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Multifactorial intervention improves outcomes in patients with type 2 diabetes

Clinical question Does an intensive multifactorial intervention improve long-term outcomes for patients with type 2 diabetes?

Bottom line For high-risk diabetic patients with microalbuminuria, an intensive intervention that includes an ACE inhibitor, lipid lowering, aspirin, and tight blood sugar control improves outcomes compared with usual care. It is not clear which specific elements were responsible for the benefit. Based on trials of individual risk factors, the authors conclude that the bulk of the response was related to use of the statin and ACE inhibitor, but the greater use of metformin could also have contributed. (Level of evidence = 1b)

Synopsis The original Steno-2 Study identified 160 white Danish patients with type 2 diabetes mellitus and persistent microalbuminuria and randomized them to receive intensive therapy or conventional therapy. Intensive therapy consisted of A1C levels 6.5% or lower, total cholesterol levels less than 175 mg/dL (4.5 mmol/L), serum triglyceride levels less than 150 mg/dL (1.7 mmol/L), BP lower than 130/80 mm Hg, aspirin, and an ACE inhibitor regardless of initial BP. Treatment targets for the conventional therapy group are not described. At the end of the intervention study those patients in the intensive therapy group were more likely to be taking an ACE inhibitor (97% vs 70%), aspirin (87% vs 56%), metformin (50% vs 34%), or a statin (85% vs 22%). They also had lower BP (15/5 mm Hg). This initial intervention study had a mean follow-up of 7.8 years; it was followed by an additional 5.5 years of follow-up during which the patients’ care was managed by their primary physician. At the end of the complete follow-up period, many of the differences in management had disappeared; after 13.3 years, there was no difference in the likelihood that patients were taking aspirin, a statin, or an ACE inhibitor. At the end of the 13.3-year study period, patients originally assigned to intensive therapy were less likely to have died (30% vs 50%; number needed to treat = 5), primarily because of fewer cardiovascular events. Patients in the intensive therapy group were also less likely to progress to dialysis (1 patient vs 6 patients; P = .04).

Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580-591.

CBT plus alternative SSRI is better than alternative SSRI alone in adolescent depression

Clinical question What is the best treatment strategy for adolescent depression resistant to an initial selective serotonin reuptake inhibitor (SSRI)?

Bottom line Cognitive behavioral therapy (CBT) plus a switch to another SSRI or venlafaxine (Effexor) is more effective than a medication switch alone for the treatment of initial SSRI-resistant major depression in adolescents. CBT alone was not evaluated. This study detected no significant difference between venlafaxine and any of the SSRIs (fluoxetine [Prozac], paroxetine [Paxil], citalopram [Celexa]). Because of safety concerns, paroxetine is not currently recommended for the treatment of adolescent depression. (Level of evidence = 1b)

Synopsis Approximately 60% of adolescents with major depression respond to an initial treatment trial with an SSRI. These investigators identified 334 adolescents, aged 12 to 18 years, with major depressive disorder who did not respond to at least 2 months of initial treatment with an SSRI (including at least 1 month with a dose of at least 40 mg fluoxetine or its equivalent). Patients randomly received in a double-blind fashion (concealed allocation assignment) 12 weeks of: (1) a change to a different SSRI, including paroxetine, citalopram, or fluoxetine; (2) a change to a different SSRI and the addition of CBT; (3) a change to venlafaxine; or (4) a change to venlafaxine and the addition of CBT. Individuals masked to group assignment evaluated treatment response using various validated depression rating tools. Complete follow-up occurred for 98% of patients for 12 weeks. The dosage schedule for SSRI intake started at 10 mg daily, with an option to increase to 40 mg daily depending on clinical response. Similarly, the venlafaxine dosage schedule started at 37.5 mg daily, with an option to increase to 225 mg daily. Using intention-to-treat analysis, significantly more patients receiving CBT plus a new SSRI or venlafaxine achieved an adequate clinical response (defined as at least a 50% improvement compared with the baseline depression rating score) than those receiving a new SSRI or venlafaxine alone (54.8% vs 40.5%; number needed to treat = 7; 95% CI 4-27). There were no significant differences in clinical response among any of the second medications prescribed, including any SSRI or venlafaxine. The study was 80% powered to detect a 15% difference between treatment groups, so a smaller true effect size difference between the treatment drugs may still exist. There was also no difference between the treatment groups in frequency of adverse events, including self-harm events.

Brent D, Emslie G, Clarke G, et al. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008;299(8):901-913.

Antibiotics do not improve outcomes after I&D of skin abscess

Clinical question Are antibiotics necessary after incision and drainage (I&D) of superficial abscess?

Bottom line Simply incising and draining a superficial skin abscess is sufficient treatment and results in a very high cure rate. Adding a beta-lactam antibiotic does not improve outcomes. This is not the final word on this subject—it is possible, although unlikely, that use of an antibiotic effective against community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) would have increased the cure rate, or that this result may not apply in populations with a lower rate of CA-MRSA—but it supports the increasingly common practice of not prescribing antibiotics following I&D of a superficial skin abscess. (Level of evidence = 1b–)

Synopsis In the era of widespread CA-MRSA, the role of antibiotics following I&D of superficial skin abscesses has been questioned. Previous studies have found that it doesn’t seem to matter whether the bacteria cultured from the abscess were actually sensitive to the antibiotic given to the patient. In this study, 166 adults were recruited from an outpatient wound clinic attached to an emergency department. All recruits had a recent onset of superficial, fluctuant skin abscess accompanied by erythema and induration, and the treating physician felt that antibiotics were warranted following I&D. Patients with comorbidities (including HIV disease and drug use) were included. Participants were randomized to receive either 7 days of oral cephalexin, 500 mg 4 times a day for 7 days, or matching placebo following I&D. The wounds were packed and patients returned daily for dressing changes and inspection of the wound. They also returned 7 days later for a final visit and assessment of healing. A few patients had their final follow-up by telephone or chart review; only two were lost to follow-up. The median age of patients was 44 years and 75% were men; approximately 75% of each group took the antibiotic or placebo as prescribed. Culture results revealed that 70% of abscesses were caused by S aureus, and 88% of those were CA-MRSA. Clinical cure at 7 days (defined as no purulence, drainage, erythema, fluctuance, warmth, pain, or induration) occurred in 90% receiving placebo and 84% receiving cephalexin (P = NS).

Rajendran PM, Young D, Maurer T, et al. Randomized, double-blind, placebo-controlled trial of cephalexin for treatment of uncomplicated skin abscesses in a population at risk for community-acquired methicillin-resistant Staphylococcus aureus infection. Antimicrob Agents Chemo. 2007;51(11):4044-4048.

ACP presents guidelines for end-of-life care

Clinical question What are useful interventions to improve end-of-life quality?

Bottom line The American College of Physicians (ACP) has the following recommendations for the care of patients at the end of life: (1) Given evidence of the benefit of treatment, regularly assess patients at the end of life for pain, dyspnea, and depression. (2) For patients with cancer-related pain, NSAIDs and opioids are effective, as are bisphosphonates for bone pain. (3) Use morphine, oral or nebulized, and oxygen to treat dyspnea. (4) Treat depression in patients with cancer with drug therapy or psychosocial interventions. Treating pain alone does not treat depression. (5) Obtain advanced directives from patients with serious illness. (Level of evidence = 1a)

Synopsis These recommendations are developed on the basis of a systematic review of research on interventions for palliative care of pain, dyspnea, and depression at the end of life, focusing on decreasing symptoms and improving quality of life. The review was based on limited available study, and future research will improve these recommendations. The evidence is as follows. Pain: Use NSAIDs, opioids, and bisphosphonates for bone pain, and palliative radiotherapy or radiopharmaceuticals for patients with cancer (moderate evidence). There is little head-to-head research to guide the choice of one drug or approach over another. Palliative care teams are only modestly more beneficial than usual care, though a single consultation is not effective. Dyspnea: Morphine is moderately effective in decreasing dyspnea symptoms in patients with advanced lung disease, and oral treatment is as effective as nebulized administration (moderate evidence). Depression: Tricyclic antidepressants, selective serotonin reuptake inhibitors, and a variety of psychosocial interventions are effective in patients with cancer (moderate evidence). Palliative care by itself does not affect depression.

Qaseem A, Snow V, Shekelle P, et al. Evidence-based interventions to improve the palliative care of pain, dyspnea, and depression at the end of life: a clinical practice from the American College of Physicians. Ann Intern Med. 2008;148(2):141-146.

Glucosamine is ineffective for hip osteoarthritis

Clinical question Is glucosamine effective in reducing pain and the progression of osteoarthritis (OA) of the hip?

Bottom line Glucosamine sulfate was ineffective in reducing pain scores or slowing progression of joint-space narrowing in patients with OA of the hip. (Level of evidence = 1b)

Synopsis The researchers enrolled 222 patients with OA of the hip who were identified from general practices in the Netherlands. The patients had mild to moderate pain scores but met the American College of Rheumatology’s clinical criteria for OA. Patients were specifically excluded if they had severe radiographic changes or were awaiting hip replacement surgery. Using concealed allocation methods, the patients were randomly assigned to receive glucosamine sulfate, 1,500 mg daily, or placebo for 2 years. Half the patients had moderate OA and nearly 10% had hip replacement during the 2 years of the study. The average score at the start of the study on the commonly used Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring system for pain was approximately 32 of a possible 100. Overall, the WOMAC pain and function scores were not significantly different between the two groups over the course of the study. Similarly, joint-space narrowing progressed similarly between the two groups of patients over the 2 years of the study. There was no difference in outcomes in patients with a higher degree of severity.

Rozendaal RM, Koes BW, van Osch GJ, et al. Effect of glucosamine sulfate on hip osteoarthritis: a randomized trial. Ann Intern Med. 2008;148(4):268-277.

ABCD score predicts 7-day stroke risk in patients with TIA

Clinical question Does the ABCD score in patients with transient ischemic attacks (TIAs) predict the risk of stroke within 7 days?

Bottom line Patients with a TIA and an ABCD score of 4 or more were at the greatest risk of developing a stroke within the subsequent 7 days. (Level of evidence = 1a)

Synopsis The ABCD score is a 6-point scale calculated on the basis of the patient’s age (60 years or older = 1 point; younger than 60 years = 0 points); BP (systolic BP at least 140 mm Hg or diastolic BP at least 90 mm Hg = 1 point); clinical features (unilateral weakness = 2 points; speech disturbance without weakness = 1 point; other symptoms = 0 points), and duration of symptoms (60 minutes or longer = 2 points; 10 to 59 minutes = 1 point; less than 10 minutes = 0 points). The scale was developed to predict which patients with TIAs will develop a stroke in the subsequent 7 days. This team of researchers conducted a prospective validation to see how well the score performs. To do this, they prospectively evaluated patients arriving in Italian emergency departments within 24 hours of the onset of TIA symptoms (based on World Health Organization standards). A neurologist conducted a follow-up assessment of patients 1 month after the TIA to ascertain their clinical course. During a 6-month period, the researchers had complete data on 274 consecutively enrolled patients with TIA. During the follow-up period, two patients had died and 15 had developed a stroke, 10 of which occurred within 7 days. No patient with an ABCD score of 3 or less had a stroke within 30 days. A total of 20% of the patients with subsequent stroke within 7 days had a score of 4, 40% had a score of 5, and 40% had a score of 6.

Sciolla R, Melis F; SINPAC Group. Rapid identification of high-risk transient ischemic attacks: prospective validation of the ABCD score. Stroke. 2008;39(2):297-302.