Over-the-counter painkillers often suffice after minor surgery

Surgery patients who were taught to manage their pain with acetaminophen and ibuprofen ended up using few or no opioid pills, a recent study found.

Volunteers in the study underwent one of six minor surgeries: laparoscopic gallbladder removal, laparoscopic repair of a groin hernia, removal of the thyroid or parathyroid gland, robot-assisted removal of the prostate, endoscopic sinus surgery, and a type of weight-loss surgery called laparoscopic sleeve gastrectomy.

Before the surgery, the 190 volunteers received counseling on pain management and were advised to take a non-opioid pain reliever every three hours, alternating between 600 milligrams of ibuprofen and 650 mg of acetaminophen.

Researchers also gave patients a small prescription of 5-mg pills containing the opioid oxycodone, counseling them to take the narcotic only if their pain was unmanageable.

When researchers contacted the patients one to three months after the surgeries, they learned that 52% hadn’t used any opioids at all.

Among those who did use opioids, 98% used no more than 10 pills and almost all agreed that their pain was manageable under this regimen, the researchers report in Journal of the American College of Surgeons.

“Over the years, surgeons often prescribed 20 to 40 oxycodone tablets after many procedures. This study and others like it suggest that those quantities were not necessary in many cases,” said Dr. Kevin Hill of the Harvard Medical School in Boston, who was not involved in the study.

“The efficacy of this protocol is more about expectation setting, education and using non-opioid pain medications which are very powerful,” coauthor Dr. Chad Brummett of the University of Michigan Medical School in Ann Arbor told Reuters Health by phone.

“The fundamental concept is that we as surgeons and dentists are gatekeepers to opioid exposure,” said coauthor Dr. Michael Englesbe, also of the University of Michigan. He noted that most heroin users and people at risk of overdose got their first exposure to opioids from a medical care provider.

Up to 10% of patients who take opioids for the first time after an operation develop long-term dependence, and this risk of dependence has been found to be associated with the size of the initial prescription, the researchers wrote.

Prior studies have also found that patients tend to have about 19 leftover pills after their recovery. In the current study, half the patients had no more than two pills left over from the small supply they had been given.

Excessive prescribing of opioids increases the risk of prolonged use and results in leftover pills getting diverted and being abused by others, especially adolescents.

In 2017 in the U.S., an estimated 11.4 million people aged 12 or older had misused opioids in the past year, according to data from the National Survey on Drug Use and Health.

The study results prove that many surgery patients don’t need opioids to manage pain and that use of these painkillers needs to be de-emphasized where possible, said Beth Darnall, a pain researcher at the Stanford University School of Medicine in California, who also was not involved in the study.

“That said, some patients absolutely need opioids, and we need to be mindful of this variability,” she added.

Brummett and Englesbe and their colleagues acknowledge in their report that this approach “might not be appropriate for more complex procedures.” Going forward, they hope to learn more about its feasibility across multiple surgical procedures and across a diverse patient population.

“It will be important to understand the patient characteristics that favor the use of this pathway,” they conclude.

SOURCE: bit.ly/2IfWeid Journal of the American College of Surgeons, online May 31, 2019.

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U.S. states unsure how to halt online sales of abortion pills amid clinic crackdown

NEW YORK (Reuters) – American women faced with new restrictions on abortions passed by a dozen U.S. states this year are turning to abortion pills from foreign online suppliers, and the states say there is little they can do to stop it.

A pharmacist poses with pills of the drug Misoprostol, made by Lupin Pharmaceuticals, in his hand at a pharmacy in Provo, Utah, U.S., June 19, 2019. Picture taken June 19, 2019. REUTERS/George Frey

In the year before many of these new restrictions passed Republican-controlled state legislatures, over 20,000 U.S. women sought the pills online from providers willing to defy U.S. federal rules over sale of the drugs that induce miscarriage.

One of them was Kayla, a 24-year-old Mississippi mother of two who terminated a pregnancy in January. She and her husband decided they could neither afford to raise another child nor get an abortion at the nearest clinic in Memphis, Tennessee.

“I wouldn’t know what to do if I didn’t have access to that,” said Kayla, who asked to be identified only by her first name. “I would probably right now be six months pregnant and miserable. It was my lifesaver.”

Abortion is one of the most divisive issues in U.S. society. Opponents cite religious beliefs about the sanctity of life, while abortion-rights activists say bans rob women of control over their bodies and futures.

The U.S. Food and Drug Administration has imposed strict rules on distribution and use of abortion pills, but state pharmaceutical regulators said they have no effective way of tracking and policing online orders from foreign doctors and pharmacies.

“We would only know that if someone were to report it to us,” said Larry Hadley, pharmacy board director in Kentucky, one of six states that passed a law this year banning abortion after six weeks, often before a woman knows she is pregnant.

Pharmacy board officials in Alabama, Ohio, Louisiana, Missouri, Georgia and North Dakota also said they were not aware of shipments of the drugs from unlicensed, foreign providers or how they would take action against them.

From March 2018 through March 2019, some 21,000 U.S. women sought the abortion-inducing pills misoprostol and mifepristone from the Austria-based website AidAccess.org, according to a University of Texas at Austin study.

“It’s reasonable to expect that as states make it even more difficult for people to access clinic-based abortion care, more people will seek alternatives including self-managed abortion,” said Jill Adams, executive director of reproductive rights legal group If/When/How.

In another measure of growing interest PlanCPills.org, a website that rates the safety of online pill providers, said the number of visitors has surged to as high as 8,000 people a day, up from a baseline of about 1,000 over the past few months.

FDA WARNINGS

The FDA has sent warning letters to foreign online providers, threatening seizure and injunctions unless they stop selling the abortion pills to American women.

“We remain very concerned … because this bypasses important safeguards designed to protect women’s health,” an FDA spokesman said in an email.

But some medical experts describe FDA regulations of these drugs as excessive. They cite studies published in medical journals showing that they pose a relatively low health risk and cause far fewer deaths among U.S. women than natural childbirth.

There is currently only one FDA-approved product, which the agency requires be dispensed in a medical office, clinic or hospital.

The pills, typically taken in the first trimester of pregnancy, thin the uterine lining to prevent the embryo from staying implanted and cause the uterus to contract, inducing a miscarriage. They should not be confused with the “morning after” pill that prevents pregnancy.

Risks from the abortion pills include possible heavy bleeding and, in rare cases, the abortion may fail, requiring follow up with surgical abortion, according to the Mayo Clinic, a prominent U.S. hospital system.

Of the 3.7 million women who took the FDA-approved brand of mifepristone to terminate a pregnancy between September 2000 and December 2018, 24 died from complications, according to FDA records.

AidAccess founder Rebecca Gomperts, a medical doctor based in Austria, received a letter from the FDA in March warning her to stop prescribing abortion pills. She has ignored it.

“I am responding to an urgent medical need of my patients,” Gomperts said in a phone interview. “I have a medical duty to do so and I do it.”

The abortion pills are typically priced at a fraction of the hundreds of dollars for a clinic abortion. Gomperts occasionally waives the cost entirely for women who cannot afford it.

Gomperts said she writes prescriptions for the pills for women who are less than nine weeks pregnant that are then filled by an Indian pharmacy. About three out of four women who contact her opt against the pills for a variety of reasons, she said.

A pharmacist shows a bottle of the drug Misoprostol, made by Lupin Pharmaceuticals, at a pharmacy in Provo, Utah, U.S., June 19, 2019. Picture taken June 19, 2019. REUTERS/George Frey

Officials in Arkansas, Indiana, Tennessee, Utah and Mississippi declined to comment or did not respond to calls.

In Texas, where the number of abortion clinics has shrunk by nearly half since 2013, Kerstin Arnold, general counsel for the Texas State Board of Pharmacy, said the state had no way of regulating pharmacies outside the United States.

“I don’t even know where we would go trying to enforce that,” she said.

Reporting by Gabriella Borter; Editing by Scott Malone and Bill Berkrot

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The time is now, get tested for HIV

Did you know today is National HIV testing day? Approximately 1.1 million people in the U.S. are living with Human Immunodeficiency Virus (HIV) today, and 1 in 7 are unaware they are infected.

Getting medical care, support, and maintaining safe behaviors can help improve the health and lives of people living with HIV.

Medicare covers HIV screenings for people with Medicare, who ask for the test, are pregnant, and people at an increased risk for the infection (such as gay and bisexual men, injection drug users, or people with multiple sexual partners).

HIV is the virus that can lead to Acquired Immunodeficiency Syndrome, or AIDS. There have been many advances in treatment, but early testing and diagnosis play key roles in reducing the spread of the disease, extending life expectancy, and cutting costs of care

Get tested. The time is now. Visit Health & Human Services’ HIV.gov website to learn more about National HIV Testing Day, June 27, and watch our video.

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Testosterone-boosting supplements may not have ingredients to support their claims, research shows

Men who want to improve their libido or build body mass may want to think twice before using testosterone-boosting supplements – also known as “T boosters” – as research shows these alternatives to traditional testosterone replacement therapy may not have ingredients to support their claims, according to Mary K. Samplaski, MD, assistant professor of clinical urology at the Keck School of Medicine of USC.

Many supplements on the market merely contain vitamins and minerals, but don’t do anything to improve testosterone. Often, people can be vulnerable to the marketing component of these products, making it difficult to tease out what is myth and what is reality.”

Mary K. Samplaski, MD, Keck School of Medicine of USC

Testosterone is the primary male sex hormone and the reason why men produce sperm and have Adam’s apples. It’s also why men develop more “masculine” features like bulging muscles, a deep voice, broad shoulders and a hairy chest. After age 30, most men experience a gradual decline in testosterone, sometimes causing these features to diminish or new symptoms to occur, like erectile dysfunction. In an attempt to turn back the hands of time, some men will turn to T boosters.

Using a structured review approach, Samplaski and a team of researchers explored the active ingredients and advertised claims of 50 T boosting supplements. Their findings were published as an original article in The World Journal of Men’s Health.

Researchers performed a Google search with the search term “Testosterone Booster,” thus mimicking a typical internet research for someone looking to increase testosterone levels, and then selected the first 50 products that came up in their search. Then, the team reviewed published scientific literature on testosterone and the 109 components found in the supplements. Zinc, fenugreek extract and vitamin B6 were three of the most common components in the supplements.

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The team also compared the content for each supplement with the Food and Drug Administration’s (FDA) Recommended Daily Allowance (RDA) and the upper tolerable intake level (UL) as set by the Institute of Medicine of the National Academy of Science.

Of the 150 supplements, researchers came across 16 general claims to benefit patients, including claims to “boost T or free T”, “build body lean mass or muscle mass”, or “increase sex drive or libido.”

While 90% of the T booster supplements claimed to boost testosterone, researchers found that less than 25% of the supplements had data to support their claims. Many also contained high doses of vitamins and minerals, occasionally more than the tolerable limit.

Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases, according to the FDA. As such, Samplaski would like to see more regulation around testosterone-boosting supplements to protect consumers. She also would like to explore disseminating handouts to her patients with more accurate information in the hopes that it encourages patients to seek a medical professional for low testosterone issues.

While no one can escape the effects of aging, Samplaski says there is something men can do to address their concerns. “The safest and most effective way for men to boost low testosterone levels is to talk with a medical professional or a nutritionist.”

Source:

University of Southern California – Health Sciences

Journal reference:

Samplaski, M.K. et al. (2019) ‘Testosterone Boosting’ Supplements Composition and Claims Are not Supported by the Academic Literature. The World Journal of Mens Health. doi.org/10.5534/wjmh.190043.

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‘An Arm And A Leg’: Why Are Drug Prices So Random? Meet Mr. PBM


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Surely, an old-time, generic drug can’t cost $720 — for a three-month supply?

After a close call with an outrageous Rx tab, host Dan Weissmann tackles the health care cost puzzle he’s been avoiding: figuring out prescription drug prices.

Here’s what he found: Your insurance company is probably in cahoots with a pharmacy benefit manager — and the negotiations that go on between them are trade secrets. No wonder it’s so hard to know what you’ll pay at the drugstore counter!

On Episode 4 of “An Arm and a Leg,” meet the behind-the-scenes negotiator that helps decide how much you pay at the pharmacy counter.


Season 2 is a co-production of Kaiser Health News and Public Road Productions.

To keep in touch with “An Arm and a Leg,” subscribe to the newsletter. You can also follow the show on Facebook and Twitter. And if you’ve got stories to tell about the health care system, the producers would love to hear from you.

To hear all Kaiser Health News podcasts, click here.

And subscribe to “An Arm and a Leg” on iTunes, Pocket Casts, Google Play or Spotify.

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FDA approves expanded label for Regeneron/Sanofi’s Dupixent

(Reuters) – The U.S. Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals Inc and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.

FILE PHOTO: The Sanofi logo at the Viva Tech start-up and technology summit in Paris, France, May 25, 2018. REUTERS/Charles Platiau/File Photo

The expanded label, which could significantly boost annual sales, is for use with other medicines to treat patients suffering from chronic rhinosinusitis with nasal polyps, the companies said in a joint statement.

The FDA first approved Dupixent in 2017 for moderate-to-severe atopic dermatitis, or eczema, and in 2018 it won U.S. approval to treat moderate-to-severe asthma as well.

Chronic rhinosinusitis is a persistent inflammation of the mucous membranes in the nose and sinuses that can lead to development of nasal polyps – teardrop shaped, noncancerous growths that can cause irritation and swelling.

The companies believe Dupixent will be able to treat between 55,000 and 90,000 adults with the condition in the United States, who have not been able to control their disease despite having used oral corticosteroids or having undergone sinus surgery.

Cowen analyst Yaron Werber, citing the drug’s effectiveness and clean safety profile, forecast that the additional approval will add $956.3 million to Dupixent’s worldwide sales in 2024, calling it “a sizable but overlooked market with few entrenched competitors.”

The companies will also have first mover advantage over other biologics, he added.

Data released earlier this month showed Roche AG and Novartis’ Xolair is able to treat patients with chronic rhinosinusitis with nasal polyps, potentially pitting it against Dupixent in this patient group.

However, it is unlikely the drug will enter market before the end of next year, Werber said.

Sanofi recorded Dupixent sales of 788 million euros ($896.43 million) in 2018. Analysts are expecting sales of about $1.86 billion this year, according to Refinitiv data.

Dupixent is an important growth driver for both Sanofi and Regeneron, whose flagship eye drug Eylea faces increased competition.

The companies are also testing it for eosinophilic esophagitis, an allergic inflammatory disease of the esophagus, chronic obstructive pulmonary disease and for food and environmental allergies.

“It is really turning out to be quite an unusual drug in the breadth of activity that we are seeing,” David Weinreich, head of Global Clinical Development at Regeneron said.

Reporting by Tamara Mathias and Manas Mishra in Bengaluru; Editing by Shailesh Kuber

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Vets with PTSD at increased risk of death from suicide, accidents

U.S. veterans with post-traumatic stress disorder (PTSD) are more likely than typical Americans to die of causes including suicide and accidental injuries, a recent study suggests.

PTSD has previously been linked to increased risk for chronic health problems like heart disease, diabetes and immune disorders as well as a greater risk of premature death, researchers note in the American Journal of Preventive Medicine. But studies to date haven’t offered a clear picture of what causes might be driving higher mortality rates among veterans with PTSD.

For the current study, researchers examined data on about 491,000 veterans who initiated treatment for PTSD between 2008 and 2013. In the year following the start of treatment, just over 5,200, or 1.1%, of the veterans died – a mortality rate 5% higher than for the general U.S. population of the same age and sex.

In particular, veterans with PTSD were roughly twice as likely to die of viral hepatitis and more than twice as likely to die of suicide or accidental injuries than counterparts in the general population.

“Although prior literature has demonstrated an elevated risk for death from suicide among veterans with PTSD, we were surprised to find that veterans with PTSD also have an elevated risk for death from accidental injury and viral hepatitis,” said Dr. Jenna Forehand, a researcher at the Veterans Affairs Medical Center in White River Junction, Vermont, who led the study.

“These findings suggest that behavioral factors may contribute to the excess mortality risk,” Forehand said by email.

More than half of the deaths from accidental injuries in the study were due to poisoning, and one quarter involved motor vehicle crashes.

Two of the more common types of viral hepatitis can be caused by certain risky behaviors like intravenous drug use or unprotected sex.

Diabetes and chronic liver disease also contributed to more deaths for veterans with PTSD than for their counterparts in the general population.

Veterans in the study ranged in age from 18 to over 65, with an average for the group of 48.5 years old. They all sought care at a VA health facility, which may mean they’re sicker than other veterans who were not treated within the VA system, the study team notes.

During the first year of VA treatment, younger veterans with PTSD were more likely to die of accidental injuries or suicide, while middle-aged and older veterans were more apt to die of cardiovascular disease or cancer.

One limitation of the study is that researchers didn’t compare mortality rates for veterans with and without PTSD, said Dr. Charles Hoge, a senior scientist at the Walter Reed Army Institute of Research in Silver Spring, Maryland, who wasn’t involved in the study.

“Thus, there is no way to know if the differences in causes of death are directly attributable to the PTSD diagnosis,” Hoge said by email.

Still, it’s not surprising that the cumulative stressors of life as a veteran with PTSD might make them more vulnerable to risky behaviors or chronic health problems that lead to an early grave, said Yu-Chu Shen a researcher at the Naval Postgraduate School in Monterey, California, who wasn’t involved in the study.

“Long exposure to stressors, especially those suffered by veterans with PTSD, will lead to destructive behaviors and premature deaths,” Shen said by email. “Reducing the stressors is the key to help this vulnerable population.”

SOURCE: bit.ly/2xfLueC American Journal of Preventive Medicine, online June 24, 2019.

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Widely Prescribed Class of Meds Might Raise Dementia Risk

News Picture: Widely Prescribed Class of Meds Might Raise Dementia Risk

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MONDAY, June 24, 2019 (HealthDay News) — Doctors often prescribe anticholinergic drugs for a variety of ills. But a new study suggests they may increase the risk of dementia in older patients.

These medicines include everything from Benadryl (diphenhydramine) to certain antipsychotics and Parkinson’s meds. They’re used to treat a wide range of other conditions, including depression, chronic obstructive pulmonary disease, overactive bladder, allergies, and gastrointestinal disorders.

Anticholinergic drugs help contract and relax muscles, and work by blocking acetylcholine, a chemical that transmits messages in the nervous system.

But the new British study found that people aged 55 and older who took strong anticholinergic medications daily for three years or more had a 50% increased risk of dementia.

“Our study adds further evidence of the potential risks associated with strong anticholinergic drugs, particularly antidepressants, bladder antimuscarinic drugs, anti-Parkinson drugs and epilepsy drugs,” said study author Carol Coupland. She works in the division of primary care at the University of Nottingham.

Anticholinergics are known to cause short-term side effects — including confusion and memory loss — but it’s unclear if long-term use increases the risk of dementia.

To find out, Coupland’s team examined the medical records of nearly 59,000 patients in the U.K. with dementia, as well as a control group of more than 225,000 patients without dementia. All the patients were 55 and older. The average age of the dementia patients was 82.

Overall, they study found an increased risk of dementia among those who took anticholinergic drugs. After accounting for other risk factors for dementia, the researchers concluded that strong anticholinergic meds were associated with an increased risk of dementia.

There was no increased risk of dementia among patients who took other types of anticholinergic drugs such as antihistamines (Benadryl) and gastrointestinal drugs.

In the one to 11 years before dementia diagnosis or the equivalent in controls, nearly 57% of dementia patients and 51% of people in the control group were prescribed at least one strong anticholinergic drug, with an average of six prescriptions in dementia patients and four in controls.

The study was published June 24 in the journal JAMA Internal Medicine.

The researchers noted that this was an observational study, so it cannot prove that anticholinergic drugs help cause dementia. For example, it’s possible that the drugs were prescribed to dementia patients to help treat very early symptoms of the disease.

However, if anticholinergics do help cause dementia, about 10% of dementia cases might be attributable to the drugs, the study authors said.

At the very least, “this study provides further evidence that doctors should be careful when prescribing certain drugs that have anticholinergic properties,” study co-author Tom Dening, head of Nottingham’s Center for Dementia, said in a university news release.

He stressed, however, that “it’s important that patients taking medications of this kind don’t just stop them abruptly, as this may be much more harmful. If patients have concerns, then they should discuss them with their doctor to consider the pros and cons of the treatment they are receiving.”

And Coupland stressed that, “the risks of this type of medication should be carefully considered by health care professionals alongside the benefits when the drugs are prescribed.” In some cases, “alternative treatments should be considered where possible, such as other types of antidepressants or alternative types of treatment for bladder conditions,” she said.

Coupland added that, “we found a greater risk for people diagnosed with dementia before the age of 80, which indicates that anticholinergic drugs should be prescribed with caution in middle-aged people as well as in older people.”

Dr. Gayatrii Devi is a neurologist specializing in memory disorders at Lenox Hill Hospital in New York City. She believes many people too easily resort to anticholinergics for sleep complaints, especially.

“There is an increasing epidemic of reliance on sleeping medications, from benzodiazepines including medications like Ambien and Xanax, to anticholinergics commonly used in many over-the-counter sleep aids, to power ourselves off at night,” she said.

Devi believes there are other behavioral ways to resume getting a good night’s sleep.

“Ideally, what we want to do is to go back to something we were born experts at — sleeping,” Devi said, “without any sleep medications.”

— Robert Preidt

MedicalNews
Copyright © 2019 HealthDay. All rights reserved.

SOURCE: Gayatri Devi, M.D., neurologist, Lenox Hill Hospital, New York City; University of Nottingham, news release, June 24, 2019

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Yes, counting steps might make you healthier

People who track their daily steps may not only be more active, they may also be less likely to develop health problems that lead to events like heart attacks or broken bones, a new study suggests.

Researchers examined data on 1,297 participants from clinical trials that randomly assigned half of the people to track steps with pedometers over 12 weeks while the rest of them did no tracking at all. When they joined the trial, people took about 7,500 steps a day and got 90 minutes a week of moderate to vigorous physical activity in at least 10-minute bouts.

Three to four years later, people who used pedometers were getting about 30 more minutes a week of moderate to vigorous physical activity, the study found. Pedometer users were also 44% less likely to experience a fracture and 66% less likely to have a serious cardiovascular event like a heart attack or stroke.

“Increasing your walking and maintaining this can reduce your risk of heart attacks, strokes and fractures over the next few years,” said lead study author Tess Harris, a professor of primary care research at St George’s University of London in the U.K.

“Pedometers can be helpful for patients to use, as they give people a clear idea of how much they are doing (self-monitoring) and can be used to set realistic goals for increasing their walking gradually,” Harris said by email. “There is no one appropriate step-count for everyone, it is important for individuals to measure their own baseline step-count and then to have a plan to gradually increase both how often they walk and how fast they walk in a safe way for them.”

People ranged in age from 45 to 75 years old when they joined the pedometer trials, and they were typically overweight or obese. Most of them were nonsmokers in good healthy without any history of cardiovascular disease, diabetes, or depression.

While people who got pedometers appeared less prone to diabetes or depression by the end of the study, the difference between this group and the participants who didn’t track steps was too small to rule out the possibility that it was due to chance.

Based on the magnitude of reduced risk for events like heart attacks and strokes, 61 people would need to track steps with a pedometer to prevent one cardiovascular event, researchers estimated.

And based on magnitude of reduced fracture risk with pedometers, 28 people would need to track steps with a pedometer to prevent one fracture, the study team calculated.

Trial participants did have some help setting realistic walking goals, and also received coaching from nurses and were encouraged to keep step diaries.

This extra support may be a key ingredient for successful health outcomes from tracking steps, said Dr. Mitesh Patel, Director of the Penn Medicine Nudge Unit at the University of Pennsylvania in Philadelphia.

“Tracking your daily activity with a pedometer, wearable, or smartphone is an important part of any physical activity program,” Patel said by email. “However, it should be combined with other behavior change strategies such as goal-setting, coaching, or social interventions to increase sustainability.”

One limitation of the study is that researchers lacked four years of data for some participants, the study team notes in Plos Medicine. Most of the participants were also white and female, and it’s possible results would be different for other populations.

Even so, there’s little harm in giving a pedometer a try, said Dr. David Geier, an orthopedic surgeon and sports medicine specialist in Charleston, South Carolina.

“Don’t obsess about the number of steps, but try to go for a walk every day,” Geier, who wasn’t involved in the study, said by email. “Hopefully it will become a habit and encourage you to become active in other ways in your life.”

SOURCE: bit.ly/2XvJi1s Plos Medicine, online June 25, 2019.

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Unproven stem cell therapies often peddled by doctors without training

At U.S. clinics advertising unproven stem cell treatments, roughly two-thirds of the clinicians may be physicians, but a new study suggests these doctors are often trained in specialties unrelated to the services they provide.

“About half of the companies we examined offer unproven stem cell treatments for conditions (for) which they do not have a physician with the appropriate residency and fellowship training,” said senior study author Zubin Master, of the Biomedical Ethics Research Program at the Mayo Clinic in Rochester, Minnesota.

“As regenerative medicine advances and potential therapies become available, it is important for patients to be treated by clinicians who are appropriately qualified to provide such care,” Master said by email.

More than 700 U.S. clinics advertise unproven stem cell treatments, Master and colleagues note in JAMA.

All too often, these treatments involve approaches that aren’t approved in the U.S. and aren’t backed by solid evidence of effectiveness from well-designed clinical trials.

Insurance typically doesn’t cover these unproven therapies, and patients may spend thousands of dollars out-of-pocket on stem cell therapies that don’t deliver promised benefits and may even leave patients worse off than before.

When clinics advertising unproven stem cell therapies promise that U.S.-trained physicians are providing these treatments, patients may be lulled into a false sense of security even when these doctors aren’t trained to provide the advertised services.

For the current study, researchers examined the training background of 608 clinicians at 166 companies advertising unproven stem cell therapies in California, Florida, and Texas.

Overall, 401 clinicians, or 66%, were physicians.

Out of 157 companies with a physician on staff, only about half had at least one doctor with training in the specialty needed for the type of services offered to patients.

Among orthopedic-focused practices, 77% had one or more physicians with the appropriate training in this specialty.

For other types of unproven stem cell therapies, only 19% of companies advertising services appeared to have physicians on staff with the appropriate training.

Many clinics were also staffed by other types of clinicians like nurses, physician assistants, podiatrists, physical therapists, dentists, and scientists.

The study focused on unproven treatments that might be ineffective and dangerous regardless of physicians’ training. It wasn’t a controlled experiment designed to prove whether or how clinician training might directly impact patient outcomes.

“Reports of serious harms, including septicemia, blindness, paralysis and death, have been increasing in recent years,” said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasn’t involved in the study.

“But even when such treatments are performed without incident, the main risk is that the patient will receive no more than an expensive, medically useless placebo,” Sipp said by email.

Unproven stem cell injections aren’t in the best interest of patients and stem cells really are not at present advisable for any medical conditions besides those already established related to blood cancers and immune disorders, said Paul Knoepfler, a professor of cell biology and human anatomy at the University of California Davis School of Medicine in Sacramento.

“Even so, the potential profits and/or illusions about the purported magic of ‘stem cells’ is clearly luring some doctors into dangerous territory outside their expertise,” Knoepfler said by email.

“Injecting unproven stem cells into patients who have health conditions outside the doctors’ area of expertise (e.g. say a dermatologist treating a brain condition) is riskier for the patient, but a surprising number of physicians are willing to do it anyway,” Knoepfler added. “They’re rolling the stem cell dice with their patients because these doctors either have unrealistic notions about the “alternative medicine” power of stem cells or the extra profit is attractive.”

SOURCE: bit.ly/2XzKGjt JAMA, online June 25, 2019.

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