

Woitowich said cost likely isn’t a major factor because researchers can still use the same number of animals in their studies.

Of the current study, Schubert said, “It’s exciting to see that there is change happening, but there’s a lot more work to be done.”

Schubert added, “In order to help make [sex-based research analysis] the norm, not only do universities need to ensure that sex-based research policies are being implemented, researchers need to understand that sex is an important biological variable.”

Stein noted that “it’s taken quite a bit of time for [women’s health research] to start to catch up, but we’re still not there yet. There’s an increased awareness that’s come from the aggressive and unapologetic drumbeat from organizations like ours that ask, ‘How could we possibly know as much as we need to know about diseases like Alzheimer’s if women aren’t included in the research?'”

The study was published online June 9 in the journal eLife.

More information

Learn more about sex differences in health from the U.S. Office on Women’s Health.

Copyright 2020 HealthDay. All rights reserved.



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Study: Racquet sports make arthritic knees worse for overweight people

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Stay off the court: For overweight people with arthritic knees, racket sports like tennis and racquetball may accelerate degeneration of the joints, a new study finds.

Exercise can benefit overweight people, but the wrong type might damage knees and lead to the need for knee replacement surgery, the researchers said.

“Fast-paced and high shear load physical activities, such as racket sports, are more harmful for overall knee joint health,” said lead researcher Dr. Silvia Schiro, from the University of California, San Francisco.

Racket sports include frequent and high-intensity lateral movements that can worsen knee osteoarthritis, as opposed to activities that mostly involve forward movements — such as running, an elliptical machine, swimming and bicycling — or forward and diagonal movements, such as ball sports, Schiro said.

“Overweight or obese people may benefit from working out with an elliptical trainer in order to lose weight and engage a healthy lifestyle,” Schiro said.

For the study, Schiro’s team used MRI scans to assess the rate of degeneration of the knee joint in 415 overweight or obese patients who were part of the U.S. Osteoarthritis Initiative.

Participants kept records of different types of physical activity, including ball sports, bicycling, jogging/running, elliptical trainer, racket sports and swimming. The participants were evaluated using the Whole-Organ Magnetic Resonance Imaging Score — “WORMS” — a measure of knee degeneration.

Patients who regularly took part in racket sports saw their WORMS increase significantly, compared with patients who used the elliptical machine, the researchers found.

Surprisingly, the same happened in those participating in racket sports when compared with those who jogged or ran. Those doing racket sports had a significantly greater degeneration in the medial tibial cartilage compartment, which is the area where arthritis often first appears.

Those using the elliptical machine showed the smallest changes in degeneration over the four years of the study.

The faster degeneration of the knee joints in people who participated in racket sports is likely due to the high-speed lateral movements inherent in such sports, Schiro said.

Overweight people who continue to play racket sports might slow degeneration in their knees by switching to sports with less fast-paced and high shear loads like badminton or doubles tennis, the researchers suggested.

Schiro emphasized that the degenerative process is complex and individualized. Some people may be able to safely play these sports, she said. But as a group, overweight and obese people who play racket sports are at higher risk for disease progression.

Knee osteoarthritis, which gradually wears down the cartilage that cushions the ends of the bones, is a major cause of pain and disability, affecting about 14 million Americans, the researchers noted.

Dr. Karen Schneider is an orthopedic surgeon at Lenox Hill Hospital in New York City. She said, “Moderate daily exercise and weight loss for those who are overweight are important in the treatment of knee and hip osteoarthritis.”

Besides improvement in bone density, cardiovascular health and mental well-being, exercise helps decrease joint stiffness associated with osteoarthritis, and improves flexibility and strength, she added.

It may seem counterintuitive that running did not increase the risk of progressive osteoarthritis, but that has been shown in other studies looking at the association of moderate running and osteoarthritis, Schneider said.

“Lower-impact exercises — such as biking, elliptical trainer and swimming — are easier on the joints and often may be preferable to patients with obesity and osteoarthritis,” she said. “For those patients who enjoy tennis, I would encourage them to play doubles on a softer surface and cross-train with other low-impact forms of exercise.”

The findings are scheduled for presentation at the upcoming virtual annual meeting of the Radiological Society of North America. Such research is considered preliminary until published in a peer-reviewed journal.

More information

For more on knee osteoarthritis, head to the American Academy of Orthopaedic Surgeons.

Copyright 2020 HealthDay. All rights reserved.



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Chinese COVID-19 vaccine said to show promise in early clinical trials

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Nov. 17 (UPI) — A vaccine against COVID-19 developed in China safely produces antibodies against the virus in 92% of the people who receive it, according to a study published Tuesday by The Lancet Infectious Diseases.

Still, antibody levels among participants receiving the shot, called CoronaVac, were lower than those seen in patients who have recovered following infection, the researchers said.

The trial was not designed to assess the effectiveness of the vaccine, however, and those studies are ongoing, they said.

“Our findings show that CoronaVac is capable of inducing a quick antibody response within four weeks of immunization by giving two doses of the vaccine at a 14-day interval,” study co-author Fengcai Zhu said in a statement.

“We believe that this makes the vaccine suitable for emergency use during the pandemic,” said Zhu, a researcher with the Jiangsu Provincial Center for Disease Control and Prevention in Nanjing, China.

The findings are the latest to fuel hopes that a viable vaccine against COVID-19 will become available in the short-term.

In recent days, both Pfizer and Moderna have released positive, preliminary results with their respective vaccines. More than 120 potential vaccines are being evaluated, and 48 are in clinical trials.

CoronaVac is a chemically inactivated whole virus vaccine based on a strain of the coronavirus that causes COVID-19, originally was isolated from a patient in China.

In this phase 1/2, two-part clinical trial — the first stage of the evaluation process — researchers administered CoronaVac to more than 700 healthy volunteers ages 18 to 59 in China between April 16 and May 5.

No participant had a history of COVID-19 infection, had not traveled to areas with high incidence of the disease and did not have signs of fever at the time the vaccine was administered, the researchers said.

In both parts of the trial, participants were split into two groups to receive one of two vaccination schedules — either two injections 14 days apart or two injections 28 days apart.

Within each of the two groups, participants were randomly assigned to receive either a low dose of the vaccine — 3 micrograms — or a high dose — 6 mcg.

Antibody responses — proteins produced by the immune system to fight off viruses — could be induced within 28 days of the first immunization by giving two doses of the vaccine at the lower dose 14 days apart, the data showed.

In the phase 1 portion of the study, the vaccine produced an immune response in 46% of participants, a figure that more than doubled to just over 92% during the second phase.

The vaccine used in the second phase of the study was produced using a different manufacturing process that may have enabled it to produce a stronger immune response, researchers said.

Participants in all dosing schedules and levels reported similar side effects, with pain at the injection site the most common.

Most of the reported side effects were mild and participants recovered within 48 hours.

CoronaVac can be stored in a standard refrigerator at 36 to 46 degrees Fahrenheit, which is “typical for many existing vaccines including flu,” and can remain in storage for up to three years, according to study co-author Dr. Gang Zeng, of China-based Sinovac Biotech, which makes the vaccine.



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Buying gun during pandemic may increase suicide risk, study says

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Those who buy guns as the pandemic rages are more likely to be suicidal than those who already own firearms, a new study finds.

In fact, among people who bought guns during the pandemic, about 70% reported having suicidal thoughts, while just 37% of other gun owners had such thoughts, researchers found.

“People who were motivated to purchase firearms during COVID-19 might have been driven by anxiety that leaves them vulnerable to suicidal ideation,” said researcher Michael Anestis, executive director of the New Jersey Gun Violence Research Center and an associate professor at the Rutgers School of Public Health in Piscataway, N.J.

“While this does not guarantee an increase in suicide rates, it represents an unusually large surge in risk made more troubling by the fact that firearms purchased during COVID-19 may remain in homes beyond the pandemic,” he said in a university news release.

During the first four months of the pandemic, more than 2.5 million Americans bought guns for first time. In March alone, when the pandemic began with a vengeance in the United States, roughly 2 million guns were purchased, Anestis said.

For the study, the researchers surveyed 3,500 Americans. A third of them owned guns.

The researchers found that of those who bought a gun during the pandemic, 70% had suicidal thoughts throughout their lives, 56% had suicidal thoughts during the past year, and 25% had suicidal thoughts during the past month.

Among people who did not buy guns during the pandemic only 56%, 24% and 12%, respectively, had suicidal thoughts during those time periods.

“Firearm owners are usually no more likely than non-firearm owners to experience suicidal thoughts,” Anestis noted. “It is possible that a higher-risk group is driving the current firearm purchasing surge, introducing long-term suicide risk into the homes of individuals who otherwise may not have acquired firearms during a time of extended social isolation, economic uncertainty and general upheaval.”

People who bought a gun during the pandemic also were also less likely to store guns in a secure way, including storing the weapons unloaded or using locking devices.

“The increase in firearm purchases is concerning, given that suicide is three times more likely in homes with firearms, and there is a hundred-fold increase in an individual’s suicide risk immediately following the purchase of a handgun,” Anestis said. “And unsafe firearm storage increases that risk.”

The report was published this week in the American Journal of Preventive Medicine.

More information

For more on guns and suicide, see Harvard University.

Copyright 2020 HealthDay. All rights reserved.



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