Jeff Evans

Users of echinacea supplements in clinical trials reduced their odds of developing the common cold by more than half, according to findings from a meta-analysis of 14 published, randomized, placebo-controlled trials.

When patients in the trials caught a cold, those who used echinacea supplements also cut a mean of 1.4 days from the duration of their illness, compared with patients who received a placebo.

The trials involved preparations of the three most common Echinacea species (E. purpurea, E. augustifolia, and E. pallida) either alone or in combination with other supplements.

Although agencies such as the World Health Organization, the Canadian Natural Health Products Directorate, and the German Federal Institute for Drugs and Medical Devices Commission E have supported the use of echinacea for the common cold, “there is controversy about the efficacy of echinacea for the prevention or treatment of the common cold with some studies showing benefit and others showing a null effect,” wrote lead investigator Sachin A. Shah, Pharm.D., of the University of Connecticut School of Pharmacy, Storrs, and associates (Lancet Infect. Dis. 2007;7:473–80).

The meta-analysis, which encompassed 1,356 patients in tests of echinacea's effect on the incidence of the common cold and 1,630 patients in determining its effect on the duration of colds, showed that echinacea users had significantly lower odds of contracting a cold (58% lower) than did placebo-treated patients.

Nine trials evaluated the effect of echinacea on the incidence of colds, while seven tested its effect on reducing the duration of colds (two trials examined both end points).

Prophylactic use of echinacea reduced the incidence of naturally occurring colds by 65%, compared with placebo.

Echinacea dropped the incidence of colds by only 35% when investigators directly inoculated participants with rhinovirus, which suggests that echinacea has a modest effect on rhinovirus but marked effects against some of the 200 other viruses that are capable of causing the common cold, the researchers wrote.

Echinacea's effects on the incidence and duration of colds were maintained regardless of whether patients contracted colds naturally or were inoculated with viruses. All of the trials pointed toward a positive effect of echinacea in reducing the odds of developing a cold, but the magnitude of this effect varied.

The investigators could not rule out the presence of publication bias, but a statistical analysis suggested that any such potential bias was not significant.

In four trials in which participants were allowed to use echinacea with other supplements, such as vitamin C, the combination significantly shortened the duration of colds.

But findings from three other trials that evaluated the effect of echinacea alone did not show any significant influence on the duration of colds.

Dr. Shah and colleagues suggested that this outcome does not mean that echinacea alone has no effect on the duration of colds because this subgroup analysis may have been “underpowered,” and comparisons to the results obtained in the overall analysis indicate that “the benefit is caused by echinacea rather than the other supplements.”

More than 800 products containing echinacea are available in a variety of forms; these may contain different parts of the plant and may contain differing levels of the molecules that are thought to underlie the proposed immunostimulatory effects of the plant, such as polysaccharides, alkamides, and chicoric acid.

The meta-analysis did not focus on the safety of echinacea, which is an inhibitor of the human cytochrome P450 3A4 enzyme; the enzyme processes many drugs and metabolites.

The researchers reported no conflicts of interest with any echinacea products.

Users of echinacea supplements in clinical trials reduced their odds of developing the common cold by more than half, according to findings from a meta-analysis of 14 published, randomized, placebo-controlled trials.

When patients in the trials caught a cold, those who used echinacea supplements also cut a mean of 1.4 days from the duration of their illness, compared with patients who received a placebo.

The trials involved preparations of the three most common Echinacea species (E. purpurea, E. augustifolia, and E. pallida) either alone or in combination with other supplements.

Although agencies such as the World Health Organization, the Canadian Natural Health Products Directorate, and the German Federal Institute for Drugs and Medical Devices Commission E have supported the use of echinacea for the common cold, “there is controversy about the efficacy of echinacea for the prevention or treatment of the common cold with some studies showing benefit and others showing a null effect,” wrote lead investigator Sachin A. Shah, Pharm.D., of the University of Connecticut School of Pharmacy, Storrs, and associates (Lancet Infect. Dis. 2007;7:473–80).

The meta-analysis, which encompassed 1,356 patients in tests of echinacea's effect on the incidence of the common cold and 1,630 patients in determining its effect on the duration of colds, showed that echinacea users had significantly lower odds of contracting a cold (58% lower) than did placebo-treated patients.

Nine trials evaluated the effect of echinacea on the incidence of colds, while seven tested its effect on reducing the duration of colds (two trials examined both end points).

Prophylactic use of echinacea reduced the incidence of naturally occurring colds by 65%, compared with placebo.

Echinacea dropped the incidence of colds by only 35% when investigators directly inoculated participants with rhinovirus, which suggests that echinacea has a modest effect on rhinovirus but marked effects against some of the 200 other viruses that are capable of causing the common cold, the researchers wrote.

Echinacea's effects on the incidence and duration of colds were maintained regardless of whether patients contracted colds naturally or were inoculated with viruses. All of the trials pointed toward a positive effect of echinacea in reducing the odds of developing a cold, but the magnitude of this effect varied.

The investigators could not rule out the presence of publication bias, but a statistical analysis suggested that any such potential bias was not significant.

In four trials in which participants were allowed to use echinacea with other supplements, such as vitamin C, the combination significantly shortened the duration of colds.

But findings from three other trials that evaluated the effect of echinacea alone did not show any significant influence on the duration of colds.

Dr. Shah and colleagues suggested that this outcome does not mean that echinacea alone has no effect on the duration of colds because this subgroup analysis may have been “underpowered,” and comparisons to the results obtained in the overall analysis indicate that “the benefit is caused by echinacea rather than the other supplements.”

More than 800 products containing echinacea are available in a variety of forms; these may contain different parts of the plant and may contain differing levels of the molecules that are thought to underlie the proposed immunostimulatory effects of the plant, such as polysaccharides, alkamides, and chicoric acid.

The meta-analysis did not focus on the safety of echinacea, which is an inhibitor of the human cytochrome P450 3A4 enzyme; the enzyme processes many drugs and metabolites.

The researchers reported no conflicts of interest with any echinacea products.

Users of echinacea supplements in clinical trials reduced their odds of developing the common cold by more than half, according to findings from a meta-analysis of 14 published, randomized, placebo-controlled trials.

When patients in the trials caught a cold, those who used echinacea supplements also cut a mean of 1.4 days from the duration of their illness, compared with patients who received a placebo.

The trials involved preparations of the three most common Echinacea species (E. purpurea, E. augustifolia, and E. pallida) either alone or in combination with other supplements.

Although agencies such as the World Health Organization, the Canadian Natural Health Products Directorate, and the German Federal Institute for Drugs and Medical Devices Commission E have supported the use of echinacea for the common cold, “there is controversy about the efficacy of echinacea for the prevention or treatment of the common cold with some studies showing benefit and others showing a null effect,” wrote lead investigator Sachin A. Shah, Pharm.D., of the University of Connecticut School of Pharmacy, Storrs, and associates (Lancet Infect. Dis. 2007;7:473–80).

The meta-analysis, which encompassed 1,356 patients in tests of echinacea's effect on the incidence of the common cold and 1,630 patients in determining its effect on the duration of colds, showed that echinacea users had significantly lower odds of contracting a cold (58% lower) than did placebo-treated patients.

Nine trials evaluated the effect of echinacea on the incidence of colds, while seven tested its effect on reducing the duration of colds (two trials examined both end points).

Prophylactic use of echinacea reduced the incidence of naturally occurring colds by 65%, compared with placebo.

Echinacea dropped the incidence of colds by only 35% when investigators directly inoculated participants with rhinovirus, which suggests that echinacea has a modest effect on rhinovirus but marked effects against some of the 200 other viruses that are capable of causing the common cold, the researchers wrote.

Echinacea's effects on the incidence and duration of colds were maintained regardless of whether patients contracted colds naturally or were inoculated with viruses. All of the trials pointed toward a positive effect of echinacea in reducing the odds of developing a cold, but the magnitude of this effect varied.

The investigators could not rule out the presence of publication bias, but a statistical analysis suggested that any such potential bias was not significant.

In four trials in which participants were allowed to use echinacea with other supplements, such as vitamin C, the combination significantly shortened the duration of colds.

But findings from three other trials that evaluated the effect of echinacea alone did not show any significant influence on the duration of colds.

Dr. Shah and colleagues suggested that this outcome does not mean that echinacea alone has no effect on the duration of colds because this subgroup analysis may have been “underpowered,” and comparisons to the results obtained in the overall analysis indicate that “the benefit is caused by echinacea rather than the other supplements.”

More than 800 products containing echinacea are available in a variety of forms; these may contain different parts of the plant and may contain differing levels of the molecules that are thought to underlie the proposed immunostimulatory effects of the plant, such as polysaccharides, alkamides, and chicoric acid.

The meta-analysis did not focus on the safety of echinacea, which is an inhibitor of the human cytochrome P450 3A4 enzyme; the enzyme processes many drugs and metabolites.

The researchers reported no conflicts of interest with any echinacea products.

Users of echinacea supplements in clinical trials reduced their odds of developing the common cold by more than half, according to findings from a meta-analysis of 14 published, randomized, placebo-controlled trials.

When patients in the trials caught a cold, those who used echinacea supplements also cut a mean of 1.4 days from the duration of their illness, compared with patients who received a placebo.

The trials involved preparations of the three most common Echinacea species (E. purpurea, E. augustifolia, and E. pallida) either alone or in combination with other supplements.

Although agencies such as the World Health Organization, the Canadian Natural Health Products Directorate, and the German Federal Institute for Drugs and Medical Devices Commission E have supported the use of echinacea for the common cold, "there is controversy about the efficacy of echinacea for the prevention or treatment of the common cold with some studies showing benefit and others showing a null effect," wrote lead investigator Sachin A. Shah, Pharm.D., of the University of Connecticut School of Pharmacy, Storrs, and associates (Lancet Infect. Dis. 2007;7:473-80).

The meta-analysis, which encompassed 1,356 patients in tests of echinacea's effect on the incidence of the common cold and 1,630 patients in determining its effect on the duration of colds, showed that echinacea users had a significantly lower odds of contracting a cold (58% lower) than did placebo-treated patients.

Nine trials evaluated the effect of echinacea on the incidence of colds, while seven tested its effect on reducing the duration of colds (two trials examined both end points).

Prophylactic use of echinacea reduced the incidence of naturally occurring colds by 65%, compared with placebo.

Echinacea dropped the incidence of colds by only 35% when investigators directly inoculated participants with rhinovirus, which suggests that echinacea has a modest effect on rhinovirus but marked effects against some of the 200 other viruses that are capable of causing the common cold, Dr. Shah and associates wrote.

Echinacea's effects on the incidence and duration of colds were maintained regardless of whether patients contracted colds naturally or were inoculated with viruses.

All of the trials pointed toward a positive effect of echinacea in reducing the odds of developing a cold, but the magnitude of this effect varied. The investigators could not rule out the presence of publication bias, but a statistical analysis suggested that any such potential bias was not significant.

In four trials in which participants were allowed to use echinacea with other supplements, such as vitamin C, the combination significantly shortened the duration of colds. But three other trials that evaluated the effect of echinacea alone did not show any significant influence on the duration of colds.

Dr. Shah and colleagues suggested that this outcome does not mean that echinacea alone has no effect on the duration of colds because this subgroup analysis may have been "underpowered," and comparisons to the results obtained in the overall analysis indicate that "the benefit is caused by echinacea rather than the other supplements."

More than 800 products containing echinacea are available in a variety of forms; these may contain different parts of the plant and may contain differing levels of the molecules that are thought to underlie the proposed immunostimulatory effects of the plant, such as polysaccharides, alkamides, and chicoric acid.

The meta-analysis did not focus on the safety of echinacea, which is an inhibitor of the human cytochrome P450 3A4 enzyme; the enzyme processes many drugs and metabolites.

The investigators reported no conflicts of interest with any echinacea products.

Users of echinacea supplements in clinical trials reduced their odds of developing the common cold by more than half, according to findings from a meta-analysis of 14 published, randomized, placebo-controlled trials.

When patients in the trials caught a cold, those who used echinacea supplements also cut a mean of 1.4 days from the duration of their illness, compared with patients who received a placebo.

The trials involved preparations of the three most common Echinacea species (E. purpurea, E. augustifolia, and E. pallida) either alone or in combination with other supplements.

Although agencies such as the World Health Organization, the Canadian Natural Health Products Directorate, and the German Federal Institute for Drugs and Medical Devices Commission E have supported the use of echinacea for the common cold, "there is controversy about the efficacy of echinacea for the prevention or treatment of the common cold with some studies showing benefit and others showing a null effect," wrote lead investigator Sachin A. Shah, Pharm.D., of the University of Connecticut School of Pharmacy, Storrs, and associates (Lancet Infect. Dis. 2007;7:473-80).

The meta-analysis, which encompassed 1,356 patients in tests of echinacea's effect on the incidence of the common cold and 1,630 patients in determining its effect on the duration of colds, showed that echinacea users had a significantly lower odds of contracting a cold (58% lower) than did placebo-treated patients.

Nine trials evaluated the effect of echinacea on the incidence of colds, while seven tested its effect on reducing the duration of colds (two trials examined both end points).

Prophylactic use of echinacea reduced the incidence of naturally occurring colds by 65%, compared with placebo.

Echinacea dropped the incidence of colds by only 35% when investigators directly inoculated participants with rhinovirus, which suggests that echinacea has a modest effect on rhinovirus but marked effects against some of the 200 other viruses that are capable of causing the common cold, Dr. Shah and associates wrote.

Echinacea's effects on the incidence and duration of colds were maintained regardless of whether patients contracted colds naturally or were inoculated with viruses.

All of the trials pointed toward a positive effect of echinacea in reducing the odds of developing a cold, but the magnitude of this effect varied. The investigators could not rule out the presence of publication bias, but a statistical analysis suggested that any such potential bias was not significant.

In four trials in which participants were allowed to use echinacea with other supplements, such as vitamin C, the combination significantly shortened the duration of colds. But three other trials that evaluated the effect of echinacea alone did not show any significant influence on the duration of colds.

Dr. Shah and colleagues suggested that this outcome does not mean that echinacea alone has no effect on the duration of colds because this subgroup analysis may have been "underpowered," and comparisons to the results obtained in the overall analysis indicate that "the benefit is caused by echinacea rather than the other supplements."

More than 800 products containing echinacea are available in a variety of forms; these may contain different parts of the plant and may contain differing levels of the molecules that are thought to underlie the proposed immunostimulatory effects of the plant, such as polysaccharides, alkamides, and chicoric acid.

The meta-analysis did not focus on the safety of echinacea, which is an inhibitor of the human cytochrome P450 3A4 enzyme; the enzyme processes many drugs and metabolites.

The investigators reported no conflicts of interest with any echinacea products.

Users of echinacea supplements in clinical trials reduced their odds of developing the common cold by more than half, according to findings from a meta-analysis of 14 published, randomized, placebo-controlled trials.

When patients in the trials caught a cold, those who used echinacea supplements also cut a mean of 1.4 days from the duration of their illness, compared with patients who received a placebo.

The trials involved preparations of the three most common Echinacea species (E. purpurea, E. augustifolia, and E. pallida) either alone or in combination with other supplements.

Although agencies such as the World Health Organization, the Canadian Natural Health Products Directorate, and the German Federal Institute for Drugs and Medical Devices Commission E have supported the use of echinacea for the common cold, "there is controversy about the efficacy of echinacea for the prevention or treatment of the common cold with some studies showing benefit and others showing a null effect," wrote lead investigator Sachin A. Shah, Pharm.D., of the University of Connecticut School of Pharmacy, Storrs, and associates (Lancet Infect. Dis. 2007;7:473-80).

The meta-analysis, which encompassed 1,356 patients in tests of echinacea's effect on the incidence of the common cold and 1,630 patients in determining its effect on the duration of colds, showed that echinacea users had a significantly lower odds of contracting a cold (58% lower) than did placebo-treated patients.

Nine trials evaluated the effect of echinacea on the incidence of colds, while seven tested its effect on reducing the duration of colds (two trials examined both end points).

Prophylactic use of echinacea reduced the incidence of naturally occurring colds by 65%, compared with placebo.

Echinacea dropped the incidence of colds by only 35% when investigators directly inoculated participants with rhinovirus, which suggests that echinacea has a modest effect on rhinovirus but marked effects against some of the 200 other viruses that are capable of causing the common cold, Dr. Shah and associates wrote.

Echinacea's effects on the incidence and duration of colds were maintained regardless of whether patients contracted colds naturally or were inoculated with viruses.

All of the trials pointed toward a positive effect of echinacea in reducing the odds of developing a cold, but the magnitude of this effect varied. The investigators could not rule out the presence of publication bias, but a statistical analysis suggested that any such potential bias was not significant.

In four trials in which participants were allowed to use echinacea with other supplements, such as vitamin C, the combination significantly shortened the duration of colds. But three other trials that evaluated the effect of echinacea alone did not show any significant influence on the duration of colds.

Dr. Shah and colleagues suggested that this outcome does not mean that echinacea alone has no effect on the duration of colds because this subgroup analysis may have been "underpowered," and comparisons to the results obtained in the overall analysis indicate that "the benefit is caused by echinacea rather than the other supplements."

More than 800 products containing echinacea are available in a variety of forms; these may contain different parts of the plant and may contain differing levels of the molecules that are thought to underlie the proposed immunostimulatory effects of the plant, such as polysaccharides, alkamides, and chicoric acid.

The meta-analysis did not focus on the safety of echinacea, which is an inhibitor of the human cytochrome P450 3A4 enzyme; the enzyme processes many drugs and metabolites.

The investigators reported no conflicts of interest with any echinacea products.

WASHINGTON — Newer radiation therapy methods for treating esophageal cancer may be inducing myocardial perfusion defects that can kill patients before the cancer does, Dr. Isis Gayed said at the annual meeting of the Society of Nuclear Medicine.

Although older radiation therapy (RT) techniques for esophageal cancer are known to induce heart disease and coronary artery disease, it is unknown whether 3-D conformal, intensity-modulated, or proton techniques spare the heart or also carry a risk of radiation-induced myocardial perfusion defects.

In a review of 13 esophageal cancer patients, Dr. Gayed and her colleagues found that cardiac complications developed in 5 patients after RT. Two of those five died as a result of myocardial perfusion abnormalities, not from cancer.

Data from previous studies have suggested that myocardial perfusion abnormalities that developed in esophageal cancer patients who underwent RT are inconsequential because the patient will die of cancer before dying or suffering from heart disease, said Dr. Gayed of the department of nuclear medicine at the University of Texas M.D. Anderson Cancer Center, Houston.

She and her associates previously published a review that found a significantly higher rate of defects in esophageal cancer patients who received RT, compared with those who did not (54% vs. 16%, respectively) (J. Nucl. Med. 2006;47:1756–62).

In the current study, all 13 patients had normal myocardial perfusion studies at baseline, except for 1 patient with a fixed septal defect and a left bundle branch block. The radiation techniques included 3-D conformal RT in six patients, intensity-modulated RT in six patients, and one with an unspecified RT type.

Three patients developed new inferior wall ischemia on myocardial perfusion imaging (MPI) after treatment with 3-D conformal RT.

Two of these three patients later died: one from bradycardia and an atrioventricular block and another from nonmalignant pericardial and pleural effusion. The other patient with inferior wall ischemia complained of chest pain upon returning to work.

WASHINGTON — Newer radiation therapy methods for treating esophageal cancer may be inducing myocardial perfusion defects that can kill patients before the cancer does, Dr. Isis Gayed said at the annual meeting of the Society of Nuclear Medicine.

Although older radiation therapy (RT) techniques for esophageal cancer are known to induce heart disease and coronary artery disease, it is unknown whether 3-D conformal, intensity-modulated, or proton techniques spare the heart or also carry a risk of radiation-induced myocardial perfusion defects.

In a review of 13 esophageal cancer patients, Dr. Gayed and her colleagues found that cardiac complications developed in 5 patients after RT. Two of those five died as a result of myocardial perfusion abnormalities, not from cancer.

Data from previous studies have suggested that myocardial perfusion abnormalities that developed in esophageal cancer patients who underwent RT are inconsequential because the patient will die of cancer before dying or suffering from heart disease, said Dr. Gayed of the department of nuclear medicine at the University of Texas M.D. Anderson Cancer Center, Houston.

She and her associates previously published a review that found a significantly higher rate of defects in esophageal cancer patients who received RT, compared with those who did not (54% vs. 16%, respectively) (J. Nucl. Med. 2006;47:1756–62).

In the current study, all 13 patients had normal myocardial perfusion studies at baseline, except for 1 patient with a fixed septal defect and a left bundle branch block. The radiation techniques included 3-D conformal RT in six patients, intensity-modulated RT in six patients, and one with an unspecified RT type.

Three patients developed new inferior wall ischemia on myocardial perfusion imaging (MPI) after treatment with 3-D conformal RT.

Two of these three patients later died: one from bradycardia and an atrioventricular block and another from nonmalignant pericardial and pleural effusion. The other patient with inferior wall ischemia complained of chest pain upon returning to work.

WASHINGTON — Newer radiation therapy methods for treating esophageal cancer may be inducing myocardial perfusion defects that can kill patients before the cancer does, Dr. Isis Gayed said at the annual meeting of the Society of Nuclear Medicine.

Although older radiation therapy (RT) techniques for esophageal cancer are known to induce heart disease and coronary artery disease, it is unknown whether 3-D conformal, intensity-modulated, or proton techniques spare the heart or also carry a risk of radiation-induced myocardial perfusion defects.

In a review of 13 esophageal cancer patients, Dr. Gayed and her colleagues found that cardiac complications developed in 5 patients after RT. Two of those five died as a result of myocardial perfusion abnormalities, not from cancer.

Data from previous studies have suggested that myocardial perfusion abnormalities that developed in esophageal cancer patients who underwent RT are inconsequential because the patient will die of cancer before dying or suffering from heart disease, said Dr. Gayed of the department of nuclear medicine at the University of Texas M.D. Anderson Cancer Center, Houston.

She and her associates previously published a review that found a significantly higher rate of defects in esophageal cancer patients who received RT, compared with those who did not (54% vs. 16%, respectively) (J. Nucl. Med. 2006;47:1756–62).

In the current study, all 13 patients had normal myocardial perfusion studies at baseline, except for 1 patient with a fixed septal defect and a left bundle branch block. The radiation techniques included 3-D conformal RT in six patients, intensity-modulated RT in six patients, and one with an unspecified RT type.

Three patients developed new inferior wall ischemia on myocardial perfusion imaging (MPI) after treatment with 3-D conformal RT.

Two of these three patients later died: one from bradycardia and an atrioventricular block and another from nonmalignant pericardial and pleural effusion. The other patient with inferior wall ischemia complained of chest pain upon returning to work.

Etanercept appears to maintain its safety through 8 years of continuous use in children with polyarticular-course juvenile rheumatoid arthritis without any incidence of cancers or serious opportunistic infections.

That is the conclusion reached by investigators of a multicenter, randomized, controlled trial that was later extended into an open-label study that specifically examined the long-term safety of the anti-tumor necrosis factor-α drug.

“Etanercept [Enbrel] was the first of the anti-TNF agents tested in children with JRA, and thus we have the longest and most clinical experience with it. This study, although small, was very reassuring,” said Dr. Daniel Lovell of the Cincinnati Children's Hospital Medical Center, in an interview.

It is indicated for reducing the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in those who have had an inadequate response to one or more disease-modifying antirheumatic drugs.

Of 69 patients who were originally randomized into the trial, Dr. Lovell and Dr. Andreas Reiff and their colleagues followed 58 patients into the open-label extension; all the patients had taken at least one dose of etanercept. Dr. Reiff originally presented the follow-up data at the annual European Congress of Rheumatology in Barcelona.

In the original randomized trial, all of the patients initially received etanercept for 3 months. Those who responded to the drug remained in the study and were randomized to either etanercept or placebo. Corticosteroids and anti-inflammatory drugs were allowed during both the randomized trial and the open-label extension, but relatively few patients were allowed to begin taking methotrexate again, said Dr. Reiff, head of the division of rheumatology and rehabilitation at Children's Hospital Los Angeles.

In the ongoing safety study, 42 of the original patients (61%) received at least 4 years of etanercept, and 16 (23%) received at least 8 continuous years of the study drug. They used the recommended dosage on the label of the subcutaneous injection formulation (0.4 mg/kg twice a week).

Overall, 16 patients (23%) reported adverse events. Long-term use did not significantly increase the rate of adverse events. Between years 4 to 8 of the follow-up period, only one severe adverse event (pyelo- nephritis) occurred. No cases of lupus; demyelinating disorders; tuberculosis or other opportunistic infections; or malignancy were reported. No deaths were reported.

Three cases of varicella infection occurred during follow-up, said Dr. Reiff. Although Dr. Lovell said that overall etanercept had a very good safety profile, he expressed caution about an increased risk of varicella in children on etanercept who lack protective antibodies to this virus.

Dr. Lovell suggested all children be tested for varicella antibodies before starting treatment with etanercept and that extra precautions be taken to avoid exposing nonimmune children taking etanercept to others with active varicella disease.

Dr. Reiff serves as an adviser and speaker for Amgen Inc. and Wyeth, which comarket etanercept in North America.

All children should be tested for varicella antibodies before starting treatment with etanercept. DR. LOVELL

Etanercept appears to maintain its safety through 8 years of continuous use in children with polyarticular-course juvenile rheumatoid arthritis without any incidence of cancers or serious opportunistic infections.

That is the conclusion reached by investigators of a multicenter, randomized, controlled trial that was later extended into an open-label study that specifically examined the long-term safety of the anti-tumor necrosis factor-α drug.

“Etanercept [Enbrel] was the first of the anti-TNF agents tested in children with JRA, and thus we have the longest and most clinical experience with it. This study, although small, was very reassuring,” said Dr. Daniel Lovell of the Cincinnati Children's Hospital Medical Center, in an interview.

It is indicated for reducing the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in those who have had an inadequate response to one or more disease-modifying antirheumatic drugs.

Of 69 patients who were originally randomized into the trial, Dr. Lovell and Dr. Andreas Reiff and their colleagues followed 58 patients into the open-label extension; all the patients had taken at least one dose of etanercept. Dr. Reiff originally presented the follow-up data at the annual European Congress of Rheumatology in Barcelona.

In the original randomized trial, all of the patients initially received etanercept for 3 months. Those who responded to the drug remained in the study and were randomized to either etanercept or placebo. Corticosteroids and anti-inflammatory drugs were allowed during both the randomized trial and the open-label extension, but relatively few patients were allowed to begin taking methotrexate again, said Dr. Reiff, head of the division of rheumatology and rehabilitation at Children's Hospital Los Angeles.

In the ongoing safety study, 42 of the original patients (61%) received at least 4 years of etanercept, and 16 (23%) received at least 8 continuous years of the study drug. They used the recommended dosage on the label of the subcutaneous injection formulation (0.4 mg/kg twice a week).

Overall, 16 patients (23%) reported adverse events. Long-term use did not significantly increase the rate of adverse events. Between years 4 to 8 of the follow-up period, only one severe adverse event (pyelo- nephritis) occurred. No cases of lupus; demyelinating disorders; tuberculosis or other opportunistic infections; or malignancy were reported. No deaths were reported.

Three cases of varicella infection occurred during follow-up, said Dr. Reiff. Although Dr. Lovell said that overall etanercept had a very good safety profile, he expressed caution about an increased risk of varicella in children on etanercept who lack protective antibodies to this virus.

Dr. Lovell suggested all children be tested for varicella antibodies before starting treatment with etanercept and that extra precautions be taken to avoid exposing nonimmune children taking etanercept to others with active varicella disease.

Dr. Reiff serves as an adviser and speaker for Amgen Inc. and Wyeth, which comarket etanercept in North America.

All children should be tested for varicella antibodies before starting treatment with etanercept. DR. LOVELL

Etanercept appears to maintain its safety through 8 years of continuous use in children with polyarticular-course juvenile rheumatoid arthritis without any incidence of cancers or serious opportunistic infections.

That is the conclusion reached by investigators of a multicenter, randomized, controlled trial that was later extended into an open-label study that specifically examined the long-term safety of the anti-tumor necrosis factor-α drug.

“Etanercept [Enbrel] was the first of the anti-TNF agents tested in children with JRA, and thus we have the longest and most clinical experience with it. This study, although small, was very reassuring,” said Dr. Daniel Lovell of the Cincinnati Children's Hospital Medical Center, in an interview.

It is indicated for reducing the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in those who have had an inadequate response to one or more disease-modifying antirheumatic drugs.

Of 69 patients who were originally randomized into the trial, Dr. Lovell and Dr. Andreas Reiff and their colleagues followed 58 patients into the open-label extension; all the patients had taken at least one dose of etanercept. Dr. Reiff originally presented the follow-up data at the annual European Congress of Rheumatology in Barcelona.

In the original randomized trial, all of the patients initially received etanercept for 3 months. Those who responded to the drug remained in the study and were randomized to either etanercept or placebo. Corticosteroids and anti-inflammatory drugs were allowed during both the randomized trial and the open-label extension, but relatively few patients were allowed to begin taking methotrexate again, said Dr. Reiff, head of the division of rheumatology and rehabilitation at Children's Hospital Los Angeles.

In the ongoing safety study, 42 of the original patients (61%) received at least 4 years of etanercept, and 16 (23%) received at least 8 continuous years of the study drug. They used the recommended dosage on the label of the subcutaneous injection formulation (0.4 mg/kg twice a week).

Overall, 16 patients (23%) reported adverse events. Long-term use did not significantly increase the rate of adverse events. Between years 4 to 8 of the follow-up period, only one severe adverse event (pyelo- nephritis) occurred. No cases of lupus; demyelinating disorders; tuberculosis or other opportunistic infections; or malignancy were reported. No deaths were reported.

Three cases of varicella infection occurred during follow-up, said Dr. Reiff. Although Dr. Lovell said that overall etanercept had a very good safety profile, he expressed caution about an increased risk of varicella in children on etanercept who lack protective antibodies to this virus.

Dr. Lovell suggested all children be tested for varicella antibodies before starting treatment with etanercept and that extra precautions be taken to avoid exposing nonimmune children taking etanercept to others with active varicella disease.

Dr. Reiff serves as an adviser and speaker for Amgen Inc. and Wyeth, which comarket etanercept in North America.

All children should be tested for varicella antibodies before starting treatment with etanercept. DR. LOVELL

BARCELONA — Genetic testing eventually may enable diagnosis of systemic-onset juvenile idiopathic arthritis before the onset of joint involvement, according to growing evidence from DNA microarrays and clinical studies.

Specifically, the testing looks for a particular gene expression profile of the disease. Such tests also have revealed pathways to explore for the prevention of arthritis or the inducement of remission, Dr. Virginia Pascual said at the annual European Congress of Rheumatology.

“One of the problems with this disease … is that many times, children have systemic symptoms but arthritis comes later, and not until arthritis shows up can we make the diagnosis. As opposed to [patients with] the majority of other forms of juvenile arthritis, these children do not have detectable autoantibodies and only very rarely do they present with uveitis,” said Dr. Pascual, pediatric rheumatologist at the Baylor Institute for Immunology Research, Dallas.

It takes an average of 3 months to make a diagnosis of systemic-onset juvenile idiopathic arthritis (SoJIA) in her clinic.

To get an idea of which genes are being turned on or off abnormally in the active phase of SoJIA, Dr. Pascual and colleagues investigated the gene expression profiles of such patients with oligonucleotide microarray technology. They found serum from patients with SoJIA could induce the expression of interleukin-1β (IL-1β) protein in peripheral blood mononuclear cells (PBMCs) from healthy patients. The expression of IL-1β occurred in a pattern related to disease activity in which patients who had arthritis and already had passed the systemic phase of disease had lower up-regulation of IL-1 protein expression than did those with active systemic symptoms.

The researchers found that inhibition of IL-1 with the IL-1 receptor antagonist anakinra (Kineret) induced complete remission in seven of nine patients with SoJIA, lowered fever in all nine, and lessened arthritis in seven of nine. Abnormal laboratory measurements in the patients (anemia, thrombocytosis, leukocytosis, and elevated erythrocyte sedimentation rate) also were corrected with anakinra treatment (J. Exp. Med. 2005;201:1479–86).

At the congress, Dr. Pascual reported on the treatment of an additional nine SoJIA patients with anakinra. In follow-up ranging from 6 to 36 months, 17 of 18 patients in her clinic have responded to the treatment. The sole nonresponder initially responded to anakinra for 3 months (after not responding in the earlier pilot study) but had a break-through flare; the patient now receives another therapy. A second patient who did not respond to anakinra in the pilot study is now in remission on the drug.

Many of these children could be tested for SoJIA in the hospital when they present with systemic symptoms, so Dr. Pascual and her associates set out to profile which genes are differentially expressed in the blood of patients with SoJIA, compared with healthy patients. These genes could then be whittled down to a more manageable set to use in diagnosing SoJIA. In a comparison of 16 patients with active SoJIA and 16 healthy control patients, the investigators found 874 differentially expressed gene transcripts in SoJIA patients. But when they took the 50 genes that best differentiated the SoJIA patients from the control patients and compared the expression pattern of SoJIA patients with those from children with other inflammatory conditions (influenza, systemic lupus erythematosus, PAPA [pyogenic arthritis, pyoderma gangrenosum, and acne] syndrome, or systemic infection with Staphylococcus aureus, Streptococcus pneumoniae, or Escherichia coli), they were disappointed to see that most of these children also differentially expressed the same genes.

Half of the patients with gram-positive bacterial infections, one-third of patients with gram-negative bacterial infections, and one-third of patients with PAPA syndrome identically expressed the same up- and down-regulated genes, she said.

Still in the hunt for a specific expression signature for SoJIA, Dr. Pascual and her associates then analyzed their microarray data differently by examining 88 genes that are differentially expressed in SoJIA patients compared with healthy control patients, but that are not dysregulated in comparisons between patients with other systemic inflammatory conditions and healthy control patients.

“These 88 genes are very stable over time,” Dr. Pascual noted, giving an example of a SoJIA patient who had two disease flares but still had the same gene expression profile for these genes in two blood samples taken 2 years apart. The researchers then reduced those 88 genes to a set of 12 genes to diagnose SoJIA.

In newly hospitalized patients with a fever of unknown origin, this set of 12 genes correctly identified SoJIA in six of seven patients; the signature was correctly negative in another two patients who had SoJIA ruled out. The 12-gene set also correctly excluded 19 of 20 patients with infectious or other inflammatory diseases. This 12-gene expression signature of SoJIA went away in nearly all patients after treatment with an IL-1 blocker. The expression signature “seems to be linked in a way to the blocking of the IL-1 pathway,” she said.

The 12-gene expression signature proved to be specific to the systemic phase of SoJIA, as it correctly identified 22 of 23 patients in the systemic phase of SoJIA, none of 12 patients who were in the arthritic phase (without systemic symptoms), and none of 12 healthy control patients.

The goal of a SoJIA expression signature is to diagnose patients with SoJIA as soon as they present to the hospital with fever (before they have arthritis) so that they can be treated with IL-1 blockers—and possibly IL-6 blockers—before they develop arthritis, Dr. Pascual said.

“We are going to apply this test now to a new cohort of patients who are going to be enrolled in a new trial with a different modality of IL-1 blockade [an IL-1 drug] in the United States,” Dr. Pascual said.

BARCELONA — Genetic testing eventually may enable diagnosis of systemic-onset juvenile idiopathic arthritis before the onset of joint involvement, according to growing evidence from DNA microarrays and clinical studies.

Specifically, the testing looks for a particular gene expression profile of the disease. Such tests also have revealed pathways to explore for the prevention of arthritis or the inducement of remission, Dr. Virginia Pascual said at the annual European Congress of Rheumatology.

“One of the problems with this disease … is that many times, children have systemic symptoms but arthritis comes later, and not until arthritis shows up can we make the diagnosis. As opposed to [patients with] the majority of other forms of juvenile arthritis, these children do not have detectable autoantibodies and only very rarely do they present with uveitis,” said Dr. Pascual, pediatric rheumatologist at the Baylor Institute for Immunology Research, Dallas.

It takes an average of 3 months to make a diagnosis of systemic-onset juvenile idiopathic arthritis (SoJIA) in her clinic.

To get an idea of which genes are being turned on or off abnormally in the active phase of SoJIA, Dr. Pascual and colleagues investigated the gene expression profiles of such patients with oligonucleotide microarray technology. They found serum from patients with SoJIA could induce the expression of interleukin-1β (IL-1β) protein in peripheral blood mononuclear cells (PBMCs) from healthy patients. The expression of IL-1β occurred in a pattern related to disease activity in which patients who had arthritis and already had passed the systemic phase of disease had lower up-regulation of IL-1 protein expression than did those with active systemic symptoms.

The researchers found that inhibition of IL-1 with the IL-1 receptor antagonist anakinra (Kineret) induced complete remission in seven of nine patients with SoJIA, lowered fever in all nine, and lessened arthritis in seven of nine. Abnormal laboratory measurements in the patients (anemia, thrombocytosis, leukocytosis, and elevated erythrocyte sedimentation rate) also were corrected with anakinra treatment (J. Exp. Med. 2005;201:1479–86).

At the congress, Dr. Pascual reported on the treatment of an additional nine SoJIA patients with anakinra. In follow-up ranging from 6 to 36 months, 17 of 18 patients in her clinic have responded to the treatment. The sole nonresponder initially responded to anakinra for 3 months (after not responding in the earlier pilot study) but had a break-through flare; the patient now receives another therapy. A second patient who did not respond to anakinra in the pilot study is now in remission on the drug.

Many of these children could be tested for SoJIA in the hospital when they present with systemic symptoms, so Dr. Pascual and her associates set out to profile which genes are differentially expressed in the blood of patients with SoJIA, compared with healthy patients. These genes could then be whittled down to a more manageable set to use in diagnosing SoJIA. In a comparison of 16 patients with active SoJIA and 16 healthy control patients, the investigators found 874 differentially expressed gene transcripts in SoJIA patients. But when they took the 50 genes that best differentiated the SoJIA patients from the control patients and compared the expression pattern of SoJIA patients with those from children with other inflammatory conditions (influenza, systemic lupus erythematosus, PAPA [pyogenic arthritis, pyoderma gangrenosum, and acne] syndrome, or systemic infection with Staphylococcus aureus, Streptococcus pneumoniae, or Escherichia coli), they were disappointed to see that most of these children also differentially expressed the same genes.

Half of the patients with gram-positive bacterial infections, one-third of patients with gram-negative bacterial infections, and one-third of patients with PAPA syndrome identically expressed the same up- and down-regulated genes, she said.

Still in the hunt for a specific expression signature for SoJIA, Dr. Pascual and her associates then analyzed their microarray data differently by examining 88 genes that are differentially expressed in SoJIA patients compared with healthy control patients, but that are not dysregulated in comparisons between patients with other systemic inflammatory conditions and healthy control patients.

“These 88 genes are very stable over time,” Dr. Pascual noted, giving an example of a SoJIA patient who had two disease flares but still had the same gene expression profile for these genes in two blood samples taken 2 years apart. The researchers then reduced those 88 genes to a set of 12 genes to diagnose SoJIA.

In newly hospitalized patients with a fever of unknown origin, this set of 12 genes correctly identified SoJIA in six of seven patients; the signature was correctly negative in another two patients who had SoJIA ruled out. The 12-gene set also correctly excluded 19 of 20 patients with infectious or other inflammatory diseases. This 12-gene expression signature of SoJIA went away in nearly all patients after treatment with an IL-1 blocker. The expression signature “seems to be linked in a way to the blocking of the IL-1 pathway,” she said.

The 12-gene expression signature proved to be specific to the systemic phase of SoJIA, as it correctly identified 22 of 23 patients in the systemic phase of SoJIA, none of 12 patients who were in the arthritic phase (without systemic symptoms), and none of 12 healthy control patients.

The goal of a SoJIA expression signature is to diagnose patients with SoJIA as soon as they present to the hospital with fever (before they have arthritis) so that they can be treated with IL-1 blockers—and possibly IL-6 blockers—before they develop arthritis, Dr. Pascual said.

“We are going to apply this test now to a new cohort of patients who are going to be enrolled in a new trial with a different modality of IL-1 blockade [an IL-1 drug] in the United States,” Dr. Pascual said.

BARCELONA — Genetic testing eventually may enable diagnosis of systemic-onset juvenile idiopathic arthritis before the onset of joint involvement, according to growing evidence from DNA microarrays and clinical studies.

Specifically, the testing looks for a particular gene expression profile of the disease. Such tests also have revealed pathways to explore for the prevention of arthritis or the inducement of remission, Dr. Virginia Pascual said at the annual European Congress of Rheumatology.

“One of the problems with this disease … is that many times, children have systemic symptoms but arthritis comes later, and not until arthritis shows up can we make the diagnosis. As opposed to [patients with] the majority of other forms of juvenile arthritis, these children do not have detectable autoantibodies and only very rarely do they present with uveitis,” said Dr. Pascual, pediatric rheumatologist at the Baylor Institute for Immunology Research, Dallas.

It takes an average of 3 months to make a diagnosis of systemic-onset juvenile idiopathic arthritis (SoJIA) in her clinic.

To get an idea of which genes are being turned on or off abnormally in the active phase of SoJIA, Dr. Pascual and colleagues investigated the gene expression profiles of such patients with oligonucleotide microarray technology. They found serum from patients with SoJIA could induce the expression of interleukin-1β (IL-1β) protein in peripheral blood mononuclear cells (PBMCs) from healthy patients. The expression of IL-1β occurred in a pattern related to disease activity in which patients who had arthritis and already had passed the systemic phase of disease had lower up-regulation of IL-1 protein expression than did those with active systemic symptoms.

The researchers found that inhibition of IL-1 with the IL-1 receptor antagonist anakinra (Kineret) induced complete remission in seven of nine patients with SoJIA, lowered fever in all nine, and lessened arthritis in seven of nine. Abnormal laboratory measurements in the patients (anemia, thrombocytosis, leukocytosis, and elevated erythrocyte sedimentation rate) also were corrected with anakinra treatment (J. Exp. Med. 2005;201:1479–86).

At the congress, Dr. Pascual reported on the treatment of an additional nine SoJIA patients with anakinra. In follow-up ranging from 6 to 36 months, 17 of 18 patients in her clinic have responded to the treatment. The sole nonresponder initially responded to anakinra for 3 months (after not responding in the earlier pilot study) but had a break-through flare; the patient now receives another therapy. A second patient who did not respond to anakinra in the pilot study is now in remission on the drug.

Many of these children could be tested for SoJIA in the hospital when they present with systemic symptoms, so Dr. Pascual and her associates set out to profile which genes are differentially expressed in the blood of patients with SoJIA, compared with healthy patients. These genes could then be whittled down to a more manageable set to use in diagnosing SoJIA. In a comparison of 16 patients with active SoJIA and 16 healthy control patients, the investigators found 874 differentially expressed gene transcripts in SoJIA patients. But when they took the 50 genes that best differentiated the SoJIA patients from the control patients and compared the expression pattern of SoJIA patients with those from children with other inflammatory conditions (influenza, systemic lupus erythematosus, PAPA [pyogenic arthritis, pyoderma gangrenosum, and acne] syndrome, or systemic infection with Staphylococcus aureus, Streptococcus pneumoniae, or Escherichia coli), they were disappointed to see that most of these children also differentially expressed the same genes.

Half of the patients with gram-positive bacterial infections, one-third of patients with gram-negative bacterial infections, and one-third of patients with PAPA syndrome identically expressed the same up- and down-regulated genes, she said.

Still in the hunt for a specific expression signature for SoJIA, Dr. Pascual and her associates then analyzed their microarray data differently by examining 88 genes that are differentially expressed in SoJIA patients compared with healthy control patients, but that are not dysregulated in comparisons between patients with other systemic inflammatory conditions and healthy control patients.

“These 88 genes are very stable over time,” Dr. Pascual noted, giving an example of a SoJIA patient who had two disease flares but still had the same gene expression profile for these genes in two blood samples taken 2 years apart. The researchers then reduced those 88 genes to a set of 12 genes to diagnose SoJIA.

In newly hospitalized patients with a fever of unknown origin, this set of 12 genes correctly identified SoJIA in six of seven patients; the signature was correctly negative in another two patients who had SoJIA ruled out. The 12-gene set also correctly excluded 19 of 20 patients with infectious or other inflammatory diseases. This 12-gene expression signature of SoJIA went away in nearly all patients after treatment with an IL-1 blocker. The expression signature “seems to be linked in a way to the blocking of the IL-1 pathway,” she said.

The 12-gene expression signature proved to be specific to the systemic phase of SoJIA, as it correctly identified 22 of 23 patients in the systemic phase of SoJIA, none of 12 patients who were in the arthritic phase (without systemic symptoms), and none of 12 healthy control patients.

The goal of a SoJIA expression signature is to diagnose patients with SoJIA as soon as they present to the hospital with fever (before they have arthritis) so that they can be treated with IL-1 blockers—and possibly IL-6 blockers—before they develop arthritis, Dr. Pascual said.

“We are going to apply this test now to a new cohort of patients who are going to be enrolled in a new trial with a different modality of IL-1 blockade [an IL-1 drug] in the United States,” Dr. Pascual said.

BARCELONA — Rheumatoid arthritis patients who use corticosteroids frequently over the long term can maintain a low disease activity state but suffer deterioration of their functional capability, Dr. Eiichi Tanaka reported at a poster session at the annual European Congress of Rheumatology.

“A low disease activity state caused by corticosteroid use may not represent a 'true' low disease activity state,” explained Dr. Tanaka of Tokyo Women's Medical University, and his associates.

The investigators followed 224 RA patients with a low disease activity state during 2000–2005. The patients had a mean age of 56 years and a mean disease duration of about 8 years, and were enrolled in the study for at least 3 years. Every 6 months, the investigators collected measurements on the Disease Activity Score-28 (DAS-28) and Japanese version of the Health Assessment Questionnaire (J-HAQ).

DAS-28 scores did not change substantially over the course of the study in 135 patients who never used corticosteroids, 33 who used steroids an average of less than 9 months per year, and 56 who took steroids an average of more than 9 months per year. None of the patients had a DAS-28 greater than 3.2 at each assessment.

But long-term functional capacity, as measured by the J-HAQ, declined in the heavy corticosteroid users, improved slightly among moderate corticosteroid users, and improved the most in patients who did not use corticosteroids. Corticosteroid use was the most significant factor contributing to the final J-HAQ score, after adjustment of a multiple linear regression analysis for age, gender, disease duration, initial J-HAQ score, and seasonal effects. A little more than 90% of the patients in each group used disease-modifying antirheumatic drugs during the study.

“Along with the achievement of a low disease activity state, long-term efficacy, long-term functional prognosis, and the quality of remission also need to be considered in the strict control of RA activity,” Dr. Tanaka and his colleagues concluded.

BARCELONA — Rheumatoid arthritis patients who use corticosteroids frequently over the long term can maintain a low disease activity state but suffer deterioration of their functional capability, Dr. Eiichi Tanaka reported at a poster session at the annual European Congress of Rheumatology.

“A low disease activity state caused by corticosteroid use may not represent a 'true' low disease activity state,” explained Dr. Tanaka of Tokyo Women's Medical University, and his associates.

The investigators followed 224 RA patients with a low disease activity state during 2000–2005. The patients had a mean age of 56 years and a mean disease duration of about 8 years, and were enrolled in the study for at least 3 years. Every 6 months, the investigators collected measurements on the Disease Activity Score-28 (DAS-28) and Japanese version of the Health Assessment Questionnaire (J-HAQ).

DAS-28 scores did not change substantially over the course of the study in 135 patients who never used corticosteroids, 33 who used steroids an average of less than 9 months per year, and 56 who took steroids an average of more than 9 months per year. None of the patients had a DAS-28 greater than 3.2 at each assessment.

But long-term functional capacity, as measured by the J-HAQ, declined in the heavy corticosteroid users, improved slightly among moderate corticosteroid users, and improved the most in patients who did not use corticosteroids. Corticosteroid use was the most significant factor contributing to the final J-HAQ score, after adjustment of a multiple linear regression analysis for age, gender, disease duration, initial J-HAQ score, and seasonal effects. A little more than 90% of the patients in each group used disease-modifying antirheumatic drugs during the study.

“Along with the achievement of a low disease activity state, long-term efficacy, long-term functional prognosis, and the quality of remission also need to be considered in the strict control of RA activity,” Dr. Tanaka and his colleagues concluded.

BARCELONA — Rheumatoid arthritis patients who use corticosteroids frequently over the long term can maintain a low disease activity state but suffer deterioration of their functional capability, Dr. Eiichi Tanaka reported at a poster session at the annual European Congress of Rheumatology.

“A low disease activity state caused by corticosteroid use may not represent a 'true' low disease activity state,” explained Dr. Tanaka of Tokyo Women's Medical University, and his associates.

The investigators followed 224 RA patients with a low disease activity state during 2000–2005. The patients had a mean age of 56 years and a mean disease duration of about 8 years, and were enrolled in the study for at least 3 years. Every 6 months, the investigators collected measurements on the Disease Activity Score-28 (DAS-28) and Japanese version of the Health Assessment Questionnaire (J-HAQ).

DAS-28 scores did not change substantially over the course of the study in 135 patients who never used corticosteroids, 33 who used steroids an average of less than 9 months per year, and 56 who took steroids an average of more than 9 months per year. None of the patients had a DAS-28 greater than 3.2 at each assessment.

But long-term functional capacity, as measured by the J-HAQ, declined in the heavy corticosteroid users, improved slightly among moderate corticosteroid users, and improved the most in patients who did not use corticosteroids. Corticosteroid use was the most significant factor contributing to the final J-HAQ score, after adjustment of a multiple linear regression analysis for age, gender, disease duration, initial J-HAQ score, and seasonal effects. A little more than 90% of the patients in each group used disease-modifying antirheumatic drugs during the study.

“Along with the achievement of a low disease activity state, long-term efficacy, long-term functional prognosis, and the quality of remission also need to be considered in the strict control of RA activity,” Dr. Tanaka and his colleagues concluded.

WASHINGTON — Sirolimus-eluting stents may induce coronary endothelial cell dysfunction in arterial segments that are distal to their placement, unlike conventional percutaneous coronary interventions, according to the results of a small study.

The antiproliferative effect of sirolimus-eluting stents inhibits neointimal hyperplasia, but this effect also may impair endothelial cell proliferation in the area distal to the stent. This could “potentially lead to coronary endothelial dysfunction,” said Dr. Kasai of the department of cardiology at Shinshu University, Matsumoto, Japan.

In a study that he presented at the annual meeting of the Society of Nuclear Medicine, Dr. Kasai and his colleagues included nine patients who underwent successful PCI for the treatment of stable angina or acute coronary syndrome after excluding patients with uncontrolled diabetes, symptoms of heart failure, or plasma brain natriuretic peptide levels greater than 100 pg/mL. Within 1 month after PCI, they quantitatively measured myocardial blood flow with 13N-ammonia PET at rest and then 30 minutes later during a cold pressor test.

The patients were instructed not to take any drugs during the morning of the testing, but all took aspirin to prevent thrombotic events. The investigators defined the left anterior descending coronary artery as the area distal to the stent.

Dr. Kasai and his associates identified seven coronary artery segments that received conventional PCI (plain balloon angioplasty or bare metal stent), six segments that received sirolimus-eluting stents (SES), and normal control segments in each patient that had less than 75% stenosis.

At rest, there was no difference in myocardial blood flow between the normal control and reperfused segments that were distal to the SES. Normal control and reperfused stent-distal segments with conventional PCI also had similar myocardial blood flow at rest. During cold pressor testing, myocardial blood flow did not differ significantly between normal control and stent-distal segments that had been reperfused with either conventional PCI or SES. But the percentage increase in myocardial blood flow from rest to stress with the cold pressor test (representing coronary endothelial function) was significantly lower in reperfused areas distal to SES (28%) than in normal control segments (47%). This was not seen in comparisons between reperfused areas distal to conventional PCI (64%) and normal control segments (54%).

WASHINGTON — Sirolimus-eluting stents may induce coronary endothelial cell dysfunction in arterial segments that are distal to their placement, unlike conventional percutaneous coronary interventions, according to the results of a small study.

The antiproliferative effect of sirolimus-eluting stents inhibits neointimal hyperplasia, but this effect also may impair endothelial cell proliferation in the area distal to the stent. This could “potentially lead to coronary endothelial dysfunction,” said Dr. Kasai of the department of cardiology at Shinshu University, Matsumoto, Japan.

In a study that he presented at the annual meeting of the Society of Nuclear Medicine, Dr. Kasai and his colleagues included nine patients who underwent successful PCI for the treatment of stable angina or acute coronary syndrome after excluding patients with uncontrolled diabetes, symptoms of heart failure, or plasma brain natriuretic peptide levels greater than 100 pg/mL. Within 1 month after PCI, they quantitatively measured myocardial blood flow with 13N-ammonia PET at rest and then 30 minutes later during a cold pressor test.

The patients were instructed not to take any drugs during the morning of the testing, but all took aspirin to prevent thrombotic events. The investigators defined the left anterior descending coronary artery as the area distal to the stent.

Dr. Kasai and his associates identified seven coronary artery segments that received conventional PCI (plain balloon angioplasty or bare metal stent), six segments that received sirolimus-eluting stents (SES), and normal control segments in each patient that had less than 75% stenosis.

At rest, there was no difference in myocardial blood flow between the normal control and reperfused segments that were distal to the SES. Normal control and reperfused stent-distal segments with conventional PCI also had similar myocardial blood flow at rest. During cold pressor testing, myocardial blood flow did not differ significantly between normal control and stent-distal segments that had been reperfused with either conventional PCI or SES. But the percentage increase in myocardial blood flow from rest to stress with the cold pressor test (representing coronary endothelial function) was significantly lower in reperfused areas distal to SES (28%) than in normal control segments (47%). This was not seen in comparisons between reperfused areas distal to conventional PCI (64%) and normal control segments (54%).

WASHINGTON — Sirolimus-eluting stents may induce coronary endothelial cell dysfunction in arterial segments that are distal to their placement, unlike conventional percutaneous coronary interventions, according to the results of a small study.

The antiproliferative effect of sirolimus-eluting stents inhibits neointimal hyperplasia, but this effect also may impair endothelial cell proliferation in the area distal to the stent. This could “potentially lead to coronary endothelial dysfunction,” said Dr. Kasai of the department of cardiology at Shinshu University, Matsumoto, Japan.

In a study that he presented at the annual meeting of the Society of Nuclear Medicine, Dr. Kasai and his colleagues included nine patients who underwent successful PCI for the treatment of stable angina or acute coronary syndrome after excluding patients with uncontrolled diabetes, symptoms of heart failure, or plasma brain natriuretic peptide levels greater than 100 pg/mL. Within 1 month after PCI, they quantitatively measured myocardial blood flow with 13N-ammonia PET at rest and then 30 minutes later during a cold pressor test.

The patients were instructed not to take any drugs during the morning of the testing, but all took aspirin to prevent thrombotic events. The investigators defined the left anterior descending coronary artery as the area distal to the stent.

Dr. Kasai and his associates identified seven coronary artery segments that received conventional PCI (plain balloon angioplasty or bare metal stent), six segments that received sirolimus-eluting stents (SES), and normal control segments in each patient that had less than 75% stenosis.

At rest, there was no difference in myocardial blood flow between the normal control and reperfused segments that were distal to the SES. Normal control and reperfused stent-distal segments with conventional PCI also had similar myocardial blood flow at rest. During cold pressor testing, myocardial blood flow did not differ significantly between normal control and stent-distal segments that had been reperfused with either conventional PCI or SES. But the percentage increase in myocardial blood flow from rest to stress with the cold pressor test (representing coronary endothelial function) was significantly lower in reperfused areas distal to SES (28%) than in normal control segments (47%). This was not seen in comparisons between reperfused areas distal to conventional PCI (64%) and normal control segments (54%).

NAPLES, FLA. — In situ melanomas that were incompletely and inadequately removed at the time of initial treatment recurred at the surgical margin with an invasive component nearly one-quarter of the time, according to a 25-year review of surgery for such lesions presented at the annual meeting of the American College of Mohs Surgery.

The finding from the single-center study suggests that wider surgical margins are necessary to prevent recurrences, said Dr. James R. DeBloom II, who is in private practice in Greenville, S.C.

Of 202 marginally recurrent melanomas that Dr. DeBloom and his colleagues have seen since 1980, the lesions have appeared most commonly on the cheek (34%). Standard excision has been the most commonly failed initial treatment (48%).

A total of 84 these lesions were biopsy-proven melanoma in situ, and 19 of these (23%) revealed an invasive component at the time of the salvage surgery. Another 24 lesions were treated initially as biopsy-proven invasive melanoma. Of these, 15 (63%) recurred with a shallower Breslow depth or as melanoma in situ, 1 (4%) recurred at the exact same level of invasion, and 8 (33%) recurred at a greater Breslow depth than before.

The overall mean Breslow depth for these initially invasive melanomas increased from 1.53 mm to 2.8 mm at the time of recurrence, Dr. DeBloom reported.

These results show "that residual disease cannot only persist, but it can also invade and worsen the patient's prognosis and should not be taken lightly," he said.

Instead of using the confusing term locally recurrent melanoma, which has been given many different definitions, he and his colleagues prefer to use more specific terms—residual or marginally recurrent melanoma—to describe "a clinical reappearance of previously treated melanoma that is immediately adjacent to the scar of primary treatment," he said.

Of all diagnosed melanomas, 17%–25% are on the head and neck. Melanomas on those locations have a marginal recurrence rate after excision of 9%–13%. "This tells us that our current treatment protocols for head and neck melanoma may be insufficient," Dr. DeBloom said.

Marginal recurrences may develop because surgeons can "cheat on margins and make them small for cosmetic and functional reasons," he said.

It also is hard to determine where the clinical margin is, especially on sun-damaged skin that may have many other pigmented lesions and a high frequency of amelanotic melanomas at the margin. Also, routine pathologic examination looks at less than 1% of the total margin, "so when we get a negative report we all feel good about that but it does not preclude a true positive margin," Dr. DeBloom said.

He also said that the 1992 recommendation from the National Institutes of Health for 5-mm surgical margins is "not sufficient for melanoma in situ and [is] not evidence based." That is why he and his associates recommend a wider margin of 1 cm for melanoma in situ on the head and neck.

NAPLES, FLA. — In situ melanomas that were incompletely and inadequately removed at the time of initial treatment recurred at the surgical margin with an invasive component nearly one-quarter of the time, according to a 25-year review of surgery for such lesions presented at the annual meeting of the American College of Mohs Surgery.

The finding from the single-center study suggests that wider surgical margins are necessary to prevent recurrences, said Dr. James R. DeBloom II, who is in private practice in Greenville, S.C.

Of 202 marginally recurrent melanomas that Dr. DeBloom and his colleagues have seen since 1980, the lesions have appeared most commonly on the cheek (34%). Standard excision has been the most commonly failed initial treatment (48%).

A total of 84 these lesions were biopsy-proven melanoma in situ, and 19 of these (23%) revealed an invasive component at the time of the salvage surgery. Another 24 lesions were treated initially as biopsy-proven invasive melanoma. Of these, 15 (63%) recurred with a shallower Breslow depth or as melanoma in situ, 1 (4%) recurred at the exact same level of invasion, and 8 (33%) recurred at a greater Breslow depth than before.

The overall mean Breslow depth for these initially invasive melanomas increased from 1.53 mm to 2.8 mm at the time of recurrence, Dr. DeBloom reported.

These results show "that residual disease cannot only persist, but it can also invade and worsen the patient's prognosis and should not be taken lightly," he said.

Instead of using the confusing term locally recurrent melanoma, which has been given many different definitions, he and his colleagues prefer to use more specific terms—residual or marginally recurrent melanoma—to describe "a clinical reappearance of previously treated melanoma that is immediately adjacent to the scar of primary treatment," he said.

Of all diagnosed melanomas, 17%–25% are on the head and neck. Melanomas on those locations have a marginal recurrence rate after excision of 9%–13%. "This tells us that our current treatment protocols for head and neck melanoma may be insufficient," Dr. DeBloom said.

Marginal recurrences may develop because surgeons can "cheat on margins and make them small for cosmetic and functional reasons," he said.

It also is hard to determine where the clinical margin is, especially on sun-damaged skin that may have many other pigmented lesions and a high frequency of amelanotic melanomas at the margin. Also, routine pathologic examination looks at less than 1% of the total margin, "so when we get a negative report we all feel good about that but it does not preclude a true positive margin," Dr. DeBloom said.

He also said that the 1992 recommendation from the National Institutes of Health for 5-mm surgical margins is "not sufficient for melanoma in situ and [is] not evidence based." That is why he and his associates recommend a wider margin of 1 cm for melanoma in situ on the head and neck.

NAPLES, FLA. — In situ melanomas that were incompletely and inadequately removed at the time of initial treatment recurred at the surgical margin with an invasive component nearly one-quarter of the time, according to a 25-year review of surgery for such lesions presented at the annual meeting of the American College of Mohs Surgery.

The finding from the single-center study suggests that wider surgical margins are necessary to prevent recurrences, said Dr. James R. DeBloom II, who is in private practice in Greenville, S.C.

Of 202 marginally recurrent melanomas that Dr. DeBloom and his colleagues have seen since 1980, the lesions have appeared most commonly on the cheek (34%). Standard excision has been the most commonly failed initial treatment (48%).

A total of 84 these lesions were biopsy-proven melanoma in situ, and 19 of these (23%) revealed an invasive component at the time of the salvage surgery. Another 24 lesions were treated initially as biopsy-proven invasive melanoma. Of these, 15 (63%) recurred with a shallower Breslow depth or as melanoma in situ, 1 (4%) recurred at the exact same level of invasion, and 8 (33%) recurred at a greater Breslow depth than before.

The overall mean Breslow depth for these initially invasive melanomas increased from 1.53 mm to 2.8 mm at the time of recurrence, Dr. DeBloom reported.

These results show "that residual disease cannot only persist, but it can also invade and worsen the patient's prognosis and should not be taken lightly," he said.

Instead of using the confusing term locally recurrent melanoma, which has been given many different definitions, he and his colleagues prefer to use more specific terms—residual or marginally recurrent melanoma—to describe "a clinical reappearance of previously treated melanoma that is immediately adjacent to the scar of primary treatment," he said.

Of all diagnosed melanomas, 17%–25% are on the head and neck. Melanomas on those locations have a marginal recurrence rate after excision of 9%–13%. "This tells us that our current treatment protocols for head and neck melanoma may be insufficient," Dr. DeBloom said.

Marginal recurrences may develop because surgeons can "cheat on margins and make them small for cosmetic and functional reasons," he said.

It also is hard to determine where the clinical margin is, especially on sun-damaged skin that may have many other pigmented lesions and a high frequency of amelanotic melanomas at the margin. Also, routine pathologic examination looks at less than 1% of the total margin, "so when we get a negative report we all feel good about that but it does not preclude a true positive margin," Dr. DeBloom said.

He also said that the 1992 recommendation from the National Institutes of Health for 5-mm surgical margins is "not sufficient for melanoma in situ and [is] not evidence based." That is why he and his associates recommend a wider margin of 1 cm for melanoma in situ on the head and neck.

NAPLES, FLA. — Microwave-assisted processing of permanent paraffin sections takes much less time than the conventional paraffin embedding process for Mohs surgery specimens, yet preserves its advantages over frozen sections in visualizing melanoma in situ, Dr. Raj Mallipeddi said at the annual meeting of the American College of Mohs Surgery.

Permanent paraffin sections are considered the standard for assessing histology, but the long time required to process them may make Mohs surgery inefficient because patients must return at least 24 hours later for additional Mohs stages or the repair procedure. Frozen sections also are considered by some clinicians to be inadequate to identify atypical melanocytes reliably, said Dr. Mallipeddi, a procedural dermatology fellow at the University of Texas Southwestern Medical Center, Dallas. Microwave tissue processing is "nothing new," and has been used in a variety of histologic procedures in the past few decades.

Dr. Mallipeddi and his associates divided 13 specimens of melanoma in situ from the initial debulking stage of surgery into 4 pieces each. They processed the pieces from each specimen using four different methods. The conventional method was used to create permanent paraffin sections, as was the group's rapid microwave technique. The researchers also made frozen sections stained with hematoxylin and eosin, and frozen sections immunostained with antibodies against MART-1, a protein found on melanocytes.

An experienced Mohs surgeon and a dermatopathologist compared all of the sections in a blind fashion to determine if there were any differences in the ability to visualize normal and abnormal melanocytes, and in the overall ability to see the epidermis and dermis.

There were no significant differences between the two paraffin techniques on those three criteria. The microwave paraffin sections proved to be significantly better than the frozen hematoxylin and eosin sections on all three criteria. Abnormal melanocytes could be visualized significantly better with the microwave paraffin technique than with frozen MART-1 sections, but the microwave method was similar to frozen MART-1 sections in identifying normal melanocytes. At 200× magnification, the morphology of atypical melanocytes was seen clearly with the microwave technique. MART-1 immunostaining on frozen sections showed melanocyte density well, but individual cell morphology was "not so well depicted," Dr. Mallipeddi said.

The method produces permanent paraffin sections in about 2 hours. The procedure involves fixing fresh tissue for 30 minutes, microwave processing for another 30 minutes, embedding the tissue in paraffin, and then staining the specimen with hematoxylin and eosin for about 10 minutes.

"We believe this technique should be investigated further in the context of Mohs micrographic surgery—not just for melanoma in situ," Dr. Mallipeddi said.

NAPLES, FLA. — Microwave-assisted processing of permanent paraffin sections takes much less time than the conventional paraffin embedding process for Mohs surgery specimens, yet preserves its advantages over frozen sections in visualizing melanoma in situ, Dr. Raj Mallipeddi said at the annual meeting of the American College of Mohs Surgery.

Permanent paraffin sections are considered the standard for assessing histology, but the long time required to process them may make Mohs surgery inefficient because patients must return at least 24 hours later for additional Mohs stages or the repair procedure. Frozen sections also are considered by some clinicians to be inadequate to identify atypical melanocytes reliably, said Dr. Mallipeddi, a procedural dermatology fellow at the University of Texas Southwestern Medical Center, Dallas. Microwave tissue processing is "nothing new," and has been used in a variety of histologic procedures in the past few decades.

Dr. Mallipeddi and his associates divided 13 specimens of melanoma in situ from the initial debulking stage of surgery into 4 pieces each. They processed the pieces from each specimen using four different methods. The conventional method was used to create permanent paraffin sections, as was the group's rapid microwave technique. The researchers also made frozen sections stained with hematoxylin and eosin, and frozen sections immunostained with antibodies against MART-1, a protein found on melanocytes.

An experienced Mohs surgeon and a dermatopathologist compared all of the sections in a blind fashion to determine if there were any differences in the ability to visualize normal and abnormal melanocytes, and in the overall ability to see the epidermis and dermis.

There were no significant differences between the two paraffin techniques on those three criteria. The microwave paraffin sections proved to be significantly better than the frozen hematoxylin and eosin sections on all three criteria. Abnormal melanocytes could be visualized significantly better with the microwave paraffin technique than with frozen MART-1 sections, but the microwave method was similar to frozen MART-1 sections in identifying normal melanocytes. At 200× magnification, the morphology of atypical melanocytes was seen clearly with the microwave technique. MART-1 immunostaining on frozen sections showed melanocyte density well, but individual cell morphology was "not so well depicted," Dr. Mallipeddi said.

The method produces permanent paraffin sections in about 2 hours. The procedure involves fixing fresh tissue for 30 minutes, microwave processing for another 30 minutes, embedding the tissue in paraffin, and then staining the specimen with hematoxylin and eosin for about 10 minutes.

"We believe this technique should be investigated further in the context of Mohs micrographic surgery—not just for melanoma in situ," Dr. Mallipeddi said.

NAPLES, FLA. — Microwave-assisted processing of permanent paraffin sections takes much less time than the conventional paraffin embedding process for Mohs surgery specimens, yet preserves its advantages over frozen sections in visualizing melanoma in situ, Dr. Raj Mallipeddi said at the annual meeting of the American College of Mohs Surgery.

Permanent paraffin sections are considered the standard for assessing histology, but the long time required to process them may make Mohs surgery inefficient because patients must return at least 24 hours later for additional Mohs stages or the repair procedure. Frozen sections also are considered by some clinicians to be inadequate to identify atypical melanocytes reliably, said Dr. Mallipeddi, a procedural dermatology fellow at the University of Texas Southwestern Medical Center, Dallas. Microwave tissue processing is "nothing new," and has been used in a variety of histologic procedures in the past few decades.

Dr. Mallipeddi and his associates divided 13 specimens of melanoma in situ from the initial debulking stage of surgery into 4 pieces each. They processed the pieces from each specimen using four different methods. The conventional method was used to create permanent paraffin sections, as was the group's rapid microwave technique. The researchers also made frozen sections stained with hematoxylin and eosin, and frozen sections immunostained with antibodies against MART-1, a protein found on melanocytes.

An experienced Mohs surgeon and a dermatopathologist compared all of the sections in a blind fashion to determine if there were any differences in the ability to visualize normal and abnormal melanocytes, and in the overall ability to see the epidermis and dermis.

There were no significant differences between the two paraffin techniques on those three criteria. The microwave paraffin sections proved to be significantly better than the frozen hematoxylin and eosin sections on all three criteria. Abnormal melanocytes could be visualized significantly better with the microwave paraffin technique than with frozen MART-1 sections, but the microwave method was similar to frozen MART-1 sections in identifying normal melanocytes. At 200× magnification, the morphology of atypical melanocytes was seen clearly with the microwave technique. MART-1 immunostaining on frozen sections showed melanocyte density well, but individual cell morphology was "not so well depicted," Dr. Mallipeddi said.

The method produces permanent paraffin sections in about 2 hours. The procedure involves fixing fresh tissue for 30 minutes, microwave processing for another 30 minutes, embedding the tissue in paraffin, and then staining the specimen with hematoxylin and eosin for about 10 minutes.

"We believe this technique should be investigated further in the context of Mohs micrographic surgery—not just for melanoma in situ," Dr. Mallipeddi said.

WASHINGTON — Breast cancer survivors may be more likely to increase their physical activity and quality of life if they are given step pedometers and an exercise guidebook, Jeffrey K.H. Vallance reported at the annual meeting of the Society of Behavioral Medicine.

In a recent prospective observational study, exercising after treatment for breast cancer and into breast cancer survivorship was associated with a 26%–40% reduction in the risk of breast cancer recurrence, breast cancer-specific mortality, and all-cause mortality (JAMA 2005;293:2479–86).

Since most breast cancer survivors do not meet the physical activity recommendations, there is a need for studies that don't require patients to come to a clinic to exercise under supervision and for distance- and home-based behavior-change interventions, said Mr. Vallance, a Ph.D. candidate in the faculty of physical education at the University of Alberta, Edmonton.

In preliminary results of a randomized trial of 377 breast cancer survivors from the Alberta Cancer Registry, Mr. Vallance and his colleagues found that patients who received an exercise guidebook alone (94), a step pedometer alone (94), or both (93) all reported significantly greater increases in moderate to vigorous physical activity per week and self-reported brisk walking at the end of 12 weeks than did patients who were given the standard physical activity recommendation over the telephone (96). The increases amounted to an additional 40–60 minutes a week of moderate to vigorous physical activity and an additional 60–90 minutes a week of brisk walking, compared with patients who were given the standard recommendation.

But only the patients who used both the guidebook and the step pedometer had significant changes in their quality of life and level of fatigue at the end of 12 weeks. There were no significant differences in quality of life and fatigue among the three intervention groups. The changes in quality of life and fatigue for patients in the combined treatment group “approached the minimal cut points for what we can term a clinically important difference,” which is any difference that might necessitate or qualify for change in a patient's management or approach to her management, Mr. Vallance said.

“This study provides some preliminary support for more distance-based behavior-change approaches,” he said, adding that it was relatively inexpensive at only $30 a person.

“I think we need to start pushing these distance-based approaches. If we consider that there are approximately 10 million cancer survivors in the [United States] alone today, then it's these novel, public health-based, distance-based approaches that might be able to target and have an impact on the greatest number of survivors.”

The investigators are currently analyzing 6-month follow-up data.

WASHINGTON — Breast cancer survivors may be more likely to increase their physical activity and quality of life if they are given step pedometers and an exercise guidebook, Jeffrey K.H. Vallance reported at the annual meeting of the Society of Behavioral Medicine.

In a recent prospective observational study, exercising after treatment for breast cancer and into breast cancer survivorship was associated with a 26%–40% reduction in the risk of breast cancer recurrence, breast cancer-specific mortality, and all-cause mortality (JAMA 2005;293:2479–86).

Since most breast cancer survivors do not meet the physical activity recommendations, there is a need for studies that don't require patients to come to a clinic to exercise under supervision and for distance- and home-based behavior-change interventions, said Mr. Vallance, a Ph.D. candidate in the faculty of physical education at the University of Alberta, Edmonton.

In preliminary results of a randomized trial of 377 breast cancer survivors from the Alberta Cancer Registry, Mr. Vallance and his colleagues found that patients who received an exercise guidebook alone (94), a step pedometer alone (94), or both (93) all reported significantly greater increases in moderate to vigorous physical activity per week and self-reported brisk walking at the end of 12 weeks than did patients who were given the standard physical activity recommendation over the telephone (96). The increases amounted to an additional 40–60 minutes a week of moderate to vigorous physical activity and an additional 60–90 minutes a week of brisk walking, compared with patients who were given the standard recommendation.

But only the patients who used both the guidebook and the step pedometer had significant changes in their quality of life and level of fatigue at the end of 12 weeks. There were no significant differences in quality of life and fatigue among the three intervention groups. The changes in quality of life and fatigue for patients in the combined treatment group “approached the minimal cut points for what we can term a clinically important difference,” which is any difference that might necessitate or qualify for change in a patient's management or approach to her management, Mr. Vallance said.

“This study provides some preliminary support for more distance-based behavior-change approaches,” he said, adding that it was relatively inexpensive at only $30 a person.

“I think we need to start pushing these distance-based approaches. If we consider that there are approximately 10 million cancer survivors in the [United States] alone today, then it's these novel, public health-based, distance-based approaches that might be able to target and have an impact on the greatest number of survivors.”

The investigators are currently analyzing 6-month follow-up data.

WASHINGTON — Breast cancer survivors may be more likely to increase their physical activity and quality of life if they are given step pedometers and an exercise guidebook, Jeffrey K.H. Vallance reported at the annual meeting of the Society of Behavioral Medicine.

In a recent prospective observational study, exercising after treatment for breast cancer and into breast cancer survivorship was associated with a 26%–40% reduction in the risk of breast cancer recurrence, breast cancer-specific mortality, and all-cause mortality (JAMA 2005;293:2479–86).

Since most breast cancer survivors do not meet the physical activity recommendations, there is a need for studies that don't require patients to come to a clinic to exercise under supervision and for distance- and home-based behavior-change interventions, said Mr. Vallance, a Ph.D. candidate in the faculty of physical education at the University of Alberta, Edmonton.

In preliminary results of a randomized trial of 377 breast cancer survivors from the Alberta Cancer Registry, Mr. Vallance and his colleagues found that patients who received an exercise guidebook alone (94), a step pedometer alone (94), or both (93) all reported significantly greater increases in moderate to vigorous physical activity per week and self-reported brisk walking at the end of 12 weeks than did patients who were given the standard physical activity recommendation over the telephone (96). The increases amounted to an additional 40–60 minutes a week of moderate to vigorous physical activity and an additional 60–90 minutes a week of brisk walking, compared with patients who were given the standard recommendation.

But only the patients who used both the guidebook and the step pedometer had significant changes in their quality of life and level of fatigue at the end of 12 weeks. There were no significant differences in quality of life and fatigue among the three intervention groups. The changes in quality of life and fatigue for patients in the combined treatment group “approached the minimal cut points for what we can term a clinically important difference,” which is any difference that might necessitate or qualify for change in a patient's management or approach to her management, Mr. Vallance said.

“This study provides some preliminary support for more distance-based behavior-change approaches,” he said, adding that it was relatively inexpensive at only $30 a person.

“I think we need to start pushing these distance-based approaches. If we consider that there are approximately 10 million cancer survivors in the [United States] alone today, then it's these novel, public health-based, distance-based approaches that might be able to target and have an impact on the greatest number of survivors.”

The investigators are currently analyzing 6-month follow-up data.