Cochrane for Clinicians July 1, 2008 Table of Contents 1) Antidepressants to Treat Nonspecific Low Back Pain Clinical Question Are medications such as tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and atypical antidepressants effective for the treatment of nonspecific low back pain? Evidence-Based Answer Although antidepressants have been shown to be superior to placebo in some forms of chronic pain, do not reduce pain or improve functional status or depression in patients with nonspecific low back pain 2) Over-the-Counter Medications for Acute Cough Symptoms Clinical Question Are over-the-counter (OTC) cough medications safe and effective in reducing acute cough symptoms in children and adults? Evidence-Based Answer Overall, the quality of evidence is poor Adults It is uncertain whether OTC cough medications are effective in reducing cough symptoms; adult studies show conflicting results from heterogeneous studies. Children, no trials show a statistically significant benefit in the treatment compared with the placebo groups. Adverse effects; Evidence is limited; however, national databases have reported ingestionrelated harms in children August 1, 2008 Table of Contents 3) Arthroscopic Surgery for Knee Osteoarthritis Clinical Scenario A 53-year-old man presents for follow-up of knee pain. Examination and plain radiography confirmed osteoarthritis. After little relief with analgesics and a corticosteroid injection, he inquires about arthroscopic surgery. Clinical Question Is arthroscopic debridement an effective therapy for improving pain and function in patients with OA of the knee? Evidence-Based Answer arthroscopic debridement does not improve outcomes for patients with osteoarthritis of the knee, Compared with other modalities of treatment such as sham surgery, joint lavage, and joint washout 4) Cranberry Products for Treatment of Urinary Tract Infection Clinical Question Does ingesting cranberry reduce the frequency of symptomatic urinary tract infections or asymptomatic bacteriuria? Evidence-Based Answer Over a 12-month period, cranberry products decrease the incidence of symptomatic (UTIs), especially in women with recurrent UTIs. Optimal dosage and form of administration (juice, tablets, or capsules) is unclear. There are no studies comparing cranberry juice with antibiotic prophylactic therapy. Unacceptable taste and gastrointestinal upset are commonly reported adverse effects. September 1, 2008 Table of Contents 5) Alendronate for Fracture Prevention in Postmenopause Clinical Scenario A 55-year-old postmenopausal woman was recently diagnosed with osteoporosis on dual energy x-ray absorptiometry. She has no history of fracture, and is currently taking a calcium and vitamin D supplement. Clinical Question Should alendronate (Fosamax) be prescribed for primary and secondary prevention of osteoporotic fractures? Evidence-Based Answer In postmenopausal women, prevention of: vertebral fractures primary secondary nonvertebral fractures primary secondary hip or wrist NNT = 50 [NNT] = 16 Not effective (NNT = 100) Adverse effects reported in 11 randomized controlled trials (RCTs) were similar for alendronate and placebo.1 6) Induction of Labor at or Beyond Term Clinical Question In low-risk pregnancies, does inducing labor at or beyond term improve maternal or neonatal outcomes? Evidence-Based Answer after due date and before 42 weeks Fetal or neonatal deaths in women; a rate of less than 0.5 percent, regardless of whether labor is induced or spontaneous. Inducing between 41 and 42 weeks, Compared with awaiting spontaneous labor, is associated with fewer perinatal deaths and fewer cases of meconium aspiration. However, there were no differences in admissions to (NICU). Induction beyond term does not increase rates of cesarean delivery. November 1, 2008 Table of Contents 7) Antioxidant Supplements Do Not Improve Mortality and May Cause Harm Clinical Scenario A 42-year-old woman with hypertension and hyperlipidemia presents for her annual physical examination. She is taking several over-the-counter antioxidant supplements because she believes that they will increase her longevity. Clinical Question Are antioxidant supplements safe and effective for preventing mortality? Evidence-Based Answer In randomized controlled trials of primary and secondary prevention,. vitamins A and E, and beta-carotene supplementation increased mortality, Vitamin C and selenium supplementation had no significant effect on mortality. March 1, 2009 Table of Contents 8) Effectiveness of Brief Alcohol Interventions in Primary Care CLINICAL QUESTION What is the effectiveness of brief alcohol interventions in primary care populations? EVIDENCE-BASED ANSWER For men who engage in excessive or hazardous drinking and present to their primary care physician for issues not specifically related to alcohol treatment, an intervention of one to four sessions administered by a physician, nurse, or psychologist is effective in reducing weekly alcohol consumption one year later. It is also effective in reducing emergency department visits and alcohol-related injuries. women The effect was not demonstrated. Longer counseling did not significantly improve the effect. 9) Dipeptidyl-peptidase-4 Inhibitors for Treatment of Type 2 Diabetes Clinical Question Are dipeptidyl-peptidase-4 (DPP-4) inhibitors safe and effective for the treatment of type 2 diabetes? Evidence-Based Answer DPP-4 inhibitor sitagliptin (Januvia) decreases A1C levels by 0.7 percent When used as: monotherapy or in conjunction with metformin (Glucophage) or thiazolidinediones, patient-oriented outcomes or long-term safety; no data. Until more studies are completed, it should only be used in individual patients when there are reasons that other better-studied agents are not sufficient. June 1, 2008 Table of Contents 10) Use of Inhaled Corticosteroids to Treat Stable COPD Clinical Scenario A 60-year-old patient with a 40 pack-year smoking history requests "something else" to treat his chronic cough and dyspnea from chronic obstructive pulmonary disease (COPD). He is already using an albuterol/ipratropium (Combivent) inhaler as needed. Clinical Question Should inhaled corticosteroids be used to treat stable COPD? Evidence-Based Answer Not reduce mortality or affect long-term disease progression, reducing COPD exacerbations and slowing declines in quality of life. 11) Low Glycemic Diets for Obesity Treatment Clinical Question Are low glycemic index or low glycemic load diets effective in the treatment of obesity? Evidence-Based Answer low glycemic index diets better reduce (BMI) and (LDL) cholesterol, Compared with high glycemic index diets or conventional energy-restricted weight loss diets. lost an additional 1 to 2 BMI units on the low glycemic index diets, The weighted mean difference showed that patients May 1, 2008 Table of Contents 12) Oral Anticoagulants vs. Antiplatelet Therapy Clinical Scenario A 70-year-old man presents for an initial visit. He is healthy, lives independently, and takes only blood pressure and cholesterol medication. On examination, his pulse is irregular. Electrocardiography (ECG) confirms atrial fibrillation. Clinical Question For patients with nonvalvular atrial fibrillation and no history of stroke or transient ischemic attack (TIA), how effective at preventing stroke is oral anticoagulation therapy compared with antiplatelet therapy? Who benefits most, and what are the associated risks? Evidence-Based Answer Compared with antiplatelet therapy, oral anticoagulation significantly reduces stroke at an average follow-up of one to three years, but does not reduce mortality. Intracranial or extracranial hemorrhage is more common with anticoagulation and must be weighed against its therapeutic benefit.1 13) Are SSRIs Effective for Treating OCD? Clinical Question Are selective serotonin reuptake inhibitors (SSRIs) effective for the treatment of obsessive-compulsive disorder (OCD)? Evidence-Based Answer SSRIs are effective for the treatment of OCD. one additional person to have a response within six to 13 weeks. If it is assumed that 10 percent of persons with OCD will recover without treatment, NNT= 12 If it is assumed that 20 percent of persons with OCD will recover without treatment, NNT= 6. April 1, 2008 Table of Contents 14) Subclinical Hypothyroidism Clinical Question Should physicians recommend thyroid hormone therapy for any nonpregnant patient with subclinical hypothyroidism? Evidence-Based Answer Although there is evidence that thyroid hormone therapy in patients with subclinical hypothyroidism may improve lipid profiles, cognitive function, and echographic left ventricular function, there is no evidence that this will decrease morbidity or mortality. 15) Abstinence-Plus Programs for Prevention of HIV Clinical Question Do abstinence-plus programs prevent human immunodeficiency virus (HIV) infection? Evidence-Based Answer Abstinence-plus is sex education that includes information on abstinence, condom use, and contraception. Compared with a variety of controls-including usual care, no intervention, or other programs-there is no evidence of increased rates of pregnancy or sexually transmitted infection (STI). Based on limited data, abstinence-plus programs increase knowledge, reduce pregnancy rates, and decrease incidence of unprotected sex and frequency of sex. March 1, 2008 Table of Contents 16) Interventions to Improve Antibiotic Prescribing Practices for Hospital Inpatients Clinical Question What strategies have been proven to improve antibiotic-prescribing practices in hospitalized patients? Evidence-Based Answer The choice of antibiotic, timing, dosage and route of administration in hospitalized patients Although both educational (persuasive) and restrictive measures of interventions are effective, Restrictive measures appear to make a more significant change in antibiotic prescribing patterns based on heterogeneous studies 17) Medical Treatments in the Short-term Management of Reflux Esophagitis Clinical Question What is the safest and most effective short-term medical treatment for reflux esophagitis? Evidence-Based Answer (PPIs) are the most effective short-term treatment for reflux esophagitis. Histamine H2 blockers are also effective compared with placebo, but are inferior to PPIs. adverse events; limited evidence about with these therapies, but long-term therapy with PPIs has been shown to increase hip fracture risk. February 15, 2008 Table of Contents Cochrane for Clinicians 18) Are Long-acting Insulin Analogues Better Than Isophane Insulin? Clinical Question Are long-acting insulin analogues (i.e., insulin glargine [Lantus] and insulin detemir [Levemir]) better than isophane insulin (NPH) in long-term treatment of type 2 diabetes? Evidence-Based Answer insulin glargine and insulin detemir have no advantage over isophane insulin in reducing A1C levels. Based on poor quality evidence In one study, isophane insulin reduced A1C levels slightly more than insulin detemir. However, patients on insulin glargine and detemir reported fewer symptomatic and overall hypoglycemic episodes. The significance of this is not clear because there were few episodes of severe hypoglycemia, and definitions of hypoglycemia varied and were prone to bias.1 None of the studies were powered to detect improvements in POEM patient-oriented outcomes, such as mortality and microvascular (e.g., retinopathy, neuropathy, nephropathy) and macrovascular (e.g., peripheral arterial disease, cardiovascular, cerebrovascular) events. Because the longest study in the review was 52 weeks, longer studies are needed to further evaluate the clinical effectiveness and safety of these long-acting insulin analogues.1 19) Cancer Genetic Risk Assessment for Individuals at Risk of Familial Breast Cancer Clinical Question Does breast cancer genetic risk assessment in those at risk of familial breast cancer lead to improvements in psychological well-being? Evidence-Based Answer Cancer genetic risk assessment reduces distress, improves accuracy of perceived breast cancer risk, and increases breast cancer and genetics knowledge. Based on limited evidence from three trials July 15, 2008 Table of Contents Clinical Evidence Concise Basal ca Clinical Questions What are the effects of interventions on treatment response and recurrence (within one year of therapy) in persons with basal cell carcinoma? Likely to be beneficial Cryotherapy/cryosurgery (as effective as photodynamic therapy; in combination with curettage, it seems to be as effective as excisional surgery) Curettage and cautery/electrodesiccation (likely to be beneficial for low-risk basal cell carcinoma)* Imiquimod 5% cream (better than placebo at six months; insufficient evidence to compare with other treatments) Photodynamic therapy Surgery (excisional or Mohs' micrographic surgery)* Unknown Fluorouracil effectiveness What are the effects of interventions on long-term recurrence (a minimum of two years after treatment) in persons with basal cell carcinoma? Likely to be beneficial Cryotherapy/cryosurgery* Curettage and cautery/electrodesiccation* Photodynamic therapy* Surgery (conventional or Mohs' micrographic surgery)† Unknown effectiveness Fluorouracil Imiquimod 5% cream *-Categorization is based on consensus and expert opinion. †-Categorization is based on consensus and observational data. June 15, 2008 Table of Contents Hepatitis C (Chronic) Clinical Questions What are the effects of interventions in treatment-naive persons with chronic infection but without liver decompensation? naive without liver decompensation? Beneficial 1) Interferon 2) Interferon plus ribavirin 3) Peginterferon 4) Peginterferon plus ribavirin not responded to interferon? Beneficial Unknown effectiveness 1) Interferon-alfa plus ribavirin Interferon Peginterferon Peginterferon plus ribavirin relapse after interferon treatment? Beneficial Interferon-alfa plus ribavirin Interferon (less effective than interferon-alfa plus ribavirin at sustaining virologic response) Likely to be Peginterferon plus ribavirin* beneficial Unknown Peginterferon effectiveness also have human immunodeficiency virus? Likely to be beneficial Interferon-alfa plus ribavirin (increased rates of sustained viral response from baseline, but less effective than peginterferon plus ribavirin) Peginterferon plus ribavirin Unknown effectiveness Interferon Peginterferon *-We found no randomized controlled trials. Categorization based on consensus. August 15, 2008 Table of Contents Clinical Evidence Concise A Publication of BMJ Publishing Group Diarrhea in Adults (Acute) Clinical Questions What are the effects of treatments for acute diarrhea in adults living in resource-rich countries? Likely to be beneficial Antimotility agents Antisecretory agents Trade-off between benefits Antibiotics (empiric use for mild-to-moderate diarrhea) and harms Unknown effectiveness Antibiotics plus antimotility agents Restricted diet Oral rehydration solutions What are the effects of treatments for mild-to-moderate traveler's diarrhea in adults from resource-rich countries traveling to resource-poor countries? Likely to be beneficial Antibiotics (empiric use) Antimotility agents Bismuth subsalicylate (reduced duration of diarrhea compared with placebo, but less effective than loperamide) Trade-off between benefits Antisecretory agents and harms Unknown effectiveness Antibiotics plus antimotility agents Restricted diet Oral rehydration solutions What are the effects of treatments for mild-to-moderate diarrhea in adults living in resource-poor countries? Likely to be beneficial Antimotility agents Antisecretory agents Unknown effectiveness Antibiotics (empiric use) Antibiotics plus antimotility agents Oral rehydration solutions What are the effects of treatments for severe diarrhea in adults living in resource-poor countries? Beneficial Amino acid-based oral rehydration solutions Rice-based oral rehydration solution Standard oral rehydration solution* Unknown effectiveness Antibiotics (empiric use) Antibiotics plus antimotility agents Antimotility agents Antisecretory agents Bicarbonate oral rehydration solution Intravenous rehydration (compared with nasogastric tube rehydration or oral rehydration solution alone) Reduced osmolarity oral rehydration solution *-Categorization based on consensus. Randomized controlled trials unlikely to be conducted. September 15, 2008 Table of Contents Clinical Evidence Concise A Publication of BMJ Publishing Group Autism Clinical Questions What are the effects of early, intensive, multidisciplinary intervention programs in children with autism? Likely to be beneficial Applied behavioral analysis* Autism Pre-school Programme* Child's Talk* More Than Words training course* Picture Exchange Communication System* TEACCH* Unknown effectiveness Early Bird Programme Floor time Portage scheme Relationship development intervention Social skills training Social Stories Son-Rise What are the effects of dietary interventions in children with autism? Unknown effectiveness Digestive enzymes Gluten- and casein-free diet Omega-3 fatty acids (fish oil) Probiotics Vitamin A Vitamin B6 (pyridoxine) plus magnesium Vitamin C What are the effects of drug treatments in children with autism? Likely to be beneficial Methylphenidate (for hyperactivity only) Trade-off between benefits and harms Risperidone Selective serotonin reuptake inhibitors* Unknown effectiveness Immune globulins Memantine Unlikely to be beneficial Secretin What are the effects of nondrug treatments in children with autism? Unknown effectiveness Auditory integration training Chelation therapy Sensory integration training TEACCH = Treatment and Education of Autistic and related Communication-handicapped CHildren. *-In the absence of robust evidence from randomized controlled trials in children with autism, categorization is based on observational evidence and strong consensus belief. October 15, 2008 Table of Contents Clinical Evidence Concise A Publication of BMJ Publishing Group Recurrent Miscarriage Clinical Questions What are the effects of treatments for unexplained recurrent miscarriage? Unknown effectiveness Aspirin (low-dose) Bed rest Corticosteroids Early scanning Human chorionic gonadotropin Lifestyle adaptation (e.g., smoking cessation, reducing alcohol consumption, losing weight) Progesterone Trophoblastic membrane infusion Vitamin supplementation Unlikely to be beneficial Intravenous immune globulin treatment Paternal white cell immunization Likely to be ineffective or harmful Estrogen What are the effects of treatments for recurrent miscarriage caused by antiphospholipid syndrome? Unknown effectiveness Aspirin (low-dose) Aspirin (low-dose) plus heparin Likely to be ineffective or Corticosteroids harmful November 15, 2008 Table of Contents Clinical Evidence Concise A Publication of BMJ Publishing Group Febrile Seizures Clinical Questions What are the effects of treatments given during episodes of fever in children with one or more previous simple febrile seizures? Unknown effectiveness Antipyretic treatments (physical antipyretic measures, paracetamol, ibuprofen) Likely to be ineffective or harmful Anticonvulsants (intermittent) What are the effects of long-term (daily, longer than one month) anticonvulsant treatment in children with a history of simple febrile seizures? Trade-off between benefits and Anticonvulsants (continuous) harms What are the effects of treatments on reducing the risk of subsequent epilepsy in children with a history of simple febrile seizures? Unlikely to be beneficial Anticonvulsants (intermittent and continuous) August 15, 2009 Table of Contents U.S. Preventive Services Task Force Screening for Prostate Cancer: Recommendation Statement The online version of this statement includes a clinical summary. Summary of Recommendations and Evidence The U.S. Preventive Services Task Force (USPSTF) concludes that the current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening in men younger than 75 years. I statement. The USPSTF recommends against screening for prostate cancer in men 75 years and older. D recommendation. U.S. Preventive Services Task Force Screening for Gestational Diabetes Mellitus: Recommendation Statement See related editorial on page 132. Summary of Recommendations The U.S. Preventive Services Task Force (USPSTF) concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for gestational diabetes mellitus, before or after 24 weeks' gestation (Table 1). I statement. Table 1. Screening for Gestational Diabetes Mellitus: Clinical Summary of the U.S. Preventive Services Task Force Recommendation Population Pregnant women who have not previously been diagnosed with diabetes Recommendation No recommendation because of insufficient evidence Grade: I Risk assessment Women at increased risk of developing gestational diabetes include those who: • Are obese • Are older than 25 years • Have a family history of diabetes • Have a history of previous gestational diabetes • Are of certain ethnic groups (e.g., Hispanic, American Indian, Asian, or black) Rationale for no The current evidence is insufficient to assess the balance between the benefits and recommendation harms of screening women for gestational diabetes before or after 24 weeks' gestation. Harms of screening include short-term anxiety in some women with positive screening results, and inconvenience to women and medical practices because most positive screening tests are likely false-positives. Suggestions for practice Until there is better evidence, physicians should discuss screening for gestational diabetes with their patients and make decisions on a case-by-case basis. The discussion should include information about the uncertain benefits and harms as well as the frequency and uncertain meaning of a positive screening test result. Screening tests If a decision is made to screen for gestational diabetes: • The screening test most commonly used in the United States is an initial 50-g one-hour glucose challenge test. • If the result on the glucose challenge test is abnormal, the patient undergoes a 100-g three-hour oral glucose tolerance test. • Two or more abnormal values on the oral glucose tolerance test are considered diagnostic for gestational diabetes. Screening intervals Most screening is conducted between 24 and 28 weeks' gestation. There is little evidence about the value of earlier screening. Other approaches Nearly all pregnant women should be encouraged to achieve to prevention moderate weight gain based on their prepregnancy body mass index and to participate in physical activity. June 15, 2009 Table of Contents U.S. Preventive Services Task Force Screening for High Blood Pressure: Reaffirmation Recommendation Statement Summary of Recommendations and Evidence The U.S. Preventive Services Task Force (USPSTF) recommends screening for high blood pressure in adults 18 years and older (see accompanying table). A recommendation. July 1, 2008 Table of Contents U.S. Preventive Services Task Force Screening for Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery: Recommendation Statement Summary of Recommendations and Evidence The USPSTF recommends against screening for bacterial vaginosis in asymptomatic pregnant women at low risk for preterm delivery. D recommendation. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for bacterial vaginosis in asymptomatic pregnant women at high risk for preterm delivery. I statement. May 1, 2008 Table of Contents U.S. Preventive Services Task Force Screening for Sickle Cell Disease in Newborns: Recommendation Statement Summary of Recommendations and Evidence The USPSTF recommends screening for sickle cell disease in newborns. A recommendation. April 1, 2008 Table of Contents U.S. Preventive Services Task Force Screening for Carotid Artery Stenosis: Recommendation Statement Summary of Recommendations and Evidence The USPSTF recommends against screening for asymptomatic carotid artery stenosis in the general adult population. D recommendation. December 1, 2007 Table of Contents U.S. Preventive Services Task Force Screening for Chlamydial Infection: Recommendation Statement Summary of Recommendations and Evidence The USPSTF recommends screening for chlamydial infection in all sexually active, nonpregnant women 24 years or younger AND in older nonpregnant women who are at increased risk. A recommendation. The USPSTF recommends screening for chlamydial infection in all pregnant women 24 years or younger AND in older pregnant women who are at increased risk. B recommendation. The USPSTF recommends against routinely providing screening for chlamydial infection in women 25 years or older, whether or not they are pregnant, if they are not at increased risk. C recommendation. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydial infection in men. I statement. September 1, 2007 Table of Contents U.S. Preventive Services Task Force Screening for Elevated Blood Lead Levels in Children and Pregnant Women: Recommendation Statement Summary of Recommendations CHILDREN The USPSTF concludes that evidence is insufficient to recommend for or against routine screening for elevated blood lead levels in asymptomatic children one to five years of age who are at increased risk. I recommendation. The USPSTF recommends against routine screening for elevated blood lead levels in asymptomatic children one to five years of age who are at average risk. D recommendation. PREGNANT WOMEN The USPSTF recommends against routine screening for elevated blood lead levels in asymptomatic pregnant women. D recommendation. July 1, 2007 Table of Contents U.S. Preventive Services Task Force Routine Aspirin or Nonsteroidal Anti-inflammatory Drugs for the Primary Prevention of Colorectal Cancer: Recommendation Statement Summary of Recommendations The USPSTF recommends against the routine use of aspirin and NSAIDs to prevent colorectal cancer in persons at average risk of colorectal cancer. D recommendation. June 1, 2007 Table of Contents U.S. Preventive Services Task Force Screening for Hemochromatosis: Recommendation Statement Summary of Recommendations The USPSTF recommends against routine genetic screening for hereditary hemochromatosis in the asymptomatic general population. D recommendation. August 1, 2006 Table of Contents U.S. Preventive Services Task Force Screening for Iron Deficiency Anemia, Including Iron Supplementations for Children and Pregnant Women: Recommendation Statement Summary of Screening Recommendations The USPSTF concludes that evidence is insufficient to recommend for or against routine screening for iron deficiency anemia in asymptomatic children six to 12 months of age. I recommendation. The USPSTF recommends routine screening for iron deficiency anemia in asymptomatic pregnant women. B recommendation. June 1, 2006 Table of Contents U.S. Preventive Services Task Force Screening for Developmental Dysplasia of the Hip: Recommendation Statement Summary of Recommendations The USPSTF concludes that evidence is insufficient to recommend routine screening for DDH in infants as a means to prevent adverse outcomes. I recommendation.