Michele G. Sullivan

NEW ORLEANS — Transanal hemorrhoidal dearterialization gets patients back to their normal activities faster than does the procedure for prolapse and hemorrhoids, and appears to be associated with fewer serious complications, Dr. Piero Nastro reported at the annual clinical congress of the American College of Surgeons.

And although dearterialization is slightly more expensive than stapled hemorrhoidopexy (SH)—about $150—the fact that most patients return to work within 4 days may actually make the procedure cheaper overall, said Dr. Nastro of Whipp's Cross University Hospital, London.

Transanal hemorrhoidal dearterialization (THD) is performed with a dedicated proctoscope outfitted with a Doppler transducer. Under ultrasound guidance, the surgeon identifies the terminal branch of the hemorrhoidal artery, and inserts two stitches to close off the blood supply. A ligation of the rectal mucosa then lifts the hemorrhoid up inside the anal canal.

The technique was introduced in Japan about 10 years ago, Dr. Nastro said. “Case studies suggest that it is safe, associated with minimal postoperative pain, easy to learn, and quick to perform.”

However, data comparing THD to other techniques are limited. Dr. Nastro's nonrandomized prospective trial compared THD with SH in 52 patients (average age 50 years) with second- and third-degree hemorrhoids. The investigators did not have approval for randomization, so they explained both procedures in detail and let the patients choose. THD was performed on 28 patients, while 24 received SH.

Postoperative pain scores were slightly, but not significantly, different between the groups. “Patients in the THD group reported slightly less immediate postoperative pain, while those in the SH group reported slightly less actual postoperative pain versus expected pain,” Dr. Nastro explained.

There were three minor complications in the THD group: one submucosal hematoma and two technical problems during surgery, which required no additional treatment. In the SH group, five complications occurred: two cases of fecal urgency; one rectal stenosis that required surgery; and two postoperative bleeds that required readmission, but were successfully addressed in one visit.

Symptoms resolved in almost all patients (25 of 28 in the THD group, and 21 of 24 in the SH group). At a mean follow-up of 4 months, there was no significant difference in recurrence.

Almost all of the THD patients (25) returned to work 4 days after their surgery, while only 50% (12) of the SH patients were able to do so. This significant difference probably makes THD more cost effective, Dr. Nastro said, because patients are not losing as much productive time to recovery.

In discussing the paper, Dr. Bradford Sklow said that THD may prove a viable alternative for SH. Stapled hemorrhoidopexy “is not the magic bullet we once thought it was,” said Dr. Sklow of Salt Lake City. “It has a learning curve, and because of the potential serious complications—including pelvic sepsis, rectovaginal fistula, and even death—physicians need special credentialing to perform it.”

THD looks to be easier to learn, he said, and, from the limited data available now, seems to be associated with fewer serious complications than SH.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Transanal hemorrhoidal dearterialization gets patients back to their normal activities faster than does the procedure for prolapse and hemorrhoids, and appears to be associated with fewer serious complications, Dr. Piero Nastro reported at the annual clinical congress of the American College of Surgeons.

And although dearterialization is slightly more expensive than stapled hemorrhoidopexy (SH)—about $150—the fact that most patients return to work within 4 days may actually make the procedure cheaper overall, said Dr. Nastro of Whipp's Cross University Hospital, London.

Transanal hemorrhoidal dearterialization (THD) is performed with a dedicated proctoscope outfitted with a Doppler transducer. Under ultrasound guidance, the surgeon identifies the terminal branch of the hemorrhoidal artery, and inserts two stitches to close off the blood supply. A ligation of the rectal mucosa then lifts the hemorrhoid up inside the anal canal.

The technique was introduced in Japan about 10 years ago, Dr. Nastro said. “Case studies suggest that it is safe, associated with minimal postoperative pain, easy to learn, and quick to perform.”

However, data comparing THD to other techniques are limited. Dr. Nastro's nonrandomized prospective trial compared THD with SH in 52 patients (average age 50 years) with second- and third-degree hemorrhoids. The investigators did not have approval for randomization, so they explained both procedures in detail and let the patients choose. THD was performed on 28 patients, while 24 received SH.

Postoperative pain scores were slightly, but not significantly, different between the groups. “Patients in the THD group reported slightly less immediate postoperative pain, while those in the SH group reported slightly less actual postoperative pain versus expected pain,” Dr. Nastro explained.

There were three minor complications in the THD group: one submucosal hematoma and two technical problems during surgery, which required no additional treatment. In the SH group, five complications occurred: two cases of fecal urgency; one rectal stenosis that required surgery; and two postoperative bleeds that required readmission, but were successfully addressed in one visit.

Symptoms resolved in almost all patients (25 of 28 in the THD group, and 21 of 24 in the SH group). At a mean follow-up of 4 months, there was no significant difference in recurrence.

Almost all of the THD patients (25) returned to work 4 days after their surgery, while only 50% (12) of the SH patients were able to do so. This significant difference probably makes THD more cost effective, Dr. Nastro said, because patients are not losing as much productive time to recovery.

In discussing the paper, Dr. Bradford Sklow said that THD may prove a viable alternative for SH. Stapled hemorrhoidopexy “is not the magic bullet we once thought it was,” said Dr. Sklow of Salt Lake City. “It has a learning curve, and because of the potential serious complications—including pelvic sepsis, rectovaginal fistula, and even death—physicians need special credentialing to perform it.”

THD looks to be easier to learn, he said, and, from the limited data available now, seems to be associated with fewer serious complications than SH.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Transanal hemorrhoidal dearterialization gets patients back to their normal activities faster than does the procedure for prolapse and hemorrhoids, and appears to be associated with fewer serious complications, Dr. Piero Nastro reported at the annual clinical congress of the American College of Surgeons.

And although dearterialization is slightly more expensive than stapled hemorrhoidopexy (SH)—about $150—the fact that most patients return to work within 4 days may actually make the procedure cheaper overall, said Dr. Nastro of Whipp's Cross University Hospital, London.

Transanal hemorrhoidal dearterialization (THD) is performed with a dedicated proctoscope outfitted with a Doppler transducer. Under ultrasound guidance, the surgeon identifies the terminal branch of the hemorrhoidal artery, and inserts two stitches to close off the blood supply. A ligation of the rectal mucosa then lifts the hemorrhoid up inside the anal canal.

The technique was introduced in Japan about 10 years ago, Dr. Nastro said. “Case studies suggest that it is safe, associated with minimal postoperative pain, easy to learn, and quick to perform.”

However, data comparing THD to other techniques are limited. Dr. Nastro's nonrandomized prospective trial compared THD with SH in 52 patients (average age 50 years) with second- and third-degree hemorrhoids. The investigators did not have approval for randomization, so they explained both procedures in detail and let the patients choose. THD was performed on 28 patients, while 24 received SH.

Postoperative pain scores were slightly, but not significantly, different between the groups. “Patients in the THD group reported slightly less immediate postoperative pain, while those in the SH group reported slightly less actual postoperative pain versus expected pain,” Dr. Nastro explained.

There were three minor complications in the THD group: one submucosal hematoma and two technical problems during surgery, which required no additional treatment. In the SH group, five complications occurred: two cases of fecal urgency; one rectal stenosis that required surgery; and two postoperative bleeds that required readmission, but were successfully addressed in one visit.

Symptoms resolved in almost all patients (25 of 28 in the THD group, and 21 of 24 in the SH group). At a mean follow-up of 4 months, there was no significant difference in recurrence.

Almost all of the THD patients (25) returned to work 4 days after their surgery, while only 50% (12) of the SH patients were able to do so. This significant difference probably makes THD more cost effective, Dr. Nastro said, because patients are not losing as much productive time to recovery.

In discussing the paper, Dr. Bradford Sklow said that THD may prove a viable alternative for SH. Stapled hemorrhoidopexy “is not the magic bullet we once thought it was,” said Dr. Sklow of Salt Lake City. “It has a learning curve, and because of the potential serious complications—including pelvic sepsis, rectovaginal fistula, and even death—physicians need special credentialing to perform it.”

THD looks to be easier to learn, he said, and, from the limited data available now, seems to be associated with fewer serious complications than SH.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Rather than unlocking a Pandora's box of nattering e-mails, an electronic patient portal that allows messaging and even access to test results can improve patient satisfaction and decrease patient visits.

"Many physicians think that this type of access is frightening," Dr. Gretchen P. Purcell said at the annual clinical congress of the American College of Surgeons. "They think they'll be barraged with messages, that patients will misinterpret their test results, and that physicians could even be held legally liable if they don't respond in time to an urgent message."

But health care providers, who are about 10 years behind the curve in the digital world, need to face up to the facts of the 21st century, said Dr. Purcell of the surgery department at the Children's Hospital at Vanderbilt in Nashville, Tenn. "Patients are demanding the same kind of online access to their medical information as they have for all other aspects of their lives. Those health care institutions that do not have a patient portal now probably will within the next 5 years."

Patient portals can be designed to suit the needs of different practices and to fulfill various functions. At a minimum, they allow patients to pay bills, schedule or change appointments, and request prescription refills. Other portals are more robust and give patients the ability to review medical records, view test results, and send messages to their health care provider, said Dr. Purcell, who is also with the biomedical informatics department at Vanderbilt Medical Center.

Among the most controversial topics are messaging and the ability to access test results, she said.

"Messaging is probably the function physicians fear the most. Many think it's the equivalent of getting and sending personal e-mail, and this brings up all kinds of worries about security and privacy."

E-mail and messaging, however, are not the same things. Messages don't go to a personal e-mail account; instead, they go to a dedicated in-box. "This message box is routinely checked by an administrative assistant or nurse—someone who can often answer many of the questions, and who would involve the physician only when necessary—similar to phone call triage."

There also are concerns that these electronic exchanges aren't part of a patient's documented record. "Some portals can make messaging part of the medical record, and some physicians have found ways to charge for this 'online consultation,'" Dr. Purcell said.

It's important to set clear expectations about response time and emergency issues. Most messaging systems tell patients that they may have to wait 2-3 business days for a personal reply and advise them to call 911 for a medical emergency.

It's not unreasonable to assume that electronic communication could allow patients to bombard offices with questions and requests. Although data are still limited, the studies that are out there suggest just the opposite, Dr. Purcell said.

Two studies published in 2005 indicate that messaging increases patient satisfaction without any corresponding increase in workload.

The first study randomized 200 patients to secure messaging or usual care. Only 46% of the patients who were given access sent any messages at all; the average was just 1.5 messages per patient per year. And although messaging didn't reduce the number of telephone calls the office received, the number of office visits in the intervention group did go down (Int. J. Med. Inform. 2005;74:705-10).

The second study randomized 606 patients to a patient communication portal or to a Web site with general health information. Only 31% of the patients given access used the portal. The message box received only one message per day per 250 patients. Again, there was no difference in the number of office telephone calls between the groups, but the patients in the portal group reported better satisfaction with communication and overall care, even if they never used the portal (J. Med. Internet Res. 2005;7:e48).

The same study indicated that secure messaging probably would not overwhelm anyone during working hours, Dr. Purcell said. "Patients tended to use the portal during nonclinic hours—the most convenient time for them—with about 73% of messaging occurring from 5 p.m. until midnight."

Patients may even be willing to pay for the added convenience of messaging, the authors concluded. Of 341 patients surveyed, 162 (48%) were willing to pay for online correspondence with their physician, with $2 cited as the median payment they thought fair.

Patient access to test results is another area of clinician concern, she said. "Obtaining test results is probably the most commonly desired and most commonly used function of a patient portal, and one that makes physicians very nervous," Dr. Purcell said.

Vanderbilt's system (www.myhealthatvanderbilt.com

NEW ORLEANS — Rather than unlocking a Pandora's box of nattering e-mails, an electronic patient portal that allows messaging and even access to test results can improve patient satisfaction and decrease patient visits.

"Many physicians think that this type of access is frightening," Dr. Gretchen P. Purcell said at the annual clinical congress of the American College of Surgeons. "They think they'll be barraged with messages, that patients will misinterpret their test results, and that physicians could even be held legally liable if they don't respond in time to an urgent message."

But health care providers, who are about 10 years behind the curve in the digital world, need to face up to the facts of the 21st century, said Dr. Purcell of the surgery department at the Children's Hospital at Vanderbilt in Nashville, Tenn. "Patients are demanding the same kind of online access to their medical information as they have for all other aspects of their lives. Those health care institutions that do not have a patient portal now probably will within the next 5 years."

Patient portals can be designed to suit the needs of different practices and to fulfill various functions. At a minimum, they allow patients to pay bills, schedule or change appointments, and request prescription refills. Other portals are more robust and give patients the ability to review medical records, view test results, and send messages to their health care provider, said Dr. Purcell, who is also with the biomedical informatics department at Vanderbilt Medical Center.

Among the most controversial topics are messaging and the ability to access test results, she said.

"Messaging is probably the function physicians fear the most. Many think it's the equivalent of getting and sending personal e-mail, and this brings up all kinds of worries about security and privacy."

E-mail and messaging, however, are not the same things. Messages don't go to a personal e-mail account; instead, they go to a dedicated in-box. "This message box is routinely checked by an administrative assistant or nurse—someone who can often answer many of the questions, and who would involve the physician only when necessary—similar to phone call triage."

There also are concerns that these electronic exchanges aren't part of a patient's documented record. "Some portals can make messaging part of the medical record, and some physicians have found ways to charge for this 'online consultation,'" Dr. Purcell said.

It's important to set clear expectations about response time and emergency issues. Most messaging systems tell patients that they may have to wait 2-3 business days for a personal reply and advise them to call 911 for a medical emergency.

It's not unreasonable to assume that electronic communication could allow patients to bombard offices with questions and requests. Although data are still limited, the studies that are out there suggest just the opposite, Dr. Purcell said.

Two studies published in 2005 indicate that messaging increases patient satisfaction without any corresponding increase in workload.

The first study randomized 200 patients to secure messaging or usual care. Only 46% of the patients who were given access sent any messages at all; the average was just 1.5 messages per patient per year. And although messaging didn't reduce the number of telephone calls the office received, the number of office visits in the intervention group did go down (Int. J. Med. Inform. 2005;74:705-10).

The second study randomized 606 patients to a patient communication portal or to a Web site with general health information. Only 31% of the patients given access used the portal. The message box received only one message per day per 250 patients. Again, there was no difference in the number of office telephone calls between the groups, but the patients in the portal group reported better satisfaction with communication and overall care, even if they never used the portal (J. Med. Internet Res. 2005;7:e48).

The same study indicated that secure messaging probably would not overwhelm anyone during working hours, Dr. Purcell said. "Patients tended to use the portal during nonclinic hours—the most convenient time for them—with about 73% of messaging occurring from 5 p.m. until midnight."

Patients may even be willing to pay for the added convenience of messaging, the authors concluded. Of 341 patients surveyed, 162 (48%) were willing to pay for online correspondence with their physician, with $2 cited as the median payment they thought fair.

Patient access to test results is another area of clinician concern, she said. "Obtaining test results is probably the most commonly desired and most commonly used function of a patient portal, and one that makes physicians very nervous," Dr. Purcell said.

Vanderbilt's system (www.myhealthatvanderbilt.com

NEW ORLEANS — Rather than unlocking a Pandora's box of nattering e-mails, an electronic patient portal that allows messaging and even access to test results can improve patient satisfaction and decrease patient visits.

"Many physicians think that this type of access is frightening," Dr. Gretchen P. Purcell said at the annual clinical congress of the American College of Surgeons. "They think they'll be barraged with messages, that patients will misinterpret their test results, and that physicians could even be held legally liable if they don't respond in time to an urgent message."

But health care providers, who are about 10 years behind the curve in the digital world, need to face up to the facts of the 21st century, said Dr. Purcell of the surgery department at the Children's Hospital at Vanderbilt in Nashville, Tenn. "Patients are demanding the same kind of online access to their medical information as they have for all other aspects of their lives. Those health care institutions that do not have a patient portal now probably will within the next 5 years."

Patient portals can be designed to suit the needs of different practices and to fulfill various functions. At a minimum, they allow patients to pay bills, schedule or change appointments, and request prescription refills. Other portals are more robust and give patients the ability to review medical records, view test results, and send messages to their health care provider, said Dr. Purcell, who is also with the biomedical informatics department at Vanderbilt Medical Center.

Among the most controversial topics are messaging and the ability to access test results, she said.

"Messaging is probably the function physicians fear the most. Many think it's the equivalent of getting and sending personal e-mail, and this brings up all kinds of worries about security and privacy."

E-mail and messaging, however, are not the same things. Messages don't go to a personal e-mail account; instead, they go to a dedicated in-box. "This message box is routinely checked by an administrative assistant or nurse—someone who can often answer many of the questions, and who would involve the physician only when necessary—similar to phone call triage."

There also are concerns that these electronic exchanges aren't part of a patient's documented record. "Some portals can make messaging part of the medical record, and some physicians have found ways to charge for this 'online consultation,'" Dr. Purcell said.

It's important to set clear expectations about response time and emergency issues. Most messaging systems tell patients that they may have to wait 2-3 business days for a personal reply and advise them to call 911 for a medical emergency.

It's not unreasonable to assume that electronic communication could allow patients to bombard offices with questions and requests. Although data are still limited, the studies that are out there suggest just the opposite, Dr. Purcell said.

Two studies published in 2005 indicate that messaging increases patient satisfaction without any corresponding increase in workload.

The first study randomized 200 patients to secure messaging or usual care. Only 46% of the patients who were given access sent any messages at all; the average was just 1.5 messages per patient per year. And although messaging didn't reduce the number of telephone calls the office received, the number of office visits in the intervention group did go down (Int. J. Med. Inform. 2005;74:705-10).

The second study randomized 606 patients to a patient communication portal or to a Web site with general health information. Only 31% of the patients given access used the portal. The message box received only one message per day per 250 patients. Again, there was no difference in the number of office telephone calls between the groups, but the patients in the portal group reported better satisfaction with communication and overall care, even if they never used the portal (J. Med. Internet Res. 2005;7:e48).

The same study indicated that secure messaging probably would not overwhelm anyone during working hours, Dr. Purcell said. "Patients tended to use the portal during nonclinic hours—the most convenient time for them—with about 73% of messaging occurring from 5 p.m. until midnight."

Patients may even be willing to pay for the added convenience of messaging, the authors concluded. Of 341 patients surveyed, 162 (48%) were willing to pay for online correspondence with their physician, with $2 cited as the median payment they thought fair.

Patient access to test results is another area of clinician concern, she said. "Obtaining test results is probably the most commonly desired and most commonly used function of a patient portal, and one that makes physicians very nervous," Dr. Purcell said.

Vanderbilt's system (www.myhealthatvanderbilt.com

NEW ORLEANS – The benefits of breast reconstruction after mastectomy persist into the long-term survivorship period, Dr. Emily Hu reported at the annual clinical congress of the American College of Surgeons.

Dr. Hu presented surveys that demonstrated greater emotional and physical well-being in breast cancer survivors who had reconstruction surgery than in those who had mastectomy only. Her cross-sectional surveys also showed that women who underwent transverse rectus abdominis myocutaneous (TRAM) reconstruction more than 8 years ago were more satisfied with the aesthetics of their reconstructed breast than were those who received an expander or implant.

Dr. Hu and her colleagues surveyed 391 women who had been treated at the University of Michigan, Ann Arbor, for breast cancer since 1977. The mean follow-up period was 7 years, ranging from 3 to 30 years. Most of the group (247) had breast reconstruction surgery, while the rest (144) had only mastectomy. The groups were divided into three survivorship periods: 5 years or less since surgery, 6-8 years since surgery, and more than 8 years since surgery.

Women rated their current general quality of life on a scale of 0 to 100, and their quality of life with regard to their breast surgery on a Likert scale (1 to 5).

Overall, both groups rated their quality of life as high (84 for the reconstruction group and 82 for the mastectomy-only group). Although there was no significant difference in overall quality of life between the groups, there was a significant difference among the short-term survivors: those who had reconstruction reported a significantly higher quality of life (88 vs. 81).

This difference disappeared over time, however, said Dr. Hu of the plastic surgery department at the university.

When the women rated specific quality of life issues with regard to their breast surgery, significant differences emerged over the long term, all of which favored reconstruction. “We asked women to compare their current quality of life in these areas to that which they experienced before their surgery,” Dr. Hu said. “In the long-term group, women who had reconstruction were 4.5 times as likely to report improvement in emotional well-being, and 4 times as likely to report improvement in physical well-being.”

These women were also six times as likely to report improved social interaction and eight times as likely to report improved sexual function as were their mastectomy-only counterparts.

“The psychosocial benefits of breast reconstruction persist into the long-term survivorship period,” Dr. Hu said. “We should continue to recommend reconstruction to patients and work to improve access for all those who desire it.”

The investigators also surveyed a group of 228 women who had undergone breast reconstruction since 1977 with either TRAM (117) or expander or implant (111). The groups were stratified into the same three follow-up periods.

In the short-term groups, there were no significant differences in overall satisfaction or aesthetic satisfaction (appearance, shape, softness, or projection of the reconstructed breast).

In the long-term group, however, significant differences emerged. Compared with survivors who received an expander or implant more than 8 years ago, TRAM patients were 6 times as likely to be satisfied with the appearance of the reconstructed breast, 24 times as likely to be satisfied with its shape, and 30 times as likely to be satisfied with its softness.

The percent of expander or implant patients satisfied with their aesthetic outcomes fell significantly from the short-term to the long-term periods, dropping from 82% to 45% satisfaction with appearance, 71% to 35% satisfaction with shape, and 67% to 35% satisfaction with softness. The number of TRAM patients satisfied with these outcomes remained consistent (75%-80%) over all the periods.

NEW ORLEANS – The benefits of breast reconstruction after mastectomy persist into the long-term survivorship period, Dr. Emily Hu reported at the annual clinical congress of the American College of Surgeons.

Dr. Hu presented surveys that demonstrated greater emotional and physical well-being in breast cancer survivors who had reconstruction surgery than in those who had mastectomy only. Her cross-sectional surveys also showed that women who underwent transverse rectus abdominis myocutaneous (TRAM) reconstruction more than 8 years ago were more satisfied with the aesthetics of their reconstructed breast than were those who received an expander or implant.

Dr. Hu and her colleagues surveyed 391 women who had been treated at the University of Michigan, Ann Arbor, for breast cancer since 1977. The mean follow-up period was 7 years, ranging from 3 to 30 years. Most of the group (247) had breast reconstruction surgery, while the rest (144) had only mastectomy. The groups were divided into three survivorship periods: 5 years or less since surgery, 6-8 years since surgery, and more than 8 years since surgery.

Women rated their current general quality of life on a scale of 0 to 100, and their quality of life with regard to their breast surgery on a Likert scale (1 to 5).

Overall, both groups rated their quality of life as high (84 for the reconstruction group and 82 for the mastectomy-only group). Although there was no significant difference in overall quality of life between the groups, there was a significant difference among the short-term survivors: those who had reconstruction reported a significantly higher quality of life (88 vs. 81).

This difference disappeared over time, however, said Dr. Hu of the plastic surgery department at the university.

When the women rated specific quality of life issues with regard to their breast surgery, significant differences emerged over the long term, all of which favored reconstruction. “We asked women to compare their current quality of life in these areas to that which they experienced before their surgery,” Dr. Hu said. “In the long-term group, women who had reconstruction were 4.5 times as likely to report improvement in emotional well-being, and 4 times as likely to report improvement in physical well-being.”

These women were also six times as likely to report improved social interaction and eight times as likely to report improved sexual function as were their mastectomy-only counterparts.

“The psychosocial benefits of breast reconstruction persist into the long-term survivorship period,” Dr. Hu said. “We should continue to recommend reconstruction to patients and work to improve access for all those who desire it.”

The investigators also surveyed a group of 228 women who had undergone breast reconstruction since 1977 with either TRAM (117) or expander or implant (111). The groups were stratified into the same three follow-up periods.

In the short-term groups, there were no significant differences in overall satisfaction or aesthetic satisfaction (appearance, shape, softness, or projection of the reconstructed breast).

In the long-term group, however, significant differences emerged. Compared with survivors who received an expander or implant more than 8 years ago, TRAM patients were 6 times as likely to be satisfied with the appearance of the reconstructed breast, 24 times as likely to be satisfied with its shape, and 30 times as likely to be satisfied with its softness.

The percent of expander or implant patients satisfied with their aesthetic outcomes fell significantly from the short-term to the long-term periods, dropping from 82% to 45% satisfaction with appearance, 71% to 35% satisfaction with shape, and 67% to 35% satisfaction with softness. The number of TRAM patients satisfied with these outcomes remained consistent (75%-80%) over all the periods.

NEW ORLEANS – The benefits of breast reconstruction after mastectomy persist into the long-term survivorship period, Dr. Emily Hu reported at the annual clinical congress of the American College of Surgeons.

Dr. Hu presented surveys that demonstrated greater emotional and physical well-being in breast cancer survivors who had reconstruction surgery than in those who had mastectomy only. Her cross-sectional surveys also showed that women who underwent transverse rectus abdominis myocutaneous (TRAM) reconstruction more than 8 years ago were more satisfied with the aesthetics of their reconstructed breast than were those who received an expander or implant.

Dr. Hu and her colleagues surveyed 391 women who had been treated at the University of Michigan, Ann Arbor, for breast cancer since 1977. The mean follow-up period was 7 years, ranging from 3 to 30 years. Most of the group (247) had breast reconstruction surgery, while the rest (144) had only mastectomy. The groups were divided into three survivorship periods: 5 years or less since surgery, 6-8 years since surgery, and more than 8 years since surgery.

Women rated their current general quality of life on a scale of 0 to 100, and their quality of life with regard to their breast surgery on a Likert scale (1 to 5).

Overall, both groups rated their quality of life as high (84 for the reconstruction group and 82 for the mastectomy-only group). Although there was no significant difference in overall quality of life between the groups, there was a significant difference among the short-term survivors: those who had reconstruction reported a significantly higher quality of life (88 vs. 81).

This difference disappeared over time, however, said Dr. Hu of the plastic surgery department at the university.

When the women rated specific quality of life issues with regard to their breast surgery, significant differences emerged over the long term, all of which favored reconstruction. “We asked women to compare their current quality of life in these areas to that which they experienced before their surgery,” Dr. Hu said. “In the long-term group, women who had reconstruction were 4.5 times as likely to report improvement in emotional well-being, and 4 times as likely to report improvement in physical well-being.”

These women were also six times as likely to report improved social interaction and eight times as likely to report improved sexual function as were their mastectomy-only counterparts.

“The psychosocial benefits of breast reconstruction persist into the long-term survivorship period,” Dr. Hu said. “We should continue to recommend reconstruction to patients and work to improve access for all those who desire it.”

The investigators also surveyed a group of 228 women who had undergone breast reconstruction since 1977 with either TRAM (117) or expander or implant (111). The groups were stratified into the same three follow-up periods.

In the short-term groups, there were no significant differences in overall satisfaction or aesthetic satisfaction (appearance, shape, softness, or projection of the reconstructed breast).

In the long-term group, however, significant differences emerged. Compared with survivors who received an expander or implant more than 8 years ago, TRAM patients were 6 times as likely to be satisfied with the appearance of the reconstructed breast, 24 times as likely to be satisfied with its shape, and 30 times as likely to be satisfied with its softness.

The percent of expander or implant patients satisfied with their aesthetic outcomes fell significantly from the short-term to the long-term periods, dropping from 82% to 45% satisfaction with appearance, 71% to 35% satisfaction with shape, and 67% to 35% satisfaction with softness. The number of TRAM patients satisfied with these outcomes remained consistent (75%-80%) over all the periods.

NEW ORLEANS —Long-term functional outcomes may decline after ileoanal pouch surgery, but most patients report higher a quality of life than they had before their surgery, Dr. Feza H. Remzi said at the annual clinical congress of the American College of Surgeons.

Dr. Remzi of the Cleveland Clinic Foundation reported the results of a long-term follow-up study of 3,080 patients who underwent ileoanal pouch formation at the clinic from 1983 to 2006.

The patients' mean age at surgery was 38 years. Most (87%) had a final diagnosis of ulcerative or indeterminate colitis. A total of 43% of patients underwent surgery because of failed medical therapy or steroid dependence. Some of the other indications were prior colectomy (33%); dysplasia, cancer, or cancer prevention (11%); and familial polyposis (4%). The most commonly performed surgical technique was a stapled anastomosis (78%). A J-pouch design was used in 82% of patients, and 17% had their pouches created with no need for a diverting ileostomy.

The 30-day complication rate was low. Wound infections occurred in 5% of patients, small bowel obstruction in 4%, sepsis in 4%, postoperative bleeding in 3%, anastomotic separation in 2.5%, and fistula in 1%. Less than 1% of patients had pouch failure in the first 30 days.

At 5–15 years after surgery, however, all complications (sepsis, fistula, anastomotic stricture, obstruction, pouch failure, and pouchitis) had a tendency to increase. Significant increases were seen in small bowel obstruction (from 16% at 5 years to 23% at 15 years) and pouchitis (from 32% to 52% over that same period).

Incontinence increased significantly over time. Although 75% of patients reported complete continence at 3 months post operatively, only 32% reported it 15 years later. But there were some significant long-term improvements. Before surgery, only 60% of patients reported rare incontinence or none at all. By 3 months after surgery, the percentage of that combined group of patients had risen to 80%, and it did not vary significantly during the next 15 years of follow-up.

There was no significant change in the number of daytime or nighttime bowel movements from baseline to 15 years. Urgency decreased significantly over the same period. However, pad usage and seepage increased.

Nonetheless, patients generally reported high quality of life scores as early as 3 months after the procedure, and these scores stayed high throughout the follow-up period, Dr. Remzi said. All patients reported significant decreases in dietary, work, social, and sexual restrictions at each time period.

In discussing the paper, Dr. Robin McLeod stressed that quality of life should be a primary end point in any evaluation of long-term outcomes after this procedure. “Although the functional outcomes are not perfect, the quality of life for these patients is very good, and they are happy with the procedure. This is one of the disconnects that can happen when we focus only on the functional outcome and don't look at the patient globally,” said Dr. McLeod of Mount Sinai Hospital, Toronto.

According to Dr. Remzi, 97% of patients said they would undergo the procedure again, and would recommend it to others. “This is a very important indication of quality of life—that they would do it all over again,” he said.

NEW ORLEANS —Long-term functional outcomes may decline after ileoanal pouch surgery, but most patients report higher a quality of life than they had before their surgery, Dr. Feza H. Remzi said at the annual clinical congress of the American College of Surgeons.

Dr. Remzi of the Cleveland Clinic Foundation reported the results of a long-term follow-up study of 3,080 patients who underwent ileoanal pouch formation at the clinic from 1983 to 2006.

The patients' mean age at surgery was 38 years. Most (87%) had a final diagnosis of ulcerative or indeterminate colitis. A total of 43% of patients underwent surgery because of failed medical therapy or steroid dependence. Some of the other indications were prior colectomy (33%); dysplasia, cancer, or cancer prevention (11%); and familial polyposis (4%). The most commonly performed surgical technique was a stapled anastomosis (78%). A J-pouch design was used in 82% of patients, and 17% had their pouches created with no need for a diverting ileostomy.

The 30-day complication rate was low. Wound infections occurred in 5% of patients, small bowel obstruction in 4%, sepsis in 4%, postoperative bleeding in 3%, anastomotic separation in 2.5%, and fistula in 1%. Less than 1% of patients had pouch failure in the first 30 days.

At 5–15 years after surgery, however, all complications (sepsis, fistula, anastomotic stricture, obstruction, pouch failure, and pouchitis) had a tendency to increase. Significant increases were seen in small bowel obstruction (from 16% at 5 years to 23% at 15 years) and pouchitis (from 32% to 52% over that same period).

Incontinence increased significantly over time. Although 75% of patients reported complete continence at 3 months post operatively, only 32% reported it 15 years later. But there were some significant long-term improvements. Before surgery, only 60% of patients reported rare incontinence or none at all. By 3 months after surgery, the percentage of that combined group of patients had risen to 80%, and it did not vary significantly during the next 15 years of follow-up.

There was no significant change in the number of daytime or nighttime bowel movements from baseline to 15 years. Urgency decreased significantly over the same period. However, pad usage and seepage increased.

Nonetheless, patients generally reported high quality of life scores as early as 3 months after the procedure, and these scores stayed high throughout the follow-up period, Dr. Remzi said. All patients reported significant decreases in dietary, work, social, and sexual restrictions at each time period.

In discussing the paper, Dr. Robin McLeod stressed that quality of life should be a primary end point in any evaluation of long-term outcomes after this procedure. “Although the functional outcomes are not perfect, the quality of life for these patients is very good, and they are happy with the procedure. This is one of the disconnects that can happen when we focus only on the functional outcome and don't look at the patient globally,” said Dr. McLeod of Mount Sinai Hospital, Toronto.

According to Dr. Remzi, 97% of patients said they would undergo the procedure again, and would recommend it to others. “This is a very important indication of quality of life—that they would do it all over again,” he said.

NEW ORLEANS —Long-term functional outcomes may decline after ileoanal pouch surgery, but most patients report higher a quality of life than they had before their surgery, Dr. Feza H. Remzi said at the annual clinical congress of the American College of Surgeons.

Dr. Remzi of the Cleveland Clinic Foundation reported the results of a long-term follow-up study of 3,080 patients who underwent ileoanal pouch formation at the clinic from 1983 to 2006.

The patients' mean age at surgery was 38 years. Most (87%) had a final diagnosis of ulcerative or indeterminate colitis. A total of 43% of patients underwent surgery because of failed medical therapy or steroid dependence. Some of the other indications were prior colectomy (33%); dysplasia, cancer, or cancer prevention (11%); and familial polyposis (4%). The most commonly performed surgical technique was a stapled anastomosis (78%). A J-pouch design was used in 82% of patients, and 17% had their pouches created with no need for a diverting ileostomy.

The 30-day complication rate was low. Wound infections occurred in 5% of patients, small bowel obstruction in 4%, sepsis in 4%, postoperative bleeding in 3%, anastomotic separation in 2.5%, and fistula in 1%. Less than 1% of patients had pouch failure in the first 30 days.

At 5–15 years after surgery, however, all complications (sepsis, fistula, anastomotic stricture, obstruction, pouch failure, and pouchitis) had a tendency to increase. Significant increases were seen in small bowel obstruction (from 16% at 5 years to 23% at 15 years) and pouchitis (from 32% to 52% over that same period).

Incontinence increased significantly over time. Although 75% of patients reported complete continence at 3 months post operatively, only 32% reported it 15 years later. But there were some significant long-term improvements. Before surgery, only 60% of patients reported rare incontinence or none at all. By 3 months after surgery, the percentage of that combined group of patients had risen to 80%, and it did not vary significantly during the next 15 years of follow-up.

There was no significant change in the number of daytime or nighttime bowel movements from baseline to 15 years. Urgency decreased significantly over the same period. However, pad usage and seepage increased.

Nonetheless, patients generally reported high quality of life scores as early as 3 months after the procedure, and these scores stayed high throughout the follow-up period, Dr. Remzi said. All patients reported significant decreases in dietary, work, social, and sexual restrictions at each time period.

In discussing the paper, Dr. Robin McLeod stressed that quality of life should be a primary end point in any evaluation of long-term outcomes after this procedure. “Although the functional outcomes are not perfect, the quality of life for these patients is very good, and they are happy with the procedure. This is one of the disconnects that can happen when we focus only on the functional outcome and don't look at the patient globally,” said Dr. McLeod of Mount Sinai Hospital, Toronto.

According to Dr. Remzi, 97% of patients said they would undergo the procedure again, and would recommend it to others. “This is a very important indication of quality of life—that they would do it all over again,” he said.

WASHINGTON — Acupuncture performed on site before and after embryo transfer has been shown to improve in vitro fertilization success rates in patients with good-quality embryos, but the same finding did not hold true in a recent study conducted in a “real world” setting, in which acupuncture was associated with a reduced success rate, Dr. LaTasha B. Craig reported at the annual meeting of the American Society for Reproductive Medicine.

In a 2002 landmark study by Paulus et al. showing a benefit with acupuncture in patients undergoing IVF (Fertil. Steril. 2002;77:721–4), acupuncture was associated with increased pregnancy rates in 80 treated patients, compared with 80 controls who received no treatment (43% vs. 26% pregnancy rates in the groups, respectively).

But that study, which was conducted in Germany, included only patients with good-quality embryos, and involved on-site acupuncture treatments, which aren't typically available at IVF centers in the United States, Dr. Craig, of the University of Oklahoma, Oklahoma City, explained in an interview.

For her study (prompted by curiosity about whether the benefits of acupuncture in IVF patients would hold up in this country, where pregnancy rates with IVF are higher than in Germany) 113 women were randomized to undergo acupuncture using a modified Paulus protocol (involving two additional acupoints) for 25 minutes before and after embryo transfer by one of two licensed acupuncturists at an off-site location or to receive no intervention before or after embryo transfer.

Patients were included in the study regardless of embryo quality.

Acupuncture in her study, which was conducted in Seattle while she was with the University of Washington, was associated with lower clinical and live birth pregnancy rates, compared with no intervention (46% vs. 72%, and 39% vs. 65%, respectively).

Clinical pregnancy was defined as a positive fetal heart rate on ultrasound at 6–7 weeks' gestation.

Live birth delivery was defined as delivery at 24 weeks or greater.

Patients in the treatment and control groups were statistically similar in regard to age, peak estradiol level, number of oocytes retrieved, fertilization method and rate, number of embryos transferred, and the proportion of blastocyst transfer, she noted.

“I expected to find no difference between the groups—not a reversal of the Paulus findings,” she said during the interview.

The fact that patients traveled to and from the IVF center in busy Seattle traffic for the acupuncture, thus possibly increasing stress levels and negating the effects of the acupuncture, may prove to be an important factor in her findings, she commented.

Of note, there were three studies of acupuncture and IVF in 2006, with two of the three showing a benefit with acupuncture, and one showing no difference.

“Now mine shows possible detriment [with acupuncture],” she said, adding that the conflicting findings suggest additional study is needed.

However, acupuncture can be very difficult to study, in part because of the lack of a good acupuncture control method.

“My belief is that acupuncture 1–2 times a week leading up to IVF is probably going to prove more effective than just providing acupuncture the day of the embryo transfer,” she added.

That's because the theory behind traditional Chinese acupuncture methods is whole-person medicine. They don't effect a change in 1 day, and the idea that every patient would be treated the same way goes against their basic training, she explained.

Dr. Craig is working to obtain funding to begin a study at the University of Oklahoma. The ideal study would compare on-site acupuncture before and after embryo transfer, off-site acupuncture before and after embryo transfer, and no treatment, she said.

WASHINGTON — Acupuncture performed on site before and after embryo transfer has been shown to improve in vitro fertilization success rates in patients with good-quality embryos, but the same finding did not hold true in a recent study conducted in a “real world” setting, in which acupuncture was associated with a reduced success rate, Dr. LaTasha B. Craig reported at the annual meeting of the American Society for Reproductive Medicine.

In a 2002 landmark study by Paulus et al. showing a benefit with acupuncture in patients undergoing IVF (Fertil. Steril. 2002;77:721–4), acupuncture was associated with increased pregnancy rates in 80 treated patients, compared with 80 controls who received no treatment (43% vs. 26% pregnancy rates in the groups, respectively).

But that study, which was conducted in Germany, included only patients with good-quality embryos, and involved on-site acupuncture treatments, which aren't typically available at IVF centers in the United States, Dr. Craig, of the University of Oklahoma, Oklahoma City, explained in an interview.

For her study (prompted by curiosity about whether the benefits of acupuncture in IVF patients would hold up in this country, where pregnancy rates with IVF are higher than in Germany) 113 women were randomized to undergo acupuncture using a modified Paulus protocol (involving two additional acupoints) for 25 minutes before and after embryo transfer by one of two licensed acupuncturists at an off-site location or to receive no intervention before or after embryo transfer.

Patients were included in the study regardless of embryo quality.

Acupuncture in her study, which was conducted in Seattle while she was with the University of Washington, was associated with lower clinical and live birth pregnancy rates, compared with no intervention (46% vs. 72%, and 39% vs. 65%, respectively).

Clinical pregnancy was defined as a positive fetal heart rate on ultrasound at 6–7 weeks' gestation.

Live birth delivery was defined as delivery at 24 weeks or greater.

Patients in the treatment and control groups were statistically similar in regard to age, peak estradiol level, number of oocytes retrieved, fertilization method and rate, number of embryos transferred, and the proportion of blastocyst transfer, she noted.

“I expected to find no difference between the groups—not a reversal of the Paulus findings,” she said during the interview.

The fact that patients traveled to and from the IVF center in busy Seattle traffic for the acupuncture, thus possibly increasing stress levels and negating the effects of the acupuncture, may prove to be an important factor in her findings, she commented.

Of note, there were three studies of acupuncture and IVF in 2006, with two of the three showing a benefit with acupuncture, and one showing no difference.

“Now mine shows possible detriment [with acupuncture],” she said, adding that the conflicting findings suggest additional study is needed.

However, acupuncture can be very difficult to study, in part because of the lack of a good acupuncture control method.

“My belief is that acupuncture 1–2 times a week leading up to IVF is probably going to prove more effective than just providing acupuncture the day of the embryo transfer,” she added.

That's because the theory behind traditional Chinese acupuncture methods is whole-person medicine. They don't effect a change in 1 day, and the idea that every patient would be treated the same way goes against their basic training, she explained.

Dr. Craig is working to obtain funding to begin a study at the University of Oklahoma. The ideal study would compare on-site acupuncture before and after embryo transfer, off-site acupuncture before and after embryo transfer, and no treatment, she said.

WASHINGTON — Acupuncture performed on site before and after embryo transfer has been shown to improve in vitro fertilization success rates in patients with good-quality embryos, but the same finding did not hold true in a recent study conducted in a “real world” setting, in which acupuncture was associated with a reduced success rate, Dr. LaTasha B. Craig reported at the annual meeting of the American Society for Reproductive Medicine.

In a 2002 landmark study by Paulus et al. showing a benefit with acupuncture in patients undergoing IVF (Fertil. Steril. 2002;77:721–4), acupuncture was associated with increased pregnancy rates in 80 treated patients, compared with 80 controls who received no treatment (43% vs. 26% pregnancy rates in the groups, respectively).

But that study, which was conducted in Germany, included only patients with good-quality embryos, and involved on-site acupuncture treatments, which aren't typically available at IVF centers in the United States, Dr. Craig, of the University of Oklahoma, Oklahoma City, explained in an interview.

For her study (prompted by curiosity about whether the benefits of acupuncture in IVF patients would hold up in this country, where pregnancy rates with IVF are higher than in Germany) 113 women were randomized to undergo acupuncture using a modified Paulus protocol (involving two additional acupoints) for 25 minutes before and after embryo transfer by one of two licensed acupuncturists at an off-site location or to receive no intervention before or after embryo transfer.

Patients were included in the study regardless of embryo quality.

Acupuncture in her study, which was conducted in Seattle while she was with the University of Washington, was associated with lower clinical and live birth pregnancy rates, compared with no intervention (46% vs. 72%, and 39% vs. 65%, respectively).

Clinical pregnancy was defined as a positive fetal heart rate on ultrasound at 6–7 weeks' gestation.

Live birth delivery was defined as delivery at 24 weeks or greater.

Patients in the treatment and control groups were statistically similar in regard to age, peak estradiol level, number of oocytes retrieved, fertilization method and rate, number of embryos transferred, and the proportion of blastocyst transfer, she noted.

“I expected to find no difference between the groups—not a reversal of the Paulus findings,” she said during the interview.

The fact that patients traveled to and from the IVF center in busy Seattle traffic for the acupuncture, thus possibly increasing stress levels and negating the effects of the acupuncture, may prove to be an important factor in her findings, she commented.

Of note, there were three studies of acupuncture and IVF in 2006, with two of the three showing a benefit with acupuncture, and one showing no difference.

“Now mine shows possible detriment [with acupuncture],” she said, adding that the conflicting findings suggest additional study is needed.

However, acupuncture can be very difficult to study, in part because of the lack of a good acupuncture control method.

“My belief is that acupuncture 1–2 times a week leading up to IVF is probably going to prove more effective than just providing acupuncture the day of the embryo transfer,” she added.

That's because the theory behind traditional Chinese acupuncture methods is whole-person medicine. They don't effect a change in 1 day, and the idea that every patient would be treated the same way goes against their basic training, she explained.

Dr. Craig is working to obtain funding to begin a study at the University of Oklahoma. The ideal study would compare on-site acupuncture before and after embryo transfer, off-site acupuncture before and after embryo transfer, and no treatment, she said.

Topiramate may be a promising treatment for alcohol dependence, significantly decreasing heavy drinking days and increasing days of abstinence, compared with placebo, Dr. Bankole A. Johnson and his colleagues reported.

“This is a different paradigm, and it gives us another way to try and treat alcoholics,” said Dr. Johnson, chair of the department of psychiatry and neurobehavioral sciences at the University of Virginia, Charlottesville, when he initially unveiled the data at the annual meeting of the Research Society on Alcoholism in Washington.

“The way we had before was to detox them by some method and then see if they relapse. But they may not need to do that,” Dr. Johnson pointed out. “You can start them [on topiramate] while they're still drinking heavily.”

The 14-week, placebo-controlled trial randomized 371 patients with alcohol dependence (mean age 47 years) to either placebo or up to 300 mg topiramate (Topamax) daily. Most of the patients (72%) were men; about 85% were white (JAMA 2007;298:1641-51).

At baseline, all the men in the study were drinking at least 35 drinks per week; the women were drinking at least 28 per week. Patients recorded their baseline alcohol consumption for 1 week as part of the screening process. They also recorded their daily drinking throughout the study.

Topiramate was significantly more effective than placebo in reducing the percentage of heavy drinking days from baseline to week 14 (82% to 44% for topiramate and 82% to 52% for placebo).

Patients taking the drug had a mean of 7% more abstinent days than did those taking placebo, a significant difference. They also drank a mean of one fewer drink per drinking day than did those taking placebo.

Topiramate was associated with significantly lower levels of gamma-glutamyltransferase, an objective measure of recent alcohol consumption.

Patients taking topiramate were almost three times more likely than were placebo patients to achieve 28 or more continuous days of nonheavy drinking, and six times more likely to achieve 28 or more days of abstinence.

Adverse events that were more common in the topiramate group included paresthesia (51% vs. 11%), taste perversion (23% vs. 5%), anorexia (20% vs. 7%), and difficulty with concentration (15% vs. 3%). Attrition attributable to adverse events was 18% for topiramate and 4% for placebo.

The authors noted that their results might not be applicable to most people seeking treatment for alcohol dependence. “As with most clinical trials [in this field], enrolled patients have to meet criteria enabling the conduct of a safe study. Because this cohort is often relatively healthier and perhaps more homogenous than the general population of all those seeking treatment for alcohol dependence, our ability to generalize without restriction from this trial to clinical practice is limited.”

Nonetheless, wrote Dr. Mark L. Willenbring in the accompanying editorial, topiramate may represent a new and valuable tool for primary care physicians. Most have little formal training in treating alcohol use disorders and do not feel qualified to care for these patients, wrote Dr. Willenbring, of the National Institute on Alcohol Abuse and Alcoholism. The usual course is to refer to a specialist (JAMA 2007;298:1691-2).

“However, access to specialized treatment has become more difficult in the last decade, and although the prevalence of alcohol use disorders has not changed substantially, even fewer patients receive treatment than did 10 years ago.”

Dr. Johnson disclosed that he is a consultant for several pharmaceutical companies, including Ortho-McNeil Janssen Scientific Affairs LLC. (Ortho-McNeil Inc. is the maker of Topamax.) Dr. Willenbring reported no disclosures.

'This is a different paradigm. … You can start them [on topiramate] while they're still drinking heavily.' DR. JOHNSON

Topiramate may be a promising treatment for alcohol dependence, significantly decreasing heavy drinking days and increasing days of abstinence, compared with placebo, Dr. Bankole A. Johnson and his colleagues reported.

“This is a different paradigm, and it gives us another way to try and treat alcoholics,” said Dr. Johnson, chair of the department of psychiatry and neurobehavioral sciences at the University of Virginia, Charlottesville, when he initially unveiled the data at the annual meeting of the Research Society on Alcoholism in Washington.

“The way we had before was to detox them by some method and then see if they relapse. But they may not need to do that,” Dr. Johnson pointed out. “You can start them [on topiramate] while they're still drinking heavily.”

The 14-week, placebo-controlled trial randomized 371 patients with alcohol dependence (mean age 47 years) to either placebo or up to 300 mg topiramate (Topamax) daily. Most of the patients (72%) were men; about 85% were white (JAMA 2007;298:1641-51).

At baseline, all the men in the study were drinking at least 35 drinks per week; the women were drinking at least 28 per week. Patients recorded their baseline alcohol consumption for 1 week as part of the screening process. They also recorded their daily drinking throughout the study.

Topiramate was significantly more effective than placebo in reducing the percentage of heavy drinking days from baseline to week 14 (82% to 44% for topiramate and 82% to 52% for placebo).

Patients taking the drug had a mean of 7% more abstinent days than did those taking placebo, a significant difference. They also drank a mean of one fewer drink per drinking day than did those taking placebo.

Topiramate was associated with significantly lower levels of gamma-glutamyltransferase, an objective measure of recent alcohol consumption.

Patients taking topiramate were almost three times more likely than were placebo patients to achieve 28 or more continuous days of nonheavy drinking, and six times more likely to achieve 28 or more days of abstinence.

Adverse events that were more common in the topiramate group included paresthesia (51% vs. 11%), taste perversion (23% vs. 5%), anorexia (20% vs. 7%), and difficulty with concentration (15% vs. 3%). Attrition attributable to adverse events was 18% for topiramate and 4% for placebo.

The authors noted that their results might not be applicable to most people seeking treatment for alcohol dependence. “As with most clinical trials [in this field], enrolled patients have to meet criteria enabling the conduct of a safe study. Because this cohort is often relatively healthier and perhaps more homogenous than the general population of all those seeking treatment for alcohol dependence, our ability to generalize without restriction from this trial to clinical practice is limited.”

Nonetheless, wrote Dr. Mark L. Willenbring in the accompanying editorial, topiramate may represent a new and valuable tool for primary care physicians. Most have little formal training in treating alcohol use disorders and do not feel qualified to care for these patients, wrote Dr. Willenbring, of the National Institute on Alcohol Abuse and Alcoholism. The usual course is to refer to a specialist (JAMA 2007;298:1691-2).

“However, access to specialized treatment has become more difficult in the last decade, and although the prevalence of alcohol use disorders has not changed substantially, even fewer patients receive treatment than did 10 years ago.”

Dr. Johnson disclosed that he is a consultant for several pharmaceutical companies, including Ortho-McNeil Janssen Scientific Affairs LLC. (Ortho-McNeil Inc. is the maker of Topamax.) Dr. Willenbring reported no disclosures.

'This is a different paradigm. … You can start them [on topiramate] while they're still drinking heavily.' DR. JOHNSON

Topiramate may be a promising treatment for alcohol dependence, significantly decreasing heavy drinking days and increasing days of abstinence, compared with placebo, Dr. Bankole A. Johnson and his colleagues reported.

“This is a different paradigm, and it gives us another way to try and treat alcoholics,” said Dr. Johnson, chair of the department of psychiatry and neurobehavioral sciences at the University of Virginia, Charlottesville, when he initially unveiled the data at the annual meeting of the Research Society on Alcoholism in Washington.

“The way we had before was to detox them by some method and then see if they relapse. But they may not need to do that,” Dr. Johnson pointed out. “You can start them [on topiramate] while they're still drinking heavily.”

The 14-week, placebo-controlled trial randomized 371 patients with alcohol dependence (mean age 47 years) to either placebo or up to 300 mg topiramate (Topamax) daily. Most of the patients (72%) were men; about 85% were white (JAMA 2007;298:1641-51).

At baseline, all the men in the study were drinking at least 35 drinks per week; the women were drinking at least 28 per week. Patients recorded their baseline alcohol consumption for 1 week as part of the screening process. They also recorded their daily drinking throughout the study.

Topiramate was significantly more effective than placebo in reducing the percentage of heavy drinking days from baseline to week 14 (82% to 44% for topiramate and 82% to 52% for placebo).

Patients taking the drug had a mean of 7% more abstinent days than did those taking placebo, a significant difference. They also drank a mean of one fewer drink per drinking day than did those taking placebo.

Topiramate was associated with significantly lower levels of gamma-glutamyltransferase, an objective measure of recent alcohol consumption.

Patients taking topiramate were almost three times more likely than were placebo patients to achieve 28 or more continuous days of nonheavy drinking, and six times more likely to achieve 28 or more days of abstinence.

Adverse events that were more common in the topiramate group included paresthesia (51% vs. 11%), taste perversion (23% vs. 5%), anorexia (20% vs. 7%), and difficulty with concentration (15% vs. 3%). Attrition attributable to adverse events was 18% for topiramate and 4% for placebo.

The authors noted that their results might not be applicable to most people seeking treatment for alcohol dependence. “As with most clinical trials [in this field], enrolled patients have to meet criteria enabling the conduct of a safe study. Because this cohort is often relatively healthier and perhaps more homogenous than the general population of all those seeking treatment for alcohol dependence, our ability to generalize without restriction from this trial to clinical practice is limited.”

Nonetheless, wrote Dr. Mark L. Willenbring in the accompanying editorial, topiramate may represent a new and valuable tool for primary care physicians. Most have little formal training in treating alcohol use disorders and do not feel qualified to care for these patients, wrote Dr. Willenbring, of the National Institute on Alcohol Abuse and Alcoholism. The usual course is to refer to a specialist (JAMA 2007;298:1691-2).

“However, access to specialized treatment has become more difficult in the last decade, and although the prevalence of alcohol use disorders has not changed substantially, even fewer patients receive treatment than did 10 years ago.”

Dr. Johnson disclosed that he is a consultant for several pharmaceutical companies, including Ortho-McNeil Janssen Scientific Affairs LLC. (Ortho-McNeil Inc. is the maker of Topamax.) Dr. Willenbring reported no disclosures.

'This is a different paradigm. … You can start them [on topiramate] while they're still drinking heavily.' DR. JOHNSON

Tramiprosate, the first antiamyloid drug to enter a phase III trial, was not significantly better than placebo in improving cognitive function in patients with Alzheimer's disease, according to officials of Neurochem Inc., manufacturer of the investigational agent and sponsor of the North American trial.

The negative results are a blow to Alzheimer's disease (AD) researchers and patient advocacy groups, said Dr. Richard J. Caselli, chair of neurology at the Mayo Clinic, Scottsdale, Ariz. “Tramiprosate was the first antiamyloid drug to reach this point, and as such, was widely watched by the Alzheimer's disease community,” Dr. Caselli said in an interview. “Its failure to achieve its therapeutic outcomes is therefore very disappointing.”

The question now is whether this failure poses a serious challenge to the amyloid hypothesis of AD pathogenesis, he said. “Possibly not, as findings from a newly released study suggest that in addition to its antiamyloid effects, tramiprosate may have a competing effect favoring tau aggregation. It remains too early to heavily discount the amyloid hypothesis, and other trials in progress will be watched expectantly.”

The North American Phase III study included 1,052 patients with mild to moderate AD, recruited from 67 sites in Canada and the United States. Patients were randomized to placebo or 100 mg or 150 mg twice daily of tramiprosate. They continued all their concomitant AD drugs during the 18-month study period.

Although there were numerical differences in favor of tramiprosate, those differences failed to reach statistical significance in any of the three primary end points: the Alzheimer's Disease Assessment Scale (ADAS-Cog), the Dementia Rating-Sum of Boxes rating scale (CDR-SB), or magnetic resonance imaging. The MRI analysis showed a trend toward larger hippocampal volume in the active group, although the investigators have not assessed that finding's possible relationship to cognitive performance, Dr. Francesco Bellini, Neurochem's president and chief executive officer, said during the teleconference during which the data were released.

Dr. Bellini hesitated to describe the study as negative, pointing out that the statistical analysis was complicated by improvement in more than 30% of the control patients. “This complicated the analysis beyond expectation, so that our results are inconclusive,” Dr. Bellini said.

Dr. Paul S. Aisen, principal investigator of the North American trial, noted the unexpected improvement of so many control patients is probably a result of the effect of concomitant medications, and will be a recurring problem in all long-term studies of disease-modifying agents for AD.

“This problem will not be unique to this program,” said Dr. Aisen, professor of neurology at Georgetown University Medical Center, Washington. “It will be faced by anyone who tries to conduct these trials. A number of the approved medications have significant effects on the primary outcomes, and during 18-month trials, these effects will be unavoidable.”

Dr. Caselli noted drug companies need to factor this into their trial designs in light of the reality that patients will not be giving up their approved medications while taking a study drug. “We should not infer that study limitations imply the study 'was not really negative, even though it appeared to be,'” he said. “Hopefully the European trial [of tramiprosate] will show something different, but after all is said and done, if both fail and we still encounter the 'Can't tell because they're on treatment' argument, then the study design needs to be changed to accommodate this. But the study was negative as performed.”

Dr. Marwan Sabbagh, director of clinical research at the Sun Health Research Institute in Sun City, Ariz., noted the real difficulty with the tramiprosate trial design centers on the lack of objective clinical end points.

“That is the peril of using cognitive outcomes of primary measures,” he said in an interview. “Many in the industry would like to see other measures used, but there are none validated or universally agreed upon.”

Future studies will need to give equal weight to specific biomarker outcomes, he said, including PET scans, MRI volumetry, and cerebrospinal fluid. “This negative study will make a lot of companies consider their development strategies more carefully.”

Neurochem's Dr. Denis Garceau said the company delayed the release of its findings, which were to have been presented publicly in June. In the meantime, Neurochem reworked the statistical analysis and sought advice from the Food and Drug Administration, said Dr. Garceau, who is senior vice president of drug development. “While recognizing the challenges of a trial of this magnitude, the FDA advised that neither the proposed adjusted models nor any further adjustments could be used for this trial to support a positive effect of tramiprosate,” Dr. Garceau said.

The data may, however, be used to modify the primary analysis plan for the ongoing European phase III trial, which includes 966 patients in 10 countries. Recruitment for that trial is complete, but significant changes are possible, including changes to the study cohort, duration of treatment, and the statistical analysis, Dr. Garceau said. A company-appointed special advisory board will review the North American trial data, suggest any changes to the European trial, and ultimately recommend to Neurochem the fate of tramiprosate.

Despite the failure, 'it remains too early to heavily discount the amyloid hypothesis.' DR. CASELLI

Tramiprosate, the first antiamyloid drug to enter a phase III trial, was not significantly better than placebo in improving cognitive function in patients with Alzheimer's disease, according to officials of Neurochem Inc., manufacturer of the investigational agent and sponsor of the North American trial.

The negative results are a blow to Alzheimer's disease (AD) researchers and patient advocacy groups, said Dr. Richard J. Caselli, chair of neurology at the Mayo Clinic, Scottsdale, Ariz. “Tramiprosate was the first antiamyloid drug to reach this point, and as such, was widely watched by the Alzheimer's disease community,” Dr. Caselli said in an interview. “Its failure to achieve its therapeutic outcomes is therefore very disappointing.”

The question now is whether this failure poses a serious challenge to the amyloid hypothesis of AD pathogenesis, he said. “Possibly not, as findings from a newly released study suggest that in addition to its antiamyloid effects, tramiprosate may have a competing effect favoring tau aggregation. It remains too early to heavily discount the amyloid hypothesis, and other trials in progress will be watched expectantly.”

The North American Phase III study included 1,052 patients with mild to moderate AD, recruited from 67 sites in Canada and the United States. Patients were randomized to placebo or 100 mg or 150 mg twice daily of tramiprosate. They continued all their concomitant AD drugs during the 18-month study period.

Although there were numerical differences in favor of tramiprosate, those differences failed to reach statistical significance in any of the three primary end points: the Alzheimer's Disease Assessment Scale (ADAS-Cog), the Dementia Rating-Sum of Boxes rating scale (CDR-SB), or magnetic resonance imaging. The MRI analysis showed a trend toward larger hippocampal volume in the active group, although the investigators have not assessed that finding's possible relationship to cognitive performance, Dr. Francesco Bellini, Neurochem's president and chief executive officer, said during the teleconference during which the data were released.

Dr. Bellini hesitated to describe the study as negative, pointing out that the statistical analysis was complicated by improvement in more than 30% of the control patients. “This complicated the analysis beyond expectation, so that our results are inconclusive,” Dr. Bellini said.

Dr. Paul S. Aisen, principal investigator of the North American trial, noted the unexpected improvement of so many control patients is probably a result of the effect of concomitant medications, and will be a recurring problem in all long-term studies of disease-modifying agents for AD.

“This problem will not be unique to this program,” said Dr. Aisen, professor of neurology at Georgetown University Medical Center, Washington. “It will be faced by anyone who tries to conduct these trials. A number of the approved medications have significant effects on the primary outcomes, and during 18-month trials, these effects will be unavoidable.”

Dr. Caselli noted drug companies need to factor this into their trial designs in light of the reality that patients will not be giving up their approved medications while taking a study drug. “We should not infer that study limitations imply the study 'was not really negative, even though it appeared to be,'” he said. “Hopefully the European trial [of tramiprosate] will show something different, but after all is said and done, if both fail and we still encounter the 'Can't tell because they're on treatment' argument, then the study design needs to be changed to accommodate this. But the study was negative as performed.”

Dr. Marwan Sabbagh, director of clinical research at the Sun Health Research Institute in Sun City, Ariz., noted the real difficulty with the tramiprosate trial design centers on the lack of objective clinical end points.

“That is the peril of using cognitive outcomes of primary measures,” he said in an interview. “Many in the industry would like to see other measures used, but there are none validated or universally agreed upon.”

Future studies will need to give equal weight to specific biomarker outcomes, he said, including PET scans, MRI volumetry, and cerebrospinal fluid. “This negative study will make a lot of companies consider their development strategies more carefully.”

Neurochem's Dr. Denis Garceau said the company delayed the release of its findings, which were to have been presented publicly in June. In the meantime, Neurochem reworked the statistical analysis and sought advice from the Food and Drug Administration, said Dr. Garceau, who is senior vice president of drug development. “While recognizing the challenges of a trial of this magnitude, the FDA advised that neither the proposed adjusted models nor any further adjustments could be used for this trial to support a positive effect of tramiprosate,” Dr. Garceau said.

The data may, however, be used to modify the primary analysis plan for the ongoing European phase III trial, which includes 966 patients in 10 countries. Recruitment for that trial is complete, but significant changes are possible, including changes to the study cohort, duration of treatment, and the statistical analysis, Dr. Garceau said. A company-appointed special advisory board will review the North American trial data, suggest any changes to the European trial, and ultimately recommend to Neurochem the fate of tramiprosate.

Despite the failure, 'it remains too early to heavily discount the amyloid hypothesis.' DR. CASELLI

Tramiprosate, the first antiamyloid drug to enter a phase III trial, was not significantly better than placebo in improving cognitive function in patients with Alzheimer's disease, according to officials of Neurochem Inc., manufacturer of the investigational agent and sponsor of the North American trial.

The negative results are a blow to Alzheimer's disease (AD) researchers and patient advocacy groups, said Dr. Richard J. Caselli, chair of neurology at the Mayo Clinic, Scottsdale, Ariz. “Tramiprosate was the first antiamyloid drug to reach this point, and as such, was widely watched by the Alzheimer's disease community,” Dr. Caselli said in an interview. “Its failure to achieve its therapeutic outcomes is therefore very disappointing.”

The question now is whether this failure poses a serious challenge to the amyloid hypothesis of AD pathogenesis, he said. “Possibly not, as findings from a newly released study suggest that in addition to its antiamyloid effects, tramiprosate may have a competing effect favoring tau aggregation. It remains too early to heavily discount the amyloid hypothesis, and other trials in progress will be watched expectantly.”

The North American Phase III study included 1,052 patients with mild to moderate AD, recruited from 67 sites in Canada and the United States. Patients were randomized to placebo or 100 mg or 150 mg twice daily of tramiprosate. They continued all their concomitant AD drugs during the 18-month study period.

Although there were numerical differences in favor of tramiprosate, those differences failed to reach statistical significance in any of the three primary end points: the Alzheimer's Disease Assessment Scale (ADAS-Cog), the Dementia Rating-Sum of Boxes rating scale (CDR-SB), or magnetic resonance imaging. The MRI analysis showed a trend toward larger hippocampal volume in the active group, although the investigators have not assessed that finding's possible relationship to cognitive performance, Dr. Francesco Bellini, Neurochem's president and chief executive officer, said during the teleconference during which the data were released.

Dr. Bellini hesitated to describe the study as negative, pointing out that the statistical analysis was complicated by improvement in more than 30% of the control patients. “This complicated the analysis beyond expectation, so that our results are inconclusive,” Dr. Bellini said.

Dr. Paul S. Aisen, principal investigator of the North American trial, noted the unexpected improvement of so many control patients is probably a result of the effect of concomitant medications, and will be a recurring problem in all long-term studies of disease-modifying agents for AD.

“This problem will not be unique to this program,” said Dr. Aisen, professor of neurology at Georgetown University Medical Center, Washington. “It will be faced by anyone who tries to conduct these trials. A number of the approved medications have significant effects on the primary outcomes, and during 18-month trials, these effects will be unavoidable.”

Dr. Caselli noted drug companies need to factor this into their trial designs in light of the reality that patients will not be giving up their approved medications while taking a study drug. “We should not infer that study limitations imply the study 'was not really negative, even though it appeared to be,'” he said. “Hopefully the European trial [of tramiprosate] will show something different, but after all is said and done, if both fail and we still encounter the 'Can't tell because they're on treatment' argument, then the study design needs to be changed to accommodate this. But the study was negative as performed.”

Dr. Marwan Sabbagh, director of clinical research at the Sun Health Research Institute in Sun City, Ariz., noted the real difficulty with the tramiprosate trial design centers on the lack of objective clinical end points.

“That is the peril of using cognitive outcomes of primary measures,” he said in an interview. “Many in the industry would like to see other measures used, but there are none validated or universally agreed upon.”

Future studies will need to give equal weight to specific biomarker outcomes, he said, including PET scans, MRI volumetry, and cerebrospinal fluid. “This negative study will make a lot of companies consider their development strategies more carefully.”

Neurochem's Dr. Denis Garceau said the company delayed the release of its findings, which were to have been presented publicly in June. In the meantime, Neurochem reworked the statistical analysis and sought advice from the Food and Drug Administration, said Dr. Garceau, who is senior vice president of drug development. “While recognizing the challenges of a trial of this magnitude, the FDA advised that neither the proposed adjusted models nor any further adjustments could be used for this trial to support a positive effect of tramiprosate,” Dr. Garceau said.

The data may, however, be used to modify the primary analysis plan for the ongoing European phase III trial, which includes 966 patients in 10 countries. Recruitment for that trial is complete, but significant changes are possible, including changes to the study cohort, duration of treatment, and the statistical analysis, Dr. Garceau said. A company-appointed special advisory board will review the North American trial data, suggest any changes to the European trial, and ultimately recommend to Neurochem the fate of tramiprosate.

Despite the failure, 'it remains too early to heavily discount the amyloid hypothesis.' DR. CASELLI

Mortality after esophagectomy is related more to patient factors than to the volume of procedures performed annually at any given hospital, or even by an individual surgeon, according to an analysis of data extracted from the Nationwide Inpatient Sample.

The study, conducted by Dr. Michael Rodgers and his colleagues at the Oregon Health and Science University in Portland, points up the difficulty of using volume thresholds to choose the best facility or surgeon to perform an esophagectomy.

The average adjusted mortality rate difference between the high- and low-volume hospitals was less than 1%, and the difference between the high- and low-volume surgeons was 3.5% (Arch. Surg. 2007;142:829–38).

Their study group comprised 3,243 esophagectomies performed from 1988 through 2000. The average national inpatient mortality rate was 11%, with a high of 14% in 1988 and low of 8.4% by 1999.

Although there was no significant trend over time, the mortality rate averaged 10% in the last 5 years of the study.

Mortality was significantly associated with gender, age, and race. Women were 1.5 times more likely to die, while blacks and patients older than 65 years faced a doubling of the risk.

Peripheral vascular disease significantly increased the risk of death.

Other comorbidities, including obesity, valvular heart disease, diabetes, and chronic pulmonary disease, were not significantly associated with an increased risk.

Hypertension appeared to be protective, but the authors believed that could be caused by coding issues, and therefore might not be not a real effect.

Mortality rates were similar at urban and rural hospitals and, in the multivariate analysis, teaching hospitals held no mortality advantage over nonteaching facilities.

Hospital volume was initially highly significantly associated with mortality, but that association disappeared when surgeon volume was factored into the analysis.

Surgeons who performed the most procedures had significantly lower patient mortality rates than did surgeons with lower volume; that difference remained significant even after overall hospital volume was factored in to the analysis.

However, the authors noted, the difference in mortality rates between surgeon groups was not great: Average inpatient mortality was 9.25% for high-volume surgeons (six or more cases per year), 7.5% for medium-volume surgeons (two to six cases per year), and 12.75% for low-volume surgeons (fewer than two cases per year).

Because of the wide scatter in each category, picking the best surgeon or hospital based on volume wouldn't work, the authors said.

“This is highlighted by the fact that one hospital with a caseload of more than 13 per year had a mortality rate of 25%, and one surgeon with caseload of more than 6 per year had a mortality rate of 40%. Choosing those particular providers on the basis of volume might well be a mistake,” they noted.

A better alternative, they suggested, would be a national system of outcome benchmarks. “A benchmark-based system simply sets clear guidelines and allows institutions and surgeons to find their own means to achieve them,” the investigators wrote. “In the medium term, it would also reassure patients that the institution they were going to had satisfactory and verified outcomes for that procedure.”

Mortality after esophagectomy is related more to patient factors than to the volume of procedures performed annually at any given hospital, or even by an individual surgeon, according to an analysis of data extracted from the Nationwide Inpatient Sample.

The study, conducted by Dr. Michael Rodgers and his colleagues at the Oregon Health and Science University in Portland, points up the difficulty of using volume thresholds to choose the best facility or surgeon to perform an esophagectomy.

The average adjusted mortality rate difference between the high- and low-volume hospitals was less than 1%, and the difference between the high- and low-volume surgeons was 3.5% (Arch. Surg. 2007;142:829–38).

Their study group comprised 3,243 esophagectomies performed from 1988 through 2000. The average national inpatient mortality rate was 11%, with a high of 14% in 1988 and low of 8.4% by 1999.

Although there was no significant trend over time, the mortality rate averaged 10% in the last 5 years of the study.

Mortality was significantly associated with gender, age, and race. Women were 1.5 times more likely to die, while blacks and patients older than 65 years faced a doubling of the risk.

Peripheral vascular disease significantly increased the risk of death.

Other comorbidities, including obesity, valvular heart disease, diabetes, and chronic pulmonary disease, were not significantly associated with an increased risk.

Hypertension appeared to be protective, but the authors believed that could be caused by coding issues, and therefore might not be not a real effect.

Mortality rates were similar at urban and rural hospitals and, in the multivariate analysis, teaching hospitals held no mortality advantage over nonteaching facilities.

Hospital volume was initially highly significantly associated with mortality, but that association disappeared when surgeon volume was factored into the analysis.

Surgeons who performed the most procedures had significantly lower patient mortality rates than did surgeons with lower volume; that difference remained significant even after overall hospital volume was factored in to the analysis.

However, the authors noted, the difference in mortality rates between surgeon groups was not great: Average inpatient mortality was 9.25% for high-volume surgeons (six or more cases per year), 7.5% for medium-volume surgeons (two to six cases per year), and 12.75% for low-volume surgeons (fewer than two cases per year).

Because of the wide scatter in each category, picking the best surgeon or hospital based on volume wouldn't work, the authors said.

“This is highlighted by the fact that one hospital with a caseload of more than 13 per year had a mortality rate of 25%, and one surgeon with caseload of more than 6 per year had a mortality rate of 40%. Choosing those particular providers on the basis of volume might well be a mistake,” they noted.

A better alternative, they suggested, would be a national system of outcome benchmarks. “A benchmark-based system simply sets clear guidelines and allows institutions and surgeons to find their own means to achieve them,” the investigators wrote. “In the medium term, it would also reassure patients that the institution they were going to had satisfactory and verified outcomes for that procedure.”

Mortality after esophagectomy is related more to patient factors than to the volume of procedures performed annually at any given hospital, or even by an individual surgeon, according to an analysis of data extracted from the Nationwide Inpatient Sample.

The study, conducted by Dr. Michael Rodgers and his colleagues at the Oregon Health and Science University in Portland, points up the difficulty of using volume thresholds to choose the best facility or surgeon to perform an esophagectomy.

The average adjusted mortality rate difference between the high- and low-volume hospitals was less than 1%, and the difference between the high- and low-volume surgeons was 3.5% (Arch. Surg. 2007;142:829–38).

Their study group comprised 3,243 esophagectomies performed from 1988 through 2000. The average national inpatient mortality rate was 11%, with a high of 14% in 1988 and low of 8.4% by 1999.

Although there was no significant trend over time, the mortality rate averaged 10% in the last 5 years of the study.

Mortality was significantly associated with gender, age, and race. Women were 1.5 times more likely to die, while blacks and patients older than 65 years faced a doubling of the risk.

Peripheral vascular disease significantly increased the risk of death.

Other comorbidities, including obesity, valvular heart disease, diabetes, and chronic pulmonary disease, were not significantly associated with an increased risk.

Hypertension appeared to be protective, but the authors believed that could be caused by coding issues, and therefore might not be not a real effect.

Mortality rates were similar at urban and rural hospitals and, in the multivariate analysis, teaching hospitals held no mortality advantage over nonteaching facilities.

Hospital volume was initially highly significantly associated with mortality, but that association disappeared when surgeon volume was factored into the analysis.

Surgeons who performed the most procedures had significantly lower patient mortality rates than did surgeons with lower volume; that difference remained significant even after overall hospital volume was factored in to the analysis.

However, the authors noted, the difference in mortality rates between surgeon groups was not great: Average inpatient mortality was 9.25% for high-volume surgeons (six or more cases per year), 7.5% for medium-volume surgeons (two to six cases per year), and 12.75% for low-volume surgeons (fewer than two cases per year).

Because of the wide scatter in each category, picking the best surgeon or hospital based on volume wouldn't work, the authors said.

“This is highlighted by the fact that one hospital with a caseload of more than 13 per year had a mortality rate of 25%, and one surgeon with caseload of more than 6 per year had a mortality rate of 40%. Choosing those particular providers on the basis of volume might well be a mistake,” they noted.

A better alternative, they suggested, would be a national system of outcome benchmarks. “A benchmark-based system simply sets clear guidelines and allows institutions and surgeons to find their own means to achieve them,” the investigators wrote. “In the medium term, it would also reassure patients that the institution they were going to had satisfactory and verified outcomes for that procedure.”

CHICAGO — Naltrexone may have little positive effect either on drinking behavior in older women with alcoholism comorbid with depression or on drug-using behavior in women with alcoholism and comorbid cocaine dependence.

Data presented at the annual meeting of the Research Society for Alcoholism—a subanalysis of a 2005 drug trial and a preview of a trial in press—hint that naltrexone may have very different effects in women than men, according to William Dundon, Ph.D., of the University of Pennsylvania, Philadelphia.

“Women metabolize alcohol differently than men, and respond to naltrexone differently as well,” he said in an interview. Naltrexone blocks the mu-opiate receptors, moderating the sense of euphoria that alcohol provides, said Dr. Dundon, a researcher at the university's Center for the Studies of Addiction. Genetic makeup may also play a significant part in a given patient's response to the drug. Dr. David Oslin, also of the university, has recently identified a genetic variant—a polymorphism of the mu-receptor gene—that seems to predict naltrexone response (Addict. Biol. 2006;11:397–403).

Dr. Dundon presented a recent gender subanalysis of a 2005 study by Dr. Oslin, demonstrating a poor naltrexone response in older women with comorbid alcoholism and depression (Am. J. Geriatr. Psychiatry 2005;13:491–500).

This study comprised 74 older adults (mean age 63 years) with alcohol dependence and depressive disorder. Most subjects (59) were male; there were only 15 female subjects.

All patients received sertraline (Zoloft) 100 mg/day for their depression, as well as 10 sessions of therapy focused on both alcohol use and depression. They were also randomized to either placebo or naltrexone (50 mg/day). At the end of the 12-week trial, 42% of the patients were considered well, with no relapse to heavy drinking and with remission of depressive symptoms. An additional 24% remained depressed, but did not have a drinking relapse.

There were no significant differences between the placebo/sertraline group and the naltrexone/sertraline groups in terms of outcome measures: relapse to heavy drinking, abstinence, remission of depression, or overall improvement.

However, the gender subanalysis showed a slightly different picture. Men with positive outcomes did equally well on either regimen, with 40% of the placebo/sertraline and 45% of the naltrexone/sertraline groups considered well by 12 weeks. In women, only about 25% of those in the naltrexone/sertraline group were considered well by the trial's end, compared with 70% of those in the placebo/sertraline group.

Because so few women were in the trial, Dr. Dundon said it's impossible to make any clinical recommendations about naltrexone's suitability for older women with comorbid depression and alcoholism.

CHICAGO — Naltrexone may have little positive effect either on drinking behavior in older women with alcoholism comorbid with depression or on drug-using behavior in women with alcoholism and comorbid cocaine dependence.

Data presented at the annual meeting of the Research Society for Alcoholism—a subanalysis of a 2005 drug trial and a preview of a trial in press—hint that naltrexone may have very different effects in women than men, according to William Dundon, Ph.D., of the University of Pennsylvania, Philadelphia.

“Women metabolize alcohol differently than men, and respond to naltrexone differently as well,” he said in an interview. Naltrexone blocks the mu-opiate receptors, moderating the sense of euphoria that alcohol provides, said Dr. Dundon, a researcher at the university's Center for the Studies of Addiction. Genetic makeup may also play a significant part in a given patient's response to the drug. Dr. David Oslin, also of the university, has recently identified a genetic variant—a polymorphism of the mu-receptor gene—that seems to predict naltrexone response (Addict. Biol. 2006;11:397–403).

Dr. Dundon presented a recent gender subanalysis of a 2005 study by Dr. Oslin, demonstrating a poor naltrexone response in older women with comorbid alcoholism and depression (Am. J. Geriatr. Psychiatry 2005;13:491–500).

This study comprised 74 older adults (mean age 63 years) with alcohol dependence and depressive disorder. Most subjects (59) were male; there were only 15 female subjects.

All patients received sertraline (Zoloft) 100 mg/day for their depression, as well as 10 sessions of therapy focused on both alcohol use and depression. They were also randomized to either placebo or naltrexone (50 mg/day). At the end of the 12-week trial, 42% of the patients were considered well, with no relapse to heavy drinking and with remission of depressive symptoms. An additional 24% remained depressed, but did not have a drinking relapse.

There were no significant differences between the placebo/sertraline group and the naltrexone/sertraline groups in terms of outcome measures: relapse to heavy drinking, abstinence, remission of depression, or overall improvement.

However, the gender subanalysis showed a slightly different picture. Men with positive outcomes did equally well on either regimen, with 40% of the placebo/sertraline and 45% of the naltrexone/sertraline groups considered well by 12 weeks. In women, only about 25% of those in the naltrexone/sertraline group were considered well by the trial's end, compared with 70% of those in the placebo/sertraline group.

Because so few women were in the trial, Dr. Dundon said it's impossible to make any clinical recommendations about naltrexone's suitability for older women with comorbid depression and alcoholism.

CHICAGO — Naltrexone may have little positive effect either on drinking behavior in older women with alcoholism comorbid with depression or on drug-using behavior in women with alcoholism and comorbid cocaine dependence.

Data presented at the annual meeting of the Research Society for Alcoholism—a subanalysis of a 2005 drug trial and a preview of a trial in press—hint that naltrexone may have very different effects in women than men, according to William Dundon, Ph.D., of the University of Pennsylvania, Philadelphia.

“Women metabolize alcohol differently than men, and respond to naltrexone differently as well,” he said in an interview. Naltrexone blocks the mu-opiate receptors, moderating the sense of euphoria that alcohol provides, said Dr. Dundon, a researcher at the university's Center for the Studies of Addiction. Genetic makeup may also play a significant part in a given patient's response to the drug. Dr. David Oslin, also of the university, has recently identified a genetic variant—a polymorphism of the mu-receptor gene—that seems to predict naltrexone response (Addict. Biol. 2006;11:397–403).

Dr. Dundon presented a recent gender subanalysis of a 2005 study by Dr. Oslin, demonstrating a poor naltrexone response in older women with comorbid alcoholism and depression (Am. J. Geriatr. Psychiatry 2005;13:491–500).

This study comprised 74 older adults (mean age 63 years) with alcohol dependence and depressive disorder. Most subjects (59) were male; there were only 15 female subjects.

All patients received sertraline (Zoloft) 100 mg/day for their depression, as well as 10 sessions of therapy focused on both alcohol use and depression. They were also randomized to either placebo or naltrexone (50 mg/day). At the end of the 12-week trial, 42% of the patients were considered well, with no relapse to heavy drinking and with remission of depressive symptoms. An additional 24% remained depressed, but did not have a drinking relapse.

There were no significant differences between the placebo/sertraline group and the naltrexone/sertraline groups in terms of outcome measures: relapse to heavy drinking, abstinence, remission of depression, or overall improvement.

However, the gender subanalysis showed a slightly different picture. Men with positive outcomes did equally well on either regimen, with 40% of the placebo/sertraline and 45% of the naltrexone/sertraline groups considered well by 12 weeks. In women, only about 25% of those in the naltrexone/sertraline group were considered well by the trial's end, compared with 70% of those in the placebo/sertraline group.

Because so few women were in the trial, Dr. Dundon said it's impossible to make any clinical recommendations about naltrexone's suitability for older women with comorbid depression and alcoholism.

CHICAGO — Paroxetine can take the anxiety out of the drinker, but it can't take the drinking out of the anxious person.

The drug did uncouple anxiety and drinking in patients who use alcohol to cope with severe generalized social anxiety, Dr. Sarah Book said at the annual meeting of the Research Society on Alcoholism. But compared with placebo, paroxetine (Paxil) had no effect on overall alcohol consumption.

Her 16-week randomized controlled trial pitted paroxetine (60 mg) against placebo in 42 patients with severe generalized anxiety and comorbid alcohol use disorders. The patients had no previous alcohol detoxification treatment. We wanted to see if we could intervene in the progression and prevent worsening of alcohol use, said Dr. Book, a psychiatrist at the Medical University of South Carolina, Charleston.

The patients' average age was 29 years; 50% were male. At baseline, their mean score on the Leibowitz Social Anxiety Scale (LSAS) was about 90, indicating severe social anxiety. Anxiety had its onset at age 12 years in these patients; the use of alcohol to cope with symptoms followed about a decade later. They were moderately dependent on alcohol, consuming about 15 drinks a week.

By week 16, the patients in the treatment group had a significantly greater decrease in their LSAS scores than did those in the placebo group (53% vs. 32%).

All of the patients completed a study-specific questionnaire on how often they drank to cope before and during social situations, and how often they would avoid such situations if they could not drink to cope. At week 16, those in the paroxetine group had significantly lower scores than did those in the placebo group, with 20% (vs. 40%) saying they still drank to cope with social situations, and 30% (vs. 70%) saying they would avoid such situations if they couldn't drink.

But when Dr. Book examined the total overall drinking, she found no differences between the groups in either frequency of drinking or quantity consumed. “We [also] saw no difference from baseline to week 1, a very important milestone in most alcohol treatment studies, and no change in drinking from baseline to end point.”

A subanalysis confirmed that paroxetine uncoupled drinking and anxiety symptoms, Dr. Book said. When anxiety scores and drinking were plotted together for all patients, it was apparent that the drug reduced drinking to cope with social anxiety. “This relationship completely went away in the paroxetine group. Yet they continued to drink the same amount overall. For these people, something else is going on to maintain their alcohol use disorder.”

GlaxoSmithKline Inc. provided the study medication; the study was funded by the National Institute of Alcohol Abuse and Alcoholism.

CHICAGO — Paroxetine can take the anxiety out of the drinker, but it can't take the drinking out of the anxious person.

The drug did uncouple anxiety and drinking in patients who use alcohol to cope with severe generalized social anxiety, Dr. Sarah Book said at the annual meeting of the Research Society on Alcoholism. But compared with placebo, paroxetine (Paxil) had no effect on overall alcohol consumption.

Her 16-week randomized controlled trial pitted paroxetine (60 mg) against placebo in 42 patients with severe generalized anxiety and comorbid alcohol use disorders. The patients had no previous alcohol detoxification treatment. We wanted to see if we could intervene in the progression and prevent worsening of alcohol use, said Dr. Book, a psychiatrist at the Medical University of South Carolina, Charleston.

The patients' average age was 29 years; 50% were male. At baseline, their mean score on the Leibowitz Social Anxiety Scale (LSAS) was about 90, indicating severe social anxiety. Anxiety had its onset at age 12 years in these patients; the use of alcohol to cope with symptoms followed about a decade later. They were moderately dependent on alcohol, consuming about 15 drinks a week.

By week 16, the patients in the treatment group had a significantly greater decrease in their LSAS scores than did those in the placebo group (53% vs. 32%).

All of the patients completed a study-specific questionnaire on how often they drank to cope before and during social situations, and how often they would avoid such situations if they could not drink to cope. At week 16, those in the paroxetine group had significantly lower scores than did those in the placebo group, with 20% (vs. 40%) saying they still drank to cope with social situations, and 30% (vs. 70%) saying they would avoid such situations if they couldn't drink.

But when Dr. Book examined the total overall drinking, she found no differences between the groups in either frequency of drinking or quantity consumed. “We [also] saw no difference from baseline to week 1, a very important milestone in most alcohol treatment studies, and no change in drinking from baseline to end point.”

A subanalysis confirmed that paroxetine uncoupled drinking and anxiety symptoms, Dr. Book said. When anxiety scores and drinking were plotted together for all patients, it was apparent that the drug reduced drinking to cope with social anxiety. “This relationship completely went away in the paroxetine group. Yet they continued to drink the same amount overall. For these people, something else is going on to maintain their alcohol use disorder.”

GlaxoSmithKline Inc. provided the study medication; the study was funded by the National Institute of Alcohol Abuse and Alcoholism.

CHICAGO — Paroxetine can take the anxiety out of the drinker, but it can't take the drinking out of the anxious person.

The drug did uncouple anxiety and drinking in patients who use alcohol to cope with severe generalized social anxiety, Dr. Sarah Book said at the annual meeting of the Research Society on Alcoholism. But compared with placebo, paroxetine (Paxil) had no effect on overall alcohol consumption.

Her 16-week randomized controlled trial pitted paroxetine (60 mg) against placebo in 42 patients with severe generalized anxiety and comorbid alcohol use disorders. The patients had no previous alcohol detoxification treatment. We wanted to see if we could intervene in the progression and prevent worsening of alcohol use, said Dr. Book, a psychiatrist at the Medical University of South Carolina, Charleston.

The patients' average age was 29 years; 50% were male. At baseline, their mean score on the Leibowitz Social Anxiety Scale (LSAS) was about 90, indicating severe social anxiety. Anxiety had its onset at age 12 years in these patients; the use of alcohol to cope with symptoms followed about a decade later. They were moderately dependent on alcohol, consuming about 15 drinks a week.

By week 16, the patients in the treatment group had a significantly greater decrease in their LSAS scores than did those in the placebo group (53% vs. 32%).

All of the patients completed a study-specific questionnaire on how often they drank to cope before and during social situations, and how often they would avoid such situations if they could not drink to cope. At week 16, those in the paroxetine group had significantly lower scores than did those in the placebo group, with 20% (vs. 40%) saying they still drank to cope with social situations, and 30% (vs. 70%) saying they would avoid such situations if they couldn't drink.

But when Dr. Book examined the total overall drinking, she found no differences between the groups in either frequency of drinking or quantity consumed. “We [also] saw no difference from baseline to week 1, a very important milestone in most alcohol treatment studies, and no change in drinking from baseline to end point.”

A subanalysis confirmed that paroxetine uncoupled drinking and anxiety symptoms, Dr. Book said. When anxiety scores and drinking were plotted together for all patients, it was apparent that the drug reduced drinking to cope with social anxiety. “This relationship completely went away in the paroxetine group. Yet they continued to drink the same amount overall. For these people, something else is going on to maintain their alcohol use disorder.”

GlaxoSmithKline Inc. provided the study medication; the study was funded by the National Institute of Alcohol Abuse and Alcoholism.