Do you ask your acne patients about which hair products they use? This common question has recently brought our attention to popular hair products that are causing an acne epidemic. Have we forgotten about “Pomade acne”? Well, it’s making a comeback. Originally described in ethnic women, new frizz-fighting hair products have resurged and so has pomade acne in all skin types and in both men and women.

Smoothing serums, heat styling sprays, leave-in products popularly known as “It’s-a-10,” “Biosilk,” “anti-frizz serums,” “heat-protectants,” “thermal setting sprays,” and “shine sprays,” contain silicone-derived ingredients and oils to control frizz, add shine, and detangle the hair. They work by smoothing the hair cuticle, and for women with difficult-to-manage hair, they have become an essential part of the daily beauty regimen.

Men are not in the clear either. Hair waxes and pomades used to style men’s hair contain greasy wax-based ingredients that also clog pores, trap bacteria, and cause inflammatory breakouts.

As a general rule in skin and body care, most products work well for what they are made to do, but when misused, they can cause mishaps. You wouldn’t moisturize your face with your hair serum would you? It seems obvious that this could cause some skin issues; however, most people will not think to correlate their acne breakouts with their hair products until we mention it. These products rub off on the face or on the pillow at night. In addition, the less we wash our hair, the more we are going to bed and getting the daytime products all over our pillowcases. Our faces are rolling around in oily, waxy, hair products all night.

Makeup is known to cause acne, and some of the makeups that are well known culprits contain the same ingredients as in hair products. Foundations, primers, and popular “BB” creams often contain cyclopentasiloxane and dimethicone. They serve a similar purpose: smoothing the skin and smoothing the hair. Both should be avoided in acne-prone patients.

Common culprits in hair products include PVP/DMAPA acrylates, cyclopentasiloxane, panthenol, dimethicone, silicone, Quaternium-70, oils, and petrolatum.

The only way to eliminate acne caused by hair products is to completely eliminate the hair product from the daily routine. However, if your patients can’t live without their hair products, here are some tips to share with them to reduce breakouts:

• Choose a hairstyle that keeps the hair away from the face, or wear hair up to avoid prolonged contact with the face, particularly while sleeping.

• Change pillowcase often (every day if possible), especially for side sleepers. Regardless of the fabric, pillowcases trap oil, dirt, and bacteria.

• Shower at night and sleep with clean hair and clean skin.

• Style hair before applying makeup. Wash hands thoroughly to remove all hair products before touching the skin.

• Cover the face prior to applying any hair sprays.

• Cover the hair at bedtime; however, tight head coverings can stimulate sweat and cause scalp breakouts.

As a general rule, any patient with difficult-to-control acne, recalcitrant acne, or acne in areas on the cheeks or hairline should eliminate these hair products in their daily routine or avoid skin contact with these products.

References

1. J Clin Aesthet Dermatol. 2010 Apr;3(4):24-38.

2. Arch Dermatol. 1972;106 (6):843-50.

3. J Am Acad Dermatol. 2003; 48:S127-33.

4. Arch Dermatol. 1970;101(5):580-584.

5. “Cosmetics in Dermatology,” Second Edition, by Zoe Diana Draelos (New York: Churchill Livingstone, 1995).

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.

Do you ask your acne patients about which hair products they use? This common question has recently brought our attention to popular hair products that are causing an acne epidemic. Have we forgotten about “Pomade acne”? Well, it’s making a comeback. Originally described in ethnic women, new frizz-fighting hair products have resurged and so has pomade acne in all skin types and in both men and women.

Smoothing serums, heat styling sprays, leave-in products popularly known as “It’s-a-10,” “Biosilk,” “anti-frizz serums,” “heat-protectants,” “thermal setting sprays,” and “shine sprays,” contain silicone-derived ingredients and oils to control frizz, add shine, and detangle the hair. They work by smoothing the hair cuticle, and for women with difficult-to-manage hair, they have become an essential part of the daily beauty regimen.

Men are not in the clear either. Hair waxes and pomades used to style men’s hair contain greasy wax-based ingredients that also clog pores, trap bacteria, and cause inflammatory breakouts.

As a general rule in skin and body care, most products work well for what they are made to do, but when misused, they can cause mishaps. You wouldn’t moisturize your face with your hair serum would you? It seems obvious that this could cause some skin issues; however, most people will not think to correlate their acne breakouts with their hair products until we mention it. These products rub off on the face or on the pillow at night. In addition, the less we wash our hair, the more we are going to bed and getting the daytime products all over our pillowcases. Our faces are rolling around in oily, waxy, hair products all night.

Makeup is known to cause acne, and some of the makeups that are well known culprits contain the same ingredients as in hair products. Foundations, primers, and popular “BB” creams often contain cyclopentasiloxane and dimethicone. They serve a similar purpose: smoothing the skin and smoothing the hair. Both should be avoided in acne-prone patients.

Common culprits in hair products include PVP/DMAPA acrylates, cyclopentasiloxane, panthenol, dimethicone, silicone, Quaternium-70, oils, and petrolatum.

The only way to eliminate acne caused by hair products is to completely eliminate the hair product from the daily routine. However, if your patients can’t live without their hair products, here are some tips to share with them to reduce breakouts:

• Choose a hairstyle that keeps the hair away from the face, or wear hair up to avoid prolonged contact with the face, particularly while sleeping.

• Change pillowcase often (every day if possible), especially for side sleepers. Regardless of the fabric, pillowcases trap oil, dirt, and bacteria.

• Shower at night and sleep with clean hair and clean skin.

• Style hair before applying makeup. Wash hands thoroughly to remove all hair products before touching the skin.

• Cover the face prior to applying any hair sprays.

• Cover the hair at bedtime; however, tight head coverings can stimulate sweat and cause scalp breakouts.

As a general rule, any patient with difficult-to-control acne, recalcitrant acne, or acne in areas on the cheeks or hairline should eliminate these hair products in their daily routine or avoid skin contact with these products.

References

1. J Clin Aesthet Dermatol. 2010 Apr;3(4):24-38.

2. Arch Dermatol. 1972;106 (6):843-50.

3. J Am Acad Dermatol. 2003; 48:S127-33.

4. Arch Dermatol. 1970;101(5):580-584.

5. “Cosmetics in Dermatology,” Second Edition, by Zoe Diana Draelos (New York: Churchill Livingstone, 1995).

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.

Do you ask your acne patients about which hair products they use? This common question has recently brought our attention to popular hair products that are causing an acne epidemic. Have we forgotten about “Pomade acne”? Well, it’s making a comeback. Originally described in ethnic women, new frizz-fighting hair products have resurged and so has pomade acne in all skin types and in both men and women.

Smoothing serums, heat styling sprays, leave-in products popularly known as “It’s-a-10,” “Biosilk,” “anti-frizz serums,” “heat-protectants,” “thermal setting sprays,” and “shine sprays,” contain silicone-derived ingredients and oils to control frizz, add shine, and detangle the hair. They work by smoothing the hair cuticle, and for women with difficult-to-manage hair, they have become an essential part of the daily beauty regimen.

Men are not in the clear either. Hair waxes and pomades used to style men’s hair contain greasy wax-based ingredients that also clog pores, trap bacteria, and cause inflammatory breakouts.

As a general rule in skin and body care, most products work well for what they are made to do, but when misused, they can cause mishaps. You wouldn’t moisturize your face with your hair serum would you? It seems obvious that this could cause some skin issues; however, most people will not think to correlate their acne breakouts with their hair products until we mention it. These products rub off on the face or on the pillow at night. In addition, the less we wash our hair, the more we are going to bed and getting the daytime products all over our pillowcases. Our faces are rolling around in oily, waxy, hair products all night.

Makeup is known to cause acne, and some of the makeups that are well known culprits contain the same ingredients as in hair products. Foundations, primers, and popular “BB” creams often contain cyclopentasiloxane and dimethicone. They serve a similar purpose: smoothing the skin and smoothing the hair. Both should be avoided in acne-prone patients.

Common culprits in hair products include PVP/DMAPA acrylates, cyclopentasiloxane, panthenol, dimethicone, silicone, Quaternium-70, oils, and petrolatum.

The only way to eliminate acne caused by hair products is to completely eliminate the hair product from the daily routine. However, if your patients can’t live without their hair products, here are some tips to share with them to reduce breakouts:

• Choose a hairstyle that keeps the hair away from the face, or wear hair up to avoid prolonged contact with the face, particularly while sleeping.

• Change pillowcase often (every day if possible), especially for side sleepers. Regardless of the fabric, pillowcases trap oil, dirt, and bacteria.

• Shower at night and sleep with clean hair and clean skin.

• Style hair before applying makeup. Wash hands thoroughly to remove all hair products before touching the skin.

• Cover the face prior to applying any hair sprays.

• Cover the hair at bedtime; however, tight head coverings can stimulate sweat and cause scalp breakouts.

As a general rule, any patient with difficult-to-control acne, recalcitrant acne, or acne in areas on the cheeks or hairline should eliminate these hair products in their daily routine or avoid skin contact with these products.

References

1. J Clin Aesthet Dermatol. 2010 Apr;3(4):24-38.

2. Arch Dermatol. 1972;106 (6):843-50.

3. J Am Acad Dermatol. 2003; 48:S127-33.

4. Arch Dermatol. 1970;101(5):580-584.

5. “Cosmetics in Dermatology,” Second Edition, by Zoe Diana Draelos (New York: Churchill Livingstone, 1995).

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub.

I appreciate the opportunity to share medical myths each month, hopefully to highlight topics where new knowledge and data may help change ways we approach common problems in medicine. I have been researching medical myths since the early 1990s, and some have actually evolved in such a way that they are no longer myths – that is, accepted practice now is very different than it was decades ago, and has incorporated updated research.

Some myths are timeless. The vitamin B12 myth I shared in this column last year continues to this day, despite evidence that has been present since the 1960s.

I will share with you two of my all-time favorite myths that have now been retired, where current practice now does not perpetuate these myths.

When I was in medical school, I was taught that the best way to treat a corneal abrasion was to patch the affected eye.¹ Pretty much everyone who was seen in an emergency department for a corneal abrasion before the 1990s left the ED with an eye patch. This standard approach was not based on any evidence of benefit of healing or decreased pain.

Dr. Harold Jackson reported in a study of patients with corneal abrasions published in 1960 that there was no difference in healing between eyes that were patched and eyes that were left unpatched.² The largest published study on eye patches for corneal abrasions involved 201 patients who were evaluated for corneal abrasions.³ The patients who did not receive an eye patch had less pain and quicker healing of the corneal abrasions. Other studies all showed no benefit to eye patches.^4,5

A Cochrane Review published in 2006 concluded: “Treating simple corneal abrasions with a patch does not improve healing rates on the first day post-injury and does not reduce pain. In addition, use of patches results in a loss of binocular vision. Therefore, it is recommended that patches should not be used for simple corneal abrasions.”⁶

A more recent study by Dr. Moreno Menghini and colleagues showed no differences in healing of traumatic corneal abrasions between groups who received an eye patch, a contact lens, or no eye covering.⁷

Another longstanding myth that is less commonly seen now is the avoidance of use of narcotics for the treatment of acute, severe abdominal pain.

The long-term teaching was that by treating abdominal pain with narcotics, you could mask the important physical exam findings in patients presenting with an acute abdomen. The source of this myth wasn’t hard to uncover. The following are quotes from Cope’s Early Diagnosis of the Acute Abdomen 15th and 16th editions (these were the editions available back when I was a medical student in the early 1980s).

From the 15th edition: “If morphine be given, it is possible for a patient to die happy in the belief that he is on the road to recovery, and in some cases the medical attendant may for a time be induced to share the elusive hope.”⁸

An even stronger position was taken in the next edition of Cope’s text: “The patient cried out for relief, the relatives are insistent that something should be done, and the humane disciple of Aesculapius may think it is his first duty to diminish or banish the too obvious agony by administering a narcotic. Such a policy is a mistake. Though it may appear cruel, it is really kind to withhold morphine until a reasonable diagnosis has been made.”⁹

No controlled trials ever questioned this long-held belief until a study done by Dr. Alex Attard and colleagues published in 1992.¹⁰ In this study, 100 patients were evaluated by an admitting officer and given an intramuscular injection of either a narcotic or saline. Surgeons who subsequently followed the patients felt equally confident in diagnosis and management in both groups. The decision to operate or observe was incorrect in two patients in the narcotic group and nine in the saline group.

Dr. H. A. Amoli and colleagues studied whether administering morphine changed exam findings in patients with acute appendiciits.¹¹ In a randomized, double-blind study design, half the patients received morphine and half received saline. Patients were examined by surgeons not involved in their care before and after drug administration, and their pain intensity and signs were recorded at each visit. The administration of morphine did not alter clinical signs or physician management plans.

In a study by Dr. Steven Pace and colleagues of patients presenting with acute abdominal pain, intravenous morphine or placebo was administered in 71 patients early in their presentation to the ED.¹² There were no differences in accuracy of diagnosis between groups. Three diagnostic or management errors were made in each group.

I think the standard of care now for corneal abrasion treatment does not include eye patching. I also believe that the old teaching of no pain medication until the surgeon has examined the patient has also been replaced with appropriate pain management occurring early in the care plan for patients presenting with acute abdominal pain.

In the case of corneal abrasions, overwhelming data showing no benefit won out. I believe that the change in the management of acute abdominal pain was a combination of data along with advances in diagnostic imaging.

References

1. Wilkins. Emergency Medicine. 1989 Williams and Wilkins, Baltimore, Md.

2. Br Med J. 1960 Sep 3;2(5200):713.

3. Ophthalmology. 1995 Dec;102(12):1936-42.

4. Lancet. 1991 Mar 16;337(8742):643.

5. Eye (Lond). 1993;7:468-71.

6. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004764.

7. Ophthalmic Res. 2013;50(1):13-8.

8. Cope’s Early Diagnosis of the Acute Abdomen, 15th Edition, Oxford University Press, 1979.

9. Cope’s Early Diagnosis of the Acute Abdomen, 16th Edition, Oxford University Press, 1983.

10. BMJ. 1992 Sep 5;305(6853):554-6.

11. Emerg Med J. 2008 Sep;25(9):586-9.

12. Acad Emerg Med. 1996 Dec;3(12):1086-92.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

I appreciate the opportunity to share medical myths each month, hopefully to highlight topics where new knowledge and data may help change ways we approach common problems in medicine. I have been researching medical myths since the early 1990s, and some have actually evolved in such a way that they are no longer myths – that is, accepted practice now is very different than it was decades ago, and has incorporated updated research.

Some myths are timeless. The vitamin B12 myth I shared in this column last year continues to this day, despite evidence that has been present since the 1960s.

I will share with you two of my all-time favorite myths that have now been retired, where current practice now does not perpetuate these myths.

When I was in medical school, I was taught that the best way to treat a corneal abrasion was to patch the affected eye.¹ Pretty much everyone who was seen in an emergency department for a corneal abrasion before the 1990s left the ED with an eye patch. This standard approach was not based on any evidence of benefit of healing or decreased pain.

Dr. Harold Jackson reported in a study of patients with corneal abrasions published in 1960 that there was no difference in healing between eyes that were patched and eyes that were left unpatched.² The largest published study on eye patches for corneal abrasions involved 201 patients who were evaluated for corneal abrasions.³ The patients who did not receive an eye patch had less pain and quicker healing of the corneal abrasions. Other studies all showed no benefit to eye patches.^4,5

A Cochrane Review published in 2006 concluded: “Treating simple corneal abrasions with a patch does not improve healing rates on the first day post-injury and does not reduce pain. In addition, use of patches results in a loss of binocular vision. Therefore, it is recommended that patches should not be used for simple corneal abrasions.”⁶

A more recent study by Dr. Moreno Menghini and colleagues showed no differences in healing of traumatic corneal abrasions between groups who received an eye patch, a contact lens, or no eye covering.⁷

Another longstanding myth that is less commonly seen now is the avoidance of use of narcotics for the treatment of acute, severe abdominal pain.

The long-term teaching was that by treating abdominal pain with narcotics, you could mask the important physical exam findings in patients presenting with an acute abdomen. The source of this myth wasn’t hard to uncover. The following are quotes from Cope’s Early Diagnosis of the Acute Abdomen 15th and 16th editions (these were the editions available back when I was a medical student in the early 1980s).

From the 15th edition: “If morphine be given, it is possible for a patient to die happy in the belief that he is on the road to recovery, and in some cases the medical attendant may for a time be induced to share the elusive hope.”⁸

An even stronger position was taken in the next edition of Cope’s text: “The patient cried out for relief, the relatives are insistent that something should be done, and the humane disciple of Aesculapius may think it is his first duty to diminish or banish the too obvious agony by administering a narcotic. Such a policy is a mistake. Though it may appear cruel, it is really kind to withhold morphine until a reasonable diagnosis has been made.”⁹

No controlled trials ever questioned this long-held belief until a study done by Dr. Alex Attard and colleagues published in 1992.¹⁰ In this study, 100 patients were evaluated by an admitting officer and given an intramuscular injection of either a narcotic or saline. Surgeons who subsequently followed the patients felt equally confident in diagnosis and management in both groups. The decision to operate or observe was incorrect in two patients in the narcotic group and nine in the saline group.

Dr. H. A. Amoli and colleagues studied whether administering morphine changed exam findings in patients with acute appendiciits.¹¹ In a randomized, double-blind study design, half the patients received morphine and half received saline. Patients were examined by surgeons not involved in their care before and after drug administration, and their pain intensity and signs were recorded at each visit. The administration of morphine did not alter clinical signs or physician management plans.

In a study by Dr. Steven Pace and colleagues of patients presenting with acute abdominal pain, intravenous morphine or placebo was administered in 71 patients early in their presentation to the ED.¹² There were no differences in accuracy of diagnosis between groups. Three diagnostic or management errors were made in each group.

I think the standard of care now for corneal abrasion treatment does not include eye patching. I also believe that the old teaching of no pain medication until the surgeon has examined the patient has also been replaced with appropriate pain management occurring early in the care plan for patients presenting with acute abdominal pain.

In the case of corneal abrasions, overwhelming data showing no benefit won out. I believe that the change in the management of acute abdominal pain was a combination of data along with advances in diagnostic imaging.

References

1. Wilkins. Emergency Medicine. 1989 Williams and Wilkins, Baltimore, Md.

2. Br Med J. 1960 Sep 3;2(5200):713.

3. Ophthalmology. 1995 Dec;102(12):1936-42.

4. Lancet. 1991 Mar 16;337(8742):643.

5. Eye (Lond). 1993;7:468-71.

6. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004764.

7. Ophthalmic Res. 2013;50(1):13-8.

8. Cope’s Early Diagnosis of the Acute Abdomen, 15th Edition, Oxford University Press, 1979.

9. Cope’s Early Diagnosis of the Acute Abdomen, 16th Edition, Oxford University Press, 1983.

10. BMJ. 1992 Sep 5;305(6853):554-6.

11. Emerg Med J. 2008 Sep;25(9):586-9.

12. Acad Emerg Med. 1996 Dec;3(12):1086-92.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

I appreciate the opportunity to share medical myths each month, hopefully to highlight topics where new knowledge and data may help change ways we approach common problems in medicine. I have been researching medical myths since the early 1990s, and some have actually evolved in such a way that they are no longer myths – that is, accepted practice now is very different than it was decades ago, and has incorporated updated research.

Some myths are timeless. The vitamin B12 myth I shared in this column last year continues to this day, despite evidence that has been present since the 1960s.

I will share with you two of my all-time favorite myths that have now been retired, where current practice now does not perpetuate these myths.

When I was in medical school, I was taught that the best way to treat a corneal abrasion was to patch the affected eye.¹ Pretty much everyone who was seen in an emergency department for a corneal abrasion before the 1990s left the ED with an eye patch. This standard approach was not based on any evidence of benefit of healing or decreased pain.

Dr. Harold Jackson reported in a study of patients with corneal abrasions published in 1960 that there was no difference in healing between eyes that were patched and eyes that were left unpatched.² The largest published study on eye patches for corneal abrasions involved 201 patients who were evaluated for corneal abrasions.³ The patients who did not receive an eye patch had less pain and quicker healing of the corneal abrasions. Other studies all showed no benefit to eye patches.^4,5

A Cochrane Review published in 2006 concluded: “Treating simple corneal abrasions with a patch does not improve healing rates on the first day post-injury and does not reduce pain. In addition, use of patches results in a loss of binocular vision. Therefore, it is recommended that patches should not be used for simple corneal abrasions.”⁶

A more recent study by Dr. Moreno Menghini and colleagues showed no differences in healing of traumatic corneal abrasions between groups who received an eye patch, a contact lens, or no eye covering.⁷

Another longstanding myth that is less commonly seen now is the avoidance of use of narcotics for the treatment of acute, severe abdominal pain.

The long-term teaching was that by treating abdominal pain with narcotics, you could mask the important physical exam findings in patients presenting with an acute abdomen. The source of this myth wasn’t hard to uncover. The following are quotes from Cope’s Early Diagnosis of the Acute Abdomen 15th and 16th editions (these were the editions available back when I was a medical student in the early 1980s).

From the 15th edition: “If morphine be given, it is possible for a patient to die happy in the belief that he is on the road to recovery, and in some cases the medical attendant may for a time be induced to share the elusive hope.”⁸

An even stronger position was taken in the next edition of Cope’s text: “The patient cried out for relief, the relatives are insistent that something should be done, and the humane disciple of Aesculapius may think it is his first duty to diminish or banish the too obvious agony by administering a narcotic. Such a policy is a mistake. Though it may appear cruel, it is really kind to withhold morphine until a reasonable diagnosis has been made.”⁹

No controlled trials ever questioned this long-held belief until a study done by Dr. Alex Attard and colleagues published in 1992.¹⁰ In this study, 100 patients were evaluated by an admitting officer and given an intramuscular injection of either a narcotic or saline. Surgeons who subsequently followed the patients felt equally confident in diagnosis and management in both groups. The decision to operate or observe was incorrect in two patients in the narcotic group and nine in the saline group.

Dr. H. A. Amoli and colleagues studied whether administering morphine changed exam findings in patients with acute appendiciits.¹¹ In a randomized, double-blind study design, half the patients received morphine and half received saline. Patients were examined by surgeons not involved in their care before and after drug administration, and their pain intensity and signs were recorded at each visit. The administration of morphine did not alter clinical signs or physician management plans.

In a study by Dr. Steven Pace and colleagues of patients presenting with acute abdominal pain, intravenous morphine or placebo was administered in 71 patients early in their presentation to the ED.¹² There were no differences in accuracy of diagnosis between groups. Three diagnostic or management errors were made in each group.

I think the standard of care now for corneal abrasion treatment does not include eye patching. I also believe that the old teaching of no pain medication until the surgeon has examined the patient has also been replaced with appropriate pain management occurring early in the care plan for patients presenting with acute abdominal pain.

In the case of corneal abrasions, overwhelming data showing no benefit won out. I believe that the change in the management of acute abdominal pain was a combination of data along with advances in diagnostic imaging.

References

1. Wilkins. Emergency Medicine. 1989 Williams and Wilkins, Baltimore, Md.

2. Br Med J. 1960 Sep 3;2(5200):713.

3. Ophthalmology. 1995 Dec;102(12):1936-42.

4. Lancet. 1991 Mar 16;337(8742):643.

5. Eye (Lond). 1993;7:468-71.

6. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004764.

7. Ophthalmic Res. 2013;50(1):13-8.

8. Cope’s Early Diagnosis of the Acute Abdomen, 15th Edition, Oxford University Press, 1979.

9. Cope’s Early Diagnosis of the Acute Abdomen, 16th Edition, Oxford University Press, 1983.

10. BMJ. 1992 Sep 5;305(6853):554-6.

11. Emerg Med J. 2008 Sep;25(9):586-9.

12. Acad Emerg Med. 1996 Dec;3(12):1086-92.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

VANCOUVER – Women with epilepsy have fertility rates comparable with healthy women in the general population, according to results from the first prospective observational cohort study to make the comparison.

During the year-long Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) study, 70% of women with epilepsy and 67% of healthy control women became pregnant, and there was no significant difference in the mean time to pregnancy between those with and without epilepsy (6 months vs. 9 months, respectively), Dr. Page Pennell reported at the annual meeting of the American Academy of Neurology.

Live births occurred in 82% of pregnancies of women with epilepsy and 80% of controls, while miscarriages occurred in 13% and 20%, respectively. Both of those rates are very similar to the general population. Another 5% of pregnancies in women with epilepsy were ectopic, terminated due to chromosomal abnormality, or lost to follow-up.

“These findings should reassure women with epilepsy and clinicians when counseling women with epilepsy who are planning pregnancy,” said Dr. Pennell, director of research for the division of epilepsy in the department of neurology at Brigham and Women’s Hospital in Boston. She is a primary investigator of the study along with Dr. Jacqueline French, professor of neurology at NYU Langone Medical Center and Dr. Cynthia Harden, system director of epilepsy services at Mount Sinai Beth Israel, both in New York.

“I think overall the findings are more in the light of myth busting. ... We don’t necessarily see a lot of problems with fertility, yet the literature suggests that the birth rates are much lower,” Dr. Harden said in an interview.

“It’s really the first solid evidence, and it’s nice because in a sea of bad news for women when it comes to family planning and achieving pregnancy and pregnancy outcomes, I think this was very positive to say that their ability to achieve pregnancy was no different than what was reported by a control population without epilepsy,” Dr. Katherine Noe, an epilepsy specialist at the Mayo Clinic in Scottsdale, Ariz., said when asked to comment on the study.

“There was certainly reason to be concerned,” said Dr. Noe, who was not involved in the study. “We have a lot of data saying that babies exposed to antiepileptic drugs are more likely to have malformations, and so you could have a baby that already early in pregnancy has severe malformations that would be more likely to end in spontaneous abortion.”

Dr. Noe said that pregnancy registry data indicate that women with epilepsy may be more likely to have a pregnancy that ends in a miscarriage. Investigators for several studies published in 2015 reported that women with epilepsy face greater risk for morbidity and adverse outcomes at the time of delivery and during pregnancy than women without epilepsy (JAMA Neurol. 2015;72[9]:981-8 and Lancet. 2016;386[10006]:1845–52). Women with epilepsy also have been thought to be more prone to infertility for various reasons, including menstrual irregularities, polycystic ovarian syndrome related to antiepileptic medications, and early menopause, she said.

Three previous studies had reported that women with epilepsy had birth rates as low as only one-quarter to one-third that of women without epilepsy. There have been many reasons reported for why that might be the case, including lower marriage rates, sexual dysfunction, lower libido (in both men and women with epilepsy), and increased number of anovulatory cycles, or greater choice to not become pregnant, Dr. Pennell said.

The WEPOD study enrolled 89 women with epilepsy and 109 healthy controls who were seeking to become pregnant and had stopped using contraception within 6 months of enrollment or were about to stop using it. The investigators excluded women with infertility, polycystic ovarian syndrome, endometriosis, endocrine disorder, and heavy smoking, or who were not in an exclusive heterosexual relationship with a significant other or spouse.

Participants received iPod touch devices with an app with which they tracked menses and intercourse, as well as antiepileptic drug use and seizures in women with epilepsy. “This was a particularly novel part of the study,” Dr. Harden said. It allowed the investigators to track adherence very well. Participants logged about 87% of their days in the app, and the investigators could see when the entries were made.

Women in both groups had a mean age of about 31 years and mean body mass index of about 25 kg/m². Overall, 52%-58% had undergone a prior pregnancy. Women with epilepsy, compared with controls, were less often Asian (17% vs. 6%) or African American (16% vs. 1%). The education level of participants was “fairly similar” between the groups, and slightly more women with epilepsy were unemployed (21% vs. 10%). Women with epilepsy also were more often married than were controls (89% vs. 75%).

During the study, 36% of women with epilepsy were still having seizures. At enrollment, most of the women’s seizure types were generalized (30%) or focal only (63%). Dr. Pennell noted that the antiseizure medications that the women were taking were typical for women of reproductive age: lamotrigine monotherapy (44%), levetiracetam monotherapy (28%), monotherapy with a strong enzyme-inducing drug (12%), other polytherapy (10%), polytherapy with a strong enzyme-inducing drug (6%), other monotherapy (3%), or no antiseizure medication (2%). A few women either added or stopped drugs during the study. A total of 18 women with epilepsy and 15 healthy controls dropped out.

As expected, age affected the likelihood of becoming pregnant, as well as number of prior pregnancies. Body mass index did not affect the likelihood of becoming pregnant, while white race and being married increased the likelihood.

In future analyses, the investigators are planning on checking whether ovulatory rates, frequency of intercourse, and time of intercourse had any impact on pregnancy, and in women with epilepsy, they will check the effect of the type of antiseizure medication and seizure-related factors.

“I think our findings will stand with future analyses.” Dr. Harden said. “The most interesting future findings may come from within the epilepsy group,” she said, noting that older antiepileptic medications have been previously associated with difficulty conceiving.

The WEPOD study was funded by the Milken Family Foundation, the Epilepsy Therapy Project, and the Epilepsy Foundation.

[email protected]

VANCOUVER – Women with epilepsy have fertility rates comparable with healthy women in the general population, according to results from the first prospective observational cohort study to make the comparison.

During the year-long Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) study, 70% of women with epilepsy and 67% of healthy control women became pregnant, and there was no significant difference in the mean time to pregnancy between those with and without epilepsy (6 months vs. 9 months, respectively), Dr. Page Pennell reported at the annual meeting of the American Academy of Neurology.

Live births occurred in 82% of pregnancies of women with epilepsy and 80% of controls, while miscarriages occurred in 13% and 20%, respectively. Both of those rates are very similar to the general population. Another 5% of pregnancies in women with epilepsy were ectopic, terminated due to chromosomal abnormality, or lost to follow-up.

“These findings should reassure women with epilepsy and clinicians when counseling women with epilepsy who are planning pregnancy,” said Dr. Pennell, director of research for the division of epilepsy in the department of neurology at Brigham and Women’s Hospital in Boston. She is a primary investigator of the study along with Dr. Jacqueline French, professor of neurology at NYU Langone Medical Center and Dr. Cynthia Harden, system director of epilepsy services at Mount Sinai Beth Israel, both in New York.

“I think overall the findings are more in the light of myth busting. ... We don’t necessarily see a lot of problems with fertility, yet the literature suggests that the birth rates are much lower,” Dr. Harden said in an interview.

“It’s really the first solid evidence, and it’s nice because in a sea of bad news for women when it comes to family planning and achieving pregnancy and pregnancy outcomes, I think this was very positive to say that their ability to achieve pregnancy was no different than what was reported by a control population without epilepsy,” Dr. Katherine Noe, an epilepsy specialist at the Mayo Clinic in Scottsdale, Ariz., said when asked to comment on the study.

“There was certainly reason to be concerned,” said Dr. Noe, who was not involved in the study. “We have a lot of data saying that babies exposed to antiepileptic drugs are more likely to have malformations, and so you could have a baby that already early in pregnancy has severe malformations that would be more likely to end in spontaneous abortion.”

Dr. Noe said that pregnancy registry data indicate that women with epilepsy may be more likely to have a pregnancy that ends in a miscarriage. Investigators for several studies published in 2015 reported that women with epilepsy face greater risk for morbidity and adverse outcomes at the time of delivery and during pregnancy than women without epilepsy (JAMA Neurol. 2015;72[9]:981-8 and Lancet. 2016;386[10006]:1845–52). Women with epilepsy also have been thought to be more prone to infertility for various reasons, including menstrual irregularities, polycystic ovarian syndrome related to antiepileptic medications, and early menopause, she said.

Three previous studies had reported that women with epilepsy had birth rates as low as only one-quarter to one-third that of women without epilepsy. There have been many reasons reported for why that might be the case, including lower marriage rates, sexual dysfunction, lower libido (in both men and women with epilepsy), and increased number of anovulatory cycles, or greater choice to not become pregnant, Dr. Pennell said.

The WEPOD study enrolled 89 women with epilepsy and 109 healthy controls who were seeking to become pregnant and had stopped using contraception within 6 months of enrollment or were about to stop using it. The investigators excluded women with infertility, polycystic ovarian syndrome, endometriosis, endocrine disorder, and heavy smoking, or who were not in an exclusive heterosexual relationship with a significant other or spouse.

Participants received iPod touch devices with an app with which they tracked menses and intercourse, as well as antiepileptic drug use and seizures in women with epilepsy. “This was a particularly novel part of the study,” Dr. Harden said. It allowed the investigators to track adherence very well. Participants logged about 87% of their days in the app, and the investigators could see when the entries were made.

Women in both groups had a mean age of about 31 years and mean body mass index of about 25 kg/m². Overall, 52%-58% had undergone a prior pregnancy. Women with epilepsy, compared with controls, were less often Asian (17% vs. 6%) or African American (16% vs. 1%). The education level of participants was “fairly similar” between the groups, and slightly more women with epilepsy were unemployed (21% vs. 10%). Women with epilepsy also were more often married than were controls (89% vs. 75%).

During the study, 36% of women with epilepsy were still having seizures. At enrollment, most of the women’s seizure types were generalized (30%) or focal only (63%). Dr. Pennell noted that the antiseizure medications that the women were taking were typical for women of reproductive age: lamotrigine monotherapy (44%), levetiracetam monotherapy (28%), monotherapy with a strong enzyme-inducing drug (12%), other polytherapy (10%), polytherapy with a strong enzyme-inducing drug (6%), other monotherapy (3%), or no antiseizure medication (2%). A few women either added or stopped drugs during the study. A total of 18 women with epilepsy and 15 healthy controls dropped out.

As expected, age affected the likelihood of becoming pregnant, as well as number of prior pregnancies. Body mass index did not affect the likelihood of becoming pregnant, while white race and being married increased the likelihood.

In future analyses, the investigators are planning on checking whether ovulatory rates, frequency of intercourse, and time of intercourse had any impact on pregnancy, and in women with epilepsy, they will check the effect of the type of antiseizure medication and seizure-related factors.

“I think our findings will stand with future analyses.” Dr. Harden said. “The most interesting future findings may come from within the epilepsy group,” she said, noting that older antiepileptic medications have been previously associated with difficulty conceiving.

The WEPOD study was funded by the Milken Family Foundation, the Epilepsy Therapy Project, and the Epilepsy Foundation.

[email protected]

VANCOUVER – Women with epilepsy have fertility rates comparable with healthy women in the general population, according to results from the first prospective observational cohort study to make the comparison.

During the year-long Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) study, 70% of women with epilepsy and 67% of healthy control women became pregnant, and there was no significant difference in the mean time to pregnancy between those with and without epilepsy (6 months vs. 9 months, respectively), Dr. Page Pennell reported at the annual meeting of the American Academy of Neurology.

Live births occurred in 82% of pregnancies of women with epilepsy and 80% of controls, while miscarriages occurred in 13% and 20%, respectively. Both of those rates are very similar to the general population. Another 5% of pregnancies in women with epilepsy were ectopic, terminated due to chromosomal abnormality, or lost to follow-up.

“These findings should reassure women with epilepsy and clinicians when counseling women with epilepsy who are planning pregnancy,” said Dr. Pennell, director of research for the division of epilepsy in the department of neurology at Brigham and Women’s Hospital in Boston. She is a primary investigator of the study along with Dr. Jacqueline French, professor of neurology at NYU Langone Medical Center and Dr. Cynthia Harden, system director of epilepsy services at Mount Sinai Beth Israel, both in New York.

“I think overall the findings are more in the light of myth busting. ... We don’t necessarily see a lot of problems with fertility, yet the literature suggests that the birth rates are much lower,” Dr. Harden said in an interview.

“It’s really the first solid evidence, and it’s nice because in a sea of bad news for women when it comes to family planning and achieving pregnancy and pregnancy outcomes, I think this was very positive to say that their ability to achieve pregnancy was no different than what was reported by a control population without epilepsy,” Dr. Katherine Noe, an epilepsy specialist at the Mayo Clinic in Scottsdale, Ariz., said when asked to comment on the study.

“There was certainly reason to be concerned,” said Dr. Noe, who was not involved in the study. “We have a lot of data saying that babies exposed to antiepileptic drugs are more likely to have malformations, and so you could have a baby that already early in pregnancy has severe malformations that would be more likely to end in spontaneous abortion.”

Dr. Noe said that pregnancy registry data indicate that women with epilepsy may be more likely to have a pregnancy that ends in a miscarriage. Investigators for several studies published in 2015 reported that women with epilepsy face greater risk for morbidity and adverse outcomes at the time of delivery and during pregnancy than women without epilepsy (JAMA Neurol. 2015;72[9]:981-8 and Lancet. 2016;386[10006]:1845–52). Women with epilepsy also have been thought to be more prone to infertility for various reasons, including menstrual irregularities, polycystic ovarian syndrome related to antiepileptic medications, and early menopause, she said.

Three previous studies had reported that women with epilepsy had birth rates as low as only one-quarter to one-third that of women without epilepsy. There have been many reasons reported for why that might be the case, including lower marriage rates, sexual dysfunction, lower libido (in both men and women with epilepsy), and increased number of anovulatory cycles, or greater choice to not become pregnant, Dr. Pennell said.

The WEPOD study enrolled 89 women with epilepsy and 109 healthy controls who were seeking to become pregnant and had stopped using contraception within 6 months of enrollment or were about to stop using it. The investigators excluded women with infertility, polycystic ovarian syndrome, endometriosis, endocrine disorder, and heavy smoking, or who were not in an exclusive heterosexual relationship with a significant other or spouse.

Participants received iPod touch devices with an app with which they tracked menses and intercourse, as well as antiepileptic drug use and seizures in women with epilepsy. “This was a particularly novel part of the study,” Dr. Harden said. It allowed the investigators to track adherence very well. Participants logged about 87% of their days in the app, and the investigators could see when the entries were made.

Women in both groups had a mean age of about 31 years and mean body mass index of about 25 kg/m². Overall, 52%-58% had undergone a prior pregnancy. Women with epilepsy, compared with controls, were less often Asian (17% vs. 6%) or African American (16% vs. 1%). The education level of participants was “fairly similar” between the groups, and slightly more women with epilepsy were unemployed (21% vs. 10%). Women with epilepsy also were more often married than were controls (89% vs. 75%).

During the study, 36% of women with epilepsy were still having seizures. At enrollment, most of the women’s seizure types were generalized (30%) or focal only (63%). Dr. Pennell noted that the antiseizure medications that the women were taking were typical for women of reproductive age: lamotrigine monotherapy (44%), levetiracetam monotherapy (28%), monotherapy with a strong enzyme-inducing drug (12%), other polytherapy (10%), polytherapy with a strong enzyme-inducing drug (6%), other monotherapy (3%), or no antiseizure medication (2%). A few women either added or stopped drugs during the study. A total of 18 women with epilepsy and 15 healthy controls dropped out.

As expected, age affected the likelihood of becoming pregnant, as well as number of prior pregnancies. Body mass index did not affect the likelihood of becoming pregnant, while white race and being married increased the likelihood.

In future analyses, the investigators are planning on checking whether ovulatory rates, frequency of intercourse, and time of intercourse had any impact on pregnancy, and in women with epilepsy, they will check the effect of the type of antiseizure medication and seizure-related factors.

“I think our findings will stand with future analyses.” Dr. Harden said. “The most interesting future findings may come from within the epilepsy group,” she said, noting that older antiepileptic medications have been previously associated with difficulty conceiving.

The WEPOD study was funded by the Milken Family Foundation, the Epilepsy Therapy Project, and the Epilepsy Foundation.

[email protected]

CHICAGO – The superiority of metabolic surgery over intensive medical therapy for achieving glycemic control in patients with type 2 diabetes was largely maintained at the final 5-year follow-up evaluation in the randomized, controlled STAMPEDE trial.

The 150 subjects, who had “fairly severe diabetes” with an average disease duration of 8 years, were randomized to receive intensive medical therapy alone, or intensive medical therapy with Roux-en-Y gastric bypass surgery or sleeve gastrectomy surgery. The primary endpoint of hemoglobin A_1c less than 6% was achieved in 5%, 29%, and 23% of patients in the groups, respectively. The difference was statistically significant in favor of both types of surgery, Dr. Philip Raymond Schauer reported at the annual meeting of the American College of Cardiology.

Furthermore, patients in the surgery groups fared better than those in the intensive medical therapy group on several other measures, including disease remission (defied as HbA_1c less than 6% without diabetes medication), HbA_1c less than 7% (the American Diabetes Association target for therapy), change in fasting plasma glucose from baseline, and changes in high- and low-density lipoprotein cholesterol levels, said Dr. Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute.

Patients in the surgery groups also experienced a significantly greater reduction in the use of antihypertensive medications and lipid-lowering agents, he added.

The “very dramatic drop” in HbA_1c seen early on in the surgical patients was, for the most part, sustained out to 5 years, he said.

The results for both surgeries were significantly better than those for intensive medical therapy, but the results with gastric bypass were more effective at 5 years than were those for sleeve gastrectomy, he added, noting that the surgery patients had better quality of life, compared with the intensive medical therapy patients.

As for adverse events in the surgery groups, no perioperative deaths occurred, and while there were some surgical complications, none resulted in long-term disability, Dr. Schauer said.

Anemia was more common in the surgery patients, but was fairly mild. The most common complication was weight gain in 20% of patients, and the overall reoperation rate was 7%.

Of note, patients in the study had body mass index ranging from 27 to 43 kg/m², and those with BMI less than 35 had similar benefits as those with more severe obesity. This is important, as many insurance companies won’t cover metabolic surgery for patients with BMI less than 35, he explained.

These findings represent the longest follow-up to date comparing the efficacy of the two most common metabolic surgery procedures with medical treatment of type 2 diabetes for maintaining glycemic control or reducing end-organ complications. Three-year outcomes of STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) were reported in 2014 (N Engl J Med. 2014;370:2002-13).

The participants ranged in age from 20 to 60 years. The average HbA_1c was about 9%, the average BMI was 36, and most were on at least three antidiabetic medications at baseline. Half were on insulin.

The findings are important, because of the roughly 25 million Americans with type 2 diabetes, only about half have good glycemic control on their current medical treatment strategies, Dr. Schauer said.

Though limited by the single-center study design, the STAMPEDE findings show that metabolic surgery is more effective long term than intensive medical therapy in patients with uncontrolled type 2 diabetes and should be considered a treatment option in this population, he concluded, adding that multicenter studies would be helpful for determining the generalizability of the findings.

Dr. Schauer reported receiving consulting fees/honoraria from Ethicon Endosurgery and The Medicines Company, and having ownership interest in Surgical Excellence.

[email protected]

CHICAGO – The superiority of metabolic surgery over intensive medical therapy for achieving glycemic control in patients with type 2 diabetes was largely maintained at the final 5-year follow-up evaluation in the randomized, controlled STAMPEDE trial.

The 150 subjects, who had “fairly severe diabetes” with an average disease duration of 8 years, were randomized to receive intensive medical therapy alone, or intensive medical therapy with Roux-en-Y gastric bypass surgery or sleeve gastrectomy surgery. The primary endpoint of hemoglobin A_1c less than 6% was achieved in 5%, 29%, and 23% of patients in the groups, respectively. The difference was statistically significant in favor of both types of surgery, Dr. Philip Raymond Schauer reported at the annual meeting of the American College of Cardiology.

Furthermore, patients in the surgery groups fared better than those in the intensive medical therapy group on several other measures, including disease remission (defied as HbA_1c less than 6% without diabetes medication), HbA_1c less than 7% (the American Diabetes Association target for therapy), change in fasting plasma glucose from baseline, and changes in high- and low-density lipoprotein cholesterol levels, said Dr. Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute.

Patients in the surgery groups also experienced a significantly greater reduction in the use of antihypertensive medications and lipid-lowering agents, he added.

The “very dramatic drop” in HbA_1c seen early on in the surgical patients was, for the most part, sustained out to 5 years, he said.

The results for both surgeries were significantly better than those for intensive medical therapy, but the results with gastric bypass were more effective at 5 years than were those for sleeve gastrectomy, he added, noting that the surgery patients had better quality of life, compared with the intensive medical therapy patients.

As for adverse events in the surgery groups, no perioperative deaths occurred, and while there were some surgical complications, none resulted in long-term disability, Dr. Schauer said.

Anemia was more common in the surgery patients, but was fairly mild. The most common complication was weight gain in 20% of patients, and the overall reoperation rate was 7%.

Of note, patients in the study had body mass index ranging from 27 to 43 kg/m², and those with BMI less than 35 had similar benefits as those with more severe obesity. This is important, as many insurance companies won’t cover metabolic surgery for patients with BMI less than 35, he explained.

These findings represent the longest follow-up to date comparing the efficacy of the two most common metabolic surgery procedures with medical treatment of type 2 diabetes for maintaining glycemic control or reducing end-organ complications. Three-year outcomes of STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) were reported in 2014 (N Engl J Med. 2014;370:2002-13).

The participants ranged in age from 20 to 60 years. The average HbA_1c was about 9%, the average BMI was 36, and most were on at least three antidiabetic medications at baseline. Half were on insulin.

The findings are important, because of the roughly 25 million Americans with type 2 diabetes, only about half have good glycemic control on their current medical treatment strategies, Dr. Schauer said.

Though limited by the single-center study design, the STAMPEDE findings show that metabolic surgery is more effective long term than intensive medical therapy in patients with uncontrolled type 2 diabetes and should be considered a treatment option in this population, he concluded, adding that multicenter studies would be helpful for determining the generalizability of the findings.

Dr. Schauer reported receiving consulting fees/honoraria from Ethicon Endosurgery and The Medicines Company, and having ownership interest in Surgical Excellence.

[email protected]

CHICAGO – The superiority of metabolic surgery over intensive medical therapy for achieving glycemic control in patients with type 2 diabetes was largely maintained at the final 5-year follow-up evaluation in the randomized, controlled STAMPEDE trial.

The 150 subjects, who had “fairly severe diabetes” with an average disease duration of 8 years, were randomized to receive intensive medical therapy alone, or intensive medical therapy with Roux-en-Y gastric bypass surgery or sleeve gastrectomy surgery. The primary endpoint of hemoglobin A_1c less than 6% was achieved in 5%, 29%, and 23% of patients in the groups, respectively. The difference was statistically significant in favor of both types of surgery, Dr. Philip Raymond Schauer reported at the annual meeting of the American College of Cardiology.

Furthermore, patients in the surgery groups fared better than those in the intensive medical therapy group on several other measures, including disease remission (defied as HbA_1c less than 6% without diabetes medication), HbA_1c less than 7% (the American Diabetes Association target for therapy), change in fasting plasma glucose from baseline, and changes in high- and low-density lipoprotein cholesterol levels, said Dr. Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute.

Patients in the surgery groups also experienced a significantly greater reduction in the use of antihypertensive medications and lipid-lowering agents, he added.

The “very dramatic drop” in HbA_1c seen early on in the surgical patients was, for the most part, sustained out to 5 years, he said.

The results for both surgeries were significantly better than those for intensive medical therapy, but the results with gastric bypass were more effective at 5 years than were those for sleeve gastrectomy, he added, noting that the surgery patients had better quality of life, compared with the intensive medical therapy patients.

As for adverse events in the surgery groups, no perioperative deaths occurred, and while there were some surgical complications, none resulted in long-term disability, Dr. Schauer said.

Anemia was more common in the surgery patients, but was fairly mild. The most common complication was weight gain in 20% of patients, and the overall reoperation rate was 7%.

Of note, patients in the study had body mass index ranging from 27 to 43 kg/m², and those with BMI less than 35 had similar benefits as those with more severe obesity. This is important, as many insurance companies won’t cover metabolic surgery for patients with BMI less than 35, he explained.

These findings represent the longest follow-up to date comparing the efficacy of the two most common metabolic surgery procedures with medical treatment of type 2 diabetes for maintaining glycemic control or reducing end-organ complications. Three-year outcomes of STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) were reported in 2014 (N Engl J Med. 2014;370:2002-13).

The participants ranged in age from 20 to 60 years. The average HbA_1c was about 9%, the average BMI was 36, and most were on at least three antidiabetic medications at baseline. Half were on insulin.

The findings are important, because of the roughly 25 million Americans with type 2 diabetes, only about half have good glycemic control on their current medical treatment strategies, Dr. Schauer said.

Though limited by the single-center study design, the STAMPEDE findings show that metabolic surgery is more effective long term than intensive medical therapy in patients with uncontrolled type 2 diabetes and should be considered a treatment option in this population, he concluded, adding that multicenter studies would be helpful for determining the generalizability of the findings.

Dr. Schauer reported receiving consulting fees/honoraria from Ethicon Endosurgery and The Medicines Company, and having ownership interest in Surgical Excellence.

[email protected]

The American College of Surgeons (ACS) is now accepting applications for the 2016 Claude H. Organ, Jr., MD, FACS, Traveling Fellowship. The deadline for all application materials is June 1.

The family and friends of the late Dr. Organ established an endowment through the ACS Foundation to provide funding for this fellowship, which is awarded annually to an outstanding young surgeon from the Society of Black Academic Surgeons, the Association of Women Surgeons, or the Surgical Section of the National Medical Association. The fellowship, in the amount of $5,000, enables a U.S. or Canadian Fellow or Associate Fellow younger than age 45 who is a member of one of these societies to attend an educational meeting or participate in an extended visit to an institution of his or her choice, tailored to his or her research interests.

Past awardees have used their fellowships to develop their careers in creative ways. The most recent fellow, Kathie-Ann Joseph, MD, MPH, FACS, associate professor of surgery, New York University School of Medicine, and chief of surgery, Bellevue Hospital Center, New York, NY, is researching how health care systems work in a major metropolitan area, with a focus on the ways that large hospitals systems manage care for underserved women.

The full requirements for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship are posted at facs.org/member-services/scholarships/special/organ. The 2016 awardee will be informed of the College’s decision by August 2016. Questions and application materials should be submitted to the attention of Kate Early, ACS Scholarships Administrator, at [email protected].

The American College of Surgeons (ACS) is now accepting applications for the 2016 Claude H. Organ, Jr., MD, FACS, Traveling Fellowship. The deadline for all application materials is June 1.

The family and friends of the late Dr. Organ established an endowment through the ACS Foundation to provide funding for this fellowship, which is awarded annually to an outstanding young surgeon from the Society of Black Academic Surgeons, the Association of Women Surgeons, or the Surgical Section of the National Medical Association. The fellowship, in the amount of $5,000, enables a U.S. or Canadian Fellow or Associate Fellow younger than age 45 who is a member of one of these societies to attend an educational meeting or participate in an extended visit to an institution of his or her choice, tailored to his or her research interests.

Past awardees have used their fellowships to develop their careers in creative ways. The most recent fellow, Kathie-Ann Joseph, MD, MPH, FACS, associate professor of surgery, New York University School of Medicine, and chief of surgery, Bellevue Hospital Center, New York, NY, is researching how health care systems work in a major metropolitan area, with a focus on the ways that large hospitals systems manage care for underserved women.

The full requirements for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship are posted at facs.org/member-services/scholarships/special/organ. The 2016 awardee will be informed of the College’s decision by August 2016. Questions and application materials should be submitted to the attention of Kate Early, ACS Scholarships Administrator, at [email protected].

The American College of Surgeons (ACS) is now accepting applications for the 2016 Claude H. Organ, Jr., MD, FACS, Traveling Fellowship. The deadline for all application materials is June 1.

The family and friends of the late Dr. Organ established an endowment through the ACS Foundation to provide funding for this fellowship, which is awarded annually to an outstanding young surgeon from the Society of Black Academic Surgeons, the Association of Women Surgeons, or the Surgical Section of the National Medical Association. The fellowship, in the amount of $5,000, enables a U.S. or Canadian Fellow or Associate Fellow younger than age 45 who is a member of one of these societies to attend an educational meeting or participate in an extended visit to an institution of his or her choice, tailored to his or her research interests.

Past awardees have used their fellowships to develop their careers in creative ways. The most recent fellow, Kathie-Ann Joseph, MD, MPH, FACS, associate professor of surgery, New York University School of Medicine, and chief of surgery, Bellevue Hospital Center, New York, NY, is researching how health care systems work in a major metropolitan area, with a focus on the ways that large hospitals systems manage care for underserved women.

The full requirements for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship are posted at facs.org/member-services/scholarships/special/organ. The 2016 awardee will be informed of the College’s decision by August 2016. Questions and application materials should be submitted to the attention of Kate Early, ACS Scholarships Administrator, at [email protected].

Have you ever run across a negative or even malicious comment about you or your practice on the web, in full view of the world? You’re certainly not alone.

Chances are it was on one of those doctor rating sites, whose supposedly “objective” evaluations are anything but fair or accurate; one curmudgeon, angry about something that usually has nothing to do with your clinical skills, can use his First Amendment–protected right to trash you unfairly, as thousands of satisfied patients remain silent.

What to do? You could hire one of the many companies in the rapidly burgeoning field of online reputation management; but that can cost hundreds to thousands of dollars per month for monitoring and intervention, and there are no guarantees of success.

A better solution is to generate your own search results – positive ones – that will overwhelm any negative comments that search engines might find. Start with the social networking sites. However you feel about networking, there’s no getting around the fact that personal pages on Facebook, LinkedIn, and Twitter rank very high on major search engines. (Some consultants say a favorable LinkedIn profile is particularly helpful because of that site’s reputation as a “professional” network.) Your community activities, charitable work, interesting hobbies – anything that casts you in a favorable light – need to be mentioned prominently in your network profiles.

You can also use Google’s profiling tool (https://plus.google.com/up/accounts/) to create a sterling bio, complete with links to URLs, photos, and anything else that shows you in the best possible light. And your Google profile will be at or near the top of any Google search.

Wikipedia articles also go to the top of most searches, so if you’re notable enough to merit mention in one – or to have one of your own – see that it is done, and updated regularly. You can’t do that yourself, however; Wikipedia’s conflict of interest rules forbid writing or editing content about yourself. Someone with a theoretically “neutral point of view” will have to do it.

If you don’t yet have a website, now would be a good time. As I’ve discussed many times, a professionally designed site will be far more attractive and polished than anything you could build yourself. Furthermore, an experienced designer will employ “search engine optimization” (SEO), meaning that content will be created in a way that is readily visible to search engine users.

Leave design and SEO to the pros, but don’t delegate the content itself; as captain of the ship you are responsible for all the facts and opinions on your site. And remember that once it’s online, it’s online forever; consider the ramifications of anything you post on any site (yours or others) before hitting the “send” button. “The most damaging item about you,” one consultant told me, “could well be something you posted yourself.” Just ask any of several prominent politicians who have famously sabotaged their own careers online.

That said, don’t be shy about creating content. Make your (noncontroversial) opinions known on Facebook and Twitter. If social networks are not your thing, add a blog to your web site and write about what you know, and what interests you. If you have expertise in a particular field, write about that.

Incidentally, if the URL for your web site is not your name, you should also register your name as a separate domain name – if only to be sure that a trickster, or someone with the same name and a bad reputation, doesn’t get it.

Set up an RSS news feed for yourself, so you’ll know immediately anytime your name pops up in news or gossip sites, or on blogs. If something untrue is posted about you, take action. Reputable news sites and blogs have their own reputations to protect, and so can usually be persuaded to correct anything that is demonstrably false. Try to get the error removed entirely, or corrected within the original article. An erratum on the last page of the next edition will be ignored, and will leave the false information online, intact.

Unfair comments on doctor rating sites are unlikely to be removed unless they are blatantly libelous; but there is nothing wrong with encouraging happy patients to write favorable reviews. Turnabout is fair play.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Have you ever run across a negative or even malicious comment about you or your practice on the web, in full view of the world? You’re certainly not alone.

Chances are it was on one of those doctor rating sites, whose supposedly “objective” evaluations are anything but fair or accurate; one curmudgeon, angry about something that usually has nothing to do with your clinical skills, can use his First Amendment–protected right to trash you unfairly, as thousands of satisfied patients remain silent.

What to do? You could hire one of the many companies in the rapidly burgeoning field of online reputation management; but that can cost hundreds to thousands of dollars per month for monitoring and intervention, and there are no guarantees of success.

A better solution is to generate your own search results – positive ones – that will overwhelm any negative comments that search engines might find. Start with the social networking sites. However you feel about networking, there’s no getting around the fact that personal pages on Facebook, LinkedIn, and Twitter rank very high on major search engines. (Some consultants say a favorable LinkedIn profile is particularly helpful because of that site’s reputation as a “professional” network.) Your community activities, charitable work, interesting hobbies – anything that casts you in a favorable light – need to be mentioned prominently in your network profiles.

You can also use Google’s profiling tool (https://plus.google.com/up/accounts/) to create a sterling bio, complete with links to URLs, photos, and anything else that shows you in the best possible light. And your Google profile will be at or near the top of any Google search.

Wikipedia articles also go to the top of most searches, so if you’re notable enough to merit mention in one – or to have one of your own – see that it is done, and updated regularly. You can’t do that yourself, however; Wikipedia’s conflict of interest rules forbid writing or editing content about yourself. Someone with a theoretically “neutral point of view” will have to do it.

If you don’t yet have a website, now would be a good time. As I’ve discussed many times, a professionally designed site will be far more attractive and polished than anything you could build yourself. Furthermore, an experienced designer will employ “search engine optimization” (SEO), meaning that content will be created in a way that is readily visible to search engine users.

Leave design and SEO to the pros, but don’t delegate the content itself; as captain of the ship you are responsible for all the facts and opinions on your site. And remember that once it’s online, it’s online forever; consider the ramifications of anything you post on any site (yours or others) before hitting the “send” button. “The most damaging item about you,” one consultant told me, “could well be something you posted yourself.” Just ask any of several prominent politicians who have famously sabotaged their own careers online.

That said, don’t be shy about creating content. Make your (noncontroversial) opinions known on Facebook and Twitter. If social networks are not your thing, add a blog to your web site and write about what you know, and what interests you. If you have expertise in a particular field, write about that.

Incidentally, if the URL for your web site is not your name, you should also register your name as a separate domain name – if only to be sure that a trickster, or someone with the same name and a bad reputation, doesn’t get it.

Set up an RSS news feed for yourself, so you’ll know immediately anytime your name pops up in news or gossip sites, or on blogs. If something untrue is posted about you, take action. Reputable news sites and blogs have their own reputations to protect, and so can usually be persuaded to correct anything that is demonstrably false. Try to get the error removed entirely, or corrected within the original article. An erratum on the last page of the next edition will be ignored, and will leave the false information online, intact.

Unfair comments on doctor rating sites are unlikely to be removed unless they are blatantly libelous; but there is nothing wrong with encouraging happy patients to write favorable reviews. Turnabout is fair play.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Have you ever run across a negative or even malicious comment about you or your practice on the web, in full view of the world? You’re certainly not alone.

Chances are it was on one of those doctor rating sites, whose supposedly “objective” evaluations are anything but fair or accurate; one curmudgeon, angry about something that usually has nothing to do with your clinical skills, can use his First Amendment–protected right to trash you unfairly, as thousands of satisfied patients remain silent.

What to do? You could hire one of the many companies in the rapidly burgeoning field of online reputation management; but that can cost hundreds to thousands of dollars per month for monitoring and intervention, and there are no guarantees of success.

A better solution is to generate your own search results – positive ones – that will overwhelm any negative comments that search engines might find. Start with the social networking sites. However you feel about networking, there’s no getting around the fact that personal pages on Facebook, LinkedIn, and Twitter rank very high on major search engines. (Some consultants say a favorable LinkedIn profile is particularly helpful because of that site’s reputation as a “professional” network.) Your community activities, charitable work, interesting hobbies – anything that casts you in a favorable light – need to be mentioned prominently in your network profiles.

You can also use Google’s profiling tool (https://plus.google.com/up/accounts/) to create a sterling bio, complete with links to URLs, photos, and anything else that shows you in the best possible light. And your Google profile will be at or near the top of any Google search.

Wikipedia articles also go to the top of most searches, so if you’re notable enough to merit mention in one – or to have one of your own – see that it is done, and updated regularly. You can’t do that yourself, however; Wikipedia’s conflict of interest rules forbid writing or editing content about yourself. Someone with a theoretically “neutral point of view” will have to do it.

If you don’t yet have a website, now would be a good time. As I’ve discussed many times, a professionally designed site will be far more attractive and polished than anything you could build yourself. Furthermore, an experienced designer will employ “search engine optimization” (SEO), meaning that content will be created in a way that is readily visible to search engine users.

Leave design and SEO to the pros, but don’t delegate the content itself; as captain of the ship you are responsible for all the facts and opinions on your site. And remember that once it’s online, it’s online forever; consider the ramifications of anything you post on any site (yours or others) before hitting the “send” button. “The most damaging item about you,” one consultant told me, “could well be something you posted yourself.” Just ask any of several prominent politicians who have famously sabotaged their own careers online.

That said, don’t be shy about creating content. Make your (noncontroversial) opinions known on Facebook and Twitter. If social networks are not your thing, add a blog to your web site and write about what you know, and what interests you. If you have expertise in a particular field, write about that.

Incidentally, if the URL for your web site is not your name, you should also register your name as a separate domain name – if only to be sure that a trickster, or someone with the same name and a bad reputation, doesn’t get it.

Set up an RSS news feed for yourself, so you’ll know immediately anytime your name pops up in news or gossip sites, or on blogs. If something untrue is posted about you, take action. Reputable news sites and blogs have their own reputations to protect, and so can usually be persuaded to correct anything that is demonstrably false. Try to get the error removed entirely, or corrected within the original article. An erratum on the last page of the next edition will be ignored, and will leave the false information online, intact.

Unfair comments on doctor rating sites are unlikely to be removed unless they are blatantly libelous; but there is nothing wrong with encouraging happy patients to write favorable reviews. Turnabout is fair play.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

CHICAGO – Sooner may be better than later when it comes to the timing of bariatric surgery in patients with morbid obesity.

Of 828 patients with body mass index of at least 35 kg/m² who underwent laparoscopic adjustable gastric banding performed by a single surgeon and were followed for up to 11 years (mean of 10 years), 423 were aged 45 years or younger, and 405 were over age 45 years at the time of surgery. A comparison of outcomes between the two age groups showed that older age at the time of surgery was an independent predictor of cardiovascular events (hazard ratio, 1.8), Maharaj Singh, Ph.D., a biostatistician at the Aurora Research Institute, Milwaukee, reported in a poster at the annual meeting of the American College of Cardiology.

James P. Gray/Wikimedia Commons/CC-ASA 3.0

Despite a similar reduction in body weight after gastric banding surgery, the older patients experienced more cardiovascular events: myocardial infarction occurred in 0.2% and 1.7% of patients in the younger and older age groups, respectively, pulmonary embolism occurred in 0.7% and 4.3%, congestive heart failure occurred in 2.8% and 7.8%, and stroke occurred in 3.7% and 7.6%, Dr. Singh said.

“Although the older group had more comorbidities, these were accounted for by multivariate analysis and age over 45 years remained an independent predictor of poor cardiovascular outcomes,” senior coauthor Dr. Arshad Jahangir, professor of medicine at the University of Wisconsin–Madison, said in an interview.

Other independent predictors of adverse cardiovascular outcomes in the study were sleep apnea (hazard ratio, 4), history of hypertension (HR, 1.9), and depression, (HR, 1.8), Dr. Jahangir said.

“Gender, race, and diabetes mellitus did not independently predict cardiovascular events,” he said.

Weight loss after bariatric surgery has been shown to reduce the risk of adverse cardiovascular events, but it has remained unclear whether the reduction in risk varies based on age at the time of surgery, he said.

The current findings suggest that the effects of laparoscopic adjustable gastric banding–induced weight loss on cardiovascular outcomes are greater in patients who undergo the surgery at a younger age, he said, adding that the findings also “raise important questions about whether better control of sleep apnea, hypertension, and depression could help further reduce cardiovascular events in morbidly obese individuals undergoing bariatric surgery and should be addressed in a prospective study of these patients.”

The authors reported having no disclosures.

[email protected]

CHICAGO – Sooner may be better than later when it comes to the timing of bariatric surgery in patients with morbid obesity.

Of 828 patients with body mass index of at least 35 kg/m² who underwent laparoscopic adjustable gastric banding performed by a single surgeon and were followed for up to 11 years (mean of 10 years), 423 were aged 45 years or younger, and 405 were over age 45 years at the time of surgery. A comparison of outcomes between the two age groups showed that older age at the time of surgery was an independent predictor of cardiovascular events (hazard ratio, 1.8), Maharaj Singh, Ph.D., a biostatistician at the Aurora Research Institute, Milwaukee, reported in a poster at the annual meeting of the American College of Cardiology.

James P. Gray/Wikimedia Commons/CC-ASA 3.0

Despite a similar reduction in body weight after gastric banding surgery, the older patients experienced more cardiovascular events: myocardial infarction occurred in 0.2% and 1.7% of patients in the younger and older age groups, respectively, pulmonary embolism occurred in 0.7% and 4.3%, congestive heart failure occurred in 2.8% and 7.8%, and stroke occurred in 3.7% and 7.6%, Dr. Singh said.

“Although the older group had more comorbidities, these were accounted for by multivariate analysis and age over 45 years remained an independent predictor of poor cardiovascular outcomes,” senior coauthor Dr. Arshad Jahangir, professor of medicine at the University of Wisconsin–Madison, said in an interview.

Other independent predictors of adverse cardiovascular outcomes in the study were sleep apnea (hazard ratio, 4), history of hypertension (HR, 1.9), and depression, (HR, 1.8), Dr. Jahangir said.

“Gender, race, and diabetes mellitus did not independently predict cardiovascular events,” he said.

Weight loss after bariatric surgery has been shown to reduce the risk of adverse cardiovascular events, but it has remained unclear whether the reduction in risk varies based on age at the time of surgery, he said.

The current findings suggest that the effects of laparoscopic adjustable gastric banding–induced weight loss on cardiovascular outcomes are greater in patients who undergo the surgery at a younger age, he said, adding that the findings also “raise important questions about whether better control of sleep apnea, hypertension, and depression could help further reduce cardiovascular events in morbidly obese individuals undergoing bariatric surgery and should be addressed in a prospective study of these patients.”

The authors reported having no disclosures.

[email protected]

CHICAGO – Sooner may be better than later when it comes to the timing of bariatric surgery in patients with morbid obesity.

Of 828 patients with body mass index of at least 35 kg/m² who underwent laparoscopic adjustable gastric banding performed by a single surgeon and were followed for up to 11 years (mean of 10 years), 423 were aged 45 years or younger, and 405 were over age 45 years at the time of surgery. A comparison of outcomes between the two age groups showed that older age at the time of surgery was an independent predictor of cardiovascular events (hazard ratio, 1.8), Maharaj Singh, Ph.D., a biostatistician at the Aurora Research Institute, Milwaukee, reported in a poster at the annual meeting of the American College of Cardiology.

James P. Gray/Wikimedia Commons/CC-ASA 3.0

Despite a similar reduction in body weight after gastric banding surgery, the older patients experienced more cardiovascular events: myocardial infarction occurred in 0.2% and 1.7% of patients in the younger and older age groups, respectively, pulmonary embolism occurred in 0.7% and 4.3%, congestive heart failure occurred in 2.8% and 7.8%, and stroke occurred in 3.7% and 7.6%, Dr. Singh said.

“Although the older group had more comorbidities, these were accounted for by multivariate analysis and age over 45 years remained an independent predictor of poor cardiovascular outcomes,” senior coauthor Dr. Arshad Jahangir, professor of medicine at the University of Wisconsin–Madison, said in an interview.

Other independent predictors of adverse cardiovascular outcomes in the study were sleep apnea (hazard ratio, 4), history of hypertension (HR, 1.9), and depression, (HR, 1.8), Dr. Jahangir said.

“Gender, race, and diabetes mellitus did not independently predict cardiovascular events,” he said.

Weight loss after bariatric surgery has been shown to reduce the risk of adverse cardiovascular events, but it has remained unclear whether the reduction in risk varies based on age at the time of surgery, he said.

The current findings suggest that the effects of laparoscopic adjustable gastric banding–induced weight loss on cardiovascular outcomes are greater in patients who undergo the surgery at a younger age, he said, adding that the findings also “raise important questions about whether better control of sleep apnea, hypertension, and depression could help further reduce cardiovascular events in morbidly obese individuals undergoing bariatric surgery and should be addressed in a prospective study of these patients.”

The authors reported having no disclosures.

[email protected]

VANCOUVER – A new American Academy of Neurology practice guideline on the efficacy and safety evidence for botulinum toxin treatment of blepharospasm, cervical dystonia, spasticity, and headache has updated the last recommendations published in 2008, but leaves some relevant clinical concerns and off-label uses unaddressed.

The 2016 update, published April 18 in Neurology, adds new individual evidence for the use of the four branded formulations of the two commercially available botulinum toxin serotypes, A and B, for the aforementioned indications rather than lumping all recommendations for botulinum toxin together as in the 2008 guidelines. However, questions remain on the differences between the different products in clinical practice, especially since the formulations show little clinical difference in head-to-head comparisons for some of the indications, especially for the serotype A formulations.

Jeff Evans/Frontline Medical News

In a press briefing on the new guidelines at the annual meeting of the American Academy of Neurology, guidelines coauthor Dr. Mark Hallett noted that nothing really surprised the experienced 14-member committee that put the guidelines together. “The reason that we chose these four different diseases is because we already had the sense that they were going to change in the particular ways that they did. We didn’t know exactly, of course, what was going to happen, but we had a sense that there were sufficient data that it was worth looking at them.”

For blepharospasm, the totality of evidence suggests that onabotulinumtoxinA (onaBoNT-A; Botox) and incobotulinumtoxinA (incoBoNT-A; Xeomin) injections should be considered and are probably safe and effective (level B recommendation), while abobotulinumtoxinA (aboBoNT-A; Dysport) may be considered (level C) and is possibly effective. The evidence shows that incoBoNT-A and onaBoNT-A have equivalent efficacy and aboBoNT-A and onaBoNT-A are possibly equivalent. There was not enough evidence to determine the efficacy of rimabotulinumtoxinB for blepharospasm (rimaBoNT-B; Myobloc).

The rigorousness of clinical trials in evaluating the efficacy and safety of botulinum toxin has evolved since the Food and Drug Administration approved onaBoNT-A and incoBoNT-A to treat blepharospasm, but no new trials have been conducted to give it a higher level of recommendation despite their well-known magnitude of benefit, said Dr. Hallett, chief of the National Institute of Neurological Disorders and Stroke medical neurology branch and its human motor control section.

New evidence added to the already well-established data on the effectiveness of botulinum toxin for cervical dystonia suggest that onaBoNT-A and incoBoNT-A are probably safe and effective and should be considered. In addition, aboBoNT-A and rimaBoNT-B have already proven effectiveness and safety and should be offered. The lack of class I studies for onaBoNT-A and incoBoNT-A led to the lower level of recommendation for them despite an extensive clinical history of their use in cervical dystonia, the guideline committee wrote (Neurology. 2016 Apr 18. doi: 10.1212/WNL.0000000000002560).

In adults with upper-limb spasticity, all three serotype A formulations – onaBoNT-A, aboBoNT-A, and incoBoNT-A – are effective and safe in reducing symptoms and improving passive limb function. All three achieved level A evidence to recommend that they should be offered. One comparative trial showed enough evidence to say that onaBoNT-A is probably superior to tizanidine for reducing upper-extremity tone and should be considered before it. RimaBoNT-B has level B evidence to advise that it should be considered and is probably safe and effective. None of the formulations have enough data to determine their efficacy on active limb function.

Fewer trials have examined the safety and effectiveness of botulinum toxin formulations for reducing lower leg spasticity in adults. The guidelines panel found enough evidence to recommend that aboBoNT-A and onaBoNT-A are safe and effective and should be offered (level A). There were no trials with high enough level of quality to determine whether incoBoNT-A or rimaBoNT-B were effective for lower-leg spasticity. None of the four agents had enough evidence to support their ability to improve active function associated with lower-limb spasticity.

At the press briefing, guidelines first author Dr. David M. Simpson expressed hope that a more refined methodology for evaluating spasticity might be achieved in future trials of botulinum toxin to detect the potentially subtle effects the agents may have on certain patients who are more likely to achieve benefits in active limb function. Currently, trials use a standardized set of outcomes to try to detect differences in patients with wide-ranging severity of symptoms and types of injury that led to spasticity. Dr. Simpson is professor of neurology at Mount Sinai in New York, as well as director of the neuromuscular diseases division and director of the clinical neurophysiology laboratories.

Positive results for onaBoNT-A in two pivotal trials in chronic migraine that were published since the last guidelines give the formulation the only FDA-approved indication for a botulinum toxin in chronic migraine and earned it a level A recommendation from the guidelines committee. However, in the trials it had a relatively small magnitude of efficacy in reducing the number of headache days by 15% versus placebo. The guidelines also advise not using onaBoNT-A in episodic migraine based on three negative trials. No high-quality trials have evaluated any formulation to change the overall 2008 guidelines’ advice that botulinum toxin is probably ineffective for treating chronic tension-type headaches.

Familiarity with appropriate dosing and side effects may allow clinicians to use the products off-label for indications in the guidelines for which clinical trials were not available, Dr. Richard L. Barbano of the movement disorders division at the University of Rochester noted in an editorial about the guidelines (Neurol Clin Pract. 2016 Apr 18. doi: 10.1212/CPJ.0000000000000244). “Off-label use is common in clinical practice. Little data exist to indicate that any of the different formulations, with attention to appropriate dosing and side effects, would not be effective in treating these other conditions. There are also a number of other neurologic conditions not discussed in the guideline in which botulinum toxin has shown efficacy, such as hemifacial spasm and other focal dystonias. Lack of sufficient high-level evidence to support a level A or B guideline recommendation does not negate their potential utility and likewise, there is little evidence to recommend one formulation over another.”

“In some circumstances where the drugs are relatively equivalent, some people prefer to stick with one so they get used to it more, and they can have more of a sense of what the dosing is, given that the doses may be different with the compounds and have different side effects,” Dr. Hallett said in an interview, noting that availability and price also might enter into a clinician’s decision on what to do.

Dr. Barbano also said that cost and value are becoming more important, and neurologists should consider when botulinum toxin therapy should be chosen among existing alternative treatment options, particularly for chronic migraine.

The guidelines are endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine and the American Society of Plastic Surgeons.

Dr. Hallett reported serving as chair of the Neurotoxin Institute Advisory Council and has received research grants from Allergan and Merz Pharmaceuticals. Dr. Simpson reported receiving research grants from and served as a consultant for Allergan, Ipsen, Merz Pharmaceuticals, and Acorda Therapeutics. Five other coauthors of the guidelines disclosed relationships with manufacturers of botulinum toxin formulations. Dr. Barbano reported serving on a scientific advisory board for Allergan and receiving research support from Allergan, Vaccinex, and Biotie.

[email protected]

VANCOUVER – A new American Academy of Neurology practice guideline on the efficacy and safety evidence for botulinum toxin treatment of blepharospasm, cervical dystonia, spasticity, and headache has updated the last recommendations published in 2008, but leaves some relevant clinical concerns and off-label uses unaddressed.

The 2016 update, published April 18 in Neurology, adds new individual evidence for the use of the four branded formulations of the two commercially available botulinum toxin serotypes, A and B, for the aforementioned indications rather than lumping all recommendations for botulinum toxin together as in the 2008 guidelines. However, questions remain on the differences between the different products in clinical practice, especially since the formulations show little clinical difference in head-to-head comparisons for some of the indications, especially for the serotype A formulations.

Jeff Evans/Frontline Medical News

In a press briefing on the new guidelines at the annual meeting of the American Academy of Neurology, guidelines coauthor Dr. Mark Hallett noted that nothing really surprised the experienced 14-member committee that put the guidelines together. “The reason that we chose these four different diseases is because we already had the sense that they were going to change in the particular ways that they did. We didn’t know exactly, of course, what was going to happen, but we had a sense that there were sufficient data that it was worth looking at them.”

For blepharospasm, the totality of evidence suggests that onabotulinumtoxinA (onaBoNT-A; Botox) and incobotulinumtoxinA (incoBoNT-A; Xeomin) injections should be considered and are probably safe and effective (level B recommendation), while abobotulinumtoxinA (aboBoNT-A; Dysport) may be considered (level C) and is possibly effective. The evidence shows that incoBoNT-A and onaBoNT-A have equivalent efficacy and aboBoNT-A and onaBoNT-A are possibly equivalent. There was not enough evidence to determine the efficacy of rimabotulinumtoxinB for blepharospasm (rimaBoNT-B; Myobloc).

The rigorousness of clinical trials in evaluating the efficacy and safety of botulinum toxin has evolved since the Food and Drug Administration approved onaBoNT-A and incoBoNT-A to treat blepharospasm, but no new trials have been conducted to give it a higher level of recommendation despite their well-known magnitude of benefit, said Dr. Hallett, chief of the National Institute of Neurological Disorders and Stroke medical neurology branch and its human motor control section.

New evidence added to the already well-established data on the effectiveness of botulinum toxin for cervical dystonia suggest that onaBoNT-A and incoBoNT-A are probably safe and effective and should be considered. In addition, aboBoNT-A and rimaBoNT-B have already proven effectiveness and safety and should be offered. The lack of class I studies for onaBoNT-A and incoBoNT-A led to the lower level of recommendation for them despite an extensive clinical history of their use in cervical dystonia, the guideline committee wrote (Neurology. 2016 Apr 18. doi: 10.1212/WNL.0000000000002560).

In adults with upper-limb spasticity, all three serotype A formulations – onaBoNT-A, aboBoNT-A, and incoBoNT-A – are effective and safe in reducing symptoms and improving passive limb function. All three achieved level A evidence to recommend that they should be offered. One comparative trial showed enough evidence to say that onaBoNT-A is probably superior to tizanidine for reducing upper-extremity tone and should be considered before it. RimaBoNT-B has level B evidence to advise that it should be considered and is probably safe and effective. None of the formulations have enough data to determine their efficacy on active limb function.

Fewer trials have examined the safety and effectiveness of botulinum toxin formulations for reducing lower leg spasticity in adults. The guidelines panel found enough evidence to recommend that aboBoNT-A and onaBoNT-A are safe and effective and should be offered (level A). There were no trials with high enough level of quality to determine whether incoBoNT-A or rimaBoNT-B were effective for lower-leg spasticity. None of the four agents had enough evidence to support their ability to improve active function associated with lower-limb spasticity.

At the press briefing, guidelines first author Dr. David M. Simpson expressed hope that a more refined methodology for evaluating spasticity might be achieved in future trials of botulinum toxin to detect the potentially subtle effects the agents may have on certain patients who are more likely to achieve benefits in active limb function. Currently, trials use a standardized set of outcomes to try to detect differences in patients with wide-ranging severity of symptoms and types of injury that led to spasticity. Dr. Simpson is professor of neurology at Mount Sinai in New York, as well as director of the neuromuscular diseases division and director of the clinical neurophysiology laboratories.

Positive results for onaBoNT-A in two pivotal trials in chronic migraine that were published since the last guidelines give the formulation the only FDA-approved indication for a botulinum toxin in chronic migraine and earned it a level A recommendation from the guidelines committee. However, in the trials it had a relatively small magnitude of efficacy in reducing the number of headache days by 15% versus placebo. The guidelines also advise not using onaBoNT-A in episodic migraine based on three negative trials. No high-quality trials have evaluated any formulation to change the overall 2008 guidelines’ advice that botulinum toxin is probably ineffective for treating chronic tension-type headaches.

Familiarity with appropriate dosing and side effects may allow clinicians to use the products off-label for indications in the guidelines for which clinical trials were not available, Dr. Richard L. Barbano of the movement disorders division at the University of Rochester noted in an editorial about the guidelines (Neurol Clin Pract. 2016 Apr 18. doi: 10.1212/CPJ.0000000000000244). “Off-label use is common in clinical practice. Little data exist to indicate that any of the different formulations, with attention to appropriate dosing and side effects, would not be effective in treating these other conditions. There are also a number of other neurologic conditions not discussed in the guideline in which botulinum toxin has shown efficacy, such as hemifacial spasm and other focal dystonias. Lack of sufficient high-level evidence to support a level A or B guideline recommendation does not negate their potential utility and likewise, there is little evidence to recommend one formulation over another.”

“In some circumstances where the drugs are relatively equivalent, some people prefer to stick with one so they get used to it more, and they can have more of a sense of what the dosing is, given that the doses may be different with the compounds and have different side effects,” Dr. Hallett said in an interview, noting that availability and price also might enter into a clinician’s decision on what to do.

Dr. Barbano also said that cost and value are becoming more important, and neurologists should consider when botulinum toxin therapy should be chosen among existing alternative treatment options, particularly for chronic migraine.

The guidelines are endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine and the American Society of Plastic Surgeons.

Dr. Hallett reported serving as chair of the Neurotoxin Institute Advisory Council and has received research grants from Allergan and Merz Pharmaceuticals. Dr. Simpson reported receiving research grants from and served as a consultant for Allergan, Ipsen, Merz Pharmaceuticals, and Acorda Therapeutics. Five other coauthors of the guidelines disclosed relationships with manufacturers of botulinum toxin formulations. Dr. Barbano reported serving on a scientific advisory board for Allergan and receiving research support from Allergan, Vaccinex, and Biotie.

[email protected]

VANCOUVER – A new American Academy of Neurology practice guideline on the efficacy and safety evidence for botulinum toxin treatment of blepharospasm, cervical dystonia, spasticity, and headache has updated the last recommendations published in 2008, but leaves some relevant clinical concerns and off-label uses unaddressed.

The 2016 update, published April 18 in Neurology, adds new individual evidence for the use of the four branded formulations of the two commercially available botulinum toxin serotypes, A and B, for the aforementioned indications rather than lumping all recommendations for botulinum toxin together as in the 2008 guidelines. However, questions remain on the differences between the different products in clinical practice, especially since the formulations show little clinical difference in head-to-head comparisons for some of the indications, especially for the serotype A formulations.

Jeff Evans/Frontline Medical News

In a press briefing on the new guidelines at the annual meeting of the American Academy of Neurology, guidelines coauthor Dr. Mark Hallett noted that nothing really surprised the experienced 14-member committee that put the guidelines together. “The reason that we chose these four different diseases is because we already had the sense that they were going to change in the particular ways that they did. We didn’t know exactly, of course, what was going to happen, but we had a sense that there were sufficient data that it was worth looking at them.”

For blepharospasm, the totality of evidence suggests that onabotulinumtoxinA (onaBoNT-A; Botox) and incobotulinumtoxinA (incoBoNT-A; Xeomin) injections should be considered and are probably safe and effective (level B recommendation), while abobotulinumtoxinA (aboBoNT-A; Dysport) may be considered (level C) and is possibly effective. The evidence shows that incoBoNT-A and onaBoNT-A have equivalent efficacy and aboBoNT-A and onaBoNT-A are possibly equivalent. There was not enough evidence to determine the efficacy of rimabotulinumtoxinB for blepharospasm (rimaBoNT-B; Myobloc).

The rigorousness of clinical trials in evaluating the efficacy and safety of botulinum toxin has evolved since the Food and Drug Administration approved onaBoNT-A and incoBoNT-A to treat blepharospasm, but no new trials have been conducted to give it a higher level of recommendation despite their well-known magnitude of benefit, said Dr. Hallett, chief of the National Institute of Neurological Disorders and Stroke medical neurology branch and its human motor control section.

New evidence added to the already well-established data on the effectiveness of botulinum toxin for cervical dystonia suggest that onaBoNT-A and incoBoNT-A are probably safe and effective and should be considered. In addition, aboBoNT-A and rimaBoNT-B have already proven effectiveness and safety and should be offered. The lack of class I studies for onaBoNT-A and incoBoNT-A led to the lower level of recommendation for them despite an extensive clinical history of their use in cervical dystonia, the guideline committee wrote (Neurology. 2016 Apr 18. doi: 10.1212/WNL.0000000000002560).

In adults with upper-limb spasticity, all three serotype A formulations – onaBoNT-A, aboBoNT-A, and incoBoNT-A – are effective and safe in reducing symptoms and improving passive limb function. All three achieved level A evidence to recommend that they should be offered. One comparative trial showed enough evidence to say that onaBoNT-A is probably superior to tizanidine for reducing upper-extremity tone and should be considered before it. RimaBoNT-B has level B evidence to advise that it should be considered and is probably safe and effective. None of the formulations have enough data to determine their efficacy on active limb function.

Fewer trials have examined the safety and effectiveness of botulinum toxin formulations for reducing lower leg spasticity in adults. The guidelines panel found enough evidence to recommend that aboBoNT-A and onaBoNT-A are safe and effective and should be offered (level A). There were no trials with high enough level of quality to determine whether incoBoNT-A or rimaBoNT-B were effective for lower-leg spasticity. None of the four agents had enough evidence to support their ability to improve active function associated with lower-limb spasticity.

At the press briefing, guidelines first author Dr. David M. Simpson expressed hope that a more refined methodology for evaluating spasticity might be achieved in future trials of botulinum toxin to detect the potentially subtle effects the agents may have on certain patients who are more likely to achieve benefits in active limb function. Currently, trials use a standardized set of outcomes to try to detect differences in patients with wide-ranging severity of symptoms and types of injury that led to spasticity. Dr. Simpson is professor of neurology at Mount Sinai in New York, as well as director of the neuromuscular diseases division and director of the clinical neurophysiology laboratories.

Positive results for onaBoNT-A in two pivotal trials in chronic migraine that were published since the last guidelines give the formulation the only FDA-approved indication for a botulinum toxin in chronic migraine and earned it a level A recommendation from the guidelines committee. However, in the trials it had a relatively small magnitude of efficacy in reducing the number of headache days by 15% versus placebo. The guidelines also advise not using onaBoNT-A in episodic migraine based on three negative trials. No high-quality trials have evaluated any formulation to change the overall 2008 guidelines’ advice that botulinum toxin is probably ineffective for treating chronic tension-type headaches.

Familiarity with appropriate dosing and side effects may allow clinicians to use the products off-label for indications in the guidelines for which clinical trials were not available, Dr. Richard L. Barbano of the movement disorders division at the University of Rochester noted in an editorial about the guidelines (Neurol Clin Pract. 2016 Apr 18. doi: 10.1212/CPJ.0000000000000244). “Off-label use is common in clinical practice. Little data exist to indicate that any of the different formulations, with attention to appropriate dosing and side effects, would not be effective in treating these other conditions. There are also a number of other neurologic conditions not discussed in the guideline in which botulinum toxin has shown efficacy, such as hemifacial spasm and other focal dystonias. Lack of sufficient high-level evidence to support a level A or B guideline recommendation does not negate their potential utility and likewise, there is little evidence to recommend one formulation over another.”

“In some circumstances where the drugs are relatively equivalent, some people prefer to stick with one so they get used to it more, and they can have more of a sense of what the dosing is, given that the doses may be different with the compounds and have different side effects,” Dr. Hallett said in an interview, noting that availability and price also might enter into a clinician’s decision on what to do.

Dr. Barbano also said that cost and value are becoming more important, and neurologists should consider when botulinum toxin therapy should be chosen among existing alternative treatment options, particularly for chronic migraine.

The guidelines are endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine and the American Society of Plastic Surgeons.

Dr. Hallett reported serving as chair of the Neurotoxin Institute Advisory Council and has received research grants from Allergan and Merz Pharmaceuticals. Dr. Simpson reported receiving research grants from and served as a consultant for Allergan, Ipsen, Merz Pharmaceuticals, and Acorda Therapeutics. Five other coauthors of the guidelines disclosed relationships with manufacturers of botulinum toxin formulations. Dr. Barbano reported serving on a scientific advisory board for Allergan and receiving research support from Allergan, Vaccinex, and Biotie.

[email protected]

From Genoa-QoL Healthcare and the University of Michigan College of Pharmacy, Ann Arbor, MI.

Abstract

• Objective: To review the Common Sense Model, a framework that can be used for understanding patients’ behavior, including taking or not taking medications as prescribed.
• Methods: Descriptive report.
• Results: Medication adherence, a critical component of achieving good patient outcomes and reducing medical costs, is dependent upon patient illness beliefs. The Common Sense Model holds that these beliefs can be categorized as illness identity, cause, consequence, control, and timeline. Effective communication is necessary to understand the beliefs that patients hold and help them understand their condition. Good communication also can allay fears and other emotions that can be disruptive to achieving good outcomes.
• Conclusion: Clinicians should seek to understand their patients’ illness beliefs and collaborate with them  to achieve desired health outcomes.

Clinical practice is based on scientific evidence, by which medical problems are diagnosed and treatment recommendations are made. However, the role of the patient may not be completely recognized as an integral part of the process of patient care. The impact of failing to adequately recognize the patient perspective is evident in medication nonadherence. Health psychology research can provide clinicians insight into patients’ perceptions and behavior. This paper reviews the Common Sense Model (CSM), a behavioral model that provides a framework that can be used in understanding patients’ behavior. In this paper I will discuss the model and how it can be a possible strategy for improving adherence.

Making the Case for CSM in Daily Practice

It can be difficult to realize that persons seeking medical attention would not take medications as prescribed by a physician. In fact, studies reveal that on average, 16.4% of prescribed medications will not be picked up from the pharmacy [1]. Of those patients who do pick up their medication, approximately 1 out of 4 will not take them as prescribed [2]. Such medication nonadherence leads to poor health outcomes and increased health care costs [3,4]. There are many reasons for medication nonadherence [5], and there is no single solution to improving medication adherence [6]. A Cochrane review of randomized controlled trials evaluating various interventions intended to enhance patient adherence to prescribed medications for medical conditions found them to have limited effectiveness. Interventions assessed included health and medication information, reminder calls, follow-up assessment of medication therapy, social support, and simplification of the treatment regimen [6]. In an exploratory study of patients with chronic health conditions, Kucukarslan et al found patients’ beliefs about their illness and their medication are integral to their health care decisions [7]. Their findings were consistent with the CSM, which is based on Leventhal’s theory of self-regulation.

Self-regulation theory states that rational people will make decisions to reduce their health threat. Patients’ perceptions of their selves and environments drives their behavior. So in the presence of a health threat, a person will seek to eliminate or reduce that threat. However, coping behavior is complex. A person may decide to follow the advice of his clinician, follow some other advice (from family, friends, advertising, etc.), or do nothing. The premise of self-regulation is that people will choose a common sense approach to their health threat [8]. Therefore, clinicians must understand their patients’ viewpoint of themselves and their health condition so they may help guide them toward healthy outcomes.

The Common Sense Model

The CSM is a framework for understanding patient behavior when faced with a health threat. It holds that patients form common sense representations of their illness using information from 5 domains [8]: (1) the identity of the illness (the label the patient gives to the condition and symptoms); (2) the cause of the illness; (3) the consequences of the illness (beliefs about how the illness will impact the patient’s well-being); (4) whether the illness can be controlled or cured; and (5) timeline (beliefs about how long the condition will last). A patient may either act to address the health threat or choose to ignore it. Patient emotions are proposed to have a role on patient behavior along with the 5 dimensions of illness perception.

Illness Identity

Illness identity is the label patients place on the health threat; it is most likely not the same as the signs and symptoms clinicians use. Therefore, the first misconnect between physician and patient may be in describing the illness. Chen et al studied illness identity as perceived by patients with hypertension [9,10]. Illness identity was defined as (1) hypertension-related symptoms, (2) symptoms experienced before and after their diagnosis; and (3) symptoms used to predict high blood pressure. Although hypertension is asymptomatic, patients do perceive symptoms such as headache associated with their hypertension. The researchers found those patients who identified more symptoms were more likely to believe that their symptoms caused the hypertension and were correspondingly less likely to use their medication. For them, when the headache subsides, so does the hypertension.

Physicians should find out how patients assess their health condition and provide them tools for evaluating their response to medication. In the case of hypertension, the physician could have the patient check their blood pressure with and without the headache to demonstrate that hypertension occurs even when the patient is not “symptomatic.” The point is to converse with the patient to learn how they view their condition. Clinicians should resist the “urge” to correct patients. Taking time to help patients better understand their condition is important. A misstep:

Patient: I can tell when my blood pressure is high. I get a pounding headache.

Doctor: High blood pressure is an asymptomatic condition. Your headaches are not caused by your high blood pressure.

Patients may choose to ignore the clinician if they feel strongly about how they define their illness. It is better to listen to the patient and offer steps to learn about their health condition. Here is a better response from the physician:

Doctor: You are telling me that you can tell when your blood pressure is high. So when your head aches your pressure is high, right?

Patient: Yes.

Doctor: Let me tell you more about high blood pressure. High blood pressure is also present without headaches...

Illness Causes

There are multiple causative factors patients may associate with their disease. Causes attributed to disease may be based on patient experiences, input from family and friends, and cultural factors. Causes may include emotional state, stress or worry, overwork, genetic predisposition, or environmental factors (eg, pollution). Jessop and Rutter found patients who perceive their condition as due to uncontrollable factors, such as chance, germs, or pollution, were less likely to take their medication [11]. Similar findings were published by Chen et al [9]. They found psychological factors, environmental risk factors (eg, smoking, diet), and even bad luck or chance associated with less likelihood of taking medications as prescribed. Clinicians should explore patients’ perceptions of causes of a condition. Patients strive to eliminate the perceived cause, thus eliminating the need to take medication. In some cultures, bad luck or chance drives patients’ decisions to not take medication, or they believe in fate and do not accept treatment. Whether they feel they can control their condition by eliminating the cause or have a fatalistic view that the cause of their condition is not within their control, the clinician must work with the patient to reduce the impact of misperceptions or significance of perceived causes.

Illness Consequence

Consequence associated with the health condition is an important factor in patient behavior [12]. Patients must understand the specific threats to their health if a condition is left untreated or uncontrolled. Patients’ view of illness consequence may be formed by their own perceived vulnerability or susceptibility and the perceived seriousness of the condition. For example, patients with hypertension should be informed about the impact of high blood pressure on their bodies and the consequence of disability from stroke, dependency on dialysis from kidney failure, or death. They may not consider themselves susceptible to illness since they “feel healthy” and may decide to delay treatment. Patients with conditions such as asthma or heart failure may believe they are cured when their symptoms abate and therefore believe they have no more need for medication. Such patients need education to understand that they are asymptomatic because they are well controlled with medication.

Illness Control

Patients may feel they can control their health condition by changing their behavior, changing their environment, and/or by taking prescribed medication. As discussed earlier, cause and control both work together to form patient beliefs and actions. Patients will take their medications as prescribed if they believe in the effectiveness of medication to control their condition [11,13–15]. Interestingly, Ross found those who felt they had more control over their illness were more likely not to take their medication as prescribed [12]. These persons are more likely to not want to become “dependent” on medication. Their  feeling was that they can make changes in their lives and thereby improve their health condition.

Physicians should invite patients’ thoughts as to what should be done to improve their health condition, and collaborate with the patient on an action plan for change if change is expected to improve/control the health condition. Follow-up to assess the patient’s health status longitudinally is necessary.

In this exchange, the patient feels he can control his hypertension on his own:

Doctor: I recommend that you start taking medication to control your blood pressure. Uncontrolled high blood pressure can lead to many health problems.

Patient: I am not ready to start taking medication.

Doctor: What are your reasons?

Patient:  I am under a lot of stress at work. Once I get control of this stress, my blood pressure will go down.

Doctor: Getting control of your stress at work is important. Let me tell you more about high blood pressure.

Patient: Okay.

Doctor: There is no one cause of your high blood pressure. Eliminating your work stress will most likely not reduce your blood pressure....

Timeline

Health conditions can be  acute, chronic, or cyclical (ie, seasonal); however, patients may have different perceptions of the duration of their health condition. In Kucukarslan et al, some patients did not believe their hypertension was a lifelong condition because they felt they would be able to cure it [7]. For example, as illustrated above, patients may believe that stress causes their hypertension, and if the stress could be controlled, then their blood pressure would normalize. Conversely, Ross et al found that patients who viewed their hypertension as a long-term condition were more likely to believe their medications were necessary and thus more likely to take their medication as prescribed [12]. A lifelong or chronic health condition is a difficult concept for patients to accept, especially ones who may view themselves as too young to have the condition.

Emotions

After being informed about their health condition, patients may feel emotions that are not apparent to the practitioner. These may include worry, depression, anger, anxiety, or fear. Emotions may impact their decision to take medication [12,14]. Listening for patients’ responses to health information provided by the clinician and letting patients know they have been heard will help allay strong negative emotions [16]. Good communication builds trust between the clinician and patient.

Conclusion

Patients receive medical advice from clinicians that may be inconsistent with their beliefs and understanding of their health condition. Studies of medication nonadherence find many factors contribute to it and no one tool to improve medication adherence exists. However, the consequence of medication nonadherence are great and include  include worsening condition, increased comorbid disease, and increased health care costs. Understanding patients’ beliefs about their health condition is an important step toward reducing medication nonadherence. The CSM provides a framework for clinicians to guide patients toward effective decision-making. Listening to the patient explain how they view their condition—how they define it, the causes, consequences, how to control it, and how long it will last or if it will progress—are important to the process of working with the patient manage their condition effectively. Clinicians’ reaction  to these perceptions are important, and dismissing them may alienate patients. Effective communication is necessary to understand patients’ perspectives and to help them manage their health condition.

Corresponding author: Suzan N. Kucukarslan, PhD, RPh, [email protected].

Financial disclosures: None.

From Genoa-QoL Healthcare and the University of Michigan College of Pharmacy, Ann Arbor, MI.

Abstract

• Objective: To review the Common Sense Model, a framework that can be used for understanding patients’ behavior, including taking or not taking medications as prescribed.
• Methods: Descriptive report.
• Results: Medication adherence, a critical component of achieving good patient outcomes and reducing medical costs, is dependent upon patient illness beliefs. The Common Sense Model holds that these beliefs can be categorized as illness identity, cause, consequence, control, and timeline. Effective communication is necessary to understand the beliefs that patients hold and help them understand their condition. Good communication also can allay fears and other emotions that can be disruptive to achieving good outcomes.
• Conclusion: Clinicians should seek to understand their patients’ illness beliefs and collaborate with them  to achieve desired health outcomes.

Clinical practice is based on scientific evidence, by which medical problems are diagnosed and treatment recommendations are made. However, the role of the patient may not be completely recognized as an integral part of the process of patient care. The impact of failing to adequately recognize the patient perspective is evident in medication nonadherence. Health psychology research can provide clinicians insight into patients’ perceptions and behavior. This paper reviews the Common Sense Model (CSM), a behavioral model that provides a framework that can be used in understanding patients’ behavior. In this paper I will discuss the model and how it can be a possible strategy for improving adherence.

Making the Case for CSM in Daily Practice

It can be difficult to realize that persons seeking medical attention would not take medications as prescribed by a physician. In fact, studies reveal that on average, 16.4% of prescribed medications will not be picked up from the pharmacy [1]. Of those patients who do pick up their medication, approximately 1 out of 4 will not take them as prescribed [2]. Such medication nonadherence leads to poor health outcomes and increased health care costs [3,4]. There are many reasons for medication nonadherence [5], and there is no single solution to improving medication adherence [6]. A Cochrane review of randomized controlled trials evaluating various interventions intended to enhance patient adherence to prescribed medications for medical conditions found them to have limited effectiveness. Interventions assessed included health and medication information, reminder calls, follow-up assessment of medication therapy, social support, and simplification of the treatment regimen [6]. In an exploratory study of patients with chronic health conditions, Kucukarslan et al found patients’ beliefs about their illness and their medication are integral to their health care decisions [7]. Their findings were consistent with the CSM, which is based on Leventhal’s theory of self-regulation.

Self-regulation theory states that rational people will make decisions to reduce their health threat. Patients’ perceptions of their selves and environments drives their behavior. So in the presence of a health threat, a person will seek to eliminate or reduce that threat. However, coping behavior is complex. A person may decide to follow the advice of his clinician, follow some other advice (from family, friends, advertising, etc.), or do nothing. The premise of self-regulation is that people will choose a common sense approach to their health threat [8]. Therefore, clinicians must understand their patients’ viewpoint of themselves and their health condition so they may help guide them toward healthy outcomes.

The Common Sense Model

The CSM is a framework for understanding patient behavior when faced with a health threat. It holds that patients form common sense representations of their illness using information from 5 domains [8]: (1) the identity of the illness (the label the patient gives to the condition and symptoms); (2) the cause of the illness; (3) the consequences of the illness (beliefs about how the illness will impact the patient’s well-being); (4) whether the illness can be controlled or cured; and (5) timeline (beliefs about how long the condition will last). A patient may either act to address the health threat or choose to ignore it. Patient emotions are proposed to have a role on patient behavior along with the 5 dimensions of illness perception.

Illness Identity

Illness identity is the label patients place on the health threat; it is most likely not the same as the signs and symptoms clinicians use. Therefore, the first misconnect between physician and patient may be in describing the illness. Chen et al studied illness identity as perceived by patients with hypertension [9,10]. Illness identity was defined as (1) hypertension-related symptoms, (2) symptoms experienced before and after their diagnosis; and (3) symptoms used to predict high blood pressure. Although hypertension is asymptomatic, patients do perceive symptoms such as headache associated with their hypertension. The researchers found those patients who identified more symptoms were more likely to believe that their symptoms caused the hypertension and were correspondingly less likely to use their medication. For them, when the headache subsides, so does the hypertension.

Physicians should find out how patients assess their health condition and provide them tools for evaluating their response to medication. In the case of hypertension, the physician could have the patient check their blood pressure with and without the headache to demonstrate that hypertension occurs even when the patient is not “symptomatic.” The point is to converse with the patient to learn how they view their condition. Clinicians should resist the “urge” to correct patients. Taking time to help patients better understand their condition is important. A misstep:

Patient: I can tell when my blood pressure is high. I get a pounding headache.

Doctor: High blood pressure is an asymptomatic condition. Your headaches are not caused by your high blood pressure.

Patients may choose to ignore the clinician if they feel strongly about how they define their illness. It is better to listen to the patient and offer steps to learn about their health condition. Here is a better response from the physician:

Doctor: You are telling me that you can tell when your blood pressure is high. So when your head aches your pressure is high, right?

Patient: Yes.

Doctor: Let me tell you more about high blood pressure. High blood pressure is also present without headaches...

Illness Causes

There are multiple causative factors patients may associate with their disease. Causes attributed to disease may be based on patient experiences, input from family and friends, and cultural factors. Causes may include emotional state, stress or worry, overwork, genetic predisposition, or environmental factors (eg, pollution). Jessop and Rutter found patients who perceive their condition as due to uncontrollable factors, such as chance, germs, or pollution, were less likely to take their medication [11]. Similar findings were published by Chen et al [9]. They found psychological factors, environmental risk factors (eg, smoking, diet), and even bad luck or chance associated with less likelihood of taking medications as prescribed. Clinicians should explore patients’ perceptions of causes of a condition. Patients strive to eliminate the perceived cause, thus eliminating the need to take medication. In some cultures, bad luck or chance drives patients’ decisions to not take medication, or they believe in fate and do not accept treatment. Whether they feel they can control their condition by eliminating the cause or have a fatalistic view that the cause of their condition is not within their control, the clinician must work with the patient to reduce the impact of misperceptions or significance of perceived causes.

Illness Consequence

Consequence associated with the health condition is an important factor in patient behavior [12]. Patients must understand the specific threats to their health if a condition is left untreated or uncontrolled. Patients’ view of illness consequence may be formed by their own perceived vulnerability or susceptibility and the perceived seriousness of the condition. For example, patients with hypertension should be informed about the impact of high blood pressure on their bodies and the consequence of disability from stroke, dependency on dialysis from kidney failure, or death. They may not consider themselves susceptible to illness since they “feel healthy” and may decide to delay treatment. Patients with conditions such as asthma or heart failure may believe they are cured when their symptoms abate and therefore believe they have no more need for medication. Such patients need education to understand that they are asymptomatic because they are well controlled with medication.

Illness Control

Patients may feel they can control their health condition by changing their behavior, changing their environment, and/or by taking prescribed medication. As discussed earlier, cause and control both work together to form patient beliefs and actions. Patients will take their medications as prescribed if they believe in the effectiveness of medication to control their condition [11,13–15]. Interestingly, Ross found those who felt they had more control over their illness were more likely not to take their medication as prescribed [12]. These persons are more likely to not want to become “dependent” on medication. Their  feeling was that they can make changes in their lives and thereby improve their health condition.

Physicians should invite patients’ thoughts as to what should be done to improve their health condition, and collaborate with the patient on an action plan for change if change is expected to improve/control the health condition. Follow-up to assess the patient’s health status longitudinally is necessary.

In this exchange, the patient feels he can control his hypertension on his own:

Doctor: I recommend that you start taking medication to control your blood pressure. Uncontrolled high blood pressure can lead to many health problems.

Patient: I am not ready to start taking medication.

Doctor: What are your reasons?

Patient:  I am under a lot of stress at work. Once I get control of this stress, my blood pressure will go down.

Doctor: Getting control of your stress at work is important. Let me tell you more about high blood pressure.

Patient: Okay.

Doctor: There is no one cause of your high blood pressure. Eliminating your work stress will most likely not reduce your blood pressure....

Timeline

Health conditions can be  acute, chronic, or cyclical (ie, seasonal); however, patients may have different perceptions of the duration of their health condition. In Kucukarslan et al, some patients did not believe their hypertension was a lifelong condition because they felt they would be able to cure it [7]. For example, as illustrated above, patients may believe that stress causes their hypertension, and if the stress could be controlled, then their blood pressure would normalize. Conversely, Ross et al found that patients who viewed their hypertension as a long-term condition were more likely to believe their medications were necessary and thus more likely to take their medication as prescribed [12]. A lifelong or chronic health condition is a difficult concept for patients to accept, especially ones who may view themselves as too young to have the condition.

Emotions

After being informed about their health condition, patients may feel emotions that are not apparent to the practitioner. These may include worry, depression, anger, anxiety, or fear. Emotions may impact their decision to take medication [12,14]. Listening for patients’ responses to health information provided by the clinician and letting patients know they have been heard will help allay strong negative emotions [16]. Good communication builds trust between the clinician and patient.

Conclusion

Patients receive medical advice from clinicians that may be inconsistent with their beliefs and understanding of their health condition. Studies of medication nonadherence find many factors contribute to it and no one tool to improve medication adherence exists. However, the consequence of medication nonadherence are great and include  include worsening condition, increased comorbid disease, and increased health care costs. Understanding patients’ beliefs about their health condition is an important step toward reducing medication nonadherence. The CSM provides a framework for clinicians to guide patients toward effective decision-making. Listening to the patient explain how they view their condition—how they define it, the causes, consequences, how to control it, and how long it will last or if it will progress—are important to the process of working with the patient manage their condition effectively. Clinicians’ reaction  to these perceptions are important, and dismissing them may alienate patients. Effective communication is necessary to understand patients’ perspectives and to help them manage their health condition.

Corresponding author: Suzan N. Kucukarslan, PhD, RPh, [email protected].

Financial disclosures: None.

From Genoa-QoL Healthcare and the University of Michigan College of Pharmacy, Ann Arbor, MI.

Abstract

• Objective: To review the Common Sense Model, a framework that can be used for understanding patients’ behavior, including taking or not taking medications as prescribed.
• Methods: Descriptive report.
• Results: Medication adherence, a critical component of achieving good patient outcomes and reducing medical costs, is dependent upon patient illness beliefs. The Common Sense Model holds that these beliefs can be categorized as illness identity, cause, consequence, control, and timeline. Effective communication is necessary to understand the beliefs that patients hold and help them understand their condition. Good communication also can allay fears and other emotions that can be disruptive to achieving good outcomes.
• Conclusion: Clinicians should seek to understand their patients’ illness beliefs and collaborate with them  to achieve desired health outcomes.

Clinical practice is based on scientific evidence, by which medical problems are diagnosed and treatment recommendations are made. However, the role of the patient may not be completely recognized as an integral part of the process of patient care. The impact of failing to adequately recognize the patient perspective is evident in medication nonadherence. Health psychology research can provide clinicians insight into patients’ perceptions and behavior. This paper reviews the Common Sense Model (CSM), a behavioral model that provides a framework that can be used in understanding patients’ behavior. In this paper I will discuss the model and how it can be a possible strategy for improving adherence.

Making the Case for CSM in Daily Practice

It can be difficult to realize that persons seeking medical attention would not take medications as prescribed by a physician. In fact, studies reveal that on average, 16.4% of prescribed medications will not be picked up from the pharmacy [1]. Of those patients who do pick up their medication, approximately 1 out of 4 will not take them as prescribed [2]. Such medication nonadherence leads to poor health outcomes and increased health care costs [3,4]. There are many reasons for medication nonadherence [5], and there is no single solution to improving medication adherence [6]. A Cochrane review of randomized controlled trials evaluating various interventions intended to enhance patient adherence to prescribed medications for medical conditions found them to have limited effectiveness. Interventions assessed included health and medication information, reminder calls, follow-up assessment of medication therapy, social support, and simplification of the treatment regimen [6]. In an exploratory study of patients with chronic health conditions, Kucukarslan et al found patients’ beliefs about their illness and their medication are integral to their health care decisions [7]. Their findings were consistent with the CSM, which is based on Leventhal’s theory of self-regulation.

Self-regulation theory states that rational people will make decisions to reduce their health threat. Patients’ perceptions of their selves and environments drives their behavior. So in the presence of a health threat, a person will seek to eliminate or reduce that threat. However, coping behavior is complex. A person may decide to follow the advice of his clinician, follow some other advice (from family, friends, advertising, etc.), or do nothing. The premise of self-regulation is that people will choose a common sense approach to their health threat [8]. Therefore, clinicians must understand their patients’ viewpoint of themselves and their health condition so they may help guide them toward healthy outcomes.

The Common Sense Model

The CSM is a framework for understanding patient behavior when faced with a health threat. It holds that patients form common sense representations of their illness using information from 5 domains [8]: (1) the identity of the illness (the label the patient gives to the condition and symptoms); (2) the cause of the illness; (3) the consequences of the illness (beliefs about how the illness will impact the patient’s well-being); (4) whether the illness can be controlled or cured; and (5) timeline (beliefs about how long the condition will last). A patient may either act to address the health threat or choose to ignore it. Patient emotions are proposed to have a role on patient behavior along with the 5 dimensions of illness perception.

Illness Identity

Illness identity is the label patients place on the health threat; it is most likely not the same as the signs and symptoms clinicians use. Therefore, the first misconnect between physician and patient may be in describing the illness. Chen et al studied illness identity as perceived by patients with hypertension [9,10]. Illness identity was defined as (1) hypertension-related symptoms, (2) symptoms experienced before and after their diagnosis; and (3) symptoms used to predict high blood pressure. Although hypertension is asymptomatic, patients do perceive symptoms such as headache associated with their hypertension. The researchers found those patients who identified more symptoms were more likely to believe that their symptoms caused the hypertension and were correspondingly less likely to use their medication. For them, when the headache subsides, so does the hypertension.

Physicians should find out how patients assess their health condition and provide them tools for evaluating their response to medication. In the case of hypertension, the physician could have the patient check their blood pressure with and without the headache to demonstrate that hypertension occurs even when the patient is not “symptomatic.” The point is to converse with the patient to learn how they view their condition. Clinicians should resist the “urge” to correct patients. Taking time to help patients better understand their condition is important. A misstep:

Patient: I can tell when my blood pressure is high. I get a pounding headache.

Doctor: High blood pressure is an asymptomatic condition. Your headaches are not caused by your high blood pressure.

Patients may choose to ignore the clinician if they feel strongly about how they define their illness. It is better to listen to the patient and offer steps to learn about their health condition. Here is a better response from the physician:

Doctor: You are telling me that you can tell when your blood pressure is high. So when your head aches your pressure is high, right?

Patient: Yes.

Doctor: Let me tell you more about high blood pressure. High blood pressure is also present without headaches...

Illness Causes

There are multiple causative factors patients may associate with their disease. Causes attributed to disease may be based on patient experiences, input from family and friends, and cultural factors. Causes may include emotional state, stress or worry, overwork, genetic predisposition, or environmental factors (eg, pollution). Jessop and Rutter found patients who perceive their condition as due to uncontrollable factors, such as chance, germs, or pollution, were less likely to take their medication [11]. Similar findings were published by Chen et al [9]. They found psychological factors, environmental risk factors (eg, smoking, diet), and even bad luck or chance associated with less likelihood of taking medications as prescribed. Clinicians should explore patients’ perceptions of causes of a condition. Patients strive to eliminate the perceived cause, thus eliminating the need to take medication. In some cultures, bad luck or chance drives patients’ decisions to not take medication, or they believe in fate and do not accept treatment. Whether they feel they can control their condition by eliminating the cause or have a fatalistic view that the cause of their condition is not within their control, the clinician must work with the patient to reduce the impact of misperceptions or significance of perceived causes.

Illness Consequence

Consequence associated with the health condition is an important factor in patient behavior [12]. Patients must understand the specific threats to their health if a condition is left untreated or uncontrolled. Patients’ view of illness consequence may be formed by their own perceived vulnerability or susceptibility and the perceived seriousness of the condition. For example, patients with hypertension should be informed about the impact of high blood pressure on their bodies and the consequence of disability from stroke, dependency on dialysis from kidney failure, or death. They may not consider themselves susceptible to illness since they “feel healthy” and may decide to delay treatment. Patients with conditions such as asthma or heart failure may believe they are cured when their symptoms abate and therefore believe they have no more need for medication. Such patients need education to understand that they are asymptomatic because they are well controlled with medication.

Illness Control

Patients may feel they can control their health condition by changing their behavior, changing their environment, and/or by taking prescribed medication. As discussed earlier, cause and control both work together to form patient beliefs and actions. Patients will take their medications as prescribed if they believe in the effectiveness of medication to control their condition [11,13–15]. Interestingly, Ross found those who felt they had more control over their illness were more likely not to take their medication as prescribed [12]. These persons are more likely to not want to become “dependent” on medication. Their  feeling was that they can make changes in their lives and thereby improve their health condition.

Physicians should invite patients’ thoughts as to what should be done to improve their health condition, and collaborate with the patient on an action plan for change if change is expected to improve/control the health condition. Follow-up to assess the patient’s health status longitudinally is necessary.

In this exchange, the patient feels he can control his hypertension on his own:

Doctor: I recommend that you start taking medication to control your blood pressure. Uncontrolled high blood pressure can lead to many health problems.

Patient: I am not ready to start taking medication.

Doctor: What are your reasons?

Patient:  I am under a lot of stress at work. Once I get control of this stress, my blood pressure will go down.

Doctor: Getting control of your stress at work is important. Let me tell you more about high blood pressure.

Patient: Okay.

Doctor: There is no one cause of your high blood pressure. Eliminating your work stress will most likely not reduce your blood pressure....

Timeline

Health conditions can be  acute, chronic, or cyclical (ie, seasonal); however, patients may have different perceptions of the duration of their health condition. In Kucukarslan et al, some patients did not believe their hypertension was a lifelong condition because they felt they would be able to cure it [7]. For example, as illustrated above, patients may believe that stress causes their hypertension, and if the stress could be controlled, then their blood pressure would normalize. Conversely, Ross et al found that patients who viewed their hypertension as a long-term condition were more likely to believe their medications were necessary and thus more likely to take their medication as prescribed [12]. A lifelong or chronic health condition is a difficult concept for patients to accept, especially ones who may view themselves as too young to have the condition.

Emotions

After being informed about their health condition, patients may feel emotions that are not apparent to the practitioner. These may include worry, depression, anger, anxiety, or fear. Emotions may impact their decision to take medication [12,14]. Listening for patients’ responses to health information provided by the clinician and letting patients know they have been heard will help allay strong negative emotions [16]. Good communication builds trust between the clinician and patient.

Conclusion

Patients receive medical advice from clinicians that may be inconsistent with their beliefs and understanding of their health condition. Studies of medication nonadherence find many factors contribute to it and no one tool to improve medication adherence exists. However, the consequence of medication nonadherence are great and include  include worsening condition, increased comorbid disease, and increased health care costs. Understanding patients’ beliefs about their health condition is an important step toward reducing medication nonadherence. The CSM provides a framework for clinicians to guide patients toward effective decision-making. Listening to the patient explain how they view their condition—how they define it, the causes, consequences, how to control it, and how long it will last or if it will progress—are important to the process of working with the patient manage their condition effectively. Clinicians’ reaction  to these perceptions are important, and dismissing them may alienate patients. Effective communication is necessary to understand patients’ perspectives and to help them manage their health condition.

Corresponding author: Suzan N. Kucukarslan, PhD, RPh, [email protected].

Financial disclosures: None.