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In the ongoing struggle to find treatments — and maybe one day even a cure — for dementia, researchers are focusing their attention on high blood pressure, long a culprit for a variety of other ills and an ailment for which many drugs are already available.

This coming fall, the U.S. National Institutes of Health will start enrolling participants in the largest trial thus far to see if lowering blood pressure even below current recommendations can reduce not only the risk of age-related cognitive decline, but also the risk of cardiovascular and kidney diseases.

The Systolic Blood Pressure Intervention Trial (SPRINT) will involve 7,500 people aged 55 and over who will be followed for a minimum of four years. The NIH is investing $114 million in the endeavor.

“We have a number of effective and safe medications to lower blood pressure,” said Dr. Lawrence Fine, chief of the clinical applications and prevention branch in the division of cardiovascular sciences at the National Heart, Lung, and Blood Institute. “For the average person right now, the recommendation is a blood pressure of 140/90 or lower. SPRINT will compare that with a goal of 120 as the top number. Will the rate of dementia for people in the lower-goal arm be lower than standard?”

Current clinical guidelines recommend systolic pressure (the top number in a blood pressure reading) of less than 140 millimeters of mercury (mm Hg) for healthy adults, and 130 mm Hg for adults with kidney disease or diabetes.

“Hypertension is very easy to medicate and very easy to measure, so they want to see if just by modifying that simple thing they could reduce the incidence of dementia,” said Ian Murray, an assistant professor of neuroscience and experimental therapeutics at the Texas A&M Health Science Center College of Medicine in College Station.

The timing is critical, as over the next several decades huge numbers of aging Baby Boomers will develop Alzheimer’s disease and other forms of dementia.

Besides sparing thousands of Americans needless suffering, “if you could reduce that number by 10 percent, your cost savings would be immense,” said William Thies, chief medical and scientific officer for the Alzheimer’s Association in Chicago.

Although experts have long suspected a link between high blood pressure and dementia, without trial data those suspicions inevitably remain hypotheses.

“What we do know is that there’s an association between high blood pressure and a higher rate of dementia — it’s not a large increased risk but there is some increase,” Fine said.

“A whole bunch of epidemiologic data says there’s a link, and one trial actually showed that if you lowered people’s blood pressure it decreased the amount of dementia,” added Thies.

That particular trial used blood pressure drugs known as calcium-channel blockers, one in an extensive armamentarium of medications for the condition. Still, no one really knows why treating high blood pressure would lower the odds of dementia if, in fact, it really does.

“We’d really like to know the answer because it would give us our first confirmed pathway to modifying the amount of dementia by treating people with known agents,” Thies said. “That would be very important.”

The SPRINT trial will randomize participants — all of whom have systolic blood pressure of 130 mm Hg or higher — either to a group taking more intensive drug therapy (three or four medications) to try to get their blood pressure under 120, or a control group taking about two medications to maintain blood pressure at the currently recommended 140.

“We may discover lower blood pressure will not reduce the rate of dementia, but if the lower goal did reduce the rate of dementia by 10 or 20 or 30 percent, that would be an important observation because we don’t have other good treatments for dementia,” Fine said. “SPRINT should provide some additional science to inform us whether lowering blood pressure to the lower goal will, in fact, reduce the rate of developing dementia.”

“There are a lot of reasons why we ought to control blood pressure anyway, but this gives us another very important reason,” Thies added.

SOURCES: Ian Murray, Ph.D., assistant professor, neuroscience and experimental therapeutics, Texas A&M Health Science Center College of Medicine, College Station; Lawrence Fine, M.D., DrPH, chief, clinical applications and prevention branch, division of cardiovascular sciences, U.S. National Heart, Lung, and Blood Institute; William Thies, Ph.D., chief medical and scientific officer, Alzheimer’s Association, Chicago

Despite supplement makers’ claims and popular perceptions, the benefits of soy in fighting hot flashes in women going through menopause remain unproven, according to a new analysis of 19 studies.

Soy contains estrogen-like compounds, and researchers have proposed that the amount of soy a woman consumes may influence her risk of having hot flashes and night sweats during menopause. These symptoms are related to the sharp drop in estrogen levels that occurs as women stop menstruating, making it possible that high consumption of estrogen-like compounds could reduce their severity — or eliminate them.

To investigate, Dr. Rafael Bolaños of San Marcos University in Lima, Peru, and colleagues searched the medical literature for clinical trials lasting at least 12 weeks in which soy products were compared with inactive placebo in menopausal women.

The researchers divided the studies into three groups based on the type of supplement used: concentrate of soy isoflavones, the estrogen-like compounds found in soy (3 studies); soy extract (6 studies), or soy dietary supplement (10 studies).

Within each group, women using soy products showed significant improvement of their hot flashes compared to the women on placebo. The extract seemed to have the strongest effects, while soy isoflavones came in second place, and soy dietary supplements came in last.

But because the various studies were so different from one another in terms of dosages used, outcomes measured, and other factors, the researchers say, firm conclusions can’t be drawn from the current analysis.

They call for more studies in which these factors are standardized to better establish whether or not soy is helpful to women with menopausal symptoms.

SOURCE: Menopause.

Gays and lesbians are excluded from many medical studies involving issues of sexual health such as impotence or low sex drive, a new report finds.

“Our study indicates that it’s more prevalent than one might have guessed.” said Roland Dunbrack, Jr., co-author of the report, which appears in the March 18 issue of the New England Journal of Medicine.

“It’s an exclusion that in many cases, maybe in most cases, doesn’t need to be used,” said Dunbrack, an associate professor at Fox Chase Cancer Center in Philadelphia.

Review boards, which approve studies at both the local and federal level, already keep a close eye on research that excludes minority groups or either gender, Dunbrack noted. He and his colleagues launched their research because they were curious about study restrictions involving gays and lesbians.

“If you want to exclude a particular group, you usually have to have a rationale for it,” he said, but there aren’t such restrictions for gays and lesbians.

The researchers suspected that the issue of inclusion — or exclusion — of gays and lesbians doesn’t come up very much outside of research into sexuality. And they found that to be the case, at least in asthma research. Of more than a thousand studies on asthma that the researchers located, none had restrictions based on sexual orientation.

However, out of 243 studies that included the words “couple,” “erectile dysfunction” or “hypoactive” (referring to low sex drive), 37 excluded non-heterosexuals in some way.

“It’s not that every study we looked at should be rewritten,” Dunbrack said, but there should be reasons given for the exclusions, and “we don’t know for these studies what these rationales would be.”

Those most likely to restrict people in same-sex relationships were industry sponsored trials, multi-regional studies and phase 3 clinical trials (the phase before drugs are typically submitted for FDA approval), the team found.

James Beaudreau, education and policy director of the Gay and Lesbian Medical Association, said it’s important to include lesbians, gays, bisexuals and transgendered people in medical research because they experience certain medical conditions at different rates.

For example, studies suggest that lesbians may be more likely to develop breast cancer than other women. Also, he said, “the health effects of stress related to living with a stigmatized identity include higher rates of depression, anxiety disorders, suicide attempts, and substance abuse.”

“The real danger is that gay and transgender people may respond differently to medical interventions, but we will never know if we don’t collect the information,” said Beaudreau, whose organization represents medical professionals.

“We don’t believe that it places an undue burden on researchers to ask questions about sexual orientation and gender identity,” he said.

SOURCES: Roland Dunbrack, Jr., Ph.D., associate professor, Program in Molecular and Translational Medicine, Fox Chase Cancer Center, Philadelphia; James Beaudreau, education and policy director, Gay and Lesbian Medical Association, San Francisco; New England Journal of Medicine

Although women have less sex as their pregnancy progresses, they don’t enjoy the experience any less, new research shows.

“We’ve studied men’s sexual health for many years, and we have not studied women’s sexual health, concerns, issues and problems in the past, and there’s a gender information gap,” said Dr. Irwin Goldstein, editor-in-chief of The Journal of Sexual Medicine, in which this new study was recently published. “This kind of study helps narrow that gap and provide information on the real behavior of real women, and gives us a sense of what to expect.”

Goldstein is director of sexual medicine at Alvarado Hospital in San Diego.

The authors of this new study, out of Lisbon, Portugal, asked 188 women aged 17 to 40 to fill out a questionnaire the day they were discharged from the hospital after the birth of a child.

Almost half (44.7 percent) of women said that their most frequent sexual intercourse took place during the first trimester of the pregnancy. A little more than one third (35.6 percent) said sex was most frequent in the second trimester.

Only 10 percent said that the most frequent sexual activity occurred in the third trimester, while 55 percent said that sex decreased at this point.

But the majority of women — 80.1 percent — said they did have intercourse at this later stage of the pregnancy. And almost 40 percent of women said they had sex during the birth week.

Roughly half of all women said there had been no change in their sex life during the first or second trimesters.

Almost one-quarter (23.4 percent) of women admitted they were afraid that sex would hurt the baby.

In the course of researching her book, The Working Woman’s Pregnancy Book, Dr. Marjorie Greenfield said that this fear sometimes came from the male partner.

“One woman said that she felt like having sex, but her husband was uncomfortable about the idea,” said Greenfield, who is division chief of general obstetrics & gynecology at University Hospitals Case Medical Center in Cleveland. “Some men say they feel the baby is watching them or that they are going to hurt the baby.”

About half of the women in the survey said their sexual satisfaction remained the same throughout the pregnancy while a lesser proportion — 27.7 percent — said it declined. Sexual desire was the same in 38.8 percent and down in 32.5 percent of the participants.

The most common type of sexual activity was vaginal (performed by 98.3 percent), followed by oral sex (38.1 percent) and anal sex (6.6 percent). About one-fifth of women said they masturbated during pregnancy.

More than 40 percent of women said they felt less attractive while they were expecting, but three-quarters said they sensed no decrease in sexual interest from their husband or partner.

In general, the authors and other experts stated, sex during pregnancy is not dangerous.

“A lot of people think it causes abortions in the third trimester or damage to the child, but regular penal-vaginal intercourse is not an issue,” Goldstein said, adding that there can be issues with air embolisms during oral sex and infections during anal sex.

And there are some people for whom sex during pregnancy can be unsafe, said Greenfield, including women with placenta previa, when the placenta lies lower in the uterus.

“Bumping into the placenta under those circumstances can cause the mom to hemorrhage,” she said.

“But for your average person, there’s only one sex act that has an increased risk for women who are pregnant,” she added. “There have been fatalities if air is blown into vagina. Anything that forces air into the vagina is not safe.”

“It’s important to recognize that desire and self-image and variables such as hormonal changes and tiredness and concern for children really affect women’s sexual drives and functions, especially as they go to the third trimester,” Goldstein said. “It’s OK to expect changes in sexual function during the pregnancy.”

SOURCES: Marjorie Greenfield, M.D., division chief, general obstetrics & gynecology, University Hospitals Case Medical Center, Cleveland, and author, The Working Woman’s Pregnancy Book; Irwin Goldstein, M.D., director, sexual medicine, Alvarado Hospital, San Diego, and editor-in-chief, Journal of Sexual Medicine, Journal of Sexual Medicine