Let’s avoid accepting this headache paradigm as gospel

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Dr. Crain’s excellent review, “Breaking the cycle of medication overuse headache” (J Fam Pract. 2021;70:20-28) provides an approach to the diagnosis and treatment of this common disorder that is consistent with most expert opinion and published guidelines. However, like most articles on this subject, it is missing a critical review of the evidence that supports the existence of this condition and the recommended treatments. 

The strong association between intractable headaches and quantity of medication used makes the diagnosis of medication overuse headache (MOH) attractive with plausible (if unproven) pathophysiological mechanisms. However, reversing the direction of causation (intractable headaches lead to more medication) seems just as likely. While MOH is taken as an article of faith by most headache experts, high-quality studies in support of this theory have not yet been performed.1

On the other hand, fear of MOH often leads to rigid, arbitrary limitations of abortive medications, blaming of the patient for their symptoms, and the substitution of a host of pharmacologic and nonpharmacologic interventions that similarly lack evidence of efficacy. Patients with chronic migraine are told to take abortive medications early in the headache but not to take them more than twice per week. They hoard their medications while trying to decide if each daily headache is the “big one” that merits depleting their limited supply of medication.

Avoiding medication “overuse” and prescribing from our growing armamentarium of effective preventive medications remain important strategies. However, until we have better evidence, we need to be a little more flexible in prescribing abortive medications and avoid accepting the MOH paradigm as gospel.

David A. Silverstein, MD
Buffalo, NY

References

1. Vandenbussche N, Laterza D, Lisicki M, et al. Medication-overuse headache: a widely recognized entity amidst ongoing debate. J Headache Pain. 2018;19:50. https://doi.org/10.1186/s10194-018-0875-x

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Dr. Crain’s excellent review, “Breaking the cycle of medication overuse headache” (J Fam Pract. 2021;70:20-28) provides an approach to the diagnosis and treatment of this common disorder that is consistent with most expert opinion and published guidelines. However, like most articles on this subject, it is missing a critical review of the evidence that supports the existence of this condition and the recommended treatments. 

The strong association between intractable headaches and quantity of medication used makes the diagnosis of medication overuse headache (MOH) attractive with plausible (if unproven) pathophysiological mechanisms. However, reversing the direction of causation (intractable headaches lead to more medication) seems just as likely. While MOH is taken as an article of faith by most headache experts, high-quality studies in support of this theory have not yet been performed.1

On the other hand, fear of MOH often leads to rigid, arbitrary limitations of abortive medications, blaming of the patient for their symptoms, and the substitution of a host of pharmacologic and nonpharmacologic interventions that similarly lack evidence of efficacy. Patients with chronic migraine are told to take abortive medications early in the headache but not to take them more than twice per week. They hoard their medications while trying to decide if each daily headache is the “big one” that merits depleting their limited supply of medication.

Avoiding medication “overuse” and prescribing from our growing armamentarium of effective preventive medications remain important strategies. However, until we have better evidence, we need to be a little more flexible in prescribing abortive medications and avoid accepting the MOH paradigm as gospel.

David A. Silverstein, MD
Buffalo, NY

Dr. Crain’s excellent review, “Breaking the cycle of medication overuse headache” (J Fam Pract. 2021;70:20-28) provides an approach to the diagnosis and treatment of this common disorder that is consistent with most expert opinion and published guidelines. However, like most articles on this subject, it is missing a critical review of the evidence that supports the existence of this condition and the recommended treatments. 

The strong association between intractable headaches and quantity of medication used makes the diagnosis of medication overuse headache (MOH) attractive with plausible (if unproven) pathophysiological mechanisms. However, reversing the direction of causation (intractable headaches lead to more medication) seems just as likely. While MOH is taken as an article of faith by most headache experts, high-quality studies in support of this theory have not yet been performed.1

On the other hand, fear of MOH often leads to rigid, arbitrary limitations of abortive medications, blaming of the patient for their symptoms, and the substitution of a host of pharmacologic and nonpharmacologic interventions that similarly lack evidence of efficacy. Patients with chronic migraine are told to take abortive medications early in the headache but not to take them more than twice per week. They hoard their medications while trying to decide if each daily headache is the “big one” that merits depleting their limited supply of medication.

Avoiding medication “overuse” and prescribing from our growing armamentarium of effective preventive medications remain important strategies. However, until we have better evidence, we need to be a little more flexible in prescribing abortive medications and avoid accepting the MOH paradigm as gospel.

David A. Silverstein, MD
Buffalo, NY

References

1. Vandenbussche N, Laterza D, Lisicki M, et al. Medication-overuse headache: a widely recognized entity amidst ongoing debate. J Headache Pain. 2018;19:50. https://doi.org/10.1186/s10194-018-0875-x

References

1. Vandenbussche N, Laterza D, Lisicki M, et al. Medication-overuse headache: a widely recognized entity amidst ongoing debate. J Headache Pain. 2018;19:50. https://doi.org/10.1186/s10194-018-0875-x

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Sizing up EMRs and patient care from the other side of the bed rail

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Dr. Unger’s guest editorial, “Med students: Look up from your EMRs” (J Fam Pract. 2015;64:517-518), vividly describes what those who have been paying attention see quite clearly: Not only has the widespread implementation of electronic medical records (EMRs) failed to deliver all it has promised, but it has made patient care worse. Many students and members of the health care team spend as little time as possible talking and listening to patients. Instead, the goal is to complete every box in our EMRs to qualify for meaningful use payments and whatever “quality” incentives are available in our local environment.

That said, I believe EMRs are very good at doing the things computers do well, and I hope I never again have to rifle through a paper chart the size of a phone book to find a critical piece of information. The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story, and the resulting diversion of the entire health care team away from caring for the patients we are supposedly here to serve.

I am tired of complaining to my patients, partners, family, friends, and anyone else who will listen. It is time for family medicine to reclaim its role as “counterculture” and lead the charge for comprehensive, continuous, compassionate care—whose centerpiece is actually talking to, listening to, and examining patients.

David A. Silverstein, MD
Buffalo, NY

The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story.

While I agree with Dr. Unger about EMRs, I respectfully disagree with his approach when he suspected he had appendicitis. When he initially ordered his own computed tomography scan, rather than seeing his own doctor or going to the emergency department, he (inadvertently) “assigned” himself as his own doctor. He then should have at least offered his history in the hospital, rather than making it a test for the student and the hospital. It sounds like an adversarial situation developed, which did not help matters. Good that he’s doing OK!

Michael Kelly, MD
Minneapolis, Minn

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Dr. Unger’s guest editorial, “Med students: Look up from your EMRs” (J Fam Pract. 2015;64:517-518), vividly describes what those who have been paying attention see quite clearly: Not only has the widespread implementation of electronic medical records (EMRs) failed to deliver all it has promised, but it has made patient care worse. Many students and members of the health care team spend as little time as possible talking and listening to patients. Instead, the goal is to complete every box in our EMRs to qualify for meaningful use payments and whatever “quality” incentives are available in our local environment.

That said, I believe EMRs are very good at doing the things computers do well, and I hope I never again have to rifle through a paper chart the size of a phone book to find a critical piece of information. The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story, and the resulting diversion of the entire health care team away from caring for the patients we are supposedly here to serve.

I am tired of complaining to my patients, partners, family, friends, and anyone else who will listen. It is time for family medicine to reclaim its role as “counterculture” and lead the charge for comprehensive, continuous, compassionate care—whose centerpiece is actually talking to, listening to, and examining patients.

David A. Silverstein, MD
Buffalo, NY

The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story.

While I agree with Dr. Unger about EMRs, I respectfully disagree with his approach when he suspected he had appendicitis. When he initially ordered his own computed tomography scan, rather than seeing his own doctor or going to the emergency department, he (inadvertently) “assigned” himself as his own doctor. He then should have at least offered his history in the hospital, rather than making it a test for the student and the hospital. It sounds like an adversarial situation developed, which did not help matters. Good that he’s doing OK!

Michael Kelly, MD
Minneapolis, Minn

Dr. Unger’s guest editorial, “Med students: Look up from your EMRs” (J Fam Pract. 2015;64:517-518), vividly describes what those who have been paying attention see quite clearly: Not only has the widespread implementation of electronic medical records (EMRs) failed to deliver all it has promised, but it has made patient care worse. Many students and members of the health care team spend as little time as possible talking and listening to patients. Instead, the goal is to complete every box in our EMRs to qualify for meaningful use payments and whatever “quality” incentives are available in our local environment.

That said, I believe EMRs are very good at doing the things computers do well, and I hope I never again have to rifle through a paper chart the size of a phone book to find a critical piece of information. The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story, and the resulting diversion of the entire health care team away from caring for the patients we are supposedly here to serve.

I am tired of complaining to my patients, partners, family, friends, and anyone else who will listen. It is time for family medicine to reclaim its role as “counterculture” and lead the charge for comprehensive, continuous, compassionate care—whose centerpiece is actually talking to, listening to, and examining patients.

David A. Silverstein, MD
Buffalo, NY

The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story.

While I agree with Dr. Unger about EMRs, I respectfully disagree with his approach when he suspected he had appendicitis. When he initially ordered his own computed tomography scan, rather than seeing his own doctor or going to the emergency department, he (inadvertently) “assigned” himself as his own doctor. He then should have at least offered his history in the hospital, rather than making it a test for the student and the hospital. It sounds like an adversarial situation developed, which did not help matters. Good that he’s doing OK!

Michael Kelly, MD
Minneapolis, Minn

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Are these CAD study findings too good to be true?

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I read with interest “A way to reverse CAD?” by Esselstyn et al (J Fam Pract. 2014;63:356-364,364a,364b) on the effects of a plant-based nutrition program on the incidence of cardiac events in patients with cardiovascular disease (CVD). If found to be effective in subsequent studies, this intervention could have tremendous clinical implications for patients. However, the article left me with many questions and concerns.

One of my concerns is that the article was written in a promotional, not scientific, tone. Although no potential conflicts of interest were reported, the lead author has published books on the topic from which he could profit. Even if one were to disregard these concerns, several methodological issues remain.

Specifically, Esselstyn et al report that over a mean 3.7 years of follow-up, 89% of patients were compliant to the program, defined as avoidance of all meat, fish, dairy, and added oils. Frankly, this statistic isn’t believable because the “compliant” patients undoubtedly consumed these products on occasion during this period. More likely, compliance was assessed by a simple Yes or No response over the phone; expectation bias would strongly influence patient reporting in this situation.

In addition, there’s no comparison of disease severity, prior interventions, weight loss, assessment of optimized medical management, or follow-up duration between the 2 groups. The differences in events reported in this study may be explained by unreported confounders.

The authors should be congratulated for presenting this work, but overall, the reporting is inadequate to form any scientific conclusions. The data lead to more questions than answers.

Larry E. Miller, PhD
Asheville, NC


Esselstyn et al report an extraordinary recurrent event rate of 0.6% among 177 patients with established cardiovascular disease who adhered to a plant-based diet for approximately 44 months. These results are so remarkable that several questions come to mind. Why didn’t the editors of The Journal of Family Practice offer any commentary on a revolutionary intervention that appears to cure cardiovascular disease? Why aren’t these results being reported and commented upon in the lay media? Why didn’t the journal note Dr. Esselstyn’s potential conflict of interest as an author who profits from the sale of books that advocate a plant-based diet?

I am glad to see studies that look at nutritional interventions getting equal billing with those funded by pharmaceutical companies, but publishing this report without comment certainly leads a reader to believe that the editors and peer reviewers accept this study at face value, and that physicians might practice accordingly.

David A. Silverstein, MD
Buffalo, NY


Authors' response:
We agree with the major point of Dr. Miller’s comments—this safe, inexpensive, and effective diet works so well at reducing coronary and other vascular disease that it raises more questions than answers, and deserves study by other groups. There was no intent to obscure the senior author’s 2007 book, Prevent and Reverse Heart Disease1; as it is mentioned in the article, a copy of the book was provided to each study participant, and it was listed among the references.

We agree that using standardized, validated instruments to evaluate dietary intake, such as food frequency questionnaires or 3- to 7-day food records, would provide more scientifically sound methodology, but we were able to assess several key features of the diet, including the 2 key ones, abstinence from animal food intake and avoidance of all oils, without such tools. Most patients transitioned to the whole foods plant-based diet from the meat and processed foods dietary pattern, with only a few eating ovo-lacto or lacto-vegetarian diets before participating in the study.

Regarding disease severity, 44 participants had a prior myocardial infarction and 119 had a prior percutaneous coronary intervention or coronary artery bypass graft surgery. Twenty-seven were scheduled for intervention that was unnecessary after they adopted the program. The frustration of current cardiovascular therapy and the potential of plant-based nutrition are succinctly expressed in our recent series of case reports.2

Caldwell B. Esselstyn Jr, MD
Mladen Golubic, MD, PhD
Michael F. Roizen, MD
Lyndhurst, Ohio

References

1. Esselstyn CB Jr. Prevent and Reverse Heart Disease. New York, New York: Penguin Group; 2007.

2. Esselstyn CB, Golubic M. The nutritional reversal of cardiovascular disease—fact or fiction? Three case reports. Exp Clin Cardiol. 2014;20:1901-1908.

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I read with interest “A way to reverse CAD?” by Esselstyn et al (J Fam Pract. 2014;63:356-364,364a,364b) on the effects of a plant-based nutrition program on the incidence of cardiac events in patients with cardiovascular disease (CVD). If found to be effective in subsequent studies, this intervention could have tremendous clinical implications for patients. However, the article left me with many questions and concerns.

One of my concerns is that the article was written in a promotional, not scientific, tone. Although no potential conflicts of interest were reported, the lead author has published books on the topic from which he could profit. Even if one were to disregard these concerns, several methodological issues remain.

Specifically, Esselstyn et al report that over a mean 3.7 years of follow-up, 89% of patients were compliant to the program, defined as avoidance of all meat, fish, dairy, and added oils. Frankly, this statistic isn’t believable because the “compliant” patients undoubtedly consumed these products on occasion during this period. More likely, compliance was assessed by a simple Yes or No response over the phone; expectation bias would strongly influence patient reporting in this situation.

In addition, there’s no comparison of disease severity, prior interventions, weight loss, assessment of optimized medical management, or follow-up duration between the 2 groups. The differences in events reported in this study may be explained by unreported confounders.

The authors should be congratulated for presenting this work, but overall, the reporting is inadequate to form any scientific conclusions. The data lead to more questions than answers.

Larry E. Miller, PhD
Asheville, NC


Esselstyn et al report an extraordinary recurrent event rate of 0.6% among 177 patients with established cardiovascular disease who adhered to a plant-based diet for approximately 44 months. These results are so remarkable that several questions come to mind. Why didn’t the editors of The Journal of Family Practice offer any commentary on a revolutionary intervention that appears to cure cardiovascular disease? Why aren’t these results being reported and commented upon in the lay media? Why didn’t the journal note Dr. Esselstyn’s potential conflict of interest as an author who profits from the sale of books that advocate a plant-based diet?

I am glad to see studies that look at nutritional interventions getting equal billing with those funded by pharmaceutical companies, but publishing this report without comment certainly leads a reader to believe that the editors and peer reviewers accept this study at face value, and that physicians might practice accordingly.

David A. Silverstein, MD
Buffalo, NY


Authors' response:
We agree with the major point of Dr. Miller’s comments—this safe, inexpensive, and effective diet works so well at reducing coronary and other vascular disease that it raises more questions than answers, and deserves study by other groups. There was no intent to obscure the senior author’s 2007 book, Prevent and Reverse Heart Disease1; as it is mentioned in the article, a copy of the book was provided to each study participant, and it was listed among the references.

We agree that using standardized, validated instruments to evaluate dietary intake, such as food frequency questionnaires or 3- to 7-day food records, would provide more scientifically sound methodology, but we were able to assess several key features of the diet, including the 2 key ones, abstinence from animal food intake and avoidance of all oils, without such tools. Most patients transitioned to the whole foods plant-based diet from the meat and processed foods dietary pattern, with only a few eating ovo-lacto or lacto-vegetarian diets before participating in the study.

Regarding disease severity, 44 participants had a prior myocardial infarction and 119 had a prior percutaneous coronary intervention or coronary artery bypass graft surgery. Twenty-seven were scheduled for intervention that was unnecessary after they adopted the program. The frustration of current cardiovascular therapy and the potential of plant-based nutrition are succinctly expressed in our recent series of case reports.2

Caldwell B. Esselstyn Jr, MD
Mladen Golubic, MD, PhD
Michael F. Roizen, MD
Lyndhurst, Ohio

I read with interest “A way to reverse CAD?” by Esselstyn et al (J Fam Pract. 2014;63:356-364,364a,364b) on the effects of a plant-based nutrition program on the incidence of cardiac events in patients with cardiovascular disease (CVD). If found to be effective in subsequent studies, this intervention could have tremendous clinical implications for patients. However, the article left me with many questions and concerns.

One of my concerns is that the article was written in a promotional, not scientific, tone. Although no potential conflicts of interest were reported, the lead author has published books on the topic from which he could profit. Even if one were to disregard these concerns, several methodological issues remain.

Specifically, Esselstyn et al report that over a mean 3.7 years of follow-up, 89% of patients were compliant to the program, defined as avoidance of all meat, fish, dairy, and added oils. Frankly, this statistic isn’t believable because the “compliant” patients undoubtedly consumed these products on occasion during this period. More likely, compliance was assessed by a simple Yes or No response over the phone; expectation bias would strongly influence patient reporting in this situation.

In addition, there’s no comparison of disease severity, prior interventions, weight loss, assessment of optimized medical management, or follow-up duration between the 2 groups. The differences in events reported in this study may be explained by unreported confounders.

The authors should be congratulated for presenting this work, but overall, the reporting is inadequate to form any scientific conclusions. The data lead to more questions than answers.

Larry E. Miller, PhD
Asheville, NC


Esselstyn et al report an extraordinary recurrent event rate of 0.6% among 177 patients with established cardiovascular disease who adhered to a plant-based diet for approximately 44 months. These results are so remarkable that several questions come to mind. Why didn’t the editors of The Journal of Family Practice offer any commentary on a revolutionary intervention that appears to cure cardiovascular disease? Why aren’t these results being reported and commented upon in the lay media? Why didn’t the journal note Dr. Esselstyn’s potential conflict of interest as an author who profits from the sale of books that advocate a plant-based diet?

I am glad to see studies that look at nutritional interventions getting equal billing with those funded by pharmaceutical companies, but publishing this report without comment certainly leads a reader to believe that the editors and peer reviewers accept this study at face value, and that physicians might practice accordingly.

David A. Silverstein, MD
Buffalo, NY


Authors' response:
We agree with the major point of Dr. Miller’s comments—this safe, inexpensive, and effective diet works so well at reducing coronary and other vascular disease that it raises more questions than answers, and deserves study by other groups. There was no intent to obscure the senior author’s 2007 book, Prevent and Reverse Heart Disease1; as it is mentioned in the article, a copy of the book was provided to each study participant, and it was listed among the references.

We agree that using standardized, validated instruments to evaluate dietary intake, such as food frequency questionnaires or 3- to 7-day food records, would provide more scientifically sound methodology, but we were able to assess several key features of the diet, including the 2 key ones, abstinence from animal food intake and avoidance of all oils, without such tools. Most patients transitioned to the whole foods plant-based diet from the meat and processed foods dietary pattern, with only a few eating ovo-lacto or lacto-vegetarian diets before participating in the study.

Regarding disease severity, 44 participants had a prior myocardial infarction and 119 had a prior percutaneous coronary intervention or coronary artery bypass graft surgery. Twenty-seven were scheduled for intervention that was unnecessary after they adopted the program. The frustration of current cardiovascular therapy and the potential of plant-based nutrition are succinctly expressed in our recent series of case reports.2

Caldwell B. Esselstyn Jr, MD
Mladen Golubic, MD, PhD
Michael F. Roizen, MD
Lyndhurst, Ohio

References

1. Esselstyn CB Jr. Prevent and Reverse Heart Disease. New York, New York: Penguin Group; 2007.

2. Esselstyn CB, Golubic M. The nutritional reversal of cardiovascular disease—fact or fiction? Three case reports. Exp Clin Cardiol. 2014;20:1901-1908.

References

1. Esselstyn CB Jr. Prevent and Reverse Heart Disease. New York, New York: Penguin Group; 2007.

2. Esselstyn CB, Golubic M. The nutritional reversal of cardiovascular disease—fact or fiction? Three case reports. Exp Clin Cardiol. 2014;20:1901-1908.

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Endometrial Sampling Analysis of 310 Procedures Performed by Family Physicians

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