Take-Home Points

• Music therapists use patient-preferred live music, increasing neurologic cues that enhance movement—a seminal recovery function in postoperative spine patients.
• Music therapy is an evidence-based, integrative treatment addressing body, mind, and spirit.
• Tension release through music therapy can serve as a critical mechanism for building resilience related to pain management.
• Music therapy and music medicine are distinct forms of clinical practice that focus on mind-body integration in the healing process.
• Music therapists, board-certified and licensed by the state as recognized healthcare professionals, address pain management, which is an increasing subspecialty in postoperative care.

About 70% of people in the United States experience at least 1 episode of back pain in their lifetime,¹ and more than 5 million are temporarily or permanently disabled by spinal disorders.^2-4 Some require surgery, which may rectify injury, but pain during recovery is often inevitable, and the road to recovery is not guaranteed to be smooth.^5-20

Postoperative spine patients are at major risk for pain management challenges.^14,15,18,20 Treatment is primarily pharmacologic and based on the surgical team’s pain management orders. Nursing care consists of monitoring the airway, vital signs, and neurovascular status and having patients rate their pain on a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). Nurses have the challenge of monitoring and continually assessing to make sure patients are achieving the optimal outcomes, particularly during the immediate postoperative period, when pain and anxiety are prominently increased.

Variability in spine surgery outcomes can be explained at least partly on the basis of prognostic psychological factors, including hypochondriasis, hysteria, depression, and poor pain coping strategies (eg, catastrophizing).²¹ In spine surgery patients, kinesiophobia (fear of moving) is a common component of distress that can impede recuperation.^21-23Psychological interventions that assist with the secondary stressors associated with pain and loss during physical recuperation are recommended, with increased attention given to the importance of treating the whole person: body, mind, and spirit.^24-29 Conventional pain-alleviating medical interventions can be enhanced with integrative therapies that empower patients to marshal their inner resources during recovery.^25-28Music therapy may be particularly suited to this effort, as it is adaptable to the patient’s individual and culturally specific needs.^29-33

Rationale for Live Music

Pain is subjective and personal, and warrants an individualized approach to care. There is a body of music medicine research on the use of recorded music in modulating psychological and physiological factors in pain perception.^30,32,34-54 This research supports the unique relationship of music to well-being, and the understanding that controlling any of these factors affects the duration, intensity, and quality of that experience.^41,43,52

These findings provide incentive for breathing-entrained music therapy interventions, which enhance the relaxation response and release of pain-related tension;^32,55-58 empower patients to unlock physical and emotional tension;^32,57,58 provide a channel for expression and body movement; and enhance blood flow and/or alleviate pain by activating neurologic areas involved in the experience of pain.^59-62Studies have found that physical endurance may be enhanced when movement is rhythmically coordinated with a musical stimulus.^63-66 Music may prolong physical endurance by inhibiting psychological feedback associated with physical exertion related to fatigue, which may translate into accelerated recovery periods. When we listen to a rhythmic sound, our brains tend to automatically synchronize, or entrain, to external rhythmic cues that can stimulate increased motor control and coordination.⁶³ Sound can arouse and raise the excitability of spinal motor neurons mediated by auditory-motor neuronal connections on the brain stem and spinal cord level.^64-66 Rhythmically organized sounds serve as a neurological function in our capacity to organize predictable timing cues that are apparent in music, and may result in an effective treatment intervention in recovery.^63,64

Music Therapy in Recovery From Spine Surgery

In music therapy, music is used within a therapeutic relationship to support or affect change in the patient and the treatment regimen.^32,33,56-58 Research on music therapy with patients who are recovering from spine surgery is scant.^67-69 Kleiber and Adamek⁶⁷ studied perceptions of music therapy in 8 adolescents after spinal fusion surgery. In their study, a music therapist provided patients with a postoperative music therapy session focusing on the use of patient-preferred live music for relaxation and expression. Although their qualitative query was based on a therapeutic approach similar to that used in the present study, only 1 session was offered during the recovery period, and follow-up was conducted by survey invitation and telephone. In addition, the number of participants was small, and there was no quantitative measure of pain or other symptoms.

Another study focused on the effects of listening to music on pain intensity and distress after spine surgery.⁶⁸ Patients in the study’s music group made their selections from prerecorded classical music and domestic and international popular songs from various genres and listened to their chosen recordings 30 minutes a day. Although the study was not a music therapy study per se, it showed a positive impact of listening to music on anxiety and pain perception in 60 adults who were randomly assigned to the music group or to a non-music control group (n = 30 in each). Differences between the music and control groups’ VAS ratings of anxiety (Ps = .018-.001) and pain (P = .001) were statistically significant.

Different from our study, the aforementioned studies did not include tension release–focused live music offered within a therapeutic relationship. Our 1.5-year pilot study, conducted prior to the present study indicated that music therapy led to increased resilience and recovery mechanisms.⁵⁸

Methods

Our mixed-methods study design combined standard medical treatment with integrative music therapy interventions based on pain assessments to better understand the effects of music therapy on the recovery of patients after spine surgery.

The Spine Institute of New York within the Department of Orthopedic Surgery at Mount Sinai Beth Israel provides surgical treatment of common spinal cord conditions. Prioritizing patient satisfaction and positive outcomes,^27,28 the institute integrates music therapy through the Louis Armstrong Center for Music and Medicine to enhance treatment of pain symptoms.

Patients were recruited by the research team as per the daily surgical schedule, or through referral by the medical team or patient care navigator. Sixty patients (35 female, 25 male) ranging in age from 40 to 55 years underwent anterior, posterior, or anterior-posterior spinal fusion and were enrolled in the study after signing a participation consent form. Minorities, women, and patients with Medicaid and Medicare were included. Patients who received a diagnosis of clinical psychosis or depression prior to spine injury were excluded.

The experimental group received music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention), and a wait-listed control group received standard care only. A randomization chart created by a blinded statistician who did not have access to the patient census determined the intervention–nonintervention schedule. Patients in the music therapy group received one 30-minute music therapy session during an 8-hour period within 72 hours after surgery.

For both groups, measurements were completed before and after the study window. Control patients were offered music therapy after completion of the post-intervention surveys in order to minimize the ethical dilemma of denying potentially helpful pain intervention. For this same reason, both groups were given the option of receiving follow-up music therapy sessions for the duration of their hospitalization.

The research team consisted of 2 licensed, board-certified music therapists. In addition, Master’s-level music therapy interns completing clinical hours as part of the trajectory for board certification served on the research team over the 5-year period 2009 to 2014, and 13 blinded research assistants helped with enrolling and collecting data on patients.

Intervention

Each music therapy session included a warm-up phase of verbal or musical discourse. Next was the treatment phase, which was based on patient need as assessed during warm-up. Treatment options included use of patient-preferred live music that supported tension release/relaxation through incentive-based clinical improvisation, singing, and/or rhythmic drumming or through breathwork and visualization. Psychoeducation about mind–body awareness through the use of breath and imagery was introduced and explained by the therapist at this time.

The improvised music intervention was focused on making salient the natural harmonic tension-resolution cycles that occur in music and that were entrained to the patient’s presentation (respiratory rate, verbal report, clinical presentation). When patient-preferred precomposed songs were used, tension resolution was achieved by sustaining cadence and resolution, also entrained to the patient’s respiratory cycles.^32,57,58

After the music therapy intervention, a period of closure or integration was facilitated by the therapist contingent on the patient’s degree of alertness. If awake, the patient was supported in a reflexive process of thoughts, impressions, or issues that may have contributed to the overall experience. If the patient was asleep, the researcher returned within 30 minutes for post-intervention interviewing. Interview information was recorded in a qualitative post-participation survey. To prevent bias, researchers who were not the treating clinicians conducted the surveys.

Outcome Measures

Both primary and secondary outcome measures were collected before and after the intervention. The primary outcome measure was VAS pain ratings, and the secondary outcome measures were scores on the Hospital Anxiety and Depression Scale (HADS), the Tampa Scale for Kinesiophobia (TSK), and the Color Analysis Scale (CAS).

VAS. With the VAS, images are used to rate pain. The scale has points labeled 0 to 10 and corresponding faces representing progression in pain intensity. The scale is quickly rendered and can be interpreted according to the patient’s recovery phase at time of rendering.

HADS. The HADS⁷⁰ provides a specific baseline for anxiety and depression as an indicator of how the patient might fare during hospitalization (admission through recovery and discharge).

TSK. The TSK⁷¹ provides insight into the patient’s perception of fear-related movement, which is an important factor in this study because of the movement required for rehabilitation. We used a shortened version of the TSK to accommodate the sensitive threshold for pain tolerance and pharmacologic side effects commonly experienced by spine patients.

CAS. The CAS was developed at the Louis Armstrong Center for Music and Medicine to assess comorbidities and dynamic aspects of pain. Through a coloring exercise, patients illustrate their pain experience, which gives tangible form to the abstract experience of pain.

Coding

We collected patients’ demographic data, including age, sex, and diagnoses. Clinical indicators of the preoperative baseline included lifestyle, surgical history, and prior experience with music or other mind–body strategies for self-regulation.

As fundamental to qualitative methodology,^72,73 the reported responses to questions were grouped into themes that were peer-tested with members of the research team before and during the coding process.

Statistical Methods

Means and standard deviations were used for continuous variables, and frequencies (percentages) for categorical variables. All outcomes were analyzed on an intent-to-treat basis. Repeated-measures analysis of variance was used to compare changes in outcomes from before to after intervention for the music and control groups. In particular, a statistically significant Group (music vs control) × Time (before vs after intervention) interaction would support the hypothesis that there would be more benefit (less pain) in the music group as a result of the music therapy. For all tests, significance was set at P < .05. SPSS Version 20 (IBM) was used for all statistical analyses. Based on previously found differences in heart rate and mobility,³¹ we assumed an effect size of 0.71 for the difference between music and control (no music), which would require 32 patients per group to achieve a power of 0.8 with an α of 0.05.

Results

Of the 136 patients who were asked to participate in the study, 76 were not enrolled; the other 60 were equally assigned to either the control group or the music therapy group (n = 30 in each) according to randomization indicated by a blinded statistician (Figure 1).

Table 2 lists the pre-intervention and post-intervention comparisons of the main outcomes between groups.

Relationship with music was coded for significance and included reports of music as a resource accessed for stimulation and/or relaxation through listening; direct involvement with instrument playing; and history of music training. 

Perceptions of surgical outcome in patients’ responses were coded across 3 themes: (1) optimistic (belief and hope in returning to original baseline of functionality), (2) indifferent (neither hopeful nor cynical about results of surgery), and (3) pessimistic (belief that nothing will restore the quality of life that existed before the spinal condition).

The CAS helped us better understand the diversity and complexity of the pain experience.

Discussion

Our hospital has the unique capability of providing music therapy to postoperative and other hospitalized patients. In this study, we compared the impact of a structured postoperative music therapy program on spine patients relative to control patients who did not receive music therapy after spine surgery.

We found a significant benefit in VAS pain levels (>1 point) but no statistically significant differences in HADS Anxiety, HADS Depression, or TSK scores. Although a 2-point difference is usually considered clinically significant, the degree of change in the music group is notable for having been achieved by nonpharmacologic means with scant chance of adverse effects. We suspect the lack of significant change in HADS Anxiety, HADS Depression, and TSK scores is attributable to the narrow study window. Given the observational data from our pilot study⁵⁸ and ongoing results with spine patients,³² it seems clear that both mood state and resilience in coping are enhanced through an ongoing relationship with music therapy.

The study of a population as vulnerable as patients recovering from spine surgery raises many issues for providers and researchers. Although it is worthwhile to determine the efficacy of integrative modalities in serving these patients, the request for participation in a protocol at such a vulnerable time was often resisted. During our pilot work, it became clear that the ability of potential subjects to comprehend and complete protocol surveys was impacted by adverse effects, including sedation drowsiness; respiratory depression; nausea and vomiting; pruritus; and urinary retention caused by the medications used for postoperative pain management. Consequently, after piloting 5 cases before the main study, we extended the enrollment window to 72 hours.

Other unforeseen intrinsic or external obstacles were identified: Patient-related issues—including availability, level of interest in participation, and inability to participate because of the medication adverse effects mentioned.

Staff investment/education—addressed over the first 3 study years with several in-services, starting with the surgical team and continuing with nursing and support staff in various combinations. These meetings led to the creation of an Institutional Review Board (IRB) approved educational sheet for inclusion in the information packet given to surgical patients on registration.

Programming interruptions—caused by the convergence of several unanticipated factors, including a delay in expedited review of the IRB renewal during the year of Hurricane Sandy and an interruption in the spine team’s service for administrative and program modification.

Conclusion

Music therapy interventions (eg, use of patient-preferred live music) offered within a therapeutic relationship favorably affected pain perceptions in patients recovering from spine surgery. This effect was achieved through several therapeutic entry points, including support of expression and opportunities for emotional catharsis.

At the core of music therapy’s efficacy is individualized treatment, through which patients are supported in their recovery of “self.” Measurable benefits—including increased comfort; reduced pain; improved gait; increased range of motion, endurance, and ability to relax; and empowerment to actively participate in one’s own care through daily activities imbued with an enhanced sense of agency—are of cardinal importance, as they may lead to quicker recovery perceptions and enhanced quality of life.

Am J Orthop. 2017;46(1):E13-E22. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Music therapists use patient-preferred live music, increasing neurologic cues that enhance movement—a seminal recovery function in postoperative spine patients.
• Music therapy is an evidence-based, integrative treatment addressing body, mind, and spirit.
• Tension release through music therapy can serve as a critical mechanism for building resilience related to pain management.
• Music therapy and music medicine are distinct forms of clinical practice that focus on mind-body integration in the healing process.
• Music therapists, board-certified and licensed by the state as recognized healthcare professionals, address pain management, which is an increasing subspecialty in postoperative care.

About 70% of people in the United States experience at least 1 episode of back pain in their lifetime,¹ and more than 5 million are temporarily or permanently disabled by spinal disorders.^2-4 Some require surgery, which may rectify injury, but pain during recovery is often inevitable, and the road to recovery is not guaranteed to be smooth.^5-20

Postoperative spine patients are at major risk for pain management challenges.^14,15,18,20 Treatment is primarily pharmacologic and based on the surgical team’s pain management orders. Nursing care consists of monitoring the airway, vital signs, and neurovascular status and having patients rate their pain on a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). Nurses have the challenge of monitoring and continually assessing to make sure patients are achieving the optimal outcomes, particularly during the immediate postoperative period, when pain and anxiety are prominently increased.

Variability in spine surgery outcomes can be explained at least partly on the basis of prognostic psychological factors, including hypochondriasis, hysteria, depression, and poor pain coping strategies (eg, catastrophizing).²¹ In spine surgery patients, kinesiophobia (fear of moving) is a common component of distress that can impede recuperation.^21-23Psychological interventions that assist with the secondary stressors associated with pain and loss during physical recuperation are recommended, with increased attention given to the importance of treating the whole person: body, mind, and spirit.^24-29 Conventional pain-alleviating medical interventions can be enhanced with integrative therapies that empower patients to marshal their inner resources during recovery.^25-28Music therapy may be particularly suited to this effort, as it is adaptable to the patient’s individual and culturally specific needs.^29-33

Rationale for Live Music

Pain is subjective and personal, and warrants an individualized approach to care. There is a body of music medicine research on the use of recorded music in modulating psychological and physiological factors in pain perception.^30,32,34-54 This research supports the unique relationship of music to well-being, and the understanding that controlling any of these factors affects the duration, intensity, and quality of that experience.^41,43,52

These findings provide incentive for breathing-entrained music therapy interventions, which enhance the relaxation response and release of pain-related tension;^32,55-58 empower patients to unlock physical and emotional tension;^32,57,58 provide a channel for expression and body movement; and enhance blood flow and/or alleviate pain by activating neurologic areas involved in the experience of pain.^59-62Studies have found that physical endurance may be enhanced when movement is rhythmically coordinated with a musical stimulus.^63-66 Music may prolong physical endurance by inhibiting psychological feedback associated with physical exertion related to fatigue, which may translate into accelerated recovery periods. When we listen to a rhythmic sound, our brains tend to automatically synchronize, or entrain, to external rhythmic cues that can stimulate increased motor control and coordination.⁶³ Sound can arouse and raise the excitability of spinal motor neurons mediated by auditory-motor neuronal connections on the brain stem and spinal cord level.^64-66 Rhythmically organized sounds serve as a neurological function in our capacity to organize predictable timing cues that are apparent in music, and may result in an effective treatment intervention in recovery.^63,64

Music Therapy in Recovery From Spine Surgery

In music therapy, music is used within a therapeutic relationship to support or affect change in the patient and the treatment regimen.^32,33,56-58 Research on music therapy with patients who are recovering from spine surgery is scant.^67-69 Kleiber and Adamek⁶⁷ studied perceptions of music therapy in 8 adolescents after spinal fusion surgery. In their study, a music therapist provided patients with a postoperative music therapy session focusing on the use of patient-preferred live music for relaxation and expression. Although their qualitative query was based on a therapeutic approach similar to that used in the present study, only 1 session was offered during the recovery period, and follow-up was conducted by survey invitation and telephone. In addition, the number of participants was small, and there was no quantitative measure of pain or other symptoms.

Another study focused on the effects of listening to music on pain intensity and distress after spine surgery.⁶⁸ Patients in the study’s music group made their selections from prerecorded classical music and domestic and international popular songs from various genres and listened to their chosen recordings 30 minutes a day. Although the study was not a music therapy study per se, it showed a positive impact of listening to music on anxiety and pain perception in 60 adults who were randomly assigned to the music group or to a non-music control group (n = 30 in each). Differences between the music and control groups’ VAS ratings of anxiety (Ps = .018-.001) and pain (P = .001) were statistically significant.

Different from our study, the aforementioned studies did not include tension release–focused live music offered within a therapeutic relationship. Our 1.5-year pilot study, conducted prior to the present study indicated that music therapy led to increased resilience and recovery mechanisms.⁵⁸

Methods

Our mixed-methods study design combined standard medical treatment with integrative music therapy interventions based on pain assessments to better understand the effects of music therapy on the recovery of patients after spine surgery.

The Spine Institute of New York within the Department of Orthopedic Surgery at Mount Sinai Beth Israel provides surgical treatment of common spinal cord conditions. Prioritizing patient satisfaction and positive outcomes,^27,28 the institute integrates music therapy through the Louis Armstrong Center for Music and Medicine to enhance treatment of pain symptoms.

Patients were recruited by the research team as per the daily surgical schedule, or through referral by the medical team or patient care navigator. Sixty patients (35 female, 25 male) ranging in age from 40 to 55 years underwent anterior, posterior, or anterior-posterior spinal fusion and were enrolled in the study after signing a participation consent form. Minorities, women, and patients with Medicaid and Medicare were included. Patients who received a diagnosis of clinical psychosis or depression prior to spine injury were excluded.

The experimental group received music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention), and a wait-listed control group received standard care only. A randomization chart created by a blinded statistician who did not have access to the patient census determined the intervention–nonintervention schedule. Patients in the music therapy group received one 30-minute music therapy session during an 8-hour period within 72 hours after surgery.

For both groups, measurements were completed before and after the study window. Control patients were offered music therapy after completion of the post-intervention surveys in order to minimize the ethical dilemma of denying potentially helpful pain intervention. For this same reason, both groups were given the option of receiving follow-up music therapy sessions for the duration of their hospitalization.

The research team consisted of 2 licensed, board-certified music therapists. In addition, Master’s-level music therapy interns completing clinical hours as part of the trajectory for board certification served on the research team over the 5-year period 2009 to 2014, and 13 blinded research assistants helped with enrolling and collecting data on patients.

Intervention

Each music therapy session included a warm-up phase of verbal or musical discourse. Next was the treatment phase, which was based on patient need as assessed during warm-up. Treatment options included use of patient-preferred live music that supported tension release/relaxation through incentive-based clinical improvisation, singing, and/or rhythmic drumming or through breathwork and visualization. Psychoeducation about mind–body awareness through the use of breath and imagery was introduced and explained by the therapist at this time.

The improvised music intervention was focused on making salient the natural harmonic tension-resolution cycles that occur in music and that were entrained to the patient’s presentation (respiratory rate, verbal report, clinical presentation). When patient-preferred precomposed songs were used, tension resolution was achieved by sustaining cadence and resolution, also entrained to the patient’s respiratory cycles.^32,57,58

After the music therapy intervention, a period of closure or integration was facilitated by the therapist contingent on the patient’s degree of alertness. If awake, the patient was supported in a reflexive process of thoughts, impressions, or issues that may have contributed to the overall experience. If the patient was asleep, the researcher returned within 30 minutes for post-intervention interviewing. Interview information was recorded in a qualitative post-participation survey. To prevent bias, researchers who were not the treating clinicians conducted the surveys.

Outcome Measures

Both primary and secondary outcome measures were collected before and after the intervention. The primary outcome measure was VAS pain ratings, and the secondary outcome measures were scores on the Hospital Anxiety and Depression Scale (HADS), the Tampa Scale for Kinesiophobia (TSK), and the Color Analysis Scale (CAS).

VAS. With the VAS, images are used to rate pain. The scale has points labeled 0 to 10 and corresponding faces representing progression in pain intensity. The scale is quickly rendered and can be interpreted according to the patient’s recovery phase at time of rendering.

HADS. The HADS⁷⁰ provides a specific baseline for anxiety and depression as an indicator of how the patient might fare during hospitalization (admission through recovery and discharge).

TSK. The TSK⁷¹ provides insight into the patient’s perception of fear-related movement, which is an important factor in this study because of the movement required for rehabilitation. We used a shortened version of the TSK to accommodate the sensitive threshold for pain tolerance and pharmacologic side effects commonly experienced by spine patients.

CAS. The CAS was developed at the Louis Armstrong Center for Music and Medicine to assess comorbidities and dynamic aspects of pain. Through a coloring exercise, patients illustrate their pain experience, which gives tangible form to the abstract experience of pain.

Coding

We collected patients’ demographic data, including age, sex, and diagnoses. Clinical indicators of the preoperative baseline included lifestyle, surgical history, and prior experience with music or other mind–body strategies for self-regulation.

As fundamental to qualitative methodology,^72,73 the reported responses to questions were grouped into themes that were peer-tested with members of the research team before and during the coding process.

Statistical Methods

Means and standard deviations were used for continuous variables, and frequencies (percentages) for categorical variables. All outcomes were analyzed on an intent-to-treat basis. Repeated-measures analysis of variance was used to compare changes in outcomes from before to after intervention for the music and control groups. In particular, a statistically significant Group (music vs control) × Time (before vs after intervention) interaction would support the hypothesis that there would be more benefit (less pain) in the music group as a result of the music therapy. For all tests, significance was set at P < .05. SPSS Version 20 (IBM) was used for all statistical analyses. Based on previously found differences in heart rate and mobility,³¹ we assumed an effect size of 0.71 for the difference between music and control (no music), which would require 32 patients per group to achieve a power of 0.8 with an α of 0.05.

Results

Of the 136 patients who were asked to participate in the study, 76 were not enrolled; the other 60 were equally assigned to either the control group or the music therapy group (n = 30 in each) according to randomization indicated by a blinded statistician (Figure 1).

Table 2 lists the pre-intervention and post-intervention comparisons of the main outcomes between groups.

Relationship with music was coded for significance and included reports of music as a resource accessed for stimulation and/or relaxation through listening; direct involvement with instrument playing; and history of music training. 

Perceptions of surgical outcome in patients’ responses were coded across 3 themes: (1) optimistic (belief and hope in returning to original baseline of functionality), (2) indifferent (neither hopeful nor cynical about results of surgery), and (3) pessimistic (belief that nothing will restore the quality of life that existed before the spinal condition).

The CAS helped us better understand the diversity and complexity of the pain experience.

Discussion

Our hospital has the unique capability of providing music therapy to postoperative and other hospitalized patients. In this study, we compared the impact of a structured postoperative music therapy program on spine patients relative to control patients who did not receive music therapy after spine surgery.

We found a significant benefit in VAS pain levels (>1 point) but no statistically significant differences in HADS Anxiety, HADS Depression, or TSK scores. Although a 2-point difference is usually considered clinically significant, the degree of change in the music group is notable for having been achieved by nonpharmacologic means with scant chance of adverse effects. We suspect the lack of significant change in HADS Anxiety, HADS Depression, and TSK scores is attributable to the narrow study window. Given the observational data from our pilot study⁵⁸ and ongoing results with spine patients,³² it seems clear that both mood state and resilience in coping are enhanced through an ongoing relationship with music therapy.

The study of a population as vulnerable as patients recovering from spine surgery raises many issues for providers and researchers. Although it is worthwhile to determine the efficacy of integrative modalities in serving these patients, the request for participation in a protocol at such a vulnerable time was often resisted. During our pilot work, it became clear that the ability of potential subjects to comprehend and complete protocol surveys was impacted by adverse effects, including sedation drowsiness; respiratory depression; nausea and vomiting; pruritus; and urinary retention caused by the medications used for postoperative pain management. Consequently, after piloting 5 cases before the main study, we extended the enrollment window to 72 hours.

Other unforeseen intrinsic or external obstacles were identified: Patient-related issues—including availability, level of interest in participation, and inability to participate because of the medication adverse effects mentioned.

Staff investment/education—addressed over the first 3 study years with several in-services, starting with the surgical team and continuing with nursing and support staff in various combinations. These meetings led to the creation of an Institutional Review Board (IRB) approved educational sheet for inclusion in the information packet given to surgical patients on registration.

Programming interruptions—caused by the convergence of several unanticipated factors, including a delay in expedited review of the IRB renewal during the year of Hurricane Sandy and an interruption in the spine team’s service for administrative and program modification.

Conclusion

Music therapy interventions (eg, use of patient-preferred live music) offered within a therapeutic relationship favorably affected pain perceptions in patients recovering from spine surgery. This effect was achieved through several therapeutic entry points, including support of expression and opportunities for emotional catharsis.

At the core of music therapy’s efficacy is individualized treatment, through which patients are supported in their recovery of “self.” Measurable benefits—including increased comfort; reduced pain; improved gait; increased range of motion, endurance, and ability to relax; and empowerment to actively participate in one’s own care through daily activities imbued with an enhanced sense of agency—are of cardinal importance, as they may lead to quicker recovery perceptions and enhanced quality of life.

Am J Orthop. 2017;46(1):E13-E22. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Music therapists use patient-preferred live music, increasing neurologic cues that enhance movement—a seminal recovery function in postoperative spine patients.
• Music therapy is an evidence-based, integrative treatment addressing body, mind, and spirit.
• Tension release through music therapy can serve as a critical mechanism for building resilience related to pain management.
• Music therapy and music medicine are distinct forms of clinical practice that focus on mind-body integration in the healing process.
• Music therapists, board-certified and licensed by the state as recognized healthcare professionals, address pain management, which is an increasing subspecialty in postoperative care.

About 70% of people in the United States experience at least 1 episode of back pain in their lifetime,¹ and more than 5 million are temporarily or permanently disabled by spinal disorders.^2-4 Some require surgery, which may rectify injury, but pain during recovery is often inevitable, and the road to recovery is not guaranteed to be smooth.^5-20

Postoperative spine patients are at major risk for pain management challenges.^14,15,18,20 Treatment is primarily pharmacologic and based on the surgical team’s pain management orders. Nursing care consists of monitoring the airway, vital signs, and neurovascular status and having patients rate their pain on a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). Nurses have the challenge of monitoring and continually assessing to make sure patients are achieving the optimal outcomes, particularly during the immediate postoperative period, when pain and anxiety are prominently increased.

Variability in spine surgery outcomes can be explained at least partly on the basis of prognostic psychological factors, including hypochondriasis, hysteria, depression, and poor pain coping strategies (eg, catastrophizing).²¹ In spine surgery patients, kinesiophobia (fear of moving) is a common component of distress that can impede recuperation.^21-23Psychological interventions that assist with the secondary stressors associated with pain and loss during physical recuperation are recommended, with increased attention given to the importance of treating the whole person: body, mind, and spirit.^24-29 Conventional pain-alleviating medical interventions can be enhanced with integrative therapies that empower patients to marshal their inner resources during recovery.^25-28Music therapy may be particularly suited to this effort, as it is adaptable to the patient’s individual and culturally specific needs.^29-33

Rationale for Live Music

Pain is subjective and personal, and warrants an individualized approach to care. There is a body of music medicine research on the use of recorded music in modulating psychological and physiological factors in pain perception.^30,32,34-54 This research supports the unique relationship of music to well-being, and the understanding that controlling any of these factors affects the duration, intensity, and quality of that experience.^41,43,52

These findings provide incentive for breathing-entrained music therapy interventions, which enhance the relaxation response and release of pain-related tension;^32,55-58 empower patients to unlock physical and emotional tension;^32,57,58 provide a channel for expression and body movement; and enhance blood flow and/or alleviate pain by activating neurologic areas involved in the experience of pain.^59-62Studies have found that physical endurance may be enhanced when movement is rhythmically coordinated with a musical stimulus.^63-66 Music may prolong physical endurance by inhibiting psychological feedback associated with physical exertion related to fatigue, which may translate into accelerated recovery periods. When we listen to a rhythmic sound, our brains tend to automatically synchronize, or entrain, to external rhythmic cues that can stimulate increased motor control and coordination.⁶³ Sound can arouse and raise the excitability of spinal motor neurons mediated by auditory-motor neuronal connections on the brain stem and spinal cord level.^64-66 Rhythmically organized sounds serve as a neurological function in our capacity to organize predictable timing cues that are apparent in music, and may result in an effective treatment intervention in recovery.^63,64

Music Therapy in Recovery From Spine Surgery

In music therapy, music is used within a therapeutic relationship to support or affect change in the patient and the treatment regimen.^32,33,56-58 Research on music therapy with patients who are recovering from spine surgery is scant.^67-69 Kleiber and Adamek⁶⁷ studied perceptions of music therapy in 8 adolescents after spinal fusion surgery. In their study, a music therapist provided patients with a postoperative music therapy session focusing on the use of patient-preferred live music for relaxation and expression. Although their qualitative query was based on a therapeutic approach similar to that used in the present study, only 1 session was offered during the recovery period, and follow-up was conducted by survey invitation and telephone. In addition, the number of participants was small, and there was no quantitative measure of pain or other symptoms.

Another study focused on the effects of listening to music on pain intensity and distress after spine surgery.⁶⁸ Patients in the study’s music group made their selections from prerecorded classical music and domestic and international popular songs from various genres and listened to their chosen recordings 30 minutes a day. Although the study was not a music therapy study per se, it showed a positive impact of listening to music on anxiety and pain perception in 60 adults who were randomly assigned to the music group or to a non-music control group (n = 30 in each). Differences between the music and control groups’ VAS ratings of anxiety (Ps = .018-.001) and pain (P = .001) were statistically significant.

Different from our study, the aforementioned studies did not include tension release–focused live music offered within a therapeutic relationship. Our 1.5-year pilot study, conducted prior to the present study indicated that music therapy led to increased resilience and recovery mechanisms.⁵⁸

Methods

Our mixed-methods study design combined standard medical treatment with integrative music therapy interventions based on pain assessments to better understand the effects of music therapy on the recovery of patients after spine surgery.

The Spine Institute of New York within the Department of Orthopedic Surgery at Mount Sinai Beth Israel provides surgical treatment of common spinal cord conditions. Prioritizing patient satisfaction and positive outcomes,^27,28 the institute integrates music therapy through the Louis Armstrong Center for Music and Medicine to enhance treatment of pain symptoms.

Patients were recruited by the research team as per the daily surgical schedule, or through referral by the medical team or patient care navigator. Sixty patients (35 female, 25 male) ranging in age from 40 to 55 years underwent anterior, posterior, or anterior-posterior spinal fusion and were enrolled in the study after signing a participation consent form. Minorities, women, and patients with Medicaid and Medicare were included. Patients who received a diagnosis of clinical psychosis or depression prior to spine injury were excluded.

The experimental group received music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention), and a wait-listed control group received standard care only. A randomization chart created by a blinded statistician who did not have access to the patient census determined the intervention–nonintervention schedule. Patients in the music therapy group received one 30-minute music therapy session during an 8-hour period within 72 hours after surgery.

For both groups, measurements were completed before and after the study window. Control patients were offered music therapy after completion of the post-intervention surveys in order to minimize the ethical dilemma of denying potentially helpful pain intervention. For this same reason, both groups were given the option of receiving follow-up music therapy sessions for the duration of their hospitalization.

The research team consisted of 2 licensed, board-certified music therapists. In addition, Master’s-level music therapy interns completing clinical hours as part of the trajectory for board certification served on the research team over the 5-year period 2009 to 2014, and 13 blinded research assistants helped with enrolling and collecting data on patients.

Intervention

Each music therapy session included a warm-up phase of verbal or musical discourse. Next was the treatment phase, which was based on patient need as assessed during warm-up. Treatment options included use of patient-preferred live music that supported tension release/relaxation through incentive-based clinical improvisation, singing, and/or rhythmic drumming or through breathwork and visualization. Psychoeducation about mind–body awareness through the use of breath and imagery was introduced and explained by the therapist at this time.

The improvised music intervention was focused on making salient the natural harmonic tension-resolution cycles that occur in music and that were entrained to the patient’s presentation (respiratory rate, verbal report, clinical presentation). When patient-preferred precomposed songs were used, tension resolution was achieved by sustaining cadence and resolution, also entrained to the patient’s respiratory cycles.^32,57,58

After the music therapy intervention, a period of closure or integration was facilitated by the therapist contingent on the patient’s degree of alertness. If awake, the patient was supported in a reflexive process of thoughts, impressions, or issues that may have contributed to the overall experience. If the patient was asleep, the researcher returned within 30 minutes for post-intervention interviewing. Interview information was recorded in a qualitative post-participation survey. To prevent bias, researchers who were not the treating clinicians conducted the surveys.

Outcome Measures

Both primary and secondary outcome measures were collected before and after the intervention. The primary outcome measure was VAS pain ratings, and the secondary outcome measures were scores on the Hospital Anxiety and Depression Scale (HADS), the Tampa Scale for Kinesiophobia (TSK), and the Color Analysis Scale (CAS).

VAS. With the VAS, images are used to rate pain. The scale has points labeled 0 to 10 and corresponding faces representing progression in pain intensity. The scale is quickly rendered and can be interpreted according to the patient’s recovery phase at time of rendering.

HADS. The HADS⁷⁰ provides a specific baseline for anxiety and depression as an indicator of how the patient might fare during hospitalization (admission through recovery and discharge).

TSK. The TSK⁷¹ provides insight into the patient’s perception of fear-related movement, which is an important factor in this study because of the movement required for rehabilitation. We used a shortened version of the TSK to accommodate the sensitive threshold for pain tolerance and pharmacologic side effects commonly experienced by spine patients.

CAS. The CAS was developed at the Louis Armstrong Center for Music and Medicine to assess comorbidities and dynamic aspects of pain. Through a coloring exercise, patients illustrate their pain experience, which gives tangible form to the abstract experience of pain.

Coding

We collected patients’ demographic data, including age, sex, and diagnoses. Clinical indicators of the preoperative baseline included lifestyle, surgical history, and prior experience with music or other mind–body strategies for self-regulation.

As fundamental to qualitative methodology,^72,73 the reported responses to questions were grouped into themes that were peer-tested with members of the research team before and during the coding process.

Statistical Methods

Means and standard deviations were used for continuous variables, and frequencies (percentages) for categorical variables. All outcomes were analyzed on an intent-to-treat basis. Repeated-measures analysis of variance was used to compare changes in outcomes from before to after intervention for the music and control groups. In particular, a statistically significant Group (music vs control) × Time (before vs after intervention) interaction would support the hypothesis that there would be more benefit (less pain) in the music group as a result of the music therapy. For all tests, significance was set at P < .05. SPSS Version 20 (IBM) was used for all statistical analyses. Based on previously found differences in heart rate and mobility,³¹ we assumed an effect size of 0.71 for the difference between music and control (no music), which would require 32 patients per group to achieve a power of 0.8 with an α of 0.05.

Results

Of the 136 patients who were asked to participate in the study, 76 were not enrolled; the other 60 were equally assigned to either the control group or the music therapy group (n = 30 in each) according to randomization indicated by a blinded statistician (Figure 1).

Table 2 lists the pre-intervention and post-intervention comparisons of the main outcomes between groups.

Relationship with music was coded for significance and included reports of music as a resource accessed for stimulation and/or relaxation through listening; direct involvement with instrument playing; and history of music training. 

Perceptions of surgical outcome in patients’ responses were coded across 3 themes: (1) optimistic (belief and hope in returning to original baseline of functionality), (2) indifferent (neither hopeful nor cynical about results of surgery), and (3) pessimistic (belief that nothing will restore the quality of life that existed before the spinal condition).

The CAS helped us better understand the diversity and complexity of the pain experience.

Discussion

Our hospital has the unique capability of providing music therapy to postoperative and other hospitalized patients. In this study, we compared the impact of a structured postoperative music therapy program on spine patients relative to control patients who did not receive music therapy after spine surgery.

We found a significant benefit in VAS pain levels (>1 point) but no statistically significant differences in HADS Anxiety, HADS Depression, or TSK scores. Although a 2-point difference is usually considered clinically significant, the degree of change in the music group is notable for having been achieved by nonpharmacologic means with scant chance of adverse effects. We suspect the lack of significant change in HADS Anxiety, HADS Depression, and TSK scores is attributable to the narrow study window. Given the observational data from our pilot study⁵⁸ and ongoing results with spine patients,³² it seems clear that both mood state and resilience in coping are enhanced through an ongoing relationship with music therapy.

The study of a population as vulnerable as patients recovering from spine surgery raises many issues for providers and researchers. Although it is worthwhile to determine the efficacy of integrative modalities in serving these patients, the request for participation in a protocol at such a vulnerable time was often resisted. During our pilot work, it became clear that the ability of potential subjects to comprehend and complete protocol surveys was impacted by adverse effects, including sedation drowsiness; respiratory depression; nausea and vomiting; pruritus; and urinary retention caused by the medications used for postoperative pain management. Consequently, after piloting 5 cases before the main study, we extended the enrollment window to 72 hours.

Other unforeseen intrinsic or external obstacles were identified: Patient-related issues—including availability, level of interest in participation, and inability to participate because of the medication adverse effects mentioned.

Staff investment/education—addressed over the first 3 study years with several in-services, starting with the surgical team and continuing with nursing and support staff in various combinations. These meetings led to the creation of an Institutional Review Board (IRB) approved educational sheet for inclusion in the information packet given to surgical patients on registration.

Programming interruptions—caused by the convergence of several unanticipated factors, including a delay in expedited review of the IRB renewal during the year of Hurricane Sandy and an interruption in the spine team’s service for administrative and program modification.

Conclusion

Music therapy interventions (eg, use of patient-preferred live music) offered within a therapeutic relationship favorably affected pain perceptions in patients recovering from spine surgery. This effect was achieved through several therapeutic entry points, including support of expression and opportunities for emotional catharsis.

At the core of music therapy’s efficacy is individualized treatment, through which patients are supported in their recovery of “self.” Measurable benefits—including increased comfort; reduced pain; improved gait; increased range of motion, endurance, and ability to relax; and empowerment to actively participate in one’s own care through daily activities imbued with an enhanced sense of agency—are of cardinal importance, as they may lead to quicker recovery perceptions and enhanced quality of life.

Am J Orthop. 2017;46(1):E13-E22. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

llaubach@frontlinemedcom.com

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

llaubach@frontlinemedcom.com

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

llaubach@frontlinemedcom.com

Delaying the clamping of the umbilical cord for 3 minutes after delivery decreased anemia for as long as 8-12 months in a population at high risk for the disorder, according to a report published online Jan. 17 in JAMA Pediatrics.

If early (within 1 minute of birth) cord clamping is avoided after delivery, fetoplacental blood moves into the newborn, augmenting his or her blood volume by 30%-40%. This is known to increase iron stores and prevent iron deficiency for at least 6 months, but until now there has been little evidence of how long this beneficial effect persists, said Ashish KC, MD, PhD, of International Maternal and Child Health, Uppsala (Sweden) University and the United Nations Children’s Fund, Lalitpur, Nepal, and associates.

arztsamui/Thinkstock

Delaying the clamping of the umbilical cord for 3 minutes after delivery decreased anemia for as long as 8-12 months in a population at high risk for the disorder, according to a report published online Jan. 17 in JAMA Pediatrics.

If early (within 1 minute of birth) cord clamping is avoided after delivery, fetoplacental blood moves into the newborn, augmenting his or her blood volume by 30%-40%. This is known to increase iron stores and prevent iron deficiency for at least 6 months, but until now there has been little evidence of how long this beneficial effect persists, said Ashish KC, MD, PhD, of International Maternal and Child Health, Uppsala (Sweden) University and the United Nations Children’s Fund, Lalitpur, Nepal, and associates.

arztsamui/Thinkstock

Delaying the clamping of the umbilical cord for 3 minutes after delivery decreased anemia for as long as 8-12 months in a population at high risk for the disorder, according to a report published online Jan. 17 in JAMA Pediatrics.

If early (within 1 minute of birth) cord clamping is avoided after delivery, fetoplacental blood moves into the newborn, augmenting his or her blood volume by 30%-40%. This is known to increase iron stores and prevent iron deficiency for at least 6 months, but until now there has been little evidence of how long this beneficial effect persists, said Ashish KC, MD, PhD, of International Maternal and Child Health, Uppsala (Sweden) University and the United Nations Children’s Fund, Lalitpur, Nepal, and associates.

arztsamui/Thinkstock

Asthma was ruled out in 33% of adults in the general Canadian population who had been diagnosed by a physician during the preceding 5 years, according to a report published online Jan. 17 in JAMA.

In a prospective multicenter cohort study involving 613 asthma patients, 203 had no evidence of current asthma when they underwent serial assessments of respiratory symptoms, lung function, and bronchial provocation testing while not taking asthma medications. More than 90% of these 203 participants safely refrained from using the medications for an additional 1-year follow-up period, said Shawn D. Aaron, MD, of Ottawa (Ont.) Hospital Research Institute, and his associates in the Canadian Respiratory Research Network.

copyright marekuliasz/Thinkstock

imnews@frontlinemedcom.com

Asthma was ruled out in 33% of adults in the general Canadian population who had been diagnosed by a physician during the preceding 5 years, according to a report published online Jan. 17 in JAMA.

In a prospective multicenter cohort study involving 613 asthma patients, 203 had no evidence of current asthma when they underwent serial assessments of respiratory symptoms, lung function, and bronchial provocation testing while not taking asthma medications. More than 90% of these 203 participants safely refrained from using the medications for an additional 1-year follow-up period, said Shawn D. Aaron, MD, of Ottawa (Ont.) Hospital Research Institute, and his associates in the Canadian Respiratory Research Network.

copyright marekuliasz/Thinkstock

imnews@frontlinemedcom.com

Asthma was ruled out in 33% of adults in the general Canadian population who had been diagnosed by a physician during the preceding 5 years, according to a report published online Jan. 17 in JAMA.

In a prospective multicenter cohort study involving 613 asthma patients, 203 had no evidence of current asthma when they underwent serial assessments of respiratory symptoms, lung function, and bronchial provocation testing while not taking asthma medications. More than 90% of these 203 participants safely refrained from using the medications for an additional 1-year follow-up period, said Shawn D. Aaron, MD, of Ottawa (Ont.) Hospital Research Institute, and his associates in the Canadian Respiratory Research Network.

copyright marekuliasz/Thinkstock

imnews@frontlinemedcom.com

An assay designed to distinguish between bacterial and viral infections of the lower respiratory tract appears effective and shows promise for helping hospital physicians reduce overprescribing of antibiotics to children, a study showed.

“It is often not possible to differentiate between bacterial and nonbacterial disease on the basis of clinical judgment alone, [so] antibiotics are prescribed almost twice as often as required in children with acute respiratory tract infections in the USA,” wrote Chantal B. van Houten of the University Medical Centre Utrecht (the Netherlands) and associates in a study published in the Lancet Infectious Diseases.

The assay in question is called ImmunoXpert, which uses three biomarkers – tumor necrosis factor–related apoptosis-inducing ligand (TRAIL), interferon-gamma–induced protein-10 (IP-10), and C-reactive protein (CRP) – to determine if a lower respiratory tract infection has a viral or bacterial origin. A total of 777 subjects, aged 2-60 months, were recruited from four hospitals in the Netherlands and two hospitals in Israel between October 16, 2013, and March 1, 2015 (Lancet Inf Dis. 2016 Dec. doi: 10.1016/S1473-3099(16)30519-9).

The patients all had fevers with unidentified sources when they presented, and had a follow-up assessment carried out 28 days after baseline. Blood samples and nasal swabs were collected within 24 hours of presentation for assay analysis. Additionally, every subject was diagnosed as “bacterial” or “viral” by a three-member panel of pediatricians, whose diagnoses were based on the data available from the follow-up assessment and from clinical and laboratory data. The panel diagnosis for each subject was used as the reference standard.

Of the 777 subjects initially recruited, 200 were excluded from the final analysis for various reasons. Of the 577 who remained, the panel diagnosed 435 as having a viral infection and 71 as having a bacterial infection; 71 were deemed “inconclusive.” The panel was unanimous in 354 of these cases, and a majority of the panel (two of the three experts) agreed in 443 of these cases. In unanimous cases, the sensitivity of distinguishing between viral and bacterial cases correctly was 87.8%, with a specificity of 93.0%. The panel’s positive and negative predictive value were 62.1% and 98.3%, respectively.

The assay’s sensitivity rate in distinguishing between viral and bacterial infections was very close: 86.7%, with a specificity of 91.1%, which the authors noted was “promising diagnostic accuracy.” The positive predictive value of the assay was 60.5%, while the negative predictive value was found to be 97.8%.

Regarding the 71 cases that were deemed “inconclusive,” Dr. van Houten and coauthors acknowledged that “such inconclusive cases are inherent to studies without a gold standard, and this was taken into account when calculating the sample size.” Additionally, they noted that follow-up studies should take into consideration the costs of utilizing assay testing like ImmunoXpert, in order to better assess the financial implications that adopting the technology would have on a health care facility.

Nevertheless, the investigators concluded, “our findings [support] the need for implementation research to examine the added clinical utility of ImmunoXpert to diagnose bacterial infection in clinical care for children with lower respiratory tract infection and fever without source presenting at the hospital.”

Funding for this study was provided by MeMed Diagnostics. Dr. van Houten and coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

An assay designed to distinguish between bacterial and viral infections of the lower respiratory tract appears effective and shows promise for helping hospital physicians reduce overprescribing of antibiotics to children, a study showed.

“It is often not possible to differentiate between bacterial and nonbacterial disease on the basis of clinical judgment alone, [so] antibiotics are prescribed almost twice as often as required in children with acute respiratory tract infections in the USA,” wrote Chantal B. van Houten of the University Medical Centre Utrecht (the Netherlands) and associates in a study published in the Lancet Infectious Diseases.

The assay in question is called ImmunoXpert, which uses three biomarkers – tumor necrosis factor–related apoptosis-inducing ligand (TRAIL), interferon-gamma–induced protein-10 (IP-10), and C-reactive protein (CRP) – to determine if a lower respiratory tract infection has a viral or bacterial origin. A total of 777 subjects, aged 2-60 months, were recruited from four hospitals in the Netherlands and two hospitals in Israel between October 16, 2013, and March 1, 2015 (Lancet Inf Dis. 2016 Dec. doi: 10.1016/S1473-3099(16)30519-9).

The patients all had fevers with unidentified sources when they presented, and had a follow-up assessment carried out 28 days after baseline. Blood samples and nasal swabs were collected within 24 hours of presentation for assay analysis. Additionally, every subject was diagnosed as “bacterial” or “viral” by a three-member panel of pediatricians, whose diagnoses were based on the data available from the follow-up assessment and from clinical and laboratory data. The panel diagnosis for each subject was used as the reference standard.

Of the 777 subjects initially recruited, 200 were excluded from the final analysis for various reasons. Of the 577 who remained, the panel diagnosed 435 as having a viral infection and 71 as having a bacterial infection; 71 were deemed “inconclusive.” The panel was unanimous in 354 of these cases, and a majority of the panel (two of the three experts) agreed in 443 of these cases. In unanimous cases, the sensitivity of distinguishing between viral and bacterial cases correctly was 87.8%, with a specificity of 93.0%. The panel’s positive and negative predictive value were 62.1% and 98.3%, respectively.

The assay’s sensitivity rate in distinguishing between viral and bacterial infections was very close: 86.7%, with a specificity of 91.1%, which the authors noted was “promising diagnostic accuracy.” The positive predictive value of the assay was 60.5%, while the negative predictive value was found to be 97.8%.

Regarding the 71 cases that were deemed “inconclusive,” Dr. van Houten and coauthors acknowledged that “such inconclusive cases are inherent to studies without a gold standard, and this was taken into account when calculating the sample size.” Additionally, they noted that follow-up studies should take into consideration the costs of utilizing assay testing like ImmunoXpert, in order to better assess the financial implications that adopting the technology would have on a health care facility.

Nevertheless, the investigators concluded, “our findings [support] the need for implementation research to examine the added clinical utility of ImmunoXpert to diagnose bacterial infection in clinical care for children with lower respiratory tract infection and fever without source presenting at the hospital.”

Funding for this study was provided by MeMed Diagnostics. Dr. van Houten and coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

An assay designed to distinguish between bacterial and viral infections of the lower respiratory tract appears effective and shows promise for helping hospital physicians reduce overprescribing of antibiotics to children, a study showed.

“It is often not possible to differentiate between bacterial and nonbacterial disease on the basis of clinical judgment alone, [so] antibiotics are prescribed almost twice as often as required in children with acute respiratory tract infections in the USA,” wrote Chantal B. van Houten of the University Medical Centre Utrecht (the Netherlands) and associates in a study published in the Lancet Infectious Diseases.

The assay in question is called ImmunoXpert, which uses three biomarkers – tumor necrosis factor–related apoptosis-inducing ligand (TRAIL), interferon-gamma–induced protein-10 (IP-10), and C-reactive protein (CRP) – to determine if a lower respiratory tract infection has a viral or bacterial origin. A total of 777 subjects, aged 2-60 months, were recruited from four hospitals in the Netherlands and two hospitals in Israel between October 16, 2013, and March 1, 2015 (Lancet Inf Dis. 2016 Dec. doi: 10.1016/S1473-3099(16)30519-9).

The patients all had fevers with unidentified sources when they presented, and had a follow-up assessment carried out 28 days after baseline. Blood samples and nasal swabs were collected within 24 hours of presentation for assay analysis. Additionally, every subject was diagnosed as “bacterial” or “viral” by a three-member panel of pediatricians, whose diagnoses were based on the data available from the follow-up assessment and from clinical and laboratory data. The panel diagnosis for each subject was used as the reference standard.

Of the 777 subjects initially recruited, 200 were excluded from the final analysis for various reasons. Of the 577 who remained, the panel diagnosed 435 as having a viral infection and 71 as having a bacterial infection; 71 were deemed “inconclusive.” The panel was unanimous in 354 of these cases, and a majority of the panel (two of the three experts) agreed in 443 of these cases. In unanimous cases, the sensitivity of distinguishing between viral and bacterial cases correctly was 87.8%, with a specificity of 93.0%. The panel’s positive and negative predictive value were 62.1% and 98.3%, respectively.

The assay’s sensitivity rate in distinguishing between viral and bacterial infections was very close: 86.7%, with a specificity of 91.1%, which the authors noted was “promising diagnostic accuracy.” The positive predictive value of the assay was 60.5%, while the negative predictive value was found to be 97.8%.

Regarding the 71 cases that were deemed “inconclusive,” Dr. van Houten and coauthors acknowledged that “such inconclusive cases are inherent to studies without a gold standard, and this was taken into account when calculating the sample size.” Additionally, they noted that follow-up studies should take into consideration the costs of utilizing assay testing like ImmunoXpert, in order to better assess the financial implications that adopting the technology would have on a health care facility.

Nevertheless, the investigators concluded, “our findings [support] the need for implementation research to examine the added clinical utility of ImmunoXpert to diagnose bacterial infection in clinical care for children with lower respiratory tract infection and fever without source presenting at the hospital.”

Funding for this study was provided by MeMed Diagnostics. Dr. van Houten and coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

CHICAGO – Applying the key principles for limiting radiation exposure for vascular surgeons and staff – not to mention patients – during endovascular procedures involves a thorough understanding of dose metrics as well as risk factors for high-dose interventions, according to recent findings reported at a symposium on vascular surgery sponsored by Northwestern University.

Melissa Kirkwood, MD, of the University of Texas Southwestern Medical Center in Dallas, reported on her institution’s experience with limiting radiation exposure in typically high-dose cases. “What we found was that even though we had a substantial amount of dose in these cases – they included a significant proportion of 5- to 10-Gy and greater than 10-Gy cases – there were still no skin injuries detected in these patients,” she said, referencing retrospective and prospective analyses (J Vasc Surg. 2014;60:742-8; J Vasc Surg. 2015;61:902-6).

CHICAGO – Applying the key principles for limiting radiation exposure for vascular surgeons and staff – not to mention patients – during endovascular procedures involves a thorough understanding of dose metrics as well as risk factors for high-dose interventions, according to recent findings reported at a symposium on vascular surgery sponsored by Northwestern University.

Melissa Kirkwood, MD, of the University of Texas Southwestern Medical Center in Dallas, reported on her institution’s experience with limiting radiation exposure in typically high-dose cases. “What we found was that even though we had a substantial amount of dose in these cases – they included a significant proportion of 5- to 10-Gy and greater than 10-Gy cases – there were still no skin injuries detected in these patients,” she said, referencing retrospective and prospective analyses (J Vasc Surg. 2014;60:742-8; J Vasc Surg. 2015;61:902-6).

CHICAGO – Applying the key principles for limiting radiation exposure for vascular surgeons and staff – not to mention patients – during endovascular procedures involves a thorough understanding of dose metrics as well as risk factors for high-dose interventions, according to recent findings reported at a symposium on vascular surgery sponsored by Northwestern University.

Melissa Kirkwood, MD, of the University of Texas Southwestern Medical Center in Dallas, reported on her institution’s experience with limiting radiation exposure in typically high-dose cases. “What we found was that even though we had a substantial amount of dose in these cases – they included a significant proportion of 5- to 10-Gy and greater than 10-Gy cases – there were still no skin injuries detected in these patients,” she said, referencing retrospective and prospective analyses (J Vasc Surg. 2014;60:742-8; J Vasc Surg. 2015;61:902-6).

About two-thirds of patient advocacy organizations report receiving funds from for-profit firms, including pharmaceutical, device and biotechnology manufacturers, according to new survey results.

The study, published online Jan. 17 in JAMA Internal Medicine, sought responses from a randomly chosen sample of 439 executives at patient advocacy organizations (PAOs), of whom 66% (n = 289) responded. The median annual revenue for the groups surveyed was nearly $300,000, and 67% (n = 165) reported receiving at least some industry funding. Of those, 12% reported that more than half their annual funding comes from industry sources.

A total of 22 PAO leaders surveyed (8%) reported that they perceived pressure to conform their organizational interests to those of corporate donors (JAMA Intern Med. 2017 Jan 17. doi: 10.1001/jamainternmed.2016.8443).

The vast majority of respondents (82%) said they found conflicts of interest to be relevant to PAOs, and most reported having a written policy on conflicts. More than half said they viewed their own organizations’ conflict of interest policies as sound.

The findings warrant a broad re-examination of PAO conflict-of-interest policies and disclosures, and a detailed examination of the specific ways in which PAOs are influenced or pressured, wrote Susannah L. Rose, PhD, of the Cleveland Clinic, and her colleagues.

PAOs do not routinely and publicly disclose all their sources of funding on websites, tax returns, or annual reports, and there are media investigations into some groups “regarding their ties to industry and the integrity of their activities,” the investigators wrote.

Dr. Rose and her colleagues recommended that PAOs disclose detailed information about industry funding on their websites and on Open Payments, a government website. The researchers acknowledged that their study relied on self-reported data, and though it was designed to obscure the identity of respondents and their organizations, the possibility of response bias exists.

Harvard University’s Edmond J. Safra Center for Ethics funded the study. One coauthor, Steven Joffe, MD, MPH, disclosed past funding from Genzyme Sanofi. No other conflicts were reported.

About two-thirds of patient advocacy organizations report receiving funds from for-profit firms, including pharmaceutical, device and biotechnology manufacturers, according to new survey results.

The study, published online Jan. 17 in JAMA Internal Medicine, sought responses from a randomly chosen sample of 439 executives at patient advocacy organizations (PAOs), of whom 66% (n = 289) responded. The median annual revenue for the groups surveyed was nearly $300,000, and 67% (n = 165) reported receiving at least some industry funding. Of those, 12% reported that more than half their annual funding comes from industry sources.

A total of 22 PAO leaders surveyed (8%) reported that they perceived pressure to conform their organizational interests to those of corporate donors (JAMA Intern Med. 2017 Jan 17. doi: 10.1001/jamainternmed.2016.8443).

The vast majority of respondents (82%) said they found conflicts of interest to be relevant to PAOs, and most reported having a written policy on conflicts. More than half said they viewed their own organizations’ conflict of interest policies as sound.

The findings warrant a broad re-examination of PAO conflict-of-interest policies and disclosures, and a detailed examination of the specific ways in which PAOs are influenced or pressured, wrote Susannah L. Rose, PhD, of the Cleveland Clinic, and her colleagues.

PAOs do not routinely and publicly disclose all their sources of funding on websites, tax returns, or annual reports, and there are media investigations into some groups “regarding their ties to industry and the integrity of their activities,” the investigators wrote.

Dr. Rose and her colleagues recommended that PAOs disclose detailed information about industry funding on their websites and on Open Payments, a government website. The researchers acknowledged that their study relied on self-reported data, and though it was designed to obscure the identity of respondents and their organizations, the possibility of response bias exists.

Harvard University’s Edmond J. Safra Center for Ethics funded the study. One coauthor, Steven Joffe, MD, MPH, disclosed past funding from Genzyme Sanofi. No other conflicts were reported.

About two-thirds of patient advocacy organizations report receiving funds from for-profit firms, including pharmaceutical, device and biotechnology manufacturers, according to new survey results.

The study, published online Jan. 17 in JAMA Internal Medicine, sought responses from a randomly chosen sample of 439 executives at patient advocacy organizations (PAOs), of whom 66% (n = 289) responded. The median annual revenue for the groups surveyed was nearly $300,000, and 67% (n = 165) reported receiving at least some industry funding. Of those, 12% reported that more than half their annual funding comes from industry sources.

A total of 22 PAO leaders surveyed (8%) reported that they perceived pressure to conform their organizational interests to those of corporate donors (JAMA Intern Med. 2017 Jan 17. doi: 10.1001/jamainternmed.2016.8443).

The vast majority of respondents (82%) said they found conflicts of interest to be relevant to PAOs, and most reported having a written policy on conflicts. More than half said they viewed their own organizations’ conflict of interest policies as sound.

The findings warrant a broad re-examination of PAO conflict-of-interest policies and disclosures, and a detailed examination of the specific ways in which PAOs are influenced or pressured, wrote Susannah L. Rose, PhD, of the Cleveland Clinic, and her colleagues.

PAOs do not routinely and publicly disclose all their sources of funding on websites, tax returns, or annual reports, and there are media investigations into some groups “regarding their ties to industry and the integrity of their activities,” the investigators wrote.

Dr. Rose and her colleagues recommended that PAOs disclose detailed information about industry funding on their websites and on Open Payments, a government website. The researchers acknowledged that their study relied on self-reported data, and though it was designed to obscure the identity of respondents and their organizations, the possibility of response bias exists.

Harvard University’s Edmond J. Safra Center for Ethics funded the study. One coauthor, Steven Joffe, MD, MPH, disclosed past funding from Genzyme Sanofi. No other conflicts were reported.

Among critically ill patients admitted to the ICU with a suspected infection, defining sepsis by an increase of 2 or more points in the Sequential Organ Failure Assessment score yielded greater prognostic accuracy for in-hospital mortality, compared with the quick SOFA and the systemic inflammatory response syndrome criteria, results from a large analysis showed.

“Accurate diagnostic criteria and consensus definitions have an important role in adult intensive care medicine, providing tools for research, benchmarking, performance monitoring, and accreditation,” researchers from The Australian and New Zealand Intensive Care Society Centre for Outcomes and Resource Evaluation reported in the Jan. 17, 2017 edition of JAMA. “Seymour and colleagues published data concerning the validity of a 2 or more–point change in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score as a means of identifying sepsis among patients who are critically ill with suspected infection, assuming a SOFA of 0 for patients not known to have preexisting organ dysfunction (JAMA. 2016; 315[8]:762-74). In addition, the concept of the quick SOFA (qSOFA) score was introduced as a possible predictive tool among encounters with suspected infection outside the intensive care unit (ICU). These data were drawn from North American cohorts and a single German cohort and have not been validated externally.”

invisioner/thinkstockphotos

dbrunk@frontlinemedcom.com

Among critically ill patients admitted to the ICU with a suspected infection, defining sepsis by an increase of 2 or more points in the Sequential Organ Failure Assessment score yielded greater prognostic accuracy for in-hospital mortality, compared with the quick SOFA and the systemic inflammatory response syndrome criteria, results from a large analysis showed.

“Accurate diagnostic criteria and consensus definitions have an important role in adult intensive care medicine, providing tools for research, benchmarking, performance monitoring, and accreditation,” researchers from The Australian and New Zealand Intensive Care Society Centre for Outcomes and Resource Evaluation reported in the Jan. 17, 2017 edition of JAMA. “Seymour and colleagues published data concerning the validity of a 2 or more–point change in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score as a means of identifying sepsis among patients who are critically ill with suspected infection, assuming a SOFA of 0 for patients not known to have preexisting organ dysfunction (JAMA. 2016; 315[8]:762-74). In addition, the concept of the quick SOFA (qSOFA) score was introduced as a possible predictive tool among encounters with suspected infection outside the intensive care unit (ICU). These data were drawn from North American cohorts and a single German cohort and have not been validated externally.”

invisioner/thinkstockphotos

dbrunk@frontlinemedcom.com

Among critically ill patients admitted to the ICU with a suspected infection, defining sepsis by an increase of 2 or more points in the Sequential Organ Failure Assessment score yielded greater prognostic accuracy for in-hospital mortality, compared with the quick SOFA and the systemic inflammatory response syndrome criteria, results from a large analysis showed.

“Accurate diagnostic criteria and consensus definitions have an important role in adult intensive care medicine, providing tools for research, benchmarking, performance monitoring, and accreditation,” researchers from The Australian and New Zealand Intensive Care Society Centre for Outcomes and Resource Evaluation reported in the Jan. 17, 2017 edition of JAMA. “Seymour and colleagues published data concerning the validity of a 2 or more–point change in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score as a means of identifying sepsis among patients who are critically ill with suspected infection, assuming a SOFA of 0 for patients not known to have preexisting organ dysfunction (JAMA. 2016; 315[8]:762-74). In addition, the concept of the quick SOFA (qSOFA) score was introduced as a possible predictive tool among encounters with suspected infection outside the intensive care unit (ICU). These data were drawn from North American cohorts and a single German cohort and have not been validated externally.”

invisioner/thinkstockphotos

dbrunk@frontlinemedcom.com

To the Editor:

A 39-year-old man with a history of hypertension and vitiligo presented with a rapid-onset, generalized, pruritic rash covering the body of 4 weeks’ duration. He reported that the rash progressively worsened after developing mild sunburn. The patient stated that the rash was extremely pruritic with a burning sensation and was tender to touch. He was treated with betamethasone valerate cream 0.1% by an outside physician and an over-the-counter anti-itch lotion with no notable improvement. His only medication was telmisartan-hydrochlorothiazide (HCTZ) for hypertension. He denied any drug allergies.

Physical examination revealed multiple discrete and coalescent planar erythematous papules and plaques involving only the depigmented vitiliginous skin of the forehead, eyelids, and nape of the neck (Figure 1A), and confluent on the lateral aspect of the bilateral forearms (Figure 1B), dorsal aspect of the right hand, and bilateral dorsi of the feet. Wickham striae were noted on the lips (Figure 1C). A clinical diagnosis of lichen planus (LP) was made. The patient initially was prescribed halobetasol propionate ointment 0.05% twice daily. He reported notable relief of pruritus with reduction of overall symptoms and new lesion formation.

A 4-mm punch biopsy was performed on the left forearm. Histopathology revealed LP. Microscopic examination of the hematoxylin and eosin–stained specimen revealed a bandlike lymphohistiocytic infiltrate that extended across the papillary dermis, focally obscuring the dermoepidermal junction where there were vacuolar changes and colloid bodies. The epidermis showed sawtooth rete ridges, wedge-shaped foci of hypergranulosis, and compact hyperkeratosis (Figure 2).

On further questioning during follow-up, the patient revealed that his hypertensive medication was changed from HCTZ, which he had been taking for the last 8 years, to the combination antihypertensive medication telmisartan-HCTZ before the onset of the skin eruption. Due to the temporal relationship between the new medication and onset of the eruption, the clinical impression was highly suspicious for drug-induced eruptive LP with Köbner phenomenon caused by the recent sunburn. Systemic workup for underlying causes of LP was negative. Laboratory tests revealed normal complete blood cell counts. The hepatitis panel included hepatitis A antibodies; hepatitis B surface, e antigen, and core antibodies; hepatitis B surface antigen and e antibodies; hepatitis C antibodies; and antinuclear antibodies, which were all negative.

The patient continued to develop new pruritic papules clinically consistent with LP. He was instructed to return to his primary care physician to change the telmisartan-HCTZ to a different class of antihypertensive medication. His medication was changed to atenolol. The patient also was instructed to continue the halobetasol propionate ointment 0.05% twice daily to the affected areas.

The patient returned for a follow-up visit 1 month later and reported notable improvement in pruritus and near-complete resolution of the LP after discontinuation of telmisartan-HCTZ. He also noted some degree of perifollicular repigmentation of the vitiliginous skin that had been unresponsive to prior therapy (Figure 3).

Lichen planus is a pruritic and inflammatory papulosquamous skin condition that presents as scaly, flat-topped, violaceous, polygonal-shaped papules commonly involving the flexor surface of the arms and legs, oral mucosa, scalp, nails, and genitalia. Clinically, LP can present in various forms including actinic, annular, atrophic, erosive, follicular, hypertrophic, linear, pigmented, and vesicular/bullous types. Koebnerization is common, especially in the linear form of LP. There are no specific laboratory findings or serologic markers seen in LP.

The exact cause of LP remains unknown. Clinical observations and anecdotal evidence have directed the cell-mediated immune response to insulting agents such as medications or contact allergy to metals triggering an abnormal cellular immune response. Various viral agents have been reported including hepatitis C virus, human herpesvirus, herpes simplex virus, and varicella-zoster virus.^1-5 Other factors such as seasonal change and the environment may contribute to the development of LP and an increase in the incidence of LP eruption has been observed from January to July throughout the United States.⁶ Lichen planus also has been associated with other altered immune-related disease such as ulcerative colitis, alopecia areata, vitiligo, dermatomyositis, morphea, lichen sclerosis, and myasthenia gravis.⁷ Increased levels of emotional stress, particularly related to family members, often is related to the onset or aggravation of symptoms.^8,9

Many drug-related LP-like and lichenoid eruptions have been reported with antihypertensive drugs, antimalarial drugs, diuretics, antidepressants, nonsteroidal anti-inflammatory drugs, antimicrobial drugs, and metals. In particular, medications such as captopril, enalapril, labetalol, propranolol, chlorothiazide, HCTZ, methyldopa, chloroquine, hydroxychloroquine, quinacrine, gold salts, penicillamine, and quinidine commonly are reported to induce lichenoid drug eruption.¹⁰

Several inflammatory papulosquamous skin conditions should be considered in the differential diagnosis before confirming the diagnosis of LP. It is important to rule out lupus erythematosus, especially if the oral mucosa and scalp are involved. In addition, erosive paraneoplastic pemphigus involving primarily the oral mucosa can resemble oral LP. Nail diseases such as psoriasis, onychomycosis, and alopecia areata should be considered as the differential diagnosis of nail disease. Genital involvement also can be seen in psoriasis and lichen sclerosus.

Treatment of LP is mainly symptomatic because of the benign nature of the disease and the high spontaneous remission rate with varying amount of time. If drugs, dental/metal implants, or underlying viral infections are the identifiable triggering factors of LP, the offending agents should be discontinued or removed. Additionally, topical or systemic treatments can be given depending on the severity of the disease, focusing mainly on symptomatic relief as well as the balance of risks and benefits associated with treatment.

Treatment options include topical and intralesional corticosteroids. Systemic medications such as oral corticosteroids and/or acitretin commonly are used in acute, severe, and disseminated cases, though treatment duration varies depending on the clinical response. Other systemic agents used to treat LP include griseofulvin, metronidazole, sulfasalazine, cyclosporine, and mycophenolate mofetil.

Phototherapy is considered an alternative therapy, especially for recalcitrant LP. UVA1 and narrowband UVB (wavelength, 311 nm) have been reported to effectively treat long-standing and therapy-resistant LP.¹¹ In addition, a small study used the excimer laser (wavelength, 308 nm), which is well tolerated by patients, to treat focal recalcitrant oral lesions with excellent results.¹² Photochemotherapy has been used with notable improvement, but the potential of carcinogenicity, especially in patients with Fitzpatrick skin types I and II, has limited its use.¹³

Our patient developed an unusual extensive LP eruption involving only vitiliginous skin shortly after initiation of the combined antihypertensive medication telmisartan-HCTZ, an angiotensin receptor blocker with a thiazide diuretic. Telmisartan and other angiotensin receptor blockers have not been reported to trigger LP; HCTZ is listed as one of the common drugs causing photosensitivity and LP.^14,15 Although it is possible that our patient exhibited a delayed lichenoid drug eruption from the HCTZ, it is noteworthy that he did not experience a single episode of LP during his 8-year history of taking HCTZ. Instead, he developed the LP eruption shortly after the addition of telmisartan to his HCTZ antihypertensive regimen. The temporal relationship led us to direct the patient to the prescribing physician to discontinue telmisartan-HCTZ. After changing his antihypertensive medication to atenolol, the patient presented with improvement within the first month and near-complete resolution 2 months after the discontinuation of telmisartan-HCTZ.

Our patient’s LP lesions only manifested on the skin affected by vitiligo, sparing the normal-pigmented skin. Studies have demonstrated an increased ratio of CD8⁺ T cells to CD4⁺ T cells as well as increased intercellular adhesion molecule 1 at the dermal level.^10,16 Both vitiligo and LP share some common histopathologic features including highly populated CD8⁺ T cells and intercellular adhesion molecule 1. In our case, LP was triggered on the vitiliginous skin by telmisartan. Vitiligo in combination with trauma induced by sunburn may represent the trigger that altered the cellular immune response and created the telmisartan-induced LP. As a result, the LP eruption was confined to the vitiliginous skin lesions.

Perifollicular repigmentation was observed in our patient after the LP lesions resolved; the patient’s vitiligo was unresponsive to prior treatment. The inflammatory process occurring in LP may exert and interfere in the underlying autoimmune cytotoxic effect toward the melanocytes and the melanin synthesis. It may be of interest to find out if the inflammatory response of LP has a positive influence on the effect of melanogenesis pathways or on the underlying autoimmune-related inflammatory process in vitiligo. Further studies are needed to investigate the role of immunotherapy targeting specific inflammatory pathways and the impact on the repigmentation in vitiligo.

Acknowledgment—Special thanks to Paul Chu, MD (Port Chester, New York).

To the Editor:

A 39-year-old man with a history of hypertension and vitiligo presented with a rapid-onset, generalized, pruritic rash covering the body of 4 weeks’ duration. He reported that the rash progressively worsened after developing mild sunburn. The patient stated that the rash was extremely pruritic with a burning sensation and was tender to touch. He was treated with betamethasone valerate cream 0.1% by an outside physician and an over-the-counter anti-itch lotion with no notable improvement. His only medication was telmisartan-hydrochlorothiazide (HCTZ) for hypertension. He denied any drug allergies.

Physical examination revealed multiple discrete and coalescent planar erythematous papules and plaques involving only the depigmented vitiliginous skin of the forehead, eyelids, and nape of the neck (Figure 1A), and confluent on the lateral aspect of the bilateral forearms (Figure 1B), dorsal aspect of the right hand, and bilateral dorsi of the feet. Wickham striae were noted on the lips (Figure 1C). A clinical diagnosis of lichen planus (LP) was made. The patient initially was prescribed halobetasol propionate ointment 0.05% twice daily. He reported notable relief of pruritus with reduction of overall symptoms and new lesion formation.

A 4-mm punch biopsy was performed on the left forearm. Histopathology revealed LP. Microscopic examination of the hematoxylin and eosin–stained specimen revealed a bandlike lymphohistiocytic infiltrate that extended across the papillary dermis, focally obscuring the dermoepidermal junction where there were vacuolar changes and colloid bodies. The epidermis showed sawtooth rete ridges, wedge-shaped foci of hypergranulosis, and compact hyperkeratosis (Figure 2).

On further questioning during follow-up, the patient revealed that his hypertensive medication was changed from HCTZ, which he had been taking for the last 8 years, to the combination antihypertensive medication telmisartan-HCTZ before the onset of the skin eruption. Due to the temporal relationship between the new medication and onset of the eruption, the clinical impression was highly suspicious for drug-induced eruptive LP with Köbner phenomenon caused by the recent sunburn. Systemic workup for underlying causes of LP was negative. Laboratory tests revealed normal complete blood cell counts. The hepatitis panel included hepatitis A antibodies; hepatitis B surface, e antigen, and core antibodies; hepatitis B surface antigen and e antibodies; hepatitis C antibodies; and antinuclear antibodies, which were all negative.

The patient continued to develop new pruritic papules clinically consistent with LP. He was instructed to return to his primary care physician to change the telmisartan-HCTZ to a different class of antihypertensive medication. His medication was changed to atenolol. The patient also was instructed to continue the halobetasol propionate ointment 0.05% twice daily to the affected areas.

The patient returned for a follow-up visit 1 month later and reported notable improvement in pruritus and near-complete resolution of the LP after discontinuation of telmisartan-HCTZ. He also noted some degree of perifollicular repigmentation of the vitiliginous skin that had been unresponsive to prior therapy (Figure 3).

Lichen planus is a pruritic and inflammatory papulosquamous skin condition that presents as scaly, flat-topped, violaceous, polygonal-shaped papules commonly involving the flexor surface of the arms and legs, oral mucosa, scalp, nails, and genitalia. Clinically, LP can present in various forms including actinic, annular, atrophic, erosive, follicular, hypertrophic, linear, pigmented, and vesicular/bullous types. Koebnerization is common, especially in the linear form of LP. There are no specific laboratory findings or serologic markers seen in LP.

The exact cause of LP remains unknown. Clinical observations and anecdotal evidence have directed the cell-mediated immune response to insulting agents such as medications or contact allergy to metals triggering an abnormal cellular immune response. Various viral agents have been reported including hepatitis C virus, human herpesvirus, herpes simplex virus, and varicella-zoster virus.^1-5 Other factors such as seasonal change and the environment may contribute to the development of LP and an increase in the incidence of LP eruption has been observed from January to July throughout the United States.⁶ Lichen planus also has been associated with other altered immune-related disease such as ulcerative colitis, alopecia areata, vitiligo, dermatomyositis, morphea, lichen sclerosis, and myasthenia gravis.⁷ Increased levels of emotional stress, particularly related to family members, often is related to the onset or aggravation of symptoms.^8,9

Many drug-related LP-like and lichenoid eruptions have been reported with antihypertensive drugs, antimalarial drugs, diuretics, antidepressants, nonsteroidal anti-inflammatory drugs, antimicrobial drugs, and metals. In particular, medications such as captopril, enalapril, labetalol, propranolol, chlorothiazide, HCTZ, methyldopa, chloroquine, hydroxychloroquine, quinacrine, gold salts, penicillamine, and quinidine commonly are reported to induce lichenoid drug eruption.¹⁰

Several inflammatory papulosquamous skin conditions should be considered in the differential diagnosis before confirming the diagnosis of LP. It is important to rule out lupus erythematosus, especially if the oral mucosa and scalp are involved. In addition, erosive paraneoplastic pemphigus involving primarily the oral mucosa can resemble oral LP. Nail diseases such as psoriasis, onychomycosis, and alopecia areata should be considered as the differential diagnosis of nail disease. Genital involvement also can be seen in psoriasis and lichen sclerosus.

Treatment of LP is mainly symptomatic because of the benign nature of the disease and the high spontaneous remission rate with varying amount of time. If drugs, dental/metal implants, or underlying viral infections are the identifiable triggering factors of LP, the offending agents should be discontinued or removed. Additionally, topical or systemic treatments can be given depending on the severity of the disease, focusing mainly on symptomatic relief as well as the balance of risks and benefits associated with treatment.

Treatment options include topical and intralesional corticosteroids. Systemic medications such as oral corticosteroids and/or acitretin commonly are used in acute, severe, and disseminated cases, though treatment duration varies depending on the clinical response. Other systemic agents used to treat LP include griseofulvin, metronidazole, sulfasalazine, cyclosporine, and mycophenolate mofetil.

Phototherapy is considered an alternative therapy, especially for recalcitrant LP. UVA1 and narrowband UVB (wavelength, 311 nm) have been reported to effectively treat long-standing and therapy-resistant LP.¹¹ In addition, a small study used the excimer laser (wavelength, 308 nm), which is well tolerated by patients, to treat focal recalcitrant oral lesions with excellent results.¹² Photochemotherapy has been used with notable improvement, but the potential of carcinogenicity, especially in patients with Fitzpatrick skin types I and II, has limited its use.¹³

Our patient developed an unusual extensive LP eruption involving only vitiliginous skin shortly after initiation of the combined antihypertensive medication telmisartan-HCTZ, an angiotensin receptor blocker with a thiazide diuretic. Telmisartan and other angiotensin receptor blockers have not been reported to trigger LP; HCTZ is listed as one of the common drugs causing photosensitivity and LP.^14,15 Although it is possible that our patient exhibited a delayed lichenoid drug eruption from the HCTZ, it is noteworthy that he did not experience a single episode of LP during his 8-year history of taking HCTZ. Instead, he developed the LP eruption shortly after the addition of telmisartan to his HCTZ antihypertensive regimen. The temporal relationship led us to direct the patient to the prescribing physician to discontinue telmisartan-HCTZ. After changing his antihypertensive medication to atenolol, the patient presented with improvement within the first month and near-complete resolution 2 months after the discontinuation of telmisartan-HCTZ.

Our patient’s LP lesions only manifested on the skin affected by vitiligo, sparing the normal-pigmented skin. Studies have demonstrated an increased ratio of CD8⁺ T cells to CD4⁺ T cells as well as increased intercellular adhesion molecule 1 at the dermal level.^10,16 Both vitiligo and LP share some common histopathologic features including highly populated CD8⁺ T cells and intercellular adhesion molecule 1. In our case, LP was triggered on the vitiliginous skin by telmisartan. Vitiligo in combination with trauma induced by sunburn may represent the trigger that altered the cellular immune response and created the telmisartan-induced LP. As a result, the LP eruption was confined to the vitiliginous skin lesions.

Perifollicular repigmentation was observed in our patient after the LP lesions resolved; the patient’s vitiligo was unresponsive to prior treatment. The inflammatory process occurring in LP may exert and interfere in the underlying autoimmune cytotoxic effect toward the melanocytes and the melanin synthesis. It may be of interest to find out if the inflammatory response of LP has a positive influence on the effect of melanogenesis pathways or on the underlying autoimmune-related inflammatory process in vitiligo. Further studies are needed to investigate the role of immunotherapy targeting specific inflammatory pathways and the impact on the repigmentation in vitiligo.

Acknowledgment—Special thanks to Paul Chu, MD (Port Chester, New York).

To the Editor:

A 39-year-old man with a history of hypertension and vitiligo presented with a rapid-onset, generalized, pruritic rash covering the body of 4 weeks’ duration. He reported that the rash progressively worsened after developing mild sunburn. The patient stated that the rash was extremely pruritic with a burning sensation and was tender to touch. He was treated with betamethasone valerate cream 0.1% by an outside physician and an over-the-counter anti-itch lotion with no notable improvement. His only medication was telmisartan-hydrochlorothiazide (HCTZ) for hypertension. He denied any drug allergies.

Physical examination revealed multiple discrete and coalescent planar erythematous papules and plaques involving only the depigmented vitiliginous skin of the forehead, eyelids, and nape of the neck (Figure 1A), and confluent on the lateral aspect of the bilateral forearms (Figure 1B), dorsal aspect of the right hand, and bilateral dorsi of the feet. Wickham striae were noted on the lips (Figure 1C). A clinical diagnosis of lichen planus (LP) was made. The patient initially was prescribed halobetasol propionate ointment 0.05% twice daily. He reported notable relief of pruritus with reduction of overall symptoms and new lesion formation.

A 4-mm punch biopsy was performed on the left forearm. Histopathology revealed LP. Microscopic examination of the hematoxylin and eosin–stained specimen revealed a bandlike lymphohistiocytic infiltrate that extended across the papillary dermis, focally obscuring the dermoepidermal junction where there were vacuolar changes and colloid bodies. The epidermis showed sawtooth rete ridges, wedge-shaped foci of hypergranulosis, and compact hyperkeratosis (Figure 2).

On further questioning during follow-up, the patient revealed that his hypertensive medication was changed from HCTZ, which he had been taking for the last 8 years, to the combination antihypertensive medication telmisartan-HCTZ before the onset of the skin eruption. Due to the temporal relationship between the new medication and onset of the eruption, the clinical impression was highly suspicious for drug-induced eruptive LP with Köbner phenomenon caused by the recent sunburn. Systemic workup for underlying causes of LP was negative. Laboratory tests revealed normal complete blood cell counts. The hepatitis panel included hepatitis A antibodies; hepatitis B surface, e antigen, and core antibodies; hepatitis B surface antigen and e antibodies; hepatitis C antibodies; and antinuclear antibodies, which were all negative.

The patient continued to develop new pruritic papules clinically consistent with LP. He was instructed to return to his primary care physician to change the telmisartan-HCTZ to a different class of antihypertensive medication. His medication was changed to atenolol. The patient also was instructed to continue the halobetasol propionate ointment 0.05% twice daily to the affected areas.

The patient returned for a follow-up visit 1 month later and reported notable improvement in pruritus and near-complete resolution of the LP after discontinuation of telmisartan-HCTZ. He also noted some degree of perifollicular repigmentation of the vitiliginous skin that had been unresponsive to prior therapy (Figure 3).

Lichen planus is a pruritic and inflammatory papulosquamous skin condition that presents as scaly, flat-topped, violaceous, polygonal-shaped papules commonly involving the flexor surface of the arms and legs, oral mucosa, scalp, nails, and genitalia. Clinically, LP can present in various forms including actinic, annular, atrophic, erosive, follicular, hypertrophic, linear, pigmented, and vesicular/bullous types. Koebnerization is common, especially in the linear form of LP. There are no specific laboratory findings or serologic markers seen in LP.

The exact cause of LP remains unknown. Clinical observations and anecdotal evidence have directed the cell-mediated immune response to insulting agents such as medications or contact allergy to metals triggering an abnormal cellular immune response. Various viral agents have been reported including hepatitis C virus, human herpesvirus, herpes simplex virus, and varicella-zoster virus.^1-5 Other factors such as seasonal change and the environment may contribute to the development of LP and an increase in the incidence of LP eruption has been observed from January to July throughout the United States.⁶ Lichen planus also has been associated with other altered immune-related disease such as ulcerative colitis, alopecia areata, vitiligo, dermatomyositis, morphea, lichen sclerosis, and myasthenia gravis.⁷ Increased levels of emotional stress, particularly related to family members, often is related to the onset or aggravation of symptoms.^8,9

Many drug-related LP-like and lichenoid eruptions have been reported with antihypertensive drugs, antimalarial drugs, diuretics, antidepressants, nonsteroidal anti-inflammatory drugs, antimicrobial drugs, and metals. In particular, medications such as captopril, enalapril, labetalol, propranolol, chlorothiazide, HCTZ, methyldopa, chloroquine, hydroxychloroquine, quinacrine, gold salts, penicillamine, and quinidine commonly are reported to induce lichenoid drug eruption.¹⁰

Several inflammatory papulosquamous skin conditions should be considered in the differential diagnosis before confirming the diagnosis of LP. It is important to rule out lupus erythematosus, especially if the oral mucosa and scalp are involved. In addition, erosive paraneoplastic pemphigus involving primarily the oral mucosa can resemble oral LP. Nail diseases such as psoriasis, onychomycosis, and alopecia areata should be considered as the differential diagnosis of nail disease. Genital involvement also can be seen in psoriasis and lichen sclerosus.

Treatment of LP is mainly symptomatic because of the benign nature of the disease and the high spontaneous remission rate with varying amount of time. If drugs, dental/metal implants, or underlying viral infections are the identifiable triggering factors of LP, the offending agents should be discontinued or removed. Additionally, topical or systemic treatments can be given depending on the severity of the disease, focusing mainly on symptomatic relief as well as the balance of risks and benefits associated with treatment.

Treatment options include topical and intralesional corticosteroids. Systemic medications such as oral corticosteroids and/or acitretin commonly are used in acute, severe, and disseminated cases, though treatment duration varies depending on the clinical response. Other systemic agents used to treat LP include griseofulvin, metronidazole, sulfasalazine, cyclosporine, and mycophenolate mofetil.

Phototherapy is considered an alternative therapy, especially for recalcitrant LP. UVA1 and narrowband UVB (wavelength, 311 nm) have been reported to effectively treat long-standing and therapy-resistant LP.¹¹ In addition, a small study used the excimer laser (wavelength, 308 nm), which is well tolerated by patients, to treat focal recalcitrant oral lesions with excellent results.¹² Photochemotherapy has been used with notable improvement, but the potential of carcinogenicity, especially in patients with Fitzpatrick skin types I and II, has limited its use.¹³

Our patient developed an unusual extensive LP eruption involving only vitiliginous skin shortly after initiation of the combined antihypertensive medication telmisartan-HCTZ, an angiotensin receptor blocker with a thiazide diuretic. Telmisartan and other angiotensin receptor blockers have not been reported to trigger LP; HCTZ is listed as one of the common drugs causing photosensitivity and LP.^14,15 Although it is possible that our patient exhibited a delayed lichenoid drug eruption from the HCTZ, it is noteworthy that he did not experience a single episode of LP during his 8-year history of taking HCTZ. Instead, he developed the LP eruption shortly after the addition of telmisartan to his HCTZ antihypertensive regimen. The temporal relationship led us to direct the patient to the prescribing physician to discontinue telmisartan-HCTZ. After changing his antihypertensive medication to atenolol, the patient presented with improvement within the first month and near-complete resolution 2 months after the discontinuation of telmisartan-HCTZ.

Our patient’s LP lesions only manifested on the skin affected by vitiligo, sparing the normal-pigmented skin. Studies have demonstrated an increased ratio of CD8⁺ T cells to CD4⁺ T cells as well as increased intercellular adhesion molecule 1 at the dermal level.^10,16 Both vitiligo and LP share some common histopathologic features including highly populated CD8⁺ T cells and intercellular adhesion molecule 1. In our case, LP was triggered on the vitiliginous skin by telmisartan. Vitiligo in combination with trauma induced by sunburn may represent the trigger that altered the cellular immune response and created the telmisartan-induced LP. As a result, the LP eruption was confined to the vitiliginous skin lesions.

Perifollicular repigmentation was observed in our patient after the LP lesions resolved; the patient’s vitiligo was unresponsive to prior treatment. The inflammatory process occurring in LP may exert and interfere in the underlying autoimmune cytotoxic effect toward the melanocytes and the melanin synthesis. It may be of interest to find out if the inflammatory response of LP has a positive influence on the effect of melanogenesis pathways or on the underlying autoimmune-related inflammatory process in vitiligo. Further studies are needed to investigate the role of immunotherapy targeting specific inflammatory pathways and the impact on the repigmentation in vitiligo.

Acknowledgment—Special thanks to Paul Chu, MD (Port Chester, New York).

The Diagnosis: Allergic Contact Dermatitis

An allergic contact dermatitis (ACD) to acrylates was suspected and 4 patches were applied to the forearm (the North American Standard Series of the North American Contact Dermatitis Group). The patches were 2-hydroxyethyl methacrylate (2-HEMA) 2.0% permissible exposure limit (peL), ethyl acrylate 0.1% peL, tosylamide formaldehyde resin 10.0% peL, and methyl methacrylate 2.0% peL. A reading at 72 hours was performed and showed a positive reaction to hydroxyethyl methacrylate, ethyl acrylate, and methyl methacrylate, and a negative patch test to tosylamide formaldehyde resin (nail polish)(Figure). The patient was diagnosed with an allergic contact hypersensitivity to the aforementioned acrylates and instructed to avoid artificial nails and acrylate glues. She also was started on oral biotin supplements. On 6-month follow-up the patient had regrowth of all 10 fingernails without brittleness or splitting. She was able to use nail polishes but avoided all acrylic artificial nails and acrylate-containing personal care products.

Acrylate Allergy and Artificial Nails

Acrylates are plastic materials formed by polymerization of acrylic or methacrylic acid monomers and have been cited as a major cause of occupational and nonoccupational contact dermatitis. Contact dermatitis to acrylates in artificial nails was first reported in the 1950s.^1,2 Products containing 100% methyl methacrylate monomers in acrylic nails were banned by the US Food and Drug Administration in the early 1970s after receiving a number of complaints.³ However, no regulation prohibits the use of methyl methacrylate monomer in cosmetic products, and various methacrylate and acrylate monomers remain widely used.⁴ With a growing popularity in artificial nails, it is expected the number of sensitized persons will increase.

Acrylate allergy from sculptured nails concern self-curing resins made from a polymer powder and a liquid monomer solution. Advantages of new UV-cured products include the lack of unpleasant smell and simplified modeling. They also do not require an irritant, such as methacrylic acid, as a bonding agent. Instead, 2-HEMA and 2-hydroxypropyl methacrylate are added. These photobonded nails colloquially are called gel nails (acid free) as opposed to acrylic nails (using methacrylic acid as a primer). It is important to note that the esters of acrylic acid but not the acid itself sensitize patients, and sensitization is not caused by the uncured gel or the monomer solution but by the remaining monomers in the cured plastic nail and the dust filings that are produced during the finishing process.

Clinical Presentation

Symptoms of an ACD to nail acrylates include pruritus and fingertip dermatitis along with nail plate dystrophy. There may be pruritus at the nail base, with subsequent dryness, thickening, and onycholysis. The brittle nails may become split, discolored, and develop paronychia. Inadvertent contact with glue monomers or other acrylate-containing substances may cause eczematous lesions at distant sites. Avoidance of the allergen often results in complete restoration of the normal nail and fingertip within months.

Sensitization

Acrylates and methacrylates are ubiquitous materials used for both industrial and commercial applications. Due to their widespread industrial use, contact allergies to acrylates including 2-HEMA, 2-hydroxypropyl methacrylate, and triethyleneglycol diacrylate (TREGDA) are common. Cross-reaction of these compounds has been observed and is postulated to be due to reaction of the (meth)acrylate carboxyethyl group with the receptors of antigen-presenting cells.⁵ As a result, an individual with an acrylate allergy sensitized to one allergen often is allergic to its similar compounds and cross-reactors and must avoid the assortment of compounds containing these ingredients, which is important for individuals with occupational sensitization to a particular acrylate who is subsequently susceptible to other acrylate-containing compounds triggering allergic reactions when reexposure occurs in different settings.

Allergens and Occupational Exposure

Acrylates in cosmetic nail products are a source of ACD for not only the customer but also the manicurist.⁶ The most frequently cited sources of ACD in beauticians are acrylate chemicals.⁷ However, acrylate compounds are an occupational hazard for a number of other specialists, including dentists and dental technicians, histology technicians, and individuals in the printing industry.^8,9 Other individuals may be sensitized to acrylates through their inclusion in adhesives, dental bonding agents, hearing aids, electrocardiogram electrodes, artificial bone cement, and a myriad of other medical and nonmedical applications.^4,10-12 For workers who cannot avoid occupational exposure to these allergens, polyvinyl alcohol and multilayer laminate gloves are recommended, as natural rubber latex gloves do not always provide adequate protection from many of these agents.¹⁰

Testing for Suspected Acrylate Allergy

Cross-reactivity among acrylates is widely considered in the literature but remains enigmatic and is an important consideration with regard to routine patch test screening.¹³ In the case of an acrylate allergy to nail products, using 2-HEMA and ethylene glycol dimethacrylate is effective in detecting sensitization by photobonded nails and in patients sensitized by powder liquid products.¹⁴ One study showed a patch test panel including 2-HEMA, ethylene glycol dimethacrylate, and TREGDA was effective in identifying the majority of individuals with an allergy to acrylates in nail products and nail technicians.¹⁵ Another study has shown the most commonly positive testing allergens to be HEMA, ethyl acrylate, and methyl methacrylate.¹⁶ If one is patch testing only one chemical, it appears 2-HEMA is preferred.¹⁷ However, broader panels of screening allergens are necessary to achieve an accurate diagnosis. Furthermore, different panels of test allergens have been shown to vary in their ability to detect an acrylate allergy in different occupational exposures.¹² 

The time to patch test read also is important. A standard read at 72 hours is warranted; however, one study showed if only one read at day 3 was done without a subsequent day 7 read, then 25% of TREGDA and 50% of 2-HEMA allergies would have been missed in patients with occupational acrylate allergy.¹⁵ Other studies have reported late-appearing and long-lasting test reactions when testing for an acrylate allergy.^18,19 Clinicians should be cognizant that an acrylate allergy may be present even if initial screening is negative but the history and clinical picture are suggestive.

The Diagnosis: Allergic Contact Dermatitis

An allergic contact dermatitis (ACD) to acrylates was suspected and 4 patches were applied to the forearm (the North American Standard Series of the North American Contact Dermatitis Group). The patches were 2-hydroxyethyl methacrylate (2-HEMA) 2.0% permissible exposure limit (peL), ethyl acrylate 0.1% peL, tosylamide formaldehyde resin 10.0% peL, and methyl methacrylate 2.0% peL. A reading at 72 hours was performed and showed a positive reaction to hydroxyethyl methacrylate, ethyl acrylate, and methyl methacrylate, and a negative patch test to tosylamide formaldehyde resin (nail polish)(Figure). The patient was diagnosed with an allergic contact hypersensitivity to the aforementioned acrylates and instructed to avoid artificial nails and acrylate glues. She also was started on oral biotin supplements. On 6-month follow-up the patient had regrowth of all 10 fingernails without brittleness or splitting. She was able to use nail polishes but avoided all acrylic artificial nails and acrylate-containing personal care products.

Acrylate Allergy and Artificial Nails

Acrylates are plastic materials formed by polymerization of acrylic or methacrylic acid monomers and have been cited as a major cause of occupational and nonoccupational contact dermatitis. Contact dermatitis to acrylates in artificial nails was first reported in the 1950s.^1,2 Products containing 100% methyl methacrylate monomers in acrylic nails were banned by the US Food and Drug Administration in the early 1970s after receiving a number of complaints.³ However, no regulation prohibits the use of methyl methacrylate monomer in cosmetic products, and various methacrylate and acrylate monomers remain widely used.⁴ With a growing popularity in artificial nails, it is expected the number of sensitized persons will increase.

Acrylate allergy from sculptured nails concern self-curing resins made from a polymer powder and a liquid monomer solution. Advantages of new UV-cured products include the lack of unpleasant smell and simplified modeling. They also do not require an irritant, such as methacrylic acid, as a bonding agent. Instead, 2-HEMA and 2-hydroxypropyl methacrylate are added. These photobonded nails colloquially are called gel nails (acid free) as opposed to acrylic nails (using methacrylic acid as a primer). It is important to note that the esters of acrylic acid but not the acid itself sensitize patients, and sensitization is not caused by the uncured gel or the monomer solution but by the remaining monomers in the cured plastic nail and the dust filings that are produced during the finishing process.

Clinical Presentation

Symptoms of an ACD to nail acrylates include pruritus and fingertip dermatitis along with nail plate dystrophy. There may be pruritus at the nail base, with subsequent dryness, thickening, and onycholysis. The brittle nails may become split, discolored, and develop paronychia. Inadvertent contact with glue monomers or other acrylate-containing substances may cause eczematous lesions at distant sites. Avoidance of the allergen often results in complete restoration of the normal nail and fingertip within months.

Sensitization

Acrylates and methacrylates are ubiquitous materials used for both industrial and commercial applications. Due to their widespread industrial use, contact allergies to acrylates including 2-HEMA, 2-hydroxypropyl methacrylate, and triethyleneglycol diacrylate (TREGDA) are common. Cross-reaction of these compounds has been observed and is postulated to be due to reaction of the (meth)acrylate carboxyethyl group with the receptors of antigen-presenting cells.⁵ As a result, an individual with an acrylate allergy sensitized to one allergen often is allergic to its similar compounds and cross-reactors and must avoid the assortment of compounds containing these ingredients, which is important for individuals with occupational sensitization to a particular acrylate who is subsequently susceptible to other acrylate-containing compounds triggering allergic reactions when reexposure occurs in different settings.

Allergens and Occupational Exposure

Acrylates in cosmetic nail products are a source of ACD for not only the customer but also the manicurist.⁶ The most frequently cited sources of ACD in beauticians are acrylate chemicals.⁷ However, acrylate compounds are an occupational hazard for a number of other specialists, including dentists and dental technicians, histology technicians, and individuals in the printing industry.^8,9 Other individuals may be sensitized to acrylates through their inclusion in adhesives, dental bonding agents, hearing aids, electrocardiogram electrodes, artificial bone cement, and a myriad of other medical and nonmedical applications.^4,10-12 For workers who cannot avoid occupational exposure to these allergens, polyvinyl alcohol and multilayer laminate gloves are recommended, as natural rubber latex gloves do not always provide adequate protection from many of these agents.¹⁰

Testing for Suspected Acrylate Allergy

Cross-reactivity among acrylates is widely considered in the literature but remains enigmatic and is an important consideration with regard to routine patch test screening.¹³ In the case of an acrylate allergy to nail products, using 2-HEMA and ethylene glycol dimethacrylate is effective in detecting sensitization by photobonded nails and in patients sensitized by powder liquid products.¹⁴ One study showed a patch test panel including 2-HEMA, ethylene glycol dimethacrylate, and TREGDA was effective in identifying the majority of individuals with an allergy to acrylates in nail products and nail technicians.¹⁵ Another study has shown the most commonly positive testing allergens to be HEMA, ethyl acrylate, and methyl methacrylate.¹⁶ If one is patch testing only one chemical, it appears 2-HEMA is preferred.¹⁷ However, broader panels of screening allergens are necessary to achieve an accurate diagnosis. Furthermore, different panels of test allergens have been shown to vary in their ability to detect an acrylate allergy in different occupational exposures.¹² 

The time to patch test read also is important. A standard read at 72 hours is warranted; however, one study showed if only one read at day 3 was done without a subsequent day 7 read, then 25% of TREGDA and 50% of 2-HEMA allergies would have been missed in patients with occupational acrylate allergy.¹⁵ Other studies have reported late-appearing and long-lasting test reactions when testing for an acrylate allergy.^18,19 Clinicians should be cognizant that an acrylate allergy may be present even if initial screening is negative but the history and clinical picture are suggestive.

The Diagnosis: Allergic Contact Dermatitis

An allergic contact dermatitis (ACD) to acrylates was suspected and 4 patches were applied to the forearm (the North American Standard Series of the North American Contact Dermatitis Group). The patches were 2-hydroxyethyl methacrylate (2-HEMA) 2.0% permissible exposure limit (peL), ethyl acrylate 0.1% peL, tosylamide formaldehyde resin 10.0% peL, and methyl methacrylate 2.0% peL. A reading at 72 hours was performed and showed a positive reaction to hydroxyethyl methacrylate, ethyl acrylate, and methyl methacrylate, and a negative patch test to tosylamide formaldehyde resin (nail polish)(Figure). The patient was diagnosed with an allergic contact hypersensitivity to the aforementioned acrylates and instructed to avoid artificial nails and acrylate glues. She also was started on oral biotin supplements. On 6-month follow-up the patient had regrowth of all 10 fingernails without brittleness or splitting. She was able to use nail polishes but avoided all acrylic artificial nails and acrylate-containing personal care products.

Acrylate Allergy and Artificial Nails

Acrylates are plastic materials formed by polymerization of acrylic or methacrylic acid monomers and have been cited as a major cause of occupational and nonoccupational contact dermatitis. Contact dermatitis to acrylates in artificial nails was first reported in the 1950s.^1,2 Products containing 100% methyl methacrylate monomers in acrylic nails were banned by the US Food and Drug Administration in the early 1970s after receiving a number of complaints.³ However, no regulation prohibits the use of methyl methacrylate monomer in cosmetic products, and various methacrylate and acrylate monomers remain widely used.⁴ With a growing popularity in artificial nails, it is expected the number of sensitized persons will increase.

Acrylate allergy from sculptured nails concern self-curing resins made from a polymer powder and a liquid monomer solution. Advantages of new UV-cured products include the lack of unpleasant smell and simplified modeling. They also do not require an irritant, such as methacrylic acid, as a bonding agent. Instead, 2-HEMA and 2-hydroxypropyl methacrylate are added. These photobonded nails colloquially are called gel nails (acid free) as opposed to acrylic nails (using methacrylic acid as a primer). It is important to note that the esters of acrylic acid but not the acid itself sensitize patients, and sensitization is not caused by the uncured gel or the monomer solution but by the remaining monomers in the cured plastic nail and the dust filings that are produced during the finishing process.

Clinical Presentation

Symptoms of an ACD to nail acrylates include pruritus and fingertip dermatitis along with nail plate dystrophy. There may be pruritus at the nail base, with subsequent dryness, thickening, and onycholysis. The brittle nails may become split, discolored, and develop paronychia. Inadvertent contact with glue monomers or other acrylate-containing substances may cause eczematous lesions at distant sites. Avoidance of the allergen often results in complete restoration of the normal nail and fingertip within months.

Sensitization

Acrylates and methacrylates are ubiquitous materials used for both industrial and commercial applications. Due to their widespread industrial use, contact allergies to acrylates including 2-HEMA, 2-hydroxypropyl methacrylate, and triethyleneglycol diacrylate (TREGDA) are common. Cross-reaction of these compounds has been observed and is postulated to be due to reaction of the (meth)acrylate carboxyethyl group with the receptors of antigen-presenting cells.⁵ As a result, an individual with an acrylate allergy sensitized to one allergen often is allergic to its similar compounds and cross-reactors and must avoid the assortment of compounds containing these ingredients, which is important for individuals with occupational sensitization to a particular acrylate who is subsequently susceptible to other acrylate-containing compounds triggering allergic reactions when reexposure occurs in different settings.

Allergens and Occupational Exposure

Acrylates in cosmetic nail products are a source of ACD for not only the customer but also the manicurist.⁶ The most frequently cited sources of ACD in beauticians are acrylate chemicals.⁷ However, acrylate compounds are an occupational hazard for a number of other specialists, including dentists and dental technicians, histology technicians, and individuals in the printing industry.^8,9 Other individuals may be sensitized to acrylates through their inclusion in adhesives, dental bonding agents, hearing aids, electrocardiogram electrodes, artificial bone cement, and a myriad of other medical and nonmedical applications.^4,10-12 For workers who cannot avoid occupational exposure to these allergens, polyvinyl alcohol and multilayer laminate gloves are recommended, as natural rubber latex gloves do not always provide adequate protection from many of these agents.¹⁰

Testing for Suspected Acrylate Allergy

Cross-reactivity among acrylates is widely considered in the literature but remains enigmatic and is an important consideration with regard to routine patch test screening.¹³ In the case of an acrylate allergy to nail products, using 2-HEMA and ethylene glycol dimethacrylate is effective in detecting sensitization by photobonded nails and in patients sensitized by powder liquid products.¹⁴ One study showed a patch test panel including 2-HEMA, ethylene glycol dimethacrylate, and TREGDA was effective in identifying the majority of individuals with an allergy to acrylates in nail products and nail technicians.¹⁵ Another study has shown the most commonly positive testing allergens to be HEMA, ethyl acrylate, and methyl methacrylate.¹⁶ If one is patch testing only one chemical, it appears 2-HEMA is preferred.¹⁷ However, broader panels of screening allergens are necessary to achieve an accurate diagnosis. Furthermore, different panels of test allergens have been shown to vary in their ability to detect an acrylate allergy in different occupational exposures.¹² 

The time to patch test read also is important. A standard read at 72 hours is warranted; however, one study showed if only one read at day 3 was done without a subsequent day 7 read, then 25% of TREGDA and 50% of 2-HEMA allergies would have been missed in patients with occupational acrylate allergy.¹⁵ Other studies have reported late-appearing and long-lasting test reactions when testing for an acrylate allergy.^18,19 Clinicians should be cognizant that an acrylate allergy may be present even if initial screening is negative but the history and clinical picture are suggestive.