Q&A

ABSTRACT

BACKGROUND: Plantar fasciitis is a common condition seen in primary care affecting up to 10% of the general population during their lifetime. Risk factors include middle age, obesity, prolonged walking, and running. Previous randomized-controlled studies of ultrasound-guided ESWT report efficacy in plantar fasciitis. A systematic review from the Cochrane Library reports limited evidence for ESWT, topical corticosteroids, corticosteroid injections, and dorsiflexion night splints. Interestingly, no evidence for effectiveness is reported for other commonly used interventions, including insoles, heel pads, strapping, and surgery.¹

POPULATION STUDIED: Participants in this study were 166 Australian patients diagnosed with clinical plantar fasciitis, defined as 6 weeks of pain over the plantar aspect of the heel, confirmed by plantar fascia thickening on ultrasound. Patients were referred to a radiology group from primary care, rheumatology, orthopedic surgery, and sports medicine practices. The patients were usually overweight and predominantly female (57%).

STUDY DESIGN AND VALIDITY: Overall this randomized, placebo-controlled, double-blind study was well designed. Patients were treated weekly for 3 consecutive weeks with a total shock wave dose of at least 1000 mJ/mm2 or place-bo (total dose 6.0 mJ/mm2). Symptoms were assessed at 6 and 12 weeks after treatment. The study used centralized randomization and controlled with low energy, low frequency “sham” ESWT. The intervention and control groups were similar and allocation of treatment was concealed (referring physicians, patients, and therapists did not know what therapy was going to be assigned before study enrollment). Patients and data evaluators were blind to treatment group assignment; however, physical therapists administering therapy were not blinded. Study subjects were surveyed after the study to determine whether they knew which therapy they had received. Blinding was moderately successful (the blinding index was 0.68, in which 1 represents complete blinding, 0 represents no blinding, and 0.5 represents random guessing about which therapy was received). Follow-up was complete with an intention-to-treat analysis (although dropouts were not included in the assessment). The study evaluated patients for 12 weeks, which seems a reasonable length of time to assess for clinical improvement in pain and function.

OUTCOMES MEASURED: The primary outcome measured was overall pain at 12 weeks. Secondary outcomes included overall, morning only, and activity pain; Maryland Foot Score ratings; walking ability; Short Form (SF-36) Health Survey quality-of-life score; and Problem Elicitation Technique score at 6 and 12 weeks. The Problem Elicitation Technique tracks changes in perceived disability and problems commonly reported by patients with plantar fasciitis, such as inability to participate in sports.

RESULTS: A total of 160 (96%) patients completed the 15-week study. Overall, both groups’ pain and function improved, but no statistically significant difference was noted in pain and function at 6 or 12 weeks. Only 1 outcome measure, the social function subset of the SF-36, showed statistically significant improvement in the placebo group at 6 weeks but not at 12 weeks. The power of the study was adequate for the primary outcome measure.

ABSTRACT

BACKGROUND: Plantar fasciitis is a common condition seen in primary care affecting up to 10% of the general population during their lifetime. Risk factors include middle age, obesity, prolonged walking, and running. Previous randomized-controlled studies of ultrasound-guided ESWT report efficacy in plantar fasciitis. A systematic review from the Cochrane Library reports limited evidence for ESWT, topical corticosteroids, corticosteroid injections, and dorsiflexion night splints. Interestingly, no evidence for effectiveness is reported for other commonly used interventions, including insoles, heel pads, strapping, and surgery.¹

POPULATION STUDIED: Participants in this study were 166 Australian patients diagnosed with clinical plantar fasciitis, defined as 6 weeks of pain over the plantar aspect of the heel, confirmed by plantar fascia thickening on ultrasound. Patients were referred to a radiology group from primary care, rheumatology, orthopedic surgery, and sports medicine practices. The patients were usually overweight and predominantly female (57%).

STUDY DESIGN AND VALIDITY: Overall this randomized, placebo-controlled, double-blind study was well designed. Patients were treated weekly for 3 consecutive weeks with a total shock wave dose of at least 1000 mJ/mm2 or place-bo (total dose 6.0 mJ/mm2). Symptoms were assessed at 6 and 12 weeks after treatment. The study used centralized randomization and controlled with low energy, low frequency “sham” ESWT. The intervention and control groups were similar and allocation of treatment was concealed (referring physicians, patients, and therapists did not know what therapy was going to be assigned before study enrollment). Patients and data evaluators were blind to treatment group assignment; however, physical therapists administering therapy were not blinded. Study subjects were surveyed after the study to determine whether they knew which therapy they had received. Blinding was moderately successful (the blinding index was 0.68, in which 1 represents complete blinding, 0 represents no blinding, and 0.5 represents random guessing about which therapy was received). Follow-up was complete with an intention-to-treat analysis (although dropouts were not included in the assessment). The study evaluated patients for 12 weeks, which seems a reasonable length of time to assess for clinical improvement in pain and function.

OUTCOMES MEASURED: The primary outcome measured was overall pain at 12 weeks. Secondary outcomes included overall, morning only, and activity pain; Maryland Foot Score ratings; walking ability; Short Form (SF-36) Health Survey quality-of-life score; and Problem Elicitation Technique score at 6 and 12 weeks. The Problem Elicitation Technique tracks changes in perceived disability and problems commonly reported by patients with plantar fasciitis, such as inability to participate in sports.

RESULTS: A total of 160 (96%) patients completed the 15-week study. Overall, both groups’ pain and function improved, but no statistically significant difference was noted in pain and function at 6 or 12 weeks. Only 1 outcome measure, the social function subset of the SF-36, showed statistically significant improvement in the placebo group at 6 weeks but not at 12 weeks. The power of the study was adequate for the primary outcome measure.

ABSTRACT

BACKGROUND: Plantar fasciitis is a common condition seen in primary care affecting up to 10% of the general population during their lifetime. Risk factors include middle age, obesity, prolonged walking, and running. Previous randomized-controlled studies of ultrasound-guided ESWT report efficacy in plantar fasciitis. A systematic review from the Cochrane Library reports limited evidence for ESWT, topical corticosteroids, corticosteroid injections, and dorsiflexion night splints. Interestingly, no evidence for effectiveness is reported for other commonly used interventions, including insoles, heel pads, strapping, and surgery.¹

POPULATION STUDIED: Participants in this study were 166 Australian patients diagnosed with clinical plantar fasciitis, defined as 6 weeks of pain over the plantar aspect of the heel, confirmed by plantar fascia thickening on ultrasound. Patients were referred to a radiology group from primary care, rheumatology, orthopedic surgery, and sports medicine practices. The patients were usually overweight and predominantly female (57%).

STUDY DESIGN AND VALIDITY: Overall this randomized, placebo-controlled, double-blind study was well designed. Patients were treated weekly for 3 consecutive weeks with a total shock wave dose of at least 1000 mJ/mm2 or place-bo (total dose 6.0 mJ/mm2). Symptoms were assessed at 6 and 12 weeks after treatment. The study used centralized randomization and controlled with low energy, low frequency “sham” ESWT. The intervention and control groups were similar and allocation of treatment was concealed (referring physicians, patients, and therapists did not know what therapy was going to be assigned before study enrollment). Patients and data evaluators were blind to treatment group assignment; however, physical therapists administering therapy were not blinded. Study subjects were surveyed after the study to determine whether they knew which therapy they had received. Blinding was moderately successful (the blinding index was 0.68, in which 1 represents complete blinding, 0 represents no blinding, and 0.5 represents random guessing about which therapy was received). Follow-up was complete with an intention-to-treat analysis (although dropouts were not included in the assessment). The study evaluated patients for 12 weeks, which seems a reasonable length of time to assess for clinical improvement in pain and function.

OUTCOMES MEASURED: The primary outcome measured was overall pain at 12 weeks. Secondary outcomes included overall, morning only, and activity pain; Maryland Foot Score ratings; walking ability; Short Form (SF-36) Health Survey quality-of-life score; and Problem Elicitation Technique score at 6 and 12 weeks. The Problem Elicitation Technique tracks changes in perceived disability and problems commonly reported by patients with plantar fasciitis, such as inability to participate in sports.

RESULTS: A total of 160 (96%) patients completed the 15-week study. Overall, both groups’ pain and function improved, but no statistically significant difference was noted in pain and function at 6 or 12 weeks. Only 1 outcome measure, the social function subset of the SF-36, showed statistically significant improvement in the placebo group at 6 weeks but not at 12 weeks. The power of the study was adequate for the primary outcome measure.

ABSTRACT

BACKGROUND: Results have been mixed from 3 previous clinical trials of the use of tamoxifen for preventing breast cancer in high-risk women. A recently updated analysis from 1 negative study showed a decrease in the incidence of estrogen-receptor–positive breast cancer, adding support for the effectiveness of tamoxifen in some high-risk women. Tamoxifen therapy, however, is associated with significant adverse outcomes that may outweigh any benefits.

POPULATION STUDIED: Recruitment took place among outpatients at breast screening centers, primary care offices, and family history clinics. The media and contact of relatives of women with breast cancer provided additional recruitment. Women aged 35 to 70 years met criteria for entry if their risk for developing breast cancer was at least double that for women between 45 and 70 years, at least 4-fold that for women between 40 and 44 years, and 10-fold that for women aged 35 to 39 years. Risk was determined by an unpublished alternative to the Gail model. Patients were excluded if they had current or desired pregnancy, previous invasive cancer, previous deep vein thrombosis or pulmonary embolism, current use of anticoagulant agents, or a life expectancy of less than 10 years.

STUDY DESIGN AND VALIDITY: In this randomized, placebo-controlled, double-blinded trial, eligible women were randomized to receive either 20 mg tamoxifen (N=3573) or a matched placebo (N=3566) daily for 5 years. Thirteen women with findings on mammogram at the time of randomization were excluded from subsequent analysis. Participants received clinical evaluations every 6 months during the 5-year active treatment interval. Follow-up continued for up to 5 years beyond treatment by annual questionnaire or clinical visit. Symptoms, side effects, diagnoses, procedures, and concomitant medications were recorded at each evaluation. A mammogram was performed every 12 to 18 months. External reviewers, masked to treatment allocation, evaluated all end points and deaths.

OUTCOMES MEASURED: The primary outcome measure was the frequency of breast cancer including ductal carcinoma in situ. Secondary outcomes included side effects, thromboembolic events, procedures, and deaths.

RESULTS: Women given tamoxifen had fewer breast cancers (n=60, 1.9%) than individuals given placebo (n=101, 2.8%; numbers needed to treat=112 for 5 years of treatment). As expected, prevention occurred at a cost of a greater incidence of venous thromboembolic events (1.2% vs 0.5%; numbers needed to harm [NNH]=137 for 5 years of treatment) and symptoms such as hot flashes and breast tenderness, and procedures including dilation and curettage and hysterectomy. More importantly, significantly more women on tamoxifen (n=25, 0.7%) died as compared with those on placebo (n=11, 0.3%; NNH=256 for 5 years of treatment).

ABSTRACT

BACKGROUND: Results have been mixed from 3 previous clinical trials of the use of tamoxifen for preventing breast cancer in high-risk women. A recently updated analysis from 1 negative study showed a decrease in the incidence of estrogen-receptor–positive breast cancer, adding support for the effectiveness of tamoxifen in some high-risk women. Tamoxifen therapy, however, is associated with significant adverse outcomes that may outweigh any benefits.

POPULATION STUDIED: Recruitment took place among outpatients at breast screening centers, primary care offices, and family history clinics. The media and contact of relatives of women with breast cancer provided additional recruitment. Women aged 35 to 70 years met criteria for entry if their risk for developing breast cancer was at least double that for women between 45 and 70 years, at least 4-fold that for women between 40 and 44 years, and 10-fold that for women aged 35 to 39 years. Risk was determined by an unpublished alternative to the Gail model. Patients were excluded if they had current or desired pregnancy, previous invasive cancer, previous deep vein thrombosis or pulmonary embolism, current use of anticoagulant agents, or a life expectancy of less than 10 years.

STUDY DESIGN AND VALIDITY: In this randomized, placebo-controlled, double-blinded trial, eligible women were randomized to receive either 20 mg tamoxifen (N=3573) or a matched placebo (N=3566) daily for 5 years. Thirteen women with findings on mammogram at the time of randomization were excluded from subsequent analysis. Participants received clinical evaluations every 6 months during the 5-year active treatment interval. Follow-up continued for up to 5 years beyond treatment by annual questionnaire or clinical visit. Symptoms, side effects, diagnoses, procedures, and concomitant medications were recorded at each evaluation. A mammogram was performed every 12 to 18 months. External reviewers, masked to treatment allocation, evaluated all end points and deaths.

OUTCOMES MEASURED: The primary outcome measure was the frequency of breast cancer including ductal carcinoma in situ. Secondary outcomes included side effects, thromboembolic events, procedures, and deaths.

RESULTS: Women given tamoxifen had fewer breast cancers (n=60, 1.9%) than individuals given placebo (n=101, 2.8%; numbers needed to treat=112 for 5 years of treatment). As expected, prevention occurred at a cost of a greater incidence of venous thromboembolic events (1.2% vs 0.5%; numbers needed to harm [NNH]=137 for 5 years of treatment) and symptoms such as hot flashes and breast tenderness, and procedures including dilation and curettage and hysterectomy. More importantly, significantly more women on tamoxifen (n=25, 0.7%) died as compared with those on placebo (n=11, 0.3%; NNH=256 for 5 years of treatment).

ABSTRACT

BACKGROUND: Results have been mixed from 3 previous clinical trials of the use of tamoxifen for preventing breast cancer in high-risk women. A recently updated analysis from 1 negative study showed a decrease in the incidence of estrogen-receptor–positive breast cancer, adding support for the effectiveness of tamoxifen in some high-risk women. Tamoxifen therapy, however, is associated with significant adverse outcomes that may outweigh any benefits.

POPULATION STUDIED: Recruitment took place among outpatients at breast screening centers, primary care offices, and family history clinics. The media and contact of relatives of women with breast cancer provided additional recruitment. Women aged 35 to 70 years met criteria for entry if their risk for developing breast cancer was at least double that for women between 45 and 70 years, at least 4-fold that for women between 40 and 44 years, and 10-fold that for women aged 35 to 39 years. Risk was determined by an unpublished alternative to the Gail model. Patients were excluded if they had current or desired pregnancy, previous invasive cancer, previous deep vein thrombosis or pulmonary embolism, current use of anticoagulant agents, or a life expectancy of less than 10 years.

STUDY DESIGN AND VALIDITY: In this randomized, placebo-controlled, double-blinded trial, eligible women were randomized to receive either 20 mg tamoxifen (N=3573) or a matched placebo (N=3566) daily for 5 years. Thirteen women with findings on mammogram at the time of randomization were excluded from subsequent analysis. Participants received clinical evaluations every 6 months during the 5-year active treatment interval. Follow-up continued for up to 5 years beyond treatment by annual questionnaire or clinical visit. Symptoms, side effects, diagnoses, procedures, and concomitant medications were recorded at each evaluation. A mammogram was performed every 12 to 18 months. External reviewers, masked to treatment allocation, evaluated all end points and deaths.

OUTCOMES MEASURED: The primary outcome measure was the frequency of breast cancer including ductal carcinoma in situ. Secondary outcomes included side effects, thromboembolic events, procedures, and deaths.

RESULTS: Women given tamoxifen had fewer breast cancers (n=60, 1.9%) than individuals given placebo (n=101, 2.8%; numbers needed to treat=112 for 5 years of treatment). As expected, prevention occurred at a cost of a greater incidence of venous thromboembolic events (1.2% vs 0.5%; numbers needed to harm [NNH]=137 for 5 years of treatment) and symptoms such as hot flashes and breast tenderness, and procedures including dilation and curettage and hysterectomy. More importantly, significantly more women on tamoxifen (n=25, 0.7%) died as compared with those on placebo (n=11, 0.3%; NNH=256 for 5 years of treatment).

ABSTRACT

BACKGROUND: Acid suppressants such as H2 blockers and proton pump inhibitors are often used for the treatment of non-ulcer dyspepsia, also known as functional dyspepsia. This study evaluated the efficacy of different doses of lansoprazole for the treatment of non-ulcer dyspepsia.

POPULATION STUDIED: The patients in this study (335 women and 118 men) were all Chinese, aged 18 to 80 years, and had been referred to an endoscopy unit. All patients had a normal upper gastrointestinal endoscopy and had had functional dyspepsia for at least 12 weeks during the previous 12 months. Functional dyspepsia was defined as persistent pain or discomfort in the upper abdomen with no evidence of organic disease, irritable bowel syndrome, or chronic severe constipation. Patients were excluded if they had classical acid regurgitation as their only symptom, or had used any acid suppressants, nonsteroidal anti-inflammatory drugs, or antibiotics in the previous 4 weeks. To be eligible for the study they had to have moderate symptoms defined by a dyspepsia score in the preceding 2 weeks.

STUDY DESIGN AND VALIDITY: This randomized controlled trial was triple blinded (the managing physicians, patients, and investigators were all blinded). The 453 patients were randomized to receive placebo or lansoprazole 15 or 30 mg daily for 4 weeks. Patient compliance was satisfactory and checked by pill counting.

OUTCOMES MEASURED: The outcomes assessed were dyspepsia and quality-of-life scores, and complete relief of symptoms. The dyspepsia score was calculated from a questionnaire that comprised 12 questions relating to dyspepsia, each of which was graded on a 5-point Likert scale. The quality-of-life score was assessed from the Short Form (SF-36) Health Survey, which contains 11 items related to general well-being.

RESULTS: Significant improvement in the dyspepsia scores at 4 weeks was noted in each of the 3 groups. The changes in dyspepsia score from baseline to the 4-week visit were similar between lansoprazole 30 mg and placebo, and lansoprazole 15 mg and placebo (approximate change from 22 at baseline to 18.7 out of a possible 60 points at 4 weeks). The changes in mean quality-of-life score from baseline to the score at 4 weeks were also similar for both doses of lansoprazole and placebo (approximate change from 60 to 64.8 out of a possible score of 100 at 4 weeks). No difference was noted in the proportion of patients with complete symptom relief between the lansoprazole groups (23%) and the placebo group (30%). Even when the results were analyzed in groups according to the severity of the dyspepsia, there was still no difference in complete relief of symptoms between the 3 groups.

ABSTRACT

BACKGROUND: Acid suppressants such as H2 blockers and proton pump inhibitors are often used for the treatment of non-ulcer dyspepsia, also known as functional dyspepsia. This study evaluated the efficacy of different doses of lansoprazole for the treatment of non-ulcer dyspepsia.

POPULATION STUDIED: The patients in this study (335 women and 118 men) were all Chinese, aged 18 to 80 years, and had been referred to an endoscopy unit. All patients had a normal upper gastrointestinal endoscopy and had had functional dyspepsia for at least 12 weeks during the previous 12 months. Functional dyspepsia was defined as persistent pain or discomfort in the upper abdomen with no evidence of organic disease, irritable bowel syndrome, or chronic severe constipation. Patients were excluded if they had classical acid regurgitation as their only symptom, or had used any acid suppressants, nonsteroidal anti-inflammatory drugs, or antibiotics in the previous 4 weeks. To be eligible for the study they had to have moderate symptoms defined by a dyspepsia score in the preceding 2 weeks.

STUDY DESIGN AND VALIDITY: This randomized controlled trial was triple blinded (the managing physicians, patients, and investigators were all blinded). The 453 patients were randomized to receive placebo or lansoprazole 15 or 30 mg daily for 4 weeks. Patient compliance was satisfactory and checked by pill counting.

OUTCOMES MEASURED: The outcomes assessed were dyspepsia and quality-of-life scores, and complete relief of symptoms. The dyspepsia score was calculated from a questionnaire that comprised 12 questions relating to dyspepsia, each of which was graded on a 5-point Likert scale. The quality-of-life score was assessed from the Short Form (SF-36) Health Survey, which contains 11 items related to general well-being.

RESULTS: Significant improvement in the dyspepsia scores at 4 weeks was noted in each of the 3 groups. The changes in dyspepsia score from baseline to the 4-week visit were similar between lansoprazole 30 mg and placebo, and lansoprazole 15 mg and placebo (approximate change from 22 at baseline to 18.7 out of a possible 60 points at 4 weeks). The changes in mean quality-of-life score from baseline to the score at 4 weeks were also similar for both doses of lansoprazole and placebo (approximate change from 60 to 64.8 out of a possible score of 100 at 4 weeks). No difference was noted in the proportion of patients with complete symptom relief between the lansoprazole groups (23%) and the placebo group (30%). Even when the results were analyzed in groups according to the severity of the dyspepsia, there was still no difference in complete relief of symptoms between the 3 groups.

ABSTRACT

BACKGROUND: Acid suppressants such as H2 blockers and proton pump inhibitors are often used for the treatment of non-ulcer dyspepsia, also known as functional dyspepsia. This study evaluated the efficacy of different doses of lansoprazole for the treatment of non-ulcer dyspepsia.

POPULATION STUDIED: The patients in this study (335 women and 118 men) were all Chinese, aged 18 to 80 years, and had been referred to an endoscopy unit. All patients had a normal upper gastrointestinal endoscopy and had had functional dyspepsia for at least 12 weeks during the previous 12 months. Functional dyspepsia was defined as persistent pain or discomfort in the upper abdomen with no evidence of organic disease, irritable bowel syndrome, or chronic severe constipation. Patients were excluded if they had classical acid regurgitation as their only symptom, or had used any acid suppressants, nonsteroidal anti-inflammatory drugs, or antibiotics in the previous 4 weeks. To be eligible for the study they had to have moderate symptoms defined by a dyspepsia score in the preceding 2 weeks.

STUDY DESIGN AND VALIDITY: This randomized controlled trial was triple blinded (the managing physicians, patients, and investigators were all blinded). The 453 patients were randomized to receive placebo or lansoprazole 15 or 30 mg daily for 4 weeks. Patient compliance was satisfactory and checked by pill counting.

OUTCOMES MEASURED: The outcomes assessed were dyspepsia and quality-of-life scores, and complete relief of symptoms. The dyspepsia score was calculated from a questionnaire that comprised 12 questions relating to dyspepsia, each of which was graded on a 5-point Likert scale. The quality-of-life score was assessed from the Short Form (SF-36) Health Survey, which contains 11 items related to general well-being.

RESULTS: Significant improvement in the dyspepsia scores at 4 weeks was noted in each of the 3 groups. The changes in dyspepsia score from baseline to the 4-week visit were similar between lansoprazole 30 mg and placebo, and lansoprazole 15 mg and placebo (approximate change from 22 at baseline to 18.7 out of a possible 60 points at 4 weeks). The changes in mean quality-of-life score from baseline to the score at 4 weeks were also similar for both doses of lansoprazole and placebo (approximate change from 60 to 64.8 out of a possible score of 100 at 4 weeks). No difference was noted in the proportion of patients with complete symptom relief between the lansoprazole groups (23%) and the placebo group (30%). Even when the results were analyzed in groups according to the severity of the dyspepsia, there was still no difference in complete relief of symptoms between the 3 groups.

ABSTRACT

BACKGROUND: Current guidelines suggest treating acute coronary syndromes (unstable angina, non-Q-wave myocardial infarction) with either coronary angiography followed by revascularization or conservative treatment with symptom-driven angiography. The goal of this study was to determine which approach is superior.

POPULATION STUDIED: The investigators enrolled 1810 patients presenting with acute coronary syndromes. Patients were eligible for the study if they had suspected cardiac chest pain. They also had to have evidence of coronary artery disease with at least 1 of following indicators of an acute coronary syndrome: evidence of ischemia on electrocardiogram, pathological Q waves suggesting previous myocardial infarction, or angiographic evidence of coronary artery disease on previous angiography. Patients were excluded if they had evidence of evolving myocardial infarction, myocardial infarction within the previous month, percutaneous intervention during the preceding 12 months, or coronary bypass at any time.

STUDY DESIGN AND VALIDITY: This study was a randomized, multicenter controlled trial. Patients were randomized to receive either conservative treatment with antianginal and antithrombotic treatment (n=915) or immediate intervention with catheterization and further intervention at the discretion of the treating cardiologist (n=895). The conservative treatment group received antianginal treatment, antithrombotic medications (aspirin and enoxaparin), and beta-blockers if not contraindicated. Additional treatments with glycoprotein IIb/IIIa inhibitors or other antiplatelet therapy were left to the discretion of the treating physician. The intervention group also received antianginal therapy and antithrombotic agents, but also received cardiac angiograms within 72 hours of presentation. Based on the findings at catheterization, additional intervention was left to the discretion of the treating cardiologist (stents, angioplasty, bypass, or medical management). Patient status was monitored for a median follow-up period of 2 years.

OUTCOMES MEASURED: The primary outcomes measured were combined rate of death, myocardial infarction, or refractory angina.

RESULTS: Of the 915 patients initially assigned to conservative treatment, 142 went on to have angiograms due to persistent symptoms. Ninety-two of these patients underwent angioplasty. Of patients in the intervention group, 311 had angioplasty, 184 had bypass surgery, and 388 were not deemed to need any surgical intervention and were treated medically. No difference was noted between the groups in overall mortality (approximately 11% in either group) or subsequent acute myocardial infarction. Patients in the intervention group were less likely to have refractory angina within 4 months (4.3% vs 9.3%, NNT=20) and within 1 year (6.5% vs 11.6%, NNT=20).

ABSTRACT

BACKGROUND: Current guidelines suggest treating acute coronary syndromes (unstable angina, non-Q-wave myocardial infarction) with either coronary angiography followed by revascularization or conservative treatment with symptom-driven angiography. The goal of this study was to determine which approach is superior.

POPULATION STUDIED: The investigators enrolled 1810 patients presenting with acute coronary syndromes. Patients were eligible for the study if they had suspected cardiac chest pain. They also had to have evidence of coronary artery disease with at least 1 of following indicators of an acute coronary syndrome: evidence of ischemia on electrocardiogram, pathological Q waves suggesting previous myocardial infarction, or angiographic evidence of coronary artery disease on previous angiography. Patients were excluded if they had evidence of evolving myocardial infarction, myocardial infarction within the previous month, percutaneous intervention during the preceding 12 months, or coronary bypass at any time.

STUDY DESIGN AND VALIDITY: This study was a randomized, multicenter controlled trial. Patients were randomized to receive either conservative treatment with antianginal and antithrombotic treatment (n=915) or immediate intervention with catheterization and further intervention at the discretion of the treating cardiologist (n=895). The conservative treatment group received antianginal treatment, antithrombotic medications (aspirin and enoxaparin), and beta-blockers if not contraindicated. Additional treatments with glycoprotein IIb/IIIa inhibitors or other antiplatelet therapy were left to the discretion of the treating physician. The intervention group also received antianginal therapy and antithrombotic agents, but also received cardiac angiograms within 72 hours of presentation. Based on the findings at catheterization, additional intervention was left to the discretion of the treating cardiologist (stents, angioplasty, bypass, or medical management). Patient status was monitored for a median follow-up period of 2 years.

OUTCOMES MEASURED: The primary outcomes measured were combined rate of death, myocardial infarction, or refractory angina.

RESULTS: Of the 915 patients initially assigned to conservative treatment, 142 went on to have angiograms due to persistent symptoms. Ninety-two of these patients underwent angioplasty. Of patients in the intervention group, 311 had angioplasty, 184 had bypass surgery, and 388 were not deemed to need any surgical intervention and were treated medically. No difference was noted between the groups in overall mortality (approximately 11% in either group) or subsequent acute myocardial infarction. Patients in the intervention group were less likely to have refractory angina within 4 months (4.3% vs 9.3%, NNT=20) and within 1 year (6.5% vs 11.6%, NNT=20).

ABSTRACT

BACKGROUND: Current guidelines suggest treating acute coronary syndromes (unstable angina, non-Q-wave myocardial infarction) with either coronary angiography followed by revascularization or conservative treatment with symptom-driven angiography. The goal of this study was to determine which approach is superior.

POPULATION STUDIED: The investigators enrolled 1810 patients presenting with acute coronary syndromes. Patients were eligible for the study if they had suspected cardiac chest pain. They also had to have evidence of coronary artery disease with at least 1 of following indicators of an acute coronary syndrome: evidence of ischemia on electrocardiogram, pathological Q waves suggesting previous myocardial infarction, or angiographic evidence of coronary artery disease on previous angiography. Patients were excluded if they had evidence of evolving myocardial infarction, myocardial infarction within the previous month, percutaneous intervention during the preceding 12 months, or coronary bypass at any time.

STUDY DESIGN AND VALIDITY: This study was a randomized, multicenter controlled trial. Patients were randomized to receive either conservative treatment with antianginal and antithrombotic treatment (n=915) or immediate intervention with catheterization and further intervention at the discretion of the treating cardiologist (n=895). The conservative treatment group received antianginal treatment, antithrombotic medications (aspirin and enoxaparin), and beta-blockers if not contraindicated. Additional treatments with glycoprotein IIb/IIIa inhibitors or other antiplatelet therapy were left to the discretion of the treating physician. The intervention group also received antianginal therapy and antithrombotic agents, but also received cardiac angiograms within 72 hours of presentation. Based on the findings at catheterization, additional intervention was left to the discretion of the treating cardiologist (stents, angioplasty, bypass, or medical management). Patient status was monitored for a median follow-up period of 2 years.

OUTCOMES MEASURED: The primary outcomes measured were combined rate of death, myocardial infarction, or refractory angina.

RESULTS: Of the 915 patients initially assigned to conservative treatment, 142 went on to have angiograms due to persistent symptoms. Ninety-two of these patients underwent angioplasty. Of patients in the intervention group, 311 had angioplasty, 184 had bypass surgery, and 388 were not deemed to need any surgical intervention and were treated medically. No difference was noted between the groups in overall mortality (approximately 11% in either group) or subsequent acute myocardial infarction. Patients in the intervention group were less likely to have refractory angina within 4 months (4.3% vs 9.3%, NNT=20) and within 1 year (6.5% vs 11.6%, NNT=20).

ABSTRACT

BACKGROUND: Despite public health campaigns and recommendations from national organizations for clinicians to encourage smoking cessation, only 2.5% of all smokers succeed in abstaining for 1 year. Currently, bupropion (Zyban) is an antidepressant approved by the FDA as an aid in smoking cessation. This study evaluated the safety and efficacy of another antidepressant, nortriptyline (Pamelor), in smokers enrolled in a smoking support group.

POPULATION STUDIED: Patients were participating in a hospital-based smoking support group in Brazil. They were in good general health, aged 18 to 65 years, and smoked more than 15 cigarettes per day. Degree of nicotine dependence was determined by the Fagerstrom questionnaire. Patients were excluded if they were depressed as determined by the Beck Depression Inventory or had a history of other psychiatric syndromes, cardiovascular disease, glaucoma, urinary retention, thyroid disease, or epilepsy, or were pregnant or breast-feeding. Patients could not be receiving nicotine replacement therapy or have taken antidepressants, benzodiazepines, or antipsychotic agents during the past month. Of 144 patients who completed the study, most were women.

STUDY DESIGN AND VALIDITY: Patients were randomly assigned to receive either placebo or nortriptyline, increased at weekly intervals from 25 to 75 mg daily. Patients and clinicians were blinded to assigned treatment. During the 6-week treatment, all patients participated in weekly group therapy supervised by the same psychiatrist. Group therapy was based on cognitive-behavioral therapy. Follow-up abstinence rates were evaluated 6 months after the treatment period.

OUTCOMES MEASURED: Success was defined as cessation of smoking 1 week after the end of the treatment period. The rate of abstinence was also determined 6 months after the end of the study.

RESULTS: Patients receiving nortriptyline were less likely to report smoking in the week after the treatment period (55.9% vs 23.7% in the placebo group, P < .001, numbers needed to treat [NNT]=3). After 6 months of follow-up, 20.6% of patients receiving nortriptyline and 5.3% of patients receiving placebo reported to be free from nicotine use (P < .012, NNT=7). Patients most likely to respond had low nicotine dependence (Fagerstrom score less than 7 out of a possible 10) and were younger than 50 years.

ABSTRACT

BACKGROUND: Despite public health campaigns and recommendations from national organizations for clinicians to encourage smoking cessation, only 2.5% of all smokers succeed in abstaining for 1 year. Currently, bupropion (Zyban) is an antidepressant approved by the FDA as an aid in smoking cessation. This study evaluated the safety and efficacy of another antidepressant, nortriptyline (Pamelor), in smokers enrolled in a smoking support group.

POPULATION STUDIED: Patients were participating in a hospital-based smoking support group in Brazil. They were in good general health, aged 18 to 65 years, and smoked more than 15 cigarettes per day. Degree of nicotine dependence was determined by the Fagerstrom questionnaire. Patients were excluded if they were depressed as determined by the Beck Depression Inventory or had a history of other psychiatric syndromes, cardiovascular disease, glaucoma, urinary retention, thyroid disease, or epilepsy, or were pregnant or breast-feeding. Patients could not be receiving nicotine replacement therapy or have taken antidepressants, benzodiazepines, or antipsychotic agents during the past month. Of 144 patients who completed the study, most were women.

STUDY DESIGN AND VALIDITY: Patients were randomly assigned to receive either placebo or nortriptyline, increased at weekly intervals from 25 to 75 mg daily. Patients and clinicians were blinded to assigned treatment. During the 6-week treatment, all patients participated in weekly group therapy supervised by the same psychiatrist. Group therapy was based on cognitive-behavioral therapy. Follow-up abstinence rates were evaluated 6 months after the treatment period.

OUTCOMES MEASURED: Success was defined as cessation of smoking 1 week after the end of the treatment period. The rate of abstinence was also determined 6 months after the end of the study.

RESULTS: Patients receiving nortriptyline were less likely to report smoking in the week after the treatment period (55.9% vs 23.7% in the placebo group, P < .001, numbers needed to treat [NNT]=3). After 6 months of follow-up, 20.6% of patients receiving nortriptyline and 5.3% of patients receiving placebo reported to be free from nicotine use (P < .012, NNT=7). Patients most likely to respond had low nicotine dependence (Fagerstrom score less than 7 out of a possible 10) and were younger than 50 years.

ABSTRACT

BACKGROUND: Despite public health campaigns and recommendations from national organizations for clinicians to encourage smoking cessation, only 2.5% of all smokers succeed in abstaining for 1 year. Currently, bupropion (Zyban) is an antidepressant approved by the FDA as an aid in smoking cessation. This study evaluated the safety and efficacy of another antidepressant, nortriptyline (Pamelor), in smokers enrolled in a smoking support group.

POPULATION STUDIED: Patients were participating in a hospital-based smoking support group in Brazil. They were in good general health, aged 18 to 65 years, and smoked more than 15 cigarettes per day. Degree of nicotine dependence was determined by the Fagerstrom questionnaire. Patients were excluded if they were depressed as determined by the Beck Depression Inventory or had a history of other psychiatric syndromes, cardiovascular disease, glaucoma, urinary retention, thyroid disease, or epilepsy, or were pregnant or breast-feeding. Patients could not be receiving nicotine replacement therapy or have taken antidepressants, benzodiazepines, or antipsychotic agents during the past month. Of 144 patients who completed the study, most were women.

STUDY DESIGN AND VALIDITY: Patients were randomly assigned to receive either placebo or nortriptyline, increased at weekly intervals from 25 to 75 mg daily. Patients and clinicians were blinded to assigned treatment. During the 6-week treatment, all patients participated in weekly group therapy supervised by the same psychiatrist. Group therapy was based on cognitive-behavioral therapy. Follow-up abstinence rates were evaluated 6 months after the treatment period.

OUTCOMES MEASURED: Success was defined as cessation of smoking 1 week after the end of the treatment period. The rate of abstinence was also determined 6 months after the end of the study.

RESULTS: Patients receiving nortriptyline were less likely to report smoking in the week after the treatment period (55.9% vs 23.7% in the placebo group, P < .001, numbers needed to treat [NNT]=3). After 6 months of follow-up, 20.6% of patients receiving nortriptyline and 5.3% of patients receiving placebo reported to be free from nicotine use (P < .012, NNT=7). Patients most likely to respond had low nicotine dependence (Fagerstrom score less than 7 out of a possible 10) and were younger than 50 years.