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‘Eye-opening’: Cognitive decline with endocrine therapy for breast cancer
Cognitive impairment seen in women with early breast cancer who undergo chemotherapy – so-called chemobrain – has now been reported in patients who are treated with endocrine therapy alone.
“The cognitive decline that we observed with endocrine therapy alone was really surprising and very eye-opening, because I think we have generally assumed that hormone therapy is very well tolerated,” lead author Lynne I. Wagner, PhD, professor of social science and health policy at Wake Forest School of Medicine, Winston-Salem, North Carolina, told Medscape Medical News.
“I think this is very important,” she added. “If you have a patient who has been on endocrine therapy for 3 years, don’t just assume that she’s fine and her cognitive function isn’t a concern, because for many women, it is very much a lingering and persistent concern.”
The findings come from a substudy analysis of 218 women who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone.
For most women in the study (58%), endocrine therapy initially consisted of an aromatase inhibitor; 37% of patients received tamoxifen, the researchers report. For chemotherapy, the most common regimens were docetaxel plus cyclophosphamide (70%) and anthracycline-based therapy (20%).
Women who received both chemotherapy and endocrine therapy experienced early and abrupt cognitive decline at 3 and 6 months following treatment; the decline leveled off at 12 and 36 months.
Women who were randomly assigned to receive endocrine therapy alone also experienced loss of cognition, but the loss was more gradual, and, by 36 months, it was the same as occurred in women who had received both chemotherapy and endocrine therapy.
The researchers also found that cognitive function did not return to pretreatment levels, regardless of the treatment the women received.
“We were surprised by the finding that women’s cognitive function did not return to pretreatment levels after finishing chemotherapy, but neither did the group receiving endocrine therapy alone. This highlights the importance of continuing to ask women who are receiving hormonal treatment for breast cancer about their cognitive function, even if they have been on treatment for a few years,” she said.
The findings come from a substudy of the Trial Assigning Individualized Treatment Options (TAILORx) and were published on April 9 in the Journal of Clinical Oncology.
An important contribution
The results of this study make an important contribution toward understanding the potential adverse cognitive effects of chemotherapy in combination with endocrine therapy and endocrine therapy alone, write Patricia A. Ganz, MD, and Kathleen Van Dyk, PhD, of the University of California, Los Angeles, in an accompanying editorial.
However, there was a difference in the effects on cognition with respect to menopausal status, and this should be a covariate or stratification variable, Ganz told Medscape Medical News.
“Clearly, this study shows that endocrine therapy is problematic. Certainly for younger women, the decrement is much worse. It may be that the brain of a young woman who has not yet gone through menopause is ill prepared, if you will, for these hormonal changes, whereas, in older women, even though they may be ill prepared for the toxicity of chemotherapy, endocrine therapy may not be as disruptive, because they have already adjusted to a low-estrogen state,” Ganz said.
“As a clinician, I can say that most of the complaints I hear are from younger women. Older women don’t really complain that much, and this may be because they are at a time in life when they don’t have to multitask, they can sleep late in the morning, and they do not have the same kind of management pressures that a younger woman would have,” she said.
“Unparalleled opportunity”
Before TAILORx, it was impossible to quantify the extent to which chemotherapy contributed to cognitive impairment, because all women received chemotherapy, Wagner told Medscape Medical News.
“We had been unable to isolate how much chemotherapy contributed versus all of the other aspects of having cancer, such as surgery, radiation therapy, and endocrine therapy. The design of TAILORx gave us an unparalleled opportunity to uniquely isolate the extent to which chemotherapy contributes to cognitive impairment,” she explained.
TAILORx enrolled 10,273 patients with breast cancer from April 2006 through October 2010. It was amended in January 2010 to include a patient-reported outcome substudy, which assessed cognitive impairment and other symptoms, such as fatigue, endocrine symptoms, and overall health-related quality of life.
All patients had hormone receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative early breast cancer and a midrange 21-gene recurrence score of 11 to 25.
Cognitive impairment was assessed in a subgroup of women using the 37-item Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog) questionnaire, which was administered at baseline and at 3, 6, 12, 24, and 36 months.
The primary endpoint was the score on the 20-item FACT-Cog Perceived Cognitive Impairment (PCI) scale, which is part of the FACT-Cog questionnaire, at 3 months after randomization. The scale scores of the PCI range from 0 to 80, with a higher score indicating better cognitive status.
Of the 734 women who were enrolled in TAILORx after the start of the substudy, 218 women in the group who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone had evaluable FACT-Cog PCI data at baseline and at 3 months.
For both treatment groups, FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months, compared to baseline scores.
However, the pattern of cognitive decline differed between the treatment groups. Among women in the chemotherapy group, impairment was more significant at 3 months (mean PCI score, –3.82; P < .001) and at 6 months (mean PCI score, –2.62; P = .02), compared with the women who received endocrine therapy alone.
PCI scores were comparable in both treatment arms at 12, 24, and 36 months.
“This was not because the women who had chemotherapy improved but because women on endocrine therapy were also reporting a gradual increase in cognitive impairment at 12 months that persisted at 24 and 36 months. So the pace of their cognitive decline was slower and more gradual,” Wagner said.
TAILORx results highlight need for effective interventions
“I was excited to see the publication of this work,” Jamie S. Myers, PhD, RN, of University of Kansas School of Nursing, Kansas City, told Medscape Medical News.
“Drs. Wagner and Cella have been so instrumental in the development of the FACT PROs, and we have used the FACT-Cog PCI subscale in much of our work. The TAILORx study provided a beautiful opportunity to capture PRO data for women with early breast cancer randomized to chemotherapy plus endocrine therapy versus endocrine therapy alone, and I was not surprised that endocrine therapy was associated with reports of cognitive decline,” Myers said in email correspondence.
“This study further confirms the work conducted by my mentor, Dr. Catherine Bender at the University of Pittsburgh. Women receiving endocrine therapy continue to report issues with cognitive function. What was encouraging about this study was confirmation that the contribution of chemotherapy to the cognitive decline that women experience does level out at 12 months for the majority of women. However, as the results clearly demonstrated, neither group in this study returned to baseline by 36 months, likely due to the ongoing impact of the endocrine therapy,” she said.
“I completely agree with the researchers that we must continue to vigilantly monitor and assess women for cognitive changes throughout their treatment trajectory. And these study results certainly highlight the need for effective interventions to either prevent or mitigate the cognitive effects of breast cancer treatment. I hope these researchers will continue to assess women’s report of cognitive function for a significant period of time after endocrine therapy is completed. This would give us very important information about the recovery trajectory for cognitive function once endocrine therapy is complete. I would also hope they would break down the results by category of endocrine therapy, for example, specific aromatase inhibitor versus tamoxifen, as this too could yield important information,” Myers said.
The study was supported by the National Cancer Institute. Wagner, Ganz, Van Dyk, and Myers have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Cognitive impairment seen in women with early breast cancer who undergo chemotherapy – so-called chemobrain – has now been reported in patients who are treated with endocrine therapy alone.
“The cognitive decline that we observed with endocrine therapy alone was really surprising and very eye-opening, because I think we have generally assumed that hormone therapy is very well tolerated,” lead author Lynne I. Wagner, PhD, professor of social science and health policy at Wake Forest School of Medicine, Winston-Salem, North Carolina, told Medscape Medical News.
“I think this is very important,” she added. “If you have a patient who has been on endocrine therapy for 3 years, don’t just assume that she’s fine and her cognitive function isn’t a concern, because for many women, it is very much a lingering and persistent concern.”
The findings come from a substudy analysis of 218 women who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone.
For most women in the study (58%), endocrine therapy initially consisted of an aromatase inhibitor; 37% of patients received tamoxifen, the researchers report. For chemotherapy, the most common regimens were docetaxel plus cyclophosphamide (70%) and anthracycline-based therapy (20%).
Women who received both chemotherapy and endocrine therapy experienced early and abrupt cognitive decline at 3 and 6 months following treatment; the decline leveled off at 12 and 36 months.
Women who were randomly assigned to receive endocrine therapy alone also experienced loss of cognition, but the loss was more gradual, and, by 36 months, it was the same as occurred in women who had received both chemotherapy and endocrine therapy.
The researchers also found that cognitive function did not return to pretreatment levels, regardless of the treatment the women received.
“We were surprised by the finding that women’s cognitive function did not return to pretreatment levels after finishing chemotherapy, but neither did the group receiving endocrine therapy alone. This highlights the importance of continuing to ask women who are receiving hormonal treatment for breast cancer about their cognitive function, even if they have been on treatment for a few years,” she said.
The findings come from a substudy of the Trial Assigning Individualized Treatment Options (TAILORx) and were published on April 9 in the Journal of Clinical Oncology.
An important contribution
The results of this study make an important contribution toward understanding the potential adverse cognitive effects of chemotherapy in combination with endocrine therapy and endocrine therapy alone, write Patricia A. Ganz, MD, and Kathleen Van Dyk, PhD, of the University of California, Los Angeles, in an accompanying editorial.
However, there was a difference in the effects on cognition with respect to menopausal status, and this should be a covariate or stratification variable, Ganz told Medscape Medical News.
“Clearly, this study shows that endocrine therapy is problematic. Certainly for younger women, the decrement is much worse. It may be that the brain of a young woman who has not yet gone through menopause is ill prepared, if you will, for these hormonal changes, whereas, in older women, even though they may be ill prepared for the toxicity of chemotherapy, endocrine therapy may not be as disruptive, because they have already adjusted to a low-estrogen state,” Ganz said.
“As a clinician, I can say that most of the complaints I hear are from younger women. Older women don’t really complain that much, and this may be because they are at a time in life when they don’t have to multitask, they can sleep late in the morning, and they do not have the same kind of management pressures that a younger woman would have,” she said.
“Unparalleled opportunity”
Before TAILORx, it was impossible to quantify the extent to which chemotherapy contributed to cognitive impairment, because all women received chemotherapy, Wagner told Medscape Medical News.
“We had been unable to isolate how much chemotherapy contributed versus all of the other aspects of having cancer, such as surgery, radiation therapy, and endocrine therapy. The design of TAILORx gave us an unparalleled opportunity to uniquely isolate the extent to which chemotherapy contributes to cognitive impairment,” she explained.
TAILORx enrolled 10,273 patients with breast cancer from April 2006 through October 2010. It was amended in January 2010 to include a patient-reported outcome substudy, which assessed cognitive impairment and other symptoms, such as fatigue, endocrine symptoms, and overall health-related quality of life.
All patients had hormone receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative early breast cancer and a midrange 21-gene recurrence score of 11 to 25.
Cognitive impairment was assessed in a subgroup of women using the 37-item Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog) questionnaire, which was administered at baseline and at 3, 6, 12, 24, and 36 months.
The primary endpoint was the score on the 20-item FACT-Cog Perceived Cognitive Impairment (PCI) scale, which is part of the FACT-Cog questionnaire, at 3 months after randomization. The scale scores of the PCI range from 0 to 80, with a higher score indicating better cognitive status.
Of the 734 women who were enrolled in TAILORx after the start of the substudy, 218 women in the group who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone had evaluable FACT-Cog PCI data at baseline and at 3 months.
For both treatment groups, FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months, compared to baseline scores.
However, the pattern of cognitive decline differed between the treatment groups. Among women in the chemotherapy group, impairment was more significant at 3 months (mean PCI score, –3.82; P < .001) and at 6 months (mean PCI score, –2.62; P = .02), compared with the women who received endocrine therapy alone.
PCI scores were comparable in both treatment arms at 12, 24, and 36 months.
“This was not because the women who had chemotherapy improved but because women on endocrine therapy were also reporting a gradual increase in cognitive impairment at 12 months that persisted at 24 and 36 months. So the pace of their cognitive decline was slower and more gradual,” Wagner said.
TAILORx results highlight need for effective interventions
“I was excited to see the publication of this work,” Jamie S. Myers, PhD, RN, of University of Kansas School of Nursing, Kansas City, told Medscape Medical News.
“Drs. Wagner and Cella have been so instrumental in the development of the FACT PROs, and we have used the FACT-Cog PCI subscale in much of our work. The TAILORx study provided a beautiful opportunity to capture PRO data for women with early breast cancer randomized to chemotherapy plus endocrine therapy versus endocrine therapy alone, and I was not surprised that endocrine therapy was associated with reports of cognitive decline,” Myers said in email correspondence.
“This study further confirms the work conducted by my mentor, Dr. Catherine Bender at the University of Pittsburgh. Women receiving endocrine therapy continue to report issues with cognitive function. What was encouraging about this study was confirmation that the contribution of chemotherapy to the cognitive decline that women experience does level out at 12 months for the majority of women. However, as the results clearly demonstrated, neither group in this study returned to baseline by 36 months, likely due to the ongoing impact of the endocrine therapy,” she said.
“I completely agree with the researchers that we must continue to vigilantly monitor and assess women for cognitive changes throughout their treatment trajectory. And these study results certainly highlight the need for effective interventions to either prevent or mitigate the cognitive effects of breast cancer treatment. I hope these researchers will continue to assess women’s report of cognitive function for a significant period of time after endocrine therapy is completed. This would give us very important information about the recovery trajectory for cognitive function once endocrine therapy is complete. I would also hope they would break down the results by category of endocrine therapy, for example, specific aromatase inhibitor versus tamoxifen, as this too could yield important information,” Myers said.
The study was supported by the National Cancer Institute. Wagner, Ganz, Van Dyk, and Myers have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Cognitive impairment seen in women with early breast cancer who undergo chemotherapy – so-called chemobrain – has now been reported in patients who are treated with endocrine therapy alone.
“The cognitive decline that we observed with endocrine therapy alone was really surprising and very eye-opening, because I think we have generally assumed that hormone therapy is very well tolerated,” lead author Lynne I. Wagner, PhD, professor of social science and health policy at Wake Forest School of Medicine, Winston-Salem, North Carolina, told Medscape Medical News.
“I think this is very important,” she added. “If you have a patient who has been on endocrine therapy for 3 years, don’t just assume that she’s fine and her cognitive function isn’t a concern, because for many women, it is very much a lingering and persistent concern.”
The findings come from a substudy analysis of 218 women who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone.
For most women in the study (58%), endocrine therapy initially consisted of an aromatase inhibitor; 37% of patients received tamoxifen, the researchers report. For chemotherapy, the most common regimens were docetaxel plus cyclophosphamide (70%) and anthracycline-based therapy (20%).
Women who received both chemotherapy and endocrine therapy experienced early and abrupt cognitive decline at 3 and 6 months following treatment; the decline leveled off at 12 and 36 months.
Women who were randomly assigned to receive endocrine therapy alone also experienced loss of cognition, but the loss was more gradual, and, by 36 months, it was the same as occurred in women who had received both chemotherapy and endocrine therapy.
The researchers also found that cognitive function did not return to pretreatment levels, regardless of the treatment the women received.
“We were surprised by the finding that women’s cognitive function did not return to pretreatment levels after finishing chemotherapy, but neither did the group receiving endocrine therapy alone. This highlights the importance of continuing to ask women who are receiving hormonal treatment for breast cancer about their cognitive function, even if they have been on treatment for a few years,” she said.
The findings come from a substudy of the Trial Assigning Individualized Treatment Options (TAILORx) and were published on April 9 in the Journal of Clinical Oncology.
An important contribution
The results of this study make an important contribution toward understanding the potential adverse cognitive effects of chemotherapy in combination with endocrine therapy and endocrine therapy alone, write Patricia A. Ganz, MD, and Kathleen Van Dyk, PhD, of the University of California, Los Angeles, in an accompanying editorial.
However, there was a difference in the effects on cognition with respect to menopausal status, and this should be a covariate or stratification variable, Ganz told Medscape Medical News.
“Clearly, this study shows that endocrine therapy is problematic. Certainly for younger women, the decrement is much worse. It may be that the brain of a young woman who has not yet gone through menopause is ill prepared, if you will, for these hormonal changes, whereas, in older women, even though they may be ill prepared for the toxicity of chemotherapy, endocrine therapy may not be as disruptive, because they have already adjusted to a low-estrogen state,” Ganz said.
“As a clinician, I can say that most of the complaints I hear are from younger women. Older women don’t really complain that much, and this may be because they are at a time in life when they don’t have to multitask, they can sleep late in the morning, and they do not have the same kind of management pressures that a younger woman would have,” she said.
“Unparalleled opportunity”
Before TAILORx, it was impossible to quantify the extent to which chemotherapy contributed to cognitive impairment, because all women received chemotherapy, Wagner told Medscape Medical News.
“We had been unable to isolate how much chemotherapy contributed versus all of the other aspects of having cancer, such as surgery, radiation therapy, and endocrine therapy. The design of TAILORx gave us an unparalleled opportunity to uniquely isolate the extent to which chemotherapy contributes to cognitive impairment,” she explained.
TAILORx enrolled 10,273 patients with breast cancer from April 2006 through October 2010. It was amended in January 2010 to include a patient-reported outcome substudy, which assessed cognitive impairment and other symptoms, such as fatigue, endocrine symptoms, and overall health-related quality of life.
All patients had hormone receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative early breast cancer and a midrange 21-gene recurrence score of 11 to 25.
Cognitive impairment was assessed in a subgroup of women using the 37-item Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog) questionnaire, which was administered at baseline and at 3, 6, 12, 24, and 36 months.
The primary endpoint was the score on the 20-item FACT-Cog Perceived Cognitive Impairment (PCI) scale, which is part of the FACT-Cog questionnaire, at 3 months after randomization. The scale scores of the PCI range from 0 to 80, with a higher score indicating better cognitive status.
Of the 734 women who were enrolled in TAILORx after the start of the substudy, 218 women in the group who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone had evaluable FACT-Cog PCI data at baseline and at 3 months.
For both treatment groups, FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months, compared to baseline scores.
However, the pattern of cognitive decline differed between the treatment groups. Among women in the chemotherapy group, impairment was more significant at 3 months (mean PCI score, –3.82; P < .001) and at 6 months (mean PCI score, –2.62; P = .02), compared with the women who received endocrine therapy alone.
PCI scores were comparable in both treatment arms at 12, 24, and 36 months.
“This was not because the women who had chemotherapy improved but because women on endocrine therapy were also reporting a gradual increase in cognitive impairment at 12 months that persisted at 24 and 36 months. So the pace of their cognitive decline was slower and more gradual,” Wagner said.
TAILORx results highlight need for effective interventions
“I was excited to see the publication of this work,” Jamie S. Myers, PhD, RN, of University of Kansas School of Nursing, Kansas City, told Medscape Medical News.
“Drs. Wagner and Cella have been so instrumental in the development of the FACT PROs, and we have used the FACT-Cog PCI subscale in much of our work. The TAILORx study provided a beautiful opportunity to capture PRO data for women with early breast cancer randomized to chemotherapy plus endocrine therapy versus endocrine therapy alone, and I was not surprised that endocrine therapy was associated with reports of cognitive decline,” Myers said in email correspondence.
“This study further confirms the work conducted by my mentor, Dr. Catherine Bender at the University of Pittsburgh. Women receiving endocrine therapy continue to report issues with cognitive function. What was encouraging about this study was confirmation that the contribution of chemotherapy to the cognitive decline that women experience does level out at 12 months for the majority of women. However, as the results clearly demonstrated, neither group in this study returned to baseline by 36 months, likely due to the ongoing impact of the endocrine therapy,” she said.
“I completely agree with the researchers that we must continue to vigilantly monitor and assess women for cognitive changes throughout their treatment trajectory. And these study results certainly highlight the need for effective interventions to either prevent or mitigate the cognitive effects of breast cancer treatment. I hope these researchers will continue to assess women’s report of cognitive function for a significant period of time after endocrine therapy is completed. This would give us very important information about the recovery trajectory for cognitive function once endocrine therapy is complete. I would also hope they would break down the results by category of endocrine therapy, for example, specific aromatase inhibitor versus tamoxifen, as this too could yield important information,” Myers said.
The study was supported by the National Cancer Institute. Wagner, Ganz, Van Dyk, and Myers have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Botox: A new option for endometriosis pain?
NATIONAL HARBOR, MD. – Botulinum toxin injection into the vagina appears to relieve pain associated with endometriosis by relaxing the pelvic floor muscles, new research suggests.
In a randomized study, women with surgically diagnosed endometriosis who had chronic pelvic pain despite optimal surgical and hormonal treatment had less pain after injection vs their counterparts who received placebo.
This result suggests pelvic floor spasm may be an important factor in endometriosis-associated pelvic pain, the investigators note.
“Botulinum toxin injection offers an alternative approach for women with pelvic pain,” lead author Barbara Illowsky Karp, MD, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Md., told Medscape Medical News.
“We focused on endometriosis, but there are reasons to think it may be effective for pelvic pain from other causes if there is spasm of the muscle,” said Karp, a neurologist who has used botulinum toxin therapeutically since it was first developed in the 1980s.
She noted that it is unknown whether the toxin will work in women who do not have actual spasm, “but the effect on spasm is not the sole effect of toxin,” as demonstrated by its use in other pain conditions.
“It seems to have a direct effect on the pain pathways in the nervous system as well,” Karp added.
The study findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
Less pain
The investigators randomly assigned 29 women between the ages of 18 and 50 years to receive injections with 100 U onabotulinumtoxinA (n = 15) or saline placebo (n = 14).
All of the women had endometriosis with chronic pelvic pain lasting at least 3 months (mean time, 6 years) and confirmed pelvic floor spasm as a main pain generator.
One month after treatment, participants were asked if they had improvement in their pain.
“Our primary outcome was just simply asking the women if they felt better or not, because we were blinded as to what treatment they received. One month is typically when the toxin reaches its maximal effect,” Karp said.
At 1 month, 11 women in the placebo group reported that they had no benefit, compared with only 4 women in the botulinum toxin group (P = .027).
The botulinum toxin group reported a greater degree of benefit compared with the placebo group (P = .030) and greater percent of improvement (P = .034).
Neither group reported substantial changes in pain rating on the visual analog scale. However, a definite pain score is often difficult to measure in women with chronic pelvic pain, coinvestigator Pamela Stratton, MD, a gynecologist in Bethesda, said.
“Some women report their pain as a 2, some as an 8. Also, women may have a lot of pain one day and not have that much pain another day, and how do you measure that? This is why we have not focused solely on the pain score but instead wanted the women to tell us if they were improved or not,” Stratton told Medscape Medical News.
Disability worsened considerably in the placebo group, but remained consistent in the botulinum toxin group. Five patients in the botulinum toxin group were able to reduce pain medication compared with one patient in the placebo group.
“Compelling” findings but early days
Commenting on the findings for Medscape Medical News, Ann E. Hansen, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, noted that this “preliminary study” showed some benefit for a complex and challenging-to-treat syndrome.
“Injection of botulinum toxin prevents local muscle contraction, thus effectively relieving a variety of neuromuscular conditions such as torticollis; spasticity; pain syndromes such as headache and migraine; and some neurologic disorders, for instance, overactive bladder,” said Hansen, who was not involved with the research.
“Using botulinum toxin injection to target pelvic floor muscle spasm, a known pain generator in women suffering from chronic pelvic pain, makes sense. Future studies will be helpful in elucidating optimal treatment protocols for this debilitating condition,” she added.
Also commenting for Medscape Medical News, Kathryn T. Hall, PhD, MPH, Brigham & Women’s Hospital, Boston, Massachusetts, called the results “quite compelling” although, “it’s still early days.”
“It remains to be seen if the treatment effect will endure or if side effects will emerge. Hopefully all will go well,” Hall said.
The study was funded by an unrestricted grant from the National Institutes of Health. Allergan provided the botulinum toxin that was used in the study. Karp, Stratton, Hansen, and Hall have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
NATIONAL HARBOR, MD. – Botulinum toxin injection into the vagina appears to relieve pain associated with endometriosis by relaxing the pelvic floor muscles, new research suggests.
In a randomized study, women with surgically diagnosed endometriosis who had chronic pelvic pain despite optimal surgical and hormonal treatment had less pain after injection vs their counterparts who received placebo.
This result suggests pelvic floor spasm may be an important factor in endometriosis-associated pelvic pain, the investigators note.
“Botulinum toxin injection offers an alternative approach for women with pelvic pain,” lead author Barbara Illowsky Karp, MD, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Md., told Medscape Medical News.
“We focused on endometriosis, but there are reasons to think it may be effective for pelvic pain from other causes if there is spasm of the muscle,” said Karp, a neurologist who has used botulinum toxin therapeutically since it was first developed in the 1980s.
She noted that it is unknown whether the toxin will work in women who do not have actual spasm, “but the effect on spasm is not the sole effect of toxin,” as demonstrated by its use in other pain conditions.
“It seems to have a direct effect on the pain pathways in the nervous system as well,” Karp added.
The study findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
Less pain
The investigators randomly assigned 29 women between the ages of 18 and 50 years to receive injections with 100 U onabotulinumtoxinA (n = 15) or saline placebo (n = 14).
All of the women had endometriosis with chronic pelvic pain lasting at least 3 months (mean time, 6 years) and confirmed pelvic floor spasm as a main pain generator.
One month after treatment, participants were asked if they had improvement in their pain.
“Our primary outcome was just simply asking the women if they felt better or not, because we were blinded as to what treatment they received. One month is typically when the toxin reaches its maximal effect,” Karp said.
At 1 month, 11 women in the placebo group reported that they had no benefit, compared with only 4 women in the botulinum toxin group (P = .027).
The botulinum toxin group reported a greater degree of benefit compared with the placebo group (P = .030) and greater percent of improvement (P = .034).
Neither group reported substantial changes in pain rating on the visual analog scale. However, a definite pain score is often difficult to measure in women with chronic pelvic pain, coinvestigator Pamela Stratton, MD, a gynecologist in Bethesda, said.
“Some women report their pain as a 2, some as an 8. Also, women may have a lot of pain one day and not have that much pain another day, and how do you measure that? This is why we have not focused solely on the pain score but instead wanted the women to tell us if they were improved or not,” Stratton told Medscape Medical News.
Disability worsened considerably in the placebo group, but remained consistent in the botulinum toxin group. Five patients in the botulinum toxin group were able to reduce pain medication compared with one patient in the placebo group.
“Compelling” findings but early days
Commenting on the findings for Medscape Medical News, Ann E. Hansen, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, noted that this “preliminary study” showed some benefit for a complex and challenging-to-treat syndrome.
“Injection of botulinum toxin prevents local muscle contraction, thus effectively relieving a variety of neuromuscular conditions such as torticollis; spasticity; pain syndromes such as headache and migraine; and some neurologic disorders, for instance, overactive bladder,” said Hansen, who was not involved with the research.
“Using botulinum toxin injection to target pelvic floor muscle spasm, a known pain generator in women suffering from chronic pelvic pain, makes sense. Future studies will be helpful in elucidating optimal treatment protocols for this debilitating condition,” she added.
Also commenting for Medscape Medical News, Kathryn T. Hall, PhD, MPH, Brigham & Women’s Hospital, Boston, Massachusetts, called the results “quite compelling” although, “it’s still early days.”
“It remains to be seen if the treatment effect will endure or if side effects will emerge. Hopefully all will go well,” Hall said.
The study was funded by an unrestricted grant from the National Institutes of Health. Allergan provided the botulinum toxin that was used in the study. Karp, Stratton, Hansen, and Hall have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
NATIONAL HARBOR, MD. – Botulinum toxin injection into the vagina appears to relieve pain associated with endometriosis by relaxing the pelvic floor muscles, new research suggests.
In a randomized study, women with surgically diagnosed endometriosis who had chronic pelvic pain despite optimal surgical and hormonal treatment had less pain after injection vs their counterparts who received placebo.
This result suggests pelvic floor spasm may be an important factor in endometriosis-associated pelvic pain, the investigators note.
“Botulinum toxin injection offers an alternative approach for women with pelvic pain,” lead author Barbara Illowsky Karp, MD, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Md., told Medscape Medical News.
“We focused on endometriosis, but there are reasons to think it may be effective for pelvic pain from other causes if there is spasm of the muscle,” said Karp, a neurologist who has used botulinum toxin therapeutically since it was first developed in the 1980s.
She noted that it is unknown whether the toxin will work in women who do not have actual spasm, “but the effect on spasm is not the sole effect of toxin,” as demonstrated by its use in other pain conditions.
“It seems to have a direct effect on the pain pathways in the nervous system as well,” Karp added.
The study findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
Less pain
The investigators randomly assigned 29 women between the ages of 18 and 50 years to receive injections with 100 U onabotulinumtoxinA (n = 15) or saline placebo (n = 14).
All of the women had endometriosis with chronic pelvic pain lasting at least 3 months (mean time, 6 years) and confirmed pelvic floor spasm as a main pain generator.
One month after treatment, participants were asked if they had improvement in their pain.
“Our primary outcome was just simply asking the women if they felt better or not, because we were blinded as to what treatment they received. One month is typically when the toxin reaches its maximal effect,” Karp said.
At 1 month, 11 women in the placebo group reported that they had no benefit, compared with only 4 women in the botulinum toxin group (P = .027).
The botulinum toxin group reported a greater degree of benefit compared with the placebo group (P = .030) and greater percent of improvement (P = .034).
Neither group reported substantial changes in pain rating on the visual analog scale. However, a definite pain score is often difficult to measure in women with chronic pelvic pain, coinvestigator Pamela Stratton, MD, a gynecologist in Bethesda, said.
“Some women report their pain as a 2, some as an 8. Also, women may have a lot of pain one day and not have that much pain another day, and how do you measure that? This is why we have not focused solely on the pain score but instead wanted the women to tell us if they were improved or not,” Stratton told Medscape Medical News.
Disability worsened considerably in the placebo group, but remained consistent in the botulinum toxin group. Five patients in the botulinum toxin group were able to reduce pain medication compared with one patient in the placebo group.
“Compelling” findings but early days
Commenting on the findings for Medscape Medical News, Ann E. Hansen, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, noted that this “preliminary study” showed some benefit for a complex and challenging-to-treat syndrome.
“Injection of botulinum toxin prevents local muscle contraction, thus effectively relieving a variety of neuromuscular conditions such as torticollis; spasticity; pain syndromes such as headache and migraine; and some neurologic disorders, for instance, overactive bladder,” said Hansen, who was not involved with the research.
“Using botulinum toxin injection to target pelvic floor muscle spasm, a known pain generator in women suffering from chronic pelvic pain, makes sense. Future studies will be helpful in elucidating optimal treatment protocols for this debilitating condition,” she added.
Also commenting for Medscape Medical News, Kathryn T. Hall, PhD, MPH, Brigham & Women’s Hospital, Boston, Massachusetts, called the results “quite compelling” although, “it’s still early days.”
“It remains to be seen if the treatment effect will endure or if side effects will emerge. Hopefully all will go well,” Hall said.
The study was funded by an unrestricted grant from the National Institutes of Health. Allergan provided the botulinum toxin that was used in the study. Karp, Stratton, Hansen, and Hall have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Implantable stimulator shows promise for chronic knee pain
NATIONAL HARBOR, MD. – Stimulation of the infrapatellar branch of the saphenous nerve with an implantable electrical device is a potentially effective treatment for chronic, intractable knee pain.
In a small case series consisting of five patients with chronic knee pain, pain intensity scores on the visual analog scale (VAS) dropped from an average of 8 out of 10 before the implant to 1.4 out of 10 when measured 6 months afterward.
Pain relief was also long lasting, with an average score at 2 years still significantly reduced from baseline, at 3 out of 10 on the VAS.
“We have a lot of patients with chronic knee pain, and unfortunately, our hands are tied in terms of what we can do for them,” lead author Kwo Wei David Ho, MD, PhD, Stanford University, California, told Medscape Medical News.
“They can use NSAIDs, physical therapy, some get steroid injections, or genicular nerve blocks, but they don’t work that well. Some have knee replacement surgery, and can still have persistent knee pain after the operation, so here we are using an alternative therapy called peripheral nerve stimulation of the saphenous nerve. This provides a way to relieve pain without nerve destruction or motor dysfunction,” Ho said.
The findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
Patient Controlled
For the study, the investigators surgically implanted five patients with intractable knee pain with the StimRouter™ (Bioness, Inc).
The device takes about 15 to 30 minutes to implant, much like a pacemaker, and reduces pain by delivering gentle electrical stimulation directly to a target peripheral nerve, in this case the saphenous nerve, to interrupt the pain signal, Ho said.
“A thin, threadlike lead, or noodle, is implanted below the skin next to the target peripheral nerve responsible for the pain signal under ultrasound guidance, and then a patch or external pulse transmitter (EPT) is worn on top of the skin. This sends electric stimulation through the skin to the lead,” he explained.
The patient can then control the EPT and adjust stimulation with a wireless handheld programmer.
“Some patients turn it on at night for a couple of hours and then turn it off, some leave it on for the entire night, or the whole day if they prefer. What we’ve been noticing in our series is that after a while, patients are using less and less, and the pain gets better and better, and eventually they stop using it entirely because the pain completely resolves,” Ho said.
Good candidates for this treatment are post-knee replacement patients with residual pain, he added.
Durable Effect
Of the five patients in the case series, four had previous knee arthroplasty.
To determine the chances of a good response to the implant, study participants underwent a diagnostic saphenous nerve block, with the rationale that if the block successfully reduced knee pain by 50% or more in the short term, patients would likely respond well to the implant.
Before the peripheral nerve stimulation implant, the average pain intensity was 7.8 out of 10 on the VAS. After stimulator implantation, the average pain intensity was 1.4 at 6 months (P = .019, in 5 patients). At 1 year, the average pain intensity score was virtually the same, at 1.5 on the VAS, (P = .0032, in 4 patients). At 2 years, the average pain intensity score was 2.75 (P = .12, in 2 patients).
“This study provides preliminary evidence that stimulation at the saphenous nerve may be effective for selected patients with chronic knee pain,” Ho said.
Commenting on the findings for Medscape Medical News, Patrick Tighe, MD, MS, University of Florida, Gainesville, said that chronic knee pain continues to present “numerous diagnostic and therapeutic challenges for many patients.”
“It may be surprising, but there is still so much we don’t know about the innervation of the knee, and we are still learning about different ways to alter the behavior of those nerves,” said Tighe, who was not involved with the current study.
“This work points to some exciting opportunities to help patients suffering from chronic knee pain. We certainly need more research in this area to figure out the optimal approach to applying these findings more widely,” he said.
Ho and Tighe have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
NATIONAL HARBOR, MD. – Stimulation of the infrapatellar branch of the saphenous nerve with an implantable electrical device is a potentially effective treatment for chronic, intractable knee pain.
In a small case series consisting of five patients with chronic knee pain, pain intensity scores on the visual analog scale (VAS) dropped from an average of 8 out of 10 before the implant to 1.4 out of 10 when measured 6 months afterward.
Pain relief was also long lasting, with an average score at 2 years still significantly reduced from baseline, at 3 out of 10 on the VAS.
“We have a lot of patients with chronic knee pain, and unfortunately, our hands are tied in terms of what we can do for them,” lead author Kwo Wei David Ho, MD, PhD, Stanford University, California, told Medscape Medical News.
“They can use NSAIDs, physical therapy, some get steroid injections, or genicular nerve blocks, but they don’t work that well. Some have knee replacement surgery, and can still have persistent knee pain after the operation, so here we are using an alternative therapy called peripheral nerve stimulation of the saphenous nerve. This provides a way to relieve pain without nerve destruction or motor dysfunction,” Ho said.
The findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
Patient Controlled
For the study, the investigators surgically implanted five patients with intractable knee pain with the StimRouter™ (Bioness, Inc).
The device takes about 15 to 30 minutes to implant, much like a pacemaker, and reduces pain by delivering gentle electrical stimulation directly to a target peripheral nerve, in this case the saphenous nerve, to interrupt the pain signal, Ho said.
“A thin, threadlike lead, or noodle, is implanted below the skin next to the target peripheral nerve responsible for the pain signal under ultrasound guidance, and then a patch or external pulse transmitter (EPT) is worn on top of the skin. This sends electric stimulation through the skin to the lead,” he explained.
The patient can then control the EPT and adjust stimulation with a wireless handheld programmer.
“Some patients turn it on at night for a couple of hours and then turn it off, some leave it on for the entire night, or the whole day if they prefer. What we’ve been noticing in our series is that after a while, patients are using less and less, and the pain gets better and better, and eventually they stop using it entirely because the pain completely resolves,” Ho said.
Good candidates for this treatment are post-knee replacement patients with residual pain, he added.
Durable Effect
Of the five patients in the case series, four had previous knee arthroplasty.
To determine the chances of a good response to the implant, study participants underwent a diagnostic saphenous nerve block, with the rationale that if the block successfully reduced knee pain by 50% or more in the short term, patients would likely respond well to the implant.
Before the peripheral nerve stimulation implant, the average pain intensity was 7.8 out of 10 on the VAS. After stimulator implantation, the average pain intensity was 1.4 at 6 months (P = .019, in 5 patients). At 1 year, the average pain intensity score was virtually the same, at 1.5 on the VAS, (P = .0032, in 4 patients). At 2 years, the average pain intensity score was 2.75 (P = .12, in 2 patients).
“This study provides preliminary evidence that stimulation at the saphenous nerve may be effective for selected patients with chronic knee pain,” Ho said.
Commenting on the findings for Medscape Medical News, Patrick Tighe, MD, MS, University of Florida, Gainesville, said that chronic knee pain continues to present “numerous diagnostic and therapeutic challenges for many patients.”
“It may be surprising, but there is still so much we don’t know about the innervation of the knee, and we are still learning about different ways to alter the behavior of those nerves,” said Tighe, who was not involved with the current study.
“This work points to some exciting opportunities to help patients suffering from chronic knee pain. We certainly need more research in this area to figure out the optimal approach to applying these findings more widely,” he said.
Ho and Tighe have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
NATIONAL HARBOR, MD. – Stimulation of the infrapatellar branch of the saphenous nerve with an implantable electrical device is a potentially effective treatment for chronic, intractable knee pain.
In a small case series consisting of five patients with chronic knee pain, pain intensity scores on the visual analog scale (VAS) dropped from an average of 8 out of 10 before the implant to 1.4 out of 10 when measured 6 months afterward.
Pain relief was also long lasting, with an average score at 2 years still significantly reduced from baseline, at 3 out of 10 on the VAS.
“We have a lot of patients with chronic knee pain, and unfortunately, our hands are tied in terms of what we can do for them,” lead author Kwo Wei David Ho, MD, PhD, Stanford University, California, told Medscape Medical News.
“They can use NSAIDs, physical therapy, some get steroid injections, or genicular nerve blocks, but they don’t work that well. Some have knee replacement surgery, and can still have persistent knee pain after the operation, so here we are using an alternative therapy called peripheral nerve stimulation of the saphenous nerve. This provides a way to relieve pain without nerve destruction or motor dysfunction,” Ho said.
The findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
Patient Controlled
For the study, the investigators surgically implanted five patients with intractable knee pain with the StimRouter™ (Bioness, Inc).
The device takes about 15 to 30 minutes to implant, much like a pacemaker, and reduces pain by delivering gentle electrical stimulation directly to a target peripheral nerve, in this case the saphenous nerve, to interrupt the pain signal, Ho said.
“A thin, threadlike lead, or noodle, is implanted below the skin next to the target peripheral nerve responsible for the pain signal under ultrasound guidance, and then a patch or external pulse transmitter (EPT) is worn on top of the skin. This sends electric stimulation through the skin to the lead,” he explained.
The patient can then control the EPT and adjust stimulation with a wireless handheld programmer.
“Some patients turn it on at night for a couple of hours and then turn it off, some leave it on for the entire night, or the whole day if they prefer. What we’ve been noticing in our series is that after a while, patients are using less and less, and the pain gets better and better, and eventually they stop using it entirely because the pain completely resolves,” Ho said.
Good candidates for this treatment are post-knee replacement patients with residual pain, he added.
Durable Effect
Of the five patients in the case series, four had previous knee arthroplasty.
To determine the chances of a good response to the implant, study participants underwent a diagnostic saphenous nerve block, with the rationale that if the block successfully reduced knee pain by 50% or more in the short term, patients would likely respond well to the implant.
Before the peripheral nerve stimulation implant, the average pain intensity was 7.8 out of 10 on the VAS. After stimulator implantation, the average pain intensity was 1.4 at 6 months (P = .019, in 5 patients). At 1 year, the average pain intensity score was virtually the same, at 1.5 on the VAS, (P = .0032, in 4 patients). At 2 years, the average pain intensity score was 2.75 (P = .12, in 2 patients).
“This study provides preliminary evidence that stimulation at the saphenous nerve may be effective for selected patients with chronic knee pain,” Ho said.
Commenting on the findings for Medscape Medical News, Patrick Tighe, MD, MS, University of Florida, Gainesville, said that chronic knee pain continues to present “numerous diagnostic and therapeutic challenges for many patients.”
“It may be surprising, but there is still so much we don’t know about the innervation of the knee, and we are still learning about different ways to alter the behavior of those nerves,” said Tighe, who was not involved with the current study.
“This work points to some exciting opportunities to help patients suffering from chronic knee pain. We certainly need more research in this area to figure out the optimal approach to applying these findings more widely,” he said.
Ho and Tighe have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Borderline personality disorder common in chronic pain patients
NATIONAL HARBOR, MD. – A significant proportion of patients who suffer from chronic pain also have features of borderline personality disorder (BPD), new research shows.
Results of a systematic literature review showed 23% of patients with chronic noncancer pain (CNCP) had some features of BPD, including difficulty maintaining relationships, as well as affect and mood instability.
“The fact that one-fourth of individuals with CNCP could have co-occurring BPD underscores the need for improved access to good psychological care,” lead investigator Fei Cao, MD, PhD, University of Missouri at Kansas City, said in an interview.
“If we treat the borderline personality disorder and address the psychiatric needs as well as the pain needs of the patient, then we will be able to treat their pain more successfully,” Cao said.
The findings were presented at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
Treatment resistance
Cao noted that a “significant number” of CNCP patients have at least some resistance to any type of pain treatment and speculated that BPD may increase treatment-resistant chronic pain.
Initially an anesthesiologist and pain medicine specialist, Cao later became a psychiatrist after recognizing the importance of addressing the underlying psychological needs of patients with chronic pain.
He noted that there is a strong psychological component to chronic pain and that many patients with chronic pain have suffered psychological trauma.
“You have to think about what may have happened to these patients. That is most important. I would not say these are difficult patients. I would say we just don’t know what happened to them,” he said.
To gain a better understanding of the prevalence of BPD in patients suffering from chronic pain and potentially provide some unexploited targets for chronic pain management, the investigators analyzed data from 11 studies published between 1994 and 2019. They found the prevalence of BPD among CNCP patients was 23.3%. Pain types included chronic headache (11.3%), arthritis (27.5%), and chronic spinal cord pain (24.3%).
We also have to treat their BPD. This can then make pain easier to control. Chronic pain management is often long-term and requires good compliance. A diagnosis of BPD might suggest poor compliance,” said Cao.
Screen for BPD
The study findings, he added, indicate a need to screen for BPD in patients with chronic pain. Interventions that are effective in the treatment of BPD and CNCP include cognitive-behavioral therapy, dialectical behavior therapy, antidepressants, and anticonvulsants.
“These should be considered as the first-line treatment in persons with comorbid pain and BPD,” Cao said.
Commenting on the findings, Ann E. Hansen, DVM, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, said the study illustrates the multifactorial nature of chronic pain syndromes, and underscores the importance of a multidisciplinary approach to evaluation and treatment.
“The authors present data showing that BPD is a common diagnosis in patients with chronic pain, thus raising provider awareness to consider BPD and to involve behavioral health colleagues in comanaging these complex patients to achieve optimal outcomes,” Hansen said.
Cao and Hansen have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
SOURCE: Cao F et al. American Academy of Pain Medicine (AAPM) 2020 Annual Meeting, Abstract 505.
NATIONAL HARBOR, MD. – A significant proportion of patients who suffer from chronic pain also have features of borderline personality disorder (BPD), new research shows.
Results of a systematic literature review showed 23% of patients with chronic noncancer pain (CNCP) had some features of BPD, including difficulty maintaining relationships, as well as affect and mood instability.
“The fact that one-fourth of individuals with CNCP could have co-occurring BPD underscores the need for improved access to good psychological care,” lead investigator Fei Cao, MD, PhD, University of Missouri at Kansas City, said in an interview.
“If we treat the borderline personality disorder and address the psychiatric needs as well as the pain needs of the patient, then we will be able to treat their pain more successfully,” Cao said.
The findings were presented at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
Treatment resistance
Cao noted that a “significant number” of CNCP patients have at least some resistance to any type of pain treatment and speculated that BPD may increase treatment-resistant chronic pain.
Initially an anesthesiologist and pain medicine specialist, Cao later became a psychiatrist after recognizing the importance of addressing the underlying psychological needs of patients with chronic pain.
He noted that there is a strong psychological component to chronic pain and that many patients with chronic pain have suffered psychological trauma.
“You have to think about what may have happened to these patients. That is most important. I would not say these are difficult patients. I would say we just don’t know what happened to them,” he said.
To gain a better understanding of the prevalence of BPD in patients suffering from chronic pain and potentially provide some unexploited targets for chronic pain management, the investigators analyzed data from 11 studies published between 1994 and 2019. They found the prevalence of BPD among CNCP patients was 23.3%. Pain types included chronic headache (11.3%), arthritis (27.5%), and chronic spinal cord pain (24.3%).
We also have to treat their BPD. This can then make pain easier to control. Chronic pain management is often long-term and requires good compliance. A diagnosis of BPD might suggest poor compliance,” said Cao.
Screen for BPD
The study findings, he added, indicate a need to screen for BPD in patients with chronic pain. Interventions that are effective in the treatment of BPD and CNCP include cognitive-behavioral therapy, dialectical behavior therapy, antidepressants, and anticonvulsants.
“These should be considered as the first-line treatment in persons with comorbid pain and BPD,” Cao said.
Commenting on the findings, Ann E. Hansen, DVM, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, said the study illustrates the multifactorial nature of chronic pain syndromes, and underscores the importance of a multidisciplinary approach to evaluation and treatment.
“The authors present data showing that BPD is a common diagnosis in patients with chronic pain, thus raising provider awareness to consider BPD and to involve behavioral health colleagues in comanaging these complex patients to achieve optimal outcomes,” Hansen said.
Cao and Hansen have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
SOURCE: Cao F et al. American Academy of Pain Medicine (AAPM) 2020 Annual Meeting, Abstract 505.
NATIONAL HARBOR, MD. – A significant proportion of patients who suffer from chronic pain also have features of borderline personality disorder (BPD), new research shows.
Results of a systematic literature review showed 23% of patients with chronic noncancer pain (CNCP) had some features of BPD, including difficulty maintaining relationships, as well as affect and mood instability.
“The fact that one-fourth of individuals with CNCP could have co-occurring BPD underscores the need for improved access to good psychological care,” lead investigator Fei Cao, MD, PhD, University of Missouri at Kansas City, said in an interview.
“If we treat the borderline personality disorder and address the psychiatric needs as well as the pain needs of the patient, then we will be able to treat their pain more successfully,” Cao said.
The findings were presented at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
Treatment resistance
Cao noted that a “significant number” of CNCP patients have at least some resistance to any type of pain treatment and speculated that BPD may increase treatment-resistant chronic pain.
Initially an anesthesiologist and pain medicine specialist, Cao later became a psychiatrist after recognizing the importance of addressing the underlying psychological needs of patients with chronic pain.
He noted that there is a strong psychological component to chronic pain and that many patients with chronic pain have suffered psychological trauma.
“You have to think about what may have happened to these patients. That is most important. I would not say these are difficult patients. I would say we just don’t know what happened to them,” he said.
To gain a better understanding of the prevalence of BPD in patients suffering from chronic pain and potentially provide some unexploited targets for chronic pain management, the investigators analyzed data from 11 studies published between 1994 and 2019. They found the prevalence of BPD among CNCP patients was 23.3%. Pain types included chronic headache (11.3%), arthritis (27.5%), and chronic spinal cord pain (24.3%).
We also have to treat their BPD. This can then make pain easier to control. Chronic pain management is often long-term and requires good compliance. A diagnosis of BPD might suggest poor compliance,” said Cao.
Screen for BPD
The study findings, he added, indicate a need to screen for BPD in patients with chronic pain. Interventions that are effective in the treatment of BPD and CNCP include cognitive-behavioral therapy, dialectical behavior therapy, antidepressants, and anticonvulsants.
“These should be considered as the first-line treatment in persons with comorbid pain and BPD,” Cao said.
Commenting on the findings, Ann E. Hansen, DVM, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, said the study illustrates the multifactorial nature of chronic pain syndromes, and underscores the importance of a multidisciplinary approach to evaluation and treatment.
“The authors present data showing that BPD is a common diagnosis in patients with chronic pain, thus raising provider awareness to consider BPD and to involve behavioral health colleagues in comanaging these complex patients to achieve optimal outcomes,” Hansen said.
Cao and Hansen have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
SOURCE: Cao F et al. American Academy of Pain Medicine (AAPM) 2020 Annual Meeting, Abstract 505.
REPORTING FROM THE AAPM 2020 ANNUAL MEETING
Contingency Tx Helps Pregnant Smokers Quit
BOCA RATON, FLA. — In a pilot study of pregnant women who continued to smoke cigarettes despite knowing they were pregnant, 11 (37%) of 30 women who received contingency management achieved abstinence, compared with just 2 (10%) of 23 women who did not.
This result highlights the effectiveness of contingency management as a strategy to help pregnant women stop smoking, Dr. Sarah Heil said at the annual meeting of the American Academy of Addiction Psychiatry.
The women in both contingent and noncontingent groups were seen every day for the first 5 days of the study. During this time, abstinence was based on a breath carbon monoxide level of 6 parts per million or less, said Dr. Heil of the University of Vermont, Burlington.
After the first 5 days, the women were seen according to the following schedule:
▸ Twice a week for 7 weeks.
▸ Once a week for the next 11 weeks.
▸ Once every other week until delivery.
▸ Once a week for the first 4 weeks post partum.
▸ Every other week for the next 8 weeks.
Abstinence in this phase of the study was assessed by measuring urine cotinine levels; levels of 80 ng/mL or less were indicative of abstinence.
The women were rewarded with vouchers, which were earned contingent on biochemically verified abstinence. The voucher value began at $6.25 and escalated at a rate of $1.25 per consecutive negative sample up to a maximum of $45.
“These vouchers are like having a bank account with us. We put their money into an account, and they are allowed to spend it on things we believe are appropriate. So there were a lot of gift certificates, paying of credit card bills, and shopping at Wal-Mart and grocery stores,” Dr. Heil said.
Women who were randomized to noncontingency management got vouchers independent of their smoking status. The vouchers were a flat $11.50 per antepartum visit, and $20 per each postpartum visit.
The women in the study had been smoking for about 8 years; most of them lived with other smokers. They smoked approximately one pack of cigarettes a day before pregnancy, but had reduced this amount by roughly 50% by the time they entered the study.
Most of the women had less than a high school education, and few were married.
To be considered abstinent at each time point, the women had to self-report that they had not had a cigarette—“not even a puff”—in the last 7 days, as well as the appropriate urine cotinine level.
The effects obtained in the study persisted 3 months after delivery, and for a further 3 months, even though the voucher program was discontinued at 3 months post partum. This was true for women in the contingent and noncontingent groups, Dr. Heil said.
Fetuses in the contingent group gained weight faster than those in the noncontingent group. Fetal weight was estimated by measuring fetal length and abdominal circumference by ultrasound.
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the United States. Placental abruptions, small gestational age, preterm and still birth, low birth weight, and increased risk for sudden infant death syndrome are all associated with cigarette smoking by the mother.
The adverse effects of smoking on the neonate cost $1,630/birth per year in 2008 dollars.
Dr. Heil said she hopes to extend her research on contingency management to include pregnant smokers who are also opioid dependent.
The effects obtained in the study persisted even after the voucher program was discontinued. DR. HEIL
BOCA RATON, FLA. — In a pilot study of pregnant women who continued to smoke cigarettes despite knowing they were pregnant, 11 (37%) of 30 women who received contingency management achieved abstinence, compared with just 2 (10%) of 23 women who did not.
This result highlights the effectiveness of contingency management as a strategy to help pregnant women stop smoking, Dr. Sarah Heil said at the annual meeting of the American Academy of Addiction Psychiatry.
The women in both contingent and noncontingent groups were seen every day for the first 5 days of the study. During this time, abstinence was based on a breath carbon monoxide level of 6 parts per million or less, said Dr. Heil of the University of Vermont, Burlington.
After the first 5 days, the women were seen according to the following schedule:
▸ Twice a week for 7 weeks.
▸ Once a week for the next 11 weeks.
▸ Once every other week until delivery.
▸ Once a week for the first 4 weeks post partum.
▸ Every other week for the next 8 weeks.
Abstinence in this phase of the study was assessed by measuring urine cotinine levels; levels of 80 ng/mL or less were indicative of abstinence.
The women were rewarded with vouchers, which were earned contingent on biochemically verified abstinence. The voucher value began at $6.25 and escalated at a rate of $1.25 per consecutive negative sample up to a maximum of $45.
“These vouchers are like having a bank account with us. We put their money into an account, and they are allowed to spend it on things we believe are appropriate. So there were a lot of gift certificates, paying of credit card bills, and shopping at Wal-Mart and grocery stores,” Dr. Heil said.
Women who were randomized to noncontingency management got vouchers independent of their smoking status. The vouchers were a flat $11.50 per antepartum visit, and $20 per each postpartum visit.
The women in the study had been smoking for about 8 years; most of them lived with other smokers. They smoked approximately one pack of cigarettes a day before pregnancy, but had reduced this amount by roughly 50% by the time they entered the study.
Most of the women had less than a high school education, and few were married.
To be considered abstinent at each time point, the women had to self-report that they had not had a cigarette—“not even a puff”—in the last 7 days, as well as the appropriate urine cotinine level.
The effects obtained in the study persisted 3 months after delivery, and for a further 3 months, even though the voucher program was discontinued at 3 months post partum. This was true for women in the contingent and noncontingent groups, Dr. Heil said.
Fetuses in the contingent group gained weight faster than those in the noncontingent group. Fetal weight was estimated by measuring fetal length and abdominal circumference by ultrasound.
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the United States. Placental abruptions, small gestational age, preterm and still birth, low birth weight, and increased risk for sudden infant death syndrome are all associated with cigarette smoking by the mother.
The adverse effects of smoking on the neonate cost $1,630/birth per year in 2008 dollars.
Dr. Heil said she hopes to extend her research on contingency management to include pregnant smokers who are also opioid dependent.
The effects obtained in the study persisted even after the voucher program was discontinued. DR. HEIL
BOCA RATON, FLA. — In a pilot study of pregnant women who continued to smoke cigarettes despite knowing they were pregnant, 11 (37%) of 30 women who received contingency management achieved abstinence, compared with just 2 (10%) of 23 women who did not.
This result highlights the effectiveness of contingency management as a strategy to help pregnant women stop smoking, Dr. Sarah Heil said at the annual meeting of the American Academy of Addiction Psychiatry.
The women in both contingent and noncontingent groups were seen every day for the first 5 days of the study. During this time, abstinence was based on a breath carbon monoxide level of 6 parts per million or less, said Dr. Heil of the University of Vermont, Burlington.
After the first 5 days, the women were seen according to the following schedule:
▸ Twice a week for 7 weeks.
▸ Once a week for the next 11 weeks.
▸ Once every other week until delivery.
▸ Once a week for the first 4 weeks post partum.
▸ Every other week for the next 8 weeks.
Abstinence in this phase of the study was assessed by measuring urine cotinine levels; levels of 80 ng/mL or less were indicative of abstinence.
The women were rewarded with vouchers, which were earned contingent on biochemically verified abstinence. The voucher value began at $6.25 and escalated at a rate of $1.25 per consecutive negative sample up to a maximum of $45.
“These vouchers are like having a bank account with us. We put their money into an account, and they are allowed to spend it on things we believe are appropriate. So there were a lot of gift certificates, paying of credit card bills, and shopping at Wal-Mart and grocery stores,” Dr. Heil said.
Women who were randomized to noncontingency management got vouchers independent of their smoking status. The vouchers were a flat $11.50 per antepartum visit, and $20 per each postpartum visit.
The women in the study had been smoking for about 8 years; most of them lived with other smokers. They smoked approximately one pack of cigarettes a day before pregnancy, but had reduced this amount by roughly 50% by the time they entered the study.
Most of the women had less than a high school education, and few were married.
To be considered abstinent at each time point, the women had to self-report that they had not had a cigarette—“not even a puff”—in the last 7 days, as well as the appropriate urine cotinine level.
The effects obtained in the study persisted 3 months after delivery, and for a further 3 months, even though the voucher program was discontinued at 3 months post partum. This was true for women in the contingent and noncontingent groups, Dr. Heil said.
Fetuses in the contingent group gained weight faster than those in the noncontingent group. Fetal weight was estimated by measuring fetal length and abdominal circumference by ultrasound.
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the United States. Placental abruptions, small gestational age, preterm and still birth, low birth weight, and increased risk for sudden infant death syndrome are all associated with cigarette smoking by the mother.
The adverse effects of smoking on the neonate cost $1,630/birth per year in 2008 dollars.
Dr. Heil said she hopes to extend her research on contingency management to include pregnant smokers who are also opioid dependent.
The effects obtained in the study persisted even after the voucher program was discontinued. DR. HEIL
Role of Bisphosphonates in ONJ Called Unclear
CHICAGO — Many people who currently take or who have taken bisphosphonates are being denied essential dental procedures because of undue fears about bisphosphonate-induced osteonecrosis of the jaw, according to a specialist in oral pathology.
“The phenomenon of ONJ seen in patients who happen to be on a bisphosphonate can also be seen in patients who have never had a bisphosphonate, but whether the bisphosphonate is directly responsible for this occurrence has not been scientifically [proved],” said Ellen Eisenberg, D.M.D., head of oral and maxillofacial pathology at the University of Connecticut Health Center in Farmington.
Dr. Eisenberg said that as a pathologist, she is unable to tell the difference between osteonecrosis of the jaw that has occurred in patients treated with radiation for head and neck cancer, in patients treated with intravenous or long-term oral bisphosphonates, or in patients who have not received either treatment.
The definitive diagnosis of bisphosphonate-associated ONJ requires exposed bone in the jaw for 8 weeks or longer. Although most cases involve a history of a surgical procedure in the mouth, most typically a tooth extraction, 40% of cases report sudden exposure of bone for no reason.
“The jaw is a very high traffic area that is subject to extreme forces, and therefore it is very likely that a patient may not recall a particularly traumatic event. Nevertheless, that trauma occurred, and that preceded the exposure of the bone,” Dr. Eisenberg said at the annual Chicago Supportive Oncology Conference.
Dr. Eisenberg emphasized that the pathogenesis of ONJ is presumptive, based on the presumed alteration in the dynamic inhibition, resorption, and apposition of bone. “However, we do not know with any scientific certainty that this [presumed alteration] is, indeed, the cause,” she said.
Until results from definitive studies show that bisphosphonates, whether oral or intravenous, are indeed the cause of ONJ, it is imperative that any patient about to embark on bisphosphonate therapy get a thorough dental examination so that any potential sites of infection or inflammatory disease can be eliminated, Dr. Eisenberg said.
Patients who develop ONJ have a host of comorbidities that may be cofactors. Right now, it is not scientifically sound to focus on just bisphosphonates as the cause, since there may be other reasons for developing ONJ, she maintained.
“There is a host of cofactors that cannot be dismissed. These patients have cancer, and when they have something like metastatic breast cancer or multiple myeloma, they are suffering from widespread disease, with all of its implications,” Dr. Eisenberg said.
Even older age can predispose an individual to develop ONJ, she added.
Dr. Eisenberg also suggested a genetic polymorphism may predispose individuals to develop bisphosphonate-associated ONJ. “It is purely conjecture, but I think that there is a subset of individuals who may be susceptible because their genetic profile predisposes them to the complication,” she said.
She added that bisphosphonates are extremely useful medications, and that harm would be done to patients if the drugs were to be discontinued out of premature fears of ONJ.
Dr. Eisenberg disclosed that she is a consultant for Novartis, which markets three intravenous bisphosphonates: Aredia (pamidronate sodium), Reclast (zoledronic acid), and Zometa (zoledronic acid).
The conference was sponsored by the Journal of Supportive Oncology. The Journal of Supportive Oncology and this news organization are owned by Elsevier.
'Whether the bisphosphonate is directly responsible … has not been scientifically [proved].' DR. EISENBERG
CHICAGO — Many people who currently take or who have taken bisphosphonates are being denied essential dental procedures because of undue fears about bisphosphonate-induced osteonecrosis of the jaw, according to a specialist in oral pathology.
“The phenomenon of ONJ seen in patients who happen to be on a bisphosphonate can also be seen in patients who have never had a bisphosphonate, but whether the bisphosphonate is directly responsible for this occurrence has not been scientifically [proved],” said Ellen Eisenberg, D.M.D., head of oral and maxillofacial pathology at the University of Connecticut Health Center in Farmington.
Dr. Eisenberg said that as a pathologist, she is unable to tell the difference between osteonecrosis of the jaw that has occurred in patients treated with radiation for head and neck cancer, in patients treated with intravenous or long-term oral bisphosphonates, or in patients who have not received either treatment.
The definitive diagnosis of bisphosphonate-associated ONJ requires exposed bone in the jaw for 8 weeks or longer. Although most cases involve a history of a surgical procedure in the mouth, most typically a tooth extraction, 40% of cases report sudden exposure of bone for no reason.
“The jaw is a very high traffic area that is subject to extreme forces, and therefore it is very likely that a patient may not recall a particularly traumatic event. Nevertheless, that trauma occurred, and that preceded the exposure of the bone,” Dr. Eisenberg said at the annual Chicago Supportive Oncology Conference.
Dr. Eisenberg emphasized that the pathogenesis of ONJ is presumptive, based on the presumed alteration in the dynamic inhibition, resorption, and apposition of bone. “However, we do not know with any scientific certainty that this [presumed alteration] is, indeed, the cause,” she said.
Until results from definitive studies show that bisphosphonates, whether oral or intravenous, are indeed the cause of ONJ, it is imperative that any patient about to embark on bisphosphonate therapy get a thorough dental examination so that any potential sites of infection or inflammatory disease can be eliminated, Dr. Eisenberg said.
Patients who develop ONJ have a host of comorbidities that may be cofactors. Right now, it is not scientifically sound to focus on just bisphosphonates as the cause, since there may be other reasons for developing ONJ, she maintained.
“There is a host of cofactors that cannot be dismissed. These patients have cancer, and when they have something like metastatic breast cancer or multiple myeloma, they are suffering from widespread disease, with all of its implications,” Dr. Eisenberg said.
Even older age can predispose an individual to develop ONJ, she added.
Dr. Eisenberg also suggested a genetic polymorphism may predispose individuals to develop bisphosphonate-associated ONJ. “It is purely conjecture, but I think that there is a subset of individuals who may be susceptible because their genetic profile predisposes them to the complication,” she said.
She added that bisphosphonates are extremely useful medications, and that harm would be done to patients if the drugs were to be discontinued out of premature fears of ONJ.
Dr. Eisenberg disclosed that she is a consultant for Novartis, which markets three intravenous bisphosphonates: Aredia (pamidronate sodium), Reclast (zoledronic acid), and Zometa (zoledronic acid).
The conference was sponsored by the Journal of Supportive Oncology. The Journal of Supportive Oncology and this news organization are owned by Elsevier.
'Whether the bisphosphonate is directly responsible … has not been scientifically [proved].' DR. EISENBERG
CHICAGO — Many people who currently take or who have taken bisphosphonates are being denied essential dental procedures because of undue fears about bisphosphonate-induced osteonecrosis of the jaw, according to a specialist in oral pathology.
“The phenomenon of ONJ seen in patients who happen to be on a bisphosphonate can also be seen in patients who have never had a bisphosphonate, but whether the bisphosphonate is directly responsible for this occurrence has not been scientifically [proved],” said Ellen Eisenberg, D.M.D., head of oral and maxillofacial pathology at the University of Connecticut Health Center in Farmington.
Dr. Eisenberg said that as a pathologist, she is unable to tell the difference between osteonecrosis of the jaw that has occurred in patients treated with radiation for head and neck cancer, in patients treated with intravenous or long-term oral bisphosphonates, or in patients who have not received either treatment.
The definitive diagnosis of bisphosphonate-associated ONJ requires exposed bone in the jaw for 8 weeks or longer. Although most cases involve a history of a surgical procedure in the mouth, most typically a tooth extraction, 40% of cases report sudden exposure of bone for no reason.
“The jaw is a very high traffic area that is subject to extreme forces, and therefore it is very likely that a patient may not recall a particularly traumatic event. Nevertheless, that trauma occurred, and that preceded the exposure of the bone,” Dr. Eisenberg said at the annual Chicago Supportive Oncology Conference.
Dr. Eisenberg emphasized that the pathogenesis of ONJ is presumptive, based on the presumed alteration in the dynamic inhibition, resorption, and apposition of bone. “However, we do not know with any scientific certainty that this [presumed alteration] is, indeed, the cause,” she said.
Until results from definitive studies show that bisphosphonates, whether oral or intravenous, are indeed the cause of ONJ, it is imperative that any patient about to embark on bisphosphonate therapy get a thorough dental examination so that any potential sites of infection or inflammatory disease can be eliminated, Dr. Eisenberg said.
Patients who develop ONJ have a host of comorbidities that may be cofactors. Right now, it is not scientifically sound to focus on just bisphosphonates as the cause, since there may be other reasons for developing ONJ, she maintained.
“There is a host of cofactors that cannot be dismissed. These patients have cancer, and when they have something like metastatic breast cancer or multiple myeloma, they are suffering from widespread disease, with all of its implications,” Dr. Eisenberg said.
Even older age can predispose an individual to develop ONJ, she added.
Dr. Eisenberg also suggested a genetic polymorphism may predispose individuals to develop bisphosphonate-associated ONJ. “It is purely conjecture, but I think that there is a subset of individuals who may be susceptible because their genetic profile predisposes them to the complication,” she said.
She added that bisphosphonates are extremely useful medications, and that harm would be done to patients if the drugs were to be discontinued out of premature fears of ONJ.
Dr. Eisenberg disclosed that she is a consultant for Novartis, which markets three intravenous bisphosphonates: Aredia (pamidronate sodium), Reclast (zoledronic acid), and Zometa (zoledronic acid).
The conference was sponsored by the Journal of Supportive Oncology. The Journal of Supportive Oncology and this news organization are owned by Elsevier.
'Whether the bisphosphonate is directly responsible … has not been scientifically [proved].' DR. EISENBERG
Botulinum Helps Control Hyperhidrosis in Teens
ORLANDO Botulinum toxin type A administered intradermally was safe and effective in reducing the severity of primary axillary hyperhidrosis, in a multicenter trial of adolescents.
The first two treatments produced relief from uncontrolled, excessive sweating, and that relief lasted about 4.5 months each time. The results suggest that teens may need only two or three treatments per year, Dr. Dee Anna Glaser reported in a poster at the annual meeting of the American Society for Dermatologic Surgery.
Treatment for up to 1 year with botulinum toxin type A was well tolerated, and patients reported marked improvements in health-related quality of life and fewer social, physical, and emotional impairments, said Dr. Glaser, professor of dermatology at St. Louis University.
In the 52-week study sponsored by Allergan Inc., 144 patients (aged 1217 years) were injected with 100 U (50 U per axilla) at each treatment session. A maximum of six treatments was allowed, depending on the response to treatment and the duration of the response; patients had to wait at least 8 weeks between treatments.
The primary efficacy end point was the patients' assessment of the severity of their underarm sweating using the 4-point Hyperhidrosis Disease Severity Scale (HDSS), where:
▸ 1 = Never noticeable and never interferes with my daily activities.
▸ 2 = Tolerable but sometimes interferes with my daily activities.
▸ 3 = Barely tolerable and frequently interferes with my daily activities.
▸ 4 = Intolerable and always interferes with my daily activities.
Before the first treatment, patients' HDSS scores ranged from 3 to 4. Four weeks after the second treatment, 62% of patients improved to an HDSS score of 1, Dr. Glaser and her associates wrote.
Sweat production was reduced by at least 50% in at least 93% of patients after the first treatment, by 75% or more in at least 79% of patients after the second treatment, and by more than 90% in at least 52% of patients after the third treatment, the investigators found.
Health outcomes were assessed at each office visit using the Children's Dermatology Life Quality Index and the Children's Hyperhidrosis Impact Questionnaire. These questionnaires measure the impact of hyperhidrosis on children's quality of life, ask about symptoms, and assess feelings regarding the impact on leisure time, school or holidays, personal relationships, sleep, and treatment.
Dr. Glaser and her associates reported that botulinum toxin type A treatment significantly improved all of these domains, with the exception of sleep.
Most adverse events with treatment were mild or moderate in severity, and none led to discontinuation. Most were related to the injection and included pain, pyrexia, bruising, erythema, irritation, and swelling. These occurred in less than 3% of patients.
Dr. Glaser disclosed that she is a consultant for Allergan.
Sweat production was reduced by at least 50% in 93% of patients after their first treatment. DR. GLASER
ORLANDO Botulinum toxin type A administered intradermally was safe and effective in reducing the severity of primary axillary hyperhidrosis, in a multicenter trial of adolescents.
The first two treatments produced relief from uncontrolled, excessive sweating, and that relief lasted about 4.5 months each time. The results suggest that teens may need only two or three treatments per year, Dr. Dee Anna Glaser reported in a poster at the annual meeting of the American Society for Dermatologic Surgery.
Treatment for up to 1 year with botulinum toxin type A was well tolerated, and patients reported marked improvements in health-related quality of life and fewer social, physical, and emotional impairments, said Dr. Glaser, professor of dermatology at St. Louis University.
In the 52-week study sponsored by Allergan Inc., 144 patients (aged 1217 years) were injected with 100 U (50 U per axilla) at each treatment session. A maximum of six treatments was allowed, depending on the response to treatment and the duration of the response; patients had to wait at least 8 weeks between treatments.
The primary efficacy end point was the patients' assessment of the severity of their underarm sweating using the 4-point Hyperhidrosis Disease Severity Scale (HDSS), where:
▸ 1 = Never noticeable and never interferes with my daily activities.
▸ 2 = Tolerable but sometimes interferes with my daily activities.
▸ 3 = Barely tolerable and frequently interferes with my daily activities.
▸ 4 = Intolerable and always interferes with my daily activities.
Before the first treatment, patients' HDSS scores ranged from 3 to 4. Four weeks after the second treatment, 62% of patients improved to an HDSS score of 1, Dr. Glaser and her associates wrote.
Sweat production was reduced by at least 50% in at least 93% of patients after the first treatment, by 75% or more in at least 79% of patients after the second treatment, and by more than 90% in at least 52% of patients after the third treatment, the investigators found.
Health outcomes were assessed at each office visit using the Children's Dermatology Life Quality Index and the Children's Hyperhidrosis Impact Questionnaire. These questionnaires measure the impact of hyperhidrosis on children's quality of life, ask about symptoms, and assess feelings regarding the impact on leisure time, school or holidays, personal relationships, sleep, and treatment.
Dr. Glaser and her associates reported that botulinum toxin type A treatment significantly improved all of these domains, with the exception of sleep.
Most adverse events with treatment were mild or moderate in severity, and none led to discontinuation. Most were related to the injection and included pain, pyrexia, bruising, erythema, irritation, and swelling. These occurred in less than 3% of patients.
Dr. Glaser disclosed that she is a consultant for Allergan.
Sweat production was reduced by at least 50% in 93% of patients after their first treatment. DR. GLASER
ORLANDO Botulinum toxin type A administered intradermally was safe and effective in reducing the severity of primary axillary hyperhidrosis, in a multicenter trial of adolescents.
The first two treatments produced relief from uncontrolled, excessive sweating, and that relief lasted about 4.5 months each time. The results suggest that teens may need only two or three treatments per year, Dr. Dee Anna Glaser reported in a poster at the annual meeting of the American Society for Dermatologic Surgery.
Treatment for up to 1 year with botulinum toxin type A was well tolerated, and patients reported marked improvements in health-related quality of life and fewer social, physical, and emotional impairments, said Dr. Glaser, professor of dermatology at St. Louis University.
In the 52-week study sponsored by Allergan Inc., 144 patients (aged 1217 years) were injected with 100 U (50 U per axilla) at each treatment session. A maximum of six treatments was allowed, depending on the response to treatment and the duration of the response; patients had to wait at least 8 weeks between treatments.
The primary efficacy end point was the patients' assessment of the severity of their underarm sweating using the 4-point Hyperhidrosis Disease Severity Scale (HDSS), where:
▸ 1 = Never noticeable and never interferes with my daily activities.
▸ 2 = Tolerable but sometimes interferes with my daily activities.
▸ 3 = Barely tolerable and frequently interferes with my daily activities.
▸ 4 = Intolerable and always interferes with my daily activities.
Before the first treatment, patients' HDSS scores ranged from 3 to 4. Four weeks after the second treatment, 62% of patients improved to an HDSS score of 1, Dr. Glaser and her associates wrote.
Sweat production was reduced by at least 50% in at least 93% of patients after the first treatment, by 75% or more in at least 79% of patients after the second treatment, and by more than 90% in at least 52% of patients after the third treatment, the investigators found.
Health outcomes were assessed at each office visit using the Children's Dermatology Life Quality Index and the Children's Hyperhidrosis Impact Questionnaire. These questionnaires measure the impact of hyperhidrosis on children's quality of life, ask about symptoms, and assess feelings regarding the impact on leisure time, school or holidays, personal relationships, sleep, and treatment.
Dr. Glaser and her associates reported that botulinum toxin type A treatment significantly improved all of these domains, with the exception of sleep.
Most adverse events with treatment were mild or moderate in severity, and none led to discontinuation. Most were related to the injection and included pain, pyrexia, bruising, erythema, irritation, and swelling. These occurred in less than 3% of patients.
Dr. Glaser disclosed that she is a consultant for Allergan.
Sweat production was reduced by at least 50% in 93% of patients after their first treatment. DR. GLASER
Bisphosphonates: ONJ Bystander or Cause?
CHICAGO — Many people who currently take or who have taken bisphosphonates are being denied essential dental procedures because of undue fears about bisphosphonate-induced osteonecrosis of the jaw, according to a specialist in oral pathology.
“The phenomenon of ONJ seen in patients who happen to be on a bisphosphonate can also be seen in patients who have never had a bisphosphonate, but whether the bisphosphonate is directly responsible for this occurrence has not been scientifically [proved],” said Ellen Eisenberg, D.M.D., head of oral and maxillofacial pathology at the University of Connecticut Health Center in Farmington.
Dr. Eisenberg, a pathologist and a consultant for Novartis, said she is unable to tell the difference between osteonecrosis of the jaw (ONJ) that has occurred in patients treated with radiation for head and neck cancer, in patients treated with intravenous or long-term oral bisphosphonates, or in patients who have not received either treatment.
“If you were to take something like 15 microscopic slides from dead bone of the jaw in such patients and ask me to tell what the difference is amongst them, I can tell you this: They all look the same,” she said.
The definitive diagnosis of bisphosphonate-associated ONJ requires exposed bone in the jaw for 8 weeks or longer. Although most cases involve a history of a surgical procedure in the mouth, most typically a tooth extraction, 40% of cases report sudden exposure of bone for no reason.
“The jaw is a high traffic area that is subject to extreme forces, and therefore it is very likely that a patient may not recall a particularly traumatic event. Nevertheless, that trauma occurred, and that preceded the exposure of the bone,” Dr. Eisenberg said at the annual Chicago Supportive Oncology Conference.
Dr. Eisenberg emphasized that the pathogenesis of ONJ is presumptive, based on the presumed alteration in the dynamic inhibition, resorption, and apposition of bone. “However, we do not know with any scientific certainty that this [presumed alteration] is, indeed, the cause,” she said.
Until results from definitive studies show that bisphosphonates, whether oral or intravenous, are indeed the cause of ONJ, it is imperative that any patient about to embark on bisphosphonate therapy get a thorough dental examination, so that any potential sites of infection or inflammatory disease can be eliminated, Dr. Eisenberg said.
Patients who develop ONJ have a host of comorbidities which may be cofactors in play. Right now, it is not scientifically sound to focus on just bisphosphonates as the cause, since there may be other reasons for developing ONJ, she maintained. For instance, patients with metastatic breast cancer or multiple myeloma suffer from widespread disease, with all of its implications, Dr. Eisenberg said.
Even older age can predispose an individual to develop ONJ, she added.
Dr. Eisenberg also suggested that a genetic polymorphism may predispose individuals to develop bisphosphonate-associated ONJ. “This is my suspicion, and it is purely conjecture, but I think that there is a subset of individuals who may be susceptible because their genetic profile predisposes them to the complication,” she said.
“What that genetic polymorphism is, I don't know, but we cannot dismiss the fact that only a very small proportion of people actually get ONJ. What is it that makes them vulnerable? Much more work needs to be done before we single out bisphosphonates as the sole cause.”
The conference is sponsored by the Journal of Supportive Oncology. The Journal of Supportive Oncology and this news organization are owned by Elsevier.
'We do not know with any scientific certainty that this [presumed alteration] is, indeed, the cause.” DR. EISENBERG
CHICAGO — Many people who currently take or who have taken bisphosphonates are being denied essential dental procedures because of undue fears about bisphosphonate-induced osteonecrosis of the jaw, according to a specialist in oral pathology.
“The phenomenon of ONJ seen in patients who happen to be on a bisphosphonate can also be seen in patients who have never had a bisphosphonate, but whether the bisphosphonate is directly responsible for this occurrence has not been scientifically [proved],” said Ellen Eisenberg, D.M.D., head of oral and maxillofacial pathology at the University of Connecticut Health Center in Farmington.
Dr. Eisenberg, a pathologist and a consultant for Novartis, said she is unable to tell the difference between osteonecrosis of the jaw (ONJ) that has occurred in patients treated with radiation for head and neck cancer, in patients treated with intravenous or long-term oral bisphosphonates, or in patients who have not received either treatment.
“If you were to take something like 15 microscopic slides from dead bone of the jaw in such patients and ask me to tell what the difference is amongst them, I can tell you this: They all look the same,” she said.
The definitive diagnosis of bisphosphonate-associated ONJ requires exposed bone in the jaw for 8 weeks or longer. Although most cases involve a history of a surgical procedure in the mouth, most typically a tooth extraction, 40% of cases report sudden exposure of bone for no reason.
“The jaw is a high traffic area that is subject to extreme forces, and therefore it is very likely that a patient may not recall a particularly traumatic event. Nevertheless, that trauma occurred, and that preceded the exposure of the bone,” Dr. Eisenberg said at the annual Chicago Supportive Oncology Conference.
Dr. Eisenberg emphasized that the pathogenesis of ONJ is presumptive, based on the presumed alteration in the dynamic inhibition, resorption, and apposition of bone. “However, we do not know with any scientific certainty that this [presumed alteration] is, indeed, the cause,” she said.
Until results from definitive studies show that bisphosphonates, whether oral or intravenous, are indeed the cause of ONJ, it is imperative that any patient about to embark on bisphosphonate therapy get a thorough dental examination, so that any potential sites of infection or inflammatory disease can be eliminated, Dr. Eisenberg said.
Patients who develop ONJ have a host of comorbidities which may be cofactors in play. Right now, it is not scientifically sound to focus on just bisphosphonates as the cause, since there may be other reasons for developing ONJ, she maintained. For instance, patients with metastatic breast cancer or multiple myeloma suffer from widespread disease, with all of its implications, Dr. Eisenberg said.
Even older age can predispose an individual to develop ONJ, she added.
Dr. Eisenberg also suggested that a genetic polymorphism may predispose individuals to develop bisphosphonate-associated ONJ. “This is my suspicion, and it is purely conjecture, but I think that there is a subset of individuals who may be susceptible because their genetic profile predisposes them to the complication,” she said.
“What that genetic polymorphism is, I don't know, but we cannot dismiss the fact that only a very small proportion of people actually get ONJ. What is it that makes them vulnerable? Much more work needs to be done before we single out bisphosphonates as the sole cause.”
The conference is sponsored by the Journal of Supportive Oncology. The Journal of Supportive Oncology and this news organization are owned by Elsevier.
'We do not know with any scientific certainty that this [presumed alteration] is, indeed, the cause.” DR. EISENBERG
CHICAGO — Many people who currently take or who have taken bisphosphonates are being denied essential dental procedures because of undue fears about bisphosphonate-induced osteonecrosis of the jaw, according to a specialist in oral pathology.
“The phenomenon of ONJ seen in patients who happen to be on a bisphosphonate can also be seen in patients who have never had a bisphosphonate, but whether the bisphosphonate is directly responsible for this occurrence has not been scientifically [proved],” said Ellen Eisenberg, D.M.D., head of oral and maxillofacial pathology at the University of Connecticut Health Center in Farmington.
Dr. Eisenberg, a pathologist and a consultant for Novartis, said she is unable to tell the difference between osteonecrosis of the jaw (ONJ) that has occurred in patients treated with radiation for head and neck cancer, in patients treated with intravenous or long-term oral bisphosphonates, or in patients who have not received either treatment.
“If you were to take something like 15 microscopic slides from dead bone of the jaw in such patients and ask me to tell what the difference is amongst them, I can tell you this: They all look the same,” she said.
The definitive diagnosis of bisphosphonate-associated ONJ requires exposed bone in the jaw for 8 weeks or longer. Although most cases involve a history of a surgical procedure in the mouth, most typically a tooth extraction, 40% of cases report sudden exposure of bone for no reason.
“The jaw is a high traffic area that is subject to extreme forces, and therefore it is very likely that a patient may not recall a particularly traumatic event. Nevertheless, that trauma occurred, and that preceded the exposure of the bone,” Dr. Eisenberg said at the annual Chicago Supportive Oncology Conference.
Dr. Eisenberg emphasized that the pathogenesis of ONJ is presumptive, based on the presumed alteration in the dynamic inhibition, resorption, and apposition of bone. “However, we do not know with any scientific certainty that this [presumed alteration] is, indeed, the cause,” she said.
Until results from definitive studies show that bisphosphonates, whether oral or intravenous, are indeed the cause of ONJ, it is imperative that any patient about to embark on bisphosphonate therapy get a thorough dental examination, so that any potential sites of infection or inflammatory disease can be eliminated, Dr. Eisenberg said.
Patients who develop ONJ have a host of comorbidities which may be cofactors in play. Right now, it is not scientifically sound to focus on just bisphosphonates as the cause, since there may be other reasons for developing ONJ, she maintained. For instance, patients with metastatic breast cancer or multiple myeloma suffer from widespread disease, with all of its implications, Dr. Eisenberg said.
Even older age can predispose an individual to develop ONJ, she added.
Dr. Eisenberg also suggested that a genetic polymorphism may predispose individuals to develop bisphosphonate-associated ONJ. “This is my suspicion, and it is purely conjecture, but I think that there is a subset of individuals who may be susceptible because their genetic profile predisposes them to the complication,” she said.
“What that genetic polymorphism is, I don't know, but we cannot dismiss the fact that only a very small proportion of people actually get ONJ. What is it that makes them vulnerable? Much more work needs to be done before we single out bisphosphonates as the sole cause.”
The conference is sponsored by the Journal of Supportive Oncology. The Journal of Supportive Oncology and this news organization are owned by Elsevier.
'We do not know with any scientific certainty that this [presumed alteration] is, indeed, the cause.” DR. EISENBERG
Access to Heroin a Boon to Refractory Addicts
BOCA RATON, FLA. – Supervised access to heroin improved the physical and mental well-being of chronic heroin addicts who were refractory to methadone maintenance treatment in Dutch and Candian studies.
In the Dutch studies, heroin-assisted treatment consisting of inhalable or injectable heroin prescribed over a 12-month period along with methadone was significantly more effective in improving physical health, mental status, and social functioning than was treatment with methadone alone, Dr. Wim van den Brink said at the annual meeting of the American Academy of Addiction Psychiatry.
These parameters improved in 50% of patients who got heroin plus methadone, compared with 27% of patients who got methadone maintenance alone in the inhalable study group, and in 56% of patients who got heroin plus methadone, compared with 31% of patients who got methadone maintenance alone in the injectable study group, said Dr. van den Brink, professor of psychiatry at the University of Amsterdam.
To be included, patients had to be chronic treatment-resistant heroin addicts. Their mean age was 39 years and 80% were male. They had been addicted to heroin for at least 16 years and had been using heroin 26 days of the last 30 days before entering the study. They had also been on methadone maintenance treatment for at least 12 years and had been using it 29 days out of the last 30 days before entry into the study. Ninety-two percent also were cocaine addicts and had used cocaine within 18 days of study entry. Of the total, 60% had physical problems, 60% had psychiatric problems, and 72% had social problems.
Patients randomized to heroin-assisted treatment with inhalable heroin (375 patients) or intravenous heroin (174 patients) could visit one of six clinics in Amsterdam three times a day, 7 days a week, and receive up to 1,000 mg/day of heroin plus 150 mg of oral methadone. Those in the methadone-only group received 150 mg of oral methadone daily.
Patients were deemed responders if they experienced a 40% or greater improvement in their physical health, mental status, or social functioning. In addition, rates of illegal activity, contact with other illicit drug users, and cocaine use declined, Dr. van den Brink reported.
At 12 months, the study finished, and about 82% of responders deteriorated again. “They had improved their physical health during [the study], but within 2 months [of it finishing] they were back to where they started. So 12 months of heroin treatment is not enough.”
A study in Canada showed similar results with prescribed heroin in addicts refractory to methadone treatment.
In the North American Opiate Medication Initiative study, heroin-assisted treatment plus methadone maintenance produced marked improvements in the subjects' health and reduced illegal activity, leading the investigators to conclude that heroin-assisted treatment is effective in North America as well as Europe.
However, whether such a strategy would work in the United States is questionable right now, he said. “Supervised heroin-assisted treatment is potentially applicable in the [United States], but an important requirement is full acceptance of the harm reduction concept. Without such acceptance, it is difficult to imagine that you could do something like this. We do not arrest people for taking drugs in the Netherlands, but in the U.S. there is a very high rate of prosecution–which is also very expensive,” he said.
The key thing is to begin to think about heroin addiction as a chronic, relapsing disease, Dr. van den Brink said. “There is no one treatment for all patients. Methadone and buprenorphine are very effective treatments, but there are patients who do not respond, so we have to think about additional options. This is how we see heroin-assisted treatment–as a last treatment option for those who've tried everything and didn't succeed.”
Dr. van den Brink disclosed relationships with several pharmaceutical companies, including Eli Lilly & Co., Merck Serono International, Alkermes Inc., H. Lundbeck A/S, Organon/Schering-Plough, and Solvay.
BOCA RATON, FLA. – Supervised access to heroin improved the physical and mental well-being of chronic heroin addicts who were refractory to methadone maintenance treatment in Dutch and Candian studies.
In the Dutch studies, heroin-assisted treatment consisting of inhalable or injectable heroin prescribed over a 12-month period along with methadone was significantly more effective in improving physical health, mental status, and social functioning than was treatment with methadone alone, Dr. Wim van den Brink said at the annual meeting of the American Academy of Addiction Psychiatry.
These parameters improved in 50% of patients who got heroin plus methadone, compared with 27% of patients who got methadone maintenance alone in the inhalable study group, and in 56% of patients who got heroin plus methadone, compared with 31% of patients who got methadone maintenance alone in the injectable study group, said Dr. van den Brink, professor of psychiatry at the University of Amsterdam.
To be included, patients had to be chronic treatment-resistant heroin addicts. Their mean age was 39 years and 80% were male. They had been addicted to heroin for at least 16 years and had been using heroin 26 days of the last 30 days before entering the study. They had also been on methadone maintenance treatment for at least 12 years and had been using it 29 days out of the last 30 days before entry into the study. Ninety-two percent also were cocaine addicts and had used cocaine within 18 days of study entry. Of the total, 60% had physical problems, 60% had psychiatric problems, and 72% had social problems.
Patients randomized to heroin-assisted treatment with inhalable heroin (375 patients) or intravenous heroin (174 patients) could visit one of six clinics in Amsterdam three times a day, 7 days a week, and receive up to 1,000 mg/day of heroin plus 150 mg of oral methadone. Those in the methadone-only group received 150 mg of oral methadone daily.
Patients were deemed responders if they experienced a 40% or greater improvement in their physical health, mental status, or social functioning. In addition, rates of illegal activity, contact with other illicit drug users, and cocaine use declined, Dr. van den Brink reported.
At 12 months, the study finished, and about 82% of responders deteriorated again. “They had improved their physical health during [the study], but within 2 months [of it finishing] they were back to where they started. So 12 months of heroin treatment is not enough.”
A study in Canada showed similar results with prescribed heroin in addicts refractory to methadone treatment.
In the North American Opiate Medication Initiative study, heroin-assisted treatment plus methadone maintenance produced marked improvements in the subjects' health and reduced illegal activity, leading the investigators to conclude that heroin-assisted treatment is effective in North America as well as Europe.
However, whether such a strategy would work in the United States is questionable right now, he said. “Supervised heroin-assisted treatment is potentially applicable in the [United States], but an important requirement is full acceptance of the harm reduction concept. Without such acceptance, it is difficult to imagine that you could do something like this. We do not arrest people for taking drugs in the Netherlands, but in the U.S. there is a very high rate of prosecution–which is also very expensive,” he said.
The key thing is to begin to think about heroin addiction as a chronic, relapsing disease, Dr. van den Brink said. “There is no one treatment for all patients. Methadone and buprenorphine are very effective treatments, but there are patients who do not respond, so we have to think about additional options. This is how we see heroin-assisted treatment–as a last treatment option for those who've tried everything and didn't succeed.”
Dr. van den Brink disclosed relationships with several pharmaceutical companies, including Eli Lilly & Co., Merck Serono International, Alkermes Inc., H. Lundbeck A/S, Organon/Schering-Plough, and Solvay.
BOCA RATON, FLA. – Supervised access to heroin improved the physical and mental well-being of chronic heroin addicts who were refractory to methadone maintenance treatment in Dutch and Candian studies.
In the Dutch studies, heroin-assisted treatment consisting of inhalable or injectable heroin prescribed over a 12-month period along with methadone was significantly more effective in improving physical health, mental status, and social functioning than was treatment with methadone alone, Dr. Wim van den Brink said at the annual meeting of the American Academy of Addiction Psychiatry.
These parameters improved in 50% of patients who got heroin plus methadone, compared with 27% of patients who got methadone maintenance alone in the inhalable study group, and in 56% of patients who got heroin plus methadone, compared with 31% of patients who got methadone maintenance alone in the injectable study group, said Dr. van den Brink, professor of psychiatry at the University of Amsterdam.
To be included, patients had to be chronic treatment-resistant heroin addicts. Their mean age was 39 years and 80% were male. They had been addicted to heroin for at least 16 years and had been using heroin 26 days of the last 30 days before entering the study. They had also been on methadone maintenance treatment for at least 12 years and had been using it 29 days out of the last 30 days before entry into the study. Ninety-two percent also were cocaine addicts and had used cocaine within 18 days of study entry. Of the total, 60% had physical problems, 60% had psychiatric problems, and 72% had social problems.
Patients randomized to heroin-assisted treatment with inhalable heroin (375 patients) or intravenous heroin (174 patients) could visit one of six clinics in Amsterdam three times a day, 7 days a week, and receive up to 1,000 mg/day of heroin plus 150 mg of oral methadone. Those in the methadone-only group received 150 mg of oral methadone daily.
Patients were deemed responders if they experienced a 40% or greater improvement in their physical health, mental status, or social functioning. In addition, rates of illegal activity, contact with other illicit drug users, and cocaine use declined, Dr. van den Brink reported.
At 12 months, the study finished, and about 82% of responders deteriorated again. “They had improved their physical health during [the study], but within 2 months [of it finishing] they were back to where they started. So 12 months of heroin treatment is not enough.”
A study in Canada showed similar results with prescribed heroin in addicts refractory to methadone treatment.
In the North American Opiate Medication Initiative study, heroin-assisted treatment plus methadone maintenance produced marked improvements in the subjects' health and reduced illegal activity, leading the investigators to conclude that heroin-assisted treatment is effective in North America as well as Europe.
However, whether such a strategy would work in the United States is questionable right now, he said. “Supervised heroin-assisted treatment is potentially applicable in the [United States], but an important requirement is full acceptance of the harm reduction concept. Without such acceptance, it is difficult to imagine that you could do something like this. We do not arrest people for taking drugs in the Netherlands, but in the U.S. there is a very high rate of prosecution–which is also very expensive,” he said.
The key thing is to begin to think about heroin addiction as a chronic, relapsing disease, Dr. van den Brink said. “There is no one treatment for all patients. Methadone and buprenorphine are very effective treatments, but there are patients who do not respond, so we have to think about additional options. This is how we see heroin-assisted treatment–as a last treatment option for those who've tried everything and didn't succeed.”
Dr. van den Brink disclosed relationships with several pharmaceutical companies, including Eli Lilly & Co., Merck Serono International, Alkermes Inc., H. Lundbeck A/S, Organon/Schering-Plough, and Solvay.
Vouchers Can Help Pregnant Smokers Abstain
BOCA RATON, FLA. – Contingency management was effective as a strategy in helping pregnant women to stop smoking.
In a pilot study of pregnant women who continued to smoke cigarettes, 11 (37%) of 30 women who received contingency management achieved abstinence, compared with just 2 (10%) of 23 women who did not, Dr. Sarah Heil said in a report at the annual meeting of the American Academy of Addiction Psychiatry.
Women in both the contingent and noncontingent groups were seen every day for the first 5 days of the study. During this time, abstinence was based on a breath carbon monoxide level of 6 parts per million or less, said Dr. Heil of the University of Vermont, Burlington.
After the first 5 days, the women were seen according to the following schedule:
▸ Twice a week for 7 weeks.
▸ Once a week for the next 11 weeks.
▸ Once every other week until delivery.
▸ Once a week for the first 4 weeks post partum.
▸ Every other week for the next 8 weeks.
Abstinence in this phase of the study was assessed by measuring urine cotinine levels; levels of 80 ng/mL or less were indicative of abstinence.
The women were rewarded with vouchers, which were earned contingent on biochemically verified abstinence. The voucher value began at $6.25 and escalated at a rate of $1.25 per consecutive negative sample up to a maximum of $45.
“These vouchers are like having a bank account with us. We put their money into an account, and they are allowed to spend it on things we believe are appropriate. So there were a lot of gift certificates, paying of credit card bills, and shopping at Wal-Mart and grocery stores,” Dr. Heil said.
Women who were randomized to noncontingency management got vouchers independent of their smoking status. The vouchers were a flat $11.50 per antepartum visit, and $20 per each postpartum visit.
The participants had been smoking for about 8 years; most of them lived with other smokers. They smoked approximately one pack of cigarettes a day before pregnancy, but had reduced this amount by roughly 50% by the time they entered the study. Most of them had less than a high school education, and few were married.
To be considered abstinent at each time point, the women had to self-report that they had not had a cigarette–“not even a puff”–in the previous 7 days, as well as the appropriate urine cotinine level.
The effects obtained in the study persisted 3 months after delivery, and for a further 3 months, even though the voucher program was discontinued at 3 months post partum. This was true for women in the contingent and noncontingent groups, Dr. Heil said.
In addition, fetuses in the contingent group gained weight faster than did those in the noncontingent group. Fetal weight was estimated by measuring fetal length and abdominal circumference by ultrasound.
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the United States. Placental abruptions, small gestational age, preterm and still birth, low birth weight, and increased risk for sudden infant death syndrome are all associated with cigarette smoking by the mother.
The adverse effects of smoking on the neonate cost $1,630/birth per year in 2008 dollars.
Dr. Heil said she hopes to extend her research on contingency management to include pregnant smokers who are also opioid dependent.
The value began at $6.25 and escalated at a rate of $1.25 per negative sample up to a maximum of $45. DR. HEIL
BOCA RATON, FLA. – Contingency management was effective as a strategy in helping pregnant women to stop smoking.
In a pilot study of pregnant women who continued to smoke cigarettes, 11 (37%) of 30 women who received contingency management achieved abstinence, compared with just 2 (10%) of 23 women who did not, Dr. Sarah Heil said in a report at the annual meeting of the American Academy of Addiction Psychiatry.
Women in both the contingent and noncontingent groups were seen every day for the first 5 days of the study. During this time, abstinence was based on a breath carbon monoxide level of 6 parts per million or less, said Dr. Heil of the University of Vermont, Burlington.
After the first 5 days, the women were seen according to the following schedule:
▸ Twice a week for 7 weeks.
▸ Once a week for the next 11 weeks.
▸ Once every other week until delivery.
▸ Once a week for the first 4 weeks post partum.
▸ Every other week for the next 8 weeks.
Abstinence in this phase of the study was assessed by measuring urine cotinine levels; levels of 80 ng/mL or less were indicative of abstinence.
The women were rewarded with vouchers, which were earned contingent on biochemically verified abstinence. The voucher value began at $6.25 and escalated at a rate of $1.25 per consecutive negative sample up to a maximum of $45.
“These vouchers are like having a bank account with us. We put their money into an account, and they are allowed to spend it on things we believe are appropriate. So there were a lot of gift certificates, paying of credit card bills, and shopping at Wal-Mart and grocery stores,” Dr. Heil said.
Women who were randomized to noncontingency management got vouchers independent of their smoking status. The vouchers were a flat $11.50 per antepartum visit, and $20 per each postpartum visit.
The participants had been smoking for about 8 years; most of them lived with other smokers. They smoked approximately one pack of cigarettes a day before pregnancy, but had reduced this amount by roughly 50% by the time they entered the study. Most of them had less than a high school education, and few were married.
To be considered abstinent at each time point, the women had to self-report that they had not had a cigarette–“not even a puff”–in the previous 7 days, as well as the appropriate urine cotinine level.
The effects obtained in the study persisted 3 months after delivery, and for a further 3 months, even though the voucher program was discontinued at 3 months post partum. This was true for women in the contingent and noncontingent groups, Dr. Heil said.
In addition, fetuses in the contingent group gained weight faster than did those in the noncontingent group. Fetal weight was estimated by measuring fetal length and abdominal circumference by ultrasound.
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the United States. Placental abruptions, small gestational age, preterm and still birth, low birth weight, and increased risk for sudden infant death syndrome are all associated with cigarette smoking by the mother.
The adverse effects of smoking on the neonate cost $1,630/birth per year in 2008 dollars.
Dr. Heil said she hopes to extend her research on contingency management to include pregnant smokers who are also opioid dependent.
The value began at $6.25 and escalated at a rate of $1.25 per negative sample up to a maximum of $45. DR. HEIL
BOCA RATON, FLA. – Contingency management was effective as a strategy in helping pregnant women to stop smoking.
In a pilot study of pregnant women who continued to smoke cigarettes, 11 (37%) of 30 women who received contingency management achieved abstinence, compared with just 2 (10%) of 23 women who did not, Dr. Sarah Heil said in a report at the annual meeting of the American Academy of Addiction Psychiatry.
Women in both the contingent and noncontingent groups were seen every day for the first 5 days of the study. During this time, abstinence was based on a breath carbon monoxide level of 6 parts per million or less, said Dr. Heil of the University of Vermont, Burlington.
After the first 5 days, the women were seen according to the following schedule:
▸ Twice a week for 7 weeks.
▸ Once a week for the next 11 weeks.
▸ Once every other week until delivery.
▸ Once a week for the first 4 weeks post partum.
▸ Every other week for the next 8 weeks.
Abstinence in this phase of the study was assessed by measuring urine cotinine levels; levels of 80 ng/mL or less were indicative of abstinence.
The women were rewarded with vouchers, which were earned contingent on biochemically verified abstinence. The voucher value began at $6.25 and escalated at a rate of $1.25 per consecutive negative sample up to a maximum of $45.
“These vouchers are like having a bank account with us. We put their money into an account, and they are allowed to spend it on things we believe are appropriate. So there were a lot of gift certificates, paying of credit card bills, and shopping at Wal-Mart and grocery stores,” Dr. Heil said.
Women who were randomized to noncontingency management got vouchers independent of their smoking status. The vouchers were a flat $11.50 per antepartum visit, and $20 per each postpartum visit.
The participants had been smoking for about 8 years; most of them lived with other smokers. They smoked approximately one pack of cigarettes a day before pregnancy, but had reduced this amount by roughly 50% by the time they entered the study. Most of them had less than a high school education, and few were married.
To be considered abstinent at each time point, the women had to self-report that they had not had a cigarette–“not even a puff”–in the previous 7 days, as well as the appropriate urine cotinine level.
The effects obtained in the study persisted 3 months after delivery, and for a further 3 months, even though the voucher program was discontinued at 3 months post partum. This was true for women in the contingent and noncontingent groups, Dr. Heil said.
In addition, fetuses in the contingent group gained weight faster than did those in the noncontingent group. Fetal weight was estimated by measuring fetal length and abdominal circumference by ultrasound.
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the United States. Placental abruptions, small gestational age, preterm and still birth, low birth weight, and increased risk for sudden infant death syndrome are all associated with cigarette smoking by the mother.
The adverse effects of smoking on the neonate cost $1,630/birth per year in 2008 dollars.
Dr. Heil said she hopes to extend her research on contingency management to include pregnant smokers who are also opioid dependent.
The value began at $6.25 and escalated at a rate of $1.25 per negative sample up to a maximum of $45. DR. HEIL