Headache & Migraine

Key clinical point: Interictal plasma amylin levels are higher in patients with chronic migraine and may serve as a better diagnostic marker than calcitonin gene-related peptide (CGRP).

Major finding: Plasma amylin levels were higher in chronic migraine patients than in episodic migraine patients and healthy controls (both P less than. 0001). Diagnostic performance was better with plasma amylin than CGRP in differentiating chronic migraine from healthy controls in adults.

Study details: The data come from a prospective case-controlled study involving 191 patients with chronic migraine, 58 patients with episodic migraine, and 68 healthy controls.

Disclosures: This study was funded by the Spanish Research Network on Cerebrovascular Diseases, Center for Applied Medical Research, University of Navarra, and Spanish Ministry of Economy and Competitiveness. The authors declared no conflicts of interest.

Source: Irimia P et al. Cephalalgia. 2020 Dec 3. doi: 10.1177/0333102420977106.

Key clinical point: Interictal plasma amylin levels are higher in patients with chronic migraine and may serve as a better diagnostic marker than calcitonin gene-related peptide (CGRP).

Major finding: Plasma amylin levels were higher in chronic migraine patients than in episodic migraine patients and healthy controls (both P less than. 0001). Diagnostic performance was better with plasma amylin than CGRP in differentiating chronic migraine from healthy controls in adults.

Study details: The data come from a prospective case-controlled study involving 191 patients with chronic migraine, 58 patients with episodic migraine, and 68 healthy controls.

Disclosures: This study was funded by the Spanish Research Network on Cerebrovascular Diseases, Center for Applied Medical Research, University of Navarra, and Spanish Ministry of Economy and Competitiveness. The authors declared no conflicts of interest.

Source: Irimia P et al. Cephalalgia. 2020 Dec 3. doi: 10.1177/0333102420977106.

Key clinical point: Interictal plasma amylin levels are higher in patients with chronic migraine and may serve as a better diagnostic marker than calcitonin gene-related peptide (CGRP).

Major finding: Plasma amylin levels were higher in chronic migraine patients than in episodic migraine patients and healthy controls (both P less than. 0001). Diagnostic performance was better with plasma amylin than CGRP in differentiating chronic migraine from healthy controls in adults.

Study details: The data come from a prospective case-controlled study involving 191 patients with chronic migraine, 58 patients with episodic migraine, and 68 healthy controls.

Disclosures: This study was funded by the Spanish Research Network on Cerebrovascular Diseases, Center for Applied Medical Research, University of Navarra, and Spanish Ministry of Economy and Competitiveness. The authors declared no conflicts of interest.

Source: Irimia P et al. Cephalalgia. 2020 Dec 3. doi: 10.1177/0333102420977106.

Key clinical point: Sex differences in recovery time were observed in pediatric patients with mild traumatic brain injury or concussion, with girls and women taking longer to recover than boys and men. Patients with comorbidities of emotional distress (i.e., anxiety or depression) and migraine recovered more slowly, independent of sex.

Major finding: Girls and women experienced slower recovery (persistent symptoms after injury: week 4, 81.6% vs. 71.2%; week 8, 58.9% vs. 44.3%; and week 12, 42.6% vs. 30.2%; P = .01) and were more likely to have preexisting anxiety (26.7% vs. 18.7%) vs. boys and men. Patients with a history of emotional distress (persistent symptoms after injury: week 4, 80.9% vs. 75.6%; week 8, 57.8% vs. 50.5%; and week 12, 48.0% vs. 33.3%; P = .009) and migraine (persistent symptoms after injury: week 4, 87.3% vs. 73.9%; week 8, 67.7% vs. 49.0%; and week 12, 55.7% vs. 33.2%; P = .001) recovered more slowly vs. those without.

Study details: A prospective cohort study of 600 pediatric patients (54% females, 72.5% adolescents) enrolled at multicenter concussion specialty clinics from the Four Corners Youth Consortium from December 2017 to July 2019.

Disclosures: The study was supported by funds from the UCLA Steve Tisch BrainSPORT Program, the Easton Clinic for Brain Health, the UCLA Brain Injury Research Center, Stan and Patti Silver, the Satterberg Foundation, and the Sports Institute at UW Medicine. The presenting author had no disclosures. Three coauthors reported various disclosures.

Source: Rosenbaum PE et al. JAMA Netw Open. 2020 Nov 2. doi: 10.1001/jamanetworkopen.2020.21463.

Key clinical point: Sex differences in recovery time were observed in pediatric patients with mild traumatic brain injury or concussion, with girls and women taking longer to recover than boys and men. Patients with comorbidities of emotional distress (i.e., anxiety or depression) and migraine recovered more slowly, independent of sex.

Major finding: Girls and women experienced slower recovery (persistent symptoms after injury: week 4, 81.6% vs. 71.2%; week 8, 58.9% vs. 44.3%; and week 12, 42.6% vs. 30.2%; P = .01) and were more likely to have preexisting anxiety (26.7% vs. 18.7%) vs. boys and men. Patients with a history of emotional distress (persistent symptoms after injury: week 4, 80.9% vs. 75.6%; week 8, 57.8% vs. 50.5%; and week 12, 48.0% vs. 33.3%; P = .009) and migraine (persistent symptoms after injury: week 4, 87.3% vs. 73.9%; week 8, 67.7% vs. 49.0%; and week 12, 55.7% vs. 33.2%; P = .001) recovered more slowly vs. those without.

Study details: A prospective cohort study of 600 pediatric patients (54% females, 72.5% adolescents) enrolled at multicenter concussion specialty clinics from the Four Corners Youth Consortium from December 2017 to July 2019.

Disclosures: The study was supported by funds from the UCLA Steve Tisch BrainSPORT Program, the Easton Clinic for Brain Health, the UCLA Brain Injury Research Center, Stan and Patti Silver, the Satterberg Foundation, and the Sports Institute at UW Medicine. The presenting author had no disclosures. Three coauthors reported various disclosures.

Source: Rosenbaum PE et al. JAMA Netw Open. 2020 Nov 2. doi: 10.1001/jamanetworkopen.2020.21463.

Key clinical point: Sex differences in recovery time were observed in pediatric patients with mild traumatic brain injury or concussion, with girls and women taking longer to recover than boys and men. Patients with comorbidities of emotional distress (i.e., anxiety or depression) and migraine recovered more slowly, independent of sex.

Major finding: Girls and women experienced slower recovery (persistent symptoms after injury: week 4, 81.6% vs. 71.2%; week 8, 58.9% vs. 44.3%; and week 12, 42.6% vs. 30.2%; P = .01) and were more likely to have preexisting anxiety (26.7% vs. 18.7%) vs. boys and men. Patients with a history of emotional distress (persistent symptoms after injury: week 4, 80.9% vs. 75.6%; week 8, 57.8% vs. 50.5%; and week 12, 48.0% vs. 33.3%; P = .009) and migraine (persistent symptoms after injury: week 4, 87.3% vs. 73.9%; week 8, 67.7% vs. 49.0%; and week 12, 55.7% vs. 33.2%; P = .001) recovered more slowly vs. those without.

Study details: A prospective cohort study of 600 pediatric patients (54% females, 72.5% adolescents) enrolled at multicenter concussion specialty clinics from the Four Corners Youth Consortium from December 2017 to July 2019.

Disclosures: The study was supported by funds from the UCLA Steve Tisch BrainSPORT Program, the Easton Clinic for Brain Health, the UCLA Brain Injury Research Center, Stan and Patti Silver, the Satterberg Foundation, and the Sports Institute at UW Medicine. The presenting author had no disclosures. Three coauthors reported various disclosures.

Source: Rosenbaum PE et al. JAMA Netw Open. 2020 Nov 2. doi: 10.1001/jamanetworkopen.2020.21463.

Key clinical point: This meta-analysis suggests that ginger is safe and effective in treating migraine patients with pain outcomes assessed at 2 hours.

Major finding: Ginger treatment was associated with substantially improved pain-free at 2 hours (risk ratio [RR], 1.79; P = .04) and decreased pain scores at 2 hours (mean difference, −1.27; P less than .00001), but showed no notable influence on treatment response (RR, 2.04; P = .43). The incidence of nausea and vomiting was lower in the ginger group vs. control group. The total adverse events were similar between groups (RR, 0.80; P = .44).

Study details: A meta-analysis of 3 randomized controlled trials including 227 participants.

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Source: Chen L et al. Am J Emerg Med. 2020 Nov 17. doi: 10.1016/j.ajem.2020.11.030.

Key clinical point: This meta-analysis suggests that ginger is safe and effective in treating migraine patients with pain outcomes assessed at 2 hours.

Major finding: Ginger treatment was associated with substantially improved pain-free at 2 hours (risk ratio [RR], 1.79; P = .04) and decreased pain scores at 2 hours (mean difference, −1.27; P less than .00001), but showed no notable influence on treatment response (RR, 2.04; P = .43). The incidence of nausea and vomiting was lower in the ginger group vs. control group. The total adverse events were similar between groups (RR, 0.80; P = .44).

Study details: A meta-analysis of 3 randomized controlled trials including 227 participants.

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Source: Chen L et al. Am J Emerg Med. 2020 Nov 17. doi: 10.1016/j.ajem.2020.11.030.

Key clinical point: This meta-analysis suggests that ginger is safe and effective in treating migraine patients with pain outcomes assessed at 2 hours.

Major finding: Ginger treatment was associated with substantially improved pain-free at 2 hours (risk ratio [RR], 1.79; P = .04) and decreased pain scores at 2 hours (mean difference, −1.27; P less than .00001), but showed no notable influence on treatment response (RR, 2.04; P = .43). The incidence of nausea and vomiting was lower in the ginger group vs. control group. The total adverse events were similar between groups (RR, 0.80; P = .44).

Study details: A meta-analysis of 3 randomized controlled trials including 227 participants.

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Source: Chen L et al. Am J Emerg Med. 2020 Nov 17. doi: 10.1016/j.ajem.2020.11.030.

Key clinical point: Along with its efficacy as a migraine preventive treatment, fremanezumab demonstrates the potential benefit for reversion from chronic migraine (CM) to episodic migraine (EM).

Major finding: The rates of reversion from CM to EM were higher in patients treated with fremanezumab vs. those treated with placebo, when reversion was defined either as an average of less than 15 headache days per month during the 3-month treatment period (quarterly: 50.5%; P = .108 and monthly: 53.7%; P = .012 vs. placebo: 44.5%) or, more stringently, as less than 15 headache days per month at months 1, 2, and 3 (quarterly: 31.2%; P = .008 and monthly: 33.7%; P = .001 vs. placebo: 22.4%).

Study details: The findings are based on a post hoc analysis of the HALO CM trial. Patients with CM (n=1,088) were randomly assigned to 1 of the 3 treatment groups (fremanezumab quarterly, n=376; fremanezumab monthly, n=379; or placebo, n=375).

Disclosures: The study was funded by Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel. Some study investigators reported being an employee of Teva Branded Pharmaceutical Products R&D, Inc., receiving honoraria from, and/or consulting for Teva Pharmaceuticals.

Source: Lipton RB et al. Headache. 2020 Nov 11. doi: 10.1111/head.13997.

Key clinical point: Along with its efficacy as a migraine preventive treatment, fremanezumab demonstrates the potential benefit for reversion from chronic migraine (CM) to episodic migraine (EM).

Major finding: The rates of reversion from CM to EM were higher in patients treated with fremanezumab vs. those treated with placebo, when reversion was defined either as an average of less than 15 headache days per month during the 3-month treatment period (quarterly: 50.5%; P = .108 and monthly: 53.7%; P = .012 vs. placebo: 44.5%) or, more stringently, as less than 15 headache days per month at months 1, 2, and 3 (quarterly: 31.2%; P = .008 and monthly: 33.7%; P = .001 vs. placebo: 22.4%).

Study details: The findings are based on a post hoc analysis of the HALO CM trial. Patients with CM (n=1,088) were randomly assigned to 1 of the 3 treatment groups (fremanezumab quarterly, n=376; fremanezumab monthly, n=379; or placebo, n=375).

Disclosures: The study was funded by Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel. Some study investigators reported being an employee of Teva Branded Pharmaceutical Products R&D, Inc., receiving honoraria from, and/or consulting for Teva Pharmaceuticals.

Source: Lipton RB et al. Headache. 2020 Nov 11. doi: 10.1111/head.13997.

Key clinical point: Along with its efficacy as a migraine preventive treatment, fremanezumab demonstrates the potential benefit for reversion from chronic migraine (CM) to episodic migraine (EM).

Major finding: The rates of reversion from CM to EM were higher in patients treated with fremanezumab vs. those treated with placebo, when reversion was defined either as an average of less than 15 headache days per month during the 3-month treatment period (quarterly: 50.5%; P = .108 and monthly: 53.7%; P = .012 vs. placebo: 44.5%) or, more stringently, as less than 15 headache days per month at months 1, 2, and 3 (quarterly: 31.2%; P = .008 and monthly: 33.7%; P = .001 vs. placebo: 22.4%).

Study details: The findings are based on a post hoc analysis of the HALO CM trial. Patients with CM (n=1,088) were randomly assigned to 1 of the 3 treatment groups (fremanezumab quarterly, n=376; fremanezumab monthly, n=379; or placebo, n=375).

Disclosures: The study was funded by Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel. Some study investigators reported being an employee of Teva Branded Pharmaceutical Products R&D, Inc., receiving honoraria from, and/or consulting for Teva Pharmaceuticals.

Source: Lipton RB et al. Headache. 2020 Nov 11. doi: 10.1111/head.13997.

Patients will soon be able to read the notes that physicians make during an episode of care, as well as information about diagnostic testing and imaging results, tests for STDs, fetal ultrasounds, and cancer biopsies. This open access is raising concerns among physicians.

As part of the 21st Century Cures Act, patients have the right to see their medical notes. Known as Open Notes, the policy will go into effect on April 5, 2021. The Department of Health & Human Services recently changed the original start date, which was to be Nov. 2, 2020.

The mandate has some physicians worrying about potential legal risks and possible violation of doctor-patient confidentiality. When asked to share their views on the new Open Notes mandate, many physicians expressed their concerns but also cited some of the positive effects that could come from this.
 

Potentially more legal woes for physicians?

A key concern raised by one physician commenter is that patients could misunderstand legitimate medical terminology or even put a physician in legal crosshairs. For example, a medical term such as “spontaneous abortion” could be misconstrued by patients. A physician might write notes with the idea that a patient is reading them and thus might alter those notes in a way that creates legal trouble.

“This layers another level of censorship and legal liability onto physicians, who in attempting to be [politically correct], may omit critical information or have to use euphemisms in order to avoid conflict,” one physician said.

She also questioned whether notes might now have to be run through legal counsel before being posted to avoid potential liability.

Another doctor questioned how physicians would be able to document patients suspected of faking injuries for pain medication, for example. Could such documentation lead to lawsuits for the doctor?

As one physician noted, some patients “are drug seekers. Some refuse to aid in their own care. Some are malingerers. Not documenting that is bad medicine.”

The possibility of violating doctor-patient confidentiality laws, particularly for teenagers, could be another negative effect of Open Notes, said one physician.

“Won’t this violate the statutes that teenagers have the right to confidential evaluations?” the commenter mused. “If charts are to be immediately available, then STDs and pregnancies they weren’t ready to talk about will now be suddenly known by their parents.”

One doctor has already faced this issue. “I already ran into this problem once,” he noted. “Now I warn those on their parents’ insurance before I start the visit. I have literally had a patient state, ‘well then we are done,’ and leave without being seen due to it.”

Another physician questioned the possibility of having to write notes differently than they do now, especially if the patients have lower reading comprehension abilities.

One physician who uses Open Notes said he receives patient requests for changes that have little to do with the actual diagnosis and relate to ancillary issues. He highlighted patients who “don’t want psych diagnosis in their chart or are concerned a diagnosis will raise their insurance premium, so they ask me to delete it.”
 

Will Open Notes erode patient communication?

One physician questioned whether it would lead to patients being less open and forthcoming about their medical concerns with doctors.

“The main problem I see is the patient not telling me the whole story, or worse, telling me the story, and then asking me not to document it (as many have done in the past) because they don’t want their spouse, family, etc. to read the notes and they have already given their permission for them to do so, for a variety of reasons,” he commented. “This includes topics of STDs, infidelity, depression, suicidal thoughts, and other symptoms the patient doesn’t want their family to read about.”
 

Some physicians envision positive developments

Many physicians are unconcerned by the new mandate. “I see some potential good in this, such as improving doctor-patient communication and more scrupulous charting,” one physician said.

A doctor working in the U.S. federal health care system noted that open access has been a part of that system for decades.

“Since health care providers work in this unveiled setting for their entire career, they usually know how to write appropriate clinical notes and what information needs to be included in them,” he wrote. “Now it’s time for the rest of the medical community to catch up to a reality that we have worked within for decades now.

“The world did not end, malpractice complaints did not increase, and physician/patient relationships were not damaged. Living in the information age, archaic practices like private notes were surely going to end at some point.”

One doctor who has been using Open Notes has had experiences in which the patient noted an error in the medical chart that needed correcting. “I have had one patient correct me on a timeline in the HPI which was helpful and I made the requested correction in that instance,” he said.

Another physician agreed. “I’ve had patients add or correct valuable information I’ve missed. Good probably outweighs the bad if we set limits on behaviors expressed by the personality disordered group. The majority of people don’t seem to care and still ask me ‘what would you do’ or ‘tell me what to do.’ It’s all about patient/physician trust.”

Another talked about how Open Notes should have little or no impact. “Here’s a novel concept – talking to our patients,” he commented. “There is nothing in every one of my chart notes that has not already been discussed with my patients and I dictate (speech to text) my findings and plan in front of them. So, if they are reviewing my office notes, it will only serve to reinforce what we have already discussed.”

“I don’t intend to change anything,” he added. “Chances are if they were to see a test result before I have a chance to discuss it with them, they will have already ‘Googled’ its meaning and we can have more meaningful interaction if they have a basic understanding of the test.”

“I understand that this is anxiety provoking, but in general I think it is appropriate for patients to have access to their notes,” said another physician. “If physicians write lousy notes that say they did things they didn’t do, that fail to actually state a diagnosis and a plan (and they often do), that is the doc’s problem, not the patient’s.”

A version of this article first appeared on Medscape.com.

Patients will soon be able to read the notes that physicians make during an episode of care, as well as information about diagnostic testing and imaging results, tests for STDs, fetal ultrasounds, and cancer biopsies. This open access is raising concerns among physicians.

As part of the 21st Century Cures Act, patients have the right to see their medical notes. Known as Open Notes, the policy will go into effect on April 5, 2021. The Department of Health & Human Services recently changed the original start date, which was to be Nov. 2, 2020.

The mandate has some physicians worrying about potential legal risks and possible violation of doctor-patient confidentiality. When asked to share their views on the new Open Notes mandate, many physicians expressed their concerns but also cited some of the positive effects that could come from this.
 

Potentially more legal woes for physicians?

A key concern raised by one physician commenter is that patients could misunderstand legitimate medical terminology or even put a physician in legal crosshairs. For example, a medical term such as “spontaneous abortion” could be misconstrued by patients. A physician might write notes with the idea that a patient is reading them and thus might alter those notes in a way that creates legal trouble.

“This layers another level of censorship and legal liability onto physicians, who in attempting to be [politically correct], may omit critical information or have to use euphemisms in order to avoid conflict,” one physician said.

She also questioned whether notes might now have to be run through legal counsel before being posted to avoid potential liability.

Another doctor questioned how physicians would be able to document patients suspected of faking injuries for pain medication, for example. Could such documentation lead to lawsuits for the doctor?

As one physician noted, some patients “are drug seekers. Some refuse to aid in their own care. Some are malingerers. Not documenting that is bad medicine.”

The possibility of violating doctor-patient confidentiality laws, particularly for teenagers, could be another negative effect of Open Notes, said one physician.

“Won’t this violate the statutes that teenagers have the right to confidential evaluations?” the commenter mused. “If charts are to be immediately available, then STDs and pregnancies they weren’t ready to talk about will now be suddenly known by their parents.”

One doctor has already faced this issue. “I already ran into this problem once,” he noted. “Now I warn those on their parents’ insurance before I start the visit. I have literally had a patient state, ‘well then we are done,’ and leave without being seen due to it.”

Another physician questioned the possibility of having to write notes differently than they do now, especially if the patients have lower reading comprehension abilities.

One physician who uses Open Notes said he receives patient requests for changes that have little to do with the actual diagnosis and relate to ancillary issues. He highlighted patients who “don’t want psych diagnosis in their chart or are concerned a diagnosis will raise their insurance premium, so they ask me to delete it.”
 

Will Open Notes erode patient communication?

One physician questioned whether it would lead to patients being less open and forthcoming about their medical concerns with doctors.

“The main problem I see is the patient not telling me the whole story, or worse, telling me the story, and then asking me not to document it (as many have done in the past) because they don’t want their spouse, family, etc. to read the notes and they have already given their permission for them to do so, for a variety of reasons,” he commented. “This includes topics of STDs, infidelity, depression, suicidal thoughts, and other symptoms the patient doesn’t want their family to read about.”
 

Some physicians envision positive developments

Many physicians are unconcerned by the new mandate. “I see some potential good in this, such as improving doctor-patient communication and more scrupulous charting,” one physician said.

A doctor working in the U.S. federal health care system noted that open access has been a part of that system for decades.

“Since health care providers work in this unveiled setting for their entire career, they usually know how to write appropriate clinical notes and what information needs to be included in them,” he wrote. “Now it’s time for the rest of the medical community to catch up to a reality that we have worked within for decades now.

“The world did not end, malpractice complaints did not increase, and physician/patient relationships were not damaged. Living in the information age, archaic practices like private notes were surely going to end at some point.”

One doctor who has been using Open Notes has had experiences in which the patient noted an error in the medical chart that needed correcting. “I have had one patient correct me on a timeline in the HPI which was helpful and I made the requested correction in that instance,” he said.

Another physician agreed. “I’ve had patients add or correct valuable information I’ve missed. Good probably outweighs the bad if we set limits on behaviors expressed by the personality disordered group. The majority of people don’t seem to care and still ask me ‘what would you do’ or ‘tell me what to do.’ It’s all about patient/physician trust.”

Another talked about how Open Notes should have little or no impact. “Here’s a novel concept – talking to our patients,” he commented. “There is nothing in every one of my chart notes that has not already been discussed with my patients and I dictate (speech to text) my findings and plan in front of them. So, if they are reviewing my office notes, it will only serve to reinforce what we have already discussed.”

“I don’t intend to change anything,” he added. “Chances are if they were to see a test result before I have a chance to discuss it with them, they will have already ‘Googled’ its meaning and we can have more meaningful interaction if they have a basic understanding of the test.”

“I understand that this is anxiety provoking, but in general I think it is appropriate for patients to have access to their notes,” said another physician. “If physicians write lousy notes that say they did things they didn’t do, that fail to actually state a diagnosis and a plan (and they often do), that is the doc’s problem, not the patient’s.”

A version of this article first appeared on Medscape.com.

Patients will soon be able to read the notes that physicians make during an episode of care, as well as information about diagnostic testing and imaging results, tests for STDs, fetal ultrasounds, and cancer biopsies. This open access is raising concerns among physicians.

As part of the 21st Century Cures Act, patients have the right to see their medical notes. Known as Open Notes, the policy will go into effect on April 5, 2021. The Department of Health & Human Services recently changed the original start date, which was to be Nov. 2, 2020.

The mandate has some physicians worrying about potential legal risks and possible violation of doctor-patient confidentiality. When asked to share their views on the new Open Notes mandate, many physicians expressed their concerns but also cited some of the positive effects that could come from this.
 

Potentially more legal woes for physicians?

A key concern raised by one physician commenter is that patients could misunderstand legitimate medical terminology or even put a physician in legal crosshairs. For example, a medical term such as “spontaneous abortion” could be misconstrued by patients. A physician might write notes with the idea that a patient is reading them and thus might alter those notes in a way that creates legal trouble.

“This layers another level of censorship and legal liability onto physicians, who in attempting to be [politically correct], may omit critical information or have to use euphemisms in order to avoid conflict,” one physician said.

She also questioned whether notes might now have to be run through legal counsel before being posted to avoid potential liability.

Another doctor questioned how physicians would be able to document patients suspected of faking injuries for pain medication, for example. Could such documentation lead to lawsuits for the doctor?

As one physician noted, some patients “are drug seekers. Some refuse to aid in their own care. Some are malingerers. Not documenting that is bad medicine.”

The possibility of violating doctor-patient confidentiality laws, particularly for teenagers, could be another negative effect of Open Notes, said one physician.

“Won’t this violate the statutes that teenagers have the right to confidential evaluations?” the commenter mused. “If charts are to be immediately available, then STDs and pregnancies they weren’t ready to talk about will now be suddenly known by their parents.”

One doctor has already faced this issue. “I already ran into this problem once,” he noted. “Now I warn those on their parents’ insurance before I start the visit. I have literally had a patient state, ‘well then we are done,’ and leave without being seen due to it.”

Another physician questioned the possibility of having to write notes differently than they do now, especially if the patients have lower reading comprehension abilities.

One physician who uses Open Notes said he receives patient requests for changes that have little to do with the actual diagnosis and relate to ancillary issues. He highlighted patients who “don’t want psych diagnosis in their chart or are concerned a diagnosis will raise their insurance premium, so they ask me to delete it.”
 

Will Open Notes erode patient communication?

One physician questioned whether it would lead to patients being less open and forthcoming about their medical concerns with doctors.

“The main problem I see is the patient not telling me the whole story, or worse, telling me the story, and then asking me not to document it (as many have done in the past) because they don’t want their spouse, family, etc. to read the notes and they have already given their permission for them to do so, for a variety of reasons,” he commented. “This includes topics of STDs, infidelity, depression, suicidal thoughts, and other symptoms the patient doesn’t want their family to read about.”
 

Some physicians envision positive developments

Many physicians are unconcerned by the new mandate. “I see some potential good in this, such as improving doctor-patient communication and more scrupulous charting,” one physician said.

A doctor working in the U.S. federal health care system noted that open access has been a part of that system for decades.

“Since health care providers work in this unveiled setting for their entire career, they usually know how to write appropriate clinical notes and what information needs to be included in them,” he wrote. “Now it’s time for the rest of the medical community to catch up to a reality that we have worked within for decades now.

“The world did not end, malpractice complaints did not increase, and physician/patient relationships were not damaged. Living in the information age, archaic practices like private notes were surely going to end at some point.”

One doctor who has been using Open Notes has had experiences in which the patient noted an error in the medical chart that needed correcting. “I have had one patient correct me on a timeline in the HPI which was helpful and I made the requested correction in that instance,” he said.

Another physician agreed. “I’ve had patients add or correct valuable information I’ve missed. Good probably outweighs the bad if we set limits on behaviors expressed by the personality disordered group. The majority of people don’t seem to care and still ask me ‘what would you do’ or ‘tell me what to do.’ It’s all about patient/physician trust.”

Another talked about how Open Notes should have little or no impact. “Here’s a novel concept – talking to our patients,” he commented. “There is nothing in every one of my chart notes that has not already been discussed with my patients and I dictate (speech to text) my findings and plan in front of them. So, if they are reviewing my office notes, it will only serve to reinforce what we have already discussed.”

“I don’t intend to change anything,” he added. “Chances are if they were to see a test result before I have a chance to discuss it with them, they will have already ‘Googled’ its meaning and we can have more meaningful interaction if they have a basic understanding of the test.”

“I understand that this is anxiety provoking, but in general I think it is appropriate for patients to have access to their notes,” said another physician. “If physicians write lousy notes that say they did things they didn’t do, that fail to actually state a diagnosis and a plan (and they often do), that is the doc’s problem, not the patient’s.”

A version of this article first appeared on Medscape.com.

Key clinical point: Mindfulness-based stress reduction (MBSR) did not improve migraine frequency more than headache education as both groups had similar decreases; however, mindfulness meditation may help treat the total burden of migraine.

Major finding: Decrease in headache frequency did not differ between the 2 groups (MBSR, −2.0 vs headache education, −2.4; P = .52). The MBSR vs. headache education group had significantly greater improvements at 36 weeks in disability (P less than .001), quality of life (P =.01), self-efficacy (P = .04), pain catastrophizing (P less than .001), depression scores (P =.008), decrease in pain intensity (P =.004), and decrease in pain unpleasantness (P =.005).

Study details: In this double-blinded, randomized clinical trial, 89 adults with a history of migraine were assigned to receive training in MBSR/yoga (n=45) or health education instruction on headaches, pathophysiology, triggers, stress, and treatment approaches (n=44).

Disclosures: This study was funded by an American Pain Society Grant from the Sharon S. Keller Chronic Pain Research Program and the National Center for Complementary and Integrative Health. RE Wells and F Zeidan reported grants from the National Institutes of Health. TT Houle reported receiving personal fees from GlaxoSmithKline, Eli Lilly, and StatReviewer. The remaining authors declared no conflicts of interest.

Source: Wells RE et al. JAMA Intern Med. 2020 Dec 14. doi: 10.1001/jamainternmed.2020.7090.

Key clinical point: Mindfulness-based stress reduction (MBSR) did not improve migraine frequency more than headache education as both groups had similar decreases; however, mindfulness meditation may help treat the total burden of migraine.

Major finding: Decrease in headache frequency did not differ between the 2 groups (MBSR, −2.0 vs headache education, −2.4; P = .52). The MBSR vs. headache education group had significantly greater improvements at 36 weeks in disability (P less than .001), quality of life (P =.01), self-efficacy (P = .04), pain catastrophizing (P less than .001), depression scores (P =.008), decrease in pain intensity (P =.004), and decrease in pain unpleasantness (P =.005).

Study details: In this double-blinded, randomized clinical trial, 89 adults with a history of migraine were assigned to receive training in MBSR/yoga (n=45) or health education instruction on headaches, pathophysiology, triggers, stress, and treatment approaches (n=44).

Disclosures: This study was funded by an American Pain Society Grant from the Sharon S. Keller Chronic Pain Research Program and the National Center for Complementary and Integrative Health. RE Wells and F Zeidan reported grants from the National Institutes of Health. TT Houle reported receiving personal fees from GlaxoSmithKline, Eli Lilly, and StatReviewer. The remaining authors declared no conflicts of interest.

Source: Wells RE et al. JAMA Intern Med. 2020 Dec 14. doi: 10.1001/jamainternmed.2020.7090.

Key clinical point: Mindfulness-based stress reduction (MBSR) did not improve migraine frequency more than headache education as both groups had similar decreases; however, mindfulness meditation may help treat the total burden of migraine.

Major finding: Decrease in headache frequency did not differ between the 2 groups (MBSR, −2.0 vs headache education, −2.4; P = .52). The MBSR vs. headache education group had significantly greater improvements at 36 weeks in disability (P less than .001), quality of life (P =.01), self-efficacy (P = .04), pain catastrophizing (P less than .001), depression scores (P =.008), decrease in pain intensity (P =.004), and decrease in pain unpleasantness (P =.005).

Study details: In this double-blinded, randomized clinical trial, 89 adults with a history of migraine were assigned to receive training in MBSR/yoga (n=45) or health education instruction on headaches, pathophysiology, triggers, stress, and treatment approaches (n=44).

Disclosures: This study was funded by an American Pain Society Grant from the Sharon S. Keller Chronic Pain Research Program and the National Center for Complementary and Integrative Health. RE Wells and F Zeidan reported grants from the National Institutes of Health. TT Houle reported receiving personal fees from GlaxoSmithKline, Eli Lilly, and StatReviewer. The remaining authors declared no conflicts of interest.

Source: Wells RE et al. JAMA Intern Med. 2020 Dec 14. doi: 10.1001/jamainternmed.2020.7090.

Key clinical point: Delivery by cesarean section is not associated with migraine later in life. However, cesarean section is associated with a modestly reduced risk of non-migrainous headache.

Major finding: Delivery by cesarean section was not associated with later development of migraine (adjusted odds ratio [aOR], 0.93; P = .63). A negative association was seen between cesarean section and non-migrainous headache (aOR, 0.77; P = .04).

Study details: The findings are based on a retrospective register-linked HUNT population cohort study of 11,194 participants (age, 19-41 years; migraine group, n=1,855 and non-migrainous headache group, n=3,358).

Disclosures: This study was supported by grants from the University of Oslo, Akershus University Hospital, and Oslo University Hospital. The authors declared no conflicts of interest.

Source: Kristoffersen ES et al. BMJ Open. 2020 Nov 18. doi: 10.1136/bmjopen-2020-040685.

Key clinical point: Delivery by cesarean section is not associated with migraine later in life. However, cesarean section is associated with a modestly reduced risk of non-migrainous headache.

Major finding: Delivery by cesarean section was not associated with later development of migraine (adjusted odds ratio [aOR], 0.93; P = .63). A negative association was seen between cesarean section and non-migrainous headache (aOR, 0.77; P = .04).

Study details: The findings are based on a retrospective register-linked HUNT population cohort study of 11,194 participants (age, 19-41 years; migraine group, n=1,855 and non-migrainous headache group, n=3,358).

Disclosures: This study was supported by grants from the University of Oslo, Akershus University Hospital, and Oslo University Hospital. The authors declared no conflicts of interest.

Source: Kristoffersen ES et al. BMJ Open. 2020 Nov 18. doi: 10.1136/bmjopen-2020-040685.

Key clinical point: Delivery by cesarean section is not associated with migraine later in life. However, cesarean section is associated with a modestly reduced risk of non-migrainous headache.

Major finding: Delivery by cesarean section was not associated with later development of migraine (adjusted odds ratio [aOR], 0.93; P = .63). A negative association was seen between cesarean section and non-migrainous headache (aOR, 0.77; P = .04).

Study details: The findings are based on a retrospective register-linked HUNT population cohort study of 11,194 participants (age, 19-41 years; migraine group, n=1,855 and non-migrainous headache group, n=3,358).

Disclosures: This study was supported by grants from the University of Oslo, Akershus University Hospital, and Oslo University Hospital. The authors declared no conflicts of interest.

Source: Kristoffersen ES et al. BMJ Open. 2020 Nov 18. doi: 10.1136/bmjopen-2020-040685.

Key clinical point: In adults with episodic migraine, intravenous eptinezumab administered every 12 weeks for up to 4 doses provides early and sustained migraine preventive efficacy and is well tolerated with an acceptable safety profile.

Major finding: The reduction in mean monthly migraine days was maintained with eptinezumab throughout the study period (100 mg: −3.9, −4.5, −4.7, and −4.5 days; 300 mg: −4.3, −4.8, −5.1, and −5.3 days; and placebo: −3.2, −3.8, −4.0, and −4.0 days during weeks 1-12, 13-24, 25-36, and 37-48, respectively). The percentage of patients with a reduction of 50% or greater and 75% or greater in migraine for each 12-week interval was consistently higher in the eptinezumab group vs. placebo group. Adverse events were similar across dosing periods.

Study details: Results of phase 3 PROMISE-1 through 1 year of treatment (up to 4 doses). In PROMISE-1, 888 patients with episodic migraine were randomly assigned in a ratio of 1:1:1:1 to receive eptinezumab 30 mg, 100 mg, 300 mg, or placebo every 12 weeks.

Disclosures: No study sponsor was identified. The presenting author has been a consultant and/or scientific advisor for Alder/Lundbeck, Amgen, Biohaven, Eli Lilly, Impel Neuropharma, and Theranica, and has received research support from Alder/Lundbeck, Allergan, Amgen, Biohaven, Charleston Labs, Eli Lilly, Electrocore, Novartis, Novo Nordisk, Satsuma, Theranica, and Vorso.

Source: Smith TR et al. Clin Ther. 2020 Nov 27. doi: 10.1016/j.clinthera.2020.11.007.

Key clinical point: In adults with episodic migraine, intravenous eptinezumab administered every 12 weeks for up to 4 doses provides early and sustained migraine preventive efficacy and is well tolerated with an acceptable safety profile.

Major finding: The reduction in mean monthly migraine days was maintained with eptinezumab throughout the study period (100 mg: −3.9, −4.5, −4.7, and −4.5 days; 300 mg: −4.3, −4.8, −5.1, and −5.3 days; and placebo: −3.2, −3.8, −4.0, and −4.0 days during weeks 1-12, 13-24, 25-36, and 37-48, respectively). The percentage of patients with a reduction of 50% or greater and 75% or greater in migraine for each 12-week interval was consistently higher in the eptinezumab group vs. placebo group. Adverse events were similar across dosing periods.

Study details: Results of phase 3 PROMISE-1 through 1 year of treatment (up to 4 doses). In PROMISE-1, 888 patients with episodic migraine were randomly assigned in a ratio of 1:1:1:1 to receive eptinezumab 30 mg, 100 mg, 300 mg, or placebo every 12 weeks.

Disclosures: No study sponsor was identified. The presenting author has been a consultant and/or scientific advisor for Alder/Lundbeck, Amgen, Biohaven, Eli Lilly, Impel Neuropharma, and Theranica, and has received research support from Alder/Lundbeck, Allergan, Amgen, Biohaven, Charleston Labs, Eli Lilly, Electrocore, Novartis, Novo Nordisk, Satsuma, Theranica, and Vorso.

Source: Smith TR et al. Clin Ther. 2020 Nov 27. doi: 10.1016/j.clinthera.2020.11.007.

Key clinical point: In adults with episodic migraine, intravenous eptinezumab administered every 12 weeks for up to 4 doses provides early and sustained migraine preventive efficacy and is well tolerated with an acceptable safety profile.

Major finding: The reduction in mean monthly migraine days was maintained with eptinezumab throughout the study period (100 mg: −3.9, −4.5, −4.7, and −4.5 days; 300 mg: −4.3, −4.8, −5.1, and −5.3 days; and placebo: −3.2, −3.8, −4.0, and −4.0 days during weeks 1-12, 13-24, 25-36, and 37-48, respectively). The percentage of patients with a reduction of 50% or greater and 75% or greater in migraine for each 12-week interval was consistently higher in the eptinezumab group vs. placebo group. Adverse events were similar across dosing periods.

Study details: Results of phase 3 PROMISE-1 through 1 year of treatment (up to 4 doses). In PROMISE-1, 888 patients with episodic migraine were randomly assigned in a ratio of 1:1:1:1 to receive eptinezumab 30 mg, 100 mg, 300 mg, or placebo every 12 weeks.

Disclosures: No study sponsor was identified. The presenting author has been a consultant and/or scientific advisor for Alder/Lundbeck, Amgen, Biohaven, Eli Lilly, Impel Neuropharma, and Theranica, and has received research support from Alder/Lundbeck, Allergan, Amgen, Biohaven, Charleston Labs, Eli Lilly, Electrocore, Novartis, Novo Nordisk, Satsuma, Theranica, and Vorso.

Source: Smith TR et al. Clin Ther. 2020 Nov 27. doi: 10.1016/j.clinthera.2020.11.007.

Key clinical point: Rimegepant was effective and had favourable safety and tolerability profiles in the preventive treatment of migraine.

Major finding: Rimegepant was superior to placebo in terms of change in the mean number of migraine days per month during weeks 9-12 (−4.3 days vs. −3.5 days; least squares mean difference, −0.8 days; P = .0099). Adverse events were reported by 133 of the patients who received rimegepant and 133 participants in the placebo group.

Study details: A multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial of 695 participants randomly assigned to receive oral rimegepant 75 mg (n = 348) or matching placebo (n=347) every other day for 12 weeks. The safety analysis included 741 participants, who received at least one dose of study medication.

Disclosures: The study was funded by Biohaven Pharmaceuticals. Some study investigators reported owning stock in, being an employee of, receiving support/grant from Biohaven Pharmaceuticals.

Source: Croop R et al. Lancet. 2020 Dec 15. doi: 10.1016/S0140-6736(20)32544-7.

Key clinical point: Rimegepant was effective and had favourable safety and tolerability profiles in the preventive treatment of migraine.

Major finding: Rimegepant was superior to placebo in terms of change in the mean number of migraine days per month during weeks 9-12 (−4.3 days vs. −3.5 days; least squares mean difference, −0.8 days; P = .0099). Adverse events were reported by 133 of the patients who received rimegepant and 133 participants in the placebo group.

Study details: A multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial of 695 participants randomly assigned to receive oral rimegepant 75 mg (n = 348) or matching placebo (n=347) every other day for 12 weeks. The safety analysis included 741 participants, who received at least one dose of study medication.

Disclosures: The study was funded by Biohaven Pharmaceuticals. Some study investigators reported owning stock in, being an employee of, receiving support/grant from Biohaven Pharmaceuticals.

Source: Croop R et al. Lancet. 2020 Dec 15. doi: 10.1016/S0140-6736(20)32544-7.

Key clinical point: Rimegepant was effective and had favourable safety and tolerability profiles in the preventive treatment of migraine.

Major finding: Rimegepant was superior to placebo in terms of change in the mean number of migraine days per month during weeks 9-12 (−4.3 days vs. −3.5 days; least squares mean difference, −0.8 days; P = .0099). Adverse events were reported by 133 of the patients who received rimegepant and 133 participants in the placebo group.

Study details: A multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial of 695 participants randomly assigned to receive oral rimegepant 75 mg (n = 348) or matching placebo (n=347) every other day for 12 weeks. The safety analysis included 741 participants, who received at least one dose of study medication.

Disclosures: The study was funded by Biohaven Pharmaceuticals. Some study investigators reported owning stock in, being an employee of, receiving support/grant from Biohaven Pharmaceuticals.

Source: Croop R et al. Lancet. 2020 Dec 15. doi: 10.1016/S0140-6736(20)32544-7.

Adjunctive oral prednisone appears to significantly reduce cluster headache attacks, new research shows. Results of the multicenter, randomized, double-blind trial show that patients who received the steroid had 25% fewer attacks in the first week of therapy, compared with their counterparts who received placebo.

In addition, more than a third of patients in the prednisone group were pain free, and for almost half, headache frequency was reduced by at least 50% at day 7 of treatment.

These findings provide clear evidence that prednisone, in conjunction with the use of verapamil, is effective in cluster headache, said lead author Mark Obermann, MD, director, Center for Neurology, Asklepios Hospitals Seesen (Germany), and associate professor, University of Duisburg-Essen (Germany).

The key message, he added, is that all patients with cluster headache should receive prednisone at the start of an episode.

The study was published online Nov. 24 in the Lancet Neurology.
 

‘Suicide headaches’

Cluster headaches are intense unilateral attacks of facial and head pain. They last 15-180 minutes and predominantly affect men. They are accompanied by trigeminal autonomic symptoms and are extremely painful. “They’re referred to as ‘suicide headaches’ because the pain is so severe that patients often report they think about killing themselves to get rid of the pain,” said Dr. Obermann.

The cause is unclear, although there is some evidence that the hypothalamus is involved. The headaches sometimes follow a “strict circadian pattern,” said Dr. Obermann. He noted that the attacks might occur over a few weeks or months and then not return for months or even years.

An estimated 1 in 1,000 people experience cluster headache, but the condition is underrecognized, and research is scarce and poorly funded. Previous research does show that the calcium channel blocker verapamil, which is used to treat high blood pressure, is effective in cluster headache. However, it takes about 14 days to work and has to be slowly titrated because of cardiac side effects, said Dr. Obermann. For these reasons, international guidelines recommend initiating short-term preventive treatment with corticosteroids to suppress, or at least lessen, cluster headache attacks until long-term prevention is effective.

Although some clinicians treat cluster headaches with corticosteroids, others don’t because of a lack of evidence that shows they are effective. “There’s no evidence whatsoever on what the correct dose is or whether it helps at all. This is the gap we wanted to close,” said Dr. Obermann.

The study included 116 adult patients with cluster headache from 10 centers who were experiencing a cluster headache episode and were not taking prophylactic medication.

The trial only included patients who had an attack within 30 days of their current episode. The investigators included this restriction to reduce the possibility of spontaneous remission, which is “a big problem” in cluster headache trials, he said. To confirm that episodes were cluster headache attacks, patients were also required to have moderate to severe pain, indicated by a score of at least 5 on a numerical rating scale in which 0 indicates no pain and 10 indicates the worse imaginable pain.

Participants were allowed to use treatments for acute attack, but these therapies were limited to triptans, high-flow oxygen, intranasal lidocaine, ergotamine, and oral analgesics.
 

Debilitating pain

Patients were randomly assigned to receive oral prednisone (n = 53) or placebo (n = 56). The study groups were matched with respect to demographic and clinical characteristics. Prednisone was initiated at 100 mg/d for 5 days and was then tapered by 20 mg every 3 days in the active-treatment group. All patients also received oral verapamil at a starting dose of 40 mg three times per day. The dose was increased every 3 days by 40 mg to a maximum of 360 mg/d.

All participants received pantoprazole 20 mg to prevent the gastric side effects of prednisone. An attack was defined as a unilateral headache of moderate to severe intensity. The study lasted 28 days.

The study’s primary outcome was the mean number of cluster headache attacks during the first week of treatment with prednisone versus placebo.

The mean number of attacks during the first week of treatment was 7.1 in the prednisone group and 9.5 in the placebo group, for a difference of –2.4 attacks (95% confidence interval, –4.8 to –0.03; P = .002). “This might not sound like much,” but reducing the number of daily attacks from, say, eight to six “really makes a difference because the attacks are so painful,” said Dr. Obermann.

The prednisone group also came out on top for a number secondary outcomes. After the first 7 days, attacks ceased in 35% of the prednisone group versus 7% in the placebo group.
 

‘Clear evidence’ of efficacy

About 49% of patients who took prednisone reported a reduction of at least 50% in attack frequency at day 7. By comparison, 15% of patients who received placebo reported such a reduction. The number of cluster attacks at day 28 was less in the prednisone group than in the patients who received placebo.

With respect to treatment effect, the difference between prednisone and placebo gradually lessened over time “in parallel to the verapamil dose reaching its therapeutic effect,” the investigators noted. “Therefore, attack frequency reduction slowly converged between groups,” they added.

The study results provide “clear evidence” and should reassure clinicians that short-term prednisone early in a cluster headache attack is effective, said Dr. Obermann.

Adverse events, which included headache, palpitations, dizziness, and nausea, were as expected and were similar in the two groups. There were only two severe adverse events, both of which occurred in participants in the placebo group.

Dr. Obermann said the investigators were surprised that so many patients in the study were taking analgesics. “Analgesics don’t work in cluster headache; they just don’t work in this kind of pain.”

He noted that prednisone exposure of study patients spanned only 19 days and amounted to only 1,100 mg, which he believes is safe.

The prednisone dose used in the study is “what most clinicians use in clinical practice,” although there have been reports of success using 500 mg of IV prednisone over 5 days, said Dr. Obermann. He added that it would be “interesting to see if 50 mg would be just as good” as a starting dose.

Potential limitations of the study include the fact that the majority of participants were White, so the findings may not be generalizable to other populations.
 

Long-awaited results

In an accompanying editorial, Anne Ducros, MD, PhD, professor of neurology and director of the Headache Center, Montpellier (France) University Hospital, said the study provides “strong and long-awaited evidence supporting the use of oral steroids as a transitional treatment option.”

The trial “raises many topics for future research,” one of which is the long-term safety of prednisone for patients with cluster headache, said Dr. Ducros. She noted that use of high-dose steroids once or twice a year for 15 years or more “has the potential for severe systemic toxic effects,” such as corticosteroid-induced osteonecrosis of the femoral head.

Other questions about corticosteroid use for patients with cluster headache remain. These include understanding whether these agents provide better efficacy than occipital nerve injections and determining the optimal verapamil regimen, she noted.

In addition, the risk for oral steroid misuse needs to be studied, she said. She noted that drug misuse is common among patients with cluster headache.

Despite these questions, the results of this new study “provide an important step forward for patients with cluster headache, for whom safe and effective transitional therapies are much needed,” Dr. Ducros wrote.


Dr. Obermann has received fees from Sanofi, Biogen, Novartis, Teva Pharmaceuticals, and Eli Lilly and grants from Allergan and Heel Pharmaceuticals outside of this work. Dr. Ducros has received fees from Amgen, Novartis, Teva, and Eli Lilly; grants from the Programme Hospitalier de Recherche Clinique and from the Appel d’Offre Interne of Montpellier University Hospital; and nonfinancial support from SOS Oxygene.

A version of this article originally appeared on Medscape.com.

Adjunctive oral prednisone appears to significantly reduce cluster headache attacks, new research shows. Results of the multicenter, randomized, double-blind trial show that patients who received the steroid had 25% fewer attacks in the first week of therapy, compared with their counterparts who received placebo.

In addition, more than a third of patients in the prednisone group were pain free, and for almost half, headache frequency was reduced by at least 50% at day 7 of treatment.

These findings provide clear evidence that prednisone, in conjunction with the use of verapamil, is effective in cluster headache, said lead author Mark Obermann, MD, director, Center for Neurology, Asklepios Hospitals Seesen (Germany), and associate professor, University of Duisburg-Essen (Germany).

The key message, he added, is that all patients with cluster headache should receive prednisone at the start of an episode.

The study was published online Nov. 24 in the Lancet Neurology.
 

‘Suicide headaches’

Cluster headaches are intense unilateral attacks of facial and head pain. They last 15-180 minutes and predominantly affect men. They are accompanied by trigeminal autonomic symptoms and are extremely painful. “They’re referred to as ‘suicide headaches’ because the pain is so severe that patients often report they think about killing themselves to get rid of the pain,” said Dr. Obermann.

The cause is unclear, although there is some evidence that the hypothalamus is involved. The headaches sometimes follow a “strict circadian pattern,” said Dr. Obermann. He noted that the attacks might occur over a few weeks or months and then not return for months or even years.

An estimated 1 in 1,000 people experience cluster headache, but the condition is underrecognized, and research is scarce and poorly funded. Previous research does show that the calcium channel blocker verapamil, which is used to treat high blood pressure, is effective in cluster headache. However, it takes about 14 days to work and has to be slowly titrated because of cardiac side effects, said Dr. Obermann. For these reasons, international guidelines recommend initiating short-term preventive treatment with corticosteroids to suppress, or at least lessen, cluster headache attacks until long-term prevention is effective.

Although some clinicians treat cluster headaches with corticosteroids, others don’t because of a lack of evidence that shows they are effective. “There’s no evidence whatsoever on what the correct dose is or whether it helps at all. This is the gap we wanted to close,” said Dr. Obermann.

The study included 116 adult patients with cluster headache from 10 centers who were experiencing a cluster headache episode and were not taking prophylactic medication.

The trial only included patients who had an attack within 30 days of their current episode. The investigators included this restriction to reduce the possibility of spontaneous remission, which is “a big problem” in cluster headache trials, he said. To confirm that episodes were cluster headache attacks, patients were also required to have moderate to severe pain, indicated by a score of at least 5 on a numerical rating scale in which 0 indicates no pain and 10 indicates the worse imaginable pain.

Participants were allowed to use treatments for acute attack, but these therapies were limited to triptans, high-flow oxygen, intranasal lidocaine, ergotamine, and oral analgesics.
 

Debilitating pain

Patients were randomly assigned to receive oral prednisone (n = 53) or placebo (n = 56). The study groups were matched with respect to demographic and clinical characteristics. Prednisone was initiated at 100 mg/d for 5 days and was then tapered by 20 mg every 3 days in the active-treatment group. All patients also received oral verapamil at a starting dose of 40 mg three times per day. The dose was increased every 3 days by 40 mg to a maximum of 360 mg/d.

All participants received pantoprazole 20 mg to prevent the gastric side effects of prednisone. An attack was defined as a unilateral headache of moderate to severe intensity. The study lasted 28 days.

The study’s primary outcome was the mean number of cluster headache attacks during the first week of treatment with prednisone versus placebo.

The mean number of attacks during the first week of treatment was 7.1 in the prednisone group and 9.5 in the placebo group, for a difference of –2.4 attacks (95% confidence interval, –4.8 to –0.03; P = .002). “This might not sound like much,” but reducing the number of daily attacks from, say, eight to six “really makes a difference because the attacks are so painful,” said Dr. Obermann.

The prednisone group also came out on top for a number secondary outcomes. After the first 7 days, attacks ceased in 35% of the prednisone group versus 7% in the placebo group.
 

‘Clear evidence’ of efficacy

About 49% of patients who took prednisone reported a reduction of at least 50% in attack frequency at day 7. By comparison, 15% of patients who received placebo reported such a reduction. The number of cluster attacks at day 28 was less in the prednisone group than in the patients who received placebo.

With respect to treatment effect, the difference between prednisone and placebo gradually lessened over time “in parallel to the verapamil dose reaching its therapeutic effect,” the investigators noted. “Therefore, attack frequency reduction slowly converged between groups,” they added.

The study results provide “clear evidence” and should reassure clinicians that short-term prednisone early in a cluster headache attack is effective, said Dr. Obermann.

Adverse events, which included headache, palpitations, dizziness, and nausea, were as expected and were similar in the two groups. There were only two severe adverse events, both of which occurred in participants in the placebo group.

Dr. Obermann said the investigators were surprised that so many patients in the study were taking analgesics. “Analgesics don’t work in cluster headache; they just don’t work in this kind of pain.”

He noted that prednisone exposure of study patients spanned only 19 days and amounted to only 1,100 mg, which he believes is safe.

The prednisone dose used in the study is “what most clinicians use in clinical practice,” although there have been reports of success using 500 mg of IV prednisone over 5 days, said Dr. Obermann. He added that it would be “interesting to see if 50 mg would be just as good” as a starting dose.

Potential limitations of the study include the fact that the majority of participants were White, so the findings may not be generalizable to other populations.
 

Long-awaited results

In an accompanying editorial, Anne Ducros, MD, PhD, professor of neurology and director of the Headache Center, Montpellier (France) University Hospital, said the study provides “strong and long-awaited evidence supporting the use of oral steroids as a transitional treatment option.”

The trial “raises many topics for future research,” one of which is the long-term safety of prednisone for patients with cluster headache, said Dr. Ducros. She noted that use of high-dose steroids once or twice a year for 15 years or more “has the potential for severe systemic toxic effects,” such as corticosteroid-induced osteonecrosis of the femoral head.

Other questions about corticosteroid use for patients with cluster headache remain. These include understanding whether these agents provide better efficacy than occipital nerve injections and determining the optimal verapamil regimen, she noted.

In addition, the risk for oral steroid misuse needs to be studied, she said. She noted that drug misuse is common among patients with cluster headache.

Despite these questions, the results of this new study “provide an important step forward for patients with cluster headache, for whom safe and effective transitional therapies are much needed,” Dr. Ducros wrote.


Dr. Obermann has received fees from Sanofi, Biogen, Novartis, Teva Pharmaceuticals, and Eli Lilly and grants from Allergan and Heel Pharmaceuticals outside of this work. Dr. Ducros has received fees from Amgen, Novartis, Teva, and Eli Lilly; grants from the Programme Hospitalier de Recherche Clinique and from the Appel d’Offre Interne of Montpellier University Hospital; and nonfinancial support from SOS Oxygene.

A version of this article originally appeared on Medscape.com.

Adjunctive oral prednisone appears to significantly reduce cluster headache attacks, new research shows. Results of the multicenter, randomized, double-blind trial show that patients who received the steroid had 25% fewer attacks in the first week of therapy, compared with their counterparts who received placebo.

In addition, more than a third of patients in the prednisone group were pain free, and for almost half, headache frequency was reduced by at least 50% at day 7 of treatment.

These findings provide clear evidence that prednisone, in conjunction with the use of verapamil, is effective in cluster headache, said lead author Mark Obermann, MD, director, Center for Neurology, Asklepios Hospitals Seesen (Germany), and associate professor, University of Duisburg-Essen (Germany).

The key message, he added, is that all patients with cluster headache should receive prednisone at the start of an episode.

The study was published online Nov. 24 in the Lancet Neurology.
 

‘Suicide headaches’

Cluster headaches are intense unilateral attacks of facial and head pain. They last 15-180 minutes and predominantly affect men. They are accompanied by trigeminal autonomic symptoms and are extremely painful. “They’re referred to as ‘suicide headaches’ because the pain is so severe that patients often report they think about killing themselves to get rid of the pain,” said Dr. Obermann.

The cause is unclear, although there is some evidence that the hypothalamus is involved. The headaches sometimes follow a “strict circadian pattern,” said Dr. Obermann. He noted that the attacks might occur over a few weeks or months and then not return for months or even years.

An estimated 1 in 1,000 people experience cluster headache, but the condition is underrecognized, and research is scarce and poorly funded. Previous research does show that the calcium channel blocker verapamil, which is used to treat high blood pressure, is effective in cluster headache. However, it takes about 14 days to work and has to be slowly titrated because of cardiac side effects, said Dr. Obermann. For these reasons, international guidelines recommend initiating short-term preventive treatment with corticosteroids to suppress, or at least lessen, cluster headache attacks until long-term prevention is effective.

Although some clinicians treat cluster headaches with corticosteroids, others don’t because of a lack of evidence that shows they are effective. “There’s no evidence whatsoever on what the correct dose is or whether it helps at all. This is the gap we wanted to close,” said Dr. Obermann.

The study included 116 adult patients with cluster headache from 10 centers who were experiencing a cluster headache episode and were not taking prophylactic medication.

The trial only included patients who had an attack within 30 days of their current episode. The investigators included this restriction to reduce the possibility of spontaneous remission, which is “a big problem” in cluster headache trials, he said. To confirm that episodes were cluster headache attacks, patients were also required to have moderate to severe pain, indicated by a score of at least 5 on a numerical rating scale in which 0 indicates no pain and 10 indicates the worse imaginable pain.

Participants were allowed to use treatments for acute attack, but these therapies were limited to triptans, high-flow oxygen, intranasal lidocaine, ergotamine, and oral analgesics.
 

Debilitating pain

Patients were randomly assigned to receive oral prednisone (n = 53) or placebo (n = 56). The study groups were matched with respect to demographic and clinical characteristics. Prednisone was initiated at 100 mg/d for 5 days and was then tapered by 20 mg every 3 days in the active-treatment group. All patients also received oral verapamil at a starting dose of 40 mg three times per day. The dose was increased every 3 days by 40 mg to a maximum of 360 mg/d.

All participants received pantoprazole 20 mg to prevent the gastric side effects of prednisone. An attack was defined as a unilateral headache of moderate to severe intensity. The study lasted 28 days.

The study’s primary outcome was the mean number of cluster headache attacks during the first week of treatment with prednisone versus placebo.

The mean number of attacks during the first week of treatment was 7.1 in the prednisone group and 9.5 in the placebo group, for a difference of –2.4 attacks (95% confidence interval, –4.8 to –0.03; P = .002). “This might not sound like much,” but reducing the number of daily attacks from, say, eight to six “really makes a difference because the attacks are so painful,” said Dr. Obermann.

The prednisone group also came out on top for a number secondary outcomes. After the first 7 days, attacks ceased in 35% of the prednisone group versus 7% in the placebo group.
 

‘Clear evidence’ of efficacy

About 49% of patients who took prednisone reported a reduction of at least 50% in attack frequency at day 7. By comparison, 15% of patients who received placebo reported such a reduction. The number of cluster attacks at day 28 was less in the prednisone group than in the patients who received placebo.

With respect to treatment effect, the difference between prednisone and placebo gradually lessened over time “in parallel to the verapamil dose reaching its therapeutic effect,” the investigators noted. “Therefore, attack frequency reduction slowly converged between groups,” they added.

The study results provide “clear evidence” and should reassure clinicians that short-term prednisone early in a cluster headache attack is effective, said Dr. Obermann.

Adverse events, which included headache, palpitations, dizziness, and nausea, were as expected and were similar in the two groups. There were only two severe adverse events, both of which occurred in participants in the placebo group.

Dr. Obermann said the investigators were surprised that so many patients in the study were taking analgesics. “Analgesics don’t work in cluster headache; they just don’t work in this kind of pain.”

He noted that prednisone exposure of study patients spanned only 19 days and amounted to only 1,100 mg, which he believes is safe.

The prednisone dose used in the study is “what most clinicians use in clinical practice,” although there have been reports of success using 500 mg of IV prednisone over 5 days, said Dr. Obermann. He added that it would be “interesting to see if 50 mg would be just as good” as a starting dose.

Potential limitations of the study include the fact that the majority of participants were White, so the findings may not be generalizable to other populations.
 

Long-awaited results

In an accompanying editorial, Anne Ducros, MD, PhD, professor of neurology and director of the Headache Center, Montpellier (France) University Hospital, said the study provides “strong and long-awaited evidence supporting the use of oral steroids as a transitional treatment option.”

The trial “raises many topics for future research,” one of which is the long-term safety of prednisone for patients with cluster headache, said Dr. Ducros. She noted that use of high-dose steroids once or twice a year for 15 years or more “has the potential for severe systemic toxic effects,” such as corticosteroid-induced osteonecrosis of the femoral head.

Other questions about corticosteroid use for patients with cluster headache remain. These include understanding whether these agents provide better efficacy than occipital nerve injections and determining the optimal verapamil regimen, she noted.

In addition, the risk for oral steroid misuse needs to be studied, she said. She noted that drug misuse is common among patients with cluster headache.

Despite these questions, the results of this new study “provide an important step forward for patients with cluster headache, for whom safe and effective transitional therapies are much needed,” Dr. Ducros wrote.


Dr. Obermann has received fees from Sanofi, Biogen, Novartis, Teva Pharmaceuticals, and Eli Lilly and grants from Allergan and Heel Pharmaceuticals outside of this work. Dr. Ducros has received fees from Amgen, Novartis, Teva, and Eli Lilly; grants from the Programme Hospitalier de Recherche Clinique and from the Appel d’Offre Interne of Montpellier University Hospital; and nonfinancial support from SOS Oxygene.

A version of this article originally appeared on Medscape.com.