Christine Kilgore

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his coinvestigators wrote (Diabetes Care 2007:30;999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain-signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

He hopes to recruit 180 patients to participate in the investigation and expects it to take at least another year to complete.

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his coinvestigators wrote (Diabetes Care 2007:30;999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain-signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

He hopes to recruit 180 patients to participate in the investigation and expects it to take at least another year to complete.

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his coinvestigators wrote (Diabetes Care 2007:30;999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain-signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

He hopes to recruit 180 patients to participate in the investigation and expects it to take at least another year to complete.

BETHESDA, MD. – A growing body of research suggests that dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) has been “one of the most mysterious of the pain disorders”–one with no known cause, leaving few physicians willing to treat it and many others believing the disorder to be psychosomatic, said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston.

However, “we now understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II … [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as having CRPS-I (defined as having no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (having a known nerve injury). However, “seeing them in the clinic with the same presentation, it doesn't take a great leap of faith to believe these guys [with CRPS-I] have a nerve injury that wasn't discovered,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. These patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Epidemiologic studies show that most patients diagnosed with CRPS are young (an average age of 39) and female (a 4:1 ratio), and that most patients recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

Results of ipsilateral and contralateral control biopsies discount a hypothesized effect of swelling on the number of nerve endings, and the fact that a control group of seven osteoarthritis patients with severe leg pain, edema, and disuse had no loss of nerve endings discounts the hypothesis that pain “burns out” nerve endings, Dr. Oaklander said. The identification of posttraumatic small-fiber loss in patients with CRPS has been validated by several other research groups, she noted.

There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia.

“The problem isn't so much with the nociceptive fibers that are degenerated–it's with their neighbors,” Dr. Oaklander said.

New animal models developed to prove causality, including her own laboratory's mouse model of distal nerve injury, have reproduced the symptoms of CRPS–from allodynia and dysautonomia to bone loss, dystonia, and a regional and mirrorlike spread of symptoms–and have shown that long-lasting pain behaviors usually remit and that the prevalence of allodynia is independent of lesion size.

“We really can't assume that it takes a severe injury to leave someone with chronic pain–in fact, the opposite may be true,” Dr. Oaklander said. “Most of those who have small-fiber damage, however, may be able to regenerate their axons, and those whose axons do not regenerate may have either mild or no degeneration of their vasa nervorum,” she said.

This patient's swollen ankle and shallow ulcers were caused by neurogenic edema, which may be triggered by the loss of small-fiber nerve endings. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. – A growing body of research suggests that dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) has been “one of the most mysterious of the pain disorders”–one with no known cause, leaving few physicians willing to treat it and many others believing the disorder to be psychosomatic, said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston.

However, “we now understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II … [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as having CRPS-I (defined as having no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (having a known nerve injury). However, “seeing them in the clinic with the same presentation, it doesn't take a great leap of faith to believe these guys [with CRPS-I] have a nerve injury that wasn't discovered,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. These patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Epidemiologic studies show that most patients diagnosed with CRPS are young (an average age of 39) and female (a 4:1 ratio), and that most patients recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

Results of ipsilateral and contralateral control biopsies discount a hypothesized effect of swelling on the number of nerve endings, and the fact that a control group of seven osteoarthritis patients with severe leg pain, edema, and disuse had no loss of nerve endings discounts the hypothesis that pain “burns out” nerve endings, Dr. Oaklander said. The identification of posttraumatic small-fiber loss in patients with CRPS has been validated by several other research groups, she noted.

There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia.

“The problem isn't so much with the nociceptive fibers that are degenerated–it's with their neighbors,” Dr. Oaklander said.

New animal models developed to prove causality, including her own laboratory's mouse model of distal nerve injury, have reproduced the symptoms of CRPS–from allodynia and dysautonomia to bone loss, dystonia, and a regional and mirrorlike spread of symptoms–and have shown that long-lasting pain behaviors usually remit and that the prevalence of allodynia is independent of lesion size.

“We really can't assume that it takes a severe injury to leave someone with chronic pain–in fact, the opposite may be true,” Dr. Oaklander said. “Most of those who have small-fiber damage, however, may be able to regenerate their axons, and those whose axons do not regenerate may have either mild or no degeneration of their vasa nervorum,” she said.

This patient's swollen ankle and shallow ulcers were caused by neurogenic edema, which may be triggered by the loss of small-fiber nerve endings. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. – A growing body of research suggests that dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) has been “one of the most mysterious of the pain disorders”–one with no known cause, leaving few physicians willing to treat it and many others believing the disorder to be psychosomatic, said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston.

However, “we now understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II … [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as having CRPS-I (defined as having no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (having a known nerve injury). However, “seeing them in the clinic with the same presentation, it doesn't take a great leap of faith to believe these guys [with CRPS-I] have a nerve injury that wasn't discovered,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. These patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Epidemiologic studies show that most patients diagnosed with CRPS are young (an average age of 39) and female (a 4:1 ratio), and that most patients recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

Results of ipsilateral and contralateral control biopsies discount a hypothesized effect of swelling on the number of nerve endings, and the fact that a control group of seven osteoarthritis patients with severe leg pain, edema, and disuse had no loss of nerve endings discounts the hypothesis that pain “burns out” nerve endings, Dr. Oaklander said. The identification of posttraumatic small-fiber loss in patients with CRPS has been validated by several other research groups, she noted.

There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia.

“The problem isn't so much with the nociceptive fibers that are degenerated–it's with their neighbors,” Dr. Oaklander said.

New animal models developed to prove causality, including her own laboratory's mouse model of distal nerve injury, have reproduced the symptoms of CRPS–from allodynia and dysautonomia to bone loss, dystonia, and a regional and mirrorlike spread of symptoms–and have shown that long-lasting pain behaviors usually remit and that the prevalence of allodynia is independent of lesion size.

“We really can't assume that it takes a severe injury to leave someone with chronic pain–in fact, the opposite may be true,” Dr. Oaklander said. “Most of those who have small-fiber damage, however, may be able to regenerate their axons, and those whose axons do not regenerate may have either mild or no degeneration of their vasa nervorum,” she said.

This patient's swollen ankle and shallow ulcers were caused by neurogenic edema, which may be triggered by the loss of small-fiber nerve endings. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his colleagues wrote (Diabetes Care 2007; 30:999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his colleagues wrote (Diabetes Care 2007; 30:999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his colleagues wrote (Diabetes Care 2007; 30:999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

BETHESDA, MD. — A small study of hydrotherapy in labor has documented a significant decrease in anxiety, a fall in stress hormones and unexpectedly, a fall in oxytocin levels and a decrease in uterine contraction frequency, Rebecca Benfield, Ph.D., reported at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Dr. Benfield, a certified nurse-midwife, has long seen benefit in bathing during labor: Women enjoy it and feel better as their pain and anxiety are decreased.

She and others have not known, however, exactly what lies behind the maternal response to hydrotherapy—the psychophysiologic mechanisms of action, for instance, and the possible effects on uterine contractility.

The recently completed study was the first, she said, in which plasma stress hormones were measured during immersion. The findings suggest that the therapy warrants attention in a randomized controlled trial and further investigation as an intervention for labor dysfunction, reported Dr. Benfield, associate professor of nursing and clinical assistant professor of obstetrics and gynecology at East Carolina University in Greenville, N.C.

Eleven healthy women in spontaneous active labor (cervical dilatation of 3–6 cm) at term were immersed to the xiphoid in 37° C water for 1 hour.

Blood samples were drawn before immersion and repeated at 15 and 45 minutes of hydrotherapy. Fetal heart rate and uterine contractions were monitored, and visual analog scales for anxiety and pain were administered before each blood draw. No analgesia was administered during the study.

Mean anxiety scores decreased from 51 mm (on a scale of 100 mm) to 33 mm at 15 minutes and 29 mm at 45 minutes. Pain also decreased, with the changes more significant in women with higher baseline pain scores vs. those with lower baseline pain scores, Dr. Benfield and her associates at East Carolina University reported in a poster presentation.

Statistically significant decreases in vasopressin (from a mean of 5.1 pg/mL at baseline to 4 pg/mL at both 15 and 45 minutes), oxytocin (from approximately 193 pg/mL at baseline to 153 pg/mL at 15 minutes and 154 pg/mL at 30 minutes), and cortisol were among the other changes.

Cortisol decreased twice as much after 15 minutes for the high baseline pain group (a mean decrease of 6.2 mcg/dL), compared with the low baseline pain group (a mean decrease of 3.1 mcg/dL).

The level of beta-endorphins increased significantly, but surprisingly, levels of epinephrine and norepinephrine did not change significantly, Dr. Benfield reported.

All women had a positive plasma volume shift (+4.1% at 15 minutes and at 45 minutes) that was positively correlated with contraction duration, while contraction frequency decreased significantly.

Contraction intensity was not measured, she said in an interview, and is therefore “a missing piece” in the understanding of hydrotherapy's effect on labor contractility.

Hydrotherapy “probably, however, will pan out to be a potentially good intervention for women with high levels of pain and those who are having some type of dysfunctional [labor] pattern … because theoretically it should provide better perfusion to the uterus,” Dr. Benfield said.

Thus far, she said, it appears that the “immersion effect—the hydrostatic pressure of the water—is what's driving the physiologic changes,” she said.

The results may also demonstrate two physiologic roles of oxytocin: its traditional role in uterine contractility and a novel role as an antistress hormone, according to Dr. Edward R. Newton, a coinvestigator for the study.

Although the study's sample size is too small to draw any conclusions about labor outcomes, no maternal or neonatal infections were attributed to the bathing, the researchers said.

BETHESDA, MD. — A small study of hydrotherapy in labor has documented a significant decrease in anxiety, a fall in stress hormones and unexpectedly, a fall in oxytocin levels and a decrease in uterine contraction frequency, Rebecca Benfield, Ph.D., reported at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Dr. Benfield, a certified nurse-midwife, has long seen benefit in bathing during labor: Women enjoy it and feel better as their pain and anxiety are decreased.

She and others have not known, however, exactly what lies behind the maternal response to hydrotherapy—the psychophysiologic mechanisms of action, for instance, and the possible effects on uterine contractility.

The recently completed study was the first, she said, in which plasma stress hormones were measured during immersion. The findings suggest that the therapy warrants attention in a randomized controlled trial and further investigation as an intervention for labor dysfunction, reported Dr. Benfield, associate professor of nursing and clinical assistant professor of obstetrics and gynecology at East Carolina University in Greenville, N.C.

Eleven healthy women in spontaneous active labor (cervical dilatation of 3–6 cm) at term were immersed to the xiphoid in 37° C water for 1 hour.

Blood samples were drawn before immersion and repeated at 15 and 45 minutes of hydrotherapy. Fetal heart rate and uterine contractions were monitored, and visual analog scales for anxiety and pain were administered before each blood draw. No analgesia was administered during the study.

Mean anxiety scores decreased from 51 mm (on a scale of 100 mm) to 33 mm at 15 minutes and 29 mm at 45 minutes. Pain also decreased, with the changes more significant in women with higher baseline pain scores vs. those with lower baseline pain scores, Dr. Benfield and her associates at East Carolina University reported in a poster presentation.

Statistically significant decreases in vasopressin (from a mean of 5.1 pg/mL at baseline to 4 pg/mL at both 15 and 45 minutes), oxytocin (from approximately 193 pg/mL at baseline to 153 pg/mL at 15 minutes and 154 pg/mL at 30 minutes), and cortisol were among the other changes.

Cortisol decreased twice as much after 15 minutes for the high baseline pain group (a mean decrease of 6.2 mcg/dL), compared with the low baseline pain group (a mean decrease of 3.1 mcg/dL).

The level of beta-endorphins increased significantly, but surprisingly, levels of epinephrine and norepinephrine did not change significantly, Dr. Benfield reported.

All women had a positive plasma volume shift (+4.1% at 15 minutes and at 45 minutes) that was positively correlated with contraction duration, while contraction frequency decreased significantly.

Contraction intensity was not measured, she said in an interview, and is therefore “a missing piece” in the understanding of hydrotherapy's effect on labor contractility.

Hydrotherapy “probably, however, will pan out to be a potentially good intervention for women with high levels of pain and those who are having some type of dysfunctional [labor] pattern … because theoretically it should provide better perfusion to the uterus,” Dr. Benfield said.

Thus far, she said, it appears that the “immersion effect—the hydrostatic pressure of the water—is what's driving the physiologic changes,” she said.

The results may also demonstrate two physiologic roles of oxytocin: its traditional role in uterine contractility and a novel role as an antistress hormone, according to Dr. Edward R. Newton, a coinvestigator for the study.

Although the study's sample size is too small to draw any conclusions about labor outcomes, no maternal or neonatal infections were attributed to the bathing, the researchers said.

BETHESDA, MD. — A small study of hydrotherapy in labor has documented a significant decrease in anxiety, a fall in stress hormones and unexpectedly, a fall in oxytocin levels and a decrease in uterine contraction frequency, Rebecca Benfield, Ph.D., reported at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Dr. Benfield, a certified nurse-midwife, has long seen benefit in bathing during labor: Women enjoy it and feel better as their pain and anxiety are decreased.

She and others have not known, however, exactly what lies behind the maternal response to hydrotherapy—the psychophysiologic mechanisms of action, for instance, and the possible effects on uterine contractility.

The recently completed study was the first, she said, in which plasma stress hormones were measured during immersion. The findings suggest that the therapy warrants attention in a randomized controlled trial and further investigation as an intervention for labor dysfunction, reported Dr. Benfield, associate professor of nursing and clinical assistant professor of obstetrics and gynecology at East Carolina University in Greenville, N.C.

Eleven healthy women in spontaneous active labor (cervical dilatation of 3–6 cm) at term were immersed to the xiphoid in 37° C water for 1 hour.

Blood samples were drawn before immersion and repeated at 15 and 45 minutes of hydrotherapy. Fetal heart rate and uterine contractions were monitored, and visual analog scales for anxiety and pain were administered before each blood draw. No analgesia was administered during the study.

Mean anxiety scores decreased from 51 mm (on a scale of 100 mm) to 33 mm at 15 minutes and 29 mm at 45 minutes. Pain also decreased, with the changes more significant in women with higher baseline pain scores vs. those with lower baseline pain scores, Dr. Benfield and her associates at East Carolina University reported in a poster presentation.

Statistically significant decreases in vasopressin (from a mean of 5.1 pg/mL at baseline to 4 pg/mL at both 15 and 45 minutes), oxytocin (from approximately 193 pg/mL at baseline to 153 pg/mL at 15 minutes and 154 pg/mL at 30 minutes), and cortisol were among the other changes.

Cortisol decreased twice as much after 15 minutes for the high baseline pain group (a mean decrease of 6.2 mcg/dL), compared with the low baseline pain group (a mean decrease of 3.1 mcg/dL).

The level of beta-endorphins increased significantly, but surprisingly, levels of epinephrine and norepinephrine did not change significantly, Dr. Benfield reported.

All women had a positive plasma volume shift (+4.1% at 15 minutes and at 45 minutes) that was positively correlated with contraction duration, while contraction frequency decreased significantly.

Contraction intensity was not measured, she said in an interview, and is therefore “a missing piece” in the understanding of hydrotherapy's effect on labor contractility.

Hydrotherapy “probably, however, will pan out to be a potentially good intervention for women with high levels of pain and those who are having some type of dysfunctional [labor] pattern … because theoretically it should provide better perfusion to the uterus,” Dr. Benfield said.

Thus far, she said, it appears that the “immersion effect—the hydrostatic pressure of the water—is what's driving the physiologic changes,” she said.

The results may also demonstrate two physiologic roles of oxytocin: its traditional role in uterine contractility and a novel role as an antistress hormone, according to Dr. Edward R. Newton, a coinvestigator for the study.

Although the study's sample size is too small to draw any conclusions about labor outcomes, no maternal or neonatal infections were attributed to the bathing, the researchers said.

BETHESDA, MD. — A growing body of research suggests dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) is “one of the most mysterious of the pain disorders,” said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston. With no known cause, few physicians are willing to treat it. Others believe it to be psychosomatic. However, “we are beginning to understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as CRPS-I (no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (a known nerve injury). However, “a physician trained to diagnose nerve injuries can identify minor nerve injuries in most CRPS-1 patients as well,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. Patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Most patients with CRPS are young (average age 39) and female (a 4:1 ratio). Most recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

The identification of posttraumatic small-fiber loss in patients with CRPS was first described in 1996 and has been validated by other researchers, she noted. There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia. “The problem isn't so much with the nociceptive fibers that are degenerated—it's with their neighbors, and the effects on the central nervous system,” Dr. Oaklander said. “We really can't assume that it takes a severe injury to leave someone with chronic pain—in fact, the opposite may be true.”

A swollen ankle and shallow ulcers are caused by neurogenic edema. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. — A growing body of research suggests dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) is “one of the most mysterious of the pain disorders,” said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston. With no known cause, few physicians are willing to treat it. Others believe it to be psychosomatic. However, “we are beginning to understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as CRPS-I (no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (a known nerve injury). However, “a physician trained to diagnose nerve injuries can identify minor nerve injuries in most CRPS-1 patients as well,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. Patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Most patients with CRPS are young (average age 39) and female (a 4:1 ratio). Most recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

The identification of posttraumatic small-fiber loss in patients with CRPS was first described in 1996 and has been validated by other researchers, she noted. There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia. “The problem isn't so much with the nociceptive fibers that are degenerated—it's with their neighbors, and the effects on the central nervous system,” Dr. Oaklander said. “We really can't assume that it takes a severe injury to leave someone with chronic pain—in fact, the opposite may be true.”

A swollen ankle and shallow ulcers are caused by neurogenic edema. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. — A growing body of research suggests dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) is “one of the most mysterious of the pain disorders,” said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston. With no known cause, few physicians are willing to treat it. Others believe it to be psychosomatic. However, “we are beginning to understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as CRPS-I (no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (a known nerve injury). However, “a physician trained to diagnose nerve injuries can identify minor nerve injuries in most CRPS-1 patients as well,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. Patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Most patients with CRPS are young (average age 39) and female (a 4:1 ratio). Most recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

The identification of posttraumatic small-fiber loss in patients with CRPS was first described in 1996 and has been validated by other researchers, she noted. There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia. “The problem isn't so much with the nociceptive fibers that are degenerated—it's with their neighbors, and the effects on the central nervous system,” Dr. Oaklander said. “We really can't assume that it takes a severe injury to leave someone with chronic pain—in fact, the opposite may be true.”

A swollen ankle and shallow ulcers are caused by neurogenic edema. Courtesy Dr. Anne Louise Oaklander

Dr. Della Corcoran's pediatric practice sits over an ice cream shop and across the street from a toy store—a setting that's unfortunate, she said, when it comes to immunization.

“Parents come in [for their children's immunizations] saying 'You're going to get ice cream or a new toy after this.' The kids hear this and think something pretty major is going to happen,” she said. Unwittingly, parents can fuel their child's anxiety and distress with such promises.

The notion that parental demeanor before and during immunization should be calm and matter-of-fact, without excessive reassurance—a notion that Dr. Corcoran tries to convey and model in her practice in Hartford, Conn.—is one of the recommended strategies included in a new review of pain reduction during pediatric immunization.

The review, led by Dr. Neil L. Schechter of the Pain Relief Program at Connecticut Children's Medical Center in Hartford, details how the pain of immunization is a source of anxiety and distress in pediatric practice, and concludes that, ironically, there is “limited research available to address the pain associated with the painful procedure most commonly performed in pediatric office settings.”

Still, according to Dr. Schechter and the small group of experts who reviewed the literature and filled gaps through consensus development, a more systematic application of existing knowledge “should go a long way” toward reducing pain and alleviating the “air of persistent tension that hangs over the clinical encounter” due to anticipation of an injection (Pediatrics 2007:119;e1184–98 [Epub doi:10.1542/peds.2006-1107]).

There is good, consistent scientific evidence, they concluded, to support a number of strategies, from parental demeanor that is supportive and nonapologetic, to the following practices:

▸ Developmentally appropriate preparation for all children over the age of 2 years.

▸ The use of sucrose (administered on a pacifier or directly instilled into the mouth) for children younger than 6 months of age.

▸ The use of distraction techniques during injection.

▸ Selective use of local anesthetics in children who are especially fearful.

Of these measures, the use of sucrose solution is “something that has not been as universally accepted, yet this probably has the strongest database,” Dr. Schechter said in an interview. “There are at least 50 articles that support the routine use of sucrose in infants under 6 months.”

Sucrose loses its efficacy by 4–6 months of age and requires more testing with and without other modalities, but at this point it “clearly has efficacy for young infants,” reliably reducing evidence of distress with injections, he and his associates said in the review.

Past infancy, the data on the influence of parental demeanor on child behavior is just as striking, Dr. Schechter said.

“Although it seems counterintuitive, children often are more distressed when parents are more rather than less involved,” the review said. “A matter-of-fact, supportive, nonapologetic approach is endorsed.”

Dr. Corcoran, who administers vaccines herself, said she tries to guide parents by example and counters excessive reassurance with pinwheels and other distraction stimuli. In response to parents' promises of toys or ice cream, she makes comments like, “Oh, you won't need a new toy after this, you'll be just fine.”

This isn't to say children shouldn't be given “realistic information” about how immunizations will feel, the review said. This information, along with what will happen and how to cope (relaxation, breathing, distraction), should all be part of preparing the child.

Coping isn't necessarily something parents help with, the authors noted: One survey of parents of preschool children showed only 10% offered any strategies to their children at all.

Pediatricians should routinely use—and instruct parents to use—engaging distraction techniques that match the child's age and temperament, because there are “strong data” that distraction reduces distress, the review said. It's unclear, however, whether particular techniques—from blowing or deep breathing to counting backward or listening to a story—are optimal.

The expense and time required for topical anesthetic use means that “universal use of local anesthetics cannot be endorsed at this time,” Dr. Schechter and his associates said. Still, for children who are needle phobic and particularly anxious, these agents “should be considered.”

Evidence is not as strong or consistent in the areas of needle length and injection site, the reviewers said. Up to 18 months of age, the standard injection site is the anterior thigh, with a 7/8- to 1-inch needle for children more than 2 months of age. Over 36 months of age, the deltoid should be used, and at any age, the ventrogluteal site may be an alternative.

Between 18 and 36 months of age, “there is controversy regarding the most appropriate site,” the reviewers said.

Until more research is done, pediatricians “should do what they're comfortable with—there is nothing definitive at this point,” Dr. Schechter said in the interview. “I think if evidence emerges, it will add pluses and minuses and not be powerful one way or the other.”

Pressure at the injection site, applied either manually or with the aid of a mechanical device, has some support in the literature and, because pressure has no adverse effects, it may have value, the reviewers said.

“The adolescents and young women coming in for the Gardasil vaccine are even anxious about these shots,” which says something about the anxiety and distress that routine immunizations cause, Dr. Corcoran said. “The pain [of immunization] is real, and it's magnified significantly by anxiety.”

Since finishing the review, Dr. Schechter has launched the “Injection Protection Project,” an educational effort to bring information and tools—from a poster and video for staff to a brochure for parents—into pediatric practices. Thus far, he has visited about 20 offices, including the three-pediatrician practice of Dr. Corcoran.

Dr. Della Corcoran's pediatric practice sits over an ice cream shop and across the street from a toy store—a setting that's unfortunate, she said, when it comes to immunization.

“Parents come in [for their children's immunizations] saying 'You're going to get ice cream or a new toy after this.' The kids hear this and think something pretty major is going to happen,” she said. Unwittingly, parents can fuel their child's anxiety and distress with such promises.

The notion that parental demeanor before and during immunization should be calm and matter-of-fact, without excessive reassurance—a notion that Dr. Corcoran tries to convey and model in her practice in Hartford, Conn.—is one of the recommended strategies included in a new review of pain reduction during pediatric immunization.

The review, led by Dr. Neil L. Schechter of the Pain Relief Program at Connecticut Children's Medical Center in Hartford, details how the pain of immunization is a source of anxiety and distress in pediatric practice, and concludes that, ironically, there is “limited research available to address the pain associated with the painful procedure most commonly performed in pediatric office settings.”

Still, according to Dr. Schechter and the small group of experts who reviewed the literature and filled gaps through consensus development, a more systematic application of existing knowledge “should go a long way” toward reducing pain and alleviating the “air of persistent tension that hangs over the clinical encounter” due to anticipation of an injection (Pediatrics 2007:119;e1184–98 [Epub doi:10.1542/peds.2006-1107]).

There is good, consistent scientific evidence, they concluded, to support a number of strategies, from parental demeanor that is supportive and nonapologetic, to the following practices:

▸ Developmentally appropriate preparation for all children over the age of 2 years.

▸ The use of sucrose (administered on a pacifier or directly instilled into the mouth) for children younger than 6 months of age.

▸ The use of distraction techniques during injection.

▸ Selective use of local anesthetics in children who are especially fearful.

Of these measures, the use of sucrose solution is “something that has not been as universally accepted, yet this probably has the strongest database,” Dr. Schechter said in an interview. “There are at least 50 articles that support the routine use of sucrose in infants under 6 months.”

Sucrose loses its efficacy by 4–6 months of age and requires more testing with and without other modalities, but at this point it “clearly has efficacy for young infants,” reliably reducing evidence of distress with injections, he and his associates said in the review.

Past infancy, the data on the influence of parental demeanor on child behavior is just as striking, Dr. Schechter said.

“Although it seems counterintuitive, children often are more distressed when parents are more rather than less involved,” the review said. “A matter-of-fact, supportive, nonapologetic approach is endorsed.”

Dr. Corcoran, who administers vaccines herself, said she tries to guide parents by example and counters excessive reassurance with pinwheels and other distraction stimuli. In response to parents' promises of toys or ice cream, she makes comments like, “Oh, you won't need a new toy after this, you'll be just fine.”

This isn't to say children shouldn't be given “realistic information” about how immunizations will feel, the review said. This information, along with what will happen and how to cope (relaxation, breathing, distraction), should all be part of preparing the child.

Coping isn't necessarily something parents help with, the authors noted: One survey of parents of preschool children showed only 10% offered any strategies to their children at all.

Pediatricians should routinely use—and instruct parents to use—engaging distraction techniques that match the child's age and temperament, because there are “strong data” that distraction reduces distress, the review said. It's unclear, however, whether particular techniques—from blowing or deep breathing to counting backward or listening to a story—are optimal.

The expense and time required for topical anesthetic use means that “universal use of local anesthetics cannot be endorsed at this time,” Dr. Schechter and his associates said. Still, for children who are needle phobic and particularly anxious, these agents “should be considered.”

Evidence is not as strong or consistent in the areas of needle length and injection site, the reviewers said. Up to 18 months of age, the standard injection site is the anterior thigh, with a 7/8- to 1-inch needle for children more than 2 months of age. Over 36 months of age, the deltoid should be used, and at any age, the ventrogluteal site may be an alternative.

Between 18 and 36 months of age, “there is controversy regarding the most appropriate site,” the reviewers said.

Until more research is done, pediatricians “should do what they're comfortable with—there is nothing definitive at this point,” Dr. Schechter said in the interview. “I think if evidence emerges, it will add pluses and minuses and not be powerful one way or the other.”

Pressure at the injection site, applied either manually or with the aid of a mechanical device, has some support in the literature and, because pressure has no adverse effects, it may have value, the reviewers said.

“The adolescents and young women coming in for the Gardasil vaccine are even anxious about these shots,” which says something about the anxiety and distress that routine immunizations cause, Dr. Corcoran said. “The pain [of immunization] is real, and it's magnified significantly by anxiety.”

Since finishing the review, Dr. Schechter has launched the “Injection Protection Project,” an educational effort to bring information and tools—from a poster and video for staff to a brochure for parents—into pediatric practices. Thus far, he has visited about 20 offices, including the three-pediatrician practice of Dr. Corcoran.

Dr. Della Corcoran's pediatric practice sits over an ice cream shop and across the street from a toy store—a setting that's unfortunate, she said, when it comes to immunization.

“Parents come in [for their children's immunizations] saying 'You're going to get ice cream or a new toy after this.' The kids hear this and think something pretty major is going to happen,” she said. Unwittingly, parents can fuel their child's anxiety and distress with such promises.

The notion that parental demeanor before and during immunization should be calm and matter-of-fact, without excessive reassurance—a notion that Dr. Corcoran tries to convey and model in her practice in Hartford, Conn.—is one of the recommended strategies included in a new review of pain reduction during pediatric immunization.

The review, led by Dr. Neil L. Schechter of the Pain Relief Program at Connecticut Children's Medical Center in Hartford, details how the pain of immunization is a source of anxiety and distress in pediatric practice, and concludes that, ironically, there is “limited research available to address the pain associated with the painful procedure most commonly performed in pediatric office settings.”

Still, according to Dr. Schechter and the small group of experts who reviewed the literature and filled gaps through consensus development, a more systematic application of existing knowledge “should go a long way” toward reducing pain and alleviating the “air of persistent tension that hangs over the clinical encounter” due to anticipation of an injection (Pediatrics 2007:119;e1184–98 [Epub doi:10.1542/peds.2006-1107]).

There is good, consistent scientific evidence, they concluded, to support a number of strategies, from parental demeanor that is supportive and nonapologetic, to the following practices:

▸ Developmentally appropriate preparation for all children over the age of 2 years.

▸ The use of sucrose (administered on a pacifier or directly instilled into the mouth) for children younger than 6 months of age.

▸ The use of distraction techniques during injection.

▸ Selective use of local anesthetics in children who are especially fearful.

Of these measures, the use of sucrose solution is “something that has not been as universally accepted, yet this probably has the strongest database,” Dr. Schechter said in an interview. “There are at least 50 articles that support the routine use of sucrose in infants under 6 months.”

Sucrose loses its efficacy by 4–6 months of age and requires more testing with and without other modalities, but at this point it “clearly has efficacy for young infants,” reliably reducing evidence of distress with injections, he and his associates said in the review.

Past infancy, the data on the influence of parental demeanor on child behavior is just as striking, Dr. Schechter said.

“Although it seems counterintuitive, children often are more distressed when parents are more rather than less involved,” the review said. “A matter-of-fact, supportive, nonapologetic approach is endorsed.”

Dr. Corcoran, who administers vaccines herself, said she tries to guide parents by example and counters excessive reassurance with pinwheels and other distraction stimuli. In response to parents' promises of toys or ice cream, she makes comments like, “Oh, you won't need a new toy after this, you'll be just fine.”

This isn't to say children shouldn't be given “realistic information” about how immunizations will feel, the review said. This information, along with what will happen and how to cope (relaxation, breathing, distraction), should all be part of preparing the child.

Coping isn't necessarily something parents help with, the authors noted: One survey of parents of preschool children showed only 10% offered any strategies to their children at all.

Pediatricians should routinely use—and instruct parents to use—engaging distraction techniques that match the child's age and temperament, because there are “strong data” that distraction reduces distress, the review said. It's unclear, however, whether particular techniques—from blowing or deep breathing to counting backward or listening to a story—are optimal.

The expense and time required for topical anesthetic use means that “universal use of local anesthetics cannot be endorsed at this time,” Dr. Schechter and his associates said. Still, for children who are needle phobic and particularly anxious, these agents “should be considered.”

Evidence is not as strong or consistent in the areas of needle length and injection site, the reviewers said. Up to 18 months of age, the standard injection site is the anterior thigh, with a 7/8- to 1-inch needle for children more than 2 months of age. Over 36 months of age, the deltoid should be used, and at any age, the ventrogluteal site may be an alternative.

Between 18 and 36 months of age, “there is controversy regarding the most appropriate site,” the reviewers said.

Until more research is done, pediatricians “should do what they're comfortable with—there is nothing definitive at this point,” Dr. Schechter said in the interview. “I think if evidence emerges, it will add pluses and minuses and not be powerful one way or the other.”

Pressure at the injection site, applied either manually or with the aid of a mechanical device, has some support in the literature and, because pressure has no adverse effects, it may have value, the reviewers said.

“The adolescents and young women coming in for the Gardasil vaccine are even anxious about these shots,” which says something about the anxiety and distress that routine immunizations cause, Dr. Corcoran said. “The pain [of immunization] is real, and it's magnified significantly by anxiety.”

Since finishing the review, Dr. Schechter has launched the “Injection Protection Project,” an educational effort to bring information and tools—from a poster and video for staff to a brochure for parents—into pediatric practices. Thus far, he has visited about 20 offices, including the three-pediatrician practice of Dr. Corcoran.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover current medications as well as future needs, said health care consultant Mary Kruczynski at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patients] haven't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is that you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses. Some carriers now require you to get every prescription authorized,” Ms. Kruczynski said.

Physicians who care for patients with cancer have meantime “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B.”

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending on the patient's Part D plan and coverage, and on the patient's spending relative to the doughnut hole and catastrophic coverage The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D. MedPAC also is expected to weigh in this year with a report on the program. For now, Ms. Kruczynski said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But that's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover current medications as well as future needs, said health care consultant Mary Kruczynski at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patients] haven't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is that you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses. Some carriers now require you to get every prescription authorized,” Ms. Kruczynski said.

Physicians who care for patients with cancer have meantime “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B.”

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending on the patient's Part D plan and coverage, and on the patient's spending relative to the doughnut hole and catastrophic coverage The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D. MedPAC also is expected to weigh in this year with a report on the program. For now, Ms. Kruczynski said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But that's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover current medications as well as future needs, said health care consultant Mary Kruczynski at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patients] haven't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is that you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses. Some carriers now require you to get every prescription authorized,” Ms. Kruczynski said.

Physicians who care for patients with cancer have meantime “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B.”

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending on the patient's Part D plan and coverage, and on the patient's spending relative to the doughnut hole and catastrophic coverage The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D. MedPAC also is expected to weigh in this year with a report on the program. For now, Ms. Kruczynski said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But that's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

“If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, Ms. Kruczynski noted.

The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs.

“They're asking for data, blood counts, medical records … and checking doses,” Ms. Kruczynski said. “Some carriers now require you to get every prescription authorized.”

Those physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski commented.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and also includes some commentary on Part D drugs, notes the word of those physicians who work with their patients to determine whether it is more beneficial to prescribe the drugs under Medicare Part D or under Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending upon the patient's Part D plan and coverage. The value of one choice over another could also depend on the patient's spending relative to the doughnut hole and any catastrophic coverage that the patient might have.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are indeed permitted to retain the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out the required change notices.

The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this in the past.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

MedPAC also is expected to weigh in this year with a report focused on the program.

For now, she said, “it's coming down to us again.”

By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.”

In the meantime, she emphasized, that help is essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

“If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, Ms. Kruczynski noted.

The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs.

“They're asking for data, blood counts, medical records … and checking doses,” Ms. Kruczynski said. “Some carriers now require you to get every prescription authorized.”

Those physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski commented.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and also includes some commentary on Part D drugs, notes the word of those physicians who work with their patients to determine whether it is more beneficial to prescribe the drugs under Medicare Part D or under Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending upon the patient's Part D plan and coverage. The value of one choice over another could also depend on the patient's spending relative to the doughnut hole and any catastrophic coverage that the patient might have.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are indeed permitted to retain the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out the required change notices.

The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this in the past.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

MedPAC also is expected to weigh in this year with a report focused on the program.

For now, she said, “it's coming down to us again.”

By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.”

In the meantime, she emphasized, that help is essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski, who is based in Langhorne, Pa.

“If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, Ms. Kruczynski noted.

The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs.

“They're asking for data, blood counts, medical records … and checking doses,” Ms. Kruczynski said. “Some carriers now require you to get every prescription authorized.”

Those physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski commented.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and also includes some commentary on Part D drugs, notes the word of those physicians who work with their patients to determine whether it is more beneficial to prescribe the drugs under Medicare Part D or under Part B.

One option might be preferable to the other, Ms. Kruczynski said, depending upon the patient's Part D plan and coverage. The value of one choice over another could also depend on the patient's spending relative to the doughnut hole and any catastrophic coverage that the patient might have.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are indeed permitted to retain the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out the required change notices.

The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this in the past.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

MedPAC also is expected to weigh in this year with a report focused on the program.

For now, she said, “it's coming down to us again.”

By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.”

In the meantime, she emphasized, that help is essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

Updated guidelines on evaluating and treating girls and women with Turner syndrome advise against the practice of delaying puberty to increase height and emphasize the importance of early diagnosis and estrogen treatment.

The guidelines from the international, multidisciplinary Turner Syndrome Consensus Study Group detail how children should be evaluated and cared for, emphasizing, for example, the importance of comprehensive educational evaluation in early childhood.

The guidelines offer age-specific suggestions for ovarian hormone replacement and say that “ideally, natural estradiol and progesterone, rather than analogs, should be delivered by transdermal or transmembranous routes so as to mimic age-appropriate physiological patterns as closely as possible.”

Regimens can vary to meet individuals' tolerance and preference, however, and “the most important consideration is that women actually take ovarian hormone replacement,” the authors say (J. Clin. Endocrinol. Metab. 2007:92:10–25).

Without it, the risk of significant osteoporosis is high. “These women can have severe osteoporosis at 25,” Dr. Carolyn A. Bondy said in an interview.

“I have a 30-year-old patient who has lost 2 inches of height and has a hump.”

Estrogen therapy often is required to induce pubertal development (30% or more will undergo some spontaneous pubertal development), but experts used to recommend delaying estrogen therapy until age 15 to optimize height potential.

Today, Dr. Bondy said, the consensus is that such delay undervalues the psychosocial importance of age-appropriate puberty. Recent evidence also suggests that low-dose estrogen does not inhibit growth hormone-enhanced increases in stature. “There's a new focus on natural, sensitive, and timely puberty induction,” she said.

“The care of adults with TS has received less attention than [has] the treatment of children, and many seem to be falling through the cracks with inadequate cardiovascular evaluation and estrogen treatment,” say the new guidelines, published in the Journal of Clinical Endocrinology & Metabolism.

On the other hand, while medical care must be improved and while many questions about care “remain unanswered,” the experts “realize now that we have a lot more well-functioning people with TS,” according to Dr. Bondy, who is chief of the developmental endocrinology branch at the National Institute of Child Health and Human Development in Bethesda, Md. She chaired the consensus conference and guideline-writing committee for the consensus group, which met last summer to update the recommendations that were issued in 2001. The guidelines mainly represent “consensus judgments” rather than evidence-based conclusions, the committee noted in its document.

The clinical spectrum of TS is “much broader and often less severe than that described in many textbooks”—a finding that seems at odds with a “high elective abortion rate for incidentally diagnosed 45,X and 45,X/mosaic fetuses,” the guidelines say. This means that the content of prenatal counseling “needs updating” with the input of TS patient and parent groups, the document says.

Recent reports of an often-normal quality of life for those receiving comprehensive medical care should encourage—not mitigate—the efforts of physicians to diagnose TS as early as possible and better appreciate its many consequences, she said. Adults with TS should then be regularly screened for hypertension, diabetes, dyslipidemia, aortic enlargement, hearing loss, osteoporosis, and thyroid and celiac diseases. Recent studies have also suggested a broader spectrum of cardiovascular abnormalities than were previously recognized, and the consensus group agreed to bring “the heart to the forefront,” Dr. Bondy said.

Updated guidelines on evaluating and treating girls and women with Turner syndrome advise against the practice of delaying puberty to increase height and emphasize the importance of early diagnosis and estrogen treatment.

The guidelines from the international, multidisciplinary Turner Syndrome Consensus Study Group detail how children should be evaluated and cared for, emphasizing, for example, the importance of comprehensive educational evaluation in early childhood.

The guidelines offer age-specific suggestions for ovarian hormone replacement and say that “ideally, natural estradiol and progesterone, rather than analogs, should be delivered by transdermal or transmembranous routes so as to mimic age-appropriate physiological patterns as closely as possible.”

Regimens can vary to meet individuals' tolerance and preference, however, and “the most important consideration is that women actually take ovarian hormone replacement,” the authors say (J. Clin. Endocrinol. Metab. 2007:92:10–25).

Without it, the risk of significant osteoporosis is high. “These women can have severe osteoporosis at 25,” Dr. Carolyn A. Bondy said in an interview.

“I have a 30-year-old patient who has lost 2 inches of height and has a hump.”

Estrogen therapy often is required to induce pubertal development (30% or more will undergo some spontaneous pubertal development), but experts used to recommend delaying estrogen therapy until age 15 to optimize height potential.

Today, Dr. Bondy said, the consensus is that such delay undervalues the psychosocial importance of age-appropriate puberty. Recent evidence also suggests that low-dose estrogen does not inhibit growth hormone-enhanced increases in stature. “There's a new focus on natural, sensitive, and timely puberty induction,” she said.

“The care of adults with TS has received less attention than [has] the treatment of children, and many seem to be falling through the cracks with inadequate cardiovascular evaluation and estrogen treatment,” say the new guidelines, published in the Journal of Clinical Endocrinology & Metabolism.

On the other hand, while medical care must be improved and while many questions about care “remain unanswered,” the experts “realize now that we have a lot more well-functioning people with TS,” according to Dr. Bondy, who is chief of the developmental endocrinology branch at the National Institute of Child Health and Human Development in Bethesda, Md. She chaired the consensus conference and guideline-writing committee for the consensus group, which met last summer to update the recommendations that were issued in 2001. The guidelines mainly represent “consensus judgments” rather than evidence-based conclusions, the committee noted in its document.

The clinical spectrum of TS is “much broader and often less severe than that described in many textbooks”—a finding that seems at odds with a “high elective abortion rate for incidentally diagnosed 45,X and 45,X/mosaic fetuses,” the guidelines say. This means that the content of prenatal counseling “needs updating” with the input of TS patient and parent groups, the document says.

Recent reports of an often-normal quality of life for those receiving comprehensive medical care should encourage—not mitigate—the efforts of physicians to diagnose TS as early as possible and better appreciate its many consequences, she said. Adults with TS should then be regularly screened for hypertension, diabetes, dyslipidemia, aortic enlargement, hearing loss, osteoporosis, and thyroid and celiac diseases. Recent studies have also suggested a broader spectrum of cardiovascular abnormalities than were previously recognized, and the consensus group agreed to bring “the heart to the forefront,” Dr. Bondy said.

Updated guidelines on evaluating and treating girls and women with Turner syndrome advise against the practice of delaying puberty to increase height and emphasize the importance of early diagnosis and estrogen treatment.

The guidelines from the international, multidisciplinary Turner Syndrome Consensus Study Group detail how children should be evaluated and cared for, emphasizing, for example, the importance of comprehensive educational evaluation in early childhood.

The guidelines offer age-specific suggestions for ovarian hormone replacement and say that “ideally, natural estradiol and progesterone, rather than analogs, should be delivered by transdermal or transmembranous routes so as to mimic age-appropriate physiological patterns as closely as possible.”

Regimens can vary to meet individuals' tolerance and preference, however, and “the most important consideration is that women actually take ovarian hormone replacement,” the authors say (J. Clin. Endocrinol. Metab. 2007:92:10–25).

Without it, the risk of significant osteoporosis is high. “These women can have severe osteoporosis at 25,” Dr. Carolyn A. Bondy said in an interview.

“I have a 30-year-old patient who has lost 2 inches of height and has a hump.”

Estrogen therapy often is required to induce pubertal development (30% or more will undergo some spontaneous pubertal development), but experts used to recommend delaying estrogen therapy until age 15 to optimize height potential.

Today, Dr. Bondy said, the consensus is that such delay undervalues the psychosocial importance of age-appropriate puberty. Recent evidence also suggests that low-dose estrogen does not inhibit growth hormone-enhanced increases in stature. “There's a new focus on natural, sensitive, and timely puberty induction,” she said.

“The care of adults with TS has received less attention than [has] the treatment of children, and many seem to be falling through the cracks with inadequate cardiovascular evaluation and estrogen treatment,” say the new guidelines, published in the Journal of Clinical Endocrinology & Metabolism.

On the other hand, while medical care must be improved and while many questions about care “remain unanswered,” the experts “realize now that we have a lot more well-functioning people with TS,” according to Dr. Bondy, who is chief of the developmental endocrinology branch at the National Institute of Child Health and Human Development in Bethesda, Md. She chaired the consensus conference and guideline-writing committee for the consensus group, which met last summer to update the recommendations that were issued in 2001. The guidelines mainly represent “consensus judgments” rather than evidence-based conclusions, the committee noted in its document.

The clinical spectrum of TS is “much broader and often less severe than that described in many textbooks”—a finding that seems at odds with a “high elective abortion rate for incidentally diagnosed 45,X and 45,X/mosaic fetuses,” the guidelines say. This means that the content of prenatal counseling “needs updating” with the input of TS patient and parent groups, the document says.

Recent reports of an often-normal quality of life for those receiving comprehensive medical care should encourage—not mitigate—the efforts of physicians to diagnose TS as early as possible and better appreciate its many consequences, she said. Adults with TS should then be regularly screened for hypertension, diabetes, dyslipidemia, aortic enlargement, hearing loss, osteoporosis, and thyroid and celiac diseases. Recent studies have also suggested a broader spectrum of cardiovascular abnormalities than were previously recognized, and the consensus group agreed to bring “the heart to the forefront,” Dr. Bondy said.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski. “If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses,” she said. “Some carriers now require you to get every prescription authorized.”

Physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski said.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

For now, she said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But for now, she emphasized, it's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski. “If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses,” she said. “Some carriers now require you to get every prescription authorized.”

Physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski said.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

For now, she said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But for now, she emphasized, it's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — Physicians treating older cancer patients must actively help them choose Medicare Part D prescription drug plans with formularies that best cover not only current medications but future needs as well, health care consultant Mary Kruczynski said at a conference sponsored by Elsevier Oncology.

“Get online and check their formulary, and if [your patient] hasn't chosen a plan, think outside the box and list all the drugs they'll possibly need in the future,” said Ms. Kruczynski, a policy analyst and board member of the Community Oncology Alliance, a Washington-based lobbying group.

Although most physicians do not have time for such legwork, “the current reality is, you can't afford not to. … If we don't, our patients can't get treated,” said Ms. Kruczynski. “If [your patients] go to the drug store and get told 'it's not on the formulary,' they come back to you,” she said.

When cancer drugs appear on multiple formularies, pricing variations can be significant—and physicians and staff might even want to help patients navigate such variations, especially as more and more oral drugs for cancer become available.

A recent cost study of seven oral cancer drugs in three markets documented significant variations, she noted. The cost of Arimidex (anastrozole), for instance, was 72% higher in Portland than in Virginia Beach (Commun. Oncol. 2006;3:753–5).

Formularies under Medicare Part D also are increasingly restrictive. Many insurers have added coverage of generic drugs and reduced coverage of brand-name drugs; some also are adopting new techniques to control the use of certain drugs. “They're asking for data, blood counts, medical records … and checking doses,” she said. “Some carriers now require you to get every prescription authorized.”

Physicians who care for patients with cancer, in the meantime, have “been bending over backwards to try to get every drug our patients need for them, even if they have to switch them from Part D to Part B … even if they get them to their doughnut hole,” or coverage gap, “and bring them into the office for an infusible under Part B,” Ms. Kruczynski said.

The Medicare Payment Advisory Commission (MedPAC) recognized such actions in its January 2007 report, she said.

The report, which focuses on Medicare payments for Part B drugs and includes some commentary on Part D drugs, notes the word of physicians who work with patients to determine whether it is better to prescribe the drugs under Part D or Part B.

The MedPAC report also relates physician accounts of patients who reach the doughnut hole and either neglect their treatment or try to stretch out their drug regimens until coverage starts again.

Concerns about patients “brown bagging” physician-administered drugs so that they can be covered under Part D—as well as observations that some physicians have established in-house pharmacies to remedy the problem—also are mentioned in the MedPAC report, Ms. Kruczynski said.

Insurance companies also are “changing their formularies midstream,” she said. That is, although Medicare drug plans are permitted to keep the same name while substantially changing costs and benefits each year, the plans sometimes fail to send out required change notices. The UnitedHealth Group, which serves the largest segment of the Medicare Part D market, has done this.

The issue of formulary changes has been included in at least some of the 42 House and 31 Senate bills addressing problems with Medicare Part D, Ms. Kruczynski noted.

For now, she said, “it's coming down to us again.” By helping patients navigate Part D, “we're essentially administering the plans of private insurance carriers for free.” But for now, she emphasized, it's essential for the health of patients.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.