Lung Cancer Screening Rates Only 2% Across US

Lung Cancer Screening Rates Only 2% Across US

Very few of the heavy smokers who are eligible for lung cancer screening in the United States have undergone such screening, a nationwide analysis has found.

The US Preventive Services Task Force (USPSTF) recommended in 2013 that all individuals aged 55 to 80 years who have a smoking history of 30 pack-years or longer and who currently smoke or have quit within the past 15 years should be screened annually for lung cancer with low-dose CT (LDCT).

There are an estimated 7 million such individuals in the United States.

In 2016, fewer than 2% of those eligible underwent LDCT at one of the nearly 1800 screening centers across the country.

The findings, which will be presented at the forthcoming American Society of Clinical Oncology (ASCO) 2018 annual meeting on June 3 (abstract 6504), were highlighted at a press briefing held ahead of the meeting.

They follow the publishing of recent data, reported by Medscape Medical News, that the majority of patients who are referred to lung cancer screening live close to the screening site, suggesting that underserved populations living in remote areas are being left out.

This very low rate of lung cancer screening is particularly stark when compared with screening rates for breast cancer. About 65% of women aged 40 or older underwent a mammogram in 2015, commented lead author Danh Pham, MD, a medical oncologist at the James Graham Brown Cancer Center, University of Louisville, Kentucky.

“This ultimately begs the question of the root of the disparity,” he said at the press briefing.

“Are physicians not referring enough? Or perhaps are eligible patients not wanting screening, even if they knew a test was available?” he continued.

Although it is “still speculation at this point,” he wondered whether there may be a stigma associated with screening for lung cancer, a disease that is “attributed to a modifiable risk factor through heavy smoking, and the at-risk population may be deterred from wanting screening if diagnosing cancer will result in confirming a poor lifestyle choice.”

This has been described as the “ostrich effect,” a term recently coined to describe frightened patients who, when faced with a major health problem, want to “stick their heads in the sand” and make it all go away.

Pham emphasized that, whatever the reason, the findings are “a call to action on everyone’s part to increase much-needed screening, whether it’s through increasing awareness or conducting additional research to urgently increase the screening of the number one cancer killer in America.”

Bruce E. Johnson, MD, president of ASCO, agreed that the low rates of lung cancer screening are “very disappointing.”

He underlined that previous estimates for lung cancer screening suggested that it saves 12,000 lives every year. By comparison, the findings of the current study indicate that 250 lives are saved each year.

However, Johnson also pointed out that, given that reimbursement for screening was only approved by the Centers for Medicare & Medicaid (CMS) in 2015 and that the analysis was conducted in 2016, the results show what happened in “the first year, so this is a measure not of a steady-state situation.”

Approached for comment, Daniel Oh, MD, clinical assistant professor of surgery at Keck School of Medicine of the University of California (USC), Los Angeles, and cofounder of the USC/Norris Lung Cancer Program, agreed that the history of lung cancer screening should be taken into account when interpreting the results.

Results from the landmark National Lung Screening Trial, which showed that screening could save lives, were published in June 2011. The USPSTF recommended screening in 2013, but it was not until February 2015 that coverage of costs by CMS was approved. “There had been concerns among clinicians that CMS was not going to approve it, which placed many physicians in limbo about whether or not to offer LDCT, due to insurance coverage concerns,” he said.

He also pointed out that, when CMS finally approved LDCT screening, “they stipulated that screening centers must report to a CMS-approved registry, which is essentially the American College of Radiology [ACR] Lung Cancer Screening Registry.”

His center was “among the first applicants for entry into the ACR registry, and we still did not become a participant until July 2015,” he said. “Taking into consideration logistics and the resolution of coverage issues, 2016 is a more accurate baseline measurement of lung cancer screening,” he noted.

The study illustrates that our nation still has not embraced lung cancer screening in earnest. Dr Daniel Oh

“That said, the study illustrates that our nation still has not embraced lung cancer screening in earnest, and we need to raise awareness among primary care physicians to improve adoption of LDCT,” he commented.

“When you consider that 60% of eligible patients receive colonoscopies, which are far more unpleasant than an LDCT, it is clear that we need to do better,” he added.

Details of the Analysis

For the current analysis, Pharm and colleagues gathered data from the Lung Cancer Screening Registry of the ACR on all LDCTs performed at all 1796 accredited radiographic screening sites in the United States in 2016.

They then used data from the 2015 National Health Interview Survey to estimate the number of eligible smokers who could have been screened on the basis of USPSTF recommendations.

The data were compiled for four US census regions, the Northeast, the South, the Midwest, and the West. The researchers calculated the screening rate by dividing the number of LDCT scans by the number of smokers eligible for screening per USPSTF recommendations.

Overall, the team calculated that an estimated 7,612,975 smokers across the United States were eligible for screening. They found that 14,080 LDCT screens were performed in the 1796 centers nationwide. From these data, they calculated the overall lung cancer screening rate to be just 1.9%.

The South had the highest number of accredited centers, at 663, as well as the highest estimated number of eligible smokers, at 3,072,095, but that region had the second lowest screening rate, at just 1.6%.

The West had the lowest screening rate, at 1.0%. There were 232 accredited centers in the West, and an estimated 1,368,694 eligible smokers.

The screening rate in the Midwest, which had 497 screening centers and an estimated 2,020,045 eligible smokers, was 1.9%.

The highest screening rate was seen in the Northeast, which had a rate of 3.5%. There, there were 404 accredited centers and an estimated 1,152,141 eligible smokers.

How to Improve Lung Cancer Screening Rates?

Discussing how screening rates could be increased, Pham said: “I think the most radical thing that we could suggest based on our study so far would potentially be making lung cancer screening a national quality health measure, just the way that CMS made breast cancer and colonoscopies a national area of improvement in 2008.”

Richard Schilsky, MD, chief medical officer at ASCO, said that “could be an effective strategy, particularly since physicians are increasingly being required to report on quality measures to optimize their reimbursement.”

Schilsky emphasized that screening for cancer is typically carried out by primary care physicians, rather than oncologists. “So one of the things that we also need to do is to be sure primary care physicians are well aware of the screening data and the importance of referring the appropriate patients for screening, and that they are aware of screening centers are available in their communities.”

For Oh, the focus should be on the patients themselves. “I think individuals simply need to be aware that screening for lung cancer exists,” he said.

“People these days are very proactive about their health, but this is a topic that is not getting a lot of attention. For example, we all see numerous commercials on TV every day telling patients to ask their doctor about a new drug, but we do not see anything analogous for lung screening awareness,” he said.

Oh nevertheless agreed with Schilsky about the importance of educating primary care physicians and the need to “clarify for them the requirements for screening and ease the workflow that is involved.

“Ultimately, I think an automated reminder in patients’ electronic health records needs to be implemented, but this will take some time,” Oh commented.

“”Surprisingly, one of the biggest obstacles for this has been the lack of an accurate smoking history in patients’ records, which often goes back to the stigma of smoking,” he said.

Another solution to the low lung cancer screening rates may come from the United Kingdom, where a pilot screening program in a supermarket parking lot quadrupled detection rates of early lung cancer.

As reported by Medscape Medical News, the pilot project, which was funded by a UK charity, used LDCT to screen current and former smokers identified from general practices. Through the program, 80% of lung cancer cases were detected while the disease was at stage I or II.

Another study that was reported by Medscape Medical News suggested that the majority of patients referred to lung cancer screening live close to the screening site, leaving out remote and underserved populations.

One other issue with lung cancer screening concerns the risk-benefit ratio. LDCT screening finds many nodules in the lung that are not cancer. As reported by Medscape Medical News, in a recent study conducted by the Veterans Health Administration, 2000 high-risk individuals were screened for lung cancer. Of those patients, 1.5% were found to have lung cancer, and around 60% of patients had positive results on screening, including one or more nodules that needed to be tracked. Incidental findings were reported in around 40% of patients. The authors concluded that lung cancer screening “benefits few, but may harm many.”

This study received funding from the Bristol-Myers Squibb Foundation. Dr OH has disclosed no relevant financial relationships, but several coauthors have reported financial relationships with pharmaceutical companies, as detailed in the abstract.

American Society of Clinical Oncology (ASCO) 2018. Abstract 6504, to be presented June 1, 2018.

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FDA OKs Asthma Inhaler Arnuity Ellipta for Kids as Young as 5

FDA Approves Denosumab for Steroid-Induced Osteoporosis

FDA Approves Denosumab for Steroid-Induced Osteoporosis

The US Food and Drug Administration (FDA) has approved denosumab (Prolia, Amgen) for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture, defined as defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. 

Denosumab is the first approved therapy for osteoporosis that specifically targets RANK ligand, an essential regulator of bone-removing cells (osteoclasts).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also recently adopted a positive opinion for the marketing of denosumab in the European Union for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults at increased risk of fracture.

This is the fifth indication for denosumab, which is already approved in the United States for the treatment of postmenopausal women with osteoporosis at high risk for fracture; men with osteoporosis at high risk for fracture; women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer; and men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.

How Long to Give Denosumab for Steroid-Induced Osteoporosis?

Both the US approval and EU positive opinion were based on data from a phase 3 study that showed patients on glucocorticoid therapy who received denosumab had greater gains in bone mineral density (BMD) compared with those who received active comparator, the bisphosphonate risedronate.

The results of this study were recently published in Lancet Diabetes & Endocrinology, as reported by Medscape Medical News.

“Patients on long-term systemic glucocorticoid medications can experience a rapid reduction in BMD within a few months of beginning treatment,” said study lead Kenneth F. Saag, MD, professor of medicine at the University of Alabama at Birmingham School of Medicine in an Amgen press release. “With this approval, patients who receive treatment with glucocorticoids now have a new option to help improve their BMD.”

In an editorial accompanying the publication of the Phase 3 study, Elena Tsourdi, MD, PhD, and Lorenz Hofbauer, MD, PhD, of Technische Universitat Dresden Medical Center, Germany agreed that denosumab “is an important step towards improved treatment options for glucocorticoid-induced osteoporosis.”

But they pointed out that BMD “is not the ideal surrogate for trials in patients with glucocorticoid-induced osteoporosis, because it underestimates fracture risk in view of the extraskeletal adverse effects of glucocorticoids on muscle function and falls.”

And physicians still don’t know how long to continue treatment with denosumab, as investigators in this trial were only able to report results out to 12 months, they noted, adding that discontinuation of denosumab has been shown to lead to a rapid decrease in BMD, at least among postmenopausal women.

And because many patients require long-term, if not life-long, glucocorticoid therapy, they consequently also need concomitant long-term bone-protective therapy, they explained.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1. For more diabetes and endocrinology news, follow us on Twitter and on Facebook.

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Trastuzumab for 6 Months Instead of 1 Year?

Trastuzumab for 6 Months Instead of 1 Year?

When the first human epidermal growth factor receptor 2 (HER2)–targeted agent, trastuzumab (Herceptin, Genentech/Roche), was approved back in 2005, it went on to transform the treatment of early breast cancer for the 12% to 15% of women with tumors that are HER2 positive.

However, its use for 1 year following surgery — as is the standard of care — was arrived at empirically. Early trials compared 1 year to 2 years of therapy.

Now, a new trial suggests that 6 months of trastuzumab has a similar efficacy but halves the incidence of cardiotoxicity that can occur as an adverse event.

This would also halve the cost of the treatment.

“We are confident that this will mark the first steps towards a reduction of the duration of trastuzumab treatment to 6 months in many women with HER2-positive breast cancer,” said lead author Helena Earl, MBBS, PhD, professor of clinical cancer medicine at the University of Cambridge in the United Kingdom.

“But we need to be very careful and cautious about saying at this point that 6 months is enough,” she added, pointing out that this is a first glimpse of the results. 

Earl was speaking at a presscast held ahead of the annual meeting of the American Society of Clinical Oncology (ASCO), where she will present these results, from the PERSEPHONE trial, on June 4 (abstract 506).

The trial, conducted in 4088 women, showed noninferiority between the two durations of therapy, said Earl. The disease-free survival rate at 4 years was 89.4% with 6 months of therapy and 89.8% with 12 months of therapy.

At the same time, only 4% of women in the 6-month group stopped trastuzumab early because of cardiac problems, compared with 8% in the 12-month group, she reported.  

Experts not involved in the study cautioned that longer-term data are needed.

“We need time for the data to mature,” commented Richard Schilsky, MD, chief medical officer at ASCO. “There are no data yet on overall survival as yet,” he pointed out. Also, these results show an average for the patient population as a whole, and there are undoubtedly women who may not do as well, he commented. The researchers are now undertaking translational work to see if they can find biomarkers that would identify women who could benefit from longer therapy.

Nevertheless, Schilsky said he found the data so far to be “quite compelling,” and he predicted that they “will signal a shift towards a shorter duration of trastuzumab adjuvant therapy.”

ASCO President Bruce Johnson, MD, from the Dana-Farber Cancer Center in Boston, Massachusetts, said the cardiotoxicity benefit is clear, but as far as efficacy is concerned, he agreed that longer-term follow-up is needed. “At this point, less than 10% of the patients have died and only 12% have relapsed…so it may be a bit early to call for a definite change in practice.”

“In my opinion, efficacy drives most of the therapeutic decision-making,” Johnson commented. “Once you are very convinced of the data, then you take into account” other considerations, such as reducing adverse events. In this case, “in order to be convinced of the data, we probably need a bit more time and a few more events,” he said.    

Approached for comment, Darcy Spicer, MD, division chief, oncology, USC Norris Comprehensive Cancer Center, Los Angeles, California, said, “The shortened duration of therapy is quite significant, remembering that the original 2-year standard of adjuvant systemic chemotherapy was shortened to today’s 1-year standard following years of subsequent clinical trials.”

“We look forward to the abstract’s presentation to determine whether or not there are patient subsets for whom shortened duration or longer duration may be more appropriate,” he added.

In addition, several more HER2-targeted drugs are now available. Therefore, Spicer said, “placing this information into an evolving treatment platform for HER2-positive patients employing other anti-HER2 therapies will be an important next step.” 

This study was funded by the National Institute for Health Research (NIHR) in the United Kingdom.  Earl reports a consulting or advisory role with Celgene, Pfizer, Roche, and AstraZeneca; expenses from Pfizer, Daiichi Sankyo, Amgen, and AstraZeneca; honoraria from AstraZeneca, Pfizer, Daiichi Sankyo, and Amgen; and research funding from Roche and Sanofi. Many coauthors also report financial relationships with pharmaceutical companies.

American Society of Clinical Oncology (ASCO) 2018. Abstract 506. To be presented June 4, 2018.

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Proposed Restrictions on Title X Funds Stirs Up Hornet's Nest

Proposed Restrictions on Title X Funds Stirs Up Hornet's Nest

Although it has not yet been officially released, a Trump administration proposal that would prohibit federal Title X family planning funds from being awarded to clinics that provide abortion services is generating comments about its potential impact from clinician groups on both sides of the abortion debate.

Under current law, funds for Title X — a program established in 1970 to provide family planning and preventive healthcare to low-income Americans — cannot be used to provide abortion or promote abortion as a method of family planning. In practice, many clinics that receive the funds — such as Planned Parenthood facilities — provide abortion services. But those services are funded by private money.

The new rule — which is under review at the White House before being formally published — would block those clinics that receive Title X money from performing abortions.

The White House has not made the proposal available to the public. One media outlet — The Hill — reported on Friday that the White House unveiled the proposal in a telephone call to groups opposed to abortion rights. The Hill said that under the rule, Title X recipients could not be co-located with abortion clinics, and they would no longer be required to tell patients that abortion is an option.

“Gag Rule” Under Scrutiny

That last point is of concern to women’s healthcare providers.

Hal Lawrence, MD, executive vice president and CEO of the American Congress of Obstetricians and Gynecologists, said in a statement emailed to Medscape Medical News, “The anticipated changes to Title X issue an ultimatum to qualified health care providers, forcing them to not only stop offering abortion in order to continue being eligible for Title X grants, but to altogether cease inclusion of abortion care in discussion of women’s reproductive health choices, thereby turning back the clock on women’s health.”

Restricting access to Title X funding “is likely to shutter health centers or dramatically narrow the scope of care health centers are able to provide,” he added.

“This ‘gag rule’ is not only unconscionable, but it undermines medical ethics by forcing health care professionals to withhold accurate and timely medical information from patients,” said Jenn Conti, MD, a fellow with Physicians for Reproductive Health, in a statement.

“If I can’t mention the word ‘abortion,’ then I am not providing my pregnant patients who want to know all of their options with complete, accurate, unbiased medical information,” she said.

The White House said the rule would not include a strict prohibition on abortion discussions. “Contrary to recent media reports, [the US Department of Health and Human Services’ (HHS’)] proposal does not include the so-called ‘gag rule’ on counseling about abortion that was part of the Reagan Administration’s Title X rule,” said an unnamed White House press secretary in a statement.

The proposal “would ensure compliance with the program’s existing statutory prohibition on funding programs in which abortion is a method of family planning. The new proposed rule would not cut funds from the Title X program. Instead, it would ensure that taxpayers do not indirectly fund abortions,” said the statement.

Many groups that oppose abortion rights said they were pleased. “The American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) applauds President Trump’s common sense clarification of the original purpose of Title X, which explicitly did not support pushing abortion as a method of family planning,” said Donna Harrison, MD, executive director of AAPLOG, in a statement emailed to Medscape Medical News.

The Susan B. Anthony (SBA) List, an organization that had lobbied for the rule, called it a “major victory.” SBA List President Marjorie Dannenfelser said in a statement, “President Trump has shown decisive leadership, delivering on a key promise to pro-life voters who worked so hard to elect him.”

The rule “doesn’t cut a single dime from family planning. It instead directs tax dollars to Title X centers that do not promote or perform abortions, such as the growing number of community and rural health centers that far outnumber Planned Parenthood facilities,” she added.

The SBA List said that Planned Parenthood receives $50 million to $60 million a year from Title X. The Title X program was allocated $286 million in 2018, according to the group.

“Family planning at Planned Parenthood means access to abortion,” said Christina Francis, MD, chairman of the AAPLOG board of directors, in the statement sent to Medscape Medical News. Francis added, “President Trump’s proposed Protect Life rule recognizes that women don’t need abortion. Title X dollars aren’t being cut, but simply redirected to abortion-free providers.”

Legal Challenges Expected

A group of Democratic senators who had urged against the rule estimated that Planned Parenthood serves 40% of Title X patients. About 4000 Title X–funded centers provide preventive healthcare — such as Pap smears, HIV testing, and breast examinations — to some 4 million men, women, and adolescents. Of those patients, two thirds have incomes below the federal poverty level, and 43% are uninsured, said the senators in a Politico article.

The concern is that the proposal will revive a rule issued by President Ronald Reagan’s administration in 1988. At the time, multiple organizations filed suit the same day to block the rule, which kept it from going into effect. The case went to the US Supreme Court, which in 1991 determined that the so-called gag rule was legal. When HHS attempted to put the rule back into effect, physician organizations, including the National Family Planning and Reproductive Health Association, sued again. Eventually, the gag rule went into effect — for just a month, until President Bill Clinton rescinded it by executive order in 1993.

The rules governing Title X that have been in effect since 2000 require financial, but not physical, separation of Title X and non–Title X activities and allow healthcare providers to counsel patients about abortion.

Legal challenges to the new Trump rule — when issued — are expected.

In early May, Planned Parenthood of Wisconsin, Planned Parenthood of Greater Ohio, and Planned Parenthood Association of Utah filed suit, along with the National Family Planning & Reproductive Health Association, against the Trump administration in federal district court in Washington, DC, alleging that a February call for Title X grant applications was illegal because it was “changing the program so that it no longer focuses on either birth control or reproductive health care and instead pushes patients toward abstinence and tries to keep patients from coming to Planned Parenthood,” said the group in a statement.

The Title X statute and regulations make it clear that the program “is meant to provide comprehensive, evidence-based contraception and reproductive health services,” they said.

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Amyloid in Cognitively Normal Predicts Later MCI, Dementia

Amyloid in Cognitively Normal Predicts Later MCI, Dementia

Elevated brain amyloid in individuals without dementia is associated with a dramatically higher risk for subsequent amnestic mild cognitive impairment (aMCI) and clinically diagnosed Alzheimer’s disease (AD), new research shows.

Investigators studied a sample of community-dwelling adults drawn from the total community in Olmsted County, Minnesota, and found that among those without cognitive impairment, amyloid-positive people were more than twice as likely as amyloid-negative people to develop aMCI.

Those with MCI and amyloid positivity were almost twice as likely to develop AD dementia as those with MCI who were amyloid negative, and the dementia risk of amyloid-positive participants with no cognitive impairment or with aMCI was 2.6-fold higher.

“This is the first large-scale, community-based trial on cognitively unimpaired people and we are confident that from within this population, the people who agreed to imaging were pretty representative of the whole population,” study author Ronald Petersen, MD, PhD, professor of neurology, Mayo Clinic College of Medicine and director, Mayo Clinic Alzheimer’s Disease Research Center, Rochester, Minnesota, told Medscape Medical News.

“Our estimates of the progression from nonimpairment to amnestic mild cognitive impairment in amyloid-positive people may provide reliable and vital data to inform future research and, from a public health perspective, provide necessary information for the government regarding how many people have these characteristics, so that if an amyloid-based therapy for AD is developed, the magnitude of cost of Medicare/Medicaid coverage can be taken into account,” he said.

The study was published online April 30 in JAMA Neurology.

Complete Capture

Elevated brain amyloid is considered to be a “key biomarker for AD pathology,” the authors note.

Analyzing the prevalence of amyloid positivity in a population without dementia “provides reliable and valid estimates of the burden of AD pathology, which are useful for sample size estimations in designing primary and secondary AD prevention trials in persons without dementia,” they write.

The researchers’ “first objective” was to “estimate the prevalence of amyloid positivity in a population without dementia,” and the second was “to estimate outcomes of amyloid positivity in a large, prospective, population-based cohort.”

In 2004, the researchers established the Mayo Clinic Study of Aging (MCSA) cohort to identify risk factors for MCI and dementia (Neuroepidemiology. 2008;30:58-69; Neurology. 2010;75:889-997) and enumerated the 70- to 89-year-olds in Olmsted County.

Participants were selected for the study by using an age- and sex-stratified sample scheme; patients with terminal illness, hospice admission, or dementia were excluded.

Beginning in 2012, the study recruited people age 50 to 69 years to “determine the timing of onset of brain pathology and cognitive impairment,” and people with dementia were recruited beginning in 2014.

Participants underwent a battery of cognitive and neurologic tests, diagnostic assessments to determine potential MCI and dementia, and measurement of covariates, such as weight, height, and apolipoprotein E (ApoE) ε4 status.

Participants also underwent amyloid positron emission tomography (PET) imaging, which was initiated in 2008 and used carbon-11 Pittsburgh compound B.

The researchers compared characteristics of participants of both sexes and several age groups who were amyloid positive or amyloid negative and who had or did not have cognitive impairment.

Logistic regression models were used to adjust for nonparticipation bias in the MCSA cohort, and a series of statistical tests were conducted to apply findings in the study sample to the findings in the population who did not participate in the study.

“One of the advantages of this study is that it is truly population-based, as compared to virtually all the good work done on amyloid imaging, which has been in a referral clinic, university, or multicenter setting,” Petersen said.

Because Olmsted has only two medical facilities that provide care to the community, “we have a unique opportunity to have complete capture of everyone who lives in this community,” he said.

Age and Sex

Of 3894 participants (mean [SD], 71.3 [9.8] years; 53.4% male), 1671 underwent PET imaging and were included in the study.

Compared with participants who underwent amyloid imaging, nonparticipants were older, were more frequently female, had fewer mean years of education, had higher rates of hypertension and strokes, and had lower global cognitive z scores.

Of the participants, 10.7% (n = 179) had prevalent MCI and 28.3% (n = 470) were ApoE ε4 carriers.

Compared with those who were amyloid negative, those who were amyloid positive more frequently had the ApoE ε4 allele, regardless of the absence or presence of MCI and regardless of age.

Among study participants without dementia, the prevalence of amyloid positivity increased with age, both in those without cognitive impairment (from

2.7% in the 50- to 59-year-old age group to 41.3% in participants aged 80 to 89 years) and in those with MCI (from 0% in the 50- to 59-year-old group to 16.4% at age 80 to 89 years).

The total prevalence of amyloid positivity across all ages was 22.0% (18.9% to 30.5%), with a higher total prevalence of amyloid positivity in women (25.6%; 95% CI, 20.8% – 30.5%) vs men (17.8%; 95% CI, 14.2% – 21.4%).

In models adjusted by age, sex, and education, the hazard ratios were 2.26 (95% CI, 1.52 – 3.35; P < .001) for both sexes combined, 1.96 (95% CI, 1.05 – 3.67; P = .04) for women, and 2.42 (95% CI, 1.46 – 4.04; P < .001) for men.

A Question of Magnitude

For amyloid-positive participants with MCI vs amyloid-negative participants with MCI, the risk for AD dementia was 1.86 (95% CI, 0.89 – 3.88; P = .10), while for amyloid-positive participants vs amyloid-negative participants with aMCI, the risk was 1.63 (95% CI, 0.78 – 3.41; P = .20).

Amyloid-positive vs amyloid-negative participants who were cognitively unimpaired or who had aMCI had a risk of 2.56 (95% CI, 1.35 – 4.88; P = .004).

In amyloid-positive people, global cognitive and memory domain z scores declined significantly during follow-up from baseline to incident aMCI and from aMCI to incident AD dementia (mean [SD] follow-up time, 3.7 [1.9] years and 3.8 [2.0] years, respectively).

“These findings are consistent with amyloid as a biomarker of AD dementia,” the authors note.

During this period, a higher proportion of deaths occurred in amyloid-positive vs amyloid-negative participants.

“This study addresses the critical question from a scientific but also a public health perspective — if we found an amyloid therapy or amyloid antibody, what is the magnitude of the audience, what is the age range, and what does amyloid positivity mean in the general population?” Petersen said.

He noted that a limitation of the study was that most older participants were white, although younger participants tended to be more racially and ethnically diverse, and the findings may not be generalizable to other groups.

“We are currently establishing a population-based sister study in Jackson, Mississippi, which will be equally weighted with African Americans and Caucasians,” he reported.

Setting the Stage

Commenting on the study for Medscape Medical News, William Klunk, MD, PhD, distinguished professor of psychiatry, University of Pittsburgh School of Medicine, Pennsylvania, who was not involved with the study, called it the “largest study to date that defines the consequences of being amyloid-positive prior to having dementia.”

He noted that early studies of amyloid positivity have led to treatment trials, such as the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) Study,  “even before definitive proof that amyloid positivity carries a big enough risk of clinically significant cognitive decline to warrant expensive, risky therapy.”

The data from this study “gives us better information upon which we can design trials that follow A4 and are also intended to ‘prevent’ AD,” he added.

Petersen emphasized that he is “not recommending that cognitively unimpaired people should have an amyloid imaging because we do not yet know what the results might mean for each individual, and the psychological impact of that scan on individuals might be variable.”

However, “we are setting the stage for how to interpret amyloid-related findings,” he said.

Petersen reports receiving personal fees as a consultant for Roche Inc. The other authors’ disclosures are listed on the original study. Klunk is the coinventor of the Pittsburgh Compound B that was used to identify amyloid positivity in this study.

JAMA Neurol. Published online April 30, 2018.  Abstract

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RF Ablation Significantly Reduces Thyroid Nodules in Biggest Study

RF Ablation Significantly Reduces Thyroid Nodules in Biggest Study

Monopolar radiofrequency ablation (RFA) shows high efficacy and safety in reducing the volume of benign thyroid nodules while avoiding the need for invasive surgery in a new study.

The authors conclude that “a single treatment course with monopolar RFA is both safe and highly effective in terms of nodule volume reduction, relief of local symptoms, and, in patients with hyperthyroidism, restoration of euthyroid function,” say Harald Dobnig, MD, of the Thyroid, Endocrine and Osteoporosis Institute Dobnig, Graz, Austria, and colleagues.

The findings were published in the April issue of Thyroid.

The study of 277 Austrian patients, the largest prospective cohort of benign thyroid nodules treated with a single monopolar RFA treatment to date, showed mean volume reduction rates after 12 months to be as much as 82%, with more than 81% of nodules showing a volume reduction of 70% or more.

Whereas approximately 90% of thyroid nodules do not increase in size over time, those that do grow can present cosmetic as well as functional problems and are commonly treated with surgery.

Thermoablative alternatives such as RFA — though primarily used by just a few research groups worldwide — offer the potential to avoid surgery and conserve normal thyroid function.

“The results of the current study are consistent with the existing literature and confirm the safety of RFA in general and the efficacy of a single treatment course of monopolar RFA in a large central European cohort,” write Dobnig and colleagues.

“The results also provide some potentially significant data for future discussions regarding possible selection criteria for patients with thyroid nodules that could be treated with RFA,” they add.

Study Included Patients With Larger Thyroid Nodules

In the current study, mean baseline nodule volume (± standard deviation) was 13.8 ± 15 mL, which corresponds to a nodule diameter of 3.0 cm, the authors note. This contrasts with the previous largest study to date, conducted in 200 participants in Asia (AJNR Am J Neuroradiol. 2015;36:1321-1325), which was retrospective and included patients with relatively smaller nodules (mean volume, 5.4 mL).

Almost 300 patients were treated as outpatients at Dobnig’s institute with a single RFA session from April 2014 to June 2017. Nodules were visible in 62.8% of patients and 40% had a symptom score of 4 or higher on a 10-point visual analog scale.

Treatment involved an internally cooled 18G RF electrode used with a free-hand “moving-shot” technique after patients received subcutaneous and local peri-thyroidal anesthesia.

Mean overall rates of nodule volume reduction were 68% ± 16% at 3 months and 82% ± 13% at 12 months (P < .001).

In addition to the 81% of nodules with a volume reduction rate of 70% or higher at 12 months, 10% had volume reductions of 60% to 70%, 6% had reductions of 50% to 60%, and only 2% had reductions of 50% or less.

Most nodules were solid or predominantly solid (74.4%), and these nodules had a mean volume of 13.6 ± 15.9 mL. The rest were mixed (12.1%) or cystic/predominantly cystic (13.5%).

Volume Reduction Rates Higher for Smaller and Cystic Nodules

In a subgroup analysis of nodules based on factors including baseline size (≤ 10  mL or > 30  mL), or nodule composition (solid, mixed or cystic), volume reduction rates were significantly higher for smaller and cystic nodules, at rates of 8.8% and 14.5% higher, respectively, than for the other groups at 12 months post-RFA (P < .001).

Importantly, scores on symptoms as well as cosmetic appearance significantly improved at 3 and 12 months (P < .001).

Specifically, the percentage of nodules that were visible with or without neck extension declined from 62.8% prior to RFA to 17.1% at 3 months post-RFA and 7.1% after 12 months.

In addition, the percentage of patients with significant symptoms (visual analog scale ≥ 4) declined from 38.2% to 0%.

Of 32 hyperthyroid patients who had follow-up data available, 27 (84%) became euthyroid, one (3.1%) developed subclinical hypothyroidism, and four (12.5%) had subclinical hyperthyroidism at their last visit.

Although RFA is currently not endorsed in the United States for the treatment of thyroid nodules, the findings add to increasing interest in the modality.

As reported by Medscape Medical News, a smaller recent study of 14 patients treated with a median of eight RFA cycles at the Mayo Clinic, Rochester, Minnesota, showed a mean nodule reduction of 44.6% at a mean follow-up of 8.6 months, with 8 of 12 patients having compressive symptoms resolved and four patients having reduced symptoms.

The authors of that study noted that skill and patient selection are key factors in RFA treatment, with appropriate candidates including those with poor ultrasonographic visualization of the nodule and poor access to the nodule.

The authors have reported no relevant financial relationships.

Thyroid. 2018;28:472-480. Full text

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Discharge From a Crowded Hospital Ward Ups Readmission Risk

Discharge From a Crowded Hospital Ward Ups Readmission Risk

Patients discharged from crowded hospital wards are more likely to be readmitted to the hospital in the subsequent 30 days, new data show.

The three strongest predictors of a patient’s readmission “are all modifiable, ward-level factors,” said lead researcher Rachel Kohn, MD, from the University of Pennsylvania in Philadelphia

These are the number of patients discharged on the same day, the number of medications administered to all patients on the ward on that day, and the number of patients that occupied a bed that day, she reported at the American Thoracic Society 2018 International Conference in San Diego.

Our theory is that, when there is more work to do, discharge planning is being neglected or not being done as thoroughly as it could be, Kohn told Medscape Medical News.

“Ward capacity strain is a novel construct,” she added. Previous researchers have looked at individual items that affect critical care response, but not much work has been done to find predictors.

When one ward performs and another doesn’t, we need to look closely at the differences, she explained.

To evaluate readmissions, Kohn and her colleagues looked at discharges from the intensive care units — 33 wards — of three Pennsylvania hospitals in 2014 and 2015.

For each of the 13,338 patients, they examined hospital capacity on the last calendar day of their hospital stay. Capacity was assessed by looking at how many beds were filled, how many medications were administered, how many patients were transported off the ward, and how many patients required telemetry monitoring, transfusions, or a sepsis assessment.

When the team analyzed the data, three top factors from nine hospital wards emerged as predictors of readmission in the subsequent 30 days.

When a lot of people are being discharged on a specific day, it means a lot will be coming back.

But there was one key factor: “When a lot of people are being discharged on a specific day, it means a lot will be coming back,” said Kohn.

When the ward is busy, discharge paperwork and medication checks might not be done as well as they should be. “The more work you’re imposing on staff, the more things can be missed,” she noted.

This might seem obvious, Kohn acknowledged, but nobody has really defined ward capacity strain.

Capacity strain has been studied in intensive care units and emergency departments, but these are easier units to look at. “You have one small physical space, so it’s easier to capture everything going on. When you start talking about wards, it’s a much larger portion of the hospital,” she said.

But wards are where the majority of patients reside, and changes there could have a substantial impact, she added.

Targeting Change

To get a sense of changes that should happen at the ward level, a lot of qualitative work — talking to ward-based clinicians, case managers, and social workers — must be undertaken.

“We need to develop a better understanding of the underlying mechanisms,” Kohn said. Our predictors “are just markers.”

“We need to look closely at where we might be able to intervene,” she added. For example, if members of the staff are consistently overburdened by medication administration, a workload threshold can be set that, when reached, prompts the addition of staff.

Changes to discharge practices might also help. Having a dedicated nurse in charge of transportation, paperwork, and medication could alleviate the burden on nurses actively caring for other patients, Kohn suggested.

This is just the beginning of our work. “Now we have to figure out how to move forward,” she told Medscape Medical News. “I’m hopeful that this will lead to ward-level and hospital-level systems practice changes that will impact survivors of critical illness.”

Slow Medicine

“Slow medicine” could be the key to recovery after discharge from the intensive care unit, Victoria Sweet, MD, from the UCSF School of Medicine in San Francisco, said during her keynote address.

Hospitals use an assembly-line approach, but we need to take the time to examine our patients and talk to them, she explained.

Helping a patient get better involves two things, Sweet told Medscape Medical News. “First, we have to start with the body: what happened before they got to the ICU, during their visit, and after. Second, find out what’s in the way of the patient getting better, instead of ‘repairing’ them.”

A starting point is the assessment of a patient’s medications and the elimination of unnecessary drugs. “I have found that often when patients are on 15 to 20 medications, they really only need five of them,” she said.

Next, the development of better follow-up practices could help, she explained, adding that a system in which hospital doctors follow their patients after discharge might make a difference.

“Focus on the top people likely to be readmitted and send them to the clinic to see the same doctor a few days later,” Sweet suggested. “Are they getting better or do they have a bladder infection?”

When you’re forced to discharge a patient who’s not ready, you have moral distress.

“We need to give patients a good doctor who has the time to do a good job,” she said.

At the hospital in California where she worked for years, Sweet said she had the “luxury” of seeing a patient more than once.

And watching somebody get better can contribute to the elimination of burnout, she added.

In fact, “it’s not burnout. It’s moral distress. “When you’re forced to discharge a patient who’s not ready, you have moral distress. We need a perspective change,” she said.

Kohn and Sweet have disclosed no relevant financial relationships.

American Thoracic Society (ATS) 2018 International Conference: Abstract P288. Presented May 20, 2018.

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Very Obese Women: Lose Weight in Pregnancy for Healthy Baby

Very Obese Women: Lose Weight in Pregnancy for Healthy Baby

Existing guidelines for weight gain and loss during pregnancy require adjustment to optimize outcomes in underweight and very obese women, and their babies, shows a large study from the French island of La Réunion.

The authors, led by Pierre-Yves Robillard, MD, from Centre Hospitalier Universitaire Sud Réunion, note that the US Institute of Medicine (IOM) 2009 recommendations are adequate for normal and overweight women, but based on these new findings, are not appropriate for thin and obese women.

Specifically, their analysis of over 52,092 full-term births found that a thin woman (with a body mass index [BMI] of 17 kg/m²) should gain 21.6 kg (48 lbs) during pregnancy (instead of 12.5–18 kg as recommended), obese woman (with a BMI of 32 kg/m²) should gain 3.6 kg (instead of 5–9 kg), and a very obese woman (with a BMI of 40 kg/m²) should actually strive to lose 6 kg (13 lbs).

Knowing the optimal gestational weight gain among the annual 135 million pregnancies worldwide is considered to be one of the holy grails of healthcare, note the authors in their introduction. This observational study goes some way to tackling the lack of consensus regarding the optimal gestational weight gain for different maternal BMI categories.

The results were published in the May issue of Heliyon.

“Women want to know what their optimal weight gain should be to have their baby as safely as possible, and their maternity care providers want to know what advice they can give women throughout their pregnancy,” said Robillard in a press release.

Determining Optimal Weight Gain (or Loss) by Pre-pregnancy BMI

The observational study had two key aims: firstly, to determine the maternal BMI range associated with a balanced risk of giving birth to a smaller or larger baby (10% small for gestational age [SGA] newborns, 10% large for gestational age [LGA]); and secondly, to investigate the interaction between maternal pre-pregnancy BMI, gestational weight gain, and neonatal birthweight centiles.

Data were drawn from 16.5 years (2001–2017) of live-birth records at the university’s maternity unit. All consecutive singleton live births (37 weeks plus) were included.

To aid the analysis, researchers proposed a term, maternal fetal corpulence symbiosis (MFCS), to describe the point at which women with a normal BMI achieve equilibrium in the risk of SGA-LGA newborns of 10% each way.

The study explored how MFCS shifts with increasing gestational weight gain in 5 kg/m² BMI increments and pinpointed the optimal weight gain for a balanced risk of having an SGA and LGA baby for each BMI category.

The data showed a point at which the proportions of SGA and LGA newborns were both 10%, which happens naturally for normal-weight women (BMI 20–24 kg/m²).

“This is a surprising finding, because the very definition of SGA (≤ 10th percentile) and LGA (≥ 90th percentile) have never been designed to correspond with maternal BMI…[which] suggests that there is a kind of biological maternal–fetal connection,” write the authors.

They found that “the natural tendency for thin women was to spontaneously have some 25% of SGA and 2% of LGA babies, while on the other side of the spectrum, very obese women had spontaneously some 20% of LGA and 5% of SGA newborns.”

In addition, Robillard and colleagues point out that, for all women, they noticed a linear association between pre-pregnancy BMI and gestational weight gain from very thin to obese mother categories, which will “greatly facilitate an individualized approach when advising women about their optimal gestational weight gain without needing to put them in fixed categories (such as underweight, normal, overweight, obese, very obese, super obese).”

Formula and Calculator to Estimate Appropriate Weight Gain/Loss

To facilitate estimating the appropriate weight gain/loss that corresponds to the balanced risk of having an SGA or LGA newborn (depending on pre-pregnancy BMI), researchers determined a linear law: opGWG (kg) = −1.2 ppBMI (kg/m²) + 42 ± 2 kg (opGWG: optimal gestational weight gain, ppBMI: maternal pre-pregnancy BMI).

For convenience, they also developed an online calculator, currently available in French, but Robillard told Medscape Medical News he is working on an English version and hopes to provide one in Spanish.

Finally, the authors add that the study findings will “enable maternity care providers and pregnant women to agree on the optimal gestational weight gain. For example, you have a BMI of 17.5 kg/m²…you should try to gain 21 kg during this pregnancy, versus your BMI is 33 kg/m², and you need to try to restrict your weight gain to 2.4 kg.”

The authors have reported no relevant financial relationships.

Heliyon. 2018;4:e00615. Full text

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DES Raises ADHD Risk in Grandchildren

DES Raises ADHD Risk in Grandchildren

The grandchildren of women who took the endocrine disrupter diethylstilbestrol (DES) during pregnancy face increased risk for attention-deficit/hyperactivity disorder (ADHD), according to results published online today in JAMA Pediatrics.

From 1938 through 1971, 5 to 10 million women in the United States were prescribed DES during pregnancy. Use began to wane in 1953, after a study found no benefit in preventing certain adverse pregnancy complications. Subsequently, in utero exposure has been linked to vaginal adenocarcinoma and adenosis in some of the “DES daughters,” and to hypospadias in grandsons and delayed regular menstrual cycles and fewer live births in granddaughters.

Previous studies in mice have shown that endocrine disruptors affect neurodevelopment of the third generation through effects on germline cells, but evidence in humans has been lacking, largely because there are few large cohorts that follow more than two generations.

For the current study, Marianthi-Anna Kioumourtzoglou, ScD, from the Department of Environmental Health Sciences at Columbia University Mailman School of Public Health, New York City, and colleagues investigated possible effects of DES exposure in humans on neurodevelopment in the third generation, and specifically, ADHD, using data from one of the few cohorts, the Nurses Health Study II.

The researchers collected health information in questionnaires mailed in 2013 to participants in the ongoing Nurses’ Health Study II about DES exposure during in utero development and attention-deficit/hyperactivity disorder (ADHD) diagnosis in their children. Using terminology borrowed from genetics, the women who took DES are referred to as the F0 generation, the study participants are their daughters (F1 generation), and the participants’ children are referred to as the F2 generation. The participants provided information on both their mothers’ DES exposure and physician-diagnosed childhood ADHD in their children.

Among 47,540 participants, 861 (1.8%) F0 mothers received DES while pregnant with the F1 participants. Of the 106,198 grandchildren, 5587 (5.3%) were diagnosed with ADHD, and the grandmothers of 137 (2.5%) of them took DES while pregnant.

The analysis showed an increased risk for ADHD among grandchildren of F0 DES users vs F0 nonusers, at 7.7% vs 5.2% (adjusted odds ratio [OR], 1.36; 95% confidence interval [CI], 1.10 – 1.67). The risk increased to an OR of 1.63 (95% CI, 1.18 – 2.25) if DES exposure occurred during the first trimester of pregnancy, suggesting a possible critical period, although the statistical power was low for the second and third trimester assessments. Sex of the grandchildren was not significant.

The researchers caution that “multigenerational neurodevelopmental deficits” associated with DES exposure in utero might add to other environmental exposure to endocrine disruptors, such as in pollution. “Because [endocrine-disrupting chemicals] are ubiquitous, the high prevalence of exposure and the possibility of cumulative consequences must be considered,” they write.

Limitations of the study include recall bias from the participants about their mothers’ exposures and maternal errors in reporting diagnoses of ADHD.

The multigenerational effects of DES exposure could arise in two ways: direct changes to the DNA sequence and epigenetic changes, which affect chromosome modifications and gene expression but not the DNA base sequence. The new study did not distinguish the two possible mechanisms.

In an accompanying editorial, Joel T. Nigg, PhD, from the Department of Psychiatry, Oregon Health & Science University, Portland, focuses on the possibility that the increased ADHD risk in the F2 generation could be a result of epigenetic changes caused by DES exposure. In addition, he notes, as the authors do, that there are a multitude of other endocrine disrupting pollutants in the environment that might also affect neurodevelopment.

“Kioumourtzoglou et al use an approach that is as important as it is underused: an examination of multigenerational transmission of environmental associations. That approach may be the most important from an epidemiological perspective,” Nigg writes.

“When it comes to psychiatric illness, we are overdue for a ‘decade of the environment’ or perhaps a ‘decade of epigenetics’ in which truly integrative science takes center stage,” he continues. “What has become clear is that environmental moderators or mediators of psychopathology and neurodevelopmental disorders should be high-priority.”

The researchers and editorial writer have disclosed no relevant financial relationships.

JAMA Pediatr. Published online May 21, 2018.

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New Guidance on Managing Postpartum Pain

New Guidance on Managing Postpartum Pain

Women experience pain in different ways in the early postpartum period, and pain management should be considered on a case-by-case basis, a new Committee Opinion from the American College of Obstetricians and Gynecologists (ACOG) advises.

“There is individual variation in pain experience, as well as differences in how women metabolize medication,” Yasser El-Sayed, MD, vice chair of ACOG’s Committee on Obstetric Practice, said in a news release. “Knowing that pain can interfere with a woman’s ability to care for herself and her infant, it’s important that ob-gyns talk with their patients about the level of pain they’re experiencing and create a tailored plan that works for them,” said El-Sayed.

“It is also critical to counsel the mother on the side effects of any drug prescribed, particularly if the mother is breastfeeding,” he added.

Stepwise Approach Best

In addition to nonpharmacologic approaches to manage postpartum pain, ACOG recommends a stepwise approach to drug therapy, starting with nonopioid agents, such as acetaminophen or nonsteriodal anti-inflammatory drugs (NSAIDs).  If needed, a milder opioid can be added, with stronger opioids added only in women who do not achieve adequate pain control, they advise.

This tiered approach helps manage pain by matching drug effectiveness to pain severity and relies heavily on shared decision-making between provider and patient. This approach can also optimize pain control while reducing the number of unused opioid tablets, ACOG says.

If a codeine-containing medication is used for postpartum pain, the risks and benefits should be reviewed with the family and the family should be educated regarding newborn signs of toxicity, ACOG advises.

“Regardless of the medication selected, it is prudent to counsel women who are prescribed opioid analgesics about the risk of central nervous system depression in the woman and the breastfed infant. Duration of use of opiate prescriptions should be limited to the shortest reasonable course expected for treating acute pain,” ACOG recommends.

ACOG also recommends that obstetricians and gynecologists be familiar with prescription drug monitoring programs and be aware that standard order sets may provide more pills than a woman with postpartum pain needs.

New mothers with an opioid use disorder who have chronic pain, or those who are using other medications or substances that may increase sedation, need additional support in managing pain, they point out.

El-Sayed noted that with increased awareness around opioid use disorder, “it is understandable that there is a desire to evaluate discharge medications. However, this should not interfere with appropriate pain management. Providers can ensure that women can get the appropriate relief they need so that they are better able to care for themselves and their infants while also prescribing responsibly,” he said.

The ACOG Committee Opinion 742, “Postpartum Pain Management,” was released May 17 and appears in the July issue of Obstetrics & Gynaecology.

Obstet Gynecol. 2018;132:e1-e7. Abstract

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Sexual Trauma Linked to Depression, PTSD, Chronic Pain

Sexual Trauma Linked to Depression, PTSD, Chronic Pain

NEW YORK — Trauma, especially sexual trauma, is linked to an increased risk for several mental illnesses and chronic medical conditions, new research suggests.

Dr Gen Shinozaki

As expected, the study of almost 400 male and female military personnel showed that a history of military-related trauma was significantly associated with posttraumatic stress disorder (PTSD).

Among only women, other risk factors for PTSD included a history of adverse childhood events and a history of military sexual trauma (MST). MST in women was also significantly linked to risk for major depressive disorder (MDD) and chronic conditions, such as fatigue and fibromyalgia.

The researchers noted that about 30% of female veterans have reported being sexually assaulted during their time of service.

Military trauma overall, but not MST specifically, was significantly associated with risk for MDD and chronic medical conditions in men. However, the investigators noted that sexual assault was reported by only five of the male participants, which may resulted in these assessments being underpowered.

“The take-away message is that if you’re working with this patient population, you really should ask about their history, which could be the root cause of their illness,” lead author Gen Shinozaki, MD, associate professor of psychiatry at the University of Iowa Carver College of Medicine, Iowa City, told Medscape Medical News.

He presented his study at a press conference and poster session here at the American Psychiatric Association (APA) 2018 annual meeting.

Generalizable?

Shinozaki added that the findings could be generalizable to all patients who have suffered a past trauma. Ranna Parekh, MD, deputy medical director for the APA and director of the organization’s Division of Diversity and Health Equity, agreed — although she noted that more studies are needed.

Dr Ranna Parekh

“The military has always been ahead of the curve, and military research helps the entire field because they begin to ask the tough questions,” she commented to Medscape Medical News.

Parekh noted that the APA recently partnered with the Society of Uniformed Services Psychiatrists to create a series of three courses for APA members who treat military personnel, veterans, and their families.

“Unfortunately, a large number of service members, particularly women, experience sexual assault during their service,” she said.

“Just last week the Pentagon shared that more 6700 Defense Department employees reported being sexually assaulted in the 2017 year, which is a 10% increase in reports from the year before,” said Parekh. “So research that explores how military sexual trauma and other traumas affect service members’ mental and physical health is particularly important.”

For this study, the investigators enrolled 388 military personnel (52% men; mean age, approximately 35 years) and used computer-assisted telephone interviews to ask about military deployment, combat experience, history of MST, and other types of trauma. The PTSD Checklist for DSM-5, the Center for Epidemiologic Studies–Depression scale, and the Adverse Childhood Experience Questionnaire were also administered.

Among all participants, 63 reported experiencing an attempted or completed sexual assault. These included 58 of the 187 women interviewed (31%).

Increased Risk

For the female participants, significantly more of those with a history of MST had MDD than those without MST (39.7% vs 23.3%; P = .03). They were also more likely to have medical comorbidities, which was defined in this study as a combination of fatigue, diabetes, chronic pain, and fibromyalgia (46.6% vs 24%; P = .004).

MST was also linked to PTSD — 32.8% of women the MST also had PTSD, compared to 7% for those who did not have a history of MST.

The investigators note that they are now conducting methylation analysis “to identify epigenetic biomarkers modulating the relationship between traumatic experience and subsequence consequences, such as PTSD and MDD.”

Parekh, who moderated the press conference, noted that the prevalence of MST found in the women in this study was, unfortunately, not a surprise. She added that she would have liked to have seen information on more men who have experienced MST, as well as information on transgender service members.

“Still, I want to give the researchers credit for bringing to light something we’ve all sort of known,” she said.

“When you have a research design that is well done, it starts to bring notice to what we’ve seen anecdotally. Then we can start looking at prevention and treatment and how we can change the larger culture, which is what we really need to get at,” added Parekh.

She noted that she “would have loved” to have heard more about the women with a history of MST who did not have PTSD. “That might help us to better understand what their points of resilience were.”

Overall, “I thought this study was great. Is it generalizable? I think we need a little more research from the military side before we can extrapolate to the larger population, but I think it’s definitely fascinating,” Parekh said.

“We should definitely be asking our female and male patients about trauma, including sexual trauma, and taking the time to work to get an honest response.”

“Tragic” but Not Surprising

Asked to comment, retired Army Colonel Elspeth Cameron Ritchie, MD, chairman of psychiatry at Washington Hospital Center in Washington, DC, told Medscape Medical News that she also wasn’t surprised by the findings.

Dr Elspeth Cameron Ritchie

“We’ve long seen an association with depression and PTSD with military sexual trauma. But this study is updated and has a fairly large sample sizes,” said Ritchie.

“What I don’t see here is when these people had their trauma. What age were these veterans when they experienced this?” she asked.

Ritchie noted that among women who enter the military, there is about a 25% to 45% prevalence rate of prior sexual trauma; the prevalence varies, depending on the definition of sexual trauma.

“One of the tragedies is that often when women come in, they’re trying to find a more stable environment. So if they are retraumatized, that can add to a past history of depression and PTSD and can increase vulnerability for military sexual trauma–related symptoms in the future,” she said.

Asked whether the current “Me Too” movement has led to a sea change, making it easier for women to come forward to report these types of problems, Ritchie said, “not yet.”

“There are still consequences if you come forward with sexual assault, which is true in the military and in the civilian world. One of the challenges is, even if a system is supportive of the claim of sexual assault, it’s still incredibly difficult to go through the process,” she said.

Ritchie noted that that’s why it’s important for clinicians to ask about a past history of sexual trauma. However, “I wouldn’t rush right there. It’s important to build up a therapeutic alliance first to make sure your patient is comfortable,” she said.

When asked about the study’s finding that only a few men experienced MST, Ritchie said that this is an area that is still very underreported. “Any kind of male-on-male contact, despite the repeal of ‘don’t ask/don’t tell,’ is still very much frowned on. And my experience is that men who have had unwanted sexual contact from other men are really hesitant to report it,” she said.

“So it’s important for caregivers to ask all patients if they’ve served in the military, build a relationship, and then ask about adverse experiences,” concluded Ritchie.

Dr Shinozaki, Dr Parekh, and Dr Ritchie have reported no relevant financial relationships.

American Psychiatric Association (APA) 2018. Abstract P5-207, presented May 7, 2018.

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Chiropractic Care Improves Usual Management for Low Back Pain

Chiropractic Care Improves Usual Management for Low Back Pain

Adding chiropractic care to standard medical management of low back pain (LBP) in a military population reduced patient-reported pain and disability and improved satisfaction scores compared with standard treatment alone, new data show.

The findings, reported by Christine M. Goertz, DC, PhD, from Palmer College of Chiropractic, Davenport, Iowa, and colleagues in an article published online May 18 in JAMA Network Open, confirm results from the team’s pilot study.

In addition, the new data align with recent guidelines from the American College of Physicians that recommend inclusion of spinal manipulation, among other nondrug treatments, as first-line therapy for acute and chronic low-back pain.

For the current study, Goertz and colleagues enrolled 750 active-duty US service members aged 18 to 50 years with LBP from three military facilities in a pragmatic comparative effectiveness trial.

Patients were screened between September 28, 2012, and November 20, 2015, and 250 patients from each of the study sites were allocated to receive usual medical care with chiropractic care (375 participants) or usual medical care alone (375 participants). Usual medical care was defined as any care recommended or prescribed by nonchiropractic military clinicians to treat LBP, including self-management advice, drug treatment, physical therapy, or referral to a pain clinic.

Patients in the chiropractic care group received standard treatment plus up to 12 chiropractic visits for spinal manipulative therapy in the low back and adjacent regions during the 6-week intervention period. Additional therapies, such as rehabilitative exercise, interferential current therapy, ultrasound therapy, cryotherapy, superficial heat, and other manual therapies, could also be included in chiropractic care.

The primary outcomes of self-reported pain intensity, as measured by the Numerical Rating Scale, and disability, based on the Roland Morris Disability Questionnaire, both favored usual and chiropractic care compared with usual care alone. At week 6, the mean difference in low-back pain intensity between the combined treatment group and the usual care alone group was −1.1 (95% confidence interval [CI], −1.4 to −0.7), and the mean difference in disability for the respective groups was −2.2 (95% CI, −3.1 to −1.2). Similar findings, although of lesser magnitude, were observed at week 12, they note.

Sensitivity analyses designed to examine possible effects of missing data on results of the primary outcomes showed effects in the same direction, with similar magnitudes and statistical significance.

Moreover, a secondary responder analysis comparing the percentage of patients with at least 30% improvement from baseline at each end point produced relative risks (RRs) favoring a greater benefit for the combined treatment at week 6 (LBP intensity: RR, 1.43 [95% CI, 1.23-1.68]; disability: RR, 1.35 [95% CI, 1.16-1.56]) and week 12 (LBP intensity: RR, 1.43 [95% CI, 1.23-1.68]; disability: RR, 1.26 [95% CI, 1.11-1.43]) in the population overall.

Some differences in RRs observed by treatment site might be explained by variations in the additional interventions, such as electric muscle stimulation and heat or cold therapy, at each site, the authors note. “Chiropractic care consisted of several therapeutic procedures in addition to spinal manipulation. Use of these therapies varied substantially by site.”

The analyses of secondary outcomes showed that overall, at weeks 6 and 12, participants in the combined treatment group reported significantly lower mean worst pain intensity within the last 24 hours (week 6: mean difference, −1.2; [95% CI, −1.6 to −0.8]; week 12: mean difference, −1.1 [95% CI, −1.6 to −0.7]) and symptom bothersomeness (week 6: mean difference, −0.4 [95% CI, −0.6 to −0.2]; week 12: mean difference, −0.4 [95% CI, −0.6 to −0.2]).

Further, patients receiving combined care had significantly better global perceived improvement at 6 weeks at all sites (odds ratio [OR], 0.18; 95% CI, 0.13-0.25), significantly greater mean satisfaction with care at 6 weeks at all sites (mean difference, 2.5; 95% CI, 2.1-2.8), and significantly less pain medication use at week 6 (OR, 0.73; 95% CI, 0.54-0.97) and week 12 (OR, 0.76; 95% CI, 0.58-1.00).

Chiropractic-related adverse events included muscle or joint stiffness, but no serious treatment-related adverse events were reported, the authors report.

“The changes in patient-reported pain intensity and disability as well as satisfaction with care and low risk of harms favoring [usual medical care] with chiropractic care found in this pragmatic clinical trial are consistent with the existing literature on spinal manipulative therapy in both military and civilian populations,” the authors write. “The magnitude of mean between-group differences for both pain…and disability…are consistent with a moderate magnitude of effect as classified by the American College of Physicians and American Pain Society guidelines.”

Although limited by the nonspecific nature of LBP and treatment variations across care sites, “[t]his trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for LBP, as currently recommended in existing guidelines,” the authors write. They note that further research is needed to understand longer-term outcomes and to assess how differences among patients and interventions influence outcomes.

In an accompanying editorial, Daniel C. Cherkin, MA, PhD, from Kaiser Permanente Washington Health Research Institute in Seattle, Washington, suggests that the findings are “unlikely to be spurious,” given the trial’s large sample size, approximately 90% follow-up rates, and strong analytic methods.

“This trial represents an important contribution to our minimal knowledge of the potential of chiropractic care to improve outcomes of care in military populations,” he writes. “These findings are particularly noteworthy because it is usually more difficult to detect meaningful treatment benefits in patient populations who have especially promising natural histories as they are young, physically fit, and unlikely to be using opioids (<6% of patients) and include a large fraction of patients with acute pain.”

Cherkin cautions that the study’s strengths should be balanced by its main limitations, which include its nonrandomized design, the lack of a measure of longer-term outcomes, problems with adherence to both treatments at one of the care sites that recruited patients via advertisement vs clinician referral, inability to determine how to explain the observed benefits in the chiropractic group, and the absence of cost-effectiveness data.

He suggests several explanations for the improved outcomes associated with chiropractic care in this study, including the fact that the chiropractic care often included treatments not included in usual medical care, such as electric muscle stimulation and heat or cold therapy, and that patients reported having higher expectations of the combined treatment over usual care. “Furthermore, it appears that patients in the group receiving [usual care] plus chiropractic care may have made more total visits than those in the group receiving [usual care] alone,” he writes.

Even so, the apparent advantages of chiropractic care in the management of LBP warrants additional study, Cherkin writes. “Future evaluations of incorporating chiropractic care into the military health care system should measure longer-term outcomes, estimate its cost-effectiveness, and consider alternative and potentially more efficient implementation strategies,” he states.

In addition, although it may be more complex than adding chiropractic to usual care, “true integration of chiropractic care into the military health care system involving professional communication and referrals between chiropractors and medical personnel has the potential for more effectively and efficiently serving patients and for providing models for other integrated health care systems in civilian settings to follow.”

The study authors disclosed financial relationships with Spine IQ, the American Chiropractic Association, Prezacor Inc, the NCMIC Foundation, RAND Corporation, the US Army Medical Research Acquisition Agency, and Samueli Institute. Cherkin has disclosed no relevant financial relationships.

JAMA Network Open. 2018;1(1):e180105.

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Community Water Quality Linked to Kidney Stones

Community Water Quality Linked to Kidney Stones

SAN FRANCISCO — The risk for kidney stones can be affected by substances found in community drinking water, new research shows.

“We did identify some novel exposures that warrant further study,” said investigator William Brubaker, MD, from Stanford University in Palo Alto, California. Some substances, such as trichloropropane — an artificial solvent — are associated with an increased risk, whereas others, such as potassium, are associated with a decreased risk.

More investigation into these substances might help explain why the incidence of kidney stones has been climbing in recent years, he said here at the American Urological Association 2018 Annual Meeting. In the United States, the incidence is elevated in the Southeast and in places with softer water, higher temperatures, and more precipitation.

Although the correlation between water quality and the incidence of kidney stones has been known for some time, only a handful of studies have looked at the association between these two variables.

“That is what set off this research,” said senior investigator Simon Conti, MD, also from Stanford University.

The team identified 218,324 emergency department visits for kidney stones from 2010 to 2012, and 27,361 surgeries, using the California Office of Statewide Health Planning and Development. They then cross-referenced these events with ZIP codes to create a stone score.

Using water-quality reports issued by the California State Water Resources Control Board from 2009 to 2012, which cover 90% of the population supplied with municipal water, investigators found 273 variables — from 3,547,535 individual tests — that seemed to be clinically relevant and were tested frequently in the majority of the ZIP codes.

To control for socioeconomic status, the investigators used data from the 2011 American Community Survey on wealth, income, education, and occupation.

Table. Associations Between Water Constituents and Kidney Stones

Water Constituent	Odds Ratio
Association
1,2,3-trichloropropane	1.56
Total organic carbon	1.42
Trichloroacetic acid	1.40
Zinc	1.34
Inverse association
Bicarbonate alkalinity	0.85
Laboratory pH	0.85
Selenium	0.84
Barium	0.83
Alkalinity (as calcium carbonate)	0.82
Dibromochloromethane	0.79
Nitrate	0.78
Ethyl tert-butyl ether	0.78
Tert-amyl methyl ether	0.78
Magnesium	0.76
Natural-source fluoride	0.74
Dibromoacetic acid	0.74
Bromoform	0.73
Sodium	0.72
Potassium	0.71
Hardness (as calcium carbonate)	0.70
Calcium	0.69
Chloride	0.67
Sulfate	0.66
2,3,7,8-tetrachlorodibenzo-p-dioxin	0.61

 

Previous research has suggested that dietary calcium, magnesium, and potassium protect against kidney stones. But some of the other the associations came as a surprise.

“This is a pretty long list of associations,” Brubaker told Medscape Medical News. “Some of these compounds haven’t been studied within the realm of kidney stone development.”

“Carbon content was associated with more stone disease,” Conti reported. “That’s a measure of how clean the water is.” He said he is intrigued by the associations between kidney stones and sulfate and zinc.

The investigators plan to study the literature for relevant information about the substances they identified. And they are considering using data from the US Environmental Protection Agency to conduct a similar nationwide study.

They might also use a fruit fly model of kidney stones to test for links with these substances. Ultimately, they envision randomized controlled trials that, for example, compare bottled water with municipal water.

Currently, the only dietary intervention that has been shown in a randomized controlled trial to reduce the risk for kidney stones is adequate hydration, Conti said. However, cutting back on sodium and animal proteins and increasing vegetable consumption might help, depending on the type of stone.

Although a high intake of dietary calcium was once considered a risk factor, research has since indicated that inadequate dietary calcium might be a bigger problem.

There are several limitations to this study, Brubaker acknowledged. Water district connections change over time; water districts have overlapping ZIP codes; the period of exposure examined was short, whereas it can take years or decades for effects to emerge; and no very small water suppliers were included in the analysis, nor were private wells, filtered water, or bottled water.

And correlation does not prove causation, he cautioned.

However, this research could have implications for public health policy, said James Borin, MD, from NYU Langone in New York City, who moderated the press conference during which the results were presented.

“One of the important things about these studies is that clinicians saw a trend and they investigated. This is the way research is supposed to be done,” he added.

Brubaker, Conti, and Borin have disclosed no relevant financial relationships.

American Urological Association (AUA) 2018 Annual Meeting: Abstract MP13-02. Presented May 18, 2018.

Follow Medscape on Twitter @Medscape and Laird Harrison @LairdH

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New Data: Finasteride Safely Prevents Prostate Cancer

New Data: Finasteride Safely Prevents Prostate Cancer

SAN FRANCISCO — Will a presentation here at the American Urological Association (AUA) 2018 Annual Meeting be a turning point in the reputation — and use — of finasteride for the prevention of prostate cancer?

Ian Thompson, MD, hopes so.

The eminent urologist and researcher reported, during a plenary session, that the daily use of finasteride, the commonly prescribed hormone-blocking agent, does not elevate the long-term risk for prostate cancer death.

Dr Ian Thompson

“Very long-term follow-up” shows that finasteride “is safe,” Thompson, who is professor emeritus at the University of Texas Health Science Center at San Antonio, said in a press statement.

“These results are transformational,” he explained. “We have found an inexpensive, effective drug that can prevent [prostate cancer].”

The new findings about prostate cancer deaths, from the landmark Prostate Cancer Prevention Trial (PCPT), might seem incongruous at first.

After all, finasteride was so effective in reducing the risk for prostate cancer in that study that the placebo-controlled PCPT was stopped early and the results were published (N Engl J Med. 2003;349:215-224).

But that is also when the troubles began, because the investigators simultaneously reported an increase in the number of high-grade cancers with the drug, compared with placebo (280 vs 237).

That finding irreparably tarnished finasteride, said Thompson, who is principal investigator of the PCPT.

“There is no question that the reason finasteride is not used for prostate cancer prevention is because of the small but statistically significant increase in high-grade disease. Absolutely no question,” Thompson told Medscape Medical News.

But new data address this old finding.

If high-grade disease is more common with finasteride than with placebo, “there should be more prostate cancer deaths [with finasteride],” he explained.

But that’s not what the researchers found in their new analysis. Instead, there were fewer prostate cancer deaths in the finasteride group than in the placebo group (42 vs 56).

The median follow-up was 18.4 years, and the cumulative follow-up was almost 300,000 years.

“We have no evidence that there’s an increase in prostate cancer death in the finasteride arm,” Thompson said. In other words, the initial study findings about an increase in high-grade disease are not consequential.

The new data took 5 years to gather, Thompson reported.

PCPT investigators matched more than 18,000 trial participants to the National Death Index, a centralized database of American death records. With this painstaking process, they were able to determine whether a trial participant had died and, if so, the cause of death.

The lion’s share of this laborious work was performed by Phyllis Goodman, MS, a biostatistician at the Fred Hutchinson Cancer Research Center in Seattle, who is a member of the PCPT team, Thompson noted.

We have answered the questions and closed the book.

With these latest data, which come 25 years after the PCPT trial was started, “we have answered the questions and closed the book,” Thompson said. It was in 1994, when he was just 39 years old, when he was named principal investigator of the study.

The PCPT is “one of the most powerful and important cancer prevention trials ever conducted,” said Joseph Smith, MD, editor of the Journal of Urology, when he introduced Thompson at the plenary session.

The trial, sponsored by the Southwest Oncology Group, was designed to determine whether daily finasteride for 7 years would prevent prostate cancer in men older than 55 years. The first 5-alpha-reductase inhibitor — which targets and blocks the action of androgens, including testosterone — is approved to treat the symptoms of prostate enlargement and male pattern baldness.

As reported in 2003, the risk for prostate cancer over the initial 7-year study period was 25% lower with finasteride than with placebo. That risk reduction now “goes out to 16 years, at least,” said Thompson.

However, more “relatively modest” sexual adverse effects have been consistently reported with finasteride than with placebo.

In affected men, “it’s like being maybe 3 years older,” he told the AUA audience. The trial also showed that the risk for gynecomastia was higher with finasteride than with placebo (4.5% vs 2.8%). And, notably, the drug has not been shown to improve overall survival.

A New Day? Two Doctors Comment

There is an “astonishing” level of interest in the prevention of prostate cancer, said Thompson. Clinicaltrials.gov has a long list of agents under investigation, such as metformin, statins, aspirin, and green tea.

But none of the studies, which are all relatively small, will ever be as authoritative as the PCPT. “You can prevent a quarter of all prostate cancers with finasteride,” he pointed out.

Who uses it today? Almost nobody.

“Who uses it today? Almost nobody,” said Thompson.

The chemopreventive agent, which is now generic, costs about $48 to $108 a month.

“I do use it for some patients, but they tend to have concomitant urinary symptoms,” said Scott Eggener, MD, from the University of Chicago.

He said he will discuss finasteride for prevention with some men. “Most guys, when they hear the data, say, ‘that sounds good’,” he added.

The sexual adverse effects are concerning, but in his experience and in clinical trials, only a small percentage of men are affected, and problems such as low libido and reduced ejaculate are reversible, Eggener told Medscape Medical News.

The reputation of finasteride — that it increases the risk for high-grade disease — is unfair. “I think it’s been completely disproven, given the totality of the research,” he said.

In another PCPT study, after 18 years of follow-up, no difference in overall survival was seen between the finasteride and placebo groups (N Engl J Med. 2013;369:603-610). This is also evidence that the high-grade cancer disparity is of no consequence.

However, by that time, the black-box warning issued by the US Food and Drug Administration had destroyed the reputation of finasteride.

Some of Eggener’s comments were echoed by Robert Abouassaly, MD, from the Cleveland Clinic.

“I use it when there is another indication, such as urinary symptoms,” he told Medscape Medical News, but he does not use it at all for prevention.

However, the data Thompson presented could have had a positive impact.

“The new data may shift the urology community’s opinion of the risk–benefit ratio for prevention of prostate cancer,” Abouassaly said. “The risks are minimal and the sexual side effects are reversible.”

Now, when speaking with a patient about finasteride for prevention, “especially if sexual health is not a high priority, I may put more emphasis on the morbidity and mortality of prostate cancer,” he noted. It is especially appropriate for men who are at higher risk for prostate cancer, such as those with a family history.

Abouassaly then gave finasteride — and the concept of prostate cancer prevention — high praise: “Looking at the data today, I would consider taking finasteride daily.”

The effect of the initial high-grade cancer finding is a “sticky fact,” said Thompson.

“It stuck since the first publication and, despite compelling evidence that the drug actually improves the detection of cancer and high-grade disease [because it shrinks the gland, making detection easier], it remains sticky,” he explained. “It will be interesting to see whether you can unstick a fact.”

The National Cancer Institute and the National Institutes of Health funded the study. Dr Thompson, Dr Eggener, and Dr Abouassaly have disclosed no relevant financial relationships.

American Urological Association (AUA) 2018 Annual Meeting. Presented May 19, 2018.

Follow Medscape senior journalist Nick Mulcahy on Twitter: @MulcahyNick

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Oral Contraceptives Associated With Increased Asthma Risk

Oral Contraceptives Associated With Increased Asthma Risk

The risk for asthma is elevated in women taking oral contraceptives, new research shows.

“What can we do with this information? That is the tricky part,” said Joe Zein, MD, from the Cleveland Clinic, who presented the finding at the American Thoracic Society 2018 International Conference in San Diego. “We need more data.”

Because there are so many formulations of contraceptives, we don’t have precise information on which formulation has an impact on which condition, he told Medscape Medical News.

“We are not making any recommendations, and we do not suggest that women stop taking oral contraceptives,” he added. Rather, the recommendation is that doctors take oral contraceptives into consideration when they assess patients with asthma.

If a patient’s asthma was previously well controlled but has become severe, the doctor should determine whether she has “started taking oral contraception or hormone therapy pills,” Zein explained.

In their cross-sectional study, Zein and his colleague assessed the health records of women 20 to 50 years of age. They identified 6,524,990 women from 26 healthcare organizations in the United States.

Of these women, 2,116,000 (32.4%) were using oral contraceptives and 692,470 (10.6%) carried a diagnosis of lifetime asthma and had been treated with bronchodilators or inhaled corticosteroids.

The prevalence of asthma was significantly higher in women taking oral contraceptives than in those who were not (14.3% vs 8.8%; P < .001).

“There may be a correlation with sex hormones,” Zein explained. “Our hypothesis is that it has something to do with increased estrogen, which may cause inflammation.”

In general, women have a higher risk for autoimmune diseases and Crohn’s disease, he noted. And a recent study showed that testosterone seems to protect males against the development of asthma (J Exp Med. 2017;214:1581-1592).

A large prospective study is needed to explore these findings in women of childbearing age who are and are not using oral contraceptives, Zein said, adding that it would need a 20-year follow-up.

The issue is “very complex,” he said. “Is it estrogen? Is it progesterone? Is there a difference with injections? Even if it is estrogen, which formulation?”

Subgroups Might Benefit From Oral Contraceptives

In fact, oral contraceptives might be of benefit to some women with asthma. This makes it difficult to arrive at a recommendation, particularly when women’s hormones change rapidly.

Subgroups of women experience exacerbations of asthma before their menstrual cycle, for example. “Taking oral contraception can blunt the sex hormones” during that time,” Zein explained. But “again, that’s a hypothesis; we don’t know 100 %.”

And studies have shown that polycystic ovary syndrome, when women have menstrual cycles without ovulation, might be associated with a higher risk for asthma, even when women are not taking oral contraceptives.

“We need to study this further,” Zein told Medscape Medical News. “That’s why we don’t want to make any conclusions. But we do want doctors to be aware of the time-sensitivity of asthma exacerbations and oral contraception, and ask questions.”

Not Just Estrogen

“In children, asthma is more prevalent in boys than girls, then around puberty it switches,” said John Mastronarde, MD, from the Providence Portland Medical Center and The Oregon Clinic’s Asthma Center. “This has always fuelled speculation that somehow sex hormones are involved.”

Although there is evidence that some women get more frequent and severe asthma attacks when they are premenstrual, “if it was really just related to estrogen, this should be true for all women,” he pointed out. “It’s clearly not as simple as just estrogen.”

The theory needs a lot more study, said Mastronarde. Although this was a very large dataset, the study had a lot of limitations.

“For example, there’s been a lot of talk about the misdiagnosis of asthma,” he told Medscape Medical News.

That being said, the large numbers provide fuel for future research. “This does raise more questions about the pathogenesis of sex hormones. We need prospective studies on this with asthma patients,” he said.

Zein and Mastronarde have disclosed no relevant financial relationships.

American Thoracic Society (ATS) 2018 International Conference: Abstract P867. Presented May 20, 2018.

Follow Medscape on Twitter @Medscape and Ingrid Hein @ingridhein

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