Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.

FDA Revamps Drug Info, Aims to Improve Safety

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Prescription drug package inserts will soon have a new format that U.S. Food and Drug Administration officials believe will reduce the risk of medical errors.

A goal of the “major revisions” recently announced by the FDA is to prioritize warning information and provide user-friendly access to the most important prescribing information. The new inserts will contain a “Highlights” section prominently displayed at the top of the first page, Dr. Andrew von Eschenbach, acting FDA commissioner, explained during a press briefing sponsored by the agency.

The new format will provide the most up-to-date information in a clearly organized, concisely written, easily accessed format so doctors can convey this vital information to patients, he said.

Other key features of the new inserts will include a table of contents that provides reference to detailed safety and efficacy information, the date of initial product approval and information about any changes to the label in the past year, a patient counseling information section, and a toll-free number and Web site for reporting adverse events.

The revisions also were designed to make prescription information more accessible via the Internet: Information will be updated in real-time to DailyMed, an interagency online health information clearinghouse, which can be accessed at http://dailymed.nlm.nih.gov

This information will also be made available soon at a new Web site called Facts@FDA

The electronic capability aspects of the new package insert requirements are one of the most “potentially exciting opportunities” created by the new system, he said, adding that the electronic information will allow physicians to access the most up-to-date prescribing information at the point of care.

This is particularly important in this age of 12-minute patient visits, said U.S. Surgeon General Richard H. Carmona during the briefing. “We made great strides today that will benefit providers and the American public by increasing the health literacy of all those who desperately need this information.”

The final rule providing for the changes—the first changes to prescription drug package inserts in 25 years—has been in the works since 2000 when a draft rule was released. The final version, released along with two guidance documents and two draft guidance documents to assist drug companies with implementing the revisions, differs little from the early draft, and was based largely on information from focus groups, physician surveys, a public meeting, and written comments.

The revisions will be phased in gradually and apply only to drugs approved in the last 5 years, as well as newly approved drugs and those that receive new indications. However, FDA officials are encouraging voluntary industrywide application of the rule for existing drugs.

The American Medical Association applauded the rule as one that will simplify the prescribing process for physicians, but some consumer advocates, such as Washington-based Public Citizen, are critical, saying the revisions fail the patients they are purported to ultimately protect.

A preamble added to the rule is a “sneak attack” on patients' rights designed to preempt lawsuits filed by patients under state law, Public Citizen said in a statement.

Further, although the revisions simplify and prioritize labeling for doctors and patients, they don't go far enough, according to Public Citizen. In many cases, patients will receive this information only if they request it. Otherwise they will receive only nonregulated patient information leaflets; these have been shown to lack scientifically accurate drug information, the group argues.

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Prescription drug package inserts will soon have a new format that U.S. Food and Drug Administration officials believe will reduce the risk of medical errors.

A goal of the “major revisions” recently announced by the FDA is to prioritize warning information and provide user-friendly access to the most important prescribing information. The new inserts will contain a “Highlights” section prominently displayed at the top of the first page, Dr. Andrew von Eschenbach, acting FDA commissioner, explained during a press briefing sponsored by the agency.

The new format will provide the most up-to-date information in a clearly organized, concisely written, easily accessed format so doctors can convey this vital information to patients, he said.

Other key features of the new inserts will include a table of contents that provides reference to detailed safety and efficacy information, the date of initial product approval and information about any changes to the label in the past year, a patient counseling information section, and a toll-free number and Web site for reporting adverse events.

The revisions also were designed to make prescription information more accessible via the Internet: Information will be updated in real-time to DailyMed, an interagency online health information clearinghouse, which can be accessed at http://dailymed.nlm.nih.gov

This information will also be made available soon at a new Web site called Facts@FDA

The electronic capability aspects of the new package insert requirements are one of the most “potentially exciting opportunities” created by the new system, he said, adding that the electronic information will allow physicians to access the most up-to-date prescribing information at the point of care.

This is particularly important in this age of 12-minute patient visits, said U.S. Surgeon General Richard H. Carmona during the briefing. “We made great strides today that will benefit providers and the American public by increasing the health literacy of all those who desperately need this information.”

The final rule providing for the changes—the first changes to prescription drug package inserts in 25 years—has been in the works since 2000 when a draft rule was released. The final version, released along with two guidance documents and two draft guidance documents to assist drug companies with implementing the revisions, differs little from the early draft, and was based largely on information from focus groups, physician surveys, a public meeting, and written comments.

The revisions will be phased in gradually and apply only to drugs approved in the last 5 years, as well as newly approved drugs and those that receive new indications. However, FDA officials are encouraging voluntary industrywide application of the rule for existing drugs.

The American Medical Association applauded the rule as one that will simplify the prescribing process for physicians, but some consumer advocates, such as Washington-based Public Citizen, are critical, saying the revisions fail the patients they are purported to ultimately protect.

A preamble added to the rule is a “sneak attack” on patients' rights designed to preempt lawsuits filed by patients under state law, Public Citizen said in a statement.

Further, although the revisions simplify and prioritize labeling for doctors and patients, they don't go far enough, according to Public Citizen. In many cases, patients will receive this information only if they request it. Otherwise they will receive only nonregulated patient information leaflets; these have been shown to lack scientifically accurate drug information, the group argues.

Prescription drug package inserts will soon have a new format that U.S. Food and Drug Administration officials believe will reduce the risk of medical errors.

A goal of the “major revisions” recently announced by the FDA is to prioritize warning information and provide user-friendly access to the most important prescribing information. The new inserts will contain a “Highlights” section prominently displayed at the top of the first page, Dr. Andrew von Eschenbach, acting FDA commissioner, explained during a press briefing sponsored by the agency.

The new format will provide the most up-to-date information in a clearly organized, concisely written, easily accessed format so doctors can convey this vital information to patients, he said.

Other key features of the new inserts will include a table of contents that provides reference to detailed safety and efficacy information, the date of initial product approval and information about any changes to the label in the past year, a patient counseling information section, and a toll-free number and Web site for reporting adverse events.

The revisions also were designed to make prescription information more accessible via the Internet: Information will be updated in real-time to DailyMed, an interagency online health information clearinghouse, which can be accessed at http://dailymed.nlm.nih.gov

This information will also be made available soon at a new Web site called Facts@FDA

The electronic capability aspects of the new package insert requirements are one of the most “potentially exciting opportunities” created by the new system, he said, adding that the electronic information will allow physicians to access the most up-to-date prescribing information at the point of care.

This is particularly important in this age of 12-minute patient visits, said U.S. Surgeon General Richard H. Carmona during the briefing. “We made great strides today that will benefit providers and the American public by increasing the health literacy of all those who desperately need this information.”

The final rule providing for the changes—the first changes to prescription drug package inserts in 25 years—has been in the works since 2000 when a draft rule was released. The final version, released along with two guidance documents and two draft guidance documents to assist drug companies with implementing the revisions, differs little from the early draft, and was based largely on information from focus groups, physician surveys, a public meeting, and written comments.

The revisions will be phased in gradually and apply only to drugs approved in the last 5 years, as well as newly approved drugs and those that receive new indications. However, FDA officials are encouraging voluntary industrywide application of the rule for existing drugs.

The American Medical Association applauded the rule as one that will simplify the prescribing process for physicians, but some consumer advocates, such as Washington-based Public Citizen, are critical, saying the revisions fail the patients they are purported to ultimately protect.

A preamble added to the rule is a “sneak attack” on patients' rights designed to preempt lawsuits filed by patients under state law, Public Citizen said in a statement.

Further, although the revisions simplify and prioritize labeling for doctors and patients, they don't go far enough, according to Public Citizen. In many cases, patients will receive this information only if they request it. Otherwise they will receive only nonregulated patient information leaflets; these have been shown to lack scientifically accurate drug information, the group argues.

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Transfusion Still Overused in Bypass Patients

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ATLANTA — Despite guidelines recommending against red blood cell transfusions in patients undergoing coronary artery bypass graft surgery, the practice remains fairly common and is often detrimental, a study shows.

Of 940 stable CABG patients from the Multicenter Study of Perioperative Ischemia Epidemiology II (EPI II), 20% received red blood cell transfusions, and these patients were significantly more likely than those who did not receive a transfusion to experience myocardial infarction (odds ratio 1.9), renal dysfunction (OR 3.4), renal failure requiring dialysis (OR 4.0), and/or harvest-site wound infection (OR 5.5), Dr. Jack Levin reported at the annual meeting of the American Society of Hematology.

Red blood cell transfusion was shown on multivariate analysis to be an independent predictor of composite morbidity outcome, cardiac morbidity, and harvest-site wound infection, said Dr. Levin of University of California, San Francisco. Transfusion also resulted in a longer hospital stay; 14.4 days for transfused patients, compared with 11.9 days for nontransfused patients.

Patients included only those from EPI II with a low to moderate risk profile, postoperative hemoglobin levels of at least 10 g/dL, minimal postoperative blood loss, and no evidence of a morbid event on the day of surgery. They were followed postoperatively for 24 hours to assess the transfusion, and until hospital discharge to assess multiorgan outcomes and resource use.

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ATLANTA — Despite guidelines recommending against red blood cell transfusions in patients undergoing coronary artery bypass graft surgery, the practice remains fairly common and is often detrimental, a study shows.

Of 940 stable CABG patients from the Multicenter Study of Perioperative Ischemia Epidemiology II (EPI II), 20% received red blood cell transfusions, and these patients were significantly more likely than those who did not receive a transfusion to experience myocardial infarction (odds ratio 1.9), renal dysfunction (OR 3.4), renal failure requiring dialysis (OR 4.0), and/or harvest-site wound infection (OR 5.5), Dr. Jack Levin reported at the annual meeting of the American Society of Hematology.

Red blood cell transfusion was shown on multivariate analysis to be an independent predictor of composite morbidity outcome, cardiac morbidity, and harvest-site wound infection, said Dr. Levin of University of California, San Francisco. Transfusion also resulted in a longer hospital stay; 14.4 days for transfused patients, compared with 11.9 days for nontransfused patients.

Patients included only those from EPI II with a low to moderate risk profile, postoperative hemoglobin levels of at least 10 g/dL, minimal postoperative blood loss, and no evidence of a morbid event on the day of surgery. They were followed postoperatively for 24 hours to assess the transfusion, and until hospital discharge to assess multiorgan outcomes and resource use.

ATLANTA — Despite guidelines recommending against red blood cell transfusions in patients undergoing coronary artery bypass graft surgery, the practice remains fairly common and is often detrimental, a study shows.

Of 940 stable CABG patients from the Multicenter Study of Perioperative Ischemia Epidemiology II (EPI II), 20% received red blood cell transfusions, and these patients were significantly more likely than those who did not receive a transfusion to experience myocardial infarction (odds ratio 1.9), renal dysfunction (OR 3.4), renal failure requiring dialysis (OR 4.0), and/or harvest-site wound infection (OR 5.5), Dr. Jack Levin reported at the annual meeting of the American Society of Hematology.

Red blood cell transfusion was shown on multivariate analysis to be an independent predictor of composite morbidity outcome, cardiac morbidity, and harvest-site wound infection, said Dr. Levin of University of California, San Francisco. Transfusion also resulted in a longer hospital stay; 14.4 days for transfused patients, compared with 11.9 days for nontransfused patients.

Patients included only those from EPI II with a low to moderate risk profile, postoperative hemoglobin levels of at least 10 g/dL, minimal postoperative blood loss, and no evidence of a morbid event on the day of surgery. They were followed postoperatively for 24 hours to assess the transfusion, and until hospital discharge to assess multiorgan outcomes and resource use.

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Adequate Body Peel Prep Aids Tx, Enhances Results

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ATLANTA — Pretreatment preparation is key to uniform application and a good outcome with the Cook body peel, Dr. Sue Ellen Cox said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

Patients should be pretreated with a retinoid, such as Tazorac (tazarotene), and an alpha hydroxy acid product, such as Lac-Hydrin. "You want the skin to turn over in advance of the procedure, but then you want to stop that about a week before the peel so that there is no irritation at the time of the peel," said Dr. Cox, a dermatologic surgeon in Chapel Hill, N.C.

Just before the peel, one should rub the skin with acetone to degrease the treatment area, then apply a "fairly uniform" thin layer of 70% glycolic acid gel, she advised. A gel formulation is important, because it serves as a partial barrier to the trichloracetic acid (TCA) that is also used as part of the Cook body peel. Too thick a layer of glycolic acid gel will prevent penetration of the TCA, she noted.

Typically, a 40% TCA concentration is applied over the glycolic acid gel. Dr. Cox said she gets the best results with 40% TCA but will try 35% first in those with very thin skin to gauge the development of the characteristic speckled white appearance that serves as the treatment end point.

The peel is stopped at this end point with a 10% sodium bicarbonate solution.

Immediately after the peel, the skin should be hydrated with Aquaphor or Vaseline, and the patient should apply a moisturizer such as Vanicream at home for long-term hydration.

Patients should be advised to use sun protection and to avoid rubbing or otherwise traumatizing the skin in the weeks after the peel, Dr. Cox said.

Skin flaking can occur for 2–4 weeks depending on the area treated. Hands, for example, will flake for about 2 weeks; legs will flake for about 4 weeks. Most patients will see about a 50% improvement after the first peel. Peels can be repeated every 1–4 months as necessary, but most patients are satisfied with the initial outcome, she said.

The Cook body peel is a safe, highly predictable peel that can be used almost anywhere on the body. Indications for this peel include actinic keratoses, lentigines, poikiloderma, hyperpigmentation, fine lines, and wrinkles. "Disseminated superficial actinic porokeratosis [DSAP] is my favorite indication; this is where I get all my referrals from my general dermatology friends," Dr. Cox said.

DSAP is very difficult to treat with other modalities, but it responds nicely to the Cook body peel, she said, noting, however, that multiple peels may be necessary in patients with this disease. The peel can be repeated every 2–4 months as needed in patients with DSAP. The lesions tend to recur, so even after achieving desired results, the peel may need to be repeated in about 2 years, she added.

This patient is shown at baseline and at 7.5 months post treatment, after receiving two Cook body peels. Photos courtesy Dr. Sue Ellen Cox

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ATLANTA — Pretreatment preparation is key to uniform application and a good outcome with the Cook body peel, Dr. Sue Ellen Cox said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

Patients should be pretreated with a retinoid, such as Tazorac (tazarotene), and an alpha hydroxy acid product, such as Lac-Hydrin. "You want the skin to turn over in advance of the procedure, but then you want to stop that about a week before the peel so that there is no irritation at the time of the peel," said Dr. Cox, a dermatologic surgeon in Chapel Hill, N.C.

Just before the peel, one should rub the skin with acetone to degrease the treatment area, then apply a "fairly uniform" thin layer of 70% glycolic acid gel, she advised. A gel formulation is important, because it serves as a partial barrier to the trichloracetic acid (TCA) that is also used as part of the Cook body peel. Too thick a layer of glycolic acid gel will prevent penetration of the TCA, she noted.

Typically, a 40% TCA concentration is applied over the glycolic acid gel. Dr. Cox said she gets the best results with 40% TCA but will try 35% first in those with very thin skin to gauge the development of the characteristic speckled white appearance that serves as the treatment end point.

The peel is stopped at this end point with a 10% sodium bicarbonate solution.

Immediately after the peel, the skin should be hydrated with Aquaphor or Vaseline, and the patient should apply a moisturizer such as Vanicream at home for long-term hydration.

Patients should be advised to use sun protection and to avoid rubbing or otherwise traumatizing the skin in the weeks after the peel, Dr. Cox said.

Skin flaking can occur for 2–4 weeks depending on the area treated. Hands, for example, will flake for about 2 weeks; legs will flake for about 4 weeks. Most patients will see about a 50% improvement after the first peel. Peels can be repeated every 1–4 months as necessary, but most patients are satisfied with the initial outcome, she said.

The Cook body peel is a safe, highly predictable peel that can be used almost anywhere on the body. Indications for this peel include actinic keratoses, lentigines, poikiloderma, hyperpigmentation, fine lines, and wrinkles. "Disseminated superficial actinic porokeratosis [DSAP] is my favorite indication; this is where I get all my referrals from my general dermatology friends," Dr. Cox said.

DSAP is very difficult to treat with other modalities, but it responds nicely to the Cook body peel, she said, noting, however, that multiple peels may be necessary in patients with this disease. The peel can be repeated every 2–4 months as needed in patients with DSAP. The lesions tend to recur, so even after achieving desired results, the peel may need to be repeated in about 2 years, she added.

This patient is shown at baseline and at 7.5 months post treatment, after receiving two Cook body peels. Photos courtesy Dr. Sue Ellen Cox

ATLANTA — Pretreatment preparation is key to uniform application and a good outcome with the Cook body peel, Dr. Sue Ellen Cox said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

Patients should be pretreated with a retinoid, such as Tazorac (tazarotene), and an alpha hydroxy acid product, such as Lac-Hydrin. "You want the skin to turn over in advance of the procedure, but then you want to stop that about a week before the peel so that there is no irritation at the time of the peel," said Dr. Cox, a dermatologic surgeon in Chapel Hill, N.C.

Just before the peel, one should rub the skin with acetone to degrease the treatment area, then apply a "fairly uniform" thin layer of 70% glycolic acid gel, she advised. A gel formulation is important, because it serves as a partial barrier to the trichloracetic acid (TCA) that is also used as part of the Cook body peel. Too thick a layer of glycolic acid gel will prevent penetration of the TCA, she noted.

Typically, a 40% TCA concentration is applied over the glycolic acid gel. Dr. Cox said she gets the best results with 40% TCA but will try 35% first in those with very thin skin to gauge the development of the characteristic speckled white appearance that serves as the treatment end point.

The peel is stopped at this end point with a 10% sodium bicarbonate solution.

Immediately after the peel, the skin should be hydrated with Aquaphor or Vaseline, and the patient should apply a moisturizer such as Vanicream at home for long-term hydration.

Patients should be advised to use sun protection and to avoid rubbing or otherwise traumatizing the skin in the weeks after the peel, Dr. Cox said.

Skin flaking can occur for 2–4 weeks depending on the area treated. Hands, for example, will flake for about 2 weeks; legs will flake for about 4 weeks. Most patients will see about a 50% improvement after the first peel. Peels can be repeated every 1–4 months as necessary, but most patients are satisfied with the initial outcome, she said.

The Cook body peel is a safe, highly predictable peel that can be used almost anywhere on the body. Indications for this peel include actinic keratoses, lentigines, poikiloderma, hyperpigmentation, fine lines, and wrinkles. "Disseminated superficial actinic porokeratosis [DSAP] is my favorite indication; this is where I get all my referrals from my general dermatology friends," Dr. Cox said.

DSAP is very difficult to treat with other modalities, but it responds nicely to the Cook body peel, she said, noting, however, that multiple peels may be necessary in patients with this disease. The peel can be repeated every 2–4 months as needed in patients with DSAP. The lesions tend to recur, so even after achieving desired results, the peel may need to be repeated in about 2 years, she added.

This patient is shown at baseline and at 7.5 months post treatment, after receiving two Cook body peels. Photos courtesy Dr. Sue Ellen Cox

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Pelvic Floor Disorders Don't Require Activity Restrictions

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ATLANTA — Most activity restrictions recommended for preventing the progression or recurrence of pelvic floor disorders are unwarranted, results of a small study suggest.

Several daily activities, such as lifting and exercising, are often restricted in patients with pelvic floor disorders and in those who undergo pelvic floor surgery, because there is concern that the activities can increase intraabdominal pressure and thereby exacerbate the disorder, Dr. Larissa F. Weir explained at the annual meeting of the American Urogynecologic Society.

In fact, of 23 physical activities tested in 30 women who were not undergoing treatment for pelvic floor disorders, most had no greater effect on intraabdominal pressure than unavoidable or typically unrestricted activities had, said Dr. Weir, who was a medical student at the University of Iowa, Iowa City, at the time of the study, but who is now a first-year resident at the San Antonio Uniformed Services Health Education Consortium.

Lifting technique with higher-weight items did, however, have an effect on intraabdominal pressure, she noted.

Activity restrictions can have a significant impact on daily life, so it is important that they are based on evidence, Dr. Weir said.

These findings lay a foundation for evidence-based revisions of current activity restriction recommendations, but prospective long-term studies of the impact of intraabdominal pressure on pelvic floor function and of the effects of physical activity on intraabdominal pressure are needed, she added.

Women in the study performed three repetitions of each activity, and intraabdominal pressures were measured using a microtip rectal catheter. The mean peak and net intraabdominal pressures associated with the repetitions were calculated and compared with the baseline values in each patient.

The peak values for activities such as coughing, climbing stairs, and lowering to and rising from the floor, and for exercises such as jumping jacks, abdominal crunches, walking, and jogging on a treadmill were not significantly different from those for rising from a chair. Rising from a chair produced significantly higher abdominal pressures than lifting 8–10 pounds, Dr. Weir said.

The activities that produced the highest peak and net pressures included lifting 20 and 35 pounds off the ground, and forceful coughing; those that produced the lowest peak and net pressures were lifting 8 pounds from a low table, from counter height, and overhead.

As weight increased, lifting technique became more important: Compared with rising from a chair, lifting 8 or 13 pounds from the floor produced less intraabdominal pressure, while lifting 20 pounds from the floor did not. But lifting 20 pounds from counter height did produce less intraabdominal pressure. Lying supine on the ground—an unrestricted activity—produced intraabdominal pressure not significantly different from lifting 35 pounds off a counter. And lifting 35 pounds off a counter produced pressure significantly less than lifting 20 pounds off the ground, she said.

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ATLANTA — Most activity restrictions recommended for preventing the progression or recurrence of pelvic floor disorders are unwarranted, results of a small study suggest.

Several daily activities, such as lifting and exercising, are often restricted in patients with pelvic floor disorders and in those who undergo pelvic floor surgery, because there is concern that the activities can increase intraabdominal pressure and thereby exacerbate the disorder, Dr. Larissa F. Weir explained at the annual meeting of the American Urogynecologic Society.

In fact, of 23 physical activities tested in 30 women who were not undergoing treatment for pelvic floor disorders, most had no greater effect on intraabdominal pressure than unavoidable or typically unrestricted activities had, said Dr. Weir, who was a medical student at the University of Iowa, Iowa City, at the time of the study, but who is now a first-year resident at the San Antonio Uniformed Services Health Education Consortium.

Lifting technique with higher-weight items did, however, have an effect on intraabdominal pressure, she noted.

Activity restrictions can have a significant impact on daily life, so it is important that they are based on evidence, Dr. Weir said.

These findings lay a foundation for evidence-based revisions of current activity restriction recommendations, but prospective long-term studies of the impact of intraabdominal pressure on pelvic floor function and of the effects of physical activity on intraabdominal pressure are needed, she added.

Women in the study performed three repetitions of each activity, and intraabdominal pressures were measured using a microtip rectal catheter. The mean peak and net intraabdominal pressures associated with the repetitions were calculated and compared with the baseline values in each patient.

The peak values for activities such as coughing, climbing stairs, and lowering to and rising from the floor, and for exercises such as jumping jacks, abdominal crunches, walking, and jogging on a treadmill were not significantly different from those for rising from a chair. Rising from a chair produced significantly higher abdominal pressures than lifting 8–10 pounds, Dr. Weir said.

The activities that produced the highest peak and net pressures included lifting 20 and 35 pounds off the ground, and forceful coughing; those that produced the lowest peak and net pressures were lifting 8 pounds from a low table, from counter height, and overhead.

As weight increased, lifting technique became more important: Compared with rising from a chair, lifting 8 or 13 pounds from the floor produced less intraabdominal pressure, while lifting 20 pounds from the floor did not. But lifting 20 pounds from counter height did produce less intraabdominal pressure. Lying supine on the ground—an unrestricted activity—produced intraabdominal pressure not significantly different from lifting 35 pounds off a counter. And lifting 35 pounds off a counter produced pressure significantly less than lifting 20 pounds off the ground, she said.

ATLANTA — Most activity restrictions recommended for preventing the progression or recurrence of pelvic floor disorders are unwarranted, results of a small study suggest.

Several daily activities, such as lifting and exercising, are often restricted in patients with pelvic floor disorders and in those who undergo pelvic floor surgery, because there is concern that the activities can increase intraabdominal pressure and thereby exacerbate the disorder, Dr. Larissa F. Weir explained at the annual meeting of the American Urogynecologic Society.

In fact, of 23 physical activities tested in 30 women who were not undergoing treatment for pelvic floor disorders, most had no greater effect on intraabdominal pressure than unavoidable or typically unrestricted activities had, said Dr. Weir, who was a medical student at the University of Iowa, Iowa City, at the time of the study, but who is now a first-year resident at the San Antonio Uniformed Services Health Education Consortium.

Lifting technique with higher-weight items did, however, have an effect on intraabdominal pressure, she noted.

Activity restrictions can have a significant impact on daily life, so it is important that they are based on evidence, Dr. Weir said.

These findings lay a foundation for evidence-based revisions of current activity restriction recommendations, but prospective long-term studies of the impact of intraabdominal pressure on pelvic floor function and of the effects of physical activity on intraabdominal pressure are needed, she added.

Women in the study performed three repetitions of each activity, and intraabdominal pressures were measured using a microtip rectal catheter. The mean peak and net intraabdominal pressures associated with the repetitions were calculated and compared with the baseline values in each patient.

The peak values for activities such as coughing, climbing stairs, and lowering to and rising from the floor, and for exercises such as jumping jacks, abdominal crunches, walking, and jogging on a treadmill were not significantly different from those for rising from a chair. Rising from a chair produced significantly higher abdominal pressures than lifting 8–10 pounds, Dr. Weir said.

The activities that produced the highest peak and net pressures included lifting 20 and 35 pounds off the ground, and forceful coughing; those that produced the lowest peak and net pressures were lifting 8 pounds from a low table, from counter height, and overhead.

As weight increased, lifting technique became more important: Compared with rising from a chair, lifting 8 or 13 pounds from the floor produced less intraabdominal pressure, while lifting 20 pounds from the floor did not. But lifting 20 pounds from counter height did produce less intraabdominal pressure. Lying supine on the ground—an unrestricted activity—produced intraabdominal pressure not significantly different from lifting 35 pounds off a counter. And lifting 35 pounds off a counter produced pressure significantly less than lifting 20 pounds off the ground, she said.

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Incontinence Risk Higher in Depressed Women

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ATLANTA – Women with postpartum depression are more likely than are nondepressed women to have urge urinary incontinence, according to findings presented in a poster at the annual meeting of the American Urogynecologic Society.

Of 146 women who participated in the cross-sectional study, 12% had postpartum depression at their 6-week visit as measured by the Edinburgh Postnatal Depression Scale. At that time, those with depression had a fourfold increase in overall and subscale scores on the Urge-Incontinence Impact Questionnaire (UIIQ), compared with nondepressed women.

This finding suggests that depressed patients have more symptoms and a greater impact on their lives from urge urinary incontinence, Dr. Dee Fenner reported during a press briefing at the meeting.

Depressed and nondepressed patients were similar in age, race, parity, and body mass index. On multivariate analysis, depression scores were shown to be affected by UIIQ score, smoking, and infant feeding mode (bottle vs. breast). But urge incontinence symptoms had the greatest effect on depression scores. In addition, depressed patients were more than twice as likely as nondepressed patients to have had a cesarean delivery, Dr. Fenner said.

That finding amplifies the association between urinary incontinence and postpartum depression because studies have shown that women who have a C-section generally are less likely to develop urge urinary incontinence than are those who deliver vaginally, she noted.

The findings have several implications. “We hope this will serve for future studies as a model to predict the onset of depression and to actually work out whether or not this is the depression causing the incontinence or the incontinence causing the depression,” Dr. Fenner said.

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ATLANTA – Women with postpartum depression are more likely than are nondepressed women to have urge urinary incontinence, according to findings presented in a poster at the annual meeting of the American Urogynecologic Society.

Of 146 women who participated in the cross-sectional study, 12% had postpartum depression at their 6-week visit as measured by the Edinburgh Postnatal Depression Scale. At that time, those with depression had a fourfold increase in overall and subscale scores on the Urge-Incontinence Impact Questionnaire (UIIQ), compared with nondepressed women.

This finding suggests that depressed patients have more symptoms and a greater impact on their lives from urge urinary incontinence, Dr. Dee Fenner reported during a press briefing at the meeting.

Depressed and nondepressed patients were similar in age, race, parity, and body mass index. On multivariate analysis, depression scores were shown to be affected by UIIQ score, smoking, and infant feeding mode (bottle vs. breast). But urge incontinence symptoms had the greatest effect on depression scores. In addition, depressed patients were more than twice as likely as nondepressed patients to have had a cesarean delivery, Dr. Fenner said.

That finding amplifies the association between urinary incontinence and postpartum depression because studies have shown that women who have a C-section generally are less likely to develop urge urinary incontinence than are those who deliver vaginally, she noted.

The findings have several implications. “We hope this will serve for future studies as a model to predict the onset of depression and to actually work out whether or not this is the depression causing the incontinence or the incontinence causing the depression,” Dr. Fenner said.

ATLANTA – Women with postpartum depression are more likely than are nondepressed women to have urge urinary incontinence, according to findings presented in a poster at the annual meeting of the American Urogynecologic Society.

Of 146 women who participated in the cross-sectional study, 12% had postpartum depression at their 6-week visit as measured by the Edinburgh Postnatal Depression Scale. At that time, those with depression had a fourfold increase in overall and subscale scores on the Urge-Incontinence Impact Questionnaire (UIIQ), compared with nondepressed women.

This finding suggests that depressed patients have more symptoms and a greater impact on their lives from urge urinary incontinence, Dr. Dee Fenner reported during a press briefing at the meeting.

Depressed and nondepressed patients were similar in age, race, parity, and body mass index. On multivariate analysis, depression scores were shown to be affected by UIIQ score, smoking, and infant feeding mode (bottle vs. breast). But urge incontinence symptoms had the greatest effect on depression scores. In addition, depressed patients were more than twice as likely as nondepressed patients to have had a cesarean delivery, Dr. Fenner said.

That finding amplifies the association between urinary incontinence and postpartum depression because studies have shown that women who have a C-section generally are less likely to develop urge urinary incontinence than are those who deliver vaginally, she noted.

The findings have several implications. “We hope this will serve for future studies as a model to predict the onset of depression and to actually work out whether or not this is the depression causing the incontinence or the incontinence causing the depression,” Dr. Fenner said.

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New Leg Vein Tx Combines Laser and RF Energy

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ATLANTA — A novel technology that combines diode laser and radiofrequency energy may be safe and effective for treating leg veins, Dr. Neil Sadick reported at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

In a two-center study involving 50 women with lower extremity red or blue leg veins up to 4 mm in diameter, the Polaris LV system (Syneron Inc., Richmond Hill, Ont.) provided at least 50% vessel clearance in 76% of patients. The clearing persisted at 6 months of follow-up, said Dr. Sadick of Cornell University, New York.

The system uses a 915-nm laser. Patients were treated with one to three passes at each of three treatment sessions scheduled at 2-week intervals.

Pre- and posttreatment photographs were graded by patients and an independent physician at a 2-month follow-up visit to determine the level of vessel clearance, and a score was generated by a novel computer-based assessment system. Independent observer analysis was corroborated by the computer imaging analysis.

Biopsy specimens also were provided for histologic assessment, which showed signs of coagulation and prominent endothelial degeneration in all treated vessels, said Dr. Sadick, who is a research consultant for Syneron.

A subsequent study showed that the Polaris LV system's effects were comparable histopathologically with those of the 1064-nm wavelength laser.

Complications with the Polaris LV system were minimal. A slight increase in the amount of hyperpigmentation and bruising was noted, compared with the 1064-nm laser, but pain was considerably less with the 915-nm laser.

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ATLANTA — A novel technology that combines diode laser and radiofrequency energy may be safe and effective for treating leg veins, Dr. Neil Sadick reported at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

In a two-center study involving 50 women with lower extremity red or blue leg veins up to 4 mm in diameter, the Polaris LV system (Syneron Inc., Richmond Hill, Ont.) provided at least 50% vessel clearance in 76% of patients. The clearing persisted at 6 months of follow-up, said Dr. Sadick of Cornell University, New York.

The system uses a 915-nm laser. Patients were treated with one to three passes at each of three treatment sessions scheduled at 2-week intervals.

Pre- and posttreatment photographs were graded by patients and an independent physician at a 2-month follow-up visit to determine the level of vessel clearance, and a score was generated by a novel computer-based assessment system. Independent observer analysis was corroborated by the computer imaging analysis.

Biopsy specimens also were provided for histologic assessment, which showed signs of coagulation and prominent endothelial degeneration in all treated vessels, said Dr. Sadick, who is a research consultant for Syneron.

A subsequent study showed that the Polaris LV system's effects were comparable histopathologically with those of the 1064-nm wavelength laser.

Complications with the Polaris LV system were minimal. A slight increase in the amount of hyperpigmentation and bruising was noted, compared with the 1064-nm laser, but pain was considerably less with the 915-nm laser.

ATLANTA — A novel technology that combines diode laser and radiofrequency energy may be safe and effective for treating leg veins, Dr. Neil Sadick reported at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

In a two-center study involving 50 women with lower extremity red or blue leg veins up to 4 mm in diameter, the Polaris LV system (Syneron Inc., Richmond Hill, Ont.) provided at least 50% vessel clearance in 76% of patients. The clearing persisted at 6 months of follow-up, said Dr. Sadick of Cornell University, New York.

The system uses a 915-nm laser. Patients were treated with one to three passes at each of three treatment sessions scheduled at 2-week intervals.

Pre- and posttreatment photographs were graded by patients and an independent physician at a 2-month follow-up visit to determine the level of vessel clearance, and a score was generated by a novel computer-based assessment system. Independent observer analysis was corroborated by the computer imaging analysis.

Biopsy specimens also were provided for histologic assessment, which showed signs of coagulation and prominent endothelial degeneration in all treated vessels, said Dr. Sadick, who is a research consultant for Syneron.

A subsequent study showed that the Polaris LV system's effects were comparable histopathologically with those of the 1064-nm wavelength laser.

Complications with the Polaris LV system were minimal. A slight increase in the amount of hyperpigmentation and bruising was noted, compared with the 1064-nm laser, but pain was considerably less with the 915-nm laser.

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Combo Device Effective for Treatment of Acne

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ATLANTA — A new device that combines pulsed light and radiofrequency energy is proving highly effective for the treatment of acne vulgaris, Dr. Neil Sadick reported at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

In 32 patients with moderate acne who were treated twice a week for 4 weeks, the combined use of optical and conducted bipolar radiofrequency energy reduced the average lesion count by 47%. Of patients surveyed, 59% rated overall improvement as good, 32% rated it as very good, and 4.5% rated it as excellent. Another 4.5% had mild or no improvement, said Dr. Sadick, clinical professor of dermatology at Cornell University, New York.

Biopsies were performed on four of the patients prior to treatment, 1 week after the initial treatment, and 1 month after the initial treatment. Compared with the baseline biopsy, the last biopsy showed a lower percentage of follicles with perifolliculitis (58% vs. 33%, respectively) and a reduction in the size of sebaceous glands (0.092 mm

The patients were treated using the Aurora AC device (Syneron Inc., Richmond Hill, Ont.). Those with Fitzpatrick skin types I-IV were treated with pulsed light of 8–10 J/cm

The combined use of optical energy and conducted bipolar radiofrequency current affects Propionibacterium acnes directly by photochemical activation of porphyrins, and by selective hyperthemia of the sebaceous glands. The radiofrequency energy supplements the optical energy and raises the temperature of the sebaceous glands, severely damaging the bacteria, Dr. Sadick explained.

Dr. Sadick is a research consultant for Syneron Inc.

Patient is shown at baseline and after 1 month of twice weekly treatments. Photos courtesy Dr. Neil Sadick

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ATLANTA — A new device that combines pulsed light and radiofrequency energy is proving highly effective for the treatment of acne vulgaris, Dr. Neil Sadick reported at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

In 32 patients with moderate acne who were treated twice a week for 4 weeks, the combined use of optical and conducted bipolar radiofrequency energy reduced the average lesion count by 47%. Of patients surveyed, 59% rated overall improvement as good, 32% rated it as very good, and 4.5% rated it as excellent. Another 4.5% had mild or no improvement, said Dr. Sadick, clinical professor of dermatology at Cornell University, New York.

Biopsies were performed on four of the patients prior to treatment, 1 week after the initial treatment, and 1 month after the initial treatment. Compared with the baseline biopsy, the last biopsy showed a lower percentage of follicles with perifolliculitis (58% vs. 33%, respectively) and a reduction in the size of sebaceous glands (0.092 mm

The patients were treated using the Aurora AC device (Syneron Inc., Richmond Hill, Ont.). Those with Fitzpatrick skin types I-IV were treated with pulsed light of 8–10 J/cm

The combined use of optical energy and conducted bipolar radiofrequency current affects Propionibacterium acnes directly by photochemical activation of porphyrins, and by selective hyperthemia of the sebaceous glands. The radiofrequency energy supplements the optical energy and raises the temperature of the sebaceous glands, severely damaging the bacteria, Dr. Sadick explained.

Dr. Sadick is a research consultant for Syneron Inc.

Patient is shown at baseline and after 1 month of twice weekly treatments. Photos courtesy Dr. Neil Sadick

ATLANTA — A new device that combines pulsed light and radiofrequency energy is proving highly effective for the treatment of acne vulgaris, Dr. Neil Sadick reported at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

In 32 patients with moderate acne who were treated twice a week for 4 weeks, the combined use of optical and conducted bipolar radiofrequency energy reduced the average lesion count by 47%. Of patients surveyed, 59% rated overall improvement as good, 32% rated it as very good, and 4.5% rated it as excellent. Another 4.5% had mild or no improvement, said Dr. Sadick, clinical professor of dermatology at Cornell University, New York.

Biopsies were performed on four of the patients prior to treatment, 1 week after the initial treatment, and 1 month after the initial treatment. Compared with the baseline biopsy, the last biopsy showed a lower percentage of follicles with perifolliculitis (58% vs. 33%, respectively) and a reduction in the size of sebaceous glands (0.092 mm

The patients were treated using the Aurora AC device (Syneron Inc., Richmond Hill, Ont.). Those with Fitzpatrick skin types I-IV were treated with pulsed light of 8–10 J/cm

The combined use of optical energy and conducted bipolar radiofrequency current affects Propionibacterium acnes directly by photochemical activation of porphyrins, and by selective hyperthemia of the sebaceous glands. The radiofrequency energy supplements the optical energy and raises the temperature of the sebaceous glands, severely damaging the bacteria, Dr. Sadick explained.

Dr. Sadick is a research consultant for Syneron Inc.

Patient is shown at baseline and after 1 month of twice weekly treatments. Photos courtesy Dr. Neil Sadick

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Anchored Rotation Flap for Cheek Prevents Ectropion

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ATLANTA — A novel anchored rotation flap for infraorbital cheek reconstruction allows full defect repair without causing lower-lid ectropion, Dr. Kord Honda said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

The technique involves the use of an anchoring suture to allow an inferiorly based rotation flap for horizontal defects of the midpupillary and medial infraorbital cheek. The suture allows horizontal redirection of the flap tension vectors, which helps prevent ectropion, explained Dr. Honda, a dermatology resident at the University of Washington, Seattle.

In four patients with defects ranging in size from 1.4 by 2.9 cm to 2.4 by 3.4 cm, outcomes at up to 3 months were excellent, with no evidence of lower-lid ectropion, he said.

The long axes of the defects in all four patients were horizontally oriented: Two were centered on the midpupillary line, and two were located medially.

The patients first underwent Mohs surgery for complete skin cancer removal; then the edges of the defect were made perpendicular. An incision was made to the midsubcutaneous fat at a 90-degree angle along the nasofacial sulcus and extended into the melolabial fold if necessary.

The flap, designed to rotate tissue from the inferior aspect of the defect, was undermined with sharp dissection in the midsubcutaneus fat. The anchoring suture was placed first and served as the key stitch. This suture was placed from the superior medial portion of the flap into the periosteum of the superior nasal sidewall or medial maxilla, Dr. Honda reported.

Testing for ectropion and eclabium was performed. The wound edges were approximated with a running 5–0 or 6–0 nylon suture with tension placed horizontally to prevent ectropion.

This anchored rotation flap is a one-stage procedure that preserves the eyelid margin and is ideal for horizontally oriented defects, he said.

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ATLANTA — A novel anchored rotation flap for infraorbital cheek reconstruction allows full defect repair without causing lower-lid ectropion, Dr. Kord Honda said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

The technique involves the use of an anchoring suture to allow an inferiorly based rotation flap for horizontal defects of the midpupillary and medial infraorbital cheek. The suture allows horizontal redirection of the flap tension vectors, which helps prevent ectropion, explained Dr. Honda, a dermatology resident at the University of Washington, Seattle.

In four patients with defects ranging in size from 1.4 by 2.9 cm to 2.4 by 3.4 cm, outcomes at up to 3 months were excellent, with no evidence of lower-lid ectropion, he said.

The long axes of the defects in all four patients were horizontally oriented: Two were centered on the midpupillary line, and two were located medially.

The patients first underwent Mohs surgery for complete skin cancer removal; then the edges of the defect were made perpendicular. An incision was made to the midsubcutaneous fat at a 90-degree angle along the nasofacial sulcus and extended into the melolabial fold if necessary.

The flap, designed to rotate tissue from the inferior aspect of the defect, was undermined with sharp dissection in the midsubcutaneus fat. The anchoring suture was placed first and served as the key stitch. This suture was placed from the superior medial portion of the flap into the periosteum of the superior nasal sidewall or medial maxilla, Dr. Honda reported.

Testing for ectropion and eclabium was performed. The wound edges were approximated with a running 5–0 or 6–0 nylon suture with tension placed horizontally to prevent ectropion.

This anchored rotation flap is a one-stage procedure that preserves the eyelid margin and is ideal for horizontally oriented defects, he said.

ATLANTA — A novel anchored rotation flap for infraorbital cheek reconstruction allows full defect repair without causing lower-lid ectropion, Dr. Kord Honda said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

The technique involves the use of an anchoring suture to allow an inferiorly based rotation flap for horizontal defects of the midpupillary and medial infraorbital cheek. The suture allows horizontal redirection of the flap tension vectors, which helps prevent ectropion, explained Dr. Honda, a dermatology resident at the University of Washington, Seattle.

In four patients with defects ranging in size from 1.4 by 2.9 cm to 2.4 by 3.4 cm, outcomes at up to 3 months were excellent, with no evidence of lower-lid ectropion, he said.

The long axes of the defects in all four patients were horizontally oriented: Two were centered on the midpupillary line, and two were located medially.

The patients first underwent Mohs surgery for complete skin cancer removal; then the edges of the defect were made perpendicular. An incision was made to the midsubcutaneous fat at a 90-degree angle along the nasofacial sulcus and extended into the melolabial fold if necessary.

The flap, designed to rotate tissue from the inferior aspect of the defect, was undermined with sharp dissection in the midsubcutaneus fat. The anchoring suture was placed first and served as the key stitch. This suture was placed from the superior medial portion of the flap into the periosteum of the superior nasal sidewall or medial maxilla, Dr. Honda reported.

Testing for ectropion and eclabium was performed. The wound edges were approximated with a running 5–0 or 6–0 nylon suture with tension placed horizontally to prevent ectropion.

This anchored rotation flap is a one-stage procedure that preserves the eyelid margin and is ideal for horizontally oriented defects, he said.

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New Laser System Offers Another Skin Tx Option

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ATLANTA — Fractional photothermolysis for skin rejuvenation provides results similar to those achieved with ablative laser resurfacing, but without the downtime, Dr. Tina Alster said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

The new fiber laser technology is particularly good for treating dyspigmentation and rhytides, and can be used on areas other than the face, such as the arms, neck, chest, and hands, said Dr. Alster, director of the Washington Institute of Dermatologic Laser Surgery.

Of about 20 lasers that she uses in her practice, the Fraxel laser (Reliant Technologies Inc., Palo Alto, Calif.) is one of those she uses most often.

According to information from Reliant, the Fraxel laser system—which is approved for the treatment of melasma but also has been used for surgical and acne scars, striae, and actinic keratoses—treats the skin fractionally, with patterns of microscopic laser spots that are 70–100 μm in diameter. Each laser spot is called a microthermal zone, or MTZ, and the laser can deliver 2,000 MTZs per cm

The use of the MTZs with adjacent untreated tissue allows fractional wound healing with rapid reepithelialization of the epidermis and collagen remodeling to depths of 400–700 μm. This is compared with the 200-μm depth achieved with traditional ablative laser treatments.

Histology following treatment shows that the stratum corneum remains intact and epidermal tissue is coagulated. Collagen remodeling is also demonstrated, explained Dr. Alster, who reported no financial interest in the device.

"You see reepithelialization of the whole site within 24 hours," she said.

Her treatment protocol involves skin cleansing and application of a blue tint, which is required for the laser to work. About 30–60 minutes prior to the procedure, she also applies a topical anesthetic containing 30% lidocaine.

Dr. Alster said she usually uses 8–10 MJ per cm

Patients usually require two to four treatments at 2− to 4-week intervals. Most come back monthly to complete the series of treatments, she said. The skin is erythematous immediately after each treatment and remains so for approximately 2 days. On day 2 or 3, a variable amount of peeling occurs, resulting in rough-feeling skin.

Results are incremental, with additional improvement seen after each treatment. Most patients will achieve 50% improvement when being treated for dyspigmentation and/or rhytides. Although the laser is not marketed as a skin tightening device, it does provide some skin tightening, Dr. Alster noted.

The results are better than what she has experienced with trichloroacetic acid peels, particularly for fine lines, she said, and the recovery time is much quicker than with ablative resurfacing.

Dr. David Goldberg of Skin Laser and Surgery Specialists of New York and New Jersey agreed that fractional photothermolysis has several applications and a relatively good safety profile, but he cautions that adverse events are still possible. Scarring, for example, can occur when the device is held in one place for too long.

Dr. Goldberg also noted that many of the effects of this laser can be achieved with other modalities.

"It clearly works," he said, but it's not the "end all and be all."

For example, acne scarring responds well to the Fraxel laser, but it can also be treated effectively with the CoolTouch or Smoothbeam lasers. Crow's-feet can be treated effectively with botulinum toxin, and lentigines can be treated effectively with the Q-switched laser and intense pulsed light, Dr. Goldberg said.

"This is not a system that you buy simply to treat lentigines; this is not a system you buy simply to treat crow's-feet … but I think that you can't argue the fact that when you put the whole picture together, it's got tremendous diversity, and that diversity has led to its popularity," he said.

Dr. Goldberg has received a research grant from Reliant Technologies Inc.

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ATLANTA — Fractional photothermolysis for skin rejuvenation provides results similar to those achieved with ablative laser resurfacing, but without the downtime, Dr. Tina Alster said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

The new fiber laser technology is particularly good for treating dyspigmentation and rhytides, and can be used on areas other than the face, such as the arms, neck, chest, and hands, said Dr. Alster, director of the Washington Institute of Dermatologic Laser Surgery.

Of about 20 lasers that she uses in her practice, the Fraxel laser (Reliant Technologies Inc., Palo Alto, Calif.) is one of those she uses most often.

According to information from Reliant, the Fraxel laser system—which is approved for the treatment of melasma but also has been used for surgical and acne scars, striae, and actinic keratoses—treats the skin fractionally, with patterns of microscopic laser spots that are 70–100 μm in diameter. Each laser spot is called a microthermal zone, or MTZ, and the laser can deliver 2,000 MTZs per cm

The use of the MTZs with adjacent untreated tissue allows fractional wound healing with rapid reepithelialization of the epidermis and collagen remodeling to depths of 400–700 μm. This is compared with the 200-μm depth achieved with traditional ablative laser treatments.

Histology following treatment shows that the stratum corneum remains intact and epidermal tissue is coagulated. Collagen remodeling is also demonstrated, explained Dr. Alster, who reported no financial interest in the device.

"You see reepithelialization of the whole site within 24 hours," she said.

Her treatment protocol involves skin cleansing and application of a blue tint, which is required for the laser to work. About 30–60 minutes prior to the procedure, she also applies a topical anesthetic containing 30% lidocaine.

Dr. Alster said she usually uses 8–10 MJ per cm

Patients usually require two to four treatments at 2− to 4-week intervals. Most come back monthly to complete the series of treatments, she said. The skin is erythematous immediately after each treatment and remains so for approximately 2 days. On day 2 or 3, a variable amount of peeling occurs, resulting in rough-feeling skin.

Results are incremental, with additional improvement seen after each treatment. Most patients will achieve 50% improvement when being treated for dyspigmentation and/or rhytides. Although the laser is not marketed as a skin tightening device, it does provide some skin tightening, Dr. Alster noted.

The results are better than what she has experienced with trichloroacetic acid peels, particularly for fine lines, she said, and the recovery time is much quicker than with ablative resurfacing.

Dr. David Goldberg of Skin Laser and Surgery Specialists of New York and New Jersey agreed that fractional photothermolysis has several applications and a relatively good safety profile, but he cautions that adverse events are still possible. Scarring, for example, can occur when the device is held in one place for too long.

Dr. Goldberg also noted that many of the effects of this laser can be achieved with other modalities.

"It clearly works," he said, but it's not the "end all and be all."

For example, acne scarring responds well to the Fraxel laser, but it can also be treated effectively with the CoolTouch or Smoothbeam lasers. Crow's-feet can be treated effectively with botulinum toxin, and lentigines can be treated effectively with the Q-switched laser and intense pulsed light, Dr. Goldberg said.

"This is not a system that you buy simply to treat lentigines; this is not a system you buy simply to treat crow's-feet … but I think that you can't argue the fact that when you put the whole picture together, it's got tremendous diversity, and that diversity has led to its popularity," he said.

Dr. Goldberg has received a research grant from Reliant Technologies Inc.

ATLANTA — Fractional photothermolysis for skin rejuvenation provides results similar to those achieved with ablative laser resurfacing, but without the downtime, Dr. Tina Alster said at the joint annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.

The new fiber laser technology is particularly good for treating dyspigmentation and rhytides, and can be used on areas other than the face, such as the arms, neck, chest, and hands, said Dr. Alster, director of the Washington Institute of Dermatologic Laser Surgery.

Of about 20 lasers that she uses in her practice, the Fraxel laser (Reliant Technologies Inc., Palo Alto, Calif.) is one of those she uses most often.

According to information from Reliant, the Fraxel laser system—which is approved for the treatment of melasma but also has been used for surgical and acne scars, striae, and actinic keratoses—treats the skin fractionally, with patterns of microscopic laser spots that are 70–100 μm in diameter. Each laser spot is called a microthermal zone, or MTZ, and the laser can deliver 2,000 MTZs per cm

The use of the MTZs with adjacent untreated tissue allows fractional wound healing with rapid reepithelialization of the epidermis and collagen remodeling to depths of 400–700 μm. This is compared with the 200-μm depth achieved with traditional ablative laser treatments.

Histology following treatment shows that the stratum corneum remains intact and epidermal tissue is coagulated. Collagen remodeling is also demonstrated, explained Dr. Alster, who reported no financial interest in the device.

"You see reepithelialization of the whole site within 24 hours," she said.

Her treatment protocol involves skin cleansing and application of a blue tint, which is required for the laser to work. About 30–60 minutes prior to the procedure, she also applies a topical anesthetic containing 30% lidocaine.

Dr. Alster said she usually uses 8–10 MJ per cm

Patients usually require two to four treatments at 2− to 4-week intervals. Most come back monthly to complete the series of treatments, she said. The skin is erythematous immediately after each treatment and remains so for approximately 2 days. On day 2 or 3, a variable amount of peeling occurs, resulting in rough-feeling skin.

Results are incremental, with additional improvement seen after each treatment. Most patients will achieve 50% improvement when being treated for dyspigmentation and/or rhytides. Although the laser is not marketed as a skin tightening device, it does provide some skin tightening, Dr. Alster noted.

The results are better than what she has experienced with trichloroacetic acid peels, particularly for fine lines, she said, and the recovery time is much quicker than with ablative resurfacing.

Dr. David Goldberg of Skin Laser and Surgery Specialists of New York and New Jersey agreed that fractional photothermolysis has several applications and a relatively good safety profile, but he cautions that adverse events are still possible. Scarring, for example, can occur when the device is held in one place for too long.

Dr. Goldberg also noted that many of the effects of this laser can be achieved with other modalities.

"It clearly works," he said, but it's not the "end all and be all."

For example, acne scarring responds well to the Fraxel laser, but it can also be treated effectively with the CoolTouch or Smoothbeam lasers. Crow's-feet can be treated effectively with botulinum toxin, and lentigines can be treated effectively with the Q-switched laser and intense pulsed light, Dr. Goldberg said.

"This is not a system that you buy simply to treat lentigines; this is not a system you buy simply to treat crow's-feet … but I think that you can't argue the fact that when you put the whole picture together, it's got tremendous diversity, and that diversity has led to its popularity," he said.

Dr. Goldberg has received a research grant from Reliant Technologies Inc.

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Gargling and Respiratory Infections

Water gargling may be effective for preventing upper respiratory tract infections, reported Kazunari Satomura, M.D., of Kyoto (Japan) University, and colleagues.

In a randomized, controlled trial involving 387 healthy volunteers aged 18–65 years, a URTI occurred in 41% of control subjects, 30% of subjects randomized to gargle with water, and 37% of subjects randomized to gargle with diluted povidone-iodine during a 60-day period.

The difference in URTI incidence between the control and water-gargling groups was significant, the investigators reported (Am. J. Prev. Med. 2005;29:302–7).

Furthermore, when water garglers developed a URTI, bronchial symptoms were attenuated; the mean peak score in bronchial symptoms was 1.40 in the control group, 0.97 in the water-gargling group, and 1.41 in the povidone-iodine garglers.

Garglers were asked to use 20 mL of water or diluted povidone-iodine for about 15 seconds three times consecutively, and to repeat at least three times daily. Subjects were followed for at least 60 days.

Water gargling is a virtually cost-free modality that could “appreciably benefit people both physically and economically around the world,” the authors concluded.

HPV in Women Over 50

Women aged 51 years are at least as likely as younger women to become infected with human papillomavirus, a study suggests; the findings indicate that cervical screening should not be discontinued after age 50.

To compare rates of HPV acquisition in older and younger women, paired archived cervical smears taken an average of 3 years apart from 656 women were tested. Of these, 567 were negative for HPV at baseline, Matthew J. Grainge, M.D., of the University of Nottingham, United Kingdom, and his colleagues reported.

Of 333 women aged 51 years at the time of a baseline smear that was HPV negative, 21% had a positive smear 3 years later, compared with 15% of 66 women aged 21 years, 14% of 85 women aged 31, and 13% of 83 women aged 41 at the time of a negative baseline smear. The differences were not statistically significant, the investigators noted (Emerg. Infect. Dis. 2005;11:1680–5).

Research is needed on the effects of HPV acquisition during middle age.

BV and Cytomegalovirus

Bacterial vaginosis appears to facilitate local cytomegalovirus replication as well as infection with multiple CMV strains, Shannon A. Ross, M.D., of the University of Alabama at Birmingham, and her colleagues found.

Conversely, the presence of CMV infection may facilitate BV, the investigators noted. An analysis of vaginal wash specimens from 52 women who presented to a sexually transmitted disease clinic showed that CMV shedding was significantly more common in women with BV (52% of 21 women), compared with those without BV (19% of 31 women). Multiple CMV strains were found in 91% of women with CMV shedding and BV vs. 83% of those with CMV shedding and no BV (J. Infect. Dis. 2005;192:1727–30).

Additional study of the correlations between BV and CMV is needed, and could provide insight regarding the effects of BV treatment on CMV replication and local inflammatory response, they concluded.

Dalbavancin vs. Linezolid

The investigational antibacterial dalbavancin appears safe and effective for treating patients with complicated skin and skin structure infections.

In a phase III trial, 854 patients with such infections were randomized to receive intravenous dalbavancin or linezolid given intravenously/orally or intravenously, Luis E. Jauregui, M.D., of St. Vincent Mercy Medical Center, Toledo, Ohio, and his colleagues reported.

The patients had infections that required significant surgical intervention or that were known or suspected to involve methicillin-resistant Staphylococcus aureus. Among evaluable patients, 89% in the dalbavancin arm and 91% in the linezolid arm had achieved clinical success about 14 days after treatment ended. The rate of MRSA eradication was 91% in the dalbavancin arm and 89% in the linezolid arm.

Adverse events were generally mild or moderate, occurring in 56% of patients in the dalbavancin arm and 61% of patients in the linezolid arm. Events considered probably or possibly associated with treatment occurred more often in the linezolid group (Clin. Infect. Dis. 2005;41:1407–15).

Dalbavancin could be an alternative to vancomycin and linezolid for complicated skin and skin structure infections caused by gram-positive pathogens, and since it can be administered in outpatient settings, it might be a reasonable option for empirical treatment of such infections suspected to be caused by MRSA, the investigators said.

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Gargling and Respiratory Infections

Water gargling may be effective for preventing upper respiratory tract infections, reported Kazunari Satomura, M.D., of Kyoto (Japan) University, and colleagues.

In a randomized, controlled trial involving 387 healthy volunteers aged 18–65 years, a URTI occurred in 41% of control subjects, 30% of subjects randomized to gargle with water, and 37% of subjects randomized to gargle with diluted povidone-iodine during a 60-day period.

The difference in URTI incidence between the control and water-gargling groups was significant, the investigators reported (Am. J. Prev. Med. 2005;29:302–7).

Furthermore, when water garglers developed a URTI, bronchial symptoms were attenuated; the mean peak score in bronchial symptoms was 1.40 in the control group, 0.97 in the water-gargling group, and 1.41 in the povidone-iodine garglers.

Garglers were asked to use 20 mL of water or diluted povidone-iodine for about 15 seconds three times consecutively, and to repeat at least three times daily. Subjects were followed for at least 60 days.

Water gargling is a virtually cost-free modality that could “appreciably benefit people both physically and economically around the world,” the authors concluded.

HPV in Women Over 50

Women aged 51 years are at least as likely as younger women to become infected with human papillomavirus, a study suggests; the findings indicate that cervical screening should not be discontinued after age 50.

To compare rates of HPV acquisition in older and younger women, paired archived cervical smears taken an average of 3 years apart from 656 women were tested. Of these, 567 were negative for HPV at baseline, Matthew J. Grainge, M.D., of the University of Nottingham, United Kingdom, and his colleagues reported.

Of 333 women aged 51 years at the time of a baseline smear that was HPV negative, 21% had a positive smear 3 years later, compared with 15% of 66 women aged 21 years, 14% of 85 women aged 31, and 13% of 83 women aged 41 at the time of a negative baseline smear. The differences were not statistically significant, the investigators noted (Emerg. Infect. Dis. 2005;11:1680–5).

Research is needed on the effects of HPV acquisition during middle age.

BV and Cytomegalovirus

Bacterial vaginosis appears to facilitate local cytomegalovirus replication as well as infection with multiple CMV strains, Shannon A. Ross, M.D., of the University of Alabama at Birmingham, and her colleagues found.

Conversely, the presence of CMV infection may facilitate BV, the investigators noted. An analysis of vaginal wash specimens from 52 women who presented to a sexually transmitted disease clinic showed that CMV shedding was significantly more common in women with BV (52% of 21 women), compared with those without BV (19% of 31 women). Multiple CMV strains were found in 91% of women with CMV shedding and BV vs. 83% of those with CMV shedding and no BV (J. Infect. Dis. 2005;192:1727–30).

Additional study of the correlations between BV and CMV is needed, and could provide insight regarding the effects of BV treatment on CMV replication and local inflammatory response, they concluded.

Dalbavancin vs. Linezolid

The investigational antibacterial dalbavancin appears safe and effective for treating patients with complicated skin and skin structure infections.

In a phase III trial, 854 patients with such infections were randomized to receive intravenous dalbavancin or linezolid given intravenously/orally or intravenously, Luis E. Jauregui, M.D., of St. Vincent Mercy Medical Center, Toledo, Ohio, and his colleagues reported.

The patients had infections that required significant surgical intervention or that were known or suspected to involve methicillin-resistant Staphylococcus aureus. Among evaluable patients, 89% in the dalbavancin arm and 91% in the linezolid arm had achieved clinical success about 14 days after treatment ended. The rate of MRSA eradication was 91% in the dalbavancin arm and 89% in the linezolid arm.

Adverse events were generally mild or moderate, occurring in 56% of patients in the dalbavancin arm and 61% of patients in the linezolid arm. Events considered probably or possibly associated with treatment occurred more often in the linezolid group (Clin. Infect. Dis. 2005;41:1407–15).

Dalbavancin could be an alternative to vancomycin and linezolid for complicated skin and skin structure infections caused by gram-positive pathogens, and since it can be administered in outpatient settings, it might be a reasonable option for empirical treatment of such infections suspected to be caused by MRSA, the investigators said.

Gargling and Respiratory Infections

Water gargling may be effective for preventing upper respiratory tract infections, reported Kazunari Satomura, M.D., of Kyoto (Japan) University, and colleagues.

In a randomized, controlled trial involving 387 healthy volunteers aged 18–65 years, a URTI occurred in 41% of control subjects, 30% of subjects randomized to gargle with water, and 37% of subjects randomized to gargle with diluted povidone-iodine during a 60-day period.

The difference in URTI incidence between the control and water-gargling groups was significant, the investigators reported (Am. J. Prev. Med. 2005;29:302–7).

Furthermore, when water garglers developed a URTI, bronchial symptoms were attenuated; the mean peak score in bronchial symptoms was 1.40 in the control group, 0.97 in the water-gargling group, and 1.41 in the povidone-iodine garglers.

Garglers were asked to use 20 mL of water or diluted povidone-iodine for about 15 seconds three times consecutively, and to repeat at least three times daily. Subjects were followed for at least 60 days.

Water gargling is a virtually cost-free modality that could “appreciably benefit people both physically and economically around the world,” the authors concluded.

HPV in Women Over 50

Women aged 51 years are at least as likely as younger women to become infected with human papillomavirus, a study suggests; the findings indicate that cervical screening should not be discontinued after age 50.

To compare rates of HPV acquisition in older and younger women, paired archived cervical smears taken an average of 3 years apart from 656 women were tested. Of these, 567 were negative for HPV at baseline, Matthew J. Grainge, M.D., of the University of Nottingham, United Kingdom, and his colleagues reported.

Of 333 women aged 51 years at the time of a baseline smear that was HPV negative, 21% had a positive smear 3 years later, compared with 15% of 66 women aged 21 years, 14% of 85 women aged 31, and 13% of 83 women aged 41 at the time of a negative baseline smear. The differences were not statistically significant, the investigators noted (Emerg. Infect. Dis. 2005;11:1680–5).

Research is needed on the effects of HPV acquisition during middle age.

BV and Cytomegalovirus

Bacterial vaginosis appears to facilitate local cytomegalovirus replication as well as infection with multiple CMV strains, Shannon A. Ross, M.D., of the University of Alabama at Birmingham, and her colleagues found.

Conversely, the presence of CMV infection may facilitate BV, the investigators noted. An analysis of vaginal wash specimens from 52 women who presented to a sexually transmitted disease clinic showed that CMV shedding was significantly more common in women with BV (52% of 21 women), compared with those without BV (19% of 31 women). Multiple CMV strains were found in 91% of women with CMV shedding and BV vs. 83% of those with CMV shedding and no BV (J. Infect. Dis. 2005;192:1727–30).

Additional study of the correlations between BV and CMV is needed, and could provide insight regarding the effects of BV treatment on CMV replication and local inflammatory response, they concluded.

Dalbavancin vs. Linezolid

The investigational antibacterial dalbavancin appears safe and effective for treating patients with complicated skin and skin structure infections.

In a phase III trial, 854 patients with such infections were randomized to receive intravenous dalbavancin or linezolid given intravenously/orally or intravenously, Luis E. Jauregui, M.D., of St. Vincent Mercy Medical Center, Toledo, Ohio, and his colleagues reported.

The patients had infections that required significant surgical intervention or that were known or suspected to involve methicillin-resistant Staphylococcus aureus. Among evaluable patients, 89% in the dalbavancin arm and 91% in the linezolid arm had achieved clinical success about 14 days after treatment ended. The rate of MRSA eradication was 91% in the dalbavancin arm and 89% in the linezolid arm.

Adverse events were generally mild or moderate, occurring in 56% of patients in the dalbavancin arm and 61% of patients in the linezolid arm. Events considered probably or possibly associated with treatment occurred more often in the linezolid group (Clin. Infect. Dis. 2005;41:1407–15).

Dalbavancin could be an alternative to vancomycin and linezolid for complicated skin and skin structure infections caused by gram-positive pathogens, and since it can be administered in outpatient settings, it might be a reasonable option for empirical treatment of such infections suspected to be caused by MRSA, the investigators said.

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