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Negative antigen test misses
For patients with an average risk of having streptococcal pharyngitis, a number of testing strategies can rule out infection, including a single negative rapid strep antigen test, which has a negative predictive value of more than 95%. In patients at higher risk of having strep, based on clinical criteria, all the test strategies being studied are more likely to be falsely negative.
While it is reasonable to rely on a variety of strategies to exclude strep throat in average-risk patients, high-risk patients with a negative rapid antigen test should have an additional rapid strep test or a throat culture to exclude strep with a certainty of greater than 95%.
For patients with an average risk of having streptococcal pharyngitis, a number of testing strategies can rule out infection, including a single negative rapid strep antigen test, which has a negative predictive value of more than 95%. In patients at higher risk of having strep, based on clinical criteria, all the test strategies being studied are more likely to be falsely negative.
While it is reasonable to rely on a variety of strategies to exclude strep throat in average-risk patients, high-risk patients with a negative rapid antigen test should have an additional rapid strep test or a throat culture to exclude strep with a certainty of greater than 95%.
For patients with an average risk of having streptococcal pharyngitis, a number of testing strategies can rule out infection, including a single negative rapid strep antigen test, which has a negative predictive value of more than 95%. In patients at higher risk of having strep, based on clinical criteria, all the test strategies being studied are more likely to be falsely negative.
While it is reasonable to rely on a variety of strategies to exclude strep throat in average-risk patients, high-risk patients with a negative rapid antigen test should have an additional rapid strep test or a throat culture to exclude strep with a certainty of greater than 95%.
Korean red ginseng effective for treatment of erectile dysfunction
Korean red ginseng (Panax ginseng*) is a safe, widely available alternative remedy that improves patients’ ability to achieve and maintain an erection sufficient for intercourse, even in a population with severe erectile dysfunction. It is a reasonable, nonprescription treatment, especially for men with reservations about taking sildenafil (Viagra). A 500-mg capsule of Korean red ginseng costs about 6 cents, compared with $10 for a tablet of sildenafil.
Korean red ginseng (Panax ginseng*) is a safe, widely available alternative remedy that improves patients’ ability to achieve and maintain an erection sufficient for intercourse, even in a population with severe erectile dysfunction. It is a reasonable, nonprescription treatment, especially for men with reservations about taking sildenafil (Viagra). A 500-mg capsule of Korean red ginseng costs about 6 cents, compared with $10 for a tablet of sildenafil.
Korean red ginseng (Panax ginseng*) is a safe, widely available alternative remedy that improves patients’ ability to achieve and maintain an erection sufficient for intercourse, even in a population with severe erectile dysfunction. It is a reasonable, nonprescription treatment, especially for men with reservations about taking sildenafil (Viagra). A 500-mg capsule of Korean red ginseng costs about 6 cents, compared with $10 for a tablet of sildenafil.
Acarbose delays onset of type 2 diabetes mellitus
ABSTRACT
BACKGROUND: Patients who develop type 2 diabetes initially pass through a state of impaired glucose tolerance. Therapies that reduce resistance to insulin or protect β cells could prevent or delay the progression to diabetes.
POPULATION STUDIED: This multinational study was conducted in Canada, Israel, and Western Europe. Investigators recruited high-risk patients through newspaper advertising. They screened 14,742 individuals with a body mass index (BMI) between 25 and 40 kg/m 2 (mean 31.0 kg/m 2 ) with a 2-hour glucose tolerance test. Eligible subjects had impaired glucose tolerance, defined as a 2-hour plasma glucose concentration of 140 mg/dL (7.8 mmol/L) and <200 mg/dL (11.1 mmol/L). Investigators excluded subjects who had a serum creatinine concentration 1.5 mg/dL, or who had taken thiazide diuretics, β-blockers or nicotinic acid within the past 3 months.1 Ninety-seven percent of the 1429 randomized patients were white and 48% were men. The average age was 54.3 years.
STUDY DESIGN AND VALIDITY: This was a randomized, double-blind, placebo-controlled trial. Randomization was done at each center in a sequential manner in blocks of 4 and 6 patients, using a centrally generated random allocation sequence and numbered drug containers. Allocation was appropriately concealed. Treatment groups were comparable at baseline. To minimize gastrointestinal side effects, patients randomized to acarbose were started at 50 mg/day and gradually increased to a maximum of 100 mg 3 times a day with meals or to the maximum tolerated dose. The mean daily dose was 197 mg. All patients met with a dietitian before randomization and then yearly, were instructed in a weight reduction or maintenance program, and were encouraged to exercise. Patients saw a nurse every 3 months for a pill count and fasting plasma glucose measurement. Patients with abnormal fasting plasma glucose levels had a 2-hour oral glucose tolerance test, and all patients had a yearly glucose tolerance test. Patients were followed for a mean of 3.3 years. Ninety-six percent of patients were accounted for at the end of the trial. All patients at the end of the trial who were not diagnosed with diabetes were placed on placebo and followed for an additional 3 months. An intention-to-treat analysis was performed using appropriate statistical methods.
OUTCOMES MEASURED: The primary outcome measured was time to development of type 2 diabetes, defined by a plasma glucose concentration of >200 mg/dL (11.1 mmol/L) after a 2-hour glucose tolerance test.
RESULT: Patients treated with acarbose were less likely to develop type 2 diabetes after 3.3 years (17% vs 26%, numbers needed to treat = 11, P = .0003). The effectiveness of acarbose became apparent at 1 year. More patients taking acarbose dropped out of the trial secondary to gastrointestinal side effects (31% vs 18%, numbers needed to harm = 8, P < .0001). When acarbose was stopped at the end of the study period, more patients who had been treated with acarbose developed diabetes in the next 3 months than did patients who were treated with placebo (15% vs 11%).
Treating patients with impaired glucose tolerance with acarbose will delay the onset of type 2 diabetes for at least 3.3 years. It is unclear whether acarbose actually prevents diabetes or just delays its onset, and whether acarbose reduces morbidity or mortality secondary to diabetes. One third of patients who take acarbose will not tolerate the medication, which must probably be continued indefinitely to remain effective. Lifestyle modification, including dietary changes and regular moderate physical activity, should be the first-line therapy to prevent diabetes in patients with impaired glucose tolerance.2 Acarbose can be used for patients who are not willing or able to change behavior.
ABSTRACT
BACKGROUND: Patients who develop type 2 diabetes initially pass through a state of impaired glucose tolerance. Therapies that reduce resistance to insulin or protect β cells could prevent or delay the progression to diabetes.
POPULATION STUDIED: This multinational study was conducted in Canada, Israel, and Western Europe. Investigators recruited high-risk patients through newspaper advertising. They screened 14,742 individuals with a body mass index (BMI) between 25 and 40 kg/m 2 (mean 31.0 kg/m 2 ) with a 2-hour glucose tolerance test. Eligible subjects had impaired glucose tolerance, defined as a 2-hour plasma glucose concentration of 140 mg/dL (7.8 mmol/L) and <200 mg/dL (11.1 mmol/L). Investigators excluded subjects who had a serum creatinine concentration 1.5 mg/dL, or who had taken thiazide diuretics, β-blockers or nicotinic acid within the past 3 months.1 Ninety-seven percent of the 1429 randomized patients were white and 48% were men. The average age was 54.3 years.
STUDY DESIGN AND VALIDITY: This was a randomized, double-blind, placebo-controlled trial. Randomization was done at each center in a sequential manner in blocks of 4 and 6 patients, using a centrally generated random allocation sequence and numbered drug containers. Allocation was appropriately concealed. Treatment groups were comparable at baseline. To minimize gastrointestinal side effects, patients randomized to acarbose were started at 50 mg/day and gradually increased to a maximum of 100 mg 3 times a day with meals or to the maximum tolerated dose. The mean daily dose was 197 mg. All patients met with a dietitian before randomization and then yearly, were instructed in a weight reduction or maintenance program, and were encouraged to exercise. Patients saw a nurse every 3 months for a pill count and fasting plasma glucose measurement. Patients with abnormal fasting plasma glucose levels had a 2-hour oral glucose tolerance test, and all patients had a yearly glucose tolerance test. Patients were followed for a mean of 3.3 years. Ninety-six percent of patients were accounted for at the end of the trial. All patients at the end of the trial who were not diagnosed with diabetes were placed on placebo and followed for an additional 3 months. An intention-to-treat analysis was performed using appropriate statistical methods.
OUTCOMES MEASURED: The primary outcome measured was time to development of type 2 diabetes, defined by a plasma glucose concentration of >200 mg/dL (11.1 mmol/L) after a 2-hour glucose tolerance test.
RESULT: Patients treated with acarbose were less likely to develop type 2 diabetes after 3.3 years (17% vs 26%, numbers needed to treat = 11, P = .0003). The effectiveness of acarbose became apparent at 1 year. More patients taking acarbose dropped out of the trial secondary to gastrointestinal side effects (31% vs 18%, numbers needed to harm = 8, P < .0001). When acarbose was stopped at the end of the study period, more patients who had been treated with acarbose developed diabetes in the next 3 months than did patients who were treated with placebo (15% vs 11%).
Treating patients with impaired glucose tolerance with acarbose will delay the onset of type 2 diabetes for at least 3.3 years. It is unclear whether acarbose actually prevents diabetes or just delays its onset, and whether acarbose reduces morbidity or mortality secondary to diabetes. One third of patients who take acarbose will not tolerate the medication, which must probably be continued indefinitely to remain effective. Lifestyle modification, including dietary changes and regular moderate physical activity, should be the first-line therapy to prevent diabetes in patients with impaired glucose tolerance.2 Acarbose can be used for patients who are not willing or able to change behavior.
ABSTRACT
BACKGROUND: Patients who develop type 2 diabetes initially pass through a state of impaired glucose tolerance. Therapies that reduce resistance to insulin or protect β cells could prevent or delay the progression to diabetes.
POPULATION STUDIED: This multinational study was conducted in Canada, Israel, and Western Europe. Investigators recruited high-risk patients through newspaper advertising. They screened 14,742 individuals with a body mass index (BMI) between 25 and 40 kg/m 2 (mean 31.0 kg/m 2 ) with a 2-hour glucose tolerance test. Eligible subjects had impaired glucose tolerance, defined as a 2-hour plasma glucose concentration of 140 mg/dL (7.8 mmol/L) and <200 mg/dL (11.1 mmol/L). Investigators excluded subjects who had a serum creatinine concentration 1.5 mg/dL, or who had taken thiazide diuretics, β-blockers or nicotinic acid within the past 3 months.1 Ninety-seven percent of the 1429 randomized patients were white and 48% were men. The average age was 54.3 years.
STUDY DESIGN AND VALIDITY: This was a randomized, double-blind, placebo-controlled trial. Randomization was done at each center in a sequential manner in blocks of 4 and 6 patients, using a centrally generated random allocation sequence and numbered drug containers. Allocation was appropriately concealed. Treatment groups were comparable at baseline. To minimize gastrointestinal side effects, patients randomized to acarbose were started at 50 mg/day and gradually increased to a maximum of 100 mg 3 times a day with meals or to the maximum tolerated dose. The mean daily dose was 197 mg. All patients met with a dietitian before randomization and then yearly, were instructed in a weight reduction or maintenance program, and were encouraged to exercise. Patients saw a nurse every 3 months for a pill count and fasting plasma glucose measurement. Patients with abnormal fasting plasma glucose levels had a 2-hour oral glucose tolerance test, and all patients had a yearly glucose tolerance test. Patients were followed for a mean of 3.3 years. Ninety-six percent of patients were accounted for at the end of the trial. All patients at the end of the trial who were not diagnosed with diabetes were placed on placebo and followed for an additional 3 months. An intention-to-treat analysis was performed using appropriate statistical methods.
OUTCOMES MEASURED: The primary outcome measured was time to development of type 2 diabetes, defined by a plasma glucose concentration of >200 mg/dL (11.1 mmol/L) after a 2-hour glucose tolerance test.
RESULT: Patients treated with acarbose were less likely to develop type 2 diabetes after 3.3 years (17% vs 26%, numbers needed to treat = 11, P = .0003). The effectiveness of acarbose became apparent at 1 year. More patients taking acarbose dropped out of the trial secondary to gastrointestinal side effects (31% vs 18%, numbers needed to harm = 8, P < .0001). When acarbose was stopped at the end of the study period, more patients who had been treated with acarbose developed diabetes in the next 3 months than did patients who were treated with placebo (15% vs 11%).
Treating patients with impaired glucose tolerance with acarbose will delay the onset of type 2 diabetes for at least 3.3 years. It is unclear whether acarbose actually prevents diabetes or just delays its onset, and whether acarbose reduces morbidity or mortality secondary to diabetes. One third of patients who take acarbose will not tolerate the medication, which must probably be continued indefinitely to remain effective. Lifestyle modification, including dietary changes and regular moderate physical activity, should be the first-line therapy to prevent diabetes in patients with impaired glucose tolerance.2 Acarbose can be used for patients who are not willing or able to change behavior.
Should patients with unstable coronary syndromes routinely undergo cardiac catheterization and appropriate revascularization?
BACKGROUND: Previous studies have not shown that routine catheterization and appropriate revascularization offers better outcomes than more conservative approaches in patients with unstable angina or myocardial infarction (MI) without ST-segment elevation. The authors hypothesized that the effectiveness of glycoprotein IIb/IIIa inhibitors and coronary stenting in patients treated with percutaneous coronary revascularization (PCR) would lead to better outcomes in patients with unstable coronary syndromes who are treated with an early invasive strategy.
POPULATION STUDIED: The investigators enrolled 2220 patients presenting with prolonged or recurrent angina at rest or with minimal effort, or with an accelerating pattern of angina. Patients also had to have 1 or more of the following: (1) electrocardiographic evidence of ischemia, (2) abnormal cardiac enzymes, or (3) documented coronary artery disease. Patients were excluded if they had persistent ST-segment elevation, secondary angina, PCR or coronary artery bypass surgery (CABG) within 6 months, left bundle branch block or a paced rhythm, factors associated with increased bleeding risk, severe congestive heart failure or cardiogenic shock, serious systemic disease, serum creatinine higher than 2.5 mg per dL, or recent treatment with ticlopidine, clopidogrel, or warfarin.
STUDY DESIGN AND VALIDITY: This was a randomized controlled trial. Investigators used a central center to randomize patients to immediate (within 48 hours) cardiac angiography with appropriate revascularization or to conservative therapy. Patients receiving conservative therapy had angiography if they met criteria for recurrent ischemia, infarction, hemodynamic instability, ischemia on exercise testing, or readmission. All conservatively managed patients without recurrent ischemia had a treadmill before discharge. All patients received intravenous heparin, aspirin, a b-blocker, nitrates, and tirofiban, a glycoprotein IIb/IIIa inhibitor. Patients were followed up for up to 6 months. The study is methodologically sound. Only 27 patients (1.2 %) were lost to follow-up at 6 months. A weakness of this study is that fewer patients in the conservative strategy group undergoing PCR received tirofiban (59%, vs 95% in the invasive strategy group). An appropriate stratified analysis of this unplanned treatment difference showed no difference in the results.
OUTCOMES MEASURED: The primary outcome was the combined incidence of death, nonfatal MI, and rehospitalization for an acute coronary syndrome at 6 months.
RESULTS: In the invasive strategy arm, 97% of patients received angiography within a median of 22 hours of randomization, and 60% underwent PCR or CABG. An additional 1% required revascularization by 6 months. Among conservatively managed patients, 51% had angiography, and 36% had revascularization during or soon after their initial hospitalization. An additional 8% had revascularization within 6 months. CABG and PCR rates were similar among patients in the 2 groups who underwent catheterization. Most patients (80%) in each group undergoing PCR received stenting.
An early invasive strategy improves outcomes among patients with unstable angina or MI without ST-segment elevation who have a troponin T greater than 0.01 ng per mL or a TIMI score greater than 2. The benefit of this strategy for patients taking aspirin is uncertain. Family physicians should refer appropriate patients with acute coronary syndromes to catheterization labs that perform large volumes of procedures with low complication rates and that routinely use tirofiban and coronary stents when performing PCR.
BACKGROUND: Previous studies have not shown that routine catheterization and appropriate revascularization offers better outcomes than more conservative approaches in patients with unstable angina or myocardial infarction (MI) without ST-segment elevation. The authors hypothesized that the effectiveness of glycoprotein IIb/IIIa inhibitors and coronary stenting in patients treated with percutaneous coronary revascularization (PCR) would lead to better outcomes in patients with unstable coronary syndromes who are treated with an early invasive strategy.
POPULATION STUDIED: The investigators enrolled 2220 patients presenting with prolonged or recurrent angina at rest or with minimal effort, or with an accelerating pattern of angina. Patients also had to have 1 or more of the following: (1) electrocardiographic evidence of ischemia, (2) abnormal cardiac enzymes, or (3) documented coronary artery disease. Patients were excluded if they had persistent ST-segment elevation, secondary angina, PCR or coronary artery bypass surgery (CABG) within 6 months, left bundle branch block or a paced rhythm, factors associated with increased bleeding risk, severe congestive heart failure or cardiogenic shock, serious systemic disease, serum creatinine higher than 2.5 mg per dL, or recent treatment with ticlopidine, clopidogrel, or warfarin.
STUDY DESIGN AND VALIDITY: This was a randomized controlled trial. Investigators used a central center to randomize patients to immediate (within 48 hours) cardiac angiography with appropriate revascularization or to conservative therapy. Patients receiving conservative therapy had angiography if they met criteria for recurrent ischemia, infarction, hemodynamic instability, ischemia on exercise testing, or readmission. All conservatively managed patients without recurrent ischemia had a treadmill before discharge. All patients received intravenous heparin, aspirin, a b-blocker, nitrates, and tirofiban, a glycoprotein IIb/IIIa inhibitor. Patients were followed up for up to 6 months. The study is methodologically sound. Only 27 patients (1.2 %) were lost to follow-up at 6 months. A weakness of this study is that fewer patients in the conservative strategy group undergoing PCR received tirofiban (59%, vs 95% in the invasive strategy group). An appropriate stratified analysis of this unplanned treatment difference showed no difference in the results.
OUTCOMES MEASURED: The primary outcome was the combined incidence of death, nonfatal MI, and rehospitalization for an acute coronary syndrome at 6 months.
RESULTS: In the invasive strategy arm, 97% of patients received angiography within a median of 22 hours of randomization, and 60% underwent PCR or CABG. An additional 1% required revascularization by 6 months. Among conservatively managed patients, 51% had angiography, and 36% had revascularization during or soon after their initial hospitalization. An additional 8% had revascularization within 6 months. CABG and PCR rates were similar among patients in the 2 groups who underwent catheterization. Most patients (80%) in each group undergoing PCR received stenting.
An early invasive strategy improves outcomes among patients with unstable angina or MI without ST-segment elevation who have a troponin T greater than 0.01 ng per mL or a TIMI score greater than 2. The benefit of this strategy for patients taking aspirin is uncertain. Family physicians should refer appropriate patients with acute coronary syndromes to catheterization labs that perform large volumes of procedures with low complication rates and that routinely use tirofiban and coronary stents when performing PCR.
BACKGROUND: Previous studies have not shown that routine catheterization and appropriate revascularization offers better outcomes than more conservative approaches in patients with unstable angina or myocardial infarction (MI) without ST-segment elevation. The authors hypothesized that the effectiveness of glycoprotein IIb/IIIa inhibitors and coronary stenting in patients treated with percutaneous coronary revascularization (PCR) would lead to better outcomes in patients with unstable coronary syndromes who are treated with an early invasive strategy.
POPULATION STUDIED: The investigators enrolled 2220 patients presenting with prolonged or recurrent angina at rest or with minimal effort, or with an accelerating pattern of angina. Patients also had to have 1 or more of the following: (1) electrocardiographic evidence of ischemia, (2) abnormal cardiac enzymes, or (3) documented coronary artery disease. Patients were excluded if they had persistent ST-segment elevation, secondary angina, PCR or coronary artery bypass surgery (CABG) within 6 months, left bundle branch block or a paced rhythm, factors associated with increased bleeding risk, severe congestive heart failure or cardiogenic shock, serious systemic disease, serum creatinine higher than 2.5 mg per dL, or recent treatment with ticlopidine, clopidogrel, or warfarin.
STUDY DESIGN AND VALIDITY: This was a randomized controlled trial. Investigators used a central center to randomize patients to immediate (within 48 hours) cardiac angiography with appropriate revascularization or to conservative therapy. Patients receiving conservative therapy had angiography if they met criteria for recurrent ischemia, infarction, hemodynamic instability, ischemia on exercise testing, or readmission. All conservatively managed patients without recurrent ischemia had a treadmill before discharge. All patients received intravenous heparin, aspirin, a b-blocker, nitrates, and tirofiban, a glycoprotein IIb/IIIa inhibitor. Patients were followed up for up to 6 months. The study is methodologically sound. Only 27 patients (1.2 %) were lost to follow-up at 6 months. A weakness of this study is that fewer patients in the conservative strategy group undergoing PCR received tirofiban (59%, vs 95% in the invasive strategy group). An appropriate stratified analysis of this unplanned treatment difference showed no difference in the results.
OUTCOMES MEASURED: The primary outcome was the combined incidence of death, nonfatal MI, and rehospitalization for an acute coronary syndrome at 6 months.
RESULTS: In the invasive strategy arm, 97% of patients received angiography within a median of 22 hours of randomization, and 60% underwent PCR or CABG. An additional 1% required revascularization by 6 months. Among conservatively managed patients, 51% had angiography, and 36% had revascularization during or soon after their initial hospitalization. An additional 8% had revascularization within 6 months. CABG and PCR rates were similar among patients in the 2 groups who underwent catheterization. Most patients (80%) in each group undergoing PCR received stenting.
An early invasive strategy improves outcomes among patients with unstable angina or MI without ST-segment elevation who have a troponin T greater than 0.01 ng per mL or a TIMI score greater than 2. The benefit of this strategy for patients taking aspirin is uncertain. Family physicians should refer appropriate patients with acute coronary syndromes to catheterization labs that perform large volumes of procedures with low complication rates and that routinely use tirofiban and coronary stents when performing PCR.