Month: December 2020

Insomnia is a sleep disorder that affects approximately 10% of adults in the United States. It is characterized by difficulty with falling asleep, staying asleep, and/or waking up too early, at least three times per week for a period of three months or more. Contrary to some beliefs that insomnia will get better by itself over time, evidence suggests that it will persist if not actively treated. In one study, 37.5% of patients with insomnia reported that their insomnia was still a problem five years later.

What are common treatment options used for insomnia?

Perhaps the most common nonpharmacological intervention used for insomnia is something called sleep hygiene. It describes a series of good sleep habits to engage in (such as keeping your bedroom quiet at night) and ones to avoid (turning off electronic devices before going to bed).

Unfortunately, as many patients know, sleep hygiene is not a very effective treatment for insomnia when implemented by itself. When sleep hygiene is used as one part of a multimodal approach, such as cognitive behavioral therapy for insomnia, it can be an effective complement to other important strategies. While cognitive behavioral therapy for insomnia is recommended as the gold-standard treatment by the American Academy of Sleep Medicine and the American College of Physicians, finding a clinician with expertise in behavioral sleep medicine can be a challenge — even via telemedicine.

Integrative treatment approaches are popular

Many people are interested in pursuing other treatment options for insomnia that do not involve prescription medications. Increasing evidence suggests that a number of approaches may be beneficial, including mindfulness-based practices and mind-body movement practices like yoga. Some people may use dietary supplements such as valerian, melatonin, chamomile, and cannabis, though evidence is more limited regarding their efficacy. You should always tell your doctor if you are taking any dietary supplements, as these may interact with other prescription medications.

An integrative option for people with insomnia and a psychiatric disorder

Insomnia is a common issue for people with a psychiatric disorder, possibly because of overlapping neurobiology. For example, someone with insomnia is 10 times more likely than someone without insomnia to also have depression. Among patients receiving psychiatric care, compression and weight have been used therapeutically. It has been hypothesized that the calming (and possibly sleep-promoting) effects of such an approach may be similar to what is experienced with acupressure or massage.

A team of researchers at the Karolinska Institute in Stockholm, Sweden conducted a study to determine whether a weighted metal chain blanket could improve insomnia symptoms compared to a light plastic chain blanket. They recruited outpatients with elevated insomnia symptoms who were being treated for one of several mood disorders: major depressive disorder, bipolar disorder, generalized anxiety disorder, or attention deficit hyperactivity disorder (ADHD).

Participants were randomly assigned to receive either a weighted metal chain blanket or a light blanket with plastic chains that were sewn on, which were the same shape and size as the metal chains on the weighted blanket. Those who were provided with a weighted metal chain blanket first tried on an 8-kilogram (17.6 pound) blanket. If this was too heavy, a 6-kilogram (13.2 pound) blanket was then provided. Over a four-week period, their sleep was assessed using surveys and a wrist-based device called an actigraph.

What did the researchers learn?

Participants who used the weighted metal chain blanket reported that their insomnia symptom severity declined significantly, while those who had used the light blanket did not experience such notable improvements. Furthermore, depressive symptoms and anxiety symptoms decreased much more for those who used the weighted blanket than those who used the light blanket. This secondary finding is consistent with other work showing that interventions designed to treat insomnia can have a meaningful impact on mood.

These promising findings are tempered by data showing that there were no significant improvements to key insomnia metrics, such as the amount of time spent awake after falling asleep, when sleep was tracked objectively using the actigraph. Other research conducted in children has also failed to demonstrate that weighted blankets significantly change sleep outcomes when measured using an actigraph.

Should you buy a weighted blanket?

While these findings are intriguing, more research is needed. It is important to note that there is a very real placebo effect for insomnia symptoms. This means that if you are someone who believes a weighted blanket could have a positive effect on your sleep tonight… well, it's quite possible that it will. For healthy adults, weighted blankets are considered safe as long as the individual can lift the blanket off when necessary. Because sleep is such a subjective experience, the cost of a weighted blanket may be money well spent — as long as you don’t forget that there are other options available to treat insomnia, with much more research data to support their effectiveness.

For years, products containing acetaminophen, such as the pain reliever Tylenol, were largely viewed as safe to take during pregnancy. Hundreds of widely available over-the-counter remedies, including popular cold, cough, and flu products, contain acetaminophen. Not surprisingly, some 65% of women in the US report taking it during pregnancy to relieve a headache or to ease an aching back.

But recently, a group of doctors and scientists issued a consensus statement in Nature Reviews Endocrinology urging increased caution around acetaminophen use in pregnancy. They noted growing evidence of its potential to interfere with fetal development, possibly leaving lingering effects on the brain, reproductive and urinary systems, and genital development. And while the issue they raise is important, it’s worth noting that the concerns come from studies done in animals and human observational studies. These types of studies cannot prove that acetaminophen is the actual cause of any of these problems.

An endocrine disruptor

Acetaminophen is known to be an endocrine disruptor. That means it can interfere with chemicals and hormones involved in healthy growth, possibly throwing it off track.

According to the consensus statement, some research suggests that exposure to acetaminophen during pregnancy — particularly high doses or frequent use — potentially increases risk for early puberty in girls, or male fertility problems such as low sperm count. It is also associated with other issues such as undescended testicles, or a birth defect called hypospadias where the opening in the tip of the penis is not in the right place. It might play a role in attention deficit disorder and negatively affect IQ.

Risks for ill effects are low

If you took acetaminophen during a current or past pregnancy, this might sound pretty scary — especially since you’ve probably always considered this medicine harmless. But while experts agree it’s important to consider potential risks when taking any over-the-counter or prescription medicines during pregnancy, you shouldn’t panic.

“The risk for an individual is low,” says Dr. Kathryn M. Rexrode, chief of the Division of Women’s Health, Department of Medicine at Harvard-affiliated Brigham and Women’s Hospital.

Chances are pretty good that if you took acetaminophen during a pregnancy, your baby likely did not, or will not, suffer any ill effects.

The research on this topic is not conclusive. Some information used to inform the consensus statement was gathered from studies on animals, or human studies with significant limitations. More research is needed to confirm that this medicine is truly causing health problems, and to determine at what doses, and at what points during a pregnancy, exposure to acetaminophen might be most harmful.

Sensible steps if you’re pregnant

Three common-sense steps can help protect you and your baby until more is known on this topic:

• Avoid acetaminophen during pregnancy when possible. Previously during preconception and pregnancy counseling, Dr. Rexrode had warned patients against using NSAID drugs, such as Advil and Aleve, and suggested taking acetaminophen instead. “Now I also tell people that some concerns have been raised about acetaminophen use during pregnancy, and explain that its use should be limited to situations where it is really needed,” says Dr. Rexrode. In short, always consider whether you really need it before you swallow a pill.
• Consult with your doctor. Always clear acetaminophen use with your doctor, particularly if you are going to be using the medicine for a long period of time. They might agree that taking it is the best option — or suggest a safer alternative.
• Minimize use. If you do need to take acetaminophen during pregnancy, take it for the shortest amount of time possible and at the lowest effective dose to reduce fetal exposure. “This advice about the lowest necessary dose for the shortest period of time is generally good counseling for all over-the-counter medication use, especially during pregnancy,” says Dr. Rexrode.

While all of this is good advice for using acetaminophen, there are times when it’s riskier not to take it. For example, if you have a high fever during pregnancy — which can harm your baby — acetaminophen may be needed to bring your fever down. Provided it’s advised by your doctor, the benefits of acetaminophen use in this case outweigh the potential risks.

Last week, the FDA authorized the Pfizer/BioNTech COVID vaccine for children ages 5 to 11. After conducting their own review, the CDC now recommends this vaccine for children in this age range, who can begin receiving their first dose within the week.

While many families have been eagerly awaiting the opportunity for their children to be immunized, others are hesitant. And most parents have questions about how COVID-19 affects younger children, vaccine safety in this age range, and whether the benefits outweigh potential risks. As a pediatric infectious disease specialist, I hear certain questions crop up repeatedly. Here’s what we know so far.

How does COVID-19 affect children in this age range?

While children continue to be much less likely than adults — especially adults 65 and older — to get severely ill from COVID-19, some children do get very sick. Thousands of children 5 to 11 have been hospitalized or need ICU-level support to recover from this infection. Almost 150 children in this age range have died from COVID-19. Additionally, over 5,000 cases of a serious inflammatory condition known as MIS-C that can follow COVID-19 infection have been reported. The majority of cases of MIS-C have occurred in children in this age range.

How has the Delta strain of the virus affected children?

The Delta strain of the virus that causes COVID spreads easily, particularly among people who haven’t received the vaccine. Children ages 5 to 11 remain more susceptible to infection, given their ineligibility to be vaccinated. In fact, more than one in five new cases recorded over the past two months while Delta infections surged in the US occurred in this age group, according to weekly reports from the American Academy of Pediatrics and the Children’s Hospital Association.

Can children spread the virus to others?

Several detailed reports describing outbreaks associated with settings such as summer camps, daycares, and schools, and those tracing transmission of COVID-19 within households, clearly demonstrate that children can spread this virus and infect others with whom they come into close contact.

Which COVID vaccines and doses are authorized for children ages 5 to 11?

Pfizer/BioNTech is the first COVID vaccine authorized by the FDA for this age group, based on results from a randomized controlled trial evaluating safety and immune responses. A separate trial launched by Moderna is being considered separately.

In a small number of children, the Pfizer/BioNTech trial compared three doses:

• 30 micrograms (the dose adults receive)
• 20 micrograms
• 10 micrograms.

This part of the trial showed that 10 micrograms, the smallest dose, resulted in fewer side effects while still generating robust immune responses similar to responses achieved with higher doses.

In the next part of the trial, more than 2,200 children ages 5 to 11 were randomly assigned to receive either a 10-microgram dose of the vaccine (two-thirds of participants) or a placebo dose (one-third of participants). All received two shots, spaced three weeks apart.

Those given the vaccine had similar immune responses as 16-to-25-year-olds who had received the full-dose series of two shots.

When Pfizer/BioNTech submitted data to the FDA, there were not many cases of symptomatic COVID-19 infections in trial participants. Out of 19 documented cases, most had received the placebo shots. Estimates suggest the efficacy rate of the vaccine is 90%. (Efficacy measures how much a vaccine reduces infection in a controlled trial.) Tests confirmed that the Delta viral strain had caused the infections.

What do we know about side effects for children this age?

Most children had no side effects other than pain at the injection site. Those who did have side effects most commonly experienced fatigue, headaches, and/or muscle aches after the second dose rather than the first dose. For example, only 6% of children had fever after the second vaccine dose. There were no cases of severe allergic reaction to the vaccine.

What is not yet known?

In very rare instances, the Pfizer/BioNTech COVID-19 vaccine is linked to myocarditis, which is an inflammation of the heart. When this occurs, it is mostly seen in young males following their second dose of an mRNA vaccine (Pfizer/BioNTech or Moderna). Most cases are mild, and children show no signs of long-term injury to the heart.

Among the 5-to-11-year-olds who received the Pfizer vaccine during the trial, there were no cases of myocarditis. However, this side effect is very rare and might not be noted until the number of children receiving the vaccine is much higher. The FDA and Pfizer/BioNTech will continue to closely monitor this age group for any occurrence of this rare side effect.

Can children get vaccinated against COVID-19 and influenza at the same time?

Yes. Children and adults can safely get both vaccines at the same time. The CDC urges everyone to get flu shots to help stay healthy during this flu season.

A randomized, controlled trial in the UK evaluated adults who received a flu shot or placebo shot in one arm and their second dose of the Pfizer/BioNTech vaccine in the other arm. The researchers reported in Preprints with The Lancet that side effects and immune responses were similar, whether the flu shot or a placebo shot was given at the same time as the COVID vaccine.

What other steps can parents take to protect children against COVID-19?

Parents should remember that an individual is not fully immunized and protected by the vaccine until 14 days after the second dose of the Pfizer vaccine. Masks are recommended for anyone who is unvaccinated, or not fully immunized, when indoors with people outside of their household. If rates of COVID-19 are high where you live, masks may be recommended indoors for vaccinated individuals as well.

Parents can continue to encourage other simple habits that help prevent colds, flu, and COVID-19, such as washing hands often, coughing or sneezing into an elbow, throwing away used tissues quickly, and avoiding crowded places and people who are ill when possible.