We all know how challenging and time-consuming it can be to convince vaccine-hesitant patients that vaccinations are what is best for them and their children. Patients are bombarded with misinformation through the news and social media that seeds or “confirms” their doubts about vaccines. And for our part, we have only a few minutes during an office visit to refute all of the false claims that are a mere click or scroll away.

To better prepare for this challenge, this article details a practical approach to discussing vaccines with your patients. Using the patient-friendly language and evidence described here, you will be well positioned to refute 13 common vaccine misconceptions and overcome the barriers that stand in the way of these lifesaving interventions.

A few important baseline concepts

In discussing vaccination with our patients, it is important to keep the following in mind:

Patients don’t refuse vaccinations just to make our lives difficult. They truly are trying to make the best decisions they can for themselves and their families. Recognizing this can significantly reduce frustration levels.

Time well spent. While educating patients about the value of vaccines takes time, the return is worth it. The more consistently we offer vaccines, along with the reasons they are important, the more likely patients are to give vaccines a second thought. In fact, studies show that provider recommendation is the most important factor in patients’ decisions to vaccinate.¹

Approach matters. In all other aspects of medicine, we attempt to use a participatory approach, involving our patients in decisions regarding their health care. When discussing vaccines, however, a participatory approach (eg, “What do you want to do about vaccines today?”) can introduce doubt into patients’ minds. Studies show that a presumptive approach (eg, “Today we are going to provide the tetanus, human papillomavirus [HPV], and meningitis vaccines”) is a much more effective way to get patients to vaccinate.²

[polldaddy:10018427]

Continue to: Barriers to counseling

Barriers to counseling. Health care providers report a variety of barriers to effective vaccine counseling (limited time and resources, lack of confidence in addressing patients’ concerns, etc).³ In addition, providers sometimes worry that strong encouragement of vaccination will create an adversarial relationship with vaccine-hesitant patients. Developing a good rapport and trusting relationship, as well as using motivational interviewing approaches, can help communicate the importance of vaccines, while leaving patients with the sense that you have heard them and respect their intentions. (See “Facilitate vaccine discussions using these 2 approaches.” ^4-7)

Continue to: If at first you don't succeed...

If at first you don’t succeed, try again because patients often have an experience that changes their mind. Perhaps a friend died of throat cancer or a family member developed a complication of the flu that required hospitalization. You never know when something will influence patients’ choices.

Don’t wait for scheduled well visits. Use every patient encounter as a means to catch patients up on missing vaccinations.

Common misconceptions and concerns and how to counter them

1. I’ve heard that vaccines can actually make you sick.

When patients raise this concern, start with an explanation of how vaccines work. Explain that our bodies protect us from foreign invaders (such as viruses and bacteria) by mounting an immune response when we are exposed to these proteins. Vaccinations work by exploiting this immune response; they expose the body to killed or weakened viral or bacterial proteins in a safe and controlled manner. In this way, our immune system will have already developed antibodies to these invaders by the time we are exposed to an active infection.

To use an analogy to war, instead of being subjected to a surprise attack where we suffer large losses in the battle, vaccination prepares us with weapons (antibodies) to defend ourselves so that our bodies are now able to successfully fight off that attack.

Because the majority of vaccines are killed virus vaccines, they cannot cause the illness against which they are meant to protect. Triggering the immune system may make some recipients feel a little “under the weather” for a day or 2, but they do not make us “sick.”

Live attenuated vaccines are similarly safe for those with a healthy immune system. We don’t administer them, however, to people who have a weakened immune system (eg, pregnant women, newborns, people with acquired immunodeficiency virus, or patients receiving chemotherapy or other types of immunosuppression) because these patients could develop the illness that we are trying to protect against.

Continue to: 2. Don't vaccines cause autism? Aren't they toxic to the nervous system?

The largest setback to vaccination efforts in recent history was a 1998 study by Andrew Wakefield that suggested that vaccination (specifically the mercury [in the form of thimerosal] present in the measles, mumps, rubella [MMR] vaccine) was linked to the development of autism.⁸ This research was subsequently debunked,⁹ and the author of the 1998 study was stripped of his medical license for falsifying data. However, the damage to vaccination efforts had already been done.

Aluminum. Thimerosal is not the only agent that patients may find concerning. Some also worry about the aluminum content of vaccines. Aluminum works as an additive to boost the body’s immune response to a vaccine. It is used only in killed virus vaccines—not in live attenuated ones. The Agency for Toxic Substances and Disease Registry monitors minimum risk levels (MRLs) of aluminum and other compounds in potentially hazardous substances. The amount of aluminum in vaccines is far below the MRL for aluminum, which is 1 mg/kg/d.¹⁰ (See “The facts about thimerosal and aluminum in vaccines.”^11-16)

Contine to: 3. I'm healthy. I never get sick. Why do I need vaccinations?

A good way to counter this comment is to respond: “Saying you don’t need vaccinations because you never get sick is like saying you don’t need to wear a seat belt because you’ve never been in a car accident.” Advise patients that we seek to vaccinate all members of a community—not just those who are sick or at high risk—to protect ourselves and to provide “herd immunity.” It’s important to explain that herd immunity is resistance to the spread of a contagious disease that results if a sufficiently high number of people (depending on the illness, typically 80%-95%) are immune to the disease, especially through vaccination.^17,18 If vaccination levels fall, we see a rise in cases of vaccine-preventable illness (as was seen during the 2017 measles outbreak in a community in Minnesota).¹⁹

Studies show that provider recommendation is the most important factor in patients' decisions to vaccinate.

Even though many of us may not suffer severe consequences of an infection, we can still pass that infection to others. While the whooping cough that a healthy 35-year-old gets may cause only prolonged annoyance or time off from work, it can kill the baby that is sitting next to that adult on the plane or bus.

4. Isn’t it true that we see fewer serious illnesses because of improved hygiene and sanitation, rather than vaccines?

Our current US sanitation standards were established under the Safe Drinking Water Act of 1974.²⁰ While improvements in hygiene, sanitation, nutrition, and other public health measures have undoubtedly decreased the spread of disease and improved survival rates, there is no denying the significant drop in disease that occurs after the introduction of a vaccine for a particular illness or the increase in cases of that disease when vaccination rates drop off.

Saying you don't need vaccinations because you never get sick is like saying you don't need to wear a seat belt because you've never been in a car accident.

By the early 1990s, our current sanitation standards were already well established. Yet we didn’t see a significant decrease in the incidence of infections with Haemophilus influenzae type b (Hib) until after the conjugate Hib vaccines were introduced (dropping from about 20,000 cases/year to 1419 cases/year by 1993).²¹

In Britain, a drop in the rate of pertussis (whooping cough) vaccination in 1974 resulted in an epidemic of more than 100,000 cases and 36 deaths by 1978. There was no decrease in hygiene or sanitation standards to explain this rise.²¹

Continue to: 5. Vaccines are just another way for "big pharma" to make "big money."

Patients may benefit from knowing that in the earlier days of vaccines, pharmaceutical companies actually moved away from production of vaccines because they were not very profitable. These days, with worldwide distribution, drug companies are back in the swing of making vaccines and, as we would expect from all companies, are in business to make a profit.

That said, health care providers receive no payments from drug companies for offering vaccines or for offering one vaccine over another. The reason we recommend vaccination is because we know it is best for our patients’ health and the health of the community.

6. We don’t see polio anymore. Why do I need the vaccine?

One of the factors contributing to the rise in antivaccine sentiment is that we rarely see vaccine-preventable illnesses (such as polio, measles, and mumps). But the absence of these illnesses is precisely due to prior years’ vaccination efforts.

Smallpox, a deadly and disfiguring disease that killed many millions of people and contributed to the downfall of the Roman, Aztec, and Incan empires, was eradicated from the planet in 1979, thanks to focused vaccination efforts by the World Health Organization. Vaccination works, but we have to keep at it.

While we no longer see as many of these vaccine-preventable illnesses in the United States, they are still present in other parts of the world. Our world is much smaller than it used to be. International travel is common, and illnesses can be reintroduced into a community with relative ease. We must remain vigilant.

Continue to: 7. I heard that vaccines are made from aborted fetal tissue.

There are 5 vaccines (varicella, rubella, hepatitis A, shingles, and rabies vaccines) that were originally made using aborted fetal tissue. In 1960, tissue from 2 fetuses aborted by maternal choice (and not for the purpose of vaccine production) was used to propagate cell lines that are still used in vaccine development today.

Human cells provide advantages for vaccine production that other cells do not. Some viruses do not grow well in animal cells. Animal cells can introduce contamination by bacteria and viruses that are not carried in human cell lines. Vaccine production can be hindered or halted, resulting in a vaccine shortage, if animal products used in development are threatened (eg, if an illness strikes egg-producing chickens; eggs are used to make the influenza vaccine).²²

Some patients, particularly those who are Catholic, may have concerns about these vaccines. The National Catholic Bioethics Center has prepared a statement regarding the use of these vaccines that may help settle any moral dilemmas.²³ It reads:

“The cell lines under consideration were begun using cells taken from one or more fetuses aborted almost 40 years ago. Since that time, the cell lines have grown independently. It is important to note that descendent cells are not the cells of the aborted child.”

“One is morally free to use the vaccine regardless of its historical association with abortion. The reason is that the risk to public health, if one chooses not to vaccinate, outweighs the legitimate concern about the origins of the vaccine. This is especially important for parents, who have a moral obligation to protect the life and health of their children and those around them.”

Continue to: 8. Vaccines aren't studied—or monitored—thoroughly enough.

Patients would benefit from knowing that vaccines are some of the most thoroughly studied products brought to market. They undergo rigorous testing and oversight, from both public and private organizations, for 10 to 15 years before being released for distribution. Post-licensure monitoring is ongoing, and the manufacturer may voluntarily participate in Phase IV trials to continue to test the safety and efficacy of a vaccine after release to market.

Monitoring adverse effects. In addition, in 1990, the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration established the Vaccine Adverse Events Reporting System (VAERS) to “detect possible signals of adverse events associated with vaccines.”²⁴ Most events reported are coincidental, but some common mild adverse events (like redness and swelling at the injection site) are often underreported.

Serious events are always thoroughly investigated and are often found unrelated. However, rare associations have been found. For example, an intestinal problem called intussusception, related to the original rotavirus vaccine, was discovered, and the vaccine causing it was removed from the market.²⁵ A new, safer rotavirus vaccine option is now available. Patients need to know that we do have an effective system of checks and balances in which we can place our trust.

9. People can become paralyzed or stop breathing after receiving a vaccination. Why run those risks?

One of the most feared reactions to vaccination is Guillain-Barré syndrome (GBS), which can cause paralysis. The CDC estimates the risk for GBS associated with the flu vaccine, for example, to be 1 to 2 cases per 1 million people vaccinated.²⁶ Another potential concern is the rate of anaphylaxis following vaccination. However, in a 2016 study in the Journal of Allergy and Clinical Immunology, the rate of anaphylaxis for all vaccines combined was only 1.31 per 1 million vaccines.²⁷

In the United States, the 2013 annual cost of 4 major vaccine-preventable illnesses in adults ≥50 years was estimated at $26.5 billion.

The risk of developing severe complications from an illness is much greater than that of developing complications from the vaccine meant to protect a person against that illness. In the United States, the population-based risk for influenza-related hospitalization in children, for example, is as high as 150 in 100,000 with as many as 125 deaths annually.²⁶

Continue to: 10. Isn't vaccination a personal choice? How does my health/illness impact the community?

Patients may not realize that most viruses are contagious from 1 to 2 days before symptoms appear, which means we can spread an illness before we even know we have it. Protecting oneself also protects those around us.

While the whooping cough that a healthy 35-year-old gets may be a prolonged annoyance or prompt some time off from work, it can kill the baby sitting next to the adult on the plane or bus.

Economic concerns. There’s also the economic impact of these illnesses to consider. This includes the personal cost of being out of school or work for an extended period and the cost of a patient’s care, which can become astronomical if hospitalization is required and which can become the country’s problem if a person lacks sufficient health insurance coverage.

A study looking at the cost of 4 major adult vaccine-preventable illnesses (influenza, pneumococcal disease, shingles, and whooping cough) in the United States in 2013 estimated the annual cost for these illnesses in adults ≥50 years to be $26.5 billion.²⁸ And that doesn’t include the cost of childhood vaccine-preventable diseases.

Countering 3 concerns about childhood vaccinations

1. I can’t afford vaccines for my child.

The Vaccines for Children program is a federally-funded program that covers the cost of all vaccines for children younger than 19 years of age who are Medicaid-eligible, American Indian, Alaskan Native, uninsured, or underinsured.²⁹ Although there may be a small administration fee charged by the provider’s office, the vaccine is free.

2. Don’t all of the vaccines recommended for children overwhelm their immune systems?

Children are exposed to so many more proteins on a daily basis (by crawling around on the floor, putting their hands in their mouths, attending school or day care, etc) than they are ever exposed to in a series of vaccines.³⁰ Exposure to these proteins in their environment and to those in vaccines only serves to boost their immunity and keep them healthier in the long run.

And thanks to advances in vaccine production, the immunologic load in vaccines is far less than it used to be. The 14 vaccines given today contain <200 bacterial and viral proteins or polysaccharides, compared with the >3000 of these immunologic components in the 7 vaccines administered in 1980.³¹

Continue to: Influenza vaccine: Patient-friendly talking points

Continue to: 3. Why don't we adhere to Dr. Sears' vaccine schedule?

There are multiple ways in which Dr. Robert Sears’ book, The Vaccine Book: Making the Right Decision for your Child, published in 2007, misrepresents vaccine science and leads patients astray in making decisions regarding vaccinations.³² Most important to note is that Dr. Sears’ Alternative Vaccine Schedule, which seeks to make it so that children do not receive more than 2 vaccinations per office visit, would require visits to a health care provider at 2, 3, 4, 5, 6, 7, 9, 12, 15, 18, and 21 months, and at 2, 2.5, 3, 3.5, 4, 5, and 6 years of age. This significantly increases the number of office visits and needle sticks, and raises the age at which vaccines are given, increasing the risk of illness outbreaks and decreasing the likelihood that parents would return to the office to complete the full series.

Acceptance of influenza and HPV vaccines remains a challenge

We are significantly less successful at getting parents and patients to agree to influenza and HPV vaccines than to the other vaccines we offer. The influenza vaccine success rate in 2016 was 59% in children and 43.3% in adults.³³ Compared to the Tdap vaccine (88%) and the meningococcal vaccine (82%), which are offered at the same age as the HPV vaccine, success rates for HPV vaccine are significantly lower. In 2016, only 60.4% of boys and girls were current on their first HPV injection and only 43.3% were up to date with the full series.³⁴

Newness of vaccines a factor?

Perhaps it is because the recommendations for these 2 vaccines are relatively new, and people don’t yet grasp the seriousness and scope of the diseases. Until 2010, the flu shot was recommended only for the very young, the elderly, and the medically high risk.

Similarly, the HPV vaccine was originally introduced for girls in 2006 and wasn’t recommended for boys until 2011.

Continue to: Human papillomavirus vaccine: Patient-friendly talking points

Continue to: A sensitive subject

A sensitive subject. Discussion of a vaccine related to a child’s sexual health makes some parents uncomfortable. Studies show that focusing on the cancer prevention aspects of the vaccine, rather than on sexual transmission of HPV, results in greater vaccine acceptance.³⁵

In 2016, only 60.4% of boys and girls were current on their first HPV vaccination and only 43.3% were up to date with the full series.

However, if discussion of sexual transmission is unavoidable, remind parents to consider their own adolescence and whether they chose to share everything with their parents. Point out that there were probably things they did that they later looked back on and thought, “What was I thinking?” Their children, no matter how wonderful and levelheaded they are, will be no different. And, as much as parents don’t want to think about it, some kids will suffer unwanted sexual contact. Shouldn’t parents protect their children as best as they can?

A teen’s right to choose? Some states have passed a Mature Minor Doctrine, which provides for mature, unemancipated teens to make their own medical decisions regarding such issues as sexuality, mental health, and drug and alcohol use without their parents’ consent. In these states, teens may elect to receive the HPV vaccine without parental permission. (Check your state’s laws for specifics, and see the 2 boxes with patient-friendly talking points for influenza vaccine^7,36-39 and human papillomavirus vaccine.^40-47)

CORRESPONDENCE
Gretchen LaSalle, MD, MultiCare Rockwood Clinic, 2214 East 29th Avenue, Spokane, WA 99203; [email protected].

We all know how challenging and time-consuming it can be to convince vaccine-hesitant patients that vaccinations are what is best for them and their children. Patients are bombarded with misinformation through the news and social media that seeds or “confirms” their doubts about vaccines. And for our part, we have only a few minutes during an office visit to refute all of the false claims that are a mere click or scroll away.

To better prepare for this challenge, this article details a practical approach to discussing vaccines with your patients. Using the patient-friendly language and evidence described here, you will be well positioned to refute 13 common vaccine misconceptions and overcome the barriers that stand in the way of these lifesaving interventions.

A few important baseline concepts

In discussing vaccination with our patients, it is important to keep the following in mind:

Patients don’t refuse vaccinations just to make our lives difficult. They truly are trying to make the best decisions they can for themselves and their families. Recognizing this can significantly reduce frustration levels.

Time well spent. While educating patients about the value of vaccines takes time, the return is worth it. The more consistently we offer vaccines, along with the reasons they are important, the more likely patients are to give vaccines a second thought. In fact, studies show that provider recommendation is the most important factor in patients’ decisions to vaccinate.¹

Approach matters. In all other aspects of medicine, we attempt to use a participatory approach, involving our patients in decisions regarding their health care. When discussing vaccines, however, a participatory approach (eg, “What do you want to do about vaccines today?”) can introduce doubt into patients’ minds. Studies show that a presumptive approach (eg, “Today we are going to provide the tetanus, human papillomavirus [HPV], and meningitis vaccines”) is a much more effective way to get patients to vaccinate.²

[polldaddy:10018427]

Continue to: Barriers to counseling

Barriers to counseling. Health care providers report a variety of barriers to effective vaccine counseling (limited time and resources, lack of confidence in addressing patients’ concerns, etc).³ In addition, providers sometimes worry that strong encouragement of vaccination will create an adversarial relationship with vaccine-hesitant patients. Developing a good rapport and trusting relationship, as well as using motivational interviewing approaches, can help communicate the importance of vaccines, while leaving patients with the sense that you have heard them and respect their intentions. (See “Facilitate vaccine discussions using these 2 approaches.” ^4-7)

Continue to: If at first you don't succeed...

If at first you don’t succeed, try again because patients often have an experience that changes their mind. Perhaps a friend died of throat cancer or a family member developed a complication of the flu that required hospitalization. You never know when something will influence patients’ choices.

Don’t wait for scheduled well visits. Use every patient encounter as a means to catch patients up on missing vaccinations.

Common misconceptions and concerns and how to counter them

1. I’ve heard that vaccines can actually make you sick.

When patients raise this concern, start with an explanation of how vaccines work. Explain that our bodies protect us from foreign invaders (such as viruses and bacteria) by mounting an immune response when we are exposed to these proteins. Vaccinations work by exploiting this immune response; they expose the body to killed or weakened viral or bacterial proteins in a safe and controlled manner. In this way, our immune system will have already developed antibodies to these invaders by the time we are exposed to an active infection.

To use an analogy to war, instead of being subjected to a surprise attack where we suffer large losses in the battle, vaccination prepares us with weapons (antibodies) to defend ourselves so that our bodies are now able to successfully fight off that attack.

Because the majority of vaccines are killed virus vaccines, they cannot cause the illness against which they are meant to protect. Triggering the immune system may make some recipients feel a little “under the weather” for a day or 2, but they do not make us “sick.”

Live attenuated vaccines are similarly safe for those with a healthy immune system. We don’t administer them, however, to people who have a weakened immune system (eg, pregnant women, newborns, people with acquired immunodeficiency virus, or patients receiving chemotherapy or other types of immunosuppression) because these patients could develop the illness that we are trying to protect against.

Continue to: 2. Don't vaccines cause autism? Aren't they toxic to the nervous system?

The largest setback to vaccination efforts in recent history was a 1998 study by Andrew Wakefield that suggested that vaccination (specifically the mercury [in the form of thimerosal] present in the measles, mumps, rubella [MMR] vaccine) was linked to the development of autism.⁸ This research was subsequently debunked,⁹ and the author of the 1998 study was stripped of his medical license for falsifying data. However, the damage to vaccination efforts had already been done.

Aluminum. Thimerosal is not the only agent that patients may find concerning. Some also worry about the aluminum content of vaccines. Aluminum works as an additive to boost the body’s immune response to a vaccine. It is used only in killed virus vaccines—not in live attenuated ones. The Agency for Toxic Substances and Disease Registry monitors minimum risk levels (MRLs) of aluminum and other compounds in potentially hazardous substances. The amount of aluminum in vaccines is far below the MRL for aluminum, which is 1 mg/kg/d.¹⁰ (See “The facts about thimerosal and aluminum in vaccines.”^11-16)

Contine to: 3. I'm healthy. I never get sick. Why do I need vaccinations?

A good way to counter this comment is to respond: “Saying you don’t need vaccinations because you never get sick is like saying you don’t need to wear a seat belt because you’ve never been in a car accident.” Advise patients that we seek to vaccinate all members of a community—not just those who are sick or at high risk—to protect ourselves and to provide “herd immunity.” It’s important to explain that herd immunity is resistance to the spread of a contagious disease that results if a sufficiently high number of people (depending on the illness, typically 80%-95%) are immune to the disease, especially through vaccination.^17,18 If vaccination levels fall, we see a rise in cases of vaccine-preventable illness (as was seen during the 2017 measles outbreak in a community in Minnesota).¹⁹

Studies show that provider recommendation is the most important factor in patients' decisions to vaccinate.

Even though many of us may not suffer severe consequences of an infection, we can still pass that infection to others. While the whooping cough that a healthy 35-year-old gets may cause only prolonged annoyance or time off from work, it can kill the baby that is sitting next to that adult on the plane or bus.

4. Isn’t it true that we see fewer serious illnesses because of improved hygiene and sanitation, rather than vaccines?

Our current US sanitation standards were established under the Safe Drinking Water Act of 1974.²⁰ While improvements in hygiene, sanitation, nutrition, and other public health measures have undoubtedly decreased the spread of disease and improved survival rates, there is no denying the significant drop in disease that occurs after the introduction of a vaccine for a particular illness or the increase in cases of that disease when vaccination rates drop off.

Saying you don't need vaccinations because you never get sick is like saying you don't need to wear a seat belt because you've never been in a car accident.

By the early 1990s, our current sanitation standards were already well established. Yet we didn’t see a significant decrease in the incidence of infections with Haemophilus influenzae type b (Hib) until after the conjugate Hib vaccines were introduced (dropping from about 20,000 cases/year to 1419 cases/year by 1993).²¹

In Britain, a drop in the rate of pertussis (whooping cough) vaccination in 1974 resulted in an epidemic of more than 100,000 cases and 36 deaths by 1978. There was no decrease in hygiene or sanitation standards to explain this rise.²¹

Continue to: 5. Vaccines are just another way for "big pharma" to make "big money."

Patients may benefit from knowing that in the earlier days of vaccines, pharmaceutical companies actually moved away from production of vaccines because they were not very profitable. These days, with worldwide distribution, drug companies are back in the swing of making vaccines and, as we would expect from all companies, are in business to make a profit.

That said, health care providers receive no payments from drug companies for offering vaccines or for offering one vaccine over another. The reason we recommend vaccination is because we know it is best for our patients’ health and the health of the community.

6. We don’t see polio anymore. Why do I need the vaccine?

One of the factors contributing to the rise in antivaccine sentiment is that we rarely see vaccine-preventable illnesses (such as polio, measles, and mumps). But the absence of these illnesses is precisely due to prior years’ vaccination efforts.

Smallpox, a deadly and disfiguring disease that killed many millions of people and contributed to the downfall of the Roman, Aztec, and Incan empires, was eradicated from the planet in 1979, thanks to focused vaccination efforts by the World Health Organization. Vaccination works, but we have to keep at it.

While we no longer see as many of these vaccine-preventable illnesses in the United States, they are still present in other parts of the world. Our world is much smaller than it used to be. International travel is common, and illnesses can be reintroduced into a community with relative ease. We must remain vigilant.

Continue to: 7. I heard that vaccines are made from aborted fetal tissue.

There are 5 vaccines (varicella, rubella, hepatitis A, shingles, and rabies vaccines) that were originally made using aborted fetal tissue. In 1960, tissue from 2 fetuses aborted by maternal choice (and not for the purpose of vaccine production) was used to propagate cell lines that are still used in vaccine development today.

Human cells provide advantages for vaccine production that other cells do not. Some viruses do not grow well in animal cells. Animal cells can introduce contamination by bacteria and viruses that are not carried in human cell lines. Vaccine production can be hindered or halted, resulting in a vaccine shortage, if animal products used in development are threatened (eg, if an illness strikes egg-producing chickens; eggs are used to make the influenza vaccine).²²

Some patients, particularly those who are Catholic, may have concerns about these vaccines. The National Catholic Bioethics Center has prepared a statement regarding the use of these vaccines that may help settle any moral dilemmas.²³ It reads:

“The cell lines under consideration were begun using cells taken from one or more fetuses aborted almost 40 years ago. Since that time, the cell lines have grown independently. It is important to note that descendent cells are not the cells of the aborted child.”

“One is morally free to use the vaccine regardless of its historical association with abortion. The reason is that the risk to public health, if one chooses not to vaccinate, outweighs the legitimate concern about the origins of the vaccine. This is especially important for parents, who have a moral obligation to protect the life and health of their children and those around them.”

Continue to: 8. Vaccines aren't studied—or monitored—thoroughly enough.

Patients would benefit from knowing that vaccines are some of the most thoroughly studied products brought to market. They undergo rigorous testing and oversight, from both public and private organizations, for 10 to 15 years before being released for distribution. Post-licensure monitoring is ongoing, and the manufacturer may voluntarily participate in Phase IV trials to continue to test the safety and efficacy of a vaccine after release to market.

Monitoring adverse effects. In addition, in 1990, the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration established the Vaccine Adverse Events Reporting System (VAERS) to “detect possible signals of adverse events associated with vaccines.”²⁴ Most events reported are coincidental, but some common mild adverse events (like redness and swelling at the injection site) are often underreported.

Serious events are always thoroughly investigated and are often found unrelated. However, rare associations have been found. For example, an intestinal problem called intussusception, related to the original rotavirus vaccine, was discovered, and the vaccine causing it was removed from the market.²⁵ A new, safer rotavirus vaccine option is now available. Patients need to know that we do have an effective system of checks and balances in which we can place our trust.

9. People can become paralyzed or stop breathing after receiving a vaccination. Why run those risks?

One of the most feared reactions to vaccination is Guillain-Barré syndrome (GBS), which can cause paralysis. The CDC estimates the risk for GBS associated with the flu vaccine, for example, to be 1 to 2 cases per 1 million people vaccinated.²⁶ Another potential concern is the rate of anaphylaxis following vaccination. However, in a 2016 study in the Journal of Allergy and Clinical Immunology, the rate of anaphylaxis for all vaccines combined was only 1.31 per 1 million vaccines.²⁷

In the United States, the 2013 annual cost of 4 major vaccine-preventable illnesses in adults ≥50 years was estimated at $26.5 billion.

The risk of developing severe complications from an illness is much greater than that of developing complications from the vaccine meant to protect a person against that illness. In the United States, the population-based risk for influenza-related hospitalization in children, for example, is as high as 150 in 100,000 with as many as 125 deaths annually.²⁶

Continue to: 10. Isn't vaccination a personal choice? How does my health/illness impact the community?

Patients may not realize that most viruses are contagious from 1 to 2 days before symptoms appear, which means we can spread an illness before we even know we have it. Protecting oneself also protects those around us.

While the whooping cough that a healthy 35-year-old gets may be a prolonged annoyance or prompt some time off from work, it can kill the baby sitting next to the adult on the plane or bus.

Economic concerns. There’s also the economic impact of these illnesses to consider. This includes the personal cost of being out of school or work for an extended period and the cost of a patient’s care, which can become astronomical if hospitalization is required and which can become the country’s problem if a person lacks sufficient health insurance coverage.

A study looking at the cost of 4 major adult vaccine-preventable illnesses (influenza, pneumococcal disease, shingles, and whooping cough) in the United States in 2013 estimated the annual cost for these illnesses in adults ≥50 years to be $26.5 billion.²⁸ And that doesn’t include the cost of childhood vaccine-preventable diseases.

Countering 3 concerns about childhood vaccinations

1. I can’t afford vaccines for my child.

The Vaccines for Children program is a federally-funded program that covers the cost of all vaccines for children younger than 19 years of age who are Medicaid-eligible, American Indian, Alaskan Native, uninsured, or underinsured.²⁹ Although there may be a small administration fee charged by the provider’s office, the vaccine is free.

2. Don’t all of the vaccines recommended for children overwhelm their immune systems?

Children are exposed to so many more proteins on a daily basis (by crawling around on the floor, putting their hands in their mouths, attending school or day care, etc) than they are ever exposed to in a series of vaccines.³⁰ Exposure to these proteins in their environment and to those in vaccines only serves to boost their immunity and keep them healthier in the long run.

And thanks to advances in vaccine production, the immunologic load in vaccines is far less than it used to be. The 14 vaccines given today contain <200 bacterial and viral proteins or polysaccharides, compared with the >3000 of these immunologic components in the 7 vaccines administered in 1980.³¹

Continue to: Influenza vaccine: Patient-friendly talking points

Continue to: 3. Why don't we adhere to Dr. Sears' vaccine schedule?

There are multiple ways in which Dr. Robert Sears’ book, The Vaccine Book: Making the Right Decision for your Child, published in 2007, misrepresents vaccine science and leads patients astray in making decisions regarding vaccinations.³² Most important to note is that Dr. Sears’ Alternative Vaccine Schedule, which seeks to make it so that children do not receive more than 2 vaccinations per office visit, would require visits to a health care provider at 2, 3, 4, 5, 6, 7, 9, 12, 15, 18, and 21 months, and at 2, 2.5, 3, 3.5, 4, 5, and 6 years of age. This significantly increases the number of office visits and needle sticks, and raises the age at which vaccines are given, increasing the risk of illness outbreaks and decreasing the likelihood that parents would return to the office to complete the full series.

Acceptance of influenza and HPV vaccines remains a challenge

We are significantly less successful at getting parents and patients to agree to influenza and HPV vaccines than to the other vaccines we offer. The influenza vaccine success rate in 2016 was 59% in children and 43.3% in adults.³³ Compared to the Tdap vaccine (88%) and the meningococcal vaccine (82%), which are offered at the same age as the HPV vaccine, success rates for HPV vaccine are significantly lower. In 2016, only 60.4% of boys and girls were current on their first HPV injection and only 43.3% were up to date with the full series.³⁴

Newness of vaccines a factor?

Perhaps it is because the recommendations for these 2 vaccines are relatively new, and people don’t yet grasp the seriousness and scope of the diseases. Until 2010, the flu shot was recommended only for the very young, the elderly, and the medically high risk.

Similarly, the HPV vaccine was originally introduced for girls in 2006 and wasn’t recommended for boys until 2011.

Continue to: Human papillomavirus vaccine: Patient-friendly talking points

Continue to: A sensitive subject

A sensitive subject. Discussion of a vaccine related to a child’s sexual health makes some parents uncomfortable. Studies show that focusing on the cancer prevention aspects of the vaccine, rather than on sexual transmission of HPV, results in greater vaccine acceptance.³⁵

In 2016, only 60.4% of boys and girls were current on their first HPV vaccination and only 43.3% were up to date with the full series.

However, if discussion of sexual transmission is unavoidable, remind parents to consider their own adolescence and whether they chose to share everything with their parents. Point out that there were probably things they did that they later looked back on and thought, “What was I thinking?” Their children, no matter how wonderful and levelheaded they are, will be no different. And, as much as parents don’t want to think about it, some kids will suffer unwanted sexual contact. Shouldn’t parents protect their children as best as they can?

A teen’s right to choose? Some states have passed a Mature Minor Doctrine, which provides for mature, unemancipated teens to make their own medical decisions regarding such issues as sexuality, mental health, and drug and alcohol use without their parents’ consent. In these states, teens may elect to receive the HPV vaccine without parental permission. (Check your state’s laws for specifics, and see the 2 boxes with patient-friendly talking points for influenza vaccine^7,36-39 and human papillomavirus vaccine.^40-47)

CORRESPONDENCE
Gretchen LaSalle, MD, MultiCare Rockwood Clinic, 2214 East 29th Avenue, Spokane, WA 99203; [email protected].

We all know how challenging and time-consuming it can be to convince vaccine-hesitant patients that vaccinations are what is best for them and their children. Patients are bombarded with misinformation through the news and social media that seeds or “confirms” their doubts about vaccines. And for our part, we have only a few minutes during an office visit to refute all of the false claims that are a mere click or scroll away.

To better prepare for this challenge, this article details a practical approach to discussing vaccines with your patients. Using the patient-friendly language and evidence described here, you will be well positioned to refute 13 common vaccine misconceptions and overcome the barriers that stand in the way of these lifesaving interventions.

A few important baseline concepts

In discussing vaccination with our patients, it is important to keep the following in mind:

Patients don’t refuse vaccinations just to make our lives difficult. They truly are trying to make the best decisions they can for themselves and their families. Recognizing this can significantly reduce frustration levels.

Time well spent. While educating patients about the value of vaccines takes time, the return is worth it. The more consistently we offer vaccines, along with the reasons they are important, the more likely patients are to give vaccines a second thought. In fact, studies show that provider recommendation is the most important factor in patients’ decisions to vaccinate.¹

Approach matters. In all other aspects of medicine, we attempt to use a participatory approach, involving our patients in decisions regarding their health care. When discussing vaccines, however, a participatory approach (eg, “What do you want to do about vaccines today?”) can introduce doubt into patients’ minds. Studies show that a presumptive approach (eg, “Today we are going to provide the tetanus, human papillomavirus [HPV], and meningitis vaccines”) is a much more effective way to get patients to vaccinate.²

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Continue to: Barriers to counseling

Barriers to counseling. Health care providers report a variety of barriers to effective vaccine counseling (limited time and resources, lack of confidence in addressing patients’ concerns, etc).³ In addition, providers sometimes worry that strong encouragement of vaccination will create an adversarial relationship with vaccine-hesitant patients. Developing a good rapport and trusting relationship, as well as using motivational interviewing approaches, can help communicate the importance of vaccines, while leaving patients with the sense that you have heard them and respect their intentions. (See “Facilitate vaccine discussions using these 2 approaches.” ^4-7)

Continue to: If at first you don't succeed...

If at first you don’t succeed, try again because patients often have an experience that changes their mind. Perhaps a friend died of throat cancer or a family member developed a complication of the flu that required hospitalization. You never know when something will influence patients’ choices.

Don’t wait for scheduled well visits. Use every patient encounter as a means to catch patients up on missing vaccinations.

Common misconceptions and concerns and how to counter them

1. I’ve heard that vaccines can actually make you sick.

When patients raise this concern, start with an explanation of how vaccines work. Explain that our bodies protect us from foreign invaders (such as viruses and bacteria) by mounting an immune response when we are exposed to these proteins. Vaccinations work by exploiting this immune response; they expose the body to killed or weakened viral or bacterial proteins in a safe and controlled manner. In this way, our immune system will have already developed antibodies to these invaders by the time we are exposed to an active infection.

To use an analogy to war, instead of being subjected to a surprise attack where we suffer large losses in the battle, vaccination prepares us with weapons (antibodies) to defend ourselves so that our bodies are now able to successfully fight off that attack.

Because the majority of vaccines are killed virus vaccines, they cannot cause the illness against which they are meant to protect. Triggering the immune system may make some recipients feel a little “under the weather” for a day or 2, but they do not make us “sick.”

Live attenuated vaccines are similarly safe for those with a healthy immune system. We don’t administer them, however, to people who have a weakened immune system (eg, pregnant women, newborns, people with acquired immunodeficiency virus, or patients receiving chemotherapy or other types of immunosuppression) because these patients could develop the illness that we are trying to protect against.

Continue to: 2. Don't vaccines cause autism? Aren't they toxic to the nervous system?

The largest setback to vaccination efforts in recent history was a 1998 study by Andrew Wakefield that suggested that vaccination (specifically the mercury [in the form of thimerosal] present in the measles, mumps, rubella [MMR] vaccine) was linked to the development of autism.⁸ This research was subsequently debunked,⁹ and the author of the 1998 study was stripped of his medical license for falsifying data. However, the damage to vaccination efforts had already been done.

Aluminum. Thimerosal is not the only agent that patients may find concerning. Some also worry about the aluminum content of vaccines. Aluminum works as an additive to boost the body’s immune response to a vaccine. It is used only in killed virus vaccines—not in live attenuated ones. The Agency for Toxic Substances and Disease Registry monitors minimum risk levels (MRLs) of aluminum and other compounds in potentially hazardous substances. The amount of aluminum in vaccines is far below the MRL for aluminum, which is 1 mg/kg/d.¹⁰ (See “The facts about thimerosal and aluminum in vaccines.”^11-16)

Contine to: 3. I'm healthy. I never get sick. Why do I need vaccinations?

A good way to counter this comment is to respond: “Saying you don’t need vaccinations because you never get sick is like saying you don’t need to wear a seat belt because you’ve never been in a car accident.” Advise patients that we seek to vaccinate all members of a community—not just those who are sick or at high risk—to protect ourselves and to provide “herd immunity.” It’s important to explain that herd immunity is resistance to the spread of a contagious disease that results if a sufficiently high number of people (depending on the illness, typically 80%-95%) are immune to the disease, especially through vaccination.^17,18 If vaccination levels fall, we see a rise in cases of vaccine-preventable illness (as was seen during the 2017 measles outbreak in a community in Minnesota).¹⁹

Studies show that provider recommendation is the most important factor in patients' decisions to vaccinate.

Even though many of us may not suffer severe consequences of an infection, we can still pass that infection to others. While the whooping cough that a healthy 35-year-old gets may cause only prolonged annoyance or time off from work, it can kill the baby that is sitting next to that adult on the plane or bus.

4. Isn’t it true that we see fewer serious illnesses because of improved hygiene and sanitation, rather than vaccines?

Our current US sanitation standards were established under the Safe Drinking Water Act of 1974.²⁰ While improvements in hygiene, sanitation, nutrition, and other public health measures have undoubtedly decreased the spread of disease and improved survival rates, there is no denying the significant drop in disease that occurs after the introduction of a vaccine for a particular illness or the increase in cases of that disease when vaccination rates drop off.

Saying you don't need vaccinations because you never get sick is like saying you don't need to wear a seat belt because you've never been in a car accident.

By the early 1990s, our current sanitation standards were already well established. Yet we didn’t see a significant decrease in the incidence of infections with Haemophilus influenzae type b (Hib) until after the conjugate Hib vaccines were introduced (dropping from about 20,000 cases/year to 1419 cases/year by 1993).²¹

In Britain, a drop in the rate of pertussis (whooping cough) vaccination in 1974 resulted in an epidemic of more than 100,000 cases and 36 deaths by 1978. There was no decrease in hygiene or sanitation standards to explain this rise.²¹

Continue to: 5. Vaccines are just another way for "big pharma" to make "big money."

Patients may benefit from knowing that in the earlier days of vaccines, pharmaceutical companies actually moved away from production of vaccines because they were not very profitable. These days, with worldwide distribution, drug companies are back in the swing of making vaccines and, as we would expect from all companies, are in business to make a profit.

That said, health care providers receive no payments from drug companies for offering vaccines or for offering one vaccine over another. The reason we recommend vaccination is because we know it is best for our patients’ health and the health of the community.

6. We don’t see polio anymore. Why do I need the vaccine?

One of the factors contributing to the rise in antivaccine sentiment is that we rarely see vaccine-preventable illnesses (such as polio, measles, and mumps). But the absence of these illnesses is precisely due to prior years’ vaccination efforts.

Smallpox, a deadly and disfiguring disease that killed many millions of people and contributed to the downfall of the Roman, Aztec, and Incan empires, was eradicated from the planet in 1979, thanks to focused vaccination efforts by the World Health Organization. Vaccination works, but we have to keep at it.

While we no longer see as many of these vaccine-preventable illnesses in the United States, they are still present in other parts of the world. Our world is much smaller than it used to be. International travel is common, and illnesses can be reintroduced into a community with relative ease. We must remain vigilant.

Continue to: 7. I heard that vaccines are made from aborted fetal tissue.

There are 5 vaccines (varicella, rubella, hepatitis A, shingles, and rabies vaccines) that were originally made using aborted fetal tissue. In 1960, tissue from 2 fetuses aborted by maternal choice (and not for the purpose of vaccine production) was used to propagate cell lines that are still used in vaccine development today.

Human cells provide advantages for vaccine production that other cells do not. Some viruses do not grow well in animal cells. Animal cells can introduce contamination by bacteria and viruses that are not carried in human cell lines. Vaccine production can be hindered or halted, resulting in a vaccine shortage, if animal products used in development are threatened (eg, if an illness strikes egg-producing chickens; eggs are used to make the influenza vaccine).²²

Some patients, particularly those who are Catholic, may have concerns about these vaccines. The National Catholic Bioethics Center has prepared a statement regarding the use of these vaccines that may help settle any moral dilemmas.²³ It reads:

“The cell lines under consideration were begun using cells taken from one or more fetuses aborted almost 40 years ago. Since that time, the cell lines have grown independently. It is important to note that descendent cells are not the cells of the aborted child.”

“One is morally free to use the vaccine regardless of its historical association with abortion. The reason is that the risk to public health, if one chooses not to vaccinate, outweighs the legitimate concern about the origins of the vaccine. This is especially important for parents, who have a moral obligation to protect the life and health of their children and those around them.”

Continue to: 8. Vaccines aren't studied—or monitored—thoroughly enough.

Patients would benefit from knowing that vaccines are some of the most thoroughly studied products brought to market. They undergo rigorous testing and oversight, from both public and private organizations, for 10 to 15 years before being released for distribution. Post-licensure monitoring is ongoing, and the manufacturer may voluntarily participate in Phase IV trials to continue to test the safety and efficacy of a vaccine after release to market.

Monitoring adverse effects. In addition, in 1990, the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration established the Vaccine Adverse Events Reporting System (VAERS) to “detect possible signals of adverse events associated with vaccines.”²⁴ Most events reported are coincidental, but some common mild adverse events (like redness and swelling at the injection site) are often underreported.

Serious events are always thoroughly investigated and are often found unrelated. However, rare associations have been found. For example, an intestinal problem called intussusception, related to the original rotavirus vaccine, was discovered, and the vaccine causing it was removed from the market.²⁵ A new, safer rotavirus vaccine option is now available. Patients need to know that we do have an effective system of checks and balances in which we can place our trust.

9. People can become paralyzed or stop breathing after receiving a vaccination. Why run those risks?

One of the most feared reactions to vaccination is Guillain-Barré syndrome (GBS), which can cause paralysis. The CDC estimates the risk for GBS associated with the flu vaccine, for example, to be 1 to 2 cases per 1 million people vaccinated.²⁶ Another potential concern is the rate of anaphylaxis following vaccination. However, in a 2016 study in the Journal of Allergy and Clinical Immunology, the rate of anaphylaxis for all vaccines combined was only 1.31 per 1 million vaccines.²⁷

In the United States, the 2013 annual cost of 4 major vaccine-preventable illnesses in adults ≥50 years was estimated at $26.5 billion.

The risk of developing severe complications from an illness is much greater than that of developing complications from the vaccine meant to protect a person against that illness. In the United States, the population-based risk for influenza-related hospitalization in children, for example, is as high as 150 in 100,000 with as many as 125 deaths annually.²⁶

Continue to: 10. Isn't vaccination a personal choice? How does my health/illness impact the community?

Patients may not realize that most viruses are contagious from 1 to 2 days before symptoms appear, which means we can spread an illness before we even know we have it. Protecting oneself also protects those around us.

While the whooping cough that a healthy 35-year-old gets may be a prolonged annoyance or prompt some time off from work, it can kill the baby sitting next to the adult on the plane or bus.

Economic concerns. There’s also the economic impact of these illnesses to consider. This includes the personal cost of being out of school or work for an extended period and the cost of a patient’s care, which can become astronomical if hospitalization is required and which can become the country’s problem if a person lacks sufficient health insurance coverage.

A study looking at the cost of 4 major adult vaccine-preventable illnesses (influenza, pneumococcal disease, shingles, and whooping cough) in the United States in 2013 estimated the annual cost for these illnesses in adults ≥50 years to be $26.5 billion.²⁸ And that doesn’t include the cost of childhood vaccine-preventable diseases.

Countering 3 concerns about childhood vaccinations

1. I can’t afford vaccines for my child.

The Vaccines for Children program is a federally-funded program that covers the cost of all vaccines for children younger than 19 years of age who are Medicaid-eligible, American Indian, Alaskan Native, uninsured, or underinsured.²⁹ Although there may be a small administration fee charged by the provider’s office, the vaccine is free.

2. Don’t all of the vaccines recommended for children overwhelm their immune systems?

Children are exposed to so many more proteins on a daily basis (by crawling around on the floor, putting their hands in their mouths, attending school or day care, etc) than they are ever exposed to in a series of vaccines.³⁰ Exposure to these proteins in their environment and to those in vaccines only serves to boost their immunity and keep them healthier in the long run.

And thanks to advances in vaccine production, the immunologic load in vaccines is far less than it used to be. The 14 vaccines given today contain <200 bacterial and viral proteins or polysaccharides, compared with the >3000 of these immunologic components in the 7 vaccines administered in 1980.³¹

Continue to: Influenza vaccine: Patient-friendly talking points

Continue to: 3. Why don't we adhere to Dr. Sears' vaccine schedule?

There are multiple ways in which Dr. Robert Sears’ book, The Vaccine Book: Making the Right Decision for your Child, published in 2007, misrepresents vaccine science and leads patients astray in making decisions regarding vaccinations.³² Most important to note is that Dr. Sears’ Alternative Vaccine Schedule, which seeks to make it so that children do not receive more than 2 vaccinations per office visit, would require visits to a health care provider at 2, 3, 4, 5, 6, 7, 9, 12, 15, 18, and 21 months, and at 2, 2.5, 3, 3.5, 4, 5, and 6 years of age. This significantly increases the number of office visits and needle sticks, and raises the age at which vaccines are given, increasing the risk of illness outbreaks and decreasing the likelihood that parents would return to the office to complete the full series.

Acceptance of influenza and HPV vaccines remains a challenge

We are significantly less successful at getting parents and patients to agree to influenza and HPV vaccines than to the other vaccines we offer. The influenza vaccine success rate in 2016 was 59% in children and 43.3% in adults.³³ Compared to the Tdap vaccine (88%) and the meningococcal vaccine (82%), which are offered at the same age as the HPV vaccine, success rates for HPV vaccine are significantly lower. In 2016, only 60.4% of boys and girls were current on their first HPV injection and only 43.3% were up to date with the full series.³⁴

Newness of vaccines a factor?

Perhaps it is because the recommendations for these 2 vaccines are relatively new, and people don’t yet grasp the seriousness and scope of the diseases. Until 2010, the flu shot was recommended only for the very young, the elderly, and the medically high risk.

Similarly, the HPV vaccine was originally introduced for girls in 2006 and wasn’t recommended for boys until 2011.

Continue to: Human papillomavirus vaccine: Patient-friendly talking points

Continue to: A sensitive subject

A sensitive subject. Discussion of a vaccine related to a child’s sexual health makes some parents uncomfortable. Studies show that focusing on the cancer prevention aspects of the vaccine, rather than on sexual transmission of HPV, results in greater vaccine acceptance.³⁵

In 2016, only 60.4% of boys and girls were current on their first HPV vaccination and only 43.3% were up to date with the full series.

However, if discussion of sexual transmission is unavoidable, remind parents to consider their own adolescence and whether they chose to share everything with their parents. Point out that there were probably things they did that they later looked back on and thought, “What was I thinking?” Their children, no matter how wonderful and levelheaded they are, will be no different. And, as much as parents don’t want to think about it, some kids will suffer unwanted sexual contact. Shouldn’t parents protect their children as best as they can?

A teen’s right to choose? Some states have passed a Mature Minor Doctrine, which provides for mature, unemancipated teens to make their own medical decisions regarding such issues as sexuality, mental health, and drug and alcohol use without their parents’ consent. In these states, teens may elect to receive the HPV vaccine without parental permission. (Check your state’s laws for specifics, and see the 2 boxes with patient-friendly talking points for influenza vaccine^7,36-39 and human papillomavirus vaccine.^40-47)

CORRESPONDENCE
Gretchen LaSalle, MD, MultiCare Rockwood Clinic, 2214 East 29th Avenue, Spokane, WA 99203; [email protected].

Image by Betty Pace

The US Food and Drug Administration (FDA) has placed a clinical hold on the investigational new drug application (IND) for CTX001. The agent is being developed for the treatment of sickle cell disease (SCD) and β-thalassemia.

The IND was submitted to the FDA in April to support the initiation of a phase 1/2 trial in the US in adult patients with SCD. The hold will be in place pending the resolution of questions as part of the FDA review.

The phase 1/2 trial in Europe in adult patients with transfusion-dependent β-thalassemia is expected to proceed according to schedule. Trial initiation is planned for the second half of 2018.

CTX001 is being co-developed and co-commercialized by CRISPR Therapeutics and Vertex Pharmaceuticals Incorporated.

The agent is an investigational ex vivo CRISPR gene edited therapy for patients with β-thalassemia or sickle cell disease.

The patient’s hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells.

The increase in HbF levels by CTX001 may potentially alleviate transfusion requirements for β-thalassemia patients and sickle crises for SCD patients. 

Image by Betty Pace

The US Food and Drug Administration (FDA) has placed a clinical hold on the investigational new drug application (IND) for CTX001. The agent is being developed for the treatment of sickle cell disease (SCD) and β-thalassemia.

The IND was submitted to the FDA in April to support the initiation of a phase 1/2 trial in the US in adult patients with SCD. The hold will be in place pending the resolution of questions as part of the FDA review.

The phase 1/2 trial in Europe in adult patients with transfusion-dependent β-thalassemia is expected to proceed according to schedule. Trial initiation is planned for the second half of 2018.

CTX001 is being co-developed and co-commercialized by CRISPR Therapeutics and Vertex Pharmaceuticals Incorporated.

The agent is an investigational ex vivo CRISPR gene edited therapy for patients with β-thalassemia or sickle cell disease.

The patient’s hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells.

The increase in HbF levels by CTX001 may potentially alleviate transfusion requirements for β-thalassemia patients and sickle crises for SCD patients. 

Image by Betty Pace

The US Food and Drug Administration (FDA) has placed a clinical hold on the investigational new drug application (IND) for CTX001. The agent is being developed for the treatment of sickle cell disease (SCD) and β-thalassemia.

The IND was submitted to the FDA in April to support the initiation of a phase 1/2 trial in the US in adult patients with SCD. The hold will be in place pending the resolution of questions as part of the FDA review.

The phase 1/2 trial in Europe in adult patients with transfusion-dependent β-thalassemia is expected to proceed according to schedule. Trial initiation is planned for the second half of 2018.

CTX001 is being co-developed and co-commercialized by CRISPR Therapeutics and Vertex Pharmaceuticals Incorporated.

The agent is an investigational ex vivo CRISPR gene edited therapy for patients with β-thalassemia or sickle cell disease.

The patient’s hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells.

The increase in HbF levels by CTX001 may potentially alleviate transfusion requirements for β-thalassemia patients and sickle crises for SCD patients. 

Resources

US Preventive Services Task Force. Screening for prostate cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018;319:1901-1913.

Carter HB. Prostate-specific antigen (PSA) screening for prostate cancer: revisiting the evidence. JAMA. 2018;319:1866-1868.

US Preventive Services Task Force. Prostate cancer screening final recommendation. Available at: https://screeningforprostatecancer.org/. Accessed May 18, 2018.

US Preventive Services Task Force. Prostate cancer: screening, 2008. Available at:  https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancer-screening-2008. Accessed May 15, 2018.

US Preventive Services Task Force. Prostate cancer: screening. May 2012. Available at: https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/prostate-cancer-screening. Accessed May 15, 2018.

Resources

US Preventive Services Task Force. Screening for prostate cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018;319:1901-1913.

Carter HB. Prostate-specific antigen (PSA) screening for prostate cancer: revisiting the evidence. JAMA. 2018;319:1866-1868.

US Preventive Services Task Force. Prostate cancer screening final recommendation. Available at: https://screeningforprostatecancer.org/. Accessed May 18, 2018.

US Preventive Services Task Force. Prostate cancer: screening, 2008. Available at:  https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancer-screening-2008. Accessed May 15, 2018.

US Preventive Services Task Force. Prostate cancer: screening. May 2012. Available at: https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/prostate-cancer-screening. Accessed May 15, 2018.

Resources

US Preventive Services Task Force. Screening for prostate cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018;319:1901-1913.

Carter HB. Prostate-specific antigen (PSA) screening for prostate cancer: revisiting the evidence. JAMA. 2018;319:1866-1868.

US Preventive Services Task Force. Prostate cancer screening final recommendation. Available at: https://screeningforprostatecancer.org/. Accessed May 18, 2018.

US Preventive Services Task Force. Prostate cancer: screening, 2008. Available at:  https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancer-screening-2008. Accessed May 15, 2018.

US Preventive Services Task Force. Prostate cancer: screening. May 2012. Available at: https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/prostate-cancer-screening. Accessed May 15, 2018.

Resources

US Preventive Services Task Force. Final recommendation statement: Falls prevention in community-dwelling older adults: interventions. Available at: https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/falls-prevention-in-older-adults-interventions1. Accessed May 8, 2018.

US Preventive Services Task Force. Interventions to prevent falls in community-dwelling older adults. US Preventive Services Task Force recommendation statement. JAMA. 2018;319:1696-1704.

Guirguis-Blake JM, Michael YL, Perdue LA, et al. Interventions to prevent falls in older adults. Updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;319:1705-1716.

Resources

US Preventive Services Task Force. Final recommendation statement: Falls prevention in community-dwelling older adults: interventions. Available at: https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/falls-prevention-in-older-adults-interventions1. Accessed May 8, 2018.

US Preventive Services Task Force. Interventions to prevent falls in community-dwelling older adults. US Preventive Services Task Force recommendation statement. JAMA. 2018;319:1696-1704.

Guirguis-Blake JM, Michael YL, Perdue LA, et al. Interventions to prevent falls in older adults. Updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;319:1705-1716.

Resources

US Preventive Services Task Force. Final recommendation statement: Falls prevention in community-dwelling older adults: interventions. Available at: https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/falls-prevention-in-older-adults-interventions1. Accessed May 8, 2018.

US Preventive Services Task Force. Interventions to prevent falls in community-dwelling older adults. US Preventive Services Task Force recommendation statement. JAMA. 2018;319:1696-1704.

Guirguis-Blake JM, Michael YL, Perdue LA, et al. Interventions to prevent falls in older adults. Updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;319:1705-1716.

The benefits of breastfeeding for infants have long been touted as numerous and supported by overwhelming evidence. The World Health Organization (WHO), American College of Obstetricians and Gynecologists, American Academy of Pediatrics (AAP), and American Academy of Family Physicians all strongly recommend exclusive breastfeeding for the first 6 months of life, citing numerous health benefits for child and mother. These groups recommend that some breastfeeding be continued through the first 12 months of life, or longer, as desired (the WHO extends the recommendation to 2 years).^1-4 In 2000, the Surgeon General of the United States released a strategic plan to increase rates of breastfeeding,⁵ setting goals (by 2010) of:

• 75% of mothers leaving the hospital breastfeeding
• 50% of babies breastfeeding at 6 months
• 25% of babies breastfeeding at 1 year.

Massive public health campaigns citing data for the many benefits of breastfeeding have been launched with the goal of increasing the breastfeeding rate. In 2014, statistics offered a testament to the success of these campaigns⁶:

• 82.5% of infants had been breastfed “ever”
• 55.3% were breastfed “some”
• 24.9% were breastfed exclusively through 6 months of age
• 33.7% were breastfed “some” at 12 months.

Breastfeeding advocacy has become clouded

In recent years, an increasing number of researchers, physicians, and authors have begun to question whether, in the United States, the benefits of breastfeeding children are exaggerated and the emphasis on breastfeeding might be leading to feelings of inadequacy, guilt, and anxiety among mothers.^7-13 In 2016, the US Preventive Services Task Force (USPSTF) amended its recommendation to “promote and support breastfeeding” to simply “support breastfeeding”—a change that created substantial debate and prompted the Task Force to clarify its stance in changing the language: In its response to public comment, the USPSTF said that its position regarding promotion had not changed, but the language in the original statement had been revised to “ensure that the autonomy of women is respected.” ^2,14-16

In contrast, others suggest counseling women on the risks of formula feeding rather than on the benefits of breastfeeding, citing substantial health outcome distinctions.¹⁷ Indeed, wide-ranging conclusions have been drawn from the same data on the topic, potentially creating uncertainty for physicians on how best to counsel women on their choice of how to feed their infant.

An increasing number of researchers and physicians have begun to question whether the benefits of breastfeeding are exaggerated.

In this article, we address this uncertainty by utilizing the most recent and comprehensive data to examine infant health outcomes. When possible, the number needed to treat (NNT) for a given outcome has been calculated or approximated, allowing the reader to estimate the likelihood of benefit for an individual mother–infant dyad. Exercise caution when interpreting the NNT, however: The numbers suggest causality that cannot be definitively established using the observational data on which those numbers are based.

Continue to: Infectious disease

Acute otitis media. Exclusive breastfeeding for 6 months is associated with a 43% reduction in the risk of acute otitis media (AOM) by 2 years of age (odds ratio [OR]=0.57; 95% confidence interval [CI], 0.44-0.75). Beyond 2 years of age, or when comparing “ever” and “never” breastfeeding, the effect disappears. All studies in this meta-analysis had serious limitations.¹⁸

Nearly half of children will have at least one case of AOM by one year of age; 80%, by 2 years.^19,20 Since the introduction of the heptavalent pneumococcal conjugate vaccine, the rate of AOM at 2 years has fallen by as much as 20%.²¹ Assuming an incidence of 60% to 80% of AOM by 2 years, only 2 or 3 infants need to be exclusively breastfed for 6 months to prevent a single case of AOM.¹⁸ Prevention of AOM through breastfeeding may be related to head position during feeding, antibacterial effects of breast milk, protective oral microbiome in the breastfed infant pharynx, and/or prevention of primary viral upper respiratory infection (URI), which nearly always precedes AOM.^18,19

Upper and lower respiratory tract infections. Infants who are exclusively breastfed for 4 months and partially breastfed after 4 months have a lower risk of URI (OR=0.65; 95% CI, 0.51-0.83) and of lower respiratory tract infection (LRTI; OR=0.50; 95% CI, 0.32-0.72).²²

The effect is stronger for URI among infants exclusively breastfed for at least 6 months (OR=0.37; 95% CI, 0.18-0.74), but is no longer significant by that time for LRTI (OR=0.33; 95% CI, 0.08-1.40). Importantly, AOM was included in the URI group, and, as previously discussed, AOM has independently been shown to have an inverse relationship with breastfeeding duration.

At 7 to 12 months of age, no association was seen between breastfeeding and the incidence of URI. Curiously, an association with LRTI was again detected for infants breastfed exclusively for 4 months and partially thereafter, but was not detected with exclusive breastfeeding for at least 6 months (OR=0.46; 95% CI, 0.31-0.69). In this study, in the first 6 months of life, 40% of infants had a URI and 8% had an LRTI. The findings in this cohort suggest an NNT of 6 or 7 for prevention of URI and an NNT of 25 for prevention of LRTI in the first 6 months of life.²²

Continue to: Children younger than 2 years are...

Children younger than 2 years are estimated to have approximately 6 bouts of the common cold a year, and essentially 100% have at least one bout—perhaps lowering the NNT for URI if applied widely. However, these data are not divided into 6-month intervals, making accurate extrapolation difficult.²³

Gastrointestinal infection. The rate of diarrheal illness in the first year of life is lower in infants who are exclusively breastfed for at least 4 months and partially breastfed after.

Both the Promotion of Breastfeeding Intervention Trial (PROBIT; a clinical trial in which infants were randomized to a breastfeeding education intervention or standard care) and a 2010 prospective cohort study in the Netherlands of more than 3400 infants found a reduction in the risk of one or more gastrointestinal (GI) infections at a similar rate.^22,24

• In PROBIT, 9.1% of infants in the intervention group, compared to 13.2% in the standard care group (OR=0.60; 95% CI, 0.40-0.91), had one or more GI infections at 12 months of age.²⁴
• In the 2010 Netherlands cohort, 8% of infants had a GI infection by 6 months of age. Infants breastfed exclusively for at least 4 or 6 months had a decreased risk for GI infection (respectively: adjusted OR=0.41; 95% CI, 0.26-0.64 and adjusted OR=0.46; 95% CI, 0.14-1.59). No such association was found for any feeding group 7 to 12 months of age.²²

These studies are notable for the low incidence of GI infection, which is frequently cited as 1.3 to 2.3 episodes per child per year in children younger than 3 years in the United States.²⁵ However, that high incidence has likely declined significantly since the introduction of rotavirus vaccine in 2006. In the years following the introduction of the vaccine, infant visits for gastroenteritis decreased by >90% in all care settings in the South, Northeast, and Midwest regions of the United States and by 53% to 63% in the West region.²⁶ Recent accurate epidemiologic information, in an era of significantly higher vaccination rates, is lacking.

Assuming the low incidence of GI infection reported in PROBIT and the Netherlands trials, about 25 to 30 infants need to be exclusively breastfed for 4 to 6 months to prevent a single GI infection during the first 6 to 12 months of life.^22,24 Assuming a 60% incidence by age 12 months before introduction of the rotavirus vaccine, the NNT would be approximately 4.²⁴ The true number is likely somewhere between those 2 NNTs.

Continue to: Hospitalization

Risk of infection is decreased. A large cohort study in Scotland, involving more than 500,000 children, found an association between exclusive breastfeeding for 6 to 8 weeks and decreased risk of hospitalization within the first 6 months of life. Formula-fed and mixed-fed infants had an increased hazard ratio (HR) for hospitalization for common childhood illness (HR=1.40; 95% CI, 1.35-1.45 for formula-fed infants and HR=1.18; 95% CI, 1.11-1.25 for mixed-fed infants).²⁷ The study also found increased rates of hospitalization for conditions for which other meta-analyses have failed to show a protective effect from breastfeeding—leading to suspicion of residual confounding in the study. Another United Kingdom cohort demonstrated lower rates of hospitalization for GI infection (NNT=171) and LRTI (NNT=115) among exclusively breastfed infants by 8 months of age.²⁸

Risk of neonatal readmission is increased. Late preterm infants who are exclusively breastfed are nearly twice as likely to be hospitalized as breastfed term or non-breastfed preterm infants, primarily due to dehydration, failure to thrive, weight loss, and hyperbilirubinemia. In fact, exclusive breastfeeding at discharge from the hospital is likely the single greatest risk factor for hospital readmission in newborns.^29,30 Term infants who are exclusively breastfed are more likely to be hospitalized compared to formula-fed or mixed-fed infants, due to hyperbilirubinemia, dehydration, hypernatremia, and weight loss (number needed to harm (NNH)=71).^30-32 For weight loss >10% of birth weight with or without hospitalization, the NNH for breastfed infants is 13.³²

Many of these hospitalizations and events could be avoided with appropriate monitoring and medically indicated supplementation; the likelihood of long-term harm is low. Formula supplementation is often avoided if possible in hospitals to promote exclusive breastfeeding; however, several small randomized clinical trials have demonstrated that limited formula supplementation in breastfed infants does not affect the breastfeeding continuation rate at 3 and 6 months, and, therefore, might be a way to decrease infant rehospitalization.^33,34

Necrotizing enterocolitis

Exclusive breastfeeding for 6 months is associated with a 43% reduction in the risk of acute otitis media by 2 years of age.

In preterm infants, breastfeeding has been associated with a lower rate of necrotizing enterocolitis. In the 2007 Agency for Healthcare Research and Quality report, the association was found to be only marginally statistically significant, and the authors warned that, first, evidence is old and heterogeneous and, second, present preterm formula is much different than the formula used in earlier studies of preterm infant nutrition and necrotizing enterocolitis.³⁵ A 2012 Cochrane review included newer studies in its analysis but reached the same conclusion on the quality and heterogeneity of available evidence, with a NNT of 25.³⁶

Continue to: Sudden infant death syndrome

There is a statistically significant association between sudden infant death syndrome (SIDS) and feeding method. Infants whose cause of death is SIDS are approximately one half as likely to have been breastfed as matched controls.^35,37

In 2005, AAP did not recommend breastfeeding as a means to reduce the risk of SIDS because available evidence was mixed, and studies at the time were poorly controlled.³⁸ Since that time, case-control meta-analyses have shed additional light on the association between SIDS and feeding method.^35,37

The protective effect exists for any amount of breastfeeding and is stronger for exclusive breastfeeding, suggesting a protective role—not simply an association. Caution should be employed with this conclusion, however, because the studies included in the meta-analysis used univariate analysis primarily and did not control sufficiently for known confounders. In addition, the authors warn that publication bias might overestimate the association.³⁸

Exclusive breastfeeding is likely the single greatest risk factor for hospital readmission in newborns.

Potential mechanisms of a protective role include decreased risk of infection and greater arousability from sleep in breastfed infants. Assuming a protective role, available data suggest that more than 3500 infants need to be breastfed to prevent one case of SIDS.³⁹

Continue to: Allergic disease

Allergic disease

Asthma. There is evidence of a small protective effect of breastfeeding “ever” on asthma at 5 to 18 years of age in high-income countries (OR=0.90; 95% CI, 0.83-0.97). A family history of asthma or atopy did not affect this finding. The authors note there is some evidence of publication bias in this review, which is the largest and most comprehensive on the topic.⁴⁰

With a lifetime prevalence of asthma in the United States of approximately 13.2%, this association would confer an NNT of roughly 76.⁴¹ Earlier, the literature demonstrated mixed and conflicting evidence, and some experts suggested an effect only when there is a family history of asthma or atopy.³⁶

Eczema. For children younger than 2 years, there is low-grade- and very-low-grade-quality evidence that exclusive breastfeeding longer than 3 to 4 months is associated with a reduced risk of eczema (OR=0.74; 95% CI, 0.57-0.97).⁴⁰

Previously, data suggested that this association existed only in children who had a family history of atopy.³⁵ The protective association, however, exists regardless of family history and does not persist beyond 2 years of age. The authors noted evidence of publication bias, reverse causation, and misdiagnosis of early childhood rashes as eczema as limitations of their findings.⁴⁰

Continue to: Reliable epidemiologic evidence...

Reliable epidemiologic evidence on the incidence of eczema in infants in the United States is limited, but the prevalence in the United States in children younger than 17 years is approximately 10.7% (with wide regional variation). Extrapolating these data generously, the NNT to prevent eczema in the first 2 years of life could be estimated at approximately 36.⁴²

Allergic rhinitis. There is low-grade- and very-low-grade-quality evidence that more breastfeeding, compared to less breastfeeding, is associated with a lower risk of allergic rhinitis in children younger than 5 years (OR=0.79; 95% CI, 0.63-0.98). The association exists regardless of family history and disappears after 5 years of age. The differentiation of allergic rhinitis from rhinovirus infection (for which there is higher-quality evidence of a protective effect with breastfeeding) must be considered when interpreting these data.⁴⁰

Reliable epidemiologic evidence on allergic rhinitis in children younger than 5 years is lacking, and incidence varies by region. A rough estimate, using data from 6- and 7-year-olds, indicates an NNT of 54 to 70.⁴³

Food allergy. There is no evidence to suggest an association between breastfeeding and food allergy, either as protective or as a risk factor, and studies are limited.⁴⁰ Interestingly, as data accumulate associating early exposure to foods with protection, some authors have proposed reexamining the recommendation from WHO and US health organizations for exclusive breastfeeding for the first 6 months of life.^7,44

Continue to: Dental health

Dental caries. There is consistent evidence that breastfeeding beyond 12 months of age is associated with the development of dental caries of deciduous teeth to 6 years of age (OR=2.90; 95% CI, 2.33-3.60). Many of the studies that showed this association did not control for the introduction of sugary foods and drinks, and there was a trend toward publication bias showing the association.⁴⁵

Dental malocclusion. There is consistent evidence for approximately a two-thirds reduction in malocclusions in deciduous teeth in breastfed infants (OR=0.32; 95% CI, 0.25-0.40). Although the large majority of these data come from low-income and middle-income countries, the incidence of malocclusion is not thought to be associated with socioeconomic status, as so many other breastfeeding outcomes are.⁴⁶

Childhood leukemia

In the largest meta-analysis available, a statistically significant inverse relationship between any breastfeeding for >6 months and childhood leukemia is evident in developed countries (OR=0.84; 95% CI, 0.78-0.91), although significant heterogeneity among studies and lack of control for confounding variables are significant limitations. In particular, an association has been demonstrated with acute lymphoblastic leukemia (ALL) but not with acute myelogenous leukemia.⁴⁷ Given the rarity of childhood ALL, approximately 12,500 infants would need to be breastfed to prevent one case.⁴⁸

Continue to: Long-term outcomes

Cognitive development. Several studies conducted in developed countries have linked breastfeeding to positive cognitive outcomes in children, including higher intelligence quotient (IQ).^35,49-52

These effects are conflicting, however, in studies that include sibling analysis and ones that control for maternal IQ.^{8,35,43,52-54} In the 2013 WHO meta-analysis, breastfeeding was associated with an increase of 2.2 points on normalized testing when only high-quality studies were included.⁵¹ A 2015 meta-analysis identified 4 high-quality studies with a large sample size and recall time <3 years, which demonstrated a mean difference of 1.76 points in IQ (95% CI, 0.25-3.26) in childhood and adolescence.⁵² Although statistically significant, this modest increase is of questionable clinical benefit and of unknown duration.

Obesity. The relationship between breastfeeding and obesity later in life is debatable. A large, systematic 2014 review of 15 cohort and 10 cross-sectional studies found a significantly reduced risk of childhood obesity among children who were breastfed (adjusted OR=0.78; 95% CI, 0.74-0.81).⁵⁵ However, the review included studies that controlled for different confounders, and smaller effects were found in studies in which more confounders were taken into account.

Available data suggest that more than 3500 infants need to be breastfed to prevent one case of SIDS.

The 2013 WHO meta-analysis found a small (approximately 10%) reduction in the prevalence of overweight or obese children, but cautioned that residual confounding and publication bias were likely.⁵¹ At 6.5 and 11.5 years of follow-up, PROBIT failed to demonstrate a protective effect for exclusively or “ever” breastfed infants.⁵⁶ Sibling analysis similarly fails to demonstrate a statistically significant relationship.⁸

Continue to: A 2015 meta-analysis of 23 high-quality studies...

A 2015 meta-analysis of 23 high-quality studies with a sample size >1500 children and controlled for important confounders showed a pooled reduction in the prevalence of overweight or obesity of 13% (95% CI, 6-19).⁵⁷ The protection in this meta-analysis showed a dilution of the effect as the participants aged and an inverse relationship of the effect with sample size.

Breastfeeding is, therefore, unlikely to play a significant, if any, role in combatting the obesity epidemic.

Hypertension. A meta-analysis of high-quality trials demonstrates a <1 mm Hg reduction in systolic blood pressure and no significant difference in diastolic pressure in breastfed infants.⁵⁷ Similarly, no significant effect of breastfeeding on blood pressure has been demonstrated in trials of preterm infants.⁵¹

Type 2 diabetes. Available data are limited and heterogeneous for the association between breastfeeding and later development of type 2 diabetes. Only 2 high-quality trials were identified in the 2013 WHO meta-analysis, and their results conflict.⁵¹ A 2015 meta-analysis identified only 3 high-quality studies, without a statistically significant relationship.⁵⁷

Dyslipidemia. Although earlier data suggested an association between breastfeeding and reduced cholesterol levels later in life, the 2013 WHO meta-analysis and a 2015 meta-analysis concluded that no association exists. The limited data available for preterm infants conflict.^51,57

Growth. There is no evidence that feeding method has a short- or long-term effect on weight gain or length gain in preterm or term infants.^35,36,58

Death. No clear association has been found between mortality and breastfeeding status in developed countries, except for the association with SIDS.³⁵

Continue to: What issues frame and guide counseling on breastfeeding?

What issues frame and guide counseling on breastfeeding?

There is that “problem” with the evidence. The evidence for infant breastfeeding status and its association with health outcomes faces significant limitations; the great majority of those limitations tend to overestimate the benefits of breastfeeding. Nearly all evidence is based on observational studies, in which causality cannot be determined and self-selection bias, recall bias, and residual confounding limit the value or strength of the findings.

The use of pacifiers before last sleep is more protective against SIDS than breastfeeding.

Breastfeeding rates are strongly socially patterned alongside socioeconomic status, race, and education level, all of which are simultaneously strongly tied to short- and long-term health outcomes.⁶ Other factors limiting the strength of the data set include varying definitions of infant feeding practices in different studies, varying definitions of outcomes and diseases, reverse causation, and evidence of publication bias in many meta-analyses. Given these shortcomings, the NNTs in this article probably represent a best-case scenario for breastfeeding outcomes for infants in the United States (TABLE 1^{18,22-24,28,36,39-43,47,48}).

Data need to be put into context. The NNTs for many breastfeeding outcomes (TABLE) compare favorably with other recommended interventions, particularly for other preventive care measures. Two examples: 81 mg/d aspirin for a 50-year-old man has an NNT of 35 to 45 for preventing nonfatal myocardial infarction, and the number needed to invite to screen with mammography to prevent one breast cancer death for a 50-year-old woman is 1339.^59,60

In both of these examples, >95% of patients will not benefit from the intervention, yet these preventive measures are routinely recommended and have a significant impact at the public health level. Notably, these outcomes are more serious than most breastfeeding outcomes; have a longer-lasting effect, better-quality data, and better data for potential harms; are causally linked to the intervention; and require much less effort and commitment of time than breastfeeding.

The question must be reckoned with: Can advocacy be harmful?

In recent years, a growing number of concerns have been raised about:

• the potential harms of breastfeeding advocacy
• exaggeration of the benefits of breastfeeding
• promotion of breastfeeding at the expense of evidence-based medicine.

The “Ten Steps to Successful Breastfeeding” program of the Baby-friendly Hospital Initiative (BFHI; launched by UNICEF and WHO) has come under scrutiny because of an increasing number of reports of sudden unexpected postnatal collapse; fall injuries; modeling and encouragement of unsafe sleep practices; an overly rigid resistance to the use of formula supplementation; and the ban on pacifier use.^61,62 The BFHI, promoted by the Centers for Disease Control and Prevention, is increasingly being adopted by hospitals with the expressed goal of increasing the breastfeeding rate from birth to discharge.

Continue to: Some of the "Ten Steps"...

Some of the “Ten Steps,” such as the call for skin-to-skin care and 24-hour rooming-in, have well-established benefit yet, when performed without supervision, can have the rare but serious unintended consequences of sudden unexpected postnatal collapse (the incidence of which may be higher than that of SIDS) and unsafe sleeping practices.^62,63

Furthermore, despite evidence that early formula supplementation, when medically necessary, does not adversely impact the breastfeeding rate, the “Ten Steps” program advises that giving formula before breast milk comes in might “lead to failure to breastfeed.”^33,34,61,63

Similarly, the ban on pacifiers is contrary to available evidence. The use of pacifiers before last sleep is more protective against SIDS than breastfeeding (NNT=2733), and there is evidence at one hospital that BFHI-inspired pacifier restriction is associated with a decrease in the rate of breastfeeding.^64,65

Other harms of advocacy are even more poorly studied. Most of the evidence for harm comes from the psychology and social science literature—not the medical literature, perhaps because the prevailing opinion in the medical community is that breastfeeding has overwhelming evidence for benefit. In fact, in the USPSTF’s 2008 recommendation, the evidence review of breastfeeding promotion practices in primary care did not identify a single study that measured harm; in the 2016 update of that recommendation, only 2 such studies were identified.^15,66

The literature that does investigate harm consistently finds that women who have difficulty breastfeeding or choose formula feeding report feelings of inadequacy, guilt, loss of agency, anxiety, and physical pain during breastfeeding that interferes with 1) their ability to bond or otherwise care for their infant and 2) competing work obligations.^11-13,67-69 Given the lack of attention paid to these variables in the medical literature, it is the individual mother who is best positioned to weigh these factors against the benefits of breastfeeding.

Continue to: Shared decision-making is best—for mother and baby

Breastfeeding might prevent certain infections in as many as 50% of infants, but a mother unable to breastfeed can take solace in the fact that >95% of breastfed infants will not realize any benefit from the preventive potential of breastfeeding in regard to hospitalization or allergic disease, and >99% will not realize benefit from either the prevention of SIDS or ALL, or from improvement in long-term health measures (except for, perhaps, a slightly higher IQ). The “breast is best” mantra is likely true at a public-health level; for the individual mother–infant dyad, however, where there is a need to balance personal, social, family, and financial factors, that mantra is an oversimplification.

The "breast is best" mantra is likely true at a public- health level; for the individual mother-infant dyad, however, that mantra is oversimplified.

Regrettably, there is a paucity of data on the risks of breastfeeding promotion—an area that deserves more study. Balancing the abundant, but often limited-quality, data on the benefits of breastfeeding and the sheer lack of data regarding the risks of advocacy represents a clinical and an ethical challenge for physicians. It is a challenge that can only be resolved through individualization of care and shared decision-making, in which the physician is expert on the benefits of breastfeeding, and the mother is expert on the personal circumstances to be weighed against those benefits.

CORRESPONDENCE
Joseph Lane Wilson, MD, ECU Brody School of Medicine, Department of Family Medicine, 101 Heart Drive, Greenville, NC 27834; [email protected].

The benefits of breastfeeding for infants have long been touted as numerous and supported by overwhelming evidence. The World Health Organization (WHO), American College of Obstetricians and Gynecologists, American Academy of Pediatrics (AAP), and American Academy of Family Physicians all strongly recommend exclusive breastfeeding for the first 6 months of life, citing numerous health benefits for child and mother. These groups recommend that some breastfeeding be continued through the first 12 months of life, or longer, as desired (the WHO extends the recommendation to 2 years).^1-4 In 2000, the Surgeon General of the United States released a strategic plan to increase rates of breastfeeding,⁵ setting goals (by 2010) of:

• 75% of mothers leaving the hospital breastfeeding
• 50% of babies breastfeeding at 6 months
• 25% of babies breastfeeding at 1 year.

Massive public health campaigns citing data for the many benefits of breastfeeding have been launched with the goal of increasing the breastfeeding rate. In 2014, statistics offered a testament to the success of these campaigns⁶:

• 82.5% of infants had been breastfed “ever”
• 55.3% were breastfed “some”
• 24.9% were breastfed exclusively through 6 months of age
• 33.7% were breastfed “some” at 12 months.

Breastfeeding advocacy has become clouded

In recent years, an increasing number of researchers, physicians, and authors have begun to question whether, in the United States, the benefits of breastfeeding children are exaggerated and the emphasis on breastfeeding might be leading to feelings of inadequacy, guilt, and anxiety among mothers.^7-13 In 2016, the US Preventive Services Task Force (USPSTF) amended its recommendation to “promote and support breastfeeding” to simply “support breastfeeding”—a change that created substantial debate and prompted the Task Force to clarify its stance in changing the language: In its response to public comment, the USPSTF said that its position regarding promotion had not changed, but the language in the original statement had been revised to “ensure that the autonomy of women is respected.” ^2,14-16

In contrast, others suggest counseling women on the risks of formula feeding rather than on the benefits of breastfeeding, citing substantial health outcome distinctions.¹⁷ Indeed, wide-ranging conclusions have been drawn from the same data on the topic, potentially creating uncertainty for physicians on how best to counsel women on their choice of how to feed their infant.

An increasing number of researchers and physicians have begun to question whether the benefits of breastfeeding are exaggerated.

In this article, we address this uncertainty by utilizing the most recent and comprehensive data to examine infant health outcomes. When possible, the number needed to treat (NNT) for a given outcome has been calculated or approximated, allowing the reader to estimate the likelihood of benefit for an individual mother–infant dyad. Exercise caution when interpreting the NNT, however: The numbers suggest causality that cannot be definitively established using the observational data on which those numbers are based.

Continue to: Infectious disease

Acute otitis media. Exclusive breastfeeding for 6 months is associated with a 43% reduction in the risk of acute otitis media (AOM) by 2 years of age (odds ratio [OR]=0.57; 95% confidence interval [CI], 0.44-0.75). Beyond 2 years of age, or when comparing “ever” and “never” breastfeeding, the effect disappears. All studies in this meta-analysis had serious limitations.¹⁸

Nearly half of children will have at least one case of AOM by one year of age; 80%, by 2 years.^19,20 Since the introduction of the heptavalent pneumococcal conjugate vaccine, the rate of AOM at 2 years has fallen by as much as 20%.²¹ Assuming an incidence of 60% to 80% of AOM by 2 years, only 2 or 3 infants need to be exclusively breastfed for 6 months to prevent a single case of AOM.¹⁸ Prevention of AOM through breastfeeding may be related to head position during feeding, antibacterial effects of breast milk, protective oral microbiome in the breastfed infant pharynx, and/or prevention of primary viral upper respiratory infection (URI), which nearly always precedes AOM.^18,19

Upper and lower respiratory tract infections. Infants who are exclusively breastfed for 4 months and partially breastfed after 4 months have a lower risk of URI (OR=0.65; 95% CI, 0.51-0.83) and of lower respiratory tract infection (LRTI; OR=0.50; 95% CI, 0.32-0.72).²²

The effect is stronger for URI among infants exclusively breastfed for at least 6 months (OR=0.37; 95% CI, 0.18-0.74), but is no longer significant by that time for LRTI (OR=0.33; 95% CI, 0.08-1.40). Importantly, AOM was included in the URI group, and, as previously discussed, AOM has independently been shown to have an inverse relationship with breastfeeding duration.

At 7 to 12 months of age, no association was seen between breastfeeding and the incidence of URI. Curiously, an association with LRTI was again detected for infants breastfed exclusively for 4 months and partially thereafter, but was not detected with exclusive breastfeeding for at least 6 months (OR=0.46; 95% CI, 0.31-0.69). In this study, in the first 6 months of life, 40% of infants had a URI and 8% had an LRTI. The findings in this cohort suggest an NNT of 6 or 7 for prevention of URI and an NNT of 25 for prevention of LRTI in the first 6 months of life.²²

Continue to: Children younger than 2 years are...

Children younger than 2 years are estimated to have approximately 6 bouts of the common cold a year, and essentially 100% have at least one bout—perhaps lowering the NNT for URI if applied widely. However, these data are not divided into 6-month intervals, making accurate extrapolation difficult.²³

Gastrointestinal infection. The rate of diarrheal illness in the first year of life is lower in infants who are exclusively breastfed for at least 4 months and partially breastfed after.

Both the Promotion of Breastfeeding Intervention Trial (PROBIT; a clinical trial in which infants were randomized to a breastfeeding education intervention or standard care) and a 2010 prospective cohort study in the Netherlands of more than 3400 infants found a reduction in the risk of one or more gastrointestinal (GI) infections at a similar rate.^22,24

• In PROBIT, 9.1% of infants in the intervention group, compared to 13.2% in the standard care group (OR=0.60; 95% CI, 0.40-0.91), had one or more GI infections at 12 months of age.²⁴
• In the 2010 Netherlands cohort, 8% of infants had a GI infection by 6 months of age. Infants breastfed exclusively for at least 4 or 6 months had a decreased risk for GI infection (respectively: adjusted OR=0.41; 95% CI, 0.26-0.64 and adjusted OR=0.46; 95% CI, 0.14-1.59). No such association was found for any feeding group 7 to 12 months of age.²²

These studies are notable for the low incidence of GI infection, which is frequently cited as 1.3 to 2.3 episodes per child per year in children younger than 3 years in the United States.²⁵ However, that high incidence has likely declined significantly since the introduction of rotavirus vaccine in 2006. In the years following the introduction of the vaccine, infant visits for gastroenteritis decreased by >90% in all care settings in the South, Northeast, and Midwest regions of the United States and by 53% to 63% in the West region.²⁶ Recent accurate epidemiologic information, in an era of significantly higher vaccination rates, is lacking.

Assuming the low incidence of GI infection reported in PROBIT and the Netherlands trials, about 25 to 30 infants need to be exclusively breastfed for 4 to 6 months to prevent a single GI infection during the first 6 to 12 months of life.^22,24 Assuming a 60% incidence by age 12 months before introduction of the rotavirus vaccine, the NNT would be approximately 4.²⁴ The true number is likely somewhere between those 2 NNTs.

Continue to: Hospitalization

Risk of infection is decreased. A large cohort study in Scotland, involving more than 500,000 children, found an association between exclusive breastfeeding for 6 to 8 weeks and decreased risk of hospitalization within the first 6 months of life. Formula-fed and mixed-fed infants had an increased hazard ratio (HR) for hospitalization for common childhood illness (HR=1.40; 95% CI, 1.35-1.45 for formula-fed infants and HR=1.18; 95% CI, 1.11-1.25 for mixed-fed infants).²⁷ The study also found increased rates of hospitalization for conditions for which other meta-analyses have failed to show a protective effect from breastfeeding—leading to suspicion of residual confounding in the study. Another United Kingdom cohort demonstrated lower rates of hospitalization for GI infection (NNT=171) and LRTI (NNT=115) among exclusively breastfed infants by 8 months of age.²⁸

Risk of neonatal readmission is increased. Late preterm infants who are exclusively breastfed are nearly twice as likely to be hospitalized as breastfed term or non-breastfed preterm infants, primarily due to dehydration, failure to thrive, weight loss, and hyperbilirubinemia. In fact, exclusive breastfeeding at discharge from the hospital is likely the single greatest risk factor for hospital readmission in newborns.^29,30 Term infants who are exclusively breastfed are more likely to be hospitalized compared to formula-fed or mixed-fed infants, due to hyperbilirubinemia, dehydration, hypernatremia, and weight loss (number needed to harm (NNH)=71).^30-32 For weight loss >10% of birth weight with or without hospitalization, the NNH for breastfed infants is 13.³²

Many of these hospitalizations and events could be avoided with appropriate monitoring and medically indicated supplementation; the likelihood of long-term harm is low. Formula supplementation is often avoided if possible in hospitals to promote exclusive breastfeeding; however, several small randomized clinical trials have demonstrated that limited formula supplementation in breastfed infants does not affect the breastfeeding continuation rate at 3 and 6 months, and, therefore, might be a way to decrease infant rehospitalization.^33,34

Necrotizing enterocolitis

Exclusive breastfeeding for 6 months is associated with a 43% reduction in the risk of acute otitis media by 2 years of age.

In preterm infants, breastfeeding has been associated with a lower rate of necrotizing enterocolitis. In the 2007 Agency for Healthcare Research and Quality report, the association was found to be only marginally statistically significant, and the authors warned that, first, evidence is old and heterogeneous and, second, present preterm formula is much different than the formula used in earlier studies of preterm infant nutrition and necrotizing enterocolitis.³⁵ A 2012 Cochrane review included newer studies in its analysis but reached the same conclusion on the quality and heterogeneity of available evidence, with a NNT of 25.³⁶

Continue to: Sudden infant death syndrome

There is a statistically significant association between sudden infant death syndrome (SIDS) and feeding method. Infants whose cause of death is SIDS are approximately one half as likely to have been breastfed as matched controls.^35,37

In 2005, AAP did not recommend breastfeeding as a means to reduce the risk of SIDS because available evidence was mixed, and studies at the time were poorly controlled.³⁸ Since that time, case-control meta-analyses have shed additional light on the association between SIDS and feeding method.^35,37

The protective effect exists for any amount of breastfeeding and is stronger for exclusive breastfeeding, suggesting a protective role—not simply an association. Caution should be employed with this conclusion, however, because the studies included in the meta-analysis used univariate analysis primarily and did not control sufficiently for known confounders. In addition, the authors warn that publication bias might overestimate the association.³⁸

Exclusive breastfeeding is likely the single greatest risk factor for hospital readmission in newborns.

Potential mechanisms of a protective role include decreased risk of infection and greater arousability from sleep in breastfed infants. Assuming a protective role, available data suggest that more than 3500 infants need to be breastfed to prevent one case of SIDS.³⁹

Continue to: Allergic disease

Allergic disease

Asthma. There is evidence of a small protective effect of breastfeeding “ever” on asthma at 5 to 18 years of age in high-income countries (OR=0.90; 95% CI, 0.83-0.97). A family history of asthma or atopy did not affect this finding. The authors note there is some evidence of publication bias in this review, which is the largest and most comprehensive on the topic.⁴⁰

With a lifetime prevalence of asthma in the United States of approximately 13.2%, this association would confer an NNT of roughly 76.⁴¹ Earlier, the literature demonstrated mixed and conflicting evidence, and some experts suggested an effect only when there is a family history of asthma or atopy.³⁶

Eczema. For children younger than 2 years, there is low-grade- and very-low-grade-quality evidence that exclusive breastfeeding longer than 3 to 4 months is associated with a reduced risk of eczema (OR=0.74; 95% CI, 0.57-0.97).⁴⁰

Previously, data suggested that this association existed only in children who had a family history of atopy.³⁵ The protective association, however, exists regardless of family history and does not persist beyond 2 years of age. The authors noted evidence of publication bias, reverse causation, and misdiagnosis of early childhood rashes as eczema as limitations of their findings.⁴⁰

Continue to: Reliable epidemiologic evidence...

Reliable epidemiologic evidence on the incidence of eczema in infants in the United States is limited, but the prevalence in the United States in children younger than 17 years is approximately 10.7% (with wide regional variation). Extrapolating these data generously, the NNT to prevent eczema in the first 2 years of life could be estimated at approximately 36.⁴²

Allergic rhinitis. There is low-grade- and very-low-grade-quality evidence that more breastfeeding, compared to less breastfeeding, is associated with a lower risk of allergic rhinitis in children younger than 5 years (OR=0.79; 95% CI, 0.63-0.98). The association exists regardless of family history and disappears after 5 years of age. The differentiation of allergic rhinitis from rhinovirus infection (for which there is higher-quality evidence of a protective effect with breastfeeding) must be considered when interpreting these data.⁴⁰

Reliable epidemiologic evidence on allergic rhinitis in children younger than 5 years is lacking, and incidence varies by region. A rough estimate, using data from 6- and 7-year-olds, indicates an NNT of 54 to 70.⁴³

Food allergy. There is no evidence to suggest an association between breastfeeding and food allergy, either as protective or as a risk factor, and studies are limited.⁴⁰ Interestingly, as data accumulate associating early exposure to foods with protection, some authors have proposed reexamining the recommendation from WHO and US health organizations for exclusive breastfeeding for the first 6 months of life.^7,44

Continue to: Dental health

Dental caries. There is consistent evidence that breastfeeding beyond 12 months of age is associated with the development of dental caries of deciduous teeth to 6 years of age (OR=2.90; 95% CI, 2.33-3.60). Many of the studies that showed this association did not control for the introduction of sugary foods and drinks, and there was a trend toward publication bias showing the association.⁴⁵

Dental malocclusion. There is consistent evidence for approximately a two-thirds reduction in malocclusions in deciduous teeth in breastfed infants (OR=0.32; 95% CI, 0.25-0.40). Although the large majority of these data come from low-income and middle-income countries, the incidence of malocclusion is not thought to be associated with socioeconomic status, as so many other breastfeeding outcomes are.⁴⁶

Childhood leukemia

In the largest meta-analysis available, a statistically significant inverse relationship between any breastfeeding for >6 months and childhood leukemia is evident in developed countries (OR=0.84; 95% CI, 0.78-0.91), although significant heterogeneity among studies and lack of control for confounding variables are significant limitations. In particular, an association has been demonstrated with acute lymphoblastic leukemia (ALL) but not with acute myelogenous leukemia.⁴⁷ Given the rarity of childhood ALL, approximately 12,500 infants would need to be breastfed to prevent one case.⁴⁸

Continue to: Long-term outcomes

Cognitive development. Several studies conducted in developed countries have linked breastfeeding to positive cognitive outcomes in children, including higher intelligence quotient (IQ).^35,49-52

These effects are conflicting, however, in studies that include sibling analysis and ones that control for maternal IQ.^{8,35,43,52-54} In the 2013 WHO meta-analysis, breastfeeding was associated with an increase of 2.2 points on normalized testing when only high-quality studies were included.⁵¹ A 2015 meta-analysis identified 4 high-quality studies with a large sample size and recall time <3 years, which demonstrated a mean difference of 1.76 points in IQ (95% CI, 0.25-3.26) in childhood and adolescence.⁵² Although statistically significant, this modest increase is of questionable clinical benefit and of unknown duration.

Obesity. The relationship between breastfeeding and obesity later in life is debatable. A large, systematic 2014 review of 15 cohort and 10 cross-sectional studies found a significantly reduced risk of childhood obesity among children who were breastfed (adjusted OR=0.78; 95% CI, 0.74-0.81).⁵⁵ However, the review included studies that controlled for different confounders, and smaller effects were found in studies in which more confounders were taken into account.

Available data suggest that more than 3500 infants need to be breastfed to prevent one case of SIDS.

The 2013 WHO meta-analysis found a small (approximately 10%) reduction in the prevalence of overweight or obese children, but cautioned that residual confounding and publication bias were likely.⁵¹ At 6.5 and 11.5 years of follow-up, PROBIT failed to demonstrate a protective effect for exclusively or “ever” breastfed infants.⁵⁶ Sibling analysis similarly fails to demonstrate a statistically significant relationship.⁸

Continue to: A 2015 meta-analysis of 23 high-quality studies...

A 2015 meta-analysis of 23 high-quality studies with a sample size >1500 children and controlled for important confounders showed a pooled reduction in the prevalence of overweight or obesity of 13% (95% CI, 6-19).⁵⁷ The protection in this meta-analysis showed a dilution of the effect as the participants aged and an inverse relationship of the effect with sample size.

Breastfeeding is, therefore, unlikely to play a significant, if any, role in combatting the obesity epidemic.

Hypertension. A meta-analysis of high-quality trials demonstrates a <1 mm Hg reduction in systolic blood pressure and no significant difference in diastolic pressure in breastfed infants.⁵⁷ Similarly, no significant effect of breastfeeding on blood pressure has been demonstrated in trials of preterm infants.⁵¹

Type 2 diabetes. Available data are limited and heterogeneous for the association between breastfeeding and later development of type 2 diabetes. Only 2 high-quality trials were identified in the 2013 WHO meta-analysis, and their results conflict.⁵¹ A 2015 meta-analysis identified only 3 high-quality studies, without a statistically significant relationship.⁵⁷

Dyslipidemia. Although earlier data suggested an association between breastfeeding and reduced cholesterol levels later in life, the 2013 WHO meta-analysis and a 2015 meta-analysis concluded that no association exists. The limited data available for preterm infants conflict.^51,57

Growth. There is no evidence that feeding method has a short- or long-term effect on weight gain or length gain in preterm or term infants.^35,36,58

Death. No clear association has been found between mortality and breastfeeding status in developed countries, except for the association with SIDS.³⁵

Continue to: What issues frame and guide counseling on breastfeeding?

What issues frame and guide counseling on breastfeeding?

There is that “problem” with the evidence. The evidence for infant breastfeeding status and its association with health outcomes faces significant limitations; the great majority of those limitations tend to overestimate the benefits of breastfeeding. Nearly all evidence is based on observational studies, in which causality cannot be determined and self-selection bias, recall bias, and residual confounding limit the value or strength of the findings.

The use of pacifiers before last sleep is more protective against SIDS than breastfeeding.

Breastfeeding rates are strongly socially patterned alongside socioeconomic status, race, and education level, all of which are simultaneously strongly tied to short- and long-term health outcomes.⁶ Other factors limiting the strength of the data set include varying definitions of infant feeding practices in different studies, varying definitions of outcomes and diseases, reverse causation, and evidence of publication bias in many meta-analyses. Given these shortcomings, the NNTs in this article probably represent a best-case scenario for breastfeeding outcomes for infants in the United States (TABLE 1^{18,22-24,28,36,39-43,47,48}).

Data need to be put into context. The NNTs for many breastfeeding outcomes (TABLE) compare favorably with other recommended interventions, particularly for other preventive care measures. Two examples: 81 mg/d aspirin for a 50-year-old man has an NNT of 35 to 45 for preventing nonfatal myocardial infarction, and the number needed to invite to screen with mammography to prevent one breast cancer death for a 50-year-old woman is 1339.^59,60

In both of these examples, >95% of patients will not benefit from the intervention, yet these preventive measures are routinely recommended and have a significant impact at the public health level. Notably, these outcomes are more serious than most breastfeeding outcomes; have a longer-lasting effect, better-quality data, and better data for potential harms; are causally linked to the intervention; and require much less effort and commitment of time than breastfeeding.

The question must be reckoned with: Can advocacy be harmful?

In recent years, a growing number of concerns have been raised about:

• the potential harms of breastfeeding advocacy
• exaggeration of the benefits of breastfeeding
• promotion of breastfeeding at the expense of evidence-based medicine.

The “Ten Steps to Successful Breastfeeding” program of the Baby-friendly Hospital Initiative (BFHI; launched by UNICEF and WHO) has come under scrutiny because of an increasing number of reports of sudden unexpected postnatal collapse; fall injuries; modeling and encouragement of unsafe sleep practices; an overly rigid resistance to the use of formula supplementation; and the ban on pacifier use.^61,62 The BFHI, promoted by the Centers for Disease Control and Prevention, is increasingly being adopted by hospitals with the expressed goal of increasing the breastfeeding rate from birth to discharge.

Continue to: Some of the "Ten Steps"...

Some of the “Ten Steps,” such as the call for skin-to-skin care and 24-hour rooming-in, have well-established benefit yet, when performed without supervision, can have the rare but serious unintended consequences of sudden unexpected postnatal collapse (the incidence of which may be higher than that of SIDS) and unsafe sleeping practices.^62,63

Furthermore, despite evidence that early formula supplementation, when medically necessary, does not adversely impact the breastfeeding rate, the “Ten Steps” program advises that giving formula before breast milk comes in might “lead to failure to breastfeed.”^33,34,61,63

Similarly, the ban on pacifiers is contrary to available evidence. The use of pacifiers before last sleep is more protective against SIDS than breastfeeding (NNT=2733), and there is evidence at one hospital that BFHI-inspired pacifier restriction is associated with a decrease in the rate of breastfeeding.^64,65

Other harms of advocacy are even more poorly studied. Most of the evidence for harm comes from the psychology and social science literature—not the medical literature, perhaps because the prevailing opinion in the medical community is that breastfeeding has overwhelming evidence for benefit. In fact, in the USPSTF’s 2008 recommendation, the evidence review of breastfeeding promotion practices in primary care did not identify a single study that measured harm; in the 2016 update of that recommendation, only 2 such studies were identified.^15,66

The literature that does investigate harm consistently finds that women who have difficulty breastfeeding or choose formula feeding report feelings of inadequacy, guilt, loss of agency, anxiety, and physical pain during breastfeeding that interferes with 1) their ability to bond or otherwise care for their infant and 2) competing work obligations.^11-13,67-69 Given the lack of attention paid to these variables in the medical literature, it is the individual mother who is best positioned to weigh these factors against the benefits of breastfeeding.

Continue to: Shared decision-making is best—for mother and baby

Breastfeeding might prevent certain infections in as many as 50% of infants, but a mother unable to breastfeed can take solace in the fact that >95% of breastfed infants will not realize any benefit from the preventive potential of breastfeeding in regard to hospitalization or allergic disease, and >99% will not realize benefit from either the prevention of SIDS or ALL, or from improvement in long-term health measures (except for, perhaps, a slightly higher IQ). The “breast is best” mantra is likely true at a public-health level; for the individual mother–infant dyad, however, where there is a need to balance personal, social, family, and financial factors, that mantra is an oversimplification.

The "breast is best" mantra is likely true at a public- health level; for the individual mother-infant dyad, however, that mantra is oversimplified.

Regrettably, there is a paucity of data on the risks of breastfeeding promotion—an area that deserves more study. Balancing the abundant, but often limited-quality, data on the benefits of breastfeeding and the sheer lack of data regarding the risks of advocacy represents a clinical and an ethical challenge for physicians. It is a challenge that can only be resolved through individualization of care and shared decision-making, in which the physician is expert on the benefits of breastfeeding, and the mother is expert on the personal circumstances to be weighed against those benefits.

CORRESPONDENCE
Joseph Lane Wilson, MD, ECU Brody School of Medicine, Department of Family Medicine, 101 Heart Drive, Greenville, NC 27834; [email protected].

The benefits of breastfeeding for infants have long been touted as numerous and supported by overwhelming evidence. The World Health Organization (WHO), American College of Obstetricians and Gynecologists, American Academy of Pediatrics (AAP), and American Academy of Family Physicians all strongly recommend exclusive breastfeeding for the first 6 months of life, citing numerous health benefits for child and mother. These groups recommend that some breastfeeding be continued through the first 12 months of life, or longer, as desired (the WHO extends the recommendation to 2 years).^1-4 In 2000, the Surgeon General of the United States released a strategic plan to increase rates of breastfeeding,⁵ setting goals (by 2010) of:

• 75% of mothers leaving the hospital breastfeeding
• 50% of babies breastfeeding at 6 months
• 25% of babies breastfeeding at 1 year.

Massive public health campaigns citing data for the many benefits of breastfeeding have been launched with the goal of increasing the breastfeeding rate. In 2014, statistics offered a testament to the success of these campaigns⁶:

• 82.5% of infants had been breastfed “ever”
• 55.3% were breastfed “some”
• 24.9% were breastfed exclusively through 6 months of age
• 33.7% were breastfed “some” at 12 months.

Breastfeeding advocacy has become clouded

In recent years, an increasing number of researchers, physicians, and authors have begun to question whether, in the United States, the benefits of breastfeeding children are exaggerated and the emphasis on breastfeeding might be leading to feelings of inadequacy, guilt, and anxiety among mothers.^7-13 In 2016, the US Preventive Services Task Force (USPSTF) amended its recommendation to “promote and support breastfeeding” to simply “support breastfeeding”—a change that created substantial debate and prompted the Task Force to clarify its stance in changing the language: In its response to public comment, the USPSTF said that its position regarding promotion had not changed, but the language in the original statement had been revised to “ensure that the autonomy of women is respected.” ^2,14-16

In contrast, others suggest counseling women on the risks of formula feeding rather than on the benefits of breastfeeding, citing substantial health outcome distinctions.¹⁷ Indeed, wide-ranging conclusions have been drawn from the same data on the topic, potentially creating uncertainty for physicians on how best to counsel women on their choice of how to feed their infant.

An increasing number of researchers and physicians have begun to question whether the benefits of breastfeeding are exaggerated.

In this article, we address this uncertainty by utilizing the most recent and comprehensive data to examine infant health outcomes. When possible, the number needed to treat (NNT) for a given outcome has been calculated or approximated, allowing the reader to estimate the likelihood of benefit for an individual mother–infant dyad. Exercise caution when interpreting the NNT, however: The numbers suggest causality that cannot be definitively established using the observational data on which those numbers are based.

Continue to: Infectious disease

Acute otitis media. Exclusive breastfeeding for 6 months is associated with a 43% reduction in the risk of acute otitis media (AOM) by 2 years of age (odds ratio [OR]=0.57; 95% confidence interval [CI], 0.44-0.75). Beyond 2 years of age, or when comparing “ever” and “never” breastfeeding, the effect disappears. All studies in this meta-analysis had serious limitations.¹⁸

Nearly half of children will have at least one case of AOM by one year of age; 80%, by 2 years.^19,20 Since the introduction of the heptavalent pneumococcal conjugate vaccine, the rate of AOM at 2 years has fallen by as much as 20%.²¹ Assuming an incidence of 60% to 80% of AOM by 2 years, only 2 or 3 infants need to be exclusively breastfed for 6 months to prevent a single case of AOM.¹⁸ Prevention of AOM through breastfeeding may be related to head position during feeding, antibacterial effects of breast milk, protective oral microbiome in the breastfed infant pharynx, and/or prevention of primary viral upper respiratory infection (URI), which nearly always precedes AOM.^18,19

Upper and lower respiratory tract infections. Infants who are exclusively breastfed for 4 months and partially breastfed after 4 months have a lower risk of URI (OR=0.65; 95% CI, 0.51-0.83) and of lower respiratory tract infection (LRTI; OR=0.50; 95% CI, 0.32-0.72).²²

The effect is stronger for URI among infants exclusively breastfed for at least 6 months (OR=0.37; 95% CI, 0.18-0.74), but is no longer significant by that time for LRTI (OR=0.33; 95% CI, 0.08-1.40). Importantly, AOM was included in the URI group, and, as previously discussed, AOM has independently been shown to have an inverse relationship with breastfeeding duration.

At 7 to 12 months of age, no association was seen between breastfeeding and the incidence of URI. Curiously, an association with LRTI was again detected for infants breastfed exclusively for 4 months and partially thereafter, but was not detected with exclusive breastfeeding for at least 6 months (OR=0.46; 95% CI, 0.31-0.69). In this study, in the first 6 months of life, 40% of infants had a URI and 8% had an LRTI. The findings in this cohort suggest an NNT of 6 or 7 for prevention of URI and an NNT of 25 for prevention of LRTI in the first 6 months of life.²²

Continue to: Children younger than 2 years are...

Children younger than 2 years are estimated to have approximately 6 bouts of the common cold a year, and essentially 100% have at least one bout—perhaps lowering the NNT for URI if applied widely. However, these data are not divided into 6-month intervals, making accurate extrapolation difficult.²³

Gastrointestinal infection. The rate of diarrheal illness in the first year of life is lower in infants who are exclusively breastfed for at least 4 months and partially breastfed after.

Both the Promotion of Breastfeeding Intervention Trial (PROBIT; a clinical trial in which infants were randomized to a breastfeeding education intervention or standard care) and a 2010 prospective cohort study in the Netherlands of more than 3400 infants found a reduction in the risk of one or more gastrointestinal (GI) infections at a similar rate.^22,24

• In PROBIT, 9.1% of infants in the intervention group, compared to 13.2% in the standard care group (OR=0.60; 95% CI, 0.40-0.91), had one or more GI infections at 12 months of age.²⁴
• In the 2010 Netherlands cohort, 8% of infants had a GI infection by 6 months of age. Infants breastfed exclusively for at least 4 or 6 months had a decreased risk for GI infection (respectively: adjusted OR=0.41; 95% CI, 0.26-0.64 and adjusted OR=0.46; 95% CI, 0.14-1.59). No such association was found for any feeding group 7 to 12 months of age.²²

These studies are notable for the low incidence of GI infection, which is frequently cited as 1.3 to 2.3 episodes per child per year in children younger than 3 years in the United States.²⁵ However, that high incidence has likely declined significantly since the introduction of rotavirus vaccine in 2006. In the years following the introduction of the vaccine, infant visits for gastroenteritis decreased by >90% in all care settings in the South, Northeast, and Midwest regions of the United States and by 53% to 63% in the West region.²⁶ Recent accurate epidemiologic information, in an era of significantly higher vaccination rates, is lacking.

Assuming the low incidence of GI infection reported in PROBIT and the Netherlands trials, about 25 to 30 infants need to be exclusively breastfed for 4 to 6 months to prevent a single GI infection during the first 6 to 12 months of life.^22,24 Assuming a 60% incidence by age 12 months before introduction of the rotavirus vaccine, the NNT would be approximately 4.²⁴ The true number is likely somewhere between those 2 NNTs.

Continue to: Hospitalization

Risk of infection is decreased. A large cohort study in Scotland, involving more than 500,000 children, found an association between exclusive breastfeeding for 6 to 8 weeks and decreased risk of hospitalization within the first 6 months of life. Formula-fed and mixed-fed infants had an increased hazard ratio (HR) for hospitalization for common childhood illness (HR=1.40; 95% CI, 1.35-1.45 for formula-fed infants and HR=1.18; 95% CI, 1.11-1.25 for mixed-fed infants).²⁷ The study also found increased rates of hospitalization for conditions for which other meta-analyses have failed to show a protective effect from breastfeeding—leading to suspicion of residual confounding in the study. Another United Kingdom cohort demonstrated lower rates of hospitalization for GI infection (NNT=171) and LRTI (NNT=115) among exclusively breastfed infants by 8 months of age.²⁸

Risk of neonatal readmission is increased. Late preterm infants who are exclusively breastfed are nearly twice as likely to be hospitalized as breastfed term or non-breastfed preterm infants, primarily due to dehydration, failure to thrive, weight loss, and hyperbilirubinemia. In fact, exclusive breastfeeding at discharge from the hospital is likely the single greatest risk factor for hospital readmission in newborns.^29,30 Term infants who are exclusively breastfed are more likely to be hospitalized compared to formula-fed or mixed-fed infants, due to hyperbilirubinemia, dehydration, hypernatremia, and weight loss (number needed to harm (NNH)=71).^30-32 For weight loss >10% of birth weight with or without hospitalization, the NNH for breastfed infants is 13.³²

Many of these hospitalizations and events could be avoided with appropriate monitoring and medically indicated supplementation; the likelihood of long-term harm is low. Formula supplementation is often avoided if possible in hospitals to promote exclusive breastfeeding; however, several small randomized clinical trials have demonstrated that limited formula supplementation in breastfed infants does not affect the breastfeeding continuation rate at 3 and 6 months, and, therefore, might be a way to decrease infant rehospitalization.^33,34

Necrotizing enterocolitis

Exclusive breastfeeding for 6 months is associated with a 43% reduction in the risk of acute otitis media by 2 years of age.

In preterm infants, breastfeeding has been associated with a lower rate of necrotizing enterocolitis. In the 2007 Agency for Healthcare Research and Quality report, the association was found to be only marginally statistically significant, and the authors warned that, first, evidence is old and heterogeneous and, second, present preterm formula is much different than the formula used in earlier studies of preterm infant nutrition and necrotizing enterocolitis.³⁵ A 2012 Cochrane review included newer studies in its analysis but reached the same conclusion on the quality and heterogeneity of available evidence, with a NNT of 25.³⁶

Continue to: Sudden infant death syndrome

There is a statistically significant association between sudden infant death syndrome (SIDS) and feeding method. Infants whose cause of death is SIDS are approximately one half as likely to have been breastfed as matched controls.^35,37

In 2005, AAP did not recommend breastfeeding as a means to reduce the risk of SIDS because available evidence was mixed, and studies at the time were poorly controlled.³⁸ Since that time, case-control meta-analyses have shed additional light on the association between SIDS and feeding method.^35,37

The protective effect exists for any amount of breastfeeding and is stronger for exclusive breastfeeding, suggesting a protective role—not simply an association. Caution should be employed with this conclusion, however, because the studies included in the meta-analysis used univariate analysis primarily and did not control sufficiently for known confounders. In addition, the authors warn that publication bias might overestimate the association.³⁸

Exclusive breastfeeding is likely the single greatest risk factor for hospital readmission in newborns.

Potential mechanisms of a protective role include decreased risk of infection and greater arousability from sleep in breastfed infants. Assuming a protective role, available data suggest that more than 3500 infants need to be breastfed to prevent one case of SIDS.³⁹

Continue to: Allergic disease

Allergic disease

Asthma. There is evidence of a small protective effect of breastfeeding “ever” on asthma at 5 to 18 years of age in high-income countries (OR=0.90; 95% CI, 0.83-0.97). A family history of asthma or atopy did not affect this finding. The authors note there is some evidence of publication bias in this review, which is the largest and most comprehensive on the topic.⁴⁰

With a lifetime prevalence of asthma in the United States of approximately 13.2%, this association would confer an NNT of roughly 76.⁴¹ Earlier, the literature demonstrated mixed and conflicting evidence, and some experts suggested an effect only when there is a family history of asthma or atopy.³⁶

Eczema. For children younger than 2 years, there is low-grade- and very-low-grade-quality evidence that exclusive breastfeeding longer than 3 to 4 months is associated with a reduced risk of eczema (OR=0.74; 95% CI, 0.57-0.97).⁴⁰

Previously, data suggested that this association existed only in children who had a family history of atopy.³⁵ The protective association, however, exists regardless of family history and does not persist beyond 2 years of age. The authors noted evidence of publication bias, reverse causation, and misdiagnosis of early childhood rashes as eczema as limitations of their findings.⁴⁰

Continue to: Reliable epidemiologic evidence...

Reliable epidemiologic evidence on the incidence of eczema in infants in the United States is limited, but the prevalence in the United States in children younger than 17 years is approximately 10.7% (with wide regional variation). Extrapolating these data generously, the NNT to prevent eczema in the first 2 years of life could be estimated at approximately 36.⁴²

Allergic rhinitis. There is low-grade- and very-low-grade-quality evidence that more breastfeeding, compared to less breastfeeding, is associated with a lower risk of allergic rhinitis in children younger than 5 years (OR=0.79; 95% CI, 0.63-0.98). The association exists regardless of family history and disappears after 5 years of age. The differentiation of allergic rhinitis from rhinovirus infection (for which there is higher-quality evidence of a protective effect with breastfeeding) must be considered when interpreting these data.⁴⁰

Reliable epidemiologic evidence on allergic rhinitis in children younger than 5 years is lacking, and incidence varies by region. A rough estimate, using data from 6- and 7-year-olds, indicates an NNT of 54 to 70.⁴³

Food allergy. There is no evidence to suggest an association between breastfeeding and food allergy, either as protective or as a risk factor, and studies are limited.⁴⁰ Interestingly, as data accumulate associating early exposure to foods with protection, some authors have proposed reexamining the recommendation from WHO and US health organizations for exclusive breastfeeding for the first 6 months of life.^7,44

Continue to: Dental health

Dental caries. There is consistent evidence that breastfeeding beyond 12 months of age is associated with the development of dental caries of deciduous teeth to 6 years of age (OR=2.90; 95% CI, 2.33-3.60). Many of the studies that showed this association did not control for the introduction of sugary foods and drinks, and there was a trend toward publication bias showing the association.⁴⁵

Dental malocclusion. There is consistent evidence for approximately a two-thirds reduction in malocclusions in deciduous teeth in breastfed infants (OR=0.32; 95% CI, 0.25-0.40). Although the large majority of these data come from low-income and middle-income countries, the incidence of malocclusion is not thought to be associated with socioeconomic status, as so many other breastfeeding outcomes are.⁴⁶

Childhood leukemia

In the largest meta-analysis available, a statistically significant inverse relationship between any breastfeeding for >6 months and childhood leukemia is evident in developed countries (OR=0.84; 95% CI, 0.78-0.91), although significant heterogeneity among studies and lack of control for confounding variables are significant limitations. In particular, an association has been demonstrated with acute lymphoblastic leukemia (ALL) but not with acute myelogenous leukemia.⁴⁷ Given the rarity of childhood ALL, approximately 12,500 infants would need to be breastfed to prevent one case.⁴⁸

Continue to: Long-term outcomes

Cognitive development. Several studies conducted in developed countries have linked breastfeeding to positive cognitive outcomes in children, including higher intelligence quotient (IQ).^35,49-52

These effects are conflicting, however, in studies that include sibling analysis and ones that control for maternal IQ.^{8,35,43,52-54} In the 2013 WHO meta-analysis, breastfeeding was associated with an increase of 2.2 points on normalized testing when only high-quality studies were included.⁵¹ A 2015 meta-analysis identified 4 high-quality studies with a large sample size and recall time <3 years, which demonstrated a mean difference of 1.76 points in IQ (95% CI, 0.25-3.26) in childhood and adolescence.⁵² Although statistically significant, this modest increase is of questionable clinical benefit and of unknown duration.

Obesity. The relationship between breastfeeding and obesity later in life is debatable. A large, systematic 2014 review of 15 cohort and 10 cross-sectional studies found a significantly reduced risk of childhood obesity among children who were breastfed (adjusted OR=0.78; 95% CI, 0.74-0.81).⁵⁵ However, the review included studies that controlled for different confounders, and smaller effects were found in studies in which more confounders were taken into account.

Available data suggest that more than 3500 infants need to be breastfed to prevent one case of SIDS.

The 2013 WHO meta-analysis found a small (approximately 10%) reduction in the prevalence of overweight or obese children, but cautioned that residual confounding and publication bias were likely.⁵¹ At 6.5 and 11.5 years of follow-up, PROBIT failed to demonstrate a protective effect for exclusively or “ever” breastfed infants.⁵⁶ Sibling analysis similarly fails to demonstrate a statistically significant relationship.⁸

Continue to: A 2015 meta-analysis of 23 high-quality studies...

A 2015 meta-analysis of 23 high-quality studies with a sample size >1500 children and controlled for important confounders showed a pooled reduction in the prevalence of overweight or obesity of 13% (95% CI, 6-19).⁵⁷ The protection in this meta-analysis showed a dilution of the effect as the participants aged and an inverse relationship of the effect with sample size.

Breastfeeding is, therefore, unlikely to play a significant, if any, role in combatting the obesity epidemic.

Hypertension. A meta-analysis of high-quality trials demonstrates a <1 mm Hg reduction in systolic blood pressure and no significant difference in diastolic pressure in breastfed infants.⁵⁷ Similarly, no significant effect of breastfeeding on blood pressure has been demonstrated in trials of preterm infants.⁵¹

Type 2 diabetes. Available data are limited and heterogeneous for the association between breastfeeding and later development of type 2 diabetes. Only 2 high-quality trials were identified in the 2013 WHO meta-analysis, and their results conflict.⁵¹ A 2015 meta-analysis identified only 3 high-quality studies, without a statistically significant relationship.⁵⁷

Dyslipidemia. Although earlier data suggested an association between breastfeeding and reduced cholesterol levels later in life, the 2013 WHO meta-analysis and a 2015 meta-analysis concluded that no association exists. The limited data available for preterm infants conflict.^51,57

Growth. There is no evidence that feeding method has a short- or long-term effect on weight gain or length gain in preterm or term infants.^35,36,58

Death. No clear association has been found between mortality and breastfeeding status in developed countries, except for the association with SIDS.³⁵

Continue to: What issues frame and guide counseling on breastfeeding?

What issues frame and guide counseling on breastfeeding?

There is that “problem” with the evidence. The evidence for infant breastfeeding status and its association with health outcomes faces significant limitations; the great majority of those limitations tend to overestimate the benefits of breastfeeding. Nearly all evidence is based on observational studies, in which causality cannot be determined and self-selection bias, recall bias, and residual confounding limit the value or strength of the findings.

The use of pacifiers before last sleep is more protective against SIDS than breastfeeding.

Breastfeeding rates are strongly socially patterned alongside socioeconomic status, race, and education level, all of which are simultaneously strongly tied to short- and long-term health outcomes.⁶ Other factors limiting the strength of the data set include varying definitions of infant feeding practices in different studies, varying definitions of outcomes and diseases, reverse causation, and evidence of publication bias in many meta-analyses. Given these shortcomings, the NNTs in this article probably represent a best-case scenario for breastfeeding outcomes for infants in the United States (TABLE 1^{18,22-24,28,36,39-43,47,48}).

Data need to be put into context. The NNTs for many breastfeeding outcomes (TABLE) compare favorably with other recommended interventions, particularly for other preventive care measures. Two examples: 81 mg/d aspirin for a 50-year-old man has an NNT of 35 to 45 for preventing nonfatal myocardial infarction, and the number needed to invite to screen with mammography to prevent one breast cancer death for a 50-year-old woman is 1339.^59,60

In both of these examples, >95% of patients will not benefit from the intervention, yet these preventive measures are routinely recommended and have a significant impact at the public health level. Notably, these outcomes are more serious than most breastfeeding outcomes; have a longer-lasting effect, better-quality data, and better data for potential harms; are causally linked to the intervention; and require much less effort and commitment of time than breastfeeding.

The question must be reckoned with: Can advocacy be harmful?

In recent years, a growing number of concerns have been raised about:

• the potential harms of breastfeeding advocacy
• exaggeration of the benefits of breastfeeding
• promotion of breastfeeding at the expense of evidence-based medicine.

The “Ten Steps to Successful Breastfeeding” program of the Baby-friendly Hospital Initiative (BFHI; launched by UNICEF and WHO) has come under scrutiny because of an increasing number of reports of sudden unexpected postnatal collapse; fall injuries; modeling and encouragement of unsafe sleep practices; an overly rigid resistance to the use of formula supplementation; and the ban on pacifier use.^61,62 The BFHI, promoted by the Centers for Disease Control and Prevention, is increasingly being adopted by hospitals with the expressed goal of increasing the breastfeeding rate from birth to discharge.

Continue to: Some of the "Ten Steps"...

Some of the “Ten Steps,” such as the call for skin-to-skin care and 24-hour rooming-in, have well-established benefit yet, when performed without supervision, can have the rare but serious unintended consequences of sudden unexpected postnatal collapse (the incidence of which may be higher than that of SIDS) and unsafe sleeping practices.^62,63

Furthermore, despite evidence that early formula supplementation, when medically necessary, does not adversely impact the breastfeeding rate, the “Ten Steps” program advises that giving formula before breast milk comes in might “lead to failure to breastfeed.”^33,34,61,63

Similarly, the ban on pacifiers is contrary to available evidence. The use of pacifiers before last sleep is more protective against SIDS than breastfeeding (NNT=2733), and there is evidence at one hospital that BFHI-inspired pacifier restriction is associated with a decrease in the rate of breastfeeding.^64,65

Other harms of advocacy are even more poorly studied. Most of the evidence for harm comes from the psychology and social science literature—not the medical literature, perhaps because the prevailing opinion in the medical community is that breastfeeding has overwhelming evidence for benefit. In fact, in the USPSTF’s 2008 recommendation, the evidence review of breastfeeding promotion practices in primary care did not identify a single study that measured harm; in the 2016 update of that recommendation, only 2 such studies were identified.^15,66

The literature that does investigate harm consistently finds that women who have difficulty breastfeeding or choose formula feeding report feelings of inadequacy, guilt, loss of agency, anxiety, and physical pain during breastfeeding that interferes with 1) their ability to bond or otherwise care for their infant and 2) competing work obligations.^11-13,67-69 Given the lack of attention paid to these variables in the medical literature, it is the individual mother who is best positioned to weigh these factors against the benefits of breastfeeding.

Continue to: Shared decision-making is best—for mother and baby

Breastfeeding might prevent certain infections in as many as 50% of infants, but a mother unable to breastfeed can take solace in the fact that >95% of breastfed infants will not realize any benefit from the preventive potential of breastfeeding in regard to hospitalization or allergic disease, and >99% will not realize benefit from either the prevention of SIDS or ALL, or from improvement in long-term health measures (except for, perhaps, a slightly higher IQ). The “breast is best” mantra is likely true at a public-health level; for the individual mother–infant dyad, however, where there is a need to balance personal, social, family, and financial factors, that mantra is an oversimplification.

The "breast is best" mantra is likely true at a public- health level; for the individual mother-infant dyad, however, that mantra is oversimplified.

Regrettably, there is a paucity of data on the risks of breastfeeding promotion—an area that deserves more study. Balancing the abundant, but often limited-quality, data on the benefits of breastfeeding and the sheer lack of data regarding the risks of advocacy represents a clinical and an ethical challenge for physicians. It is a challenge that can only be resolved through individualization of care and shared decision-making, in which the physician is expert on the benefits of breastfeeding, and the mother is expert on the personal circumstances to be weighed against those benefits.

CORRESPONDENCE
Joseph Lane Wilson, MD, ECU Brody School of Medicine, Department of Family Medicine, 101 Heart Drive, Greenville, NC 27834; [email protected].

Here are 4 articles from the June issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Dermatology Practice Gaps: Missed Diagnoses

To take the posttest, go to: https://bit.ly/2IhaxSm
Expires February 11, 2019

2. When to Worry About Congenital Melanocytic Nevi

To take the posttest, go to: https://bit.ly/2IhMOBC
Expires March 2, 2019

3. Unscheduled Visits for Pain After Hernia Surgery Common, Costly

To take the posttest, go to: https://bit.ly/2GbfWIV
Expires February 15, 2019

4. Melanoma Incidence Increased in Older Non-Hispanic Whites

To take the posttest, go to: https://bit.ly/2wOkVzZ
Expires February 9, 2019

Here are 4 articles from the June issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Dermatology Practice Gaps: Missed Diagnoses

To take the posttest, go to: https://bit.ly/2IhaxSm
Expires February 11, 2019

2. When to Worry About Congenital Melanocytic Nevi

To take the posttest, go to: https://bit.ly/2IhMOBC
Expires March 2, 2019

3. Unscheduled Visits for Pain After Hernia Surgery Common, Costly

To take the posttest, go to: https://bit.ly/2GbfWIV
Expires February 15, 2019

4. Melanoma Incidence Increased in Older Non-Hispanic Whites

To take the posttest, go to: https://bit.ly/2wOkVzZ
Expires February 9, 2019

Here are 4 articles from the June issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Dermatology Practice Gaps: Missed Diagnoses

To take the posttest, go to: https://bit.ly/2IhaxSm
Expires February 11, 2019

2. When to Worry About Congenital Melanocytic Nevi

To take the posttest, go to: https://bit.ly/2IhMOBC
Expires March 2, 2019

3. Unscheduled Visits for Pain After Hernia Surgery Common, Costly

To take the posttest, go to: https://bit.ly/2GbfWIV
Expires February 15, 2019

4. Melanoma Incidence Increased in Older Non-Hispanic Whites

To take the posttest, go to: https://bit.ly/2wOkVzZ
Expires February 9, 2019

In the article, “Point-of-care ultrasound: Coming soon to primary care?” (J Fam Pract. 2018;67:70-79), Bornemann et al outline potential uses for point-of-care ultrasound (POCUS), describing in detail its role in cardiovascular and pulmonary exams, screening for abdominal aortic aneurysms, and diagnosing deep vein thrombosis. The American Academy of Family Physicians, in the Recommended Curriculum Guidelines for Family Medicine Residents (available at: https://www.aafp.org/medical-school-residency/program-directors/curriculum.html), also discusses obstetric and gynecologic uses for POCUS, such as determining fetal presentation and distinguishing viable pregnancy from miscarriage.

In my practice, I most often use POCUS for gynecologic and pregnancy-related issues, such as to ensure proper placement of an intrauterine device (IUD) when the strings are not visible, to determine gestational age in patients with uncertain last menstrual periods, and to confirm pregnancy location when patients have risk factors for, or symptoms suggestive of, ectopic pregnancy.

The breadth of care provided in family medicine is what makes it special. We must make sure that as we expand our care with new technologies, we do not trade tried and true uses of those technologies for newer ones.

Zoey Thill, MD, MPP
Bronx, NY

In the article, “Point-of-care ultrasound: Coming soon to primary care?” (J Fam Pract. 2018;67:70-79), Bornemann et al outline potential uses for point-of-care ultrasound (POCUS), describing in detail its role in cardiovascular and pulmonary exams, screening for abdominal aortic aneurysms, and diagnosing deep vein thrombosis. The American Academy of Family Physicians, in the Recommended Curriculum Guidelines for Family Medicine Residents (available at: https://www.aafp.org/medical-school-residency/program-directors/curriculum.html), also discusses obstetric and gynecologic uses for POCUS, such as determining fetal presentation and distinguishing viable pregnancy from miscarriage.

In my practice, I most often use POCUS for gynecologic and pregnancy-related issues, such as to ensure proper placement of an intrauterine device (IUD) when the strings are not visible, to determine gestational age in patients with uncertain last menstrual periods, and to confirm pregnancy location when patients have risk factors for, or symptoms suggestive of, ectopic pregnancy.

The breadth of care provided in family medicine is what makes it special. We must make sure that as we expand our care with new technologies, we do not trade tried and true uses of those technologies for newer ones.

Zoey Thill, MD, MPP
Bronx, NY

In the article, “Point-of-care ultrasound: Coming soon to primary care?” (J Fam Pract. 2018;67:70-79), Bornemann et al outline potential uses for point-of-care ultrasound (POCUS), describing in detail its role in cardiovascular and pulmonary exams, screening for abdominal aortic aneurysms, and diagnosing deep vein thrombosis. The American Academy of Family Physicians, in the Recommended Curriculum Guidelines for Family Medicine Residents (available at: https://www.aafp.org/medical-school-residency/program-directors/curriculum.html), also discusses obstetric and gynecologic uses for POCUS, such as determining fetal presentation and distinguishing viable pregnancy from miscarriage.

In my practice, I most often use POCUS for gynecologic and pregnancy-related issues, such as to ensure proper placement of an intrauterine device (IUD) when the strings are not visible, to determine gestational age in patients with uncertain last menstrual periods, and to confirm pregnancy location when patients have risk factors for, or symptoms suggestive of, ectopic pregnancy.

The breadth of care provided in family medicine is what makes it special. We must make sure that as we expand our care with new technologies, we do not trade tried and true uses of those technologies for newer ones.

Zoey Thill, MD, MPP
Bronx, NY

This country continues to struggle with the issue of how to pay for health care. But regardless of the source of payment, primary care usually gets caught in the middle. Squeezed between volume and value, family physicians know all too well the gap that exists between what our patients need and what our training and health care system allow us to provide.

This knowledge prompted me to change how I conduct my day-to-day office visits. To routinely restore healing to the patient-provider conversation, I developed a tool called the HOPE (Healing Oriented Practices and Environments) Note. It consists of a set of questions to ask during a routine office visit that are specifically geared toward uncovering and addressing patients’ personal determinants of health and healing.

During a HOPE consultation, I seek to reframe the orientation from one that focuses only on disease treatment to one that emphasizes self-healing. Example questions include: What matters to you? What brings you joy? How is your social support? What do you eat? How is your sleep? What is your home like? Do you feel safe? How do you manage stress?

From there, I develop a personalized health promotion plan adjusted to the patient’s needs, personality, readiness, resources, and circumstances. Usually, patients benefit from additional assistance, such as health coaching and ways to measure and track progress. I have created a HOPE Note Checklist to teach students and residents about this approach, and a patient guide to help prepare patients for the visit ahead of time. (To access the guide and other free HOPE Note tools, see www.drwaynejonas.com/hope.)

Of course, these tools won’t single-handedly solve the issue of health care costs. But by practicing in a way that prioritizes what really matters to patients, we begin to take health care reform into our own hands.

Wayne B. Jonas, MD
Alexandria, Va

This country continues to struggle with the issue of how to pay for health care. But regardless of the source of payment, primary care usually gets caught in the middle. Squeezed between volume and value, family physicians know all too well the gap that exists between what our patients need and what our training and health care system allow us to provide.

This knowledge prompted me to change how I conduct my day-to-day office visits. To routinely restore healing to the patient-provider conversation, I developed a tool called the HOPE (Healing Oriented Practices and Environments) Note. It consists of a set of questions to ask during a routine office visit that are specifically geared toward uncovering and addressing patients’ personal determinants of health and healing.

During a HOPE consultation, I seek to reframe the orientation from one that focuses only on disease treatment to one that emphasizes self-healing. Example questions include: What matters to you? What brings you joy? How is your social support? What do you eat? How is your sleep? What is your home like? Do you feel safe? How do you manage stress?

From there, I develop a personalized health promotion plan adjusted to the patient’s needs, personality, readiness, resources, and circumstances. Usually, patients benefit from additional assistance, such as health coaching and ways to measure and track progress. I have created a HOPE Note Checklist to teach students and residents about this approach, and a patient guide to help prepare patients for the visit ahead of time. (To access the guide and other free HOPE Note tools, see www.drwaynejonas.com/hope.)

Of course, these tools won’t single-handedly solve the issue of health care costs. But by practicing in a way that prioritizes what really matters to patients, we begin to take health care reform into our own hands.

Wayne B. Jonas, MD
Alexandria, Va

This country continues to struggle with the issue of how to pay for health care. But regardless of the source of payment, primary care usually gets caught in the middle. Squeezed between volume and value, family physicians know all too well the gap that exists between what our patients need and what our training and health care system allow us to provide.

This knowledge prompted me to change how I conduct my day-to-day office visits. To routinely restore healing to the patient-provider conversation, I developed a tool called the HOPE (Healing Oriented Practices and Environments) Note. It consists of a set of questions to ask during a routine office visit that are specifically geared toward uncovering and addressing patients’ personal determinants of health and healing.

During a HOPE consultation, I seek to reframe the orientation from one that focuses only on disease treatment to one that emphasizes self-healing. Example questions include: What matters to you? What brings you joy? How is your social support? What do you eat? How is your sleep? What is your home like? Do you feel safe? How do you manage stress?

From there, I develop a personalized health promotion plan adjusted to the patient’s needs, personality, readiness, resources, and circumstances. Usually, patients benefit from additional assistance, such as health coaching and ways to measure and track progress. I have created a HOPE Note Checklist to teach students and residents about this approach, and a patient guide to help prepare patients for the visit ahead of time. (To access the guide and other free HOPE Note tools, see www.drwaynejonas.com/hope.)

Of course, these tools won’t single-handedly solve the issue of health care costs. But by practicing in a way that prioritizes what really matters to patients, we begin to take health care reform into our own hands.

Wayne B. Jonas, MD
Alexandria, Va

This month's article by Dr. Yuen and colleagues on cognitive biases and the diagnostic errors that can result is a humbling reminder of the limitations of our brains and the need for us to be ever vigilant about the accuracy of our clinical diagnoses.

According to the article, at least 8 different kinds of bias can unintentionally derail our efforts to make the correct diagnosis. In my editorial last month (J Fam Pract. 2018;67:268), I presented data showing that up to 30% of patients with a physician’s diagnosis of asthma do not, in fact, have asthma. These mistaken diagnoses are most likely due to the bias known as “diagnostic momentum,” which is the tendency of physicians to accept a diagnosis without questioning its validity.

We are also prone to anchoring. Because family physicians (FPs) are very busy and use type 1 reasoning (pattern recognition or intuitive reasoning) more frequently than type 2 reasoning (analytical thinking, which requires more time), I suspect we are most susceptible to the bias of premature closure of the diagnostic process, also called anchoring. At times we attach too much weight to preliminary findings and don’t dig deep enough into the history or physical findings to confirm or support our diagnoses.

A memorable example of my own cognitive bias was my treatment of a middle-aged woman with hyperlipidemia. I thought I was being a good doctor, treating her appropriately with a statin. Luckily for her, she saw one of my partners when I was on vacation. My partner walked into the room and immediately recognized her myxedematous face as a sign of hypothyroidism. Her thyroid stimulating hormone level was 124 mIU/L! She was cured with thyroid hormone replacement and did not need a statin at all. I had not taken the time to think through the case carefully. And I had not noticed her gradual weight gain or the changes to her face.

My partner saw the patient's myxedematous face and knew she had hypothyroidism—not hyperlipidemia.

Lulled by common diagnoses. Another difficulty for FPs and other primary care practitioners is that most of the patients we see have a common illness that is easy to diagnose. Recognizing shingles, eczema, acute appendicitis, and viral respiratory infections and managing chronic illnesses such as hypertension, diabetes, and chronic obstructive pulmonary disease (COPD) is second nature to us. But we must constantly be on the lookout for uncommon and potentially serious conditions. A classic example is not considering alpha-1 antitrypsin deficiency in a patient with COPD who does not smoke.

The bottom line: Take an extra minute or 2 to think through every diagnosis carefully—especially when one or more of the puzzle pieces do not fit together properly.

This month's article by Dr. Yuen and colleagues on cognitive biases and the diagnostic errors that can result is a humbling reminder of the limitations of our brains and the need for us to be ever vigilant about the accuracy of our clinical diagnoses.

According to the article, at least 8 different kinds of bias can unintentionally derail our efforts to make the correct diagnosis. In my editorial last month (J Fam Pract. 2018;67:268), I presented data showing that up to 30% of patients with a physician’s diagnosis of asthma do not, in fact, have asthma. These mistaken diagnoses are most likely due to the bias known as “diagnostic momentum,” which is the tendency of physicians to accept a diagnosis without questioning its validity.

We are also prone to anchoring. Because family physicians (FPs) are very busy and use type 1 reasoning (pattern recognition or intuitive reasoning) more frequently than type 2 reasoning (analytical thinking, which requires more time), I suspect we are most susceptible to the bias of premature closure of the diagnostic process, also called anchoring. At times we attach too much weight to preliminary findings and don’t dig deep enough into the history or physical findings to confirm or support our diagnoses.

A memorable example of my own cognitive bias was my treatment of a middle-aged woman with hyperlipidemia. I thought I was being a good doctor, treating her appropriately with a statin. Luckily for her, she saw one of my partners when I was on vacation. My partner walked into the room and immediately recognized her myxedematous face as a sign of hypothyroidism. Her thyroid stimulating hormone level was 124 mIU/L! She was cured with thyroid hormone replacement and did not need a statin at all. I had not taken the time to think through the case carefully. And I had not noticed her gradual weight gain or the changes to her face.

My partner saw the patient's myxedematous face and knew she had hypothyroidism—not hyperlipidemia.

Lulled by common diagnoses. Another difficulty for FPs and other primary care practitioners is that most of the patients we see have a common illness that is easy to diagnose. Recognizing shingles, eczema, acute appendicitis, and viral respiratory infections and managing chronic illnesses such as hypertension, diabetes, and chronic obstructive pulmonary disease (COPD) is second nature to us. But we must constantly be on the lookout for uncommon and potentially serious conditions. A classic example is not considering alpha-1 antitrypsin deficiency in a patient with COPD who does not smoke.

The bottom line: Take an extra minute or 2 to think through every diagnosis carefully—especially when one or more of the puzzle pieces do not fit together properly.

This month's article by Dr. Yuen and colleagues on cognitive biases and the diagnostic errors that can result is a humbling reminder of the limitations of our brains and the need for us to be ever vigilant about the accuracy of our clinical diagnoses.

According to the article, at least 8 different kinds of bias can unintentionally derail our efforts to make the correct diagnosis. In my editorial last month (J Fam Pract. 2018;67:268), I presented data showing that up to 30% of patients with a physician’s diagnosis of asthma do not, in fact, have asthma. These mistaken diagnoses are most likely due to the bias known as “diagnostic momentum,” which is the tendency of physicians to accept a diagnosis without questioning its validity.

We are also prone to anchoring. Because family physicians (FPs) are very busy and use type 1 reasoning (pattern recognition or intuitive reasoning) more frequently than type 2 reasoning (analytical thinking, which requires more time), I suspect we are most susceptible to the bias of premature closure of the diagnostic process, also called anchoring. At times we attach too much weight to preliminary findings and don’t dig deep enough into the history or physical findings to confirm or support our diagnoses.

A memorable example of my own cognitive bias was my treatment of a middle-aged woman with hyperlipidemia. I thought I was being a good doctor, treating her appropriately with a statin. Luckily for her, she saw one of my partners when I was on vacation. My partner walked into the room and immediately recognized her myxedematous face as a sign of hypothyroidism. Her thyroid stimulating hormone level was 124 mIU/L! She was cured with thyroid hormone replacement and did not need a statin at all. I had not taken the time to think through the case carefully. And I had not noticed her gradual weight gain or the changes to her face.

My partner saw the patient's myxedematous face and knew she had hypothyroidism—not hyperlipidemia.

Lulled by common diagnoses. Another difficulty for FPs and other primary care practitioners is that most of the patients we see have a common illness that is easy to diagnose. Recognizing shingles, eczema, acute appendicitis, and viral respiratory infections and managing chronic illnesses such as hypertension, diabetes, and chronic obstructive pulmonary disease (COPD) is second nature to us. But we must constantly be on the lookout for uncommon and potentially serious conditions. A classic example is not considering alpha-1 antitrypsin deficiency in a patient with COPD who does not smoke.

The bottom line: Take an extra minute or 2 to think through every diagnosis carefully—especially when one or more of the puzzle pieces do not fit together properly.

Illustrative Case

A 23-year-old nulliparous female at term with an uncomplicated pregnancy presents to labor and delivery. She reports regular contractions for the last several hours and is admitted in labor for an anticipated vaginal delivery. She has not had anything to eat or drink for the last 3 hours and says she’s hungry.

What type of diet should you order for this patient? Should you place any restrictions in the diet order?

Since the first reports of Mendelson Syndrome (aspiration during general anesthesia) in the early 1940s,² many health care providers managing laboring women restrict their diets to clear liquids or less with little evidence to support the decision. In a recent survey of Canadian hospitals, for example, 51% of laboring women who did not receive an epidural during the active phase of labor were placed on restricted diets of only clear fluids and/or ice chips; this number rose to 83% for women who did receive an epidural.³

Dietary restrictions continue to be enforced despite the fact that only about 5% of obstetric patients require general anesthesia.¹ In a study of 172,334 patients ≥18 years of age in the general population undergoing a total of 215,488 emergency or elective surgeries with general anesthesia, the risk of aspiration was 1:895 and 1:3886, respectively.⁴ Of the 66 patients who aspirated, 42 had no respiratory sequelae.

Similarly, Robinson et al noted that anesthesia-associated aspiration fatalities have been much lower in more recent studies than in historical ones—approximately 1 in 350,000 anesthesia events compared with 1 in 45,000 to 240,000—and are more commonly observed during intubation for emergency surgery.⁵

The current American College of Obstetricians and Gynecologists guidance is to restrict oral intake to clear liquids during labor for low-risk patients, with further restriction for those at increased risk for aspiration.⁶ The meta-analysis described here looked at the risks and benefits of a less restrictive diet during labor.

Continue to: STUDY SUMMARY

Meta-analysis finds not one case of aspiration

This meta-analysis of 10 RCTs, including 3982 laboring women, analyzed the effect of food intake on labor and the risks and benefits associated with less restrictive diets for low-risk women in labor.¹ Women were included in the trials if they had singleton pregnancies with cephalic presentation at the time of delivery. The women had varying cervical dilation at the time of presentation. Seven of 10 studies involved women with a gestational age ≥37 weeks, 2 studies set the gestational age threshold at 36 weeks, and one study included women with a gestational age ≥30 weeks.

Dietary restrictions during labor for women at low risk of complications/surgery are not justified based on current data.

In the intervention groups, the authors studied varying degrees of diets and/or intakes, ranging from oral carbohydrate solutions to low-fat food to a completely unrestricted diet. One study accounted for 61% of the patients in this review and compared intake of low-fat foods to ice chips, water, or sips of water until delivery. The primary outcome of the meta-analysis was duration of labor.

Results. The authors of the meta-analysis found that the patients in the intervention groups, compared with the control groups, had a shorter mean duration of labor by 16 minutes (95% confidence interval [CI], -25 to -7). Apgar scores and the rates of Cesarean delivery, operative vaginal delivery, epidural analgesia, and admission to the neonatal intensive care unit were similar in the intervention and control groups. Maternal vomiting was also similar: 37.6% in the intervention group and 36.5% in the control group (relative risk=1.00; 95% CI, 0.81-1.23). None of the 3982 patients experienced aspiration pneumonia or pneumonitis.¹

WHAT’S NEW

Restricting diets during labor is outdated

For years, women’s diets have been restricted during labor without sufficient evidence to support the practice. In this systematic review and meta-analysis, Ciardulli and colleagues did not find a single case of aspiration pneumonitis—the outcome on which the rationale for restricting diets during labor is based. A 2013 Cochrane review by Singata et al also found no harm in less restrictive diets for low-risk women in labor.⁷ Ciardulli et al concluded that dietary restrictions for women at low risk of complications/surgery during labor are not justified based on current data.

Continue to: CAVEATS

Underpowered and missing information

This meta-analysis found no occurrences of aspiration pneumonia or pneumonitis; however, it was underpowered to identify these rare complications. This is partially due to the unusual need for general anesthesia in low-risk patients, as noted earlier. Data on the total number of women who underwent general anesthesia in the current review were limited, as not every study within the meta-analysis included this information.

CHALLENGES TO IMPLEMENTATION

Stemming the cultural tide

One challenge to implementation is changing the culture of practice regarding low-risk pregnant women in labor, as well as the opinions of other health care providers and hospital policies that oppose less restrictive oral intake during labor.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Illustrative Case

A 23-year-old nulliparous female at term with an uncomplicated pregnancy presents to labor and delivery. She reports regular contractions for the last several hours and is admitted in labor for an anticipated vaginal delivery. She has not had anything to eat or drink for the last 3 hours and says she’s hungry.

What type of diet should you order for this patient? Should you place any restrictions in the diet order?

Since the first reports of Mendelson Syndrome (aspiration during general anesthesia) in the early 1940s,² many health care providers managing laboring women restrict their diets to clear liquids or less with little evidence to support the decision. In a recent survey of Canadian hospitals, for example, 51% of laboring women who did not receive an epidural during the active phase of labor were placed on restricted diets of only clear fluids and/or ice chips; this number rose to 83% for women who did receive an epidural.³

Dietary restrictions continue to be enforced despite the fact that only about 5% of obstetric patients require general anesthesia.¹ In a study of 172,334 patients ≥18 years of age in the general population undergoing a total of 215,488 emergency or elective surgeries with general anesthesia, the risk of aspiration was 1:895 and 1:3886, respectively.⁴ Of the 66 patients who aspirated, 42 had no respiratory sequelae.

Similarly, Robinson et al noted that anesthesia-associated aspiration fatalities have been much lower in more recent studies than in historical ones—approximately 1 in 350,000 anesthesia events compared with 1 in 45,000 to 240,000—and are more commonly observed during intubation for emergency surgery.⁵

The current American College of Obstetricians and Gynecologists guidance is to restrict oral intake to clear liquids during labor for low-risk patients, with further restriction for those at increased risk for aspiration.⁶ The meta-analysis described here looked at the risks and benefits of a less restrictive diet during labor.

Continue to: STUDY SUMMARY

Meta-analysis finds not one case of aspiration

This meta-analysis of 10 RCTs, including 3982 laboring women, analyzed the effect of food intake on labor and the risks and benefits associated with less restrictive diets for low-risk women in labor.¹ Women were included in the trials if they had singleton pregnancies with cephalic presentation at the time of delivery. The women had varying cervical dilation at the time of presentation. Seven of 10 studies involved women with a gestational age ≥37 weeks, 2 studies set the gestational age threshold at 36 weeks, and one study included women with a gestational age ≥30 weeks.

Dietary restrictions during labor for women at low risk of complications/surgery are not justified based on current data.

In the intervention groups, the authors studied varying degrees of diets and/or intakes, ranging from oral carbohydrate solutions to low-fat food to a completely unrestricted diet. One study accounted for 61% of the patients in this review and compared intake of low-fat foods to ice chips, water, or sips of water until delivery. The primary outcome of the meta-analysis was duration of labor.

Results. The authors of the meta-analysis found that the patients in the intervention groups, compared with the control groups, had a shorter mean duration of labor by 16 minutes (95% confidence interval [CI], -25 to -7). Apgar scores and the rates of Cesarean delivery, operative vaginal delivery, epidural analgesia, and admission to the neonatal intensive care unit were similar in the intervention and control groups. Maternal vomiting was also similar: 37.6% in the intervention group and 36.5% in the control group (relative risk=1.00; 95% CI, 0.81-1.23). None of the 3982 patients experienced aspiration pneumonia or pneumonitis.¹

WHAT’S NEW

Restricting diets during labor is outdated

For years, women’s diets have been restricted during labor without sufficient evidence to support the practice. In this systematic review and meta-analysis, Ciardulli and colleagues did not find a single case of aspiration pneumonitis—the outcome on which the rationale for restricting diets during labor is based. A 2013 Cochrane review by Singata et al also found no harm in less restrictive diets for low-risk women in labor.⁷ Ciardulli et al concluded that dietary restrictions for women at low risk of complications/surgery during labor are not justified based on current data.

Continue to: CAVEATS

Underpowered and missing information

This meta-analysis found no occurrences of aspiration pneumonia or pneumonitis; however, it was underpowered to identify these rare complications. This is partially due to the unusual need for general anesthesia in low-risk patients, as noted earlier. Data on the total number of women who underwent general anesthesia in the current review were limited, as not every study within the meta-analysis included this information.

CHALLENGES TO IMPLEMENTATION

Stemming the cultural tide

One challenge to implementation is changing the culture of practice regarding low-risk pregnant women in labor, as well as the opinions of other health care providers and hospital policies that oppose less restrictive oral intake during labor.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Illustrative Case

A 23-year-old nulliparous female at term with an uncomplicated pregnancy presents to labor and delivery. She reports regular contractions for the last several hours and is admitted in labor for an anticipated vaginal delivery. She has not had anything to eat or drink for the last 3 hours and says she’s hungry.

What type of diet should you order for this patient? Should you place any restrictions in the diet order?

Since the first reports of Mendelson Syndrome (aspiration during general anesthesia) in the early 1940s,² many health care providers managing laboring women restrict their diets to clear liquids or less with little evidence to support the decision. In a recent survey of Canadian hospitals, for example, 51% of laboring women who did not receive an epidural during the active phase of labor were placed on restricted diets of only clear fluids and/or ice chips; this number rose to 83% for women who did receive an epidural.³

Dietary restrictions continue to be enforced despite the fact that only about 5% of obstetric patients require general anesthesia.¹ In a study of 172,334 patients ≥18 years of age in the general population undergoing a total of 215,488 emergency or elective surgeries with general anesthesia, the risk of aspiration was 1:895 and 1:3886, respectively.⁴ Of the 66 patients who aspirated, 42 had no respiratory sequelae.

Similarly, Robinson et al noted that anesthesia-associated aspiration fatalities have been much lower in more recent studies than in historical ones—approximately 1 in 350,000 anesthesia events compared with 1 in 45,000 to 240,000—and are more commonly observed during intubation for emergency surgery.⁵

The current American College of Obstetricians and Gynecologists guidance is to restrict oral intake to clear liquids during labor for low-risk patients, with further restriction for those at increased risk for aspiration.⁶ The meta-analysis described here looked at the risks and benefits of a less restrictive diet during labor.

Continue to: STUDY SUMMARY

Meta-analysis finds not one case of aspiration

This meta-analysis of 10 RCTs, including 3982 laboring women, analyzed the effect of food intake on labor and the risks and benefits associated with less restrictive diets for low-risk women in labor.¹ Women were included in the trials if they had singleton pregnancies with cephalic presentation at the time of delivery. The women had varying cervical dilation at the time of presentation. Seven of 10 studies involved women with a gestational age ≥37 weeks, 2 studies set the gestational age threshold at 36 weeks, and one study included women with a gestational age ≥30 weeks.

Dietary restrictions during labor for women at low risk of complications/surgery are not justified based on current data.

In the intervention groups, the authors studied varying degrees of diets and/or intakes, ranging from oral carbohydrate solutions to low-fat food to a completely unrestricted diet. One study accounted for 61% of the patients in this review and compared intake of low-fat foods to ice chips, water, or sips of water until delivery. The primary outcome of the meta-analysis was duration of labor.

Results. The authors of the meta-analysis found that the patients in the intervention groups, compared with the control groups, had a shorter mean duration of labor by 16 minutes (95% confidence interval [CI], -25 to -7). Apgar scores and the rates of Cesarean delivery, operative vaginal delivery, epidural analgesia, and admission to the neonatal intensive care unit were similar in the intervention and control groups. Maternal vomiting was also similar: 37.6% in the intervention group and 36.5% in the control group (relative risk=1.00; 95% CI, 0.81-1.23). None of the 3982 patients experienced aspiration pneumonia or pneumonitis.¹

WHAT’S NEW

Restricting diets during labor is outdated

For years, women’s diets have been restricted during labor without sufficient evidence to support the practice. In this systematic review and meta-analysis, Ciardulli and colleagues did not find a single case of aspiration pneumonitis—the outcome on which the rationale for restricting diets during labor is based. A 2013 Cochrane review by Singata et al also found no harm in less restrictive diets for low-risk women in labor.⁷ Ciardulli et al concluded that dietary restrictions for women at low risk of complications/surgery during labor are not justified based on current data.

Continue to: CAVEATS

Underpowered and missing information

This meta-analysis found no occurrences of aspiration pneumonia or pneumonitis; however, it was underpowered to identify these rare complications. This is partially due to the unusual need for general anesthesia in low-risk patients, as noted earlier. Data on the total number of women who underwent general anesthesia in the current review were limited, as not every study within the meta-analysis included this information.

CHALLENGES TO IMPLEMENTATION

Stemming the cultural tide

One challenge to implementation is changing the culture of practice regarding low-risk pregnant women in labor, as well as the opinions of other health care providers and hospital policies that oppose less restrictive oral intake during labor.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.