Jeff Evans

ATLANTA – The potential benefits of advanced directives and other plans for future treatment during psychiatric incompetency have not received the attention they deserve from the mental health community, speakers said at the American Psychiatric Association's Institute on Psychiatric Services.

Plans for future treatment that take the form of psychiatric advanced directives, crisis cards, and joint crisis plans are well accepted in many circumstances by psychiatric patients at risk for future hospitalization. But the infrastructure to uphold the legitimacy and continuity of such plans often does not exist or is circumvented by conflicting laws.

Psychiatric advanced directives (PADs) are “very often not something that the person thinks up themselves. It's often something that we as advocates invite a person to consider,” said Peter Stastny, M.D., of the department of psychiatry at Albert Einstein College of Medicine, New York.

A PAD can be a written instruction, a health care proxy, or both, and sometimes a living will. New York state requires that one person be the proxy for a patient's physical and mental health care.

Crisis cards allow patients to document their own wishes independent of a clinical team. On the other hand, patients collaborate with their personal contacts and treatment teams to create joint crisis plans to provide for care when the patients are not well. Patients who are offered a PAD typically have some psychotic symptoms in addition to a schizophrenia spectrum disorder or mood disorder.

Patients Generally Support PADs

In face-to-face interviews with 1,100 patients in five states, 73% said that they would want to complete a PAD. Yet only 7% of patients had already done so, reported Jeff Swanson, Ph.D., of the department of psychiatry and behavioral science at Duke University, Durham, N.C.

Patients were more likely to want an advanced directive if they were female, were of a racial or ethnic minority, had a history of self-harm, were under heavy external pressure to take medications, had police involved in a prior crisis, and had a low level of personal autonomy or mastery.

Patients who had none of these six characteristics had only a 55% probability of wanting a PAD. But patients who had all six had a 98% probability of desiring a PAD, Dr. Swanson said.

In interviews with 20 psychiatric patients who received training in how to create a PAD in New York, Dr. Stastny and his associates discovered that the patients understood the meaning of advanced directives and the important responsibility they give to patients.

The PAD was often seen as helpful rather than as antagonistic, Dr. Stastny said.

Half of the patients chose to create a PAD; the other half did not. The patients had been in the care of state-run or nonprofit mental health clinics for 10–20 years and had been hospitalized many times.

Patients with a PAD could select psychiatric medications they preferred to receive and those medications that they specifically did not wish to receive. They had to make a special effort to indicate that they preferred to receive no psychiatric medications since this was not one of the options stated on the PAD form.

They also could indicate which treatment facilities and doctors they preferred. Another section allowed patients to list approaches that helped them when they were having a hard time. “Everyone seemed to be concerned with improving their treatment and their chances of getting the best possible treatment,” Dr. Stastny said.

The training included how to select a health care proxy and determine what authority that person might have.

The patients completed the training by selecting a proxy. Many of the patients selected a sibling, an uncle, or a more distant family member, since they did not want to burden their parents further. Some patients wanted their primary health care provider to be their proxy, but this might present a conflict of interest.

The 20 patients in Dr. Stastny's study were among 6,000 patients in New York who were trained in writing PADs for 1.5 years as part of Kendra's Law, which was enacted in 1999. Kendra's Law provided about $1 million in funding for written PAD training. Kendra's Law permits court-ordered, assisted outpatient treatment in New York to individuals with mental illness who may deteriorate in the future because of a history of lack of compliance with treatment for their illness. Their lack of compliance may have caused them to be hospitalized, receive treatment services in a correctional facility, or act violently toward themselves or others.

The booklet that New York patients received as a part of PAD training was taken out of circulation because the New York State Office of Mental Health considered the PAD forms to be too complex for patients, Dr. Stastny said. The state no longer funds the PAD training project.

Lack of Support Stymies PADs

The reform of advanced directives in psychiatry is not a progressive movement that is gathering support and growing in practice, said Kim Hopper, Ph.D., an anthropologist at the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, N.Y.

Reform is a defensive maneuver against a set of coercive measures in the community, he said.

Some states have loopholes that allow civil commitment statutes to trump PADs in practice. In some cases, the PAD may be circumvented if the directions it contains go against community standards of care.

If patients don't expect the system to respond, Dr. Hopper asked, then why should they go through the work of actually creating the PAD when they may be setting themselves up for bitter disappointment? “That's the highest risk of this kind of intervention,” he said.

PADs, crisis cards, and joint crisis plans will face obstacles in becoming legitimate means of directing future treatment unless they are given official endorsement, are authorized and archived by respected sources, and can be easily accessed at treatment centers. PADs, crisis cards, or joint crisis plans carried by a patient will not be taken seriously by emergency departments if the staff have no interest in these programs or if bureaucratic support is lacking, Dr. Hopper said.

An ongoing randomized study in North Carolina has shown that 79% of 123 patients who received help from a trained facilitator were able to complete a PAD within 1 month. In contrast, only 6% of 60 patients who received a referral, information on PADs, and PAD forms–but no facilitator–completed a PAD within 6 months, Dr. Swanson said.

The provision of a facilitator would, in itself, represent an investment by a mental health system to provide the service of creating plans for future treatment, Dr. Hopper noted.

The PADs were placed on the U.S. Living Will Registry (located at www.uslivingwillregistry.com

Overall, 15% of the 123 patients have refused to have a facilitated PAD session, while another 4% met with their facilitator and then refused to create a PAD. All of the patients had some psychotic symptoms.

Plans in England Face Trouble, Too

In England, plans for future treatment also have largely been developed as a reaction to an increasing demand for fewer restrictions on involuntary hospitalization or outpatient commitment for noncompliant patients who may be dangerous to themselves or others.

Highly publicized cases of violent crimes committed by mentally ill individuals in England have brought about several draft bills for mental health reform that take away some of the rights of patients to direct their future treatment when they are unable to do so on their own behalf.

Currently, a draft bill on mental health reform includes a very broad definition of a mental disorder that involves “virtually any disturbance of psychological functioning” and a broad definition of minimal treatment that includes rehabilitation and habilitation (training, social skills, and education). The bill says that if patients pose a substantial risk of harm to others, the patients must be hospitalized against their will, even if there is an alternative, lawful treatment, noted George Szmukler, M.D., dean of the Institute of Psychiatry at King's College, London.

PADs currently cannot be used in England. Dr. Szmukler and his colleagues introduced two alternatives to a PAD–crisis cards and joint crisis plans–in a pilot study conducted in a community psychiatric service of 106 patients with psychosis who were at high risk of crisis. Many of the patients were reluctant to participate, but after 9 months 40% had agreed. All of these patients opted for a joint crisis plan.

The patients who chose to participate were more likely to have an affective disorder, a history of suicidal ideation, fewer hospital admissions, and nonblack ethnicity. Although the patients had guidance, the choice of information included in the plan was up to the patients themselves. The joint crisis plans provided important information to health care providers when the patient was too ill to do so and reduced hospital admissions by 30% in the follow-up year. The plans were used in 73% of patient crises and 81% of hospital admissions (Acta Psychiatr. Scand. 1999;100:56–61).

After the pilot study, Dr. Szmukler, Claire Henderson, M.B., also of the Institute of Psychiatry, and their associates conducted the first randomized, controlled trial to assess the impact of joint crisis plans. But only 36% of the eligible patients in the study were ultimately randomized in the single-blind trial (BMJ 2004;329:136–40). Of 160 patients who had a psychotic illness or nonpsychotic bipolar disorder, significantly fewer of those who completed a joint crisis plan required compulsory hospital admission (13%) than did patients who received a control intervention (27%).

As a result, the patients with a joint crisis plan spent significantly fewer days on average as inpatients in compulsory detention than did control patients (14 days vs. 31 days). The control intervention consisted of leaflets containing information about local services, mental illness and treatments, England's Mental Health Act of 1983, and local provider organizations.

ATLANTA – The potential benefits of advanced directives and other plans for future treatment during psychiatric incompetency have not received the attention they deserve from the mental health community, speakers said at the American Psychiatric Association's Institute on Psychiatric Services.

Plans for future treatment that take the form of psychiatric advanced directives, crisis cards, and joint crisis plans are well accepted in many circumstances by psychiatric patients at risk for future hospitalization. But the infrastructure to uphold the legitimacy and continuity of such plans often does not exist or is circumvented by conflicting laws.

Psychiatric advanced directives (PADs) are “very often not something that the person thinks up themselves. It's often something that we as advocates invite a person to consider,” said Peter Stastny, M.D., of the department of psychiatry at Albert Einstein College of Medicine, New York.

A PAD can be a written instruction, a health care proxy, or both, and sometimes a living will. New York state requires that one person be the proxy for a patient's physical and mental health care.

Crisis cards allow patients to document their own wishes independent of a clinical team. On the other hand, patients collaborate with their personal contacts and treatment teams to create joint crisis plans to provide for care when the patients are not well. Patients who are offered a PAD typically have some psychotic symptoms in addition to a schizophrenia spectrum disorder or mood disorder.

Patients Generally Support PADs

In face-to-face interviews with 1,100 patients in five states, 73% said that they would want to complete a PAD. Yet only 7% of patients had already done so, reported Jeff Swanson, Ph.D., of the department of psychiatry and behavioral science at Duke University, Durham, N.C.

Patients were more likely to want an advanced directive if they were female, were of a racial or ethnic minority, had a history of self-harm, were under heavy external pressure to take medications, had police involved in a prior crisis, and had a low level of personal autonomy or mastery.

Patients who had none of these six characteristics had only a 55% probability of wanting a PAD. But patients who had all six had a 98% probability of desiring a PAD, Dr. Swanson said.

In interviews with 20 psychiatric patients who received training in how to create a PAD in New York, Dr. Stastny and his associates discovered that the patients understood the meaning of advanced directives and the important responsibility they give to patients.

The PAD was often seen as helpful rather than as antagonistic, Dr. Stastny said.

Half of the patients chose to create a PAD; the other half did not. The patients had been in the care of state-run or nonprofit mental health clinics for 10–20 years and had been hospitalized many times.

Patients with a PAD could select psychiatric medications they preferred to receive and those medications that they specifically did not wish to receive. They had to make a special effort to indicate that they preferred to receive no psychiatric medications since this was not one of the options stated on the PAD form.

They also could indicate which treatment facilities and doctors they preferred. Another section allowed patients to list approaches that helped them when they were having a hard time. “Everyone seemed to be concerned with improving their treatment and their chances of getting the best possible treatment,” Dr. Stastny said.

The training included how to select a health care proxy and determine what authority that person might have.

The patients completed the training by selecting a proxy. Many of the patients selected a sibling, an uncle, or a more distant family member, since they did not want to burden their parents further. Some patients wanted their primary health care provider to be their proxy, but this might present a conflict of interest.

The 20 patients in Dr. Stastny's study were among 6,000 patients in New York who were trained in writing PADs for 1.5 years as part of Kendra's Law, which was enacted in 1999. Kendra's Law provided about $1 million in funding for written PAD training. Kendra's Law permits court-ordered, assisted outpatient treatment in New York to individuals with mental illness who may deteriorate in the future because of a history of lack of compliance with treatment for their illness. Their lack of compliance may have caused them to be hospitalized, receive treatment services in a correctional facility, or act violently toward themselves or others.

The booklet that New York patients received as a part of PAD training was taken out of circulation because the New York State Office of Mental Health considered the PAD forms to be too complex for patients, Dr. Stastny said. The state no longer funds the PAD training project.

Lack of Support Stymies PADs

The reform of advanced directives in psychiatry is not a progressive movement that is gathering support and growing in practice, said Kim Hopper, Ph.D., an anthropologist at the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, N.Y.

Reform is a defensive maneuver against a set of coercive measures in the community, he said.

Some states have loopholes that allow civil commitment statutes to trump PADs in practice. In some cases, the PAD may be circumvented if the directions it contains go against community standards of care.

If patients don't expect the system to respond, Dr. Hopper asked, then why should they go through the work of actually creating the PAD when they may be setting themselves up for bitter disappointment? “That's the highest risk of this kind of intervention,” he said.

PADs, crisis cards, and joint crisis plans will face obstacles in becoming legitimate means of directing future treatment unless they are given official endorsement, are authorized and archived by respected sources, and can be easily accessed at treatment centers. PADs, crisis cards, or joint crisis plans carried by a patient will not be taken seriously by emergency departments if the staff have no interest in these programs or if bureaucratic support is lacking, Dr. Hopper said.

An ongoing randomized study in North Carolina has shown that 79% of 123 patients who received help from a trained facilitator were able to complete a PAD within 1 month. In contrast, only 6% of 60 patients who received a referral, information on PADs, and PAD forms–but no facilitator–completed a PAD within 6 months, Dr. Swanson said.

The provision of a facilitator would, in itself, represent an investment by a mental health system to provide the service of creating plans for future treatment, Dr. Hopper noted.

The PADs were placed on the U.S. Living Will Registry (located at www.uslivingwillregistry.com

Overall, 15% of the 123 patients have refused to have a facilitated PAD session, while another 4% met with their facilitator and then refused to create a PAD. All of the patients had some psychotic symptoms.

Plans in England Face Trouble, Too

In England, plans for future treatment also have largely been developed as a reaction to an increasing demand for fewer restrictions on involuntary hospitalization or outpatient commitment for noncompliant patients who may be dangerous to themselves or others.

Highly publicized cases of violent crimes committed by mentally ill individuals in England have brought about several draft bills for mental health reform that take away some of the rights of patients to direct their future treatment when they are unable to do so on their own behalf.

Currently, a draft bill on mental health reform includes a very broad definition of a mental disorder that involves “virtually any disturbance of psychological functioning” and a broad definition of minimal treatment that includes rehabilitation and habilitation (training, social skills, and education). The bill says that if patients pose a substantial risk of harm to others, the patients must be hospitalized against their will, even if there is an alternative, lawful treatment, noted George Szmukler, M.D., dean of the Institute of Psychiatry at King's College, London.

PADs currently cannot be used in England. Dr. Szmukler and his colleagues introduced two alternatives to a PAD–crisis cards and joint crisis plans–in a pilot study conducted in a community psychiatric service of 106 patients with psychosis who were at high risk of crisis. Many of the patients were reluctant to participate, but after 9 months 40% had agreed. All of these patients opted for a joint crisis plan.

The patients who chose to participate were more likely to have an affective disorder, a history of suicidal ideation, fewer hospital admissions, and nonblack ethnicity. Although the patients had guidance, the choice of information included in the plan was up to the patients themselves. The joint crisis plans provided important information to health care providers when the patient was too ill to do so and reduced hospital admissions by 30% in the follow-up year. The plans were used in 73% of patient crises and 81% of hospital admissions (Acta Psychiatr. Scand. 1999;100:56–61).

After the pilot study, Dr. Szmukler, Claire Henderson, M.B., also of the Institute of Psychiatry, and their associates conducted the first randomized, controlled trial to assess the impact of joint crisis plans. But only 36% of the eligible patients in the study were ultimately randomized in the single-blind trial (BMJ 2004;329:136–40). Of 160 patients who had a psychotic illness or nonpsychotic bipolar disorder, significantly fewer of those who completed a joint crisis plan required compulsory hospital admission (13%) than did patients who received a control intervention (27%).

As a result, the patients with a joint crisis plan spent significantly fewer days on average as inpatients in compulsory detention than did control patients (14 days vs. 31 days). The control intervention consisted of leaflets containing information about local services, mental illness and treatments, England's Mental Health Act of 1983, and local provider organizations.

ATLANTA – The potential benefits of advanced directives and other plans for future treatment during psychiatric incompetency have not received the attention they deserve from the mental health community, speakers said at the American Psychiatric Association's Institute on Psychiatric Services.

Plans for future treatment that take the form of psychiatric advanced directives, crisis cards, and joint crisis plans are well accepted in many circumstances by psychiatric patients at risk for future hospitalization. But the infrastructure to uphold the legitimacy and continuity of such plans often does not exist or is circumvented by conflicting laws.

Psychiatric advanced directives (PADs) are “very often not something that the person thinks up themselves. It's often something that we as advocates invite a person to consider,” said Peter Stastny, M.D., of the department of psychiatry at Albert Einstein College of Medicine, New York.

A PAD can be a written instruction, a health care proxy, or both, and sometimes a living will. New York state requires that one person be the proxy for a patient's physical and mental health care.

Crisis cards allow patients to document their own wishes independent of a clinical team. On the other hand, patients collaborate with their personal contacts and treatment teams to create joint crisis plans to provide for care when the patients are not well. Patients who are offered a PAD typically have some psychotic symptoms in addition to a schizophrenia spectrum disorder or mood disorder.

Patients Generally Support PADs

In face-to-face interviews with 1,100 patients in five states, 73% said that they would want to complete a PAD. Yet only 7% of patients had already done so, reported Jeff Swanson, Ph.D., of the department of psychiatry and behavioral science at Duke University, Durham, N.C.

Patients were more likely to want an advanced directive if they were female, were of a racial or ethnic minority, had a history of self-harm, were under heavy external pressure to take medications, had police involved in a prior crisis, and had a low level of personal autonomy or mastery.

Patients who had none of these six characteristics had only a 55% probability of wanting a PAD. But patients who had all six had a 98% probability of desiring a PAD, Dr. Swanson said.

In interviews with 20 psychiatric patients who received training in how to create a PAD in New York, Dr. Stastny and his associates discovered that the patients understood the meaning of advanced directives and the important responsibility they give to patients.

The PAD was often seen as helpful rather than as antagonistic, Dr. Stastny said.

Half of the patients chose to create a PAD; the other half did not. The patients had been in the care of state-run or nonprofit mental health clinics for 10–20 years and had been hospitalized many times.

Patients with a PAD could select psychiatric medications they preferred to receive and those medications that they specifically did not wish to receive. They had to make a special effort to indicate that they preferred to receive no psychiatric medications since this was not one of the options stated on the PAD form.

They also could indicate which treatment facilities and doctors they preferred. Another section allowed patients to list approaches that helped them when they were having a hard time. “Everyone seemed to be concerned with improving their treatment and their chances of getting the best possible treatment,” Dr. Stastny said.

The training included how to select a health care proxy and determine what authority that person might have.

The patients completed the training by selecting a proxy. Many of the patients selected a sibling, an uncle, or a more distant family member, since they did not want to burden their parents further. Some patients wanted their primary health care provider to be their proxy, but this might present a conflict of interest.

The 20 patients in Dr. Stastny's study were among 6,000 patients in New York who were trained in writing PADs for 1.5 years as part of Kendra's Law, which was enacted in 1999. Kendra's Law provided about $1 million in funding for written PAD training. Kendra's Law permits court-ordered, assisted outpatient treatment in New York to individuals with mental illness who may deteriorate in the future because of a history of lack of compliance with treatment for their illness. Their lack of compliance may have caused them to be hospitalized, receive treatment services in a correctional facility, or act violently toward themselves or others.

The booklet that New York patients received as a part of PAD training was taken out of circulation because the New York State Office of Mental Health considered the PAD forms to be too complex for patients, Dr. Stastny said. The state no longer funds the PAD training project.

Lack of Support Stymies PADs

The reform of advanced directives in psychiatry is not a progressive movement that is gathering support and growing in practice, said Kim Hopper, Ph.D., an anthropologist at the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, N.Y.

Reform is a defensive maneuver against a set of coercive measures in the community, he said.

Some states have loopholes that allow civil commitment statutes to trump PADs in practice. In some cases, the PAD may be circumvented if the directions it contains go against community standards of care.

If patients don't expect the system to respond, Dr. Hopper asked, then why should they go through the work of actually creating the PAD when they may be setting themselves up for bitter disappointment? “That's the highest risk of this kind of intervention,” he said.

PADs, crisis cards, and joint crisis plans will face obstacles in becoming legitimate means of directing future treatment unless they are given official endorsement, are authorized and archived by respected sources, and can be easily accessed at treatment centers. PADs, crisis cards, or joint crisis plans carried by a patient will not be taken seriously by emergency departments if the staff have no interest in these programs or if bureaucratic support is lacking, Dr. Hopper said.

An ongoing randomized study in North Carolina has shown that 79% of 123 patients who received help from a trained facilitator were able to complete a PAD within 1 month. In contrast, only 6% of 60 patients who received a referral, information on PADs, and PAD forms–but no facilitator–completed a PAD within 6 months, Dr. Swanson said.

The provision of a facilitator would, in itself, represent an investment by a mental health system to provide the service of creating plans for future treatment, Dr. Hopper noted.

The PADs were placed on the U.S. Living Will Registry (located at www.uslivingwillregistry.com

Overall, 15% of the 123 patients have refused to have a facilitated PAD session, while another 4% met with their facilitator and then refused to create a PAD. All of the patients had some psychotic symptoms.

Plans in England Face Trouble, Too

In England, plans for future treatment also have largely been developed as a reaction to an increasing demand for fewer restrictions on involuntary hospitalization or outpatient commitment for noncompliant patients who may be dangerous to themselves or others.

Highly publicized cases of violent crimes committed by mentally ill individuals in England have brought about several draft bills for mental health reform that take away some of the rights of patients to direct their future treatment when they are unable to do so on their own behalf.

Currently, a draft bill on mental health reform includes a very broad definition of a mental disorder that involves “virtually any disturbance of psychological functioning” and a broad definition of minimal treatment that includes rehabilitation and habilitation (training, social skills, and education). The bill says that if patients pose a substantial risk of harm to others, the patients must be hospitalized against their will, even if there is an alternative, lawful treatment, noted George Szmukler, M.D., dean of the Institute of Psychiatry at King's College, London.

PADs currently cannot be used in England. Dr. Szmukler and his colleagues introduced two alternatives to a PAD–crisis cards and joint crisis plans–in a pilot study conducted in a community psychiatric service of 106 patients with psychosis who were at high risk of crisis. Many of the patients were reluctant to participate, but after 9 months 40% had agreed. All of these patients opted for a joint crisis plan.

The patients who chose to participate were more likely to have an affective disorder, a history of suicidal ideation, fewer hospital admissions, and nonblack ethnicity. Although the patients had guidance, the choice of information included in the plan was up to the patients themselves. The joint crisis plans provided important information to health care providers when the patient was too ill to do so and reduced hospital admissions by 30% in the follow-up year. The plans were used in 73% of patient crises and 81% of hospital admissions (Acta Psychiatr. Scand. 1999;100:56–61).

After the pilot study, Dr. Szmukler, Claire Henderson, M.B., also of the Institute of Psychiatry, and their associates conducted the first randomized, controlled trial to assess the impact of joint crisis plans. But only 36% of the eligible patients in the study were ultimately randomized in the single-blind trial (BMJ 2004;329:136–40). Of 160 patients who had a psychotic illness or nonpsychotic bipolar disorder, significantly fewer of those who completed a joint crisis plan required compulsory hospital admission (13%) than did patients who received a control intervention (27%).

As a result, the patients with a joint crisis plan spent significantly fewer days on average as inpatients in compulsory detention than did control patients (14 days vs. 31 days). The control intervention consisted of leaflets containing information about local services, mental illness and treatments, England's Mental Health Act of 1983, and local provider organizations.

BALTIMORE – Psychopharmacologic medications now are often used to alleviate or modify behavior symptoms or comorbid disorders in children with autism, but they do not appear to correct the disorder's core deficits, Scott M. Myers, M.D., said at a meeting on developmental disabilities sponsored by Johns Hopkins University.

The goals of treatment for children with autistic spectrum disorders include maximizing their functional independence and quality of life; promoting their learning, development, and socialization; and alleviating family distress. The reduction of maladaptive behaviors may help to achieve these goals, stressed Dr. Myers, a neurodevelopmental pediatrician at the Geisinger Medical Center in Danville, Pa.

“I think it's important to focus on treating the specific impairments rather than [on] the diagnostic categorization,” he said.

Dr. Myers said he considers using psychopharmacologic medications when behaviors and symptoms interfere with learning and academic performance, socialization, health and safety, and quality of life. Examples of target behaviors include hyperactivity, aggression, self-injury, inattention, mood lability, sleep disturbance, anxiety, and interfering repetitive behaviors.

The Food and Drug Administration has not approved any drug for the treatment of autism in children or adults.

Studies involving more than 2,000 families with an autistic child in North Carolina and Ohio found that about 45%–50% of children with autism were taking psychotropic medication. In these studies, 22% of the children received antidepressants, 15%–17% took antipsychotics, and 11%–14% took stimulants. About 12% of children with autism were taking anticonvulsants (J. Child Adolesc. Psychopharmacol. 2002;12:311–21; J. Autism Dev. Disord. 2003;33:527–34).

But despite their frequent use, medications take a secondary role to educational and behavioral interventions in the treatment of autistic spectrum disorders, he said.

Sometimes medical or environmental factors may cause or exacerbate a behavior or set of behaviors. Pain or discomfort may be the result of an infection, a dental problem, constipation, occult fracture, headache, esophagitis, gastritis, or allergies. Obstructive apnea can interfere with sleep and contribute to daytime behavior problems. Seizures may require treatment, and the medications used to treat them can affect behavior. Iron or zinc deficiency may be a treatable cause of pica.

Awareness of these potential factors will help to direct appropriate therapy, Dr. Myers said. He advises beginning with low doses that are carefully titrated because autistic patients may require very low or very high doses of psychopharmacologic medications, especially the serotonergic agents. Changes in medications or doses should not be made hastily, and only one change in medication should be made at a time.

▸ Selective serotonin reuptake inhibitors (SSRIs). Fluoxetine (Prozac) is the best studied of the SSRIs in children with autistic spectrum disorders, although no double-blind controlled trials have been conducted. In a study of 129 children with autism aged 2–8 years, 17% had an excellent response and 52% had a good response to treatment with fluoxetine at 0.15–0.5 mg/kg for a mean of about 3 years. The highest-functioning children benefited most from fluoxetine, as did those with hyperlexia, a family history of major affective disorder, or a family history of unusual intellectual achievement (Dev. Med. Child Neurol. 2002;44:652–9).

Limited evidence exists for choosing any one specific SSRI over another. Instead, it may be best to consider the drug's half-life and capacity to inhibit cytochrome P450 enzymes. Fluoxetine, sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa), and escitalopram (Lexapro) are available in liquid form, he added.

Most of the benefits that may occur with SSRI therapy in children with autism are reflected in improved ratings of affect, general behavior, social interaction, rituals, perseveration, stereotypy, and depressive symptoms. SSRIs have been noted to cause adverse reactions in these patients.

▸ Atypical antipsychotics. Two double-blind, placebo-controlled trials have demonstrated positive responses to the atypical antipsychotic risperidone (Risperdal). In these two trials totaling 132 patients, 57%–69% of patients responded positively to risperidone, compared with 6%–12% of placebo patients (Arch. Gen. Psychiatry 1998;55:633–41; N. Engl. J. Med. 2002;347:314–21).

Reports of the use of other atypical antipsychotics–such as olanzapine (Zy-prexa), quetiapine (Seroquel), and ziprasidone (Geodon)–have come from small case series or open-label studies with some success in about half of patients.

▸ α-2 Adrenergic agonists. Very little empirical evidence exists for the use of these agents, which include clonidine (Catapres) and guanfacine (Tenex), in children with autism. Two small (eight and nine patients), double-blind, controlled trials of clonidine each demonstrated modest, short-term improvement in inattention, hyperactivity, impulsivity, and hyperarousal behaviors (J. Clin. Psychopharmacol. 1992;12:322–7; J. Clin. Psychiatry 1992;53:77–82). A retrospective study of guanfacine showed that 24% of 80 patients aged 3–18 years had clinically improved hyperactivity, inattention, and tics (J. Child Adolesc. Psychopharmacol. 2004;14:233–41). Additional research is warranted.

▸ CNS stimulants. Methylphenidate has proved to be effective in improving hyperactivity, impulsivity, and inattention in some patients without worsening behavior or increasing symptoms, such as stereotypies or irritability, but such is not the case for all patients, Dr. Myers said.

▸ Anticonvulsants. In an open-label study of valproic acid, 10 of 14 patients had a sustained clinical response with decreases in affective instability, impulsivity, aggression, and core symptoms. All of the patients who had any electroencephalograph abnormalities or seizures responded to valproic acid (J. Clin. Psychiatry 2001;62:530–4). Lamotrigine (Lamictal) did not have any noticeable effects separate from placebo in a double-blind trial of 28 autistic patients, despite some encouraging results in a previous open-label trial (J. Autism Dev. Disord. 2001;31:175–81; Neuropediatrics 1994;25:284–9).

BALTIMORE – Psychopharmacologic medications now are often used to alleviate or modify behavior symptoms or comorbid disorders in children with autism, but they do not appear to correct the disorder's core deficits, Scott M. Myers, M.D., said at a meeting on developmental disabilities sponsored by Johns Hopkins University.

The goals of treatment for children with autistic spectrum disorders include maximizing their functional independence and quality of life; promoting their learning, development, and socialization; and alleviating family distress. The reduction of maladaptive behaviors may help to achieve these goals, stressed Dr. Myers, a neurodevelopmental pediatrician at the Geisinger Medical Center in Danville, Pa.

“I think it's important to focus on treating the specific impairments rather than [on] the diagnostic categorization,” he said.

Dr. Myers said he considers using psychopharmacologic medications when behaviors and symptoms interfere with learning and academic performance, socialization, health and safety, and quality of life. Examples of target behaviors include hyperactivity, aggression, self-injury, inattention, mood lability, sleep disturbance, anxiety, and interfering repetitive behaviors.

The Food and Drug Administration has not approved any drug for the treatment of autism in children or adults.

Studies involving more than 2,000 families with an autistic child in North Carolina and Ohio found that about 45%–50% of children with autism were taking psychotropic medication. In these studies, 22% of the children received antidepressants, 15%–17% took antipsychotics, and 11%–14% took stimulants. About 12% of children with autism were taking anticonvulsants (J. Child Adolesc. Psychopharmacol. 2002;12:311–21; J. Autism Dev. Disord. 2003;33:527–34).

But despite their frequent use, medications take a secondary role to educational and behavioral interventions in the treatment of autistic spectrum disorders, he said.

Sometimes medical or environmental factors may cause or exacerbate a behavior or set of behaviors. Pain or discomfort may be the result of an infection, a dental problem, constipation, occult fracture, headache, esophagitis, gastritis, or allergies. Obstructive apnea can interfere with sleep and contribute to daytime behavior problems. Seizures may require treatment, and the medications used to treat them can affect behavior. Iron or zinc deficiency may be a treatable cause of pica.

Awareness of these potential factors will help to direct appropriate therapy, Dr. Myers said. He advises beginning with low doses that are carefully titrated because autistic patients may require very low or very high doses of psychopharmacologic medications, especially the serotonergic agents. Changes in medications or doses should not be made hastily, and only one change in medication should be made at a time.

▸ Selective serotonin reuptake inhibitors (SSRIs). Fluoxetine (Prozac) is the best studied of the SSRIs in children with autistic spectrum disorders, although no double-blind controlled trials have been conducted. In a study of 129 children with autism aged 2–8 years, 17% had an excellent response and 52% had a good response to treatment with fluoxetine at 0.15–0.5 mg/kg for a mean of about 3 years. The highest-functioning children benefited most from fluoxetine, as did those with hyperlexia, a family history of major affective disorder, or a family history of unusual intellectual achievement (Dev. Med. Child Neurol. 2002;44:652–9).

Limited evidence exists for choosing any one specific SSRI over another. Instead, it may be best to consider the drug's half-life and capacity to inhibit cytochrome P450 enzymes. Fluoxetine, sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa), and escitalopram (Lexapro) are available in liquid form, he added.

Most of the benefits that may occur with SSRI therapy in children with autism are reflected in improved ratings of affect, general behavior, social interaction, rituals, perseveration, stereotypy, and depressive symptoms. SSRIs have been noted to cause adverse reactions in these patients.

▸ Atypical antipsychotics. Two double-blind, placebo-controlled trials have demonstrated positive responses to the atypical antipsychotic risperidone (Risperdal). In these two trials totaling 132 patients, 57%–69% of patients responded positively to risperidone, compared with 6%–12% of placebo patients (Arch. Gen. Psychiatry 1998;55:633–41; N. Engl. J. Med. 2002;347:314–21).

Reports of the use of other atypical antipsychotics–such as olanzapine (Zy-prexa), quetiapine (Seroquel), and ziprasidone (Geodon)–have come from small case series or open-label studies with some success in about half of patients.

▸ α-2 Adrenergic agonists. Very little empirical evidence exists for the use of these agents, which include clonidine (Catapres) and guanfacine (Tenex), in children with autism. Two small (eight and nine patients), double-blind, controlled trials of clonidine each demonstrated modest, short-term improvement in inattention, hyperactivity, impulsivity, and hyperarousal behaviors (J. Clin. Psychopharmacol. 1992;12:322–7; J. Clin. Psychiatry 1992;53:77–82). A retrospective study of guanfacine showed that 24% of 80 patients aged 3–18 years had clinically improved hyperactivity, inattention, and tics (J. Child Adolesc. Psychopharmacol. 2004;14:233–41). Additional research is warranted.

▸ CNS stimulants. Methylphenidate has proved to be effective in improving hyperactivity, impulsivity, and inattention in some patients without worsening behavior or increasing symptoms, such as stereotypies or irritability, but such is not the case for all patients, Dr. Myers said.

▸ Anticonvulsants. In an open-label study of valproic acid, 10 of 14 patients had a sustained clinical response with decreases in affective instability, impulsivity, aggression, and core symptoms. All of the patients who had any electroencephalograph abnormalities or seizures responded to valproic acid (J. Clin. Psychiatry 2001;62:530–4). Lamotrigine (Lamictal) did not have any noticeable effects separate from placebo in a double-blind trial of 28 autistic patients, despite some encouraging results in a previous open-label trial (J. Autism Dev. Disord. 2001;31:175–81; Neuropediatrics 1994;25:284–9).

BALTIMORE – Psychopharmacologic medications now are often used to alleviate or modify behavior symptoms or comorbid disorders in children with autism, but they do not appear to correct the disorder's core deficits, Scott M. Myers, M.D., said at a meeting on developmental disabilities sponsored by Johns Hopkins University.

The goals of treatment for children with autistic spectrum disorders include maximizing their functional independence and quality of life; promoting their learning, development, and socialization; and alleviating family distress. The reduction of maladaptive behaviors may help to achieve these goals, stressed Dr. Myers, a neurodevelopmental pediatrician at the Geisinger Medical Center in Danville, Pa.

“I think it's important to focus on treating the specific impairments rather than [on] the diagnostic categorization,” he said.

Dr. Myers said he considers using psychopharmacologic medications when behaviors and symptoms interfere with learning and academic performance, socialization, health and safety, and quality of life. Examples of target behaviors include hyperactivity, aggression, self-injury, inattention, mood lability, sleep disturbance, anxiety, and interfering repetitive behaviors.

The Food and Drug Administration has not approved any drug for the treatment of autism in children or adults.

Studies involving more than 2,000 families with an autistic child in North Carolina and Ohio found that about 45%–50% of children with autism were taking psychotropic medication. In these studies, 22% of the children received antidepressants, 15%–17% took antipsychotics, and 11%–14% took stimulants. About 12% of children with autism were taking anticonvulsants (J. Child Adolesc. Psychopharmacol. 2002;12:311–21; J. Autism Dev. Disord. 2003;33:527–34).

But despite their frequent use, medications take a secondary role to educational and behavioral interventions in the treatment of autistic spectrum disorders, he said.

Sometimes medical or environmental factors may cause or exacerbate a behavior or set of behaviors. Pain or discomfort may be the result of an infection, a dental problem, constipation, occult fracture, headache, esophagitis, gastritis, or allergies. Obstructive apnea can interfere with sleep and contribute to daytime behavior problems. Seizures may require treatment, and the medications used to treat them can affect behavior. Iron or zinc deficiency may be a treatable cause of pica.

Awareness of these potential factors will help to direct appropriate therapy, Dr. Myers said. He advises beginning with low doses that are carefully titrated because autistic patients may require very low or very high doses of psychopharmacologic medications, especially the serotonergic agents. Changes in medications or doses should not be made hastily, and only one change in medication should be made at a time.

▸ Selective serotonin reuptake inhibitors (SSRIs). Fluoxetine (Prozac) is the best studied of the SSRIs in children with autistic spectrum disorders, although no double-blind controlled trials have been conducted. In a study of 129 children with autism aged 2–8 years, 17% had an excellent response and 52% had a good response to treatment with fluoxetine at 0.15–0.5 mg/kg for a mean of about 3 years. The highest-functioning children benefited most from fluoxetine, as did those with hyperlexia, a family history of major affective disorder, or a family history of unusual intellectual achievement (Dev. Med. Child Neurol. 2002;44:652–9).

Limited evidence exists for choosing any one specific SSRI over another. Instead, it may be best to consider the drug's half-life and capacity to inhibit cytochrome P450 enzymes. Fluoxetine, sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa), and escitalopram (Lexapro) are available in liquid form, he added.

Most of the benefits that may occur with SSRI therapy in children with autism are reflected in improved ratings of affect, general behavior, social interaction, rituals, perseveration, stereotypy, and depressive symptoms. SSRIs have been noted to cause adverse reactions in these patients.

▸ Atypical antipsychotics. Two double-blind, placebo-controlled trials have demonstrated positive responses to the atypical antipsychotic risperidone (Risperdal). In these two trials totaling 132 patients, 57%–69% of patients responded positively to risperidone, compared with 6%–12% of placebo patients (Arch. Gen. Psychiatry 1998;55:633–41; N. Engl. J. Med. 2002;347:314–21).

Reports of the use of other atypical antipsychotics–such as olanzapine (Zy-prexa), quetiapine (Seroquel), and ziprasidone (Geodon)–have come from small case series or open-label studies with some success in about half of patients.

▸ α-2 Adrenergic agonists. Very little empirical evidence exists for the use of these agents, which include clonidine (Catapres) and guanfacine (Tenex), in children with autism. Two small (eight and nine patients), double-blind, controlled trials of clonidine each demonstrated modest, short-term improvement in inattention, hyperactivity, impulsivity, and hyperarousal behaviors (J. Clin. Psychopharmacol. 1992;12:322–7; J. Clin. Psychiatry 1992;53:77–82). A retrospective study of guanfacine showed that 24% of 80 patients aged 3–18 years had clinically improved hyperactivity, inattention, and tics (J. Child Adolesc. Psychopharmacol. 2004;14:233–41). Additional research is warranted.

▸ CNS stimulants. Methylphenidate has proved to be effective in improving hyperactivity, impulsivity, and inattention in some patients without worsening behavior or increasing symptoms, such as stereotypies or irritability, but such is not the case for all patients, Dr. Myers said.

▸ Anticonvulsants. In an open-label study of valproic acid, 10 of 14 patients had a sustained clinical response with decreases in affective instability, impulsivity, aggression, and core symptoms. All of the patients who had any electroencephalograph abnormalities or seizures responded to valproic acid (J. Clin. Psychiatry 2001;62:530–4). Lamotrigine (Lamictal) did not have any noticeable effects separate from placebo in a double-blind trial of 28 autistic patients, despite some encouraging results in a previous open-label trial (J. Autism Dev. Disord. 2001;31:175–81; Neuropediatrics 1994;25:284–9).

Detecting Colorectal Ca From Feces

Fecal DNA testing detects advanced colorectal neoplasia in asymptomatic patients at average risk for colorectal cancer with a significantly greater sensitivity than fecal occult-blood testing, reported Thomas F. Imperiale, M.D., of Indiana University, Indianapolis, and his associates.

In 418 patients with advanced neoplasia (tubular adenoma 1 cm or larger, villous polyp, polyp with high-grade dysplasia, or cancer), fecal DNA testing had a significantly greater sensitivity than fecal occult-blood testing (18% vs. 11%). The sensitivity of fecal DNA testing was 52% in detecting invasive cancer alone and 41% for carcinoma in situ and invasive cancer together. Fecal occult-blood testing remained nearly the same at 13% and 14%, respectively (N. Engl. J. Med. 2004;351:2704–14).

Other studies of fecal DNA testing have reported sensitivities of 64% and 90% for cancer, but they tested patients known to have colorectal cancer and not asymptomatic patients. Colonoscopy was the reference standard in this study, which included 2,507 patients with an average age of 70 years. Dr. Imperiale and most of his colleagues in the study reported that they have received consulting fees or grants from, own shares in, or have been employed by Exact Sciences, which funded the trial and analyzed stool samples…

Diabetes in Chronic Hepatitis C

Type 2 diabetes is independently associated with histologically advanced chronic hepatitis C infection, according to the results of a prospective cross-sectional study.

The prevalence of type 2 diabetes mellitus (DM) in patients with chronic hepatitis C virus (HCV) infection ranged from 5% among 80 patients with early histological disease (fibrosis stage 0–2) to 21% among 56 patients with advanced histological disease (fibrosis stage 3–4), reported Claudia O. Zein, M.D., of the Mayo Clinic and Foundation, Rochester, Minn., and colleagues. Patients with advanced histological disease had a significantly higher prevalence of DM than the general population (8%) and a control cohort of 179 patients from the same institution with either primary biliary cirrhosis or primary sclerosing cholangitis (7%), regardless of the presence of advanced histological disease in the control patients (Am. J. Gastroenterol. 2005;100:48–55).

Advanced histological hepatitis C and family history of DM remained independently associated with DM after controlling for other diabetes risk factors and other variables. None of the patients with chronic hepatitis C infection had taken interferon or corticosteroids.

Hemorrhoidectomy Methods Compared

Hemorrhoidectomy performed with a Ligasure hemostatic device causes less postoperative pain and takes less time to do than hemorrhoidectomy with the Harmonic Scalpel, reported Shek Yuen Kwok, M.D., and colleagues at the Pamela Youde Nethersole Eastern Hospital, Hong Kong.

Seven days after patients with a total of three grade 3 or 4 hemorrhoids underwent a hemorrhoidectomy in a single-blind, randomized trial, the median postoperative pain score (assessed pain with a visual analog score) for the 24 patients in the Ligasure group was significantly lower than that for 23 patients in the Harmonic Scalpel group (2.6 vs. 4.8) (Dis. Colon Rectum [online] Dec. 21, 2004).

The Ligasure operation took significantly less time to perform than did the procedure using the Harmonic Scalpel (11 min. vs. 18 min.). No differences in complications or other parameters were found.

Endoscopic Enteryx Therapy for GERD

Augmentation of the lateral esophageal sphincter with the Enteryx procedure can significantly reduce heartburn symptoms and the use of proton pump inhibitors (PPIs) in gastroesophageal reflux disease patients, reported Jacques Devière, M.D., of the Free University of Brussels and his colleagues.

Of 32 patients who underwent the procedure—endoscopic implantation of Enteryx, a nonresorbable copolymer—in a randomized, patient-blinded trial, 78% reduced their use of PPIs by 50% or more after 3 months, compared with 53% of 32 patients who underwent a sham procedure consisting of an upper GI endoscopy. The GERD health-related quality-of-life heartburn score improved 3 months after the procedure by a significantly greater amount on average in Enteryx patients than in sham patients (63% vs. 25%) (Gastroenterology [online] accepted Dec. 4, 2004;

www.gastrojournal.org

Around the time of the 3-month follow-up, 20 of 23 patients in the sham group who were eligible for Enteryx treatment underwent the procedure, whereas 6 of 9 eligible patients in the Enteryx group were retreated. Six months after the initial procedure, PPI usage and heartburn symptoms remained stable in the Enteryx group and improved in the sham group because many of the patients in that group.

Detecting Colorectal Ca From Feces

Fecal DNA testing detects advanced colorectal neoplasia in asymptomatic patients at average risk for colorectal cancer with a significantly greater sensitivity than fecal occult-blood testing, reported Thomas F. Imperiale, M.D., of Indiana University, Indianapolis, and his associates.

In 418 patients with advanced neoplasia (tubular adenoma 1 cm or larger, villous polyp, polyp with high-grade dysplasia, or cancer), fecal DNA testing had a significantly greater sensitivity than fecal occult-blood testing (18% vs. 11%). The sensitivity of fecal DNA testing was 52% in detecting invasive cancer alone and 41% for carcinoma in situ and invasive cancer together. Fecal occult-blood testing remained nearly the same at 13% and 14%, respectively (N. Engl. J. Med. 2004;351:2704–14).

Other studies of fecal DNA testing have reported sensitivities of 64% and 90% for cancer, but they tested patients known to have colorectal cancer and not asymptomatic patients. Colonoscopy was the reference standard in this study, which included 2,507 patients with an average age of 70 years. Dr. Imperiale and most of his colleagues in the study reported that they have received consulting fees or grants from, own shares in, or have been employed by Exact Sciences, which funded the trial and analyzed stool samples…

Diabetes in Chronic Hepatitis C

Type 2 diabetes is independently associated with histologically advanced chronic hepatitis C infection, according to the results of a prospective cross-sectional study.

The prevalence of type 2 diabetes mellitus (DM) in patients with chronic hepatitis C virus (HCV) infection ranged from 5% among 80 patients with early histological disease (fibrosis stage 0–2) to 21% among 56 patients with advanced histological disease (fibrosis stage 3–4), reported Claudia O. Zein, M.D., of the Mayo Clinic and Foundation, Rochester, Minn., and colleagues. Patients with advanced histological disease had a significantly higher prevalence of DM than the general population (8%) and a control cohort of 179 patients from the same institution with either primary biliary cirrhosis or primary sclerosing cholangitis (7%), regardless of the presence of advanced histological disease in the control patients (Am. J. Gastroenterol. 2005;100:48–55).

Advanced histological hepatitis C and family history of DM remained independently associated with DM after controlling for other diabetes risk factors and other variables. None of the patients with chronic hepatitis C infection had taken interferon or corticosteroids.

Hemorrhoidectomy Methods Compared

Hemorrhoidectomy performed with a Ligasure hemostatic device causes less postoperative pain and takes less time to do than hemorrhoidectomy with the Harmonic Scalpel, reported Shek Yuen Kwok, M.D., and colleagues at the Pamela Youde Nethersole Eastern Hospital, Hong Kong.

Seven days after patients with a total of three grade 3 or 4 hemorrhoids underwent a hemorrhoidectomy in a single-blind, randomized trial, the median postoperative pain score (assessed pain with a visual analog score) for the 24 patients in the Ligasure group was significantly lower than that for 23 patients in the Harmonic Scalpel group (2.6 vs. 4.8) (Dis. Colon Rectum [online] Dec. 21, 2004).

The Ligasure operation took significantly less time to perform than did the procedure using the Harmonic Scalpel (11 min. vs. 18 min.). No differences in complications or other parameters were found.

Endoscopic Enteryx Therapy for GERD

Augmentation of the lateral esophageal sphincter with the Enteryx procedure can significantly reduce heartburn symptoms and the use of proton pump inhibitors (PPIs) in gastroesophageal reflux disease patients, reported Jacques Devière, M.D., of the Free University of Brussels and his colleagues.

Of 32 patients who underwent the procedure—endoscopic implantation of Enteryx, a nonresorbable copolymer—in a randomized, patient-blinded trial, 78% reduced their use of PPIs by 50% or more after 3 months, compared with 53% of 32 patients who underwent a sham procedure consisting of an upper GI endoscopy. The GERD health-related quality-of-life heartburn score improved 3 months after the procedure by a significantly greater amount on average in Enteryx patients than in sham patients (63% vs. 25%) (Gastroenterology [online] accepted Dec. 4, 2004;

www.gastrojournal.org

Around the time of the 3-month follow-up, 20 of 23 patients in the sham group who were eligible for Enteryx treatment underwent the procedure, whereas 6 of 9 eligible patients in the Enteryx group were retreated. Six months after the initial procedure, PPI usage and heartburn symptoms remained stable in the Enteryx group and improved in the sham group because many of the patients in that group.

Detecting Colorectal Ca From Feces

Fecal DNA testing detects advanced colorectal neoplasia in asymptomatic patients at average risk for colorectal cancer with a significantly greater sensitivity than fecal occult-blood testing, reported Thomas F. Imperiale, M.D., of Indiana University, Indianapolis, and his associates.

In 418 patients with advanced neoplasia (tubular adenoma 1 cm or larger, villous polyp, polyp with high-grade dysplasia, or cancer), fecal DNA testing had a significantly greater sensitivity than fecal occult-blood testing (18% vs. 11%). The sensitivity of fecal DNA testing was 52% in detecting invasive cancer alone and 41% for carcinoma in situ and invasive cancer together. Fecal occult-blood testing remained nearly the same at 13% and 14%, respectively (N. Engl. J. Med. 2004;351:2704–14).

Other studies of fecal DNA testing have reported sensitivities of 64% and 90% for cancer, but they tested patients known to have colorectal cancer and not asymptomatic patients. Colonoscopy was the reference standard in this study, which included 2,507 patients with an average age of 70 years. Dr. Imperiale and most of his colleagues in the study reported that they have received consulting fees or grants from, own shares in, or have been employed by Exact Sciences, which funded the trial and analyzed stool samples…

Diabetes in Chronic Hepatitis C

Type 2 diabetes is independently associated with histologically advanced chronic hepatitis C infection, according to the results of a prospective cross-sectional study.

The prevalence of type 2 diabetes mellitus (DM) in patients with chronic hepatitis C virus (HCV) infection ranged from 5% among 80 patients with early histological disease (fibrosis stage 0–2) to 21% among 56 patients with advanced histological disease (fibrosis stage 3–4), reported Claudia O. Zein, M.D., of the Mayo Clinic and Foundation, Rochester, Minn., and colleagues. Patients with advanced histological disease had a significantly higher prevalence of DM than the general population (8%) and a control cohort of 179 patients from the same institution with either primary biliary cirrhosis or primary sclerosing cholangitis (7%), regardless of the presence of advanced histological disease in the control patients (Am. J. Gastroenterol. 2005;100:48–55).

Advanced histological hepatitis C and family history of DM remained independently associated with DM after controlling for other diabetes risk factors and other variables. None of the patients with chronic hepatitis C infection had taken interferon or corticosteroids.

Hemorrhoidectomy Methods Compared

Hemorrhoidectomy performed with a Ligasure hemostatic device causes less postoperative pain and takes less time to do than hemorrhoidectomy with the Harmonic Scalpel, reported Shek Yuen Kwok, M.D., and colleagues at the Pamela Youde Nethersole Eastern Hospital, Hong Kong.

Seven days after patients with a total of three grade 3 or 4 hemorrhoids underwent a hemorrhoidectomy in a single-blind, randomized trial, the median postoperative pain score (assessed pain with a visual analog score) for the 24 patients in the Ligasure group was significantly lower than that for 23 patients in the Harmonic Scalpel group (2.6 vs. 4.8) (Dis. Colon Rectum [online] Dec. 21, 2004).

The Ligasure operation took significantly less time to perform than did the procedure using the Harmonic Scalpel (11 min. vs. 18 min.). No differences in complications or other parameters were found.

Endoscopic Enteryx Therapy for GERD

Augmentation of the lateral esophageal sphincter with the Enteryx procedure can significantly reduce heartburn symptoms and the use of proton pump inhibitors (PPIs) in gastroesophageal reflux disease patients, reported Jacques Devière, M.D., of the Free University of Brussels and his colleagues.

Of 32 patients who underwent the procedure—endoscopic implantation of Enteryx, a nonresorbable copolymer—in a randomized, patient-blinded trial, 78% reduced their use of PPIs by 50% or more after 3 months, compared with 53% of 32 patients who underwent a sham procedure consisting of an upper GI endoscopy. The GERD health-related quality-of-life heartburn score improved 3 months after the procedure by a significantly greater amount on average in Enteryx patients than in sham patients (63% vs. 25%) (Gastroenterology [online] accepted Dec. 4, 2004;

www.gastrojournal.org

Around the time of the 3-month follow-up, 20 of 23 patients in the sham group who were eligible for Enteryx treatment underwent the procedure, whereas 6 of 9 eligible patients in the Enteryx group were retreated. Six months after the initial procedure, PPI usage and heartburn symptoms remained stable in the Enteryx group and improved in the sham group because many of the patients in that group.

ORLANDO, FLA. — Important issues remain unresolved regarding the accuracy of CT colonography, or virtual colonoscopy, and how it might influence the use of conventional colonoscopy in clinical practice, Douglas K. Rex, M.D., said at the annual meeting of the American College of Gastroenterology.

Clinical studies of CT colonography have had mixed results. Only one of the four major published studies has reported that CT colonography has sensitivity and specificity similar to that of colonoscopy (N. Engl. J. Med. 2003;349:2191–200). It is essentially “impossible” to assess why that study obtained better results than the other three, because the researchers in each of the studies used substantially different methods to perform CT colonography. Participating doctors in the studies also had different levels of experience in using the screening technique, noted Dr. Rex, outgoing president of the American College of Gastroenterology (ACG).

Other factors related to CT colonography may drive some patients away from choosing the screening test. Some patients may not like CT colonography because lesions detected during the procedure cannot be removed at the time they are discovered, unlike with colonoscopy.

Radiation may pose too high a risk to patients if CT colonography becomes the primary screening test. In fact, a poster abstract presented by Douglas O. Faigel, M.D., at the meeting estimated that if CT colonography were to become the primary screening test, 25 patients per 100,000 screened would die from radiation, compared with no patients per 100,000 if colonoscopy was the primary screening test.

The high up-front costs for CT colonography machinery and software also present a barrier to increased use of the screening modality.

Currently, patients who undergo CT colonography receive a thorough bowel preparation comparable with that of colonoscopy. As long as bowel preparation is necessary for CT colonography, some patients will choose CT colonography while many others still will choose colonoscopy, said Dr. Rex, director of endoscopy at Indiana University Hospital, Indianapolis.

But any effect that improves the relative acceptability of CT colonography to people also might affect adherence to screening recommendations and replace the current standard of colonoscopy. A recent study showed that CT colonography is sensitive and specific in detecting colorectal polyps when patients ingest an iodinated contrast agent that tags feces so that physicians can later subtract stool from the image without any special bowel preparation (Gastroenterology 2004; 127:1300–11). Improvements such as this “could drive patient preferences” for CT colonography, Dr. Rex said.

Several questions about CT colonography remain unanswered:

▸ Will it increase adherence to colorectal cancer screening recommendations?

Currently, about 40% of the U.S. population eligible to receive colorectal cancer screening follows screening recommendations. If about two-thirds of the population eligible to receive colorectal cancer screening chose to be screened with CT colonography instead of colonoscopy, the number of all colonoscopies performed in the United States would decrease by 20%, according to a recently published model presented at the 2004 Digestive Diseases Week (Gastroenterology 2004;127:1312–21). It suggested that the current level of adherence to colorectal cancer screening recommendations would have to increase by 77% to maintain the current number of colonoscopies performed in the United States.

But another study showed that patients do not differ in their adherence to screening recommendations when they can undergo only colonoscopy or CT colonography, or when they are offered a choice between CT colonography and colonoscopy (Am. J. Gastroenterol. 2004;99:1145–51).

▸ What cutoff size for polyps detected by CT colonography should be used to refer patients for polypectomy during colonoscopy?

Some endoscopists have proposed a cutoff size of 1 cm for polyps even though a minority of sporadic colorectal adenomas will progress to invasive cancer.

The ACG has stated that patients with polyps 6 mm or larger or who have three or more adenomas of any size should be offered colonoscopy. This recommendation came from data on the histology of these polyps in older studies, wherein 1% of polyps 6–9 mm had invasive cancer and 4% had high-grade dysplasia. No recent studies have examined the histology of small polyps.

Little is known about the natural history of small polyps when they are left for observation.

In a study of 116 polyps, those 6–9 mm changed little in size during a 3-year observation period before they were removed, Dr. Rex said.

The paucity of data on the natural history of small polyps makes it hard for endoscopists to believe that “without histology, people are going to accept that they have a normal exam,” Dr. Rex said. These patients are actually more likely to undergo additional testing that imparts more cancer and radiation risks and the costs associated with them.

About 30%–40% of patients with three or more adenomas detected by CT colonography may be referred for a colonoscopy, compared with about 10% of patients who have a 1-cm or larger polyp detected by CT colonography, Dr. Rex said.

If CT colonography becomes well established as a result of additional studies that prove its effectiveness, gastroenterologists will be well-suited to read the 3-D fly-throughs of the colon created during CT colonography; many internal medicine subspecialists read their own radiology or ultrasound tests, Dr. Rex added.

Colorectal cancer screening with CT colonography currently must be performed with a high volume of patients to offset the major capital investments in CT colonography equipment. Insurance providers do not cover colorectal cancer screening with CT colonography, since no permanent CPT code exists yet for the test. Most parts of the country don't have a large enough population to make CT colonography screening feasible at the moment, he said.

ORLANDO, FLA. — Important issues remain unresolved regarding the accuracy of CT colonography, or virtual colonoscopy, and how it might influence the use of conventional colonoscopy in clinical practice, Douglas K. Rex, M.D., said at the annual meeting of the American College of Gastroenterology.

Clinical studies of CT colonography have had mixed results. Only one of the four major published studies has reported that CT colonography has sensitivity and specificity similar to that of colonoscopy (N. Engl. J. Med. 2003;349:2191–200). It is essentially “impossible” to assess why that study obtained better results than the other three, because the researchers in each of the studies used substantially different methods to perform CT colonography. Participating doctors in the studies also had different levels of experience in using the screening technique, noted Dr. Rex, outgoing president of the American College of Gastroenterology (ACG).

Other factors related to CT colonography may drive some patients away from choosing the screening test. Some patients may not like CT colonography because lesions detected during the procedure cannot be removed at the time they are discovered, unlike with colonoscopy.

Radiation may pose too high a risk to patients if CT colonography becomes the primary screening test. In fact, a poster abstract presented by Douglas O. Faigel, M.D., at the meeting estimated that if CT colonography were to become the primary screening test, 25 patients per 100,000 screened would die from radiation, compared with no patients per 100,000 if colonoscopy was the primary screening test.

The high up-front costs for CT colonography machinery and software also present a barrier to increased use of the screening modality.

Currently, patients who undergo CT colonography receive a thorough bowel preparation comparable with that of colonoscopy. As long as bowel preparation is necessary for CT colonography, some patients will choose CT colonography while many others still will choose colonoscopy, said Dr. Rex, director of endoscopy at Indiana University Hospital, Indianapolis.

But any effect that improves the relative acceptability of CT colonography to people also might affect adherence to screening recommendations and replace the current standard of colonoscopy. A recent study showed that CT colonography is sensitive and specific in detecting colorectal polyps when patients ingest an iodinated contrast agent that tags feces so that physicians can later subtract stool from the image without any special bowel preparation (Gastroenterology 2004; 127:1300–11). Improvements such as this “could drive patient preferences” for CT colonography, Dr. Rex said.

Several questions about CT colonography remain unanswered:

▸ Will it increase adherence to colorectal cancer screening recommendations?

Currently, about 40% of the U.S. population eligible to receive colorectal cancer screening follows screening recommendations. If about two-thirds of the population eligible to receive colorectal cancer screening chose to be screened with CT colonography instead of colonoscopy, the number of all colonoscopies performed in the United States would decrease by 20%, according to a recently published model presented at the 2004 Digestive Diseases Week (Gastroenterology 2004;127:1312–21). It suggested that the current level of adherence to colorectal cancer screening recommendations would have to increase by 77% to maintain the current number of colonoscopies performed in the United States.

But another study showed that patients do not differ in their adherence to screening recommendations when they can undergo only colonoscopy or CT colonography, or when they are offered a choice between CT colonography and colonoscopy (Am. J. Gastroenterol. 2004;99:1145–51).

▸ What cutoff size for polyps detected by CT colonography should be used to refer patients for polypectomy during colonoscopy?

Some endoscopists have proposed a cutoff size of 1 cm for polyps even though a minority of sporadic colorectal adenomas will progress to invasive cancer.

The ACG has stated that patients with polyps 6 mm or larger or who have three or more adenomas of any size should be offered colonoscopy. This recommendation came from data on the histology of these polyps in older studies, wherein 1% of polyps 6–9 mm had invasive cancer and 4% had high-grade dysplasia. No recent studies have examined the histology of small polyps.

Little is known about the natural history of small polyps when they are left for observation.

In a study of 116 polyps, those 6–9 mm changed little in size during a 3-year observation period before they were removed, Dr. Rex said.

The paucity of data on the natural history of small polyps makes it hard for endoscopists to believe that “without histology, people are going to accept that they have a normal exam,” Dr. Rex said. These patients are actually more likely to undergo additional testing that imparts more cancer and radiation risks and the costs associated with them.

About 30%–40% of patients with three or more adenomas detected by CT colonography may be referred for a colonoscopy, compared with about 10% of patients who have a 1-cm or larger polyp detected by CT colonography, Dr. Rex said.

If CT colonography becomes well established as a result of additional studies that prove its effectiveness, gastroenterologists will be well-suited to read the 3-D fly-throughs of the colon created during CT colonography; many internal medicine subspecialists read their own radiology or ultrasound tests, Dr. Rex added.

Colorectal cancer screening with CT colonography currently must be performed with a high volume of patients to offset the major capital investments in CT colonography equipment. Insurance providers do not cover colorectal cancer screening with CT colonography, since no permanent CPT code exists yet for the test. Most parts of the country don't have a large enough population to make CT colonography screening feasible at the moment, he said.

ORLANDO, FLA. — Important issues remain unresolved regarding the accuracy of CT colonography, or virtual colonoscopy, and how it might influence the use of conventional colonoscopy in clinical practice, Douglas K. Rex, M.D., said at the annual meeting of the American College of Gastroenterology.

Clinical studies of CT colonography have had mixed results. Only one of the four major published studies has reported that CT colonography has sensitivity and specificity similar to that of colonoscopy (N. Engl. J. Med. 2003;349:2191–200). It is essentially “impossible” to assess why that study obtained better results than the other three, because the researchers in each of the studies used substantially different methods to perform CT colonography. Participating doctors in the studies also had different levels of experience in using the screening technique, noted Dr. Rex, outgoing president of the American College of Gastroenterology (ACG).

Other factors related to CT colonography may drive some patients away from choosing the screening test. Some patients may not like CT colonography because lesions detected during the procedure cannot be removed at the time they are discovered, unlike with colonoscopy.

Radiation may pose too high a risk to patients if CT colonography becomes the primary screening test. In fact, a poster abstract presented by Douglas O. Faigel, M.D., at the meeting estimated that if CT colonography were to become the primary screening test, 25 patients per 100,000 screened would die from radiation, compared with no patients per 100,000 if colonoscopy was the primary screening test.

The high up-front costs for CT colonography machinery and software also present a barrier to increased use of the screening modality.

Currently, patients who undergo CT colonography receive a thorough bowel preparation comparable with that of colonoscopy. As long as bowel preparation is necessary for CT colonography, some patients will choose CT colonography while many others still will choose colonoscopy, said Dr. Rex, director of endoscopy at Indiana University Hospital, Indianapolis.

But any effect that improves the relative acceptability of CT colonography to people also might affect adherence to screening recommendations and replace the current standard of colonoscopy. A recent study showed that CT colonography is sensitive and specific in detecting colorectal polyps when patients ingest an iodinated contrast agent that tags feces so that physicians can later subtract stool from the image without any special bowel preparation (Gastroenterology 2004; 127:1300–11). Improvements such as this “could drive patient preferences” for CT colonography, Dr. Rex said.

Several questions about CT colonography remain unanswered:

▸ Will it increase adherence to colorectal cancer screening recommendations?

Currently, about 40% of the U.S. population eligible to receive colorectal cancer screening follows screening recommendations. If about two-thirds of the population eligible to receive colorectal cancer screening chose to be screened with CT colonography instead of colonoscopy, the number of all colonoscopies performed in the United States would decrease by 20%, according to a recently published model presented at the 2004 Digestive Diseases Week (Gastroenterology 2004;127:1312–21). It suggested that the current level of adherence to colorectal cancer screening recommendations would have to increase by 77% to maintain the current number of colonoscopies performed in the United States.

But another study showed that patients do not differ in their adherence to screening recommendations when they can undergo only colonoscopy or CT colonography, or when they are offered a choice between CT colonography and colonoscopy (Am. J. Gastroenterol. 2004;99:1145–51).

▸ What cutoff size for polyps detected by CT colonography should be used to refer patients for polypectomy during colonoscopy?

Some endoscopists have proposed a cutoff size of 1 cm for polyps even though a minority of sporadic colorectal adenomas will progress to invasive cancer.

The ACG has stated that patients with polyps 6 mm or larger or who have three or more adenomas of any size should be offered colonoscopy. This recommendation came from data on the histology of these polyps in older studies, wherein 1% of polyps 6–9 mm had invasive cancer and 4% had high-grade dysplasia. No recent studies have examined the histology of small polyps.

Little is known about the natural history of small polyps when they are left for observation.

In a study of 116 polyps, those 6–9 mm changed little in size during a 3-year observation period before they were removed, Dr. Rex said.

The paucity of data on the natural history of small polyps makes it hard for endoscopists to believe that “without histology, people are going to accept that they have a normal exam,” Dr. Rex said. These patients are actually more likely to undergo additional testing that imparts more cancer and radiation risks and the costs associated with them.

About 30%–40% of patients with three or more adenomas detected by CT colonography may be referred for a colonoscopy, compared with about 10% of patients who have a 1-cm or larger polyp detected by CT colonography, Dr. Rex said.

If CT colonography becomes well established as a result of additional studies that prove its effectiveness, gastroenterologists will be well-suited to read the 3-D fly-throughs of the colon created during CT colonography; many internal medicine subspecialists read their own radiology or ultrasound tests, Dr. Rex added.

Colorectal cancer screening with CT colonography currently must be performed with a high volume of patients to offset the major capital investments in CT colonography equipment. Insurance providers do not cover colorectal cancer screening with CT colonography, since no permanent CPT code exists yet for the test. Most parts of the country don't have a large enough population to make CT colonography screening feasible at the moment, he said.

ORLANDO, FLA. — Colorectal cancer occurs at a high enough rate in African Americans and Hispanics under 50 years of age to warrant screening starting at age 40, according to Jaydutt Vadgama, Ph.D., of the Charles R. Drew University of Medicine and Science, Los Angeles.

In a retrospective study, Dr. Vadgama found that of 148 patients who had been diagnosed with colorectal cancer at the Martin Luther King/Drew Medical Center during 1996–2004, 38 (26%) were younger than 50 years of age. At diagnosis, the 38 patients had a median age of 42 years at diagnosis. Half of the patients under age 50 had a family history of colorectal cancer.

During 1993–1997, 46% of the 11,615 cases of colorectal cancer in African Americans and Hispanics in California occurred in patients younger than 50 years.

“Colorectal cancer screening should be considered in African Americans and Hispanics beginning at age 40 regardless of family history,” the researchers suggested in a presentation at the annual meeting of the American College of Gastroenterology.

The college's guidelines on colorectal cancer screening, published in 2000, recommend that patients at higher than average risk for colorectal cancer (because of family history among two or more first-degree relatives) should be screened by colonoscopy at an age of 40 years or 10 years younger than the age of the youngest affected relative at diagnosis, whichever is earlier.

ORLANDO, FLA. — Colorectal cancer occurs at a high enough rate in African Americans and Hispanics under 50 years of age to warrant screening starting at age 40, according to Jaydutt Vadgama, Ph.D., of the Charles R. Drew University of Medicine and Science, Los Angeles.

In a retrospective study, Dr. Vadgama found that of 148 patients who had been diagnosed with colorectal cancer at the Martin Luther King/Drew Medical Center during 1996–2004, 38 (26%) were younger than 50 years of age. At diagnosis, the 38 patients had a median age of 42 years at diagnosis. Half of the patients under age 50 had a family history of colorectal cancer.

During 1993–1997, 46% of the 11,615 cases of colorectal cancer in African Americans and Hispanics in California occurred in patients younger than 50 years.

“Colorectal cancer screening should be considered in African Americans and Hispanics beginning at age 40 regardless of family history,” the researchers suggested in a presentation at the annual meeting of the American College of Gastroenterology.

The college's guidelines on colorectal cancer screening, published in 2000, recommend that patients at higher than average risk for colorectal cancer (because of family history among two or more first-degree relatives) should be screened by colonoscopy at an age of 40 years or 10 years younger than the age of the youngest affected relative at diagnosis, whichever is earlier.

ORLANDO, FLA. — Colorectal cancer occurs at a high enough rate in African Americans and Hispanics under 50 years of age to warrant screening starting at age 40, according to Jaydutt Vadgama, Ph.D., of the Charles R. Drew University of Medicine and Science, Los Angeles.

In a retrospective study, Dr. Vadgama found that of 148 patients who had been diagnosed with colorectal cancer at the Martin Luther King/Drew Medical Center during 1996–2004, 38 (26%) were younger than 50 years of age. At diagnosis, the 38 patients had a median age of 42 years at diagnosis. Half of the patients under age 50 had a family history of colorectal cancer.

During 1993–1997, 46% of the 11,615 cases of colorectal cancer in African Americans and Hispanics in California occurred in patients younger than 50 years.

“Colorectal cancer screening should be considered in African Americans and Hispanics beginning at age 40 regardless of family history,” the researchers suggested in a presentation at the annual meeting of the American College of Gastroenterology.

The college's guidelines on colorectal cancer screening, published in 2000, recommend that patients at higher than average risk for colorectal cancer (because of family history among two or more first-degree relatives) should be screened by colonoscopy at an age of 40 years or 10 years younger than the age of the youngest affected relative at diagnosis, whichever is earlier.

The focus of liver and biliary disease research in the United States through 2015 has been set with the release of the National Institutes of Health's Action Plan for Liver Disease Research.

The decade-long initiative is the result of coordinated effort between federal health agencies and the 18 institutes, centers, and offices in the NIH that support liver and biliary disease research. The plan is geared toward the rapid translation of findings from basic research to clinical practice, and vice versa.

Employees of NIH and federal agencies developed the plan with help from extramural researchers, physicians, and representatives of professional and patient advocacy groups.

The action plan includes 214 research goals, but 10 major goals cut across multiple disciplines in liver and biliary disease research:

▸ Improve the success rate of therapy for chronic hepatitis C.

▸ Develop effective antiviral therapy regimens for the long-term management of chronic hepatitis B.

▸ Develop effective therapies for the treatment of nonalcoholic and alcoholic fatty liver disease.

▸ Detect hepatic fibrosis with tests that are sensitive, specific, and noninvasive.

▸ Detect hepatocellular carcinoma at earlier stages in high-risk patients with new screening tests.

▸ Develop ways to prevent gallstones.

▸ Understand further the etiology of biliary atresia.

▸ Improve the safety, and determine the best use, of living donor liver transplantation.

▸ Develop standardized and objective diagnostic criteria of major liver diseases and their grading and staging.

▸ Reduce the overall mortality from chronic liver disease and cirrhosis.

In the plan, each research goal is rated according to whether it is a short- (1–3 years), medium- (4–6 years), or long-term (7–10 years) goal and whether the degree of difficulty of reaching the goal involves high, intermediate, or low risk.

The Liver Disease Subcommittee of the statutory Digestive Diseases Interagency Coordinating Committee will assess the plan through announcements and periodic meetings, including open meetings after 5 and 10 years.

NIH's investment in liver and biliary disease research has increased from about $125 million in 1993 to $388 million in 2003.

To review the full action plan, go to www.niddk.nih.gov/fund/divisions/ddn/ldrb/ldrb_action_plan.htm

The focus of liver and biliary disease research in the United States through 2015 has been set with the release of the National Institutes of Health's Action Plan for Liver Disease Research.

The decade-long initiative is the result of coordinated effort between federal health agencies and the 18 institutes, centers, and offices in the NIH that support liver and biliary disease research. The plan is geared toward the rapid translation of findings from basic research to clinical practice, and vice versa.

Employees of NIH and federal agencies developed the plan with help from extramural researchers, physicians, and representatives of professional and patient advocacy groups.

The action plan includes 214 research goals, but 10 major goals cut across multiple disciplines in liver and biliary disease research:

▸ Improve the success rate of therapy for chronic hepatitis C.

▸ Develop effective antiviral therapy regimens for the long-term management of chronic hepatitis B.

▸ Develop effective therapies for the treatment of nonalcoholic and alcoholic fatty liver disease.

▸ Detect hepatic fibrosis with tests that are sensitive, specific, and noninvasive.

▸ Detect hepatocellular carcinoma at earlier stages in high-risk patients with new screening tests.

▸ Develop ways to prevent gallstones.

▸ Understand further the etiology of biliary atresia.

▸ Improve the safety, and determine the best use, of living donor liver transplantation.

▸ Develop standardized and objective diagnostic criteria of major liver diseases and their grading and staging.

▸ Reduce the overall mortality from chronic liver disease and cirrhosis.

In the plan, each research goal is rated according to whether it is a short- (1–3 years), medium- (4–6 years), or long-term (7–10 years) goal and whether the degree of difficulty of reaching the goal involves high, intermediate, or low risk.

The Liver Disease Subcommittee of the statutory Digestive Diseases Interagency Coordinating Committee will assess the plan through announcements and periodic meetings, including open meetings after 5 and 10 years.

NIH's investment in liver and biliary disease research has increased from about $125 million in 1993 to $388 million in 2003.

To review the full action plan, go to www.niddk.nih.gov/fund/divisions/ddn/ldrb/ldrb_action_plan.htm

The focus of liver and biliary disease research in the United States through 2015 has been set with the release of the National Institutes of Health's Action Plan for Liver Disease Research.

The decade-long initiative is the result of coordinated effort between federal health agencies and the 18 institutes, centers, and offices in the NIH that support liver and biliary disease research. The plan is geared toward the rapid translation of findings from basic research to clinical practice, and vice versa.

Employees of NIH and federal agencies developed the plan with help from extramural researchers, physicians, and representatives of professional and patient advocacy groups.

The action plan includes 214 research goals, but 10 major goals cut across multiple disciplines in liver and biliary disease research:

▸ Improve the success rate of therapy for chronic hepatitis C.

▸ Develop effective antiviral therapy regimens for the long-term management of chronic hepatitis B.

▸ Develop effective therapies for the treatment of nonalcoholic and alcoholic fatty liver disease.

▸ Detect hepatic fibrosis with tests that are sensitive, specific, and noninvasive.

▸ Detect hepatocellular carcinoma at earlier stages in high-risk patients with new screening tests.

▸ Develop ways to prevent gallstones.

▸ Understand further the etiology of biliary atresia.

▸ Improve the safety, and determine the best use, of living donor liver transplantation.

▸ Develop standardized and objective diagnostic criteria of major liver diseases and their grading and staging.

▸ Reduce the overall mortality from chronic liver disease and cirrhosis.

In the plan, each research goal is rated according to whether it is a short- (1–3 years), medium- (4–6 years), or long-term (7–10 years) goal and whether the degree of difficulty of reaching the goal involves high, intermediate, or low risk.

The Liver Disease Subcommittee of the statutory Digestive Diseases Interagency Coordinating Committee will assess the plan through announcements and periodic meetings, including open meetings after 5 and 10 years.

NIH's investment in liver and biliary disease research has increased from about $125 million in 1993 to $388 million in 2003.

To review the full action plan, go to www.niddk.nih.gov/fund/divisions/ddn/ldrb/ldrb_action_plan.htm

WASHINGTON — Surgical resection is an effective treatment for primary squamous cell carcinoma arising on the tongue, K. Matsuura, M.D., reported at the Sixth International Conference on Head and Neck Cancer.

Of 313 patients who were evaluated for malignant tongue tumors from July 1992 through June 2000 at the National Cancer Center Hospital East in Kashiwa, Japan, 274 had squamous cell carcinoma (SCC) of the tongue. These 274 patients, with a median age of 59 years, had a median follow-up of 65 months. At presentation, 35% of the patients had stage III or IV SCC, while 28% of patients overall had a nodal metastasis at the first treatment, said Dr. Matsuura of the division of head and neck surgery at the hospital.

Surgical resection of the primary tumor was the only treatment modality in 95% of cases; the remaining 5% received either chemotherapy alone or chemotherapy followed by surgery.

Primary lymph node-negative carcinoma of the tongue was resected to a safety margin of 10 mm without prophylactic dissection of the neck. But conservative neck dissection was indicated in lymph node-negative patients who underwent surgery with the pull-through method and/or reconstruction, he said, as well as in node-positive patients.

Tumors recurred in 37% of stage I, 44% of stage II, 57% of stage III, and 58% of stage IV cases. A total of 59% of recurrences took place within 6 months of treatment. By 12 months, 77% of tumor recurrences had happened; and by 24 months, 90% of the recurrences had developed. Recurrences were twice as likely in lymph nodes of the neck than at the primary tumor site, Dr. Matsuura pointed out at the meeting, which was sponsored by the American Head and Neck Society.

WASHINGTON — Surgical resection is an effective treatment for primary squamous cell carcinoma arising on the tongue, K. Matsuura, M.D., reported at the Sixth International Conference on Head and Neck Cancer.

Of 313 patients who were evaluated for malignant tongue tumors from July 1992 through June 2000 at the National Cancer Center Hospital East in Kashiwa, Japan, 274 had squamous cell carcinoma (SCC) of the tongue. These 274 patients, with a median age of 59 years, had a median follow-up of 65 months. At presentation, 35% of the patients had stage III or IV SCC, while 28% of patients overall had a nodal metastasis at the first treatment, said Dr. Matsuura of the division of head and neck surgery at the hospital.

Surgical resection of the primary tumor was the only treatment modality in 95% of cases; the remaining 5% received either chemotherapy alone or chemotherapy followed by surgery.

Primary lymph node-negative carcinoma of the tongue was resected to a safety margin of 10 mm without prophylactic dissection of the neck. But conservative neck dissection was indicated in lymph node-negative patients who underwent surgery with the pull-through method and/or reconstruction, he said, as well as in node-positive patients.

Tumors recurred in 37% of stage I, 44% of stage II, 57% of stage III, and 58% of stage IV cases. A total of 59% of recurrences took place within 6 months of treatment. By 12 months, 77% of tumor recurrences had happened; and by 24 months, 90% of the recurrences had developed. Recurrences were twice as likely in lymph nodes of the neck than at the primary tumor site, Dr. Matsuura pointed out at the meeting, which was sponsored by the American Head and Neck Society.

WASHINGTON — Surgical resection is an effective treatment for primary squamous cell carcinoma arising on the tongue, K. Matsuura, M.D., reported at the Sixth International Conference on Head and Neck Cancer.

Of 313 patients who were evaluated for malignant tongue tumors from July 1992 through June 2000 at the National Cancer Center Hospital East in Kashiwa, Japan, 274 had squamous cell carcinoma (SCC) of the tongue. These 274 patients, with a median age of 59 years, had a median follow-up of 65 months. At presentation, 35% of the patients had stage III or IV SCC, while 28% of patients overall had a nodal metastasis at the first treatment, said Dr. Matsuura of the division of head and neck surgery at the hospital.

Surgical resection of the primary tumor was the only treatment modality in 95% of cases; the remaining 5% received either chemotherapy alone or chemotherapy followed by surgery.

Primary lymph node-negative carcinoma of the tongue was resected to a safety margin of 10 mm without prophylactic dissection of the neck. But conservative neck dissection was indicated in lymph node-negative patients who underwent surgery with the pull-through method and/or reconstruction, he said, as well as in node-positive patients.

Tumors recurred in 37% of stage I, 44% of stage II, 57% of stage III, and 58% of stage IV cases. A total of 59% of recurrences took place within 6 months of treatment. By 12 months, 77% of tumor recurrences had happened; and by 24 months, 90% of the recurrences had developed. Recurrences were twice as likely in lymph nodes of the neck than at the primary tumor site, Dr. Matsuura pointed out at the meeting, which was sponsored by the American Head and Neck Society.

Finding Virtual Colonoscopy's Role

Colonoscopy is the most sensitive screening test for colon cancer and polyps, reported Don C. Rockey, M.D., of Duke University Medical Center, Durham, N.C., and his colleagues.

But variability in the results of studies comparing virtual colonoscopy with conventional colonoscopy suggest that it's too soon to dismiss virtual colonoscopy, Steve Halligan, M.D., and Wendy Atkin, M.D., of St. Mark's Hospital, Northwick Park, England, said in an editorial.

In Dr. Rockey's prospective, multicenter study, 614 patients with a high likelihood of having colon abnormalities underwent air contrast barium enema, computed tomographic colonography (CTC—also known as virtual colonoscopy), and conventional colonoscopy.

Conventional colonoscopy consistently had a sensitivity of about 99% per patient for lesions 10 mm or larger, 6-9 mm, and 5 mm or smaller, whereas CTC had lower sensitivity for lesions of 10 mm or larger (59%), 6-9 mm (51%), and 5 mm or smaller (45%). Barium enema fared even worse, with sensitivity in each patient of 48% for lesions 10 mm or larger, 35% for 6-9 mm, and 32% for 5 mm or smaller. The reference standard used in the study was the combined data set for all three procedures (Lancet [online] Dec. 17, 2004;www.thelancet.com

The investigators also found that experienced radiologist observers (more than 50 CTC cases) did not detect lesions any better than did those with less experience who completed a CTC training module, although other studies have reported dissimilar findings, according to Dr. Halligan and Dr. Atkin (Lancet [online] Dec. 17, 2004;www.thelancet.com

HCV Therapy During HIV Coinfection

Pegylated interferon alfa-2b plus ribavirin is more effective than standard interferon alfa-2b plus ribavirin in treating patients with hepatitis C viral infections of genotype 1 or 4 who are coinfected with HIV, reported Fabrice Carrat, M.D., of Université Paris 6, and associates.

Significantly more patients infected with genotype 1 or 4 hepatitis C virus (HCV) developed a sustained virologic response (SVR) with peginterferon alfa-2b (Peg-Intron) plus ribavirin (Rebetol) than with interferon alfa-2b (Intron A) plus ribavirin (17% of 125 patients vs. 6% of 129 patients) at the end of 72 weeks of treatment. The SVR rate did not differ between the two groups among patients infected with HCV of genotype 2, 3, or 5 in the randomized, open-label study. An SVR in patients with HCV genotype 1 or 4 infection was associated independently with peginterferon treatment and an HCV viral load of 5.7 log10 IU × 103/L or less (JAMA 2004;292:2839-48).

Dr. Carrat and some of the other investigators reported receiving research grants or travel grants from and/or serving as a consultant to Schering-Plough, which markets Peg-Intron, Intron A, and Rebetol.

Fat and Fiber in Risk for GERD

A diet high in fat may be associated with an increased risk of gastroesophageal reflux disease and erosive esophagitis, reported Hashem B. El-Serag, M.D., of the Houston Veterans Affairs Medical Center, and his colleagues (Gut 2005;54:11-7).

A total of 371 employees from the Houston VA Medical Center fully answered questions to a cross-sectional survey. A high fat intake was associated significantly with GERD symptoms in overweight individuals, although it was not associated with an increased risk of esophageal erosions. Fiber intake was inversely associated with the risk of GERD symptoms after adjustment for body mass index, total energy intake, and demographic variables. The researchers cautioned that body mass index might have had modifying effects on the associations between fat and fiber intake and GERD symptoms. Avoidance or increased intake of certain foods as well as the level of physical activity might have affeccted the development of GERD in the survey respondents.

Mexican Genetic Link to Gallstones

Mexicans with gallstone disease appear to have a genetic predisposition to develop the condition, according to the results of a prospective, case-control study.

A significantly higher percentage of 146 patients with gallstone disease (GD) had a family history of the disease (48%), compared with 28% of 955 control patients without the disease, said Nahum Méndez-Sánchez, M.D., and colleagues at the Medica Sur Clinic and Foundation, Mexico City (Am. J. Gastroenterol. 2004;99:2166-70).

Patients with a history of GD were significantly more likely to have the HLA antigen allele B39 than were control patients (16% vs. 6%). Control patients were significantly younger on average than the GD patients (45 years vs. 54 years) and had a significantly lower average body mass index (26.4 kg/m2 vs. 27.4 kg/m2).

Finding Virtual Colonoscopy's Role

Colonoscopy is the most sensitive screening test for colon cancer and polyps, reported Don C. Rockey, M.D., of Duke University Medical Center, Durham, N.C., and his colleagues.

But variability in the results of studies comparing virtual colonoscopy with conventional colonoscopy suggest that it's too soon to dismiss virtual colonoscopy, Steve Halligan, M.D., and Wendy Atkin, M.D., of St. Mark's Hospital, Northwick Park, England, said in an editorial.

In Dr. Rockey's prospective, multicenter study, 614 patients with a high likelihood of having colon abnormalities underwent air contrast barium enema, computed tomographic colonography (CTC—also known as virtual colonoscopy), and conventional colonoscopy.

Conventional colonoscopy consistently had a sensitivity of about 99% per patient for lesions 10 mm or larger, 6-9 mm, and 5 mm or smaller, whereas CTC had lower sensitivity for lesions of 10 mm or larger (59%), 6-9 mm (51%), and 5 mm or smaller (45%). Barium enema fared even worse, with sensitivity in each patient of 48% for lesions 10 mm or larger, 35% for 6-9 mm, and 32% for 5 mm or smaller. The reference standard used in the study was the combined data set for all three procedures (Lancet [online] Dec. 17, 2004;www.thelancet.com

The investigators also found that experienced radiologist observers (more than 50 CTC cases) did not detect lesions any better than did those with less experience who completed a CTC training module, although other studies have reported dissimilar findings, according to Dr. Halligan and Dr. Atkin (Lancet [online] Dec. 17, 2004;www.thelancet.com

HCV Therapy During HIV Coinfection

Pegylated interferon alfa-2b plus ribavirin is more effective than standard interferon alfa-2b plus ribavirin in treating patients with hepatitis C viral infections of genotype 1 or 4 who are coinfected with HIV, reported Fabrice Carrat, M.D., of Université Paris 6, and associates.

Significantly more patients infected with genotype 1 or 4 hepatitis C virus (HCV) developed a sustained virologic response (SVR) with peginterferon alfa-2b (Peg-Intron) plus ribavirin (Rebetol) than with interferon alfa-2b (Intron A) plus ribavirin (17% of 125 patients vs. 6% of 129 patients) at the end of 72 weeks of treatment. The SVR rate did not differ between the two groups among patients infected with HCV of genotype 2, 3, or 5 in the randomized, open-label study. An SVR in patients with HCV genotype 1 or 4 infection was associated independently with peginterferon treatment and an HCV viral load of 5.7 log10 IU × 103/L or less (JAMA 2004;292:2839-48).

Dr. Carrat and some of the other investigators reported receiving research grants or travel grants from and/or serving as a consultant to Schering-Plough, which markets Peg-Intron, Intron A, and Rebetol.

Fat and Fiber in Risk for GERD

A diet high in fat may be associated with an increased risk of gastroesophageal reflux disease and erosive esophagitis, reported Hashem B. El-Serag, M.D., of the Houston Veterans Affairs Medical Center, and his colleagues (Gut 2005;54:11-7).

A total of 371 employees from the Houston VA Medical Center fully answered questions to a cross-sectional survey. A high fat intake was associated significantly with GERD symptoms in overweight individuals, although it was not associated with an increased risk of esophageal erosions. Fiber intake was inversely associated with the risk of GERD symptoms after adjustment for body mass index, total energy intake, and demographic variables. The researchers cautioned that body mass index might have had modifying effects on the associations between fat and fiber intake and GERD symptoms. Avoidance or increased intake of certain foods as well as the level of physical activity might have affeccted the development of GERD in the survey respondents.

Mexican Genetic Link to Gallstones

Mexicans with gallstone disease appear to have a genetic predisposition to develop the condition, according to the results of a prospective, case-control study.

A significantly higher percentage of 146 patients with gallstone disease (GD) had a family history of the disease (48%), compared with 28% of 955 control patients without the disease, said Nahum Méndez-Sánchez, M.D., and colleagues at the Medica Sur Clinic and Foundation, Mexico City (Am. J. Gastroenterol. 2004;99:2166-70).

Patients with a history of GD were significantly more likely to have the HLA antigen allele B39 than were control patients (16% vs. 6%). Control patients were significantly younger on average than the GD patients (45 years vs. 54 years) and had a significantly lower average body mass index (26.4 kg/m2 vs. 27.4 kg/m2).

Finding Virtual Colonoscopy's Role

Colonoscopy is the most sensitive screening test for colon cancer and polyps, reported Don C. Rockey, M.D., of Duke University Medical Center, Durham, N.C., and his colleagues.

But variability in the results of studies comparing virtual colonoscopy with conventional colonoscopy suggest that it's too soon to dismiss virtual colonoscopy, Steve Halligan, M.D., and Wendy Atkin, M.D., of St. Mark's Hospital, Northwick Park, England, said in an editorial.

In Dr. Rockey's prospective, multicenter study, 614 patients with a high likelihood of having colon abnormalities underwent air contrast barium enema, computed tomographic colonography (CTC—also known as virtual colonoscopy), and conventional colonoscopy.

Conventional colonoscopy consistently had a sensitivity of about 99% per patient for lesions 10 mm or larger, 6-9 mm, and 5 mm or smaller, whereas CTC had lower sensitivity for lesions of 10 mm or larger (59%), 6-9 mm (51%), and 5 mm or smaller (45%). Barium enema fared even worse, with sensitivity in each patient of 48% for lesions 10 mm or larger, 35% for 6-9 mm, and 32% for 5 mm or smaller. The reference standard used in the study was the combined data set for all three procedures (Lancet [online] Dec. 17, 2004;www.thelancet.com

The investigators also found that experienced radiologist observers (more than 50 CTC cases) did not detect lesions any better than did those with less experience who completed a CTC training module, although other studies have reported dissimilar findings, according to Dr. Halligan and Dr. Atkin (Lancet [online] Dec. 17, 2004;www.thelancet.com

HCV Therapy During HIV Coinfection

Pegylated interferon alfa-2b plus ribavirin is more effective than standard interferon alfa-2b plus ribavirin in treating patients with hepatitis C viral infections of genotype 1 or 4 who are coinfected with HIV, reported Fabrice Carrat, M.D., of Université Paris 6, and associates.

Significantly more patients infected with genotype 1 or 4 hepatitis C virus (HCV) developed a sustained virologic response (SVR) with peginterferon alfa-2b (Peg-Intron) plus ribavirin (Rebetol) than with interferon alfa-2b (Intron A) plus ribavirin (17% of 125 patients vs. 6% of 129 patients) at the end of 72 weeks of treatment. The SVR rate did not differ between the two groups among patients infected with HCV of genotype 2, 3, or 5 in the randomized, open-label study. An SVR in patients with HCV genotype 1 or 4 infection was associated independently with peginterferon treatment and an HCV viral load of 5.7 log10 IU × 103/L or less (JAMA 2004;292:2839-48).

Dr. Carrat and some of the other investigators reported receiving research grants or travel grants from and/or serving as a consultant to Schering-Plough, which markets Peg-Intron, Intron A, and Rebetol.

Fat and Fiber in Risk for GERD

A diet high in fat may be associated with an increased risk of gastroesophageal reflux disease and erosive esophagitis, reported Hashem B. El-Serag, M.D., of the Houston Veterans Affairs Medical Center, and his colleagues (Gut 2005;54:11-7).

A total of 371 employees from the Houston VA Medical Center fully answered questions to a cross-sectional survey. A high fat intake was associated significantly with GERD symptoms in overweight individuals, although it was not associated with an increased risk of esophageal erosions. Fiber intake was inversely associated with the risk of GERD symptoms after adjustment for body mass index, total energy intake, and demographic variables. The researchers cautioned that body mass index might have had modifying effects on the associations between fat and fiber intake and GERD symptoms. Avoidance or increased intake of certain foods as well as the level of physical activity might have affeccted the development of GERD in the survey respondents.

Mexican Genetic Link to Gallstones

Mexicans with gallstone disease appear to have a genetic predisposition to develop the condition, according to the results of a prospective, case-control study.

A significantly higher percentage of 146 patients with gallstone disease (GD) had a family history of the disease (48%), compared with 28% of 955 control patients without the disease, said Nahum Méndez-Sánchez, M.D., and colleagues at the Medica Sur Clinic and Foundation, Mexico City (Am. J. Gastroenterol. 2004;99:2166-70).

Patients with a history of GD were significantly more likely to have the HLA antigen allele B39 than were control patients (16% vs. 6%). Control patients were significantly younger on average than the GD patients (45 years vs. 54 years) and had a significantly lower average body mass index (26.4 kg/m2 vs. 27.4 kg/m2).

ORLANDO, FLA. — Colonoscopy may be the preferred method of screening for colorectal cancer in women because many of their cancers occur in the right colon, Philip S. Schoenfeld, M.D., reported at the annual meeting of the American College of Gastroenterology.

That conclusion differs from some researchers' suggestion that low-risk women aged 50-59 years who screen negative via flexible sigmoidoscopy might not need colonoscopy because they are at low risk for colorectal cancer (CRC). These researchers have suggested that performing colonoscopies in such women might be stretching the limited endoscopic resources too thin.

The problem is that flexible sigmoidoscopy may find only about one-third of the women who have advanced neoplasia on colonoscopy, said Dr. Schoenfeld of the University of Michigan, Ann Arbor.

He reached that conclusion when he saw the results of the Colorectal Neoplasia Screening With Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Centers (CONCeRN) trial. Dr. Schoenfeld was the primary investigator in the study, which included asymptomatic women between 50 and 79 years of age referred for CRC screening and asymptomatic women 40-79 years of age with positive family history of CRC who had undergone colonoscopies at Naval medical centers.

The study excluded women who had undergone flexible sigmoidoscopy in the previous 5 years or colonoscopy or barium enema in the last 10 years or who had a history of a positive fecal occult blood test (FOBT), adenomas, iron-deficiency anemia, polyposis syndrome, inflammatory bowel disease, or hematochezia, or weight loss in the last 6 months.

Of 1,463 women who had a colonoscopy completed to the cecum, 4·9% had advanced neoplasia, including adenomas larger than 10 mm, adenomas with high-grade dysplasia, villose adenomas, or CRC. The incidence of advanced neoplasia increased with age: 3·8% in 50- to 59-year-olds, 4·9% in 60- to 69-year-olds, and 7·6% in 70- to 79-year-olds.

The investigators compared the women in the CONCeRN trial with asymptomatic men referred for CRC screening via colonoscopy from Veterans Affairs Cooperative Study 380 (N. Engl. J. Med. 2000;343:162-8). About 10% of men from that study had advanced neoplasia.

Dr. Schoenfeld and his associates estimated the diagnostic yield of flexible sigmoidoscopy by examining the proportion of patients with advanced neoplasia in the left (distal) colon. Patients also were included in the diagnostic yield of flexible sigmoidoscopy if they had small adenomas in the distal colon—which normally necessitate a colonoscopy—and then were found to have advanced neoplasia in the proximal (right) colon.

When men and women from the two trials were matched for age, negative FOBT status, and negative family history of CRC, advanced neoplasia was found in significantly more men aged 50-59 years (4·7%) and 60-69 years (10·6%) than in women aged 50-59 years (2·9%) and 60-69 years (5%). But in women, advanced neoplasia occurred significantly more often in the right than in the left colon. Flexible sigmoidoscopy would have had an estimated diagnostic yield of only 35% in these women. This is significantly less than the estimated diagnostic yield of 66% obtained by flexible sigmoidoscopy in men in the Veterans Affairs study.

If flexible sigmoidoscopy had been performed in all the women in the CONCeRN trial, advanced neoplasia would have been found in only 1·7%, and 3·2% with advanced neoplasia would have been missed, he said.

Flexible sigmoidoscopy would have missed more cases of advanced neoplasia in women than in men, despite its increased prevalence in men, because of its left-sided distribution in men, Dr. Schoenfeld added.

ORLANDO, FLA. — Colonoscopy may be the preferred method of screening for colorectal cancer in women because many of their cancers occur in the right colon, Philip S. Schoenfeld, M.D., reported at the annual meeting of the American College of Gastroenterology.

That conclusion differs from some researchers' suggestion that low-risk women aged 50-59 years who screen negative via flexible sigmoidoscopy might not need colonoscopy because they are at low risk for colorectal cancer (CRC). These researchers have suggested that performing colonoscopies in such women might be stretching the limited endoscopic resources too thin.

The problem is that flexible sigmoidoscopy may find only about one-third of the women who have advanced neoplasia on colonoscopy, said Dr. Schoenfeld of the University of Michigan, Ann Arbor.

He reached that conclusion when he saw the results of the Colorectal Neoplasia Screening With Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Centers (CONCeRN) trial. Dr. Schoenfeld was the primary investigator in the study, which included asymptomatic women between 50 and 79 years of age referred for CRC screening and asymptomatic women 40-79 years of age with positive family history of CRC who had undergone colonoscopies at Naval medical centers.

The study excluded women who had undergone flexible sigmoidoscopy in the previous 5 years or colonoscopy or barium enema in the last 10 years or who had a history of a positive fecal occult blood test (FOBT), adenomas, iron-deficiency anemia, polyposis syndrome, inflammatory bowel disease, or hematochezia, or weight loss in the last 6 months.

Of 1,463 women who had a colonoscopy completed to the cecum, 4·9% had advanced neoplasia, including adenomas larger than 10 mm, adenomas with high-grade dysplasia, villose adenomas, or CRC. The incidence of advanced neoplasia increased with age: 3·8% in 50- to 59-year-olds, 4·9% in 60- to 69-year-olds, and 7·6% in 70- to 79-year-olds.

The investigators compared the women in the CONCeRN trial with asymptomatic men referred for CRC screening via colonoscopy from Veterans Affairs Cooperative Study 380 (N. Engl. J. Med. 2000;343:162-8). About 10% of men from that study had advanced neoplasia.

Dr. Schoenfeld and his associates estimated the diagnostic yield of flexible sigmoidoscopy by examining the proportion of patients with advanced neoplasia in the left (distal) colon. Patients also were included in the diagnostic yield of flexible sigmoidoscopy if they had small adenomas in the distal colon—which normally necessitate a colonoscopy—and then were found to have advanced neoplasia in the proximal (right) colon.

When men and women from the two trials were matched for age, negative FOBT status, and negative family history of CRC, advanced neoplasia was found in significantly more men aged 50-59 years (4·7%) and 60-69 years (10·6%) than in women aged 50-59 years (2·9%) and 60-69 years (5%). But in women, advanced neoplasia occurred significantly more often in the right than in the left colon. Flexible sigmoidoscopy would have had an estimated diagnostic yield of only 35% in these women. This is significantly less than the estimated diagnostic yield of 66% obtained by flexible sigmoidoscopy in men in the Veterans Affairs study.

If flexible sigmoidoscopy had been performed in all the women in the CONCeRN trial, advanced neoplasia would have been found in only 1·7%, and 3·2% with advanced neoplasia would have been missed, he said.

Flexible sigmoidoscopy would have missed more cases of advanced neoplasia in women than in men, despite its increased prevalence in men, because of its left-sided distribution in men, Dr. Schoenfeld added.

ORLANDO, FLA. — Colonoscopy may be the preferred method of screening for colorectal cancer in women because many of their cancers occur in the right colon, Philip S. Schoenfeld, M.D., reported at the annual meeting of the American College of Gastroenterology.

That conclusion differs from some researchers' suggestion that low-risk women aged 50-59 years who screen negative via flexible sigmoidoscopy might not need colonoscopy because they are at low risk for colorectal cancer (CRC). These researchers have suggested that performing colonoscopies in such women might be stretching the limited endoscopic resources too thin.

The problem is that flexible sigmoidoscopy may find only about one-third of the women who have advanced neoplasia on colonoscopy, said Dr. Schoenfeld of the University of Michigan, Ann Arbor.

He reached that conclusion when he saw the results of the Colorectal Neoplasia Screening With Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Centers (CONCeRN) trial. Dr. Schoenfeld was the primary investigator in the study, which included asymptomatic women between 50 and 79 years of age referred for CRC screening and asymptomatic women 40-79 years of age with positive family history of CRC who had undergone colonoscopies at Naval medical centers.

The study excluded women who had undergone flexible sigmoidoscopy in the previous 5 years or colonoscopy or barium enema in the last 10 years or who had a history of a positive fecal occult blood test (FOBT), adenomas, iron-deficiency anemia, polyposis syndrome, inflammatory bowel disease, or hematochezia, or weight loss in the last 6 months.

Of 1,463 women who had a colonoscopy completed to the cecum, 4·9% had advanced neoplasia, including adenomas larger than 10 mm, adenomas with high-grade dysplasia, villose adenomas, or CRC. The incidence of advanced neoplasia increased with age: 3·8% in 50- to 59-year-olds, 4·9% in 60- to 69-year-olds, and 7·6% in 70- to 79-year-olds.

The investigators compared the women in the CONCeRN trial with asymptomatic men referred for CRC screening via colonoscopy from Veterans Affairs Cooperative Study 380 (N. Engl. J. Med. 2000;343:162-8). About 10% of men from that study had advanced neoplasia.

Dr. Schoenfeld and his associates estimated the diagnostic yield of flexible sigmoidoscopy by examining the proportion of patients with advanced neoplasia in the left (distal) colon. Patients also were included in the diagnostic yield of flexible sigmoidoscopy if they had small adenomas in the distal colon—which normally necessitate a colonoscopy—and then were found to have advanced neoplasia in the proximal (right) colon.

When men and women from the two trials were matched for age, negative FOBT status, and negative family history of CRC, advanced neoplasia was found in significantly more men aged 50-59 years (4·7%) and 60-69 years (10·6%) than in women aged 50-59 years (2·9%) and 60-69 years (5%). But in women, advanced neoplasia occurred significantly more often in the right than in the left colon. Flexible sigmoidoscopy would have had an estimated diagnostic yield of only 35% in these women. This is significantly less than the estimated diagnostic yield of 66% obtained by flexible sigmoidoscopy in men in the Veterans Affairs study.

If flexible sigmoidoscopy had been performed in all the women in the CONCeRN trial, advanced neoplasia would have been found in only 1·7%, and 3·2% with advanced neoplasia would have been missed, he said.

Flexible sigmoidoscopy would have missed more cases of advanced neoplasia in women than in men, despite its increased prevalence in men, because of its left-sided distribution in men, Dr. Schoenfeld added.