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Do African American asthmatics perceive and describe their asthma symptoms differently than white asthmatics?
BACKGROUND: African Americans experience higher death rates from asthma than whites. Understanding potential differences in how these 2 ethnic groups describe or experience their symptoms during an asthma exacerbation may improve asthma management in African Americans.
POPULATION STUDIED: The investigators studied 40 adult asthmatics with atopy whose baseline asthma therapy consisted of only intermittent b-agonists. Patients were excluded if they used inhaled or oral steroids, theophylline, or antihistamines within 6 weeks of the study. Also, patients were not enrolled if they had hypertension, heart disease, diabetes, malignancy, or immune disorders or if they had used tobacco within the past year or had a cumulative history greater than 10 pack-years. Eight patients were dropped because sufficient airflow obstruction could not be induced; 6 of those were African American. Of the resultant African American group 75% were women, but only 56% of the whites were women.
STUDY DESIGN AND VALIDITY: This study was an experimental protocol, artificially inducing bronchocontriction in otherwise asymptomatic asthmatics. Subjects were given methacholine to induce bronchoconstriction, resulting in a 30% drop in forced expiratory volume in 1 second (FEV1). Two minutes after dosing, subjects described the sensations they experienced in their own words. The descriptions were clustered into general groups for those descriptors used by at least 75% of the group participants. Subjects also rated the severity of breathlessness by visual analog scale (VAS) and by selecting word or number descriptors. This experimental study was tightly controlled to be able to accurately match the symptoms in the 2 ethnic groups. However, this design may not reflect the more complicated and variable patients seen in everyday practice. Also, the study was performed in one geographic area (northern California), and patients in other areas may use a different vocabulary to express their symptoms. Similarly, induced bronchoconstriction may be experienced differently than a natural occurring asthma attack. Also, our ability to generalize the results is frequently limited in qualitative studies such as this one.
OUTCOMES MEASURED: The categories of phrases used to describe the sensation of breathlessness comprised the primary outcome. Symptom severity was a secondary outcome.
RESULTS: Words used to describe the symptoms during airflow obstruction differed between the 2 ethnic groups. African Americans were statistically more likely to use upper airway descriptors to explain their breathlessness: “tight throat,” “voice tight,” “itchy throat,” “tough breath,” and “scared-agitated” were the word clusters most often used. Whites were more apt to use lower airway terms, such as “deep breath,” “out of air,” “aware of breathing,” “hurts to breathe,” and “lightheaded.” No subjects used the traditional medical terminology of “shortness of breath” or “wheezing.” African American subjects rated their baseline breathlessness slightly greater than whites (14.25 vs 11.0 on a 0-100 VAS, P <.04). As expected, severity scores increased as FEV1 decreased. At a 20% reduction, whites reported a greater sense of breathlessness, but there was no difference between the 2 groups at a 30% reduction in FEV1.
This study alerts clinicians to the possibility that African American asthmatics may be more likely to use upper airway terms to describe their airflow obstructive symptoms. This descriptive study does not demonstrate any differences in patient-oriented outcomes. However, the potential harm of missing an asthma exacerbation warrants the small additional effort of clinicians to pursue bronchospasm as a possible etiology in asthmatics presenting with upper airway symptoms.
BACKGROUND: African Americans experience higher death rates from asthma than whites. Understanding potential differences in how these 2 ethnic groups describe or experience their symptoms during an asthma exacerbation may improve asthma management in African Americans.
POPULATION STUDIED: The investigators studied 40 adult asthmatics with atopy whose baseline asthma therapy consisted of only intermittent b-agonists. Patients were excluded if they used inhaled or oral steroids, theophylline, or antihistamines within 6 weeks of the study. Also, patients were not enrolled if they had hypertension, heart disease, diabetes, malignancy, or immune disorders or if they had used tobacco within the past year or had a cumulative history greater than 10 pack-years. Eight patients were dropped because sufficient airflow obstruction could not be induced; 6 of those were African American. Of the resultant African American group 75% were women, but only 56% of the whites were women.
STUDY DESIGN AND VALIDITY: This study was an experimental protocol, artificially inducing bronchocontriction in otherwise asymptomatic asthmatics. Subjects were given methacholine to induce bronchoconstriction, resulting in a 30% drop in forced expiratory volume in 1 second (FEV1). Two minutes after dosing, subjects described the sensations they experienced in their own words. The descriptions were clustered into general groups for those descriptors used by at least 75% of the group participants. Subjects also rated the severity of breathlessness by visual analog scale (VAS) and by selecting word or number descriptors. This experimental study was tightly controlled to be able to accurately match the symptoms in the 2 ethnic groups. However, this design may not reflect the more complicated and variable patients seen in everyday practice. Also, the study was performed in one geographic area (northern California), and patients in other areas may use a different vocabulary to express their symptoms. Similarly, induced bronchoconstriction may be experienced differently than a natural occurring asthma attack. Also, our ability to generalize the results is frequently limited in qualitative studies such as this one.
OUTCOMES MEASURED: The categories of phrases used to describe the sensation of breathlessness comprised the primary outcome. Symptom severity was a secondary outcome.
RESULTS: Words used to describe the symptoms during airflow obstruction differed between the 2 ethnic groups. African Americans were statistically more likely to use upper airway descriptors to explain their breathlessness: “tight throat,” “voice tight,” “itchy throat,” “tough breath,” and “scared-agitated” were the word clusters most often used. Whites were more apt to use lower airway terms, such as “deep breath,” “out of air,” “aware of breathing,” “hurts to breathe,” and “lightheaded.” No subjects used the traditional medical terminology of “shortness of breath” or “wheezing.” African American subjects rated their baseline breathlessness slightly greater than whites (14.25 vs 11.0 on a 0-100 VAS, P <.04). As expected, severity scores increased as FEV1 decreased. At a 20% reduction, whites reported a greater sense of breathlessness, but there was no difference between the 2 groups at a 30% reduction in FEV1.
This study alerts clinicians to the possibility that African American asthmatics may be more likely to use upper airway terms to describe their airflow obstructive symptoms. This descriptive study does not demonstrate any differences in patient-oriented outcomes. However, the potential harm of missing an asthma exacerbation warrants the small additional effort of clinicians to pursue bronchospasm as a possible etiology in asthmatics presenting with upper airway symptoms.
BACKGROUND: African Americans experience higher death rates from asthma than whites. Understanding potential differences in how these 2 ethnic groups describe or experience their symptoms during an asthma exacerbation may improve asthma management in African Americans.
POPULATION STUDIED: The investigators studied 40 adult asthmatics with atopy whose baseline asthma therapy consisted of only intermittent b-agonists. Patients were excluded if they used inhaled or oral steroids, theophylline, or antihistamines within 6 weeks of the study. Also, patients were not enrolled if they had hypertension, heart disease, diabetes, malignancy, or immune disorders or if they had used tobacco within the past year or had a cumulative history greater than 10 pack-years. Eight patients were dropped because sufficient airflow obstruction could not be induced; 6 of those were African American. Of the resultant African American group 75% were women, but only 56% of the whites were women.
STUDY DESIGN AND VALIDITY: This study was an experimental protocol, artificially inducing bronchocontriction in otherwise asymptomatic asthmatics. Subjects were given methacholine to induce bronchoconstriction, resulting in a 30% drop in forced expiratory volume in 1 second (FEV1). Two minutes after dosing, subjects described the sensations they experienced in their own words. The descriptions were clustered into general groups for those descriptors used by at least 75% of the group participants. Subjects also rated the severity of breathlessness by visual analog scale (VAS) and by selecting word or number descriptors. This experimental study was tightly controlled to be able to accurately match the symptoms in the 2 ethnic groups. However, this design may not reflect the more complicated and variable patients seen in everyday practice. Also, the study was performed in one geographic area (northern California), and patients in other areas may use a different vocabulary to express their symptoms. Similarly, induced bronchoconstriction may be experienced differently than a natural occurring asthma attack. Also, our ability to generalize the results is frequently limited in qualitative studies such as this one.
OUTCOMES MEASURED: The categories of phrases used to describe the sensation of breathlessness comprised the primary outcome. Symptom severity was a secondary outcome.
RESULTS: Words used to describe the symptoms during airflow obstruction differed between the 2 ethnic groups. African Americans were statistically more likely to use upper airway descriptors to explain their breathlessness: “tight throat,” “voice tight,” “itchy throat,” “tough breath,” and “scared-agitated” were the word clusters most often used. Whites were more apt to use lower airway terms, such as “deep breath,” “out of air,” “aware of breathing,” “hurts to breathe,” and “lightheaded.” No subjects used the traditional medical terminology of “shortness of breath” or “wheezing.” African American subjects rated their baseline breathlessness slightly greater than whites (14.25 vs 11.0 on a 0-100 VAS, P <.04). As expected, severity scores increased as FEV1 decreased. At a 20% reduction, whites reported a greater sense of breathlessness, but there was no difference between the 2 groups at a 30% reduction in FEV1.
This study alerts clinicians to the possibility that African American asthmatics may be more likely to use upper airway terms to describe their airflow obstructive symptoms. This descriptive study does not demonstrate any differences in patient-oriented outcomes. However, the potential harm of missing an asthma exacerbation warrants the small additional effort of clinicians to pursue bronchospasm as a possible etiology in asthmatics presenting with upper airway symptoms.
Is electron-beam computed tomography (EBCT) a reliable tool for predicting coronary outcomes in an asymptomatic population?
BACKGROUND: Coronary artery disease remains the leading cause of death in the United States. Currently clinicians rely on traditional models of risk-factor analysis to predict coronary outcomes. EBCT has recently been identified as a tool for measuring calcium within the coronary arteries and promoted as a means of predicting coronary risk. The use of EBCT as a prognostic or screening tool is based on the premise of a causal and incremental association between coronary artery calcium and atherosclerosis.1,2 More coronary calcium means more atherosclerotic heart disease, which in turn means a higher risk for coronary events. The objective of this study was to review the literature on EBCT as a noninvasive method for predicting subsequent coronary events.
POPULATION STUDIED: The average age of a study participant in the 5 identified studies was 57 years, and 74% were men. The study setting (ie, primary care or referral) and the subject ethnicity were not reported. The baseline cardiovascular risk of participants was inconsistently reported.
STUDY DESIGN AND VALIDITY: This study was a meta-analysis. The authors searched the literature for articles pertaining to EBCT, heart disease, and prognosis. Studies were included if they were performed on an asymptomatic adult population with adequate follow-up (minimum of 36 months) and assessment of coronary outcomes (myocardial infarction [MI] or death) was reported. The authors included data from ongoing and unpublished studies. Incomplete data were imputed in a conservative fashion to limit bias toward the alternative hypothesis. Two authors independently reviewed the data, and differences were reconciled by group consensus. A random effects model was used to calculate summary estimates of the risk ratios.
OUTCOMES MEASURED: The primary outcome measures were risk ratios for hard coronary events (MI and cardiac death) and combined events (MI, cardiac death, and revascularization procedures).
RESULTS: Nine studies (4 published articles and 5 abstracts) were identified. Three were duplicate publications that reported the same data as another study, and one had only 33% follow-up; these were appropriately excluded. The remaining 5 studies with 4348 patients were included. There was significant heterogeneity between studies, with the best designed study having among the lowest risk ratios (2.3). The summary estimates calculated using a random effects model showed that patients with higher calcium scores by EBCT were at an increased risk of hard events (summary risk ratio=4.2; 95% confidence interval [CI], 1.6-11.3) and combined events (summary risk ratio=8.7; 95% CI, 2.7-28.1). However, these calculations should not have been reported in the first place because of the broad methodologic differences between studies and their significant heterogeneity. These major flaws greatly weaken the conclusions that can be drawn from this meta-analysis.
EBCT is a relatively costly test ($300-$400) in search of a clinical niche. It is no better at predicting coronary outcomes than traditional risk-factor modeling or the use of Framingham data. There is no evidence to support the routine use of EBCT as a screening tool for coronary disease in an asymptomatic population.
BACKGROUND: Coronary artery disease remains the leading cause of death in the United States. Currently clinicians rely on traditional models of risk-factor analysis to predict coronary outcomes. EBCT has recently been identified as a tool for measuring calcium within the coronary arteries and promoted as a means of predicting coronary risk. The use of EBCT as a prognostic or screening tool is based on the premise of a causal and incremental association between coronary artery calcium and atherosclerosis.1,2 More coronary calcium means more atherosclerotic heart disease, which in turn means a higher risk for coronary events. The objective of this study was to review the literature on EBCT as a noninvasive method for predicting subsequent coronary events.
POPULATION STUDIED: The average age of a study participant in the 5 identified studies was 57 years, and 74% were men. The study setting (ie, primary care or referral) and the subject ethnicity were not reported. The baseline cardiovascular risk of participants was inconsistently reported.
STUDY DESIGN AND VALIDITY: This study was a meta-analysis. The authors searched the literature for articles pertaining to EBCT, heart disease, and prognosis. Studies were included if they were performed on an asymptomatic adult population with adequate follow-up (minimum of 36 months) and assessment of coronary outcomes (myocardial infarction [MI] or death) was reported. The authors included data from ongoing and unpublished studies. Incomplete data were imputed in a conservative fashion to limit bias toward the alternative hypothesis. Two authors independently reviewed the data, and differences were reconciled by group consensus. A random effects model was used to calculate summary estimates of the risk ratios.
OUTCOMES MEASURED: The primary outcome measures were risk ratios for hard coronary events (MI and cardiac death) and combined events (MI, cardiac death, and revascularization procedures).
RESULTS: Nine studies (4 published articles and 5 abstracts) were identified. Three were duplicate publications that reported the same data as another study, and one had only 33% follow-up; these were appropriately excluded. The remaining 5 studies with 4348 patients were included. There was significant heterogeneity between studies, with the best designed study having among the lowest risk ratios (2.3). The summary estimates calculated using a random effects model showed that patients with higher calcium scores by EBCT were at an increased risk of hard events (summary risk ratio=4.2; 95% confidence interval [CI], 1.6-11.3) and combined events (summary risk ratio=8.7; 95% CI, 2.7-28.1). However, these calculations should not have been reported in the first place because of the broad methodologic differences between studies and their significant heterogeneity. These major flaws greatly weaken the conclusions that can be drawn from this meta-analysis.
EBCT is a relatively costly test ($300-$400) in search of a clinical niche. It is no better at predicting coronary outcomes than traditional risk-factor modeling or the use of Framingham data. There is no evidence to support the routine use of EBCT as a screening tool for coronary disease in an asymptomatic population.
BACKGROUND: Coronary artery disease remains the leading cause of death in the United States. Currently clinicians rely on traditional models of risk-factor analysis to predict coronary outcomes. EBCT has recently been identified as a tool for measuring calcium within the coronary arteries and promoted as a means of predicting coronary risk. The use of EBCT as a prognostic or screening tool is based on the premise of a causal and incremental association between coronary artery calcium and atherosclerosis.1,2 More coronary calcium means more atherosclerotic heart disease, which in turn means a higher risk for coronary events. The objective of this study was to review the literature on EBCT as a noninvasive method for predicting subsequent coronary events.
POPULATION STUDIED: The average age of a study participant in the 5 identified studies was 57 years, and 74% were men. The study setting (ie, primary care or referral) and the subject ethnicity were not reported. The baseline cardiovascular risk of participants was inconsistently reported.
STUDY DESIGN AND VALIDITY: This study was a meta-analysis. The authors searched the literature for articles pertaining to EBCT, heart disease, and prognosis. Studies were included if they were performed on an asymptomatic adult population with adequate follow-up (minimum of 36 months) and assessment of coronary outcomes (myocardial infarction [MI] or death) was reported. The authors included data from ongoing and unpublished studies. Incomplete data were imputed in a conservative fashion to limit bias toward the alternative hypothesis. Two authors independently reviewed the data, and differences were reconciled by group consensus. A random effects model was used to calculate summary estimates of the risk ratios.
OUTCOMES MEASURED: The primary outcome measures were risk ratios for hard coronary events (MI and cardiac death) and combined events (MI, cardiac death, and revascularization procedures).
RESULTS: Nine studies (4 published articles and 5 abstracts) were identified. Three were duplicate publications that reported the same data as another study, and one had only 33% follow-up; these were appropriately excluded. The remaining 5 studies with 4348 patients were included. There was significant heterogeneity between studies, with the best designed study having among the lowest risk ratios (2.3). The summary estimates calculated using a random effects model showed that patients with higher calcium scores by EBCT were at an increased risk of hard events (summary risk ratio=4.2; 95% confidence interval [CI], 1.6-11.3) and combined events (summary risk ratio=8.7; 95% CI, 2.7-28.1). However, these calculations should not have been reported in the first place because of the broad methodologic differences between studies and their significant heterogeneity. These major flaws greatly weaken the conclusions that can be drawn from this meta-analysis.
EBCT is a relatively costly test ($300-$400) in search of a clinical niche. It is no better at predicting coronary outcomes than traditional risk-factor modeling or the use of Framingham data. There is no evidence to support the routine use of EBCT as a screening tool for coronary disease in an asymptomatic population.
Does nefazadone alone, the cognitive behavioral-analysis system of psychotherapy, or the combination of both work best for patients with chronic depression?
BACKGROUND: Approximately 3% of the population suffer from chronic depression. These persons have significant impairments in psychosocial function and work performance, use health care resources disproportionately, and have more suicide attempts and hospitalizations than patients with acute depression. Because chronic depression often responds poorly to monotherapy, the authors compared nefazadone with and without cognitive behavioral-analysis psychotherapy in this group.
POPULATION STUDIED: The investigators screened 1035 patients and enrolled 681. Patients were excluded for a large number of comorbid conditions. Patients who had failed to respond to an adequate trial of nefazadone or the cognitive behavioral-analysis system of psychotherapy were also excluded. The remaining 681 patients came from 12 academic centers between 1996 and 1997. They were aged between 18 and 75 years and scored at least 20 on the Hamilton Rating Scale for Depression. Approximately one third had a history of anxiety disorder, and more than half had a diagnosis of coexisting personality disorder.
STUDY DESIGN AND VALIDITY: Patients were randomly assigned to receive nefazadone, psychotherapy, or a combination of both. Although patients and clinicians were not blinded to their treatment group, the clinical raters who evaluated the Hamilton Rating Scale for Depression were masked regarding the treatment assignment. The investigators performed a modified intention-to-treat analysis that included all patients who attended at least one treatment session and had at least one assessment after the baseline evaluation. The groups were similar in terms of diagnosis, duration of symptoms, past antidepressant use, previous psychotherapy, and global assessment of function score.
OUTCOMES MEASURED: The primary outcome was the overall rate of response at 12 weeks, which was the sum of patients with a satisfactory response and remission using the Hamilton Depression Score Rating Scale. A satisfactory response was defined as a reduction of 50% on the rating scale from baseline to weeks 10 and 12, while remission was defined as a score of 8 or less at weeks 10 and 12.
RESULTS: For the modified intention-to-treat analysis, the overall rates of response were 48% in the psychotherapy group (95% confidence interval [CI], 41.5%-54.8%), 48% (95% CI, 41%-54.3%) in the nefazadone group, and 73% (95% CI, 68.6%-80.1%) in the combined treatment group (P <.001 for the difference between each monotherapy and combined therapy). The rates of remission were 33% in the psychotherapy group, 29% in the nefazadone group, and 48% in the combined treatment group (P <.001). The rates of discontinuation were similar in the 3 groups, with 24% not completing the trial. Patients receiving nefazadone were more likely to withdraw because of adverse drug effects (including headache, dry mouth, somnolence, dizziness, agitation, and gastrointestinal symptoms), while those in psychotherapy tended to withdraw because of time constraints or because they wanted medication instead of psychotherapy.
Patients with chronic depression benefit more from a combination of medical treatment with nefazadone and cognitive behavioral-analysis psychotherapy than from either intervention alone (number needed to treat=4). For every 4 patients treated with combined therapy instead of monotherapy, 1 additional patient will have a satisfactory response or remission at 12 weeks. It is unclear how long the effect lasts or how long such therapy would be needed. It is likely that other antidepressants will give similar results to nefazadone.
BACKGROUND: Approximately 3% of the population suffer from chronic depression. These persons have significant impairments in psychosocial function and work performance, use health care resources disproportionately, and have more suicide attempts and hospitalizations than patients with acute depression. Because chronic depression often responds poorly to monotherapy, the authors compared nefazadone with and without cognitive behavioral-analysis psychotherapy in this group.
POPULATION STUDIED: The investigators screened 1035 patients and enrolled 681. Patients were excluded for a large number of comorbid conditions. Patients who had failed to respond to an adequate trial of nefazadone or the cognitive behavioral-analysis system of psychotherapy were also excluded. The remaining 681 patients came from 12 academic centers between 1996 and 1997. They were aged between 18 and 75 years and scored at least 20 on the Hamilton Rating Scale for Depression. Approximately one third had a history of anxiety disorder, and more than half had a diagnosis of coexisting personality disorder.
STUDY DESIGN AND VALIDITY: Patients were randomly assigned to receive nefazadone, psychotherapy, or a combination of both. Although patients and clinicians were not blinded to their treatment group, the clinical raters who evaluated the Hamilton Rating Scale for Depression were masked regarding the treatment assignment. The investigators performed a modified intention-to-treat analysis that included all patients who attended at least one treatment session and had at least one assessment after the baseline evaluation. The groups were similar in terms of diagnosis, duration of symptoms, past antidepressant use, previous psychotherapy, and global assessment of function score.
OUTCOMES MEASURED: The primary outcome was the overall rate of response at 12 weeks, which was the sum of patients with a satisfactory response and remission using the Hamilton Depression Score Rating Scale. A satisfactory response was defined as a reduction of 50% on the rating scale from baseline to weeks 10 and 12, while remission was defined as a score of 8 or less at weeks 10 and 12.
RESULTS: For the modified intention-to-treat analysis, the overall rates of response were 48% in the psychotherapy group (95% confidence interval [CI], 41.5%-54.8%), 48% (95% CI, 41%-54.3%) in the nefazadone group, and 73% (95% CI, 68.6%-80.1%) in the combined treatment group (P <.001 for the difference between each monotherapy and combined therapy). The rates of remission were 33% in the psychotherapy group, 29% in the nefazadone group, and 48% in the combined treatment group (P <.001). The rates of discontinuation were similar in the 3 groups, with 24% not completing the trial. Patients receiving nefazadone were more likely to withdraw because of adverse drug effects (including headache, dry mouth, somnolence, dizziness, agitation, and gastrointestinal symptoms), while those in psychotherapy tended to withdraw because of time constraints or because they wanted medication instead of psychotherapy.
Patients with chronic depression benefit more from a combination of medical treatment with nefazadone and cognitive behavioral-analysis psychotherapy than from either intervention alone (number needed to treat=4). For every 4 patients treated with combined therapy instead of monotherapy, 1 additional patient will have a satisfactory response or remission at 12 weeks. It is unclear how long the effect lasts or how long such therapy would be needed. It is likely that other antidepressants will give similar results to nefazadone.
BACKGROUND: Approximately 3% of the population suffer from chronic depression. These persons have significant impairments in psychosocial function and work performance, use health care resources disproportionately, and have more suicide attempts and hospitalizations than patients with acute depression. Because chronic depression often responds poorly to monotherapy, the authors compared nefazadone with and without cognitive behavioral-analysis psychotherapy in this group.
POPULATION STUDIED: The investigators screened 1035 patients and enrolled 681. Patients were excluded for a large number of comorbid conditions. Patients who had failed to respond to an adequate trial of nefazadone or the cognitive behavioral-analysis system of psychotherapy were also excluded. The remaining 681 patients came from 12 academic centers between 1996 and 1997. They were aged between 18 and 75 years and scored at least 20 on the Hamilton Rating Scale for Depression. Approximately one third had a history of anxiety disorder, and more than half had a diagnosis of coexisting personality disorder.
STUDY DESIGN AND VALIDITY: Patients were randomly assigned to receive nefazadone, psychotherapy, or a combination of both. Although patients and clinicians were not blinded to their treatment group, the clinical raters who evaluated the Hamilton Rating Scale for Depression were masked regarding the treatment assignment. The investigators performed a modified intention-to-treat analysis that included all patients who attended at least one treatment session and had at least one assessment after the baseline evaluation. The groups were similar in terms of diagnosis, duration of symptoms, past antidepressant use, previous psychotherapy, and global assessment of function score.
OUTCOMES MEASURED: The primary outcome was the overall rate of response at 12 weeks, which was the sum of patients with a satisfactory response and remission using the Hamilton Depression Score Rating Scale. A satisfactory response was defined as a reduction of 50% on the rating scale from baseline to weeks 10 and 12, while remission was defined as a score of 8 or less at weeks 10 and 12.
RESULTS: For the modified intention-to-treat analysis, the overall rates of response were 48% in the psychotherapy group (95% confidence interval [CI], 41.5%-54.8%), 48% (95% CI, 41%-54.3%) in the nefazadone group, and 73% (95% CI, 68.6%-80.1%) in the combined treatment group (P <.001 for the difference between each monotherapy and combined therapy). The rates of remission were 33% in the psychotherapy group, 29% in the nefazadone group, and 48% in the combined treatment group (P <.001). The rates of discontinuation were similar in the 3 groups, with 24% not completing the trial. Patients receiving nefazadone were more likely to withdraw because of adverse drug effects (including headache, dry mouth, somnolence, dizziness, agitation, and gastrointestinal symptoms), while those in psychotherapy tended to withdraw because of time constraints or because they wanted medication instead of psychotherapy.
Patients with chronic depression benefit more from a combination of medical treatment with nefazadone and cognitive behavioral-analysis psychotherapy than from either intervention alone (number needed to treat=4). For every 4 patients treated with combined therapy instead of monotherapy, 1 additional patient will have a satisfactory response or remission at 12 weeks. It is unclear how long the effect lasts or how long such therapy would be needed. It is likely that other antidepressants will give similar results to nefazadone.
Does the addition of mouth-to-mouth ventilation to chest compressions improve survival in bystander treatment of cardiac arrest?
BACKGROUND: Cardiopulmonary resuscitation (CPR) initiated at the scene of a cardiac arrest may increase survival by up to 50%. In some locations 911 dispatchers provide instructions for CPR to untrained bystanders. Bystanders who witness a cardiac arrest often do not perform CPR because of fears of contamination and contagion. A pilot study performed in King County, Washington, showed a 3.5% increase in survival with chest compressions alone when compared with chest compressions with mouth-to-mouth ventilation.
POPULATION STUDIED: The study was performed in the Seattle, Washington, area with a fire department-based emergency medical care system. Patients were enrolled if they had a cardiac arrest diagnosed over the telephone by the dispatcher and there was a bystander willing to be instructed. A total of 1296 patients were included in the trial. Of these, 776 were excluded on the basis of a subsequent paramedic report of drug or alcohol overdose, carbon monoxide poisoning, trauma, or absence of cardiac arrest. The 520 remaining patients had an average age of 68 years, 64% were men, 58% had a witnessed cardiac arrest, and 88% occurred in a home.
STUDY DESIGN AND VALIDITY: After receiving a 911 call the emergency medical services (EMS) dispatcher would determine if the patient was eligible for this study. On the basis of computer randomization, the dispatcher provided instructions for traditional CPR or chest compressions alone. A total of 1296 patients were randomized; after exclusions 520 were analyzed. Of these, 241 were assigned to receive chest compressions alone and 279 to receive the traditional method of CPR. The study design was reasonable given the limitations of performing a trial under these circumstances.
OUTCOMES MEASURED: The primary outcome measured was survival to hospital discharge. Secondary outcomes included admission to the hospital, neurologic status of the survivors, duration of instructions, and bystander opinions.
RESULTS: Of the 520 patients included in the study, 64 survived to hospital discharge. Twenty-nine patients (10.4%) survived in the CPR with mouth-to-mouth ventilation group, and 35 patients (14.6%) survived in the chest compressions only group. There was no statistically significant difference in survival to discharge between the 2 groups (P=.18). A similar nonsignificant trend was noted for hospitalizations, with 34.1% of patients in the CPR group admitted to the hospital and 40.2% of the patients in the chest compressions-only group admitted (P=.15). There was no difference found in neurologic morbidity after a mean follow-up time of 2.4 years. Fewer bystanders refused the instructions in the compressions-only group (7.2% vs 2.9%), and instruction time was much shorter (1 minute vs 2.4 minutes). Compliance of the EMS dispatchers with the written protocol was excellent.
Chest compressions alone are as effective as CPR with mouth-to-mouth ventilation during the first few minutes of a cardiac arrest. This study was performed in an urban area with prompt EMS response (approximately 4 minutes to arrive on the scene). Whether these findings would apply in areas with longer response times is unknown: The overall effect may be hard to identify given the very poor outcomes associated with longer response times. Although not part of the study, the authors speculate that opening the airway may be a beneficial adjunct maneuver, since the compressions alone can move some air. When offering untrained bystanders instructions during cardiac arrests, EMS dispatchers need not teach mouth-to-mouth ventilation.
BACKGROUND: Cardiopulmonary resuscitation (CPR) initiated at the scene of a cardiac arrest may increase survival by up to 50%. In some locations 911 dispatchers provide instructions for CPR to untrained bystanders. Bystanders who witness a cardiac arrest often do not perform CPR because of fears of contamination and contagion. A pilot study performed in King County, Washington, showed a 3.5% increase in survival with chest compressions alone when compared with chest compressions with mouth-to-mouth ventilation.
POPULATION STUDIED: The study was performed in the Seattle, Washington, area with a fire department-based emergency medical care system. Patients were enrolled if they had a cardiac arrest diagnosed over the telephone by the dispatcher and there was a bystander willing to be instructed. A total of 1296 patients were included in the trial. Of these, 776 were excluded on the basis of a subsequent paramedic report of drug or alcohol overdose, carbon monoxide poisoning, trauma, or absence of cardiac arrest. The 520 remaining patients had an average age of 68 years, 64% were men, 58% had a witnessed cardiac arrest, and 88% occurred in a home.
STUDY DESIGN AND VALIDITY: After receiving a 911 call the emergency medical services (EMS) dispatcher would determine if the patient was eligible for this study. On the basis of computer randomization, the dispatcher provided instructions for traditional CPR or chest compressions alone. A total of 1296 patients were randomized; after exclusions 520 were analyzed. Of these, 241 were assigned to receive chest compressions alone and 279 to receive the traditional method of CPR. The study design was reasonable given the limitations of performing a trial under these circumstances.
OUTCOMES MEASURED: The primary outcome measured was survival to hospital discharge. Secondary outcomes included admission to the hospital, neurologic status of the survivors, duration of instructions, and bystander opinions.
RESULTS: Of the 520 patients included in the study, 64 survived to hospital discharge. Twenty-nine patients (10.4%) survived in the CPR with mouth-to-mouth ventilation group, and 35 patients (14.6%) survived in the chest compressions only group. There was no statistically significant difference in survival to discharge between the 2 groups (P=.18). A similar nonsignificant trend was noted for hospitalizations, with 34.1% of patients in the CPR group admitted to the hospital and 40.2% of the patients in the chest compressions-only group admitted (P=.15). There was no difference found in neurologic morbidity after a mean follow-up time of 2.4 years. Fewer bystanders refused the instructions in the compressions-only group (7.2% vs 2.9%), and instruction time was much shorter (1 minute vs 2.4 minutes). Compliance of the EMS dispatchers with the written protocol was excellent.
Chest compressions alone are as effective as CPR with mouth-to-mouth ventilation during the first few minutes of a cardiac arrest. This study was performed in an urban area with prompt EMS response (approximately 4 minutes to arrive on the scene). Whether these findings would apply in areas with longer response times is unknown: The overall effect may be hard to identify given the very poor outcomes associated with longer response times. Although not part of the study, the authors speculate that opening the airway may be a beneficial adjunct maneuver, since the compressions alone can move some air. When offering untrained bystanders instructions during cardiac arrests, EMS dispatchers need not teach mouth-to-mouth ventilation.
BACKGROUND: Cardiopulmonary resuscitation (CPR) initiated at the scene of a cardiac arrest may increase survival by up to 50%. In some locations 911 dispatchers provide instructions for CPR to untrained bystanders. Bystanders who witness a cardiac arrest often do not perform CPR because of fears of contamination and contagion. A pilot study performed in King County, Washington, showed a 3.5% increase in survival with chest compressions alone when compared with chest compressions with mouth-to-mouth ventilation.
POPULATION STUDIED: The study was performed in the Seattle, Washington, area with a fire department-based emergency medical care system. Patients were enrolled if they had a cardiac arrest diagnosed over the telephone by the dispatcher and there was a bystander willing to be instructed. A total of 1296 patients were included in the trial. Of these, 776 were excluded on the basis of a subsequent paramedic report of drug or alcohol overdose, carbon monoxide poisoning, trauma, or absence of cardiac arrest. The 520 remaining patients had an average age of 68 years, 64% were men, 58% had a witnessed cardiac arrest, and 88% occurred in a home.
STUDY DESIGN AND VALIDITY: After receiving a 911 call the emergency medical services (EMS) dispatcher would determine if the patient was eligible for this study. On the basis of computer randomization, the dispatcher provided instructions for traditional CPR or chest compressions alone. A total of 1296 patients were randomized; after exclusions 520 were analyzed. Of these, 241 were assigned to receive chest compressions alone and 279 to receive the traditional method of CPR. The study design was reasonable given the limitations of performing a trial under these circumstances.
OUTCOMES MEASURED: The primary outcome measured was survival to hospital discharge. Secondary outcomes included admission to the hospital, neurologic status of the survivors, duration of instructions, and bystander opinions.
RESULTS: Of the 520 patients included in the study, 64 survived to hospital discharge. Twenty-nine patients (10.4%) survived in the CPR with mouth-to-mouth ventilation group, and 35 patients (14.6%) survived in the chest compressions only group. There was no statistically significant difference in survival to discharge between the 2 groups (P=.18). A similar nonsignificant trend was noted for hospitalizations, with 34.1% of patients in the CPR group admitted to the hospital and 40.2% of the patients in the chest compressions-only group admitted (P=.15). There was no difference found in neurologic morbidity after a mean follow-up time of 2.4 years. Fewer bystanders refused the instructions in the compressions-only group (7.2% vs 2.9%), and instruction time was much shorter (1 minute vs 2.4 minutes). Compliance of the EMS dispatchers with the written protocol was excellent.
Chest compressions alone are as effective as CPR with mouth-to-mouth ventilation during the first few minutes of a cardiac arrest. This study was performed in an urban area with prompt EMS response (approximately 4 minutes to arrive on the scene). Whether these findings would apply in areas with longer response times is unknown: The overall effect may be hard to identify given the very poor outcomes associated with longer response times. Although not part of the study, the authors speculate that opening the airway may be a beneficial adjunct maneuver, since the compressions alone can move some air. When offering untrained bystanders instructions during cardiac arrests, EMS dispatchers need not teach mouth-to-mouth ventilation.
Does coffee protect against the development of Parkinson disease (PD)?
BACKGROUND: The suffering of patients with PD is substantial, and understanding risk factors for its development could make prevention or amelioration of its course possible. This prospective cohort study evaluated the effect of coffee and caffeine on the development of PD.
POPULATION STUDIED: A total of 8004 Japanese American men aged between 45 and 68 years were enrolled in the Honolulu Heart Program between 1965 and 1968. The subjects were identified through World War II selective services files; the median age was 53 years at enrollment. Women, other races, and younger men were not represented in this study, so family physicians should be cautious about generalizing the results to those patients.
STUDY DESIGN AND VALIDITY: This prospective cohort study was initiated more than 30 years ago. Caffeine and coffee intake was assessed at enrollment by 24-hour dietary recall, and 6 years later by food frequency questionnaire. Incident cases of PD were identified by review of hospitalization records, death certificates, and local neurologists’ records using well-established published case definitions and after 1991 direct examination of the entire cohort by a study neurologist. Proportional hazards modeling was used to adjust for age and cigarette smoking and to assess potential confounding by alcohol intake, dietary fat, physical activity, cholesterol, hypertension, and diabetes. This study was well done. Its strengths include its prospective design, rigorous assessment of dietary intake, excellent follow-up, careful case ascertainment, and assessment for a variety of confounding variables. Minor weaknesses include the lack of reviewers blind to exposure and the possibility of other confounding variables, such as medical treatments or dietary trace elements.
OUTCOMES MEASURED: The primary outcome was the relative risk of PD for different levels of coffee and caffeine consumption. The authors did not measure the clinical outcomes of PD, such as functional status or quality of life, which might be valuable for primary care physicians who are considering advising substantial lifestyle change to prevent PD.
RESULTS: A total of 8004 subjects (99.9% of the original cohort) were followed for an average of 27 years; 102 cases of PD were identified. The adjusted relative risk of developing PD was 5.1 (95% confidence interval, 1.8-14.4; number needed to treat=125) for noncoffee drinkers compared with those who drank 28 ounces or more of coffee per day. A dose-response relationship was observed; higher amounts of daily coffee intake were associated with lower relative risks of PD. This relationship was also seen with caffeine and caffeine derived from noncoffee sources. Other nutrients found in coffee (ie, niacin) or used in coffee (ie, milk or sugar) were analyzed and found to have no impact on the relationship observed between coffee and PD.
This well-designed prospective study provides good evidence that an inverse relationship exists between coffee intake and the development of PD and suggests that caffeine may be an important mediator of this effect. However, a single study does not prove that coffee is protective. The mechanism by which coffee may protect against PD is not understood, and confounding variables not measured in this study could be responsible for the results obtained. Consistent findings with multiple well-designed studies in a variety of populations are needed before a causal relationship can be established.
Should family physicians advise patients to drink coffee? The prevalence of PD in family practice is significant but still relatively small. The increased rate of PD for patients with more usual amounts of coffee each day (4-28 oz/day) is modest. There may also be health risks of drinking large amounts of coffee per day, although few have been identified in the literature. Clinicians should not counsel patients to drink coffee to protect against PD until more data become available.
BACKGROUND: The suffering of patients with PD is substantial, and understanding risk factors for its development could make prevention or amelioration of its course possible. This prospective cohort study evaluated the effect of coffee and caffeine on the development of PD.
POPULATION STUDIED: A total of 8004 Japanese American men aged between 45 and 68 years were enrolled in the Honolulu Heart Program between 1965 and 1968. The subjects were identified through World War II selective services files; the median age was 53 years at enrollment. Women, other races, and younger men were not represented in this study, so family physicians should be cautious about generalizing the results to those patients.
STUDY DESIGN AND VALIDITY: This prospective cohort study was initiated more than 30 years ago. Caffeine and coffee intake was assessed at enrollment by 24-hour dietary recall, and 6 years later by food frequency questionnaire. Incident cases of PD were identified by review of hospitalization records, death certificates, and local neurologists’ records using well-established published case definitions and after 1991 direct examination of the entire cohort by a study neurologist. Proportional hazards modeling was used to adjust for age and cigarette smoking and to assess potential confounding by alcohol intake, dietary fat, physical activity, cholesterol, hypertension, and diabetes. This study was well done. Its strengths include its prospective design, rigorous assessment of dietary intake, excellent follow-up, careful case ascertainment, and assessment for a variety of confounding variables. Minor weaknesses include the lack of reviewers blind to exposure and the possibility of other confounding variables, such as medical treatments or dietary trace elements.
OUTCOMES MEASURED: The primary outcome was the relative risk of PD for different levels of coffee and caffeine consumption. The authors did not measure the clinical outcomes of PD, such as functional status or quality of life, which might be valuable for primary care physicians who are considering advising substantial lifestyle change to prevent PD.
RESULTS: A total of 8004 subjects (99.9% of the original cohort) were followed for an average of 27 years; 102 cases of PD were identified. The adjusted relative risk of developing PD was 5.1 (95% confidence interval, 1.8-14.4; number needed to treat=125) for noncoffee drinkers compared with those who drank 28 ounces or more of coffee per day. A dose-response relationship was observed; higher amounts of daily coffee intake were associated with lower relative risks of PD. This relationship was also seen with caffeine and caffeine derived from noncoffee sources. Other nutrients found in coffee (ie, niacin) or used in coffee (ie, milk or sugar) were analyzed and found to have no impact on the relationship observed between coffee and PD.
This well-designed prospective study provides good evidence that an inverse relationship exists between coffee intake and the development of PD and suggests that caffeine may be an important mediator of this effect. However, a single study does not prove that coffee is protective. The mechanism by which coffee may protect against PD is not understood, and confounding variables not measured in this study could be responsible for the results obtained. Consistent findings with multiple well-designed studies in a variety of populations are needed before a causal relationship can be established.
Should family physicians advise patients to drink coffee? The prevalence of PD in family practice is significant but still relatively small. The increased rate of PD for patients with more usual amounts of coffee each day (4-28 oz/day) is modest. There may also be health risks of drinking large amounts of coffee per day, although few have been identified in the literature. Clinicians should not counsel patients to drink coffee to protect against PD until more data become available.
BACKGROUND: The suffering of patients with PD is substantial, and understanding risk factors for its development could make prevention or amelioration of its course possible. This prospective cohort study evaluated the effect of coffee and caffeine on the development of PD.
POPULATION STUDIED: A total of 8004 Japanese American men aged between 45 and 68 years were enrolled in the Honolulu Heart Program between 1965 and 1968. The subjects were identified through World War II selective services files; the median age was 53 years at enrollment. Women, other races, and younger men were not represented in this study, so family physicians should be cautious about generalizing the results to those patients.
STUDY DESIGN AND VALIDITY: This prospective cohort study was initiated more than 30 years ago. Caffeine and coffee intake was assessed at enrollment by 24-hour dietary recall, and 6 years later by food frequency questionnaire. Incident cases of PD were identified by review of hospitalization records, death certificates, and local neurologists’ records using well-established published case definitions and after 1991 direct examination of the entire cohort by a study neurologist. Proportional hazards modeling was used to adjust for age and cigarette smoking and to assess potential confounding by alcohol intake, dietary fat, physical activity, cholesterol, hypertension, and diabetes. This study was well done. Its strengths include its prospective design, rigorous assessment of dietary intake, excellent follow-up, careful case ascertainment, and assessment for a variety of confounding variables. Minor weaknesses include the lack of reviewers blind to exposure and the possibility of other confounding variables, such as medical treatments or dietary trace elements.
OUTCOMES MEASURED: The primary outcome was the relative risk of PD for different levels of coffee and caffeine consumption. The authors did not measure the clinical outcomes of PD, such as functional status or quality of life, which might be valuable for primary care physicians who are considering advising substantial lifestyle change to prevent PD.
RESULTS: A total of 8004 subjects (99.9% of the original cohort) were followed for an average of 27 years; 102 cases of PD were identified. The adjusted relative risk of developing PD was 5.1 (95% confidence interval, 1.8-14.4; number needed to treat=125) for noncoffee drinkers compared with those who drank 28 ounces or more of coffee per day. A dose-response relationship was observed; higher amounts of daily coffee intake were associated with lower relative risks of PD. This relationship was also seen with caffeine and caffeine derived from noncoffee sources. Other nutrients found in coffee (ie, niacin) or used in coffee (ie, milk or sugar) were analyzed and found to have no impact on the relationship observed between coffee and PD.
This well-designed prospective study provides good evidence that an inverse relationship exists between coffee intake and the development of PD and suggests that caffeine may be an important mediator of this effect. However, a single study does not prove that coffee is protective. The mechanism by which coffee may protect against PD is not understood, and confounding variables not measured in this study could be responsible for the results obtained. Consistent findings with multiple well-designed studies in a variety of populations are needed before a causal relationship can be established.
Should family physicians advise patients to drink coffee? The prevalence of PD in family practice is significant but still relatively small. The increased rate of PD for patients with more usual amounts of coffee each day (4-28 oz/day) is modest. There may also be health risks of drinking large amounts of coffee per day, although few have been identified in the literature. Clinicians should not counsel patients to drink coffee to protect against PD until more data become available.
In children with asthma, do inhaled steroids reduce linear growth (height)?
BACKGROUND: Inhaled corticosteroids have been recommended as an important part of asthma therapy in children; however, there have been concerns about long-term side effects of these medications. In 1994, Allen1 published a meta-analysis of trials of inhaled steroids that suggested that inhaled corticosteroids (beclomethasone dipropionate) were not associated with growth delay. Because of some methodologic criticisms of that meta-analysis and because of 3 newer studies on the topic, the authors of this Cochrane review decided to reexamine the literature.
POPULATION STUDIED: The authors performed an exhaustive search of the literature using the methods typically employed by Cochrane reviewers, including searching the Cochrane Airways Group Asthma Trials registry, searching bibliographies of trials on the subject, and contacting colleagues and researchers in the field. The authors selected only studies involving children (aged <18 years) with asthma who had not been taking inhaled or oral steroids for at least 3 months. These studies had to be randomized controlled trials comparing beclomethasone with nonsteroidal medication and had to have data from which linear growth velocity could be calculated. Interestingly, there was no overlap between the studies evaluated (regardless of inclusion) for this review and the studies included in the meta-analysis by Allen. Only 3 studies were found that met the inclusion criteria. The patients in these studies were diagnosed with clinically stable asthma in the mild to moderate category. No information on the ages of the subjects was available from the primary authors. All of these trials used 200 mg of beclomethasone delivered by diskhaler (a dry powder inhaler) for 7 to 12 months.
STUDY DESIGN AND VALIDITY: The review methodology used was standard for the Cochrane Collaboration. The authors assessed study quality by examining randomization adequacy, allocation concealment, blinding, and description of withdrawals. They performed the final study selection independently and resolved disagreement by consensus. They both abstracted the data and contacted the primary authors of the original studies to fill in data where needed. The appropriate subgroup and sensitivity analyses were planned and performed when necessary.
OUTCOMES MEASURED: The main outcome measure was change in growth velocity (measured in cm/yr).
RESULTS: There were some important differences between the trials that could have implications for the generalizability and validity of the review, such as the definition of asthma and the 10% to 25% dropout rates. The dropout rates were adequately explained in each study, but only one study used intention-to-treat analysis to compensate for the dropout rates. There was a mean reduction in growth velocity of 1.54 cm per year (95% confidence interval, 1.15-1.94 cm/yr), corresponding to a reduction in growth velocity of 25%. The sensitivity analyses performed for methodologic quality, publication bias, and statistical model did not reveal any significant concerns for the validity of the meta-analysis, and there was no significant heterogeneity between the studies.
The authors of this study found a decrease in growth velocity with chronic administration of inhaled beclomethasone in children with asthma. The lack of published data about other inhaled steroids makes it difficult to generalize this finding. This reduction does seem, however, to be independent of the usual confounders of height (eg, severity of asthma, parental height, and so forth). In addition, there were no data in this review concerning final adult height to address the clinical impact of steroids on the age-related change in growth velocity. Given the concerning results of this study, clinicians should counsel families about the beneficial effects of inhaled steroids on controlling asthma and their possible negative effects on growth and should minimize the dose of any required inhaled steroid therapy.
BACKGROUND: Inhaled corticosteroids have been recommended as an important part of asthma therapy in children; however, there have been concerns about long-term side effects of these medications. In 1994, Allen1 published a meta-analysis of trials of inhaled steroids that suggested that inhaled corticosteroids (beclomethasone dipropionate) were not associated with growth delay. Because of some methodologic criticisms of that meta-analysis and because of 3 newer studies on the topic, the authors of this Cochrane review decided to reexamine the literature.
POPULATION STUDIED: The authors performed an exhaustive search of the literature using the methods typically employed by Cochrane reviewers, including searching the Cochrane Airways Group Asthma Trials registry, searching bibliographies of trials on the subject, and contacting colleagues and researchers in the field. The authors selected only studies involving children (aged <18 years) with asthma who had not been taking inhaled or oral steroids for at least 3 months. These studies had to be randomized controlled trials comparing beclomethasone with nonsteroidal medication and had to have data from which linear growth velocity could be calculated. Interestingly, there was no overlap between the studies evaluated (regardless of inclusion) for this review and the studies included in the meta-analysis by Allen. Only 3 studies were found that met the inclusion criteria. The patients in these studies were diagnosed with clinically stable asthma in the mild to moderate category. No information on the ages of the subjects was available from the primary authors. All of these trials used 200 mg of beclomethasone delivered by diskhaler (a dry powder inhaler) for 7 to 12 months.
STUDY DESIGN AND VALIDITY: The review methodology used was standard for the Cochrane Collaboration. The authors assessed study quality by examining randomization adequacy, allocation concealment, blinding, and description of withdrawals. They performed the final study selection independently and resolved disagreement by consensus. They both abstracted the data and contacted the primary authors of the original studies to fill in data where needed. The appropriate subgroup and sensitivity analyses were planned and performed when necessary.
OUTCOMES MEASURED: The main outcome measure was change in growth velocity (measured in cm/yr).
RESULTS: There were some important differences between the trials that could have implications for the generalizability and validity of the review, such as the definition of asthma and the 10% to 25% dropout rates. The dropout rates were adequately explained in each study, but only one study used intention-to-treat analysis to compensate for the dropout rates. There was a mean reduction in growth velocity of 1.54 cm per year (95% confidence interval, 1.15-1.94 cm/yr), corresponding to a reduction in growth velocity of 25%. The sensitivity analyses performed for methodologic quality, publication bias, and statistical model did not reveal any significant concerns for the validity of the meta-analysis, and there was no significant heterogeneity between the studies.
The authors of this study found a decrease in growth velocity with chronic administration of inhaled beclomethasone in children with asthma. The lack of published data about other inhaled steroids makes it difficult to generalize this finding. This reduction does seem, however, to be independent of the usual confounders of height (eg, severity of asthma, parental height, and so forth). In addition, there were no data in this review concerning final adult height to address the clinical impact of steroids on the age-related change in growth velocity. Given the concerning results of this study, clinicians should counsel families about the beneficial effects of inhaled steroids on controlling asthma and their possible negative effects on growth and should minimize the dose of any required inhaled steroid therapy.
BACKGROUND: Inhaled corticosteroids have been recommended as an important part of asthma therapy in children; however, there have been concerns about long-term side effects of these medications. In 1994, Allen1 published a meta-analysis of trials of inhaled steroids that suggested that inhaled corticosteroids (beclomethasone dipropionate) were not associated with growth delay. Because of some methodologic criticisms of that meta-analysis and because of 3 newer studies on the topic, the authors of this Cochrane review decided to reexamine the literature.
POPULATION STUDIED: The authors performed an exhaustive search of the literature using the methods typically employed by Cochrane reviewers, including searching the Cochrane Airways Group Asthma Trials registry, searching bibliographies of trials on the subject, and contacting colleagues and researchers in the field. The authors selected only studies involving children (aged <18 years) with asthma who had not been taking inhaled or oral steroids for at least 3 months. These studies had to be randomized controlled trials comparing beclomethasone with nonsteroidal medication and had to have data from which linear growth velocity could be calculated. Interestingly, there was no overlap between the studies evaluated (regardless of inclusion) for this review and the studies included in the meta-analysis by Allen. Only 3 studies were found that met the inclusion criteria. The patients in these studies were diagnosed with clinically stable asthma in the mild to moderate category. No information on the ages of the subjects was available from the primary authors. All of these trials used 200 mg of beclomethasone delivered by diskhaler (a dry powder inhaler) for 7 to 12 months.
STUDY DESIGN AND VALIDITY: The review methodology used was standard for the Cochrane Collaboration. The authors assessed study quality by examining randomization adequacy, allocation concealment, blinding, and description of withdrawals. They performed the final study selection independently and resolved disagreement by consensus. They both abstracted the data and contacted the primary authors of the original studies to fill in data where needed. The appropriate subgroup and sensitivity analyses were planned and performed when necessary.
OUTCOMES MEASURED: The main outcome measure was change in growth velocity (measured in cm/yr).
RESULTS: There were some important differences between the trials that could have implications for the generalizability and validity of the review, such as the definition of asthma and the 10% to 25% dropout rates. The dropout rates were adequately explained in each study, but only one study used intention-to-treat analysis to compensate for the dropout rates. There was a mean reduction in growth velocity of 1.54 cm per year (95% confidence interval, 1.15-1.94 cm/yr), corresponding to a reduction in growth velocity of 25%. The sensitivity analyses performed for methodologic quality, publication bias, and statistical model did not reveal any significant concerns for the validity of the meta-analysis, and there was no significant heterogeneity between the studies.
The authors of this study found a decrease in growth velocity with chronic administration of inhaled beclomethasone in children with asthma. The lack of published data about other inhaled steroids makes it difficult to generalize this finding. This reduction does seem, however, to be independent of the usual confounders of height (eg, severity of asthma, parental height, and so forth). In addition, there were no data in this review concerning final adult height to address the clinical impact of steroids on the age-related change in growth velocity. Given the concerning results of this study, clinicians should counsel families about the beneficial effects of inhaled steroids on controlling asthma and their possible negative effects on growth and should minimize the dose of any required inhaled steroid therapy.
Is gingko biloba more effective than placebo for the treatment of intermittent claudication?
BACKGROUND: Intermittent claudication is a painful symptom of peripheral arterial disease. Nonsurgical treatment consists of modification of lifestyle risk factors (quit smoking, lower cholesterol levels), regular physical exercise, and a variety of medications. The clinical effectiveness of these interventions has usually been modest. Gingko biloba, a commonly used medicinal herb, has active ingredients that inhibit platelets and potentially decrease red blood cell aggregation. Because of these actions, it has been tested for intermittent claudication. Although some controlled studies have suggested benefit, the results have been inconclusive. The authors performed a meta-analysis to better summarize the current evidence.
POPULATION STUDIED: A total of 415 patients were included in this analysis. Their demographic information was not provided.
STUDY DESIGN AND VALIDITY: This was a meta-analysis of the existing literature. Manuscripts were identified for inclusion through a systematic search of 6 appropriate databases, contacting manufacturers of the product for published and unpublished literature, and contacting authors for additional data. Eight randomized controlled trials (RCTs) were identified that compared gingko with placebo and included an assessment of walking distance. Two researchers independently reviewed each study, grading them on quality (randomization strategy, description of withdrawals and dropouts, blinding protocol) and extracting information on pain-free walking distance. Appropriate statistical tools were used to find the pooled difference in pain-free walking distance between gingko and placebo.
OUTCOMES MEASURED: The primary outcome studied was pain-free walking distance. Seven of the 8 studies also reported maximal walking distance at baseline and after randomization to gingko or placebo. Three of the 8 studies used the same standardized assessment of treadmill walking that included ergometer speed of 3 km per hour on a grade of 12%.
RESULTS: Six of the 8 RCTs had a quality score of at least 4 on a scale of 1 to 5. Seven of the studies showed that gingko was more effective than placebo; however, only 4 of those studies were statistically significant. When all 8 studies were pooled, gingko increased pain-free walking distance by 34 meters (95% confidence interval, 26-43 m) more than placebo. When the authors pooled different subsets of articles, similar results were found. Side effects of gingko were not reported in 3 of the studies. In the remaining 5 studies, the primary side effects were abdominal complaints, nausea, and dyspepsia, although the rates were not given.
Gingko biloba extract (120 or 160 mg a day) for 24 weeks improves pain-free walking distance by 37 yards when compared with placebo. This improvement is similar to other medications used for intermittent claudication that cost at least twice as much. Gingko biloba may be an effective adjunct to smoking cessation and a walking program for intermittent claudication.
BACKGROUND: Intermittent claudication is a painful symptom of peripheral arterial disease. Nonsurgical treatment consists of modification of lifestyle risk factors (quit smoking, lower cholesterol levels), regular physical exercise, and a variety of medications. The clinical effectiveness of these interventions has usually been modest. Gingko biloba, a commonly used medicinal herb, has active ingredients that inhibit platelets and potentially decrease red blood cell aggregation. Because of these actions, it has been tested for intermittent claudication. Although some controlled studies have suggested benefit, the results have been inconclusive. The authors performed a meta-analysis to better summarize the current evidence.
POPULATION STUDIED: A total of 415 patients were included in this analysis. Their demographic information was not provided.
STUDY DESIGN AND VALIDITY: This was a meta-analysis of the existing literature. Manuscripts were identified for inclusion through a systematic search of 6 appropriate databases, contacting manufacturers of the product for published and unpublished literature, and contacting authors for additional data. Eight randomized controlled trials (RCTs) were identified that compared gingko with placebo and included an assessment of walking distance. Two researchers independently reviewed each study, grading them on quality (randomization strategy, description of withdrawals and dropouts, blinding protocol) and extracting information on pain-free walking distance. Appropriate statistical tools were used to find the pooled difference in pain-free walking distance between gingko and placebo.
OUTCOMES MEASURED: The primary outcome studied was pain-free walking distance. Seven of the 8 studies also reported maximal walking distance at baseline and after randomization to gingko or placebo. Three of the 8 studies used the same standardized assessment of treadmill walking that included ergometer speed of 3 km per hour on a grade of 12%.
RESULTS: Six of the 8 RCTs had a quality score of at least 4 on a scale of 1 to 5. Seven of the studies showed that gingko was more effective than placebo; however, only 4 of those studies were statistically significant. When all 8 studies were pooled, gingko increased pain-free walking distance by 34 meters (95% confidence interval, 26-43 m) more than placebo. When the authors pooled different subsets of articles, similar results were found. Side effects of gingko were not reported in 3 of the studies. In the remaining 5 studies, the primary side effects were abdominal complaints, nausea, and dyspepsia, although the rates were not given.
Gingko biloba extract (120 or 160 mg a day) for 24 weeks improves pain-free walking distance by 37 yards when compared with placebo. This improvement is similar to other medications used for intermittent claudication that cost at least twice as much. Gingko biloba may be an effective adjunct to smoking cessation and a walking program for intermittent claudication.
BACKGROUND: Intermittent claudication is a painful symptom of peripheral arterial disease. Nonsurgical treatment consists of modification of lifestyle risk factors (quit smoking, lower cholesterol levels), regular physical exercise, and a variety of medications. The clinical effectiveness of these interventions has usually been modest. Gingko biloba, a commonly used medicinal herb, has active ingredients that inhibit platelets and potentially decrease red blood cell aggregation. Because of these actions, it has been tested for intermittent claudication. Although some controlled studies have suggested benefit, the results have been inconclusive. The authors performed a meta-analysis to better summarize the current evidence.
POPULATION STUDIED: A total of 415 patients were included in this analysis. Their demographic information was not provided.
STUDY DESIGN AND VALIDITY: This was a meta-analysis of the existing literature. Manuscripts were identified for inclusion through a systematic search of 6 appropriate databases, contacting manufacturers of the product for published and unpublished literature, and contacting authors for additional data. Eight randomized controlled trials (RCTs) were identified that compared gingko with placebo and included an assessment of walking distance. Two researchers independently reviewed each study, grading them on quality (randomization strategy, description of withdrawals and dropouts, blinding protocol) and extracting information on pain-free walking distance. Appropriate statistical tools were used to find the pooled difference in pain-free walking distance between gingko and placebo.
OUTCOMES MEASURED: The primary outcome studied was pain-free walking distance. Seven of the 8 studies also reported maximal walking distance at baseline and after randomization to gingko or placebo. Three of the 8 studies used the same standardized assessment of treadmill walking that included ergometer speed of 3 km per hour on a grade of 12%.
RESULTS: Six of the 8 RCTs had a quality score of at least 4 on a scale of 1 to 5. Seven of the studies showed that gingko was more effective than placebo; however, only 4 of those studies were statistically significant. When all 8 studies were pooled, gingko increased pain-free walking distance by 34 meters (95% confidence interval, 26-43 m) more than placebo. When the authors pooled different subsets of articles, similar results were found. Side effects of gingko were not reported in 3 of the studies. In the remaining 5 studies, the primary side effects were abdominal complaints, nausea, and dyspepsia, although the rates were not given.
Gingko biloba extract (120 or 160 mg a day) for 24 weeks improves pain-free walking distance by 37 yards when compared with placebo. This improvement is similar to other medications used for intermittent claudication that cost at least twice as much. Gingko biloba may be an effective adjunct to smoking cessation and a walking program for intermittent claudication.
Does a high-fiber dietary supplement of wheat bran reduce the recurrence rate of colorectal adenomas?
BACKGROUND: Dietary factors, particularly insoluble fibers, have been investigated in the pathogenesis of adenomas and colorectal cancer. It has been suggested that dietary fiber confers a protective effect on the risk of recurrent colorectal adenomas. Previous studies have had varying results and have largely been case-control studies, prohibiting any firm clinical recommendations.
POPULATION STUDIED: The investigators enrolled 1429 patients aged 40 to 80 years. All patients had one or more histologically confirmed colorectal adenomas at least 3 mm in diameter removed within the 3 months before recruitment. An adequate nutritional status, normal renal and liver function, and normal functional status were required. Exclusion criteria included: a dietary fiber intake of less than 30 g per day, having invasive cancer within the previous 5 years, a history of colon resection, 2 or more first-degree relatives with colorectal cancer, and severe metabolic disorders or other severe illnesses.
STUDY DESIGN AND VALIDITY: This was a double-blinded randomized prospective trial. All patients underwent a baseline colonoscopy and successfully completed a 6-week run-in period by consuming at least 75% of the amount of a low-fiber supplement (2g/day). They were then randomized to either a high-fiber (13.5g/day, 802 subjects) or a low-fiber (2g/day, 627 subjects) supplement of wheat bran cereal. Since an interim analysis demonstrated that a higher proportion of the high-fiber group discontinued the designated supplement, the original 1:1 randomization schedule was changed to 4:1 in favor of the high-fiber group. Follow-up colonoscopy was planned for 1 year after randomization and again 2 years later. However, national screening recommendations for people with a history of colorectal adenomas changed and led to a decreased rate of colonoscopy at 1 year among subjects enrolled in the latter part of the trial. A strength of the study is the fact that the intervention was realistic and applicable to almost any primary care setting. However, the run-in period did ensure a group that was more compliant than average.
OUTCOMES MEASURED: The primary outcome was the presence or absence of new adenomas at the time of follow-up colonoscopy. Multivariate adjusted odds ratios and relative risks for recurrent adenomas were calculated.
RESULTS: A total of 1303 subjects (91.2%) completed the study. Median follow-up time was 35 months. Half of the subjects in each group had at least one adenoma found during the final follow-up colonoscopy (47% high fiber vs 51.2% low fiber, P=.13). The multivariate adjusted odds ratio for recurrent adenomas in the high-fiber versus low-fiber groups was 0.88 (95% confidence interval [CI], 0.70-1.11; P=.28) and the relative risk of adenoma recurrence was 0.99 (95% CI, 0.71-1.36; P=.93). No statistically significant difference was found between groups when analysis was restricted to the subset of 889 subjects who underwent both a 1-year colonoscopy and a repeat examination 2 years later. There was also no significant difference between groups in regard to adenoma size or histologic appearance. Compliance with the dietary supplement regimen was statistically different between the 2 groups, with a lower rate of consumption of the high-fiber supplement.
The study authors found no statistically significant reduction in the rate of recurrent colorectal adenoma with consumption of a high-dose dietary supplement of wheat bran fiber. Furthermore, a high-fiber diet did not alter the number of adenomas or the histologic features of the recurrent adenomas. The results are consistent with another study1 in the same issue of the journal. Although a high-fiber diet cannot be recommended for the prevention of recurrent colorectal adenomas, there may be other health benefits.
BACKGROUND: Dietary factors, particularly insoluble fibers, have been investigated in the pathogenesis of adenomas and colorectal cancer. It has been suggested that dietary fiber confers a protective effect on the risk of recurrent colorectal adenomas. Previous studies have had varying results and have largely been case-control studies, prohibiting any firm clinical recommendations.
POPULATION STUDIED: The investigators enrolled 1429 patients aged 40 to 80 years. All patients had one or more histologically confirmed colorectal adenomas at least 3 mm in diameter removed within the 3 months before recruitment. An adequate nutritional status, normal renal and liver function, and normal functional status were required. Exclusion criteria included: a dietary fiber intake of less than 30 g per day, having invasive cancer within the previous 5 years, a history of colon resection, 2 or more first-degree relatives with colorectal cancer, and severe metabolic disorders or other severe illnesses.
STUDY DESIGN AND VALIDITY: This was a double-blinded randomized prospective trial. All patients underwent a baseline colonoscopy and successfully completed a 6-week run-in period by consuming at least 75% of the amount of a low-fiber supplement (2g/day). They were then randomized to either a high-fiber (13.5g/day, 802 subjects) or a low-fiber (2g/day, 627 subjects) supplement of wheat bran cereal. Since an interim analysis demonstrated that a higher proportion of the high-fiber group discontinued the designated supplement, the original 1:1 randomization schedule was changed to 4:1 in favor of the high-fiber group. Follow-up colonoscopy was planned for 1 year after randomization and again 2 years later. However, national screening recommendations for people with a history of colorectal adenomas changed and led to a decreased rate of colonoscopy at 1 year among subjects enrolled in the latter part of the trial. A strength of the study is the fact that the intervention was realistic and applicable to almost any primary care setting. However, the run-in period did ensure a group that was more compliant than average.
OUTCOMES MEASURED: The primary outcome was the presence or absence of new adenomas at the time of follow-up colonoscopy. Multivariate adjusted odds ratios and relative risks for recurrent adenomas were calculated.
RESULTS: A total of 1303 subjects (91.2%) completed the study. Median follow-up time was 35 months. Half of the subjects in each group had at least one adenoma found during the final follow-up colonoscopy (47% high fiber vs 51.2% low fiber, P=.13). The multivariate adjusted odds ratio for recurrent adenomas in the high-fiber versus low-fiber groups was 0.88 (95% confidence interval [CI], 0.70-1.11; P=.28) and the relative risk of adenoma recurrence was 0.99 (95% CI, 0.71-1.36; P=.93). No statistically significant difference was found between groups when analysis was restricted to the subset of 889 subjects who underwent both a 1-year colonoscopy and a repeat examination 2 years later. There was also no significant difference between groups in regard to adenoma size or histologic appearance. Compliance with the dietary supplement regimen was statistically different between the 2 groups, with a lower rate of consumption of the high-fiber supplement.
The study authors found no statistically significant reduction in the rate of recurrent colorectal adenoma with consumption of a high-dose dietary supplement of wheat bran fiber. Furthermore, a high-fiber diet did not alter the number of adenomas or the histologic features of the recurrent adenomas. The results are consistent with another study1 in the same issue of the journal. Although a high-fiber diet cannot be recommended for the prevention of recurrent colorectal adenomas, there may be other health benefits.
BACKGROUND: Dietary factors, particularly insoluble fibers, have been investigated in the pathogenesis of adenomas and colorectal cancer. It has been suggested that dietary fiber confers a protective effect on the risk of recurrent colorectal adenomas. Previous studies have had varying results and have largely been case-control studies, prohibiting any firm clinical recommendations.
POPULATION STUDIED: The investigators enrolled 1429 patients aged 40 to 80 years. All patients had one or more histologically confirmed colorectal adenomas at least 3 mm in diameter removed within the 3 months before recruitment. An adequate nutritional status, normal renal and liver function, and normal functional status were required. Exclusion criteria included: a dietary fiber intake of less than 30 g per day, having invasive cancer within the previous 5 years, a history of colon resection, 2 or more first-degree relatives with colorectal cancer, and severe metabolic disorders or other severe illnesses.
STUDY DESIGN AND VALIDITY: This was a double-blinded randomized prospective trial. All patients underwent a baseline colonoscopy and successfully completed a 6-week run-in period by consuming at least 75% of the amount of a low-fiber supplement (2g/day). They were then randomized to either a high-fiber (13.5g/day, 802 subjects) or a low-fiber (2g/day, 627 subjects) supplement of wheat bran cereal. Since an interim analysis demonstrated that a higher proportion of the high-fiber group discontinued the designated supplement, the original 1:1 randomization schedule was changed to 4:1 in favor of the high-fiber group. Follow-up colonoscopy was planned for 1 year after randomization and again 2 years later. However, national screening recommendations for people with a history of colorectal adenomas changed and led to a decreased rate of colonoscopy at 1 year among subjects enrolled in the latter part of the trial. A strength of the study is the fact that the intervention was realistic and applicable to almost any primary care setting. However, the run-in period did ensure a group that was more compliant than average.
OUTCOMES MEASURED: The primary outcome was the presence or absence of new adenomas at the time of follow-up colonoscopy. Multivariate adjusted odds ratios and relative risks for recurrent adenomas were calculated.
RESULTS: A total of 1303 subjects (91.2%) completed the study. Median follow-up time was 35 months. Half of the subjects in each group had at least one adenoma found during the final follow-up colonoscopy (47% high fiber vs 51.2% low fiber, P=.13). The multivariate adjusted odds ratio for recurrent adenomas in the high-fiber versus low-fiber groups was 0.88 (95% confidence interval [CI], 0.70-1.11; P=.28) and the relative risk of adenoma recurrence was 0.99 (95% CI, 0.71-1.36; P=.93). No statistically significant difference was found between groups when analysis was restricted to the subset of 889 subjects who underwent both a 1-year colonoscopy and a repeat examination 2 years later. There was also no significant difference between groups in regard to adenoma size or histologic appearance. Compliance with the dietary supplement regimen was statistically different between the 2 groups, with a lower rate of consumption of the high-fiber supplement.
The study authors found no statistically significant reduction in the rate of recurrent colorectal adenoma with consumption of a high-dose dietary supplement of wheat bran fiber. Furthermore, a high-fiber diet did not alter the number of adenomas or the histologic features of the recurrent adenomas. The results are consistent with another study1 in the same issue of the journal. Although a high-fiber diet cannot be recommended for the prevention of recurrent colorectal adenomas, there may be other health benefits.
Can we reduce the use of echocardiography by using other clinical information to identify patients at very low risk for left ventricular systolic dysfunction?
BACKGROUND: About one third of all echocardiograms are ordered to evaluate left ventricular (LV) dysfunction. If other clinical markers could be used to identify patients at very low risk for LV dysfunction, some of these echocardiograms would be unnecessary. Eliminating unnecessary echocardiograms might help control health care costs without reducing the quality of care.
POPULATION STUDIED: The study sample consisted of 330 consecutive inpatients who underwent echocardiography to evaluate LV dysfunction. Of these subjects, 300 had an electrocardiogram (EKG) within 1 week before the echocardiogram, and the other 30 subjects who did not have EKGs were eliminated from the sample.
STUDY DESIGN AND VALIDITY: Variables related to medical history, physical examination, chest radiography, and EKG findings were identified using chart review. These variables were analyzed using a logistic regression model to determine which variables could be used to identify patients at very low risk for LV dysfunction on subsequent echocardiogram. EKGs were evaluated for the following abnormalities: Q waves, poor R-wave progression, LV hypertrophy, S-T segment abnormalities, left bundle branch block, or a paced rhythm. Subjects who had none of these abnormalities were classified as having normal EKGs. A patient with a right bundle branch block or a rate disturbances could have been classified as having a normal EKG. The regression model and sample size are appropriate for this type of analysis. The model could be strengthened by validating it using similar subjects not involved in the initial development of the model.
OUTCOMES MEASURED: The primary outcome was LV systolic dysfunction defined as an echocardiogram with an LV ejection fraction less than 0.45 as assessed by an echocardiographer blinded to other clinical information.
RESULTS: Of the 300 patients, 124 (41%) had LV systolic dysfunction on echocardiogram. The variables found to be important predictors of LV dysfunction were male sex, cardiomegaly on chest radiograph, and left bundle branch block on EKG. Of the 300 subjects, 118 (39%) had normal EKGs. Only 2 subjects with normal EKG findings had LV dysfunction on echocardiography. One had a right bundle branch block and known valvular disease. The other patient had undergone cardiac bypass surgery between the time the EKG was recorded and the time the echocardiograph was performed.
Hospitalized patients with normal EKGs are very unlikely to have LV dysfunction. Echocardiograms ordered specifically to eval-uate LV dysfunction in these patients are unnecessary. These results have not been confirmed in outpatients and may not apply.
BACKGROUND: About one third of all echocardiograms are ordered to evaluate left ventricular (LV) dysfunction. If other clinical markers could be used to identify patients at very low risk for LV dysfunction, some of these echocardiograms would be unnecessary. Eliminating unnecessary echocardiograms might help control health care costs without reducing the quality of care.
POPULATION STUDIED: The study sample consisted of 330 consecutive inpatients who underwent echocardiography to evaluate LV dysfunction. Of these subjects, 300 had an electrocardiogram (EKG) within 1 week before the echocardiogram, and the other 30 subjects who did not have EKGs were eliminated from the sample.
STUDY DESIGN AND VALIDITY: Variables related to medical history, physical examination, chest radiography, and EKG findings were identified using chart review. These variables were analyzed using a logistic regression model to determine which variables could be used to identify patients at very low risk for LV dysfunction on subsequent echocardiogram. EKGs were evaluated for the following abnormalities: Q waves, poor R-wave progression, LV hypertrophy, S-T segment abnormalities, left bundle branch block, or a paced rhythm. Subjects who had none of these abnormalities were classified as having normal EKGs. A patient with a right bundle branch block or a rate disturbances could have been classified as having a normal EKG. The regression model and sample size are appropriate for this type of analysis. The model could be strengthened by validating it using similar subjects not involved in the initial development of the model.
OUTCOMES MEASURED: The primary outcome was LV systolic dysfunction defined as an echocardiogram with an LV ejection fraction less than 0.45 as assessed by an echocardiographer blinded to other clinical information.
RESULTS: Of the 300 patients, 124 (41%) had LV systolic dysfunction on echocardiogram. The variables found to be important predictors of LV dysfunction were male sex, cardiomegaly on chest radiograph, and left bundle branch block on EKG. Of the 300 subjects, 118 (39%) had normal EKGs. Only 2 subjects with normal EKG findings had LV dysfunction on echocardiography. One had a right bundle branch block and known valvular disease. The other patient had undergone cardiac bypass surgery between the time the EKG was recorded and the time the echocardiograph was performed.
Hospitalized patients with normal EKGs are very unlikely to have LV dysfunction. Echocardiograms ordered specifically to eval-uate LV dysfunction in these patients are unnecessary. These results have not been confirmed in outpatients and may not apply.
BACKGROUND: About one third of all echocardiograms are ordered to evaluate left ventricular (LV) dysfunction. If other clinical markers could be used to identify patients at very low risk for LV dysfunction, some of these echocardiograms would be unnecessary. Eliminating unnecessary echocardiograms might help control health care costs without reducing the quality of care.
POPULATION STUDIED: The study sample consisted of 330 consecutive inpatients who underwent echocardiography to evaluate LV dysfunction. Of these subjects, 300 had an electrocardiogram (EKG) within 1 week before the echocardiogram, and the other 30 subjects who did not have EKGs were eliminated from the sample.
STUDY DESIGN AND VALIDITY: Variables related to medical history, physical examination, chest radiography, and EKG findings were identified using chart review. These variables were analyzed using a logistic regression model to determine which variables could be used to identify patients at very low risk for LV dysfunction on subsequent echocardiogram. EKGs were evaluated for the following abnormalities: Q waves, poor R-wave progression, LV hypertrophy, S-T segment abnormalities, left bundle branch block, or a paced rhythm. Subjects who had none of these abnormalities were classified as having normal EKGs. A patient with a right bundle branch block or a rate disturbances could have been classified as having a normal EKG. The regression model and sample size are appropriate for this type of analysis. The model could be strengthened by validating it using similar subjects not involved in the initial development of the model.
OUTCOMES MEASURED: The primary outcome was LV systolic dysfunction defined as an echocardiogram with an LV ejection fraction less than 0.45 as assessed by an echocardiographer blinded to other clinical information.
RESULTS: Of the 300 patients, 124 (41%) had LV systolic dysfunction on echocardiogram. The variables found to be important predictors of LV dysfunction were male sex, cardiomegaly on chest radiograph, and left bundle branch block on EKG. Of the 300 subjects, 118 (39%) had normal EKGs. Only 2 subjects with normal EKG findings had LV dysfunction on echocardiography. One had a right bundle branch block and known valvular disease. The other patient had undergone cardiac bypass surgery between the time the EKG was recorded and the time the echocardiograph was performed.
Hospitalized patients with normal EKGs are very unlikely to have LV dysfunction. Echocardiograms ordered specifically to eval-uate LV dysfunction in these patients are unnecessary. These results have not been confirmed in outpatients and may not apply.
Does carotid endarterectomy benefit patients with carotid stenosis but no symptoms?
BACKGROUND: Carotid endarterectomy (CEA) benefits patients with symptomatic carotid stenoses. However, given the perioperative morbidity, mortality, and cost of the procedure, it is unclear whether patients with carotid stenosis and no symptoms benefit. The authors of this meta-analysis reviewed trials on the topic to look for an overall answer.
POPULATION STUDIED: The patients studied had carotid stenosis of any degree but had never had symptoms such as transient ischemic attack (TIA) or cerebrovascular accident. Stenosis was diagnosed using a wide variety of modalities. Of the 2206 patients identified in all studies, 73% were men, and the average age was 66 years.
STUDY DESIGN AND VALIDITY: This was a Cochrane meta-analysis of randomized controlled trials of CEA versus medical management for patients with asymptomatic carotid stenosis. Studies were identified by searching MEDLINE, Current Contents, and the Cochrane Stroke Group Trials Registry. Experts in the field were also contacted to identify any additional published or unpublished trials. The diagnostic criteria for carotid stenosis varied widely among the studies and included angiography, oculoplethysmography, and clinical carotid auscultation. All surgical approaches to CEA were grouped together, while medical management was essentially watchful waiting. Depending on the study, aspirin was given to no patients, to only the medical management patients, or to both the medical and surgical patients. Follow-up varied from 24 to 48 months. Two reviewers independently evaluated the quality of the 7 identified trials and then extracted the data. Three trials were excluded: One because it is still in progress and without data; one because of randomization flaws; and one because the methodology was unclear and was suspicious for flaws.
OUTCOMES MEASURED: The primary outcomes were stroke or death in the CEA perioperative period (from the time of randomization till 30 days after) and stroke or death during long-term follow-up. TIA was not included as an outcome. Differences in the severity of stroke outcome and quality of life could not be assessed.
RESULTS: The CEA patients incurred more stroke or death in the perioperative period (event rate=3.1% vs 0.4% in medical patients; relative risk=6.5; 95% confidence interval, 2.6-16.0), yielding a number needed to harm of 37. For every 37 patients who underwent CEA, one had a stroke or died during the perioperative period who would not have died if medically managed. However at 3-year follow-up, CEA patients did slightly better in terms of stroke and death than medical management: The number needed to treat to prevent one ipsilateral stroke or perioperative death during 3 years was 53; to prevent any stroke or perioperative death, 43; and to prevent any stroke or any death, 33. However, none of these results achieved statistical significance. When trials comparing surgery to medical management with aspirin were removed from analysis statistical significance was reached, but clinical impact was essentially unchanged.
When compared with watchful medical management, carotid endarterectomy incurs clear perioperative harms yet yields only a small long-term benefit (a slightly reduced risk of stroke and death during 3 years). Furthermore, aspirin had to be factored out to reach statistically significant differences, yet we would routinely give aspirin as part of medical management. If your local surgeons have complication rates significantly lower than 3.1%, it might make intervention more favorable. It is also unclear whether the degree of asymptomatic stenosis would change outcomes. But for the average patient give aspirin, and advise against endarterectomy for asymptomatic carotid stenosis.
BACKGROUND: Carotid endarterectomy (CEA) benefits patients with symptomatic carotid stenoses. However, given the perioperative morbidity, mortality, and cost of the procedure, it is unclear whether patients with carotid stenosis and no symptoms benefit. The authors of this meta-analysis reviewed trials on the topic to look for an overall answer.
POPULATION STUDIED: The patients studied had carotid stenosis of any degree but had never had symptoms such as transient ischemic attack (TIA) or cerebrovascular accident. Stenosis was diagnosed using a wide variety of modalities. Of the 2206 patients identified in all studies, 73% were men, and the average age was 66 years.
STUDY DESIGN AND VALIDITY: This was a Cochrane meta-analysis of randomized controlled trials of CEA versus medical management for patients with asymptomatic carotid stenosis. Studies were identified by searching MEDLINE, Current Contents, and the Cochrane Stroke Group Trials Registry. Experts in the field were also contacted to identify any additional published or unpublished trials. The diagnostic criteria for carotid stenosis varied widely among the studies and included angiography, oculoplethysmography, and clinical carotid auscultation. All surgical approaches to CEA were grouped together, while medical management was essentially watchful waiting. Depending on the study, aspirin was given to no patients, to only the medical management patients, or to both the medical and surgical patients. Follow-up varied from 24 to 48 months. Two reviewers independently evaluated the quality of the 7 identified trials and then extracted the data. Three trials were excluded: One because it is still in progress and without data; one because of randomization flaws; and one because the methodology was unclear and was suspicious for flaws.
OUTCOMES MEASURED: The primary outcomes were stroke or death in the CEA perioperative period (from the time of randomization till 30 days after) and stroke or death during long-term follow-up. TIA was not included as an outcome. Differences in the severity of stroke outcome and quality of life could not be assessed.
RESULTS: The CEA patients incurred more stroke or death in the perioperative period (event rate=3.1% vs 0.4% in medical patients; relative risk=6.5; 95% confidence interval, 2.6-16.0), yielding a number needed to harm of 37. For every 37 patients who underwent CEA, one had a stroke or died during the perioperative period who would not have died if medically managed. However at 3-year follow-up, CEA patients did slightly better in terms of stroke and death than medical management: The number needed to treat to prevent one ipsilateral stroke or perioperative death during 3 years was 53; to prevent any stroke or perioperative death, 43; and to prevent any stroke or any death, 33. However, none of these results achieved statistical significance. When trials comparing surgery to medical management with aspirin were removed from analysis statistical significance was reached, but clinical impact was essentially unchanged.
When compared with watchful medical management, carotid endarterectomy incurs clear perioperative harms yet yields only a small long-term benefit (a slightly reduced risk of stroke and death during 3 years). Furthermore, aspirin had to be factored out to reach statistically significant differences, yet we would routinely give aspirin as part of medical management. If your local surgeons have complication rates significantly lower than 3.1%, it might make intervention more favorable. It is also unclear whether the degree of asymptomatic stenosis would change outcomes. But for the average patient give aspirin, and advise against endarterectomy for asymptomatic carotid stenosis.
BACKGROUND: Carotid endarterectomy (CEA) benefits patients with symptomatic carotid stenoses. However, given the perioperative morbidity, mortality, and cost of the procedure, it is unclear whether patients with carotid stenosis and no symptoms benefit. The authors of this meta-analysis reviewed trials on the topic to look for an overall answer.
POPULATION STUDIED: The patients studied had carotid stenosis of any degree but had never had symptoms such as transient ischemic attack (TIA) or cerebrovascular accident. Stenosis was diagnosed using a wide variety of modalities. Of the 2206 patients identified in all studies, 73% were men, and the average age was 66 years.
STUDY DESIGN AND VALIDITY: This was a Cochrane meta-analysis of randomized controlled trials of CEA versus medical management for patients with asymptomatic carotid stenosis. Studies were identified by searching MEDLINE, Current Contents, and the Cochrane Stroke Group Trials Registry. Experts in the field were also contacted to identify any additional published or unpublished trials. The diagnostic criteria for carotid stenosis varied widely among the studies and included angiography, oculoplethysmography, and clinical carotid auscultation. All surgical approaches to CEA were grouped together, while medical management was essentially watchful waiting. Depending on the study, aspirin was given to no patients, to only the medical management patients, or to both the medical and surgical patients. Follow-up varied from 24 to 48 months. Two reviewers independently evaluated the quality of the 7 identified trials and then extracted the data. Three trials were excluded: One because it is still in progress and without data; one because of randomization flaws; and one because the methodology was unclear and was suspicious for flaws.
OUTCOMES MEASURED: The primary outcomes were stroke or death in the CEA perioperative period (from the time of randomization till 30 days after) and stroke or death during long-term follow-up. TIA was not included as an outcome. Differences in the severity of stroke outcome and quality of life could not be assessed.
RESULTS: The CEA patients incurred more stroke or death in the perioperative period (event rate=3.1% vs 0.4% in medical patients; relative risk=6.5; 95% confidence interval, 2.6-16.0), yielding a number needed to harm of 37. For every 37 patients who underwent CEA, one had a stroke or died during the perioperative period who would not have died if medically managed. However at 3-year follow-up, CEA patients did slightly better in terms of stroke and death than medical management: The number needed to treat to prevent one ipsilateral stroke or perioperative death during 3 years was 53; to prevent any stroke or perioperative death, 43; and to prevent any stroke or any death, 33. However, none of these results achieved statistical significance. When trials comparing surgery to medical management with aspirin were removed from analysis statistical significance was reached, but clinical impact was essentially unchanged.
When compared with watchful medical management, carotid endarterectomy incurs clear perioperative harms yet yields only a small long-term benefit (a slightly reduced risk of stroke and death during 3 years). Furthermore, aspirin had to be factored out to reach statistically significant differences, yet we would routinely give aspirin as part of medical management. If your local surgeons have complication rates significantly lower than 3.1%, it might make intervention more favorable. It is also unclear whether the degree of asymptomatic stenosis would change outcomes. But for the average patient give aspirin, and advise against endarterectomy for asymptomatic carotid stenosis.