Monday, April 15, 2019

Migraine prevention - what's changed?

- Michael J. Arnold, MD

Since getting a migraine headache every Friday during junior high school, I have always been interested in preventing migraines. In medical school, I realized that it was likely the nitrates in the hot dogs served on Fridays at the school cafeteria that were to blame – perhaps with a boost from adolescent hormones.

Powerful Placebo Effect

A recent study on migraine prevention in children opened my eyes to the power of the placebo effect. A 2017 National Institutes of Health-sponsored trial comparing topiramate (the only FDA approved drug for migraine prophylaxis in children) and amitriptyline was stopped early because placebo was more effective than either active drug. Although both medications were effective, placebo was even better, producing a 50% reduction in headache frequency in 61% of children assigned to that arm of the study.

In adult studies, the placebo effect is nearly as strong. Between 20 and 50% of patients achieve a 50% reduction in headache frequency with placebo, and few medications do much better. While a portion of this is likely due to the waxing course of migraine, the placebo response rate tends to be over 20% even for patients with more than 15 migraines per month. The best medications, including topiramate, valproate, and some beta blockers, help 25% more people than placebo halve their migraine frequency, leading to a Number Needed to Treat (NNT) of four. Amitriptyline works 9% better than placebo, with a NNT of 12.

Complementary Therapy

If matching placebo gives at least a 25% response rate, could it be worth trying a safe herbal medication with some evidence of being better? Herbal medications such as feverfew, 6.25 mg three times daily, riboflavin 400 mg daily and magnesium 600 mg daily have limited evidence of being better than placebo with only mild side effects. Another small trial suggested that nightly melatonin was better at reducing migraines than amitriptyline and placebo, with the only common side effect being fatigue. Acupuncture has a NNT of 10 for halving the number of migraines when compared to sham acupuncture, but only 4 when compared to usual care.

A complementary therapy to avoid is butterbur (petasites), which has the best evidence for benefit but can be hepatotoxic. Without FDA regulation of the supplement industry, use is not recommended in the United States.

New Injections for Migraine Prevention

You may have heard of erenumab, a monthly injected medication for migraine prevention comprised of antibodies focused on the calcium gene related peptide system. Erenumab is joined by similar medications fremanezumab and galcanezumab, all of which are priced at $575 per monthly injection, compared to the $150 retail price for 60 tabs of topiramate at 50 mg. These injections have evidence of benefit over placebo with NNTs of either 5 or 6 to reduce headache frequency by 50%.

The American Headache Association recommends trying at least two other medication classes before prescribing these injections, but most studies of these drugs specifically excluded patients who had failed multiple previous medications. A single trial did study erenumab in patients who had failed two medications, and the 50% headache frequency reduction was met in 14% with placebo and 30% with erenumab, leading to a NNT of 7.

Short term side effects were rare and minor (injection site reactions and constipation). However, none of these trials followed patients for longer than three months. These medicines may be valuable for selected patients, but much is yet to be proven. An article in the January 1, 2019 issue of AFP covers migraine prophylaxis in more depth.

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Dr. Arnold is AFP's 2019-20 Jay Siwek Medical Editing Fellow. The views expressed in this blog post are those of the author and do not necessarily reflect the official policy or position of the Department of the Navy, Uniformed Services University of the Health Sciences, Department of Defense, or the U.S. Government.

Monday, April 8, 2019

Reimagining advance care planning for patients with serious illness

- Kenny Lin, MD, MPH

It is difficult to overstate the damage done by the fictional political term "death panel," which claimed that a 2009 legislative proposal to pay physicians for providing counseling to Medicare patients about advance directives and end-of-life care options amounted to a group of federal bureaucrats deciding whether an older or disabled person would be permitted to live or die. Not until 2016 did the Centers for Medicare & Medicaid Services (CMS) create Current Procedural Terminology (CPT) codes that allowed billing for advance care planning services, and clinicians have been slow to use them. According to a recent study in JAMA Internal Medicine, only about 2% of Medicare fee-for-service beneficiaries age 65 years or older had advance care planning visits. As expected, geriatricians and palliative medicine specialists were more likely to use the codes than other physicians. Even so, two-thirds of hospice and palliative medicine specialists did not use the codes at all in 2017, which suggested that billing did not reflect actual counseling practices.

Other articles have documented the challenges of incorporating patients' values and preferences into care plans when they are already experiencing serious illness. An analysis of recorded clinician-family conferences about critically ill patients found that in more than half, "there was no deliberation about how to apply patients' values and preferences in the current clinical situation," and in 1 out of every 4 discussions, the patient's values and preferences were not even mentioned. Similarly, a medical oncologist reflected in Health Affairs about the care team's failure to manage expectations of a patient with advanced (and ultimately fatal) lung cancer who, "because she was looking for rescue," declined to discuss goals of care as an outpatient even as treatments proved ineffective and her health deteriorated:

I'm not sure how well we managed Wendy's care at the end of her life. On the one hand, she achieved her short-term goal of attending the family gathering. On the other hand, she spent nearly the entire last month of her life hospitalized. She died in an intensive care unit, intubated, on a ventilator, and unable to say goodbye to love ones. She was not enrolled in hospice. We don't know whether we met Wendy's goals of care because we never managed to define them.

Two editorials in the March 1 issue of AFP addressed how family physicians can prepare patients better for end-of-life decisions by "thinking about [advance care planning] as an iterative and integrative process," rather than as a document to be filled out and then filed away. Primary care teams can use the Serious Illness Conversation Guide to assess patients' understanding of their illness, explore what matters most to them, and communicate goals of care to family members and subspecialists. Lack of training and time constraints remain barriers, however. Innovative residency curricula on advance care planning, such as this medical-legal partnership described in Family Medicine, may improve physicians' comfort level with these conversations. Having Medicare and private insurers pay for advance care planning discussions is a helpful first step, but as Drs. Joanna Paladino and Erik Fromme observed, "clinicians cannot improve the care of people with serious illness alone—to be successful, they need health system changes that support better conversations over the continuum of care."

Monday, April 1, 2019

Introducing Dr. Mike Arnold, the first Jay Siwek Medical Editing Fellow

- Jennifer Middleton, MD, MPH

It's my pleasure to introduce the first Jay Siwek Medical Editing Fellow at AFP, Dr. Mike Arnold, whose fellowship year began on March 1. Here are some highlights from a recent interview I had the privilege to conduct with Dr. Arnold:

Tell us a little about yourself and your background.

I’m a bit of a late-comer to medicine. The Navy paid for my college in exchange for weekly marching and four years of service after graduation. They sent me to submarines, and I stayed for eight years. My medical training was through Uniformed Services University (USU), the only medical school where students are paid a salary to attend. In my opinion, NYU’s tuition-free plan is only starting to catch up to that hidden gem. In the thirteen years since graduation, I’ve been stationed as far away as Naples, Italy and the Pacific island of Guam. I recently served as residency faculty at the Naval Hospital in Jacksonville, Florida where I was trained. I’ve been able to practice in tents, ships and run-down gymnasiums. The Navy returned me to USU as faculty last year, where I am blown away by the intelligence and enthusiasm of our medical students.

What got you interested in medical editing and writing?

The journals. Military family physicians have a tradition of packing a large stack of journals when going on deployment. We also love apps because they lighten our load. We often fall behind at our stateside hospitals, but during deployment we read voraciously. Being stationed overseas with limited specialists leads to the same. I believe that this is why you see so many journal authors with military rank. We have come to read, appreciate and depend on them, so we aspire to contribute.

What are you hoping to get out of the fellowship?

I have learned so much about writing articles from editors. I relish trying to assemble evidence to help colleagues in their daily work. Everything I have written has been vastly improved by peer reviewers and editors, the best of whom are able to say “I see what you were trying to do there, but this sentence is very confusing.” I want to get that skill: the ability to partner with authors to improve an article without taking over or losing the author’s voice. I also want to see what the secret formula is for selecting topics to keep thousands of colleagues up to date in the broadest medical specialty.

Is there anything else you'd like AFP readers to know about you?

Just that I try to be well rounded. I’m an intermittent scuba diver, skier, marathon runner, swimmer, biker and sailor. I am getting older and question how long before I have to take things off that list. I spent two years as a Ford engineer designing a V6 engine upgrade and still like to tinker. I’ve been married for twenty years and we have a nineteen year-old college sophomore who is passionately pursuing economics.

Michael J. Arnold, MD
CDR, MC, USN
Uniformed Services University

The views expressed in this article are those of the author and do not necessarily reflect the official policy or position of the Department of the Navy, Uniformed Services University of the Health Sciences, Department of Defense, or the U.S. Government.

Tuesday, March 26, 2019

Apps can detect atrial fibrillation, but benefits and harms are uncertain

- Kenny Lin, MD, MPH

The March 15 issue of AFP included a recommendation statement from the U.S. Preventive Services Task Force (USPSTF) and Putting Prevention Into Practice case study on screening for atrial fibrillation with electrocardiography (ECG). The USPSTF concluded that current evidence is insufficient to assess the balance of benefits and harms of testing for atrial fibrillation in primary care patients without suggestive symptoms. In an accompanying editorial, Drs. John Mandrola and Andrew Foy discussed several potential downsides of ECG screening for atrial fibrillation: low prevalence, a high number needed to screen to prevent one stroke, high costs, false positive results, and uncertainty about the effects of anticoagulants in persons with subclinical atrial fibrillation.

At the American College of Cardiology meeting last week, Dr. Mandrola interviewed Dr. Mintu Turakhia, a co-principal investigator of the Apple Heart Study, regarding initial findings reported at the conference. More than 400,000 U.S. adults with Apple Watches installed an app that used an algorithm to analyze heart rate variability and notified users if five out of six samples over a 48-hour period suggested an irregular heart rate. Of the 2100 individuals (~0.5%) who received these notifications, the positive predictive value for ECG-confirmed atrial fibrillation was 84%. The app's sensitivity and false negative rate are unknown because users who did not receive notifications did not have ECG monitoring. Also, the study was not designed to evaluate health outcomes.

A planned pragmatic randomized trial will enroll adults age 65 years and older to determine if screening for atrial fibrillation and other heart rhythm abnormalities using the Apple Watch app leads to reduced stroke rates and/or improved cardiovascular health. In the meantime, family physicians will likely start seeing more patients for evaluation of possible cardiac rhythm abnormalities detected by wearable devices. A recent JAMA article reviewed the limitations of such devices at detecting atrial fibrillation, tachycardia, and bradycardia and offered a suggested approach to evaluation and management.

Monday, March 18, 2019

Connecting chronic stress and disease

- Jennifer Middleton, MD, MPH

The March 1 issue of AFP includes a feature article on "Gas, Bloating, and Belching: Approach to Evaluation and Management" which discusses the high prevalence of functional gastrointestinal disorders (FGIDs). The authors note that "[t]hese disorders are characterized by disordered motility and visceral hypersensitivity that are often worsened by psychological distress." FGIDs, of course, are far from the only conditions precipitated or worsened by stress; a new study out last week found a correlation between years of stressful employment and type 2 diabetes in women. Increasingly, a history of highly stressful experiences, such as interpersonal violence (IPV) and/or adverse childhood experiences (ACEs), has been linked to diabetes, cardiovascular disease, and cancer. Identifying and responding to our patients' stress, regardless of degree or cause, may help them to lead healthier lives.

A recent article in Annals of Family Medicine elucidates the relationship between stress and physical symptoms:
Chronic stress profoundly impacts the body’s cardiovascular, endocrine, and immune systems, increasing the risk of atherosclerosis, diabetes, and infection. Even when controlling for traditional risk factors, diseases like obesity, heart disease, asthma, and even certain cancers are more likely to occur in survivors of violence. The link between medical disease and history of abuse, however, is often obscured by the way these patients present: survivors rarely volunteer their histories of violence, often making somatic and nonspecific complaints the only tip-off to a deeper problem.
A willingness to explore our patients' sources of stress, and potentially dive into deeper issues, is a critical first step to making these connections. The BATHE technique is one way to explore these issues; there are also tools available to screen for a history of ACEs and/or IPV.

Several resources exist to help our patients respond to their stress. The American Academy of Pediatrics has information on their website to enable practices to become trauma-centered to better help patients with a history of ACEs. The National Domestic Violence Hotline website has resources for patients who are experiencing IPV, and additional local resources may be available in your area as well. Family physicians may choose to provide counseling in their offices and/or refer to a local counseling center. Basic stress management techniques can benefit most patients, regardless of the severity of their stress; familydoctor.org has a page on "Managing Daily Stress" with practical, simple steps.

Our willingness to engage with our patients' stressors, and normalize the strength of the mind-body connection, may help them improve their health-related quality of life. As family physicians who often have meaningful, long-standing relationships with our patients, we are well-suited to engage in these processes.

Monday, March 11, 2019

Guest Post: Family doctors can easily treat hepatitis B "in-house"

- Richard Andrews, MD, MPH

In 2008, I replaced another family physician as the sole physician at HOPE Clinic, a federally qualified health center in southwest Houston. The clinic was founded by members of the local Asian community to ensure that Asians would have a place to receive linguistically and culturally-appropriate medical care. From the outset, we treated anyone who came in the door, including many non-Asian patients. Due to our core mission, we cared for a large proportion of foreign-born patients from all over the world, speaking more than eighty different languages.

Many of our patients' countries of origin, including China, Vietnam, Myanmar, Iraq, and Nigeria, have a high (>= 8%) or intermediate (2-7%) prevalence of chronic hepatitis B (CHB), leading to a high prevalence in our patients. Initially, they were reflexively referred to hepatologists, but due to access and cost barriers, the community asked us to start treating hepatitis B right at HOPE.

I was an experienced, board-certified family physician, but I had never done any hepatitis B management. I sought training with local hepatologists, mostly through lectures and question-and-answer sessions, and gradually became comfortable with the vocabulary, epidemiology, concepts, and pharmacology of care for patients with hepatitis B.

Because of the HOPE Clinic's origins, most of our hepatitis B patients are of Asian ancestry. In the United States as a whole, roughly half of patients with CHB are of Asian descent, but in your community you might find a different ethnic/language mix. We are seeing an increasing number of non-Asian patients with CHB, including younger native-born Anglo patients with a history of unsafe drug use. Significantly, many American adults have not received hepatitis B vaccinations, leaving them susceptible to infection from sex, injection drug use, or snorting cocaine.

Different social approaches to drug use and addiction in some European countries (such as Portugal) have coincided with marked reductions in the number of new cases of viral hepatitis and HIV. Conversely, infection rates in Americans appear to be increasing. Now that a two-dose hepatitis B vaccine is available, family doctors have a valuable role to play in screening and immunizing susceptible patients, and in managing their patients with CHB.

Factors that make uncomplicated CHB care easy to learn for family physicians

Factor
Remarks

Many patients don’t need antiviral medications

These visits are particularly simple

Very few medications are used, usually just one at a time

1.       Entecavir
2.       Two forms of tenofovir:  TAF or TDF
3.       Interferon use is rare at primary care level
4.       Older medications not used in USA due to resistance

Medications are well tolerated

One pill per day, side effects are uncommon

Medications are effective

Most patients achieve viral levels below the limits of detection, viral resistance is uncommon.

Straightforward liver cancer surveillance

RUQ abdomen ultrasound and serum AFP every six months in cirrhotics.
Other patients:  RUQ u/s + AFP q 6-12 mos. based on guidelines.
Consider CT/MRI as appropriate

Infrequent visits needed

Once patient is established, 2-3 visits per year is a typical pattern

Telehealth/telemedicine

The availability of free online-video specialist consultation is increasing.
Example:  check for availability in your region, at https://echo.unm.edu/locations-2/echo-hubs-superhubs-united-states/

Though there are only two listed ECHO hepatitis B-specific programs in the USA, there are 64 infectious disease programs, many of which include viral hepatitis

Knowing when to refer

Decompensated cirrhosis:  ascites, esophageal variceal bleed, hepatic encephalopathy, bacterial peritonitis, hepatorenal syndrome, liver cancer.