Evidence- based Medicine Literature Review Jauch Symposium, May 2014

EBM – Key Concepts POEMS - Patient Oriented Evidence that Matters - changes our practice Strategies to keep up - 50,000 RCTs by 2019 Evaluating articles in context

Evidenced-based Sources Dynamed Essential Evidence Plus Cochrane Database ACP Journal Club US Preventive task force Trip database Some specialty guidelines

Oxford Centre Evidence Levels 1A- Systematic reviews 1B - Randomized controlled trials 2 - Cohort studies 3 - Case-control 4 - Case series 5 - Expert Opinion A,B,C, and D

EBM – Key Concepts Keep track of systematic reviews and randomized controlled trials with patient-oriented results Consider using synthesized database to keep up with literature Evaluate new information in context and for practice change

Diets/Supplements

Mediterranean diet What we know – Observational studies and a secondary prevention trial showed decrease cv risk Low fat diets standard treatment Takes extreme decrease in cholesterol intake to create plaque reversal Study for primary prevention vs low fat diet

Mediterranean diet 7447 people in Spain yrs old with type 2 DM or 3 risk factors followed for 4.8 yrs Mediterranean diet + olive oil or + nuts (mix of hazelnuts, almonds, and walnuts) Low fat diet Scores for diet adherence similar Combined endpoint of MI, stroke and death – both arms did better than low fat

Mediterranean diet But… all the benefit was in the prevention of ischemic strokes, and no sign women Reduction from 2.4% to 1.6% event rate Subgroups better if BMI > 30, nonsmokers, better adherence, htn, dyslipids, neg FH And the nuts or the olive oil was donated by food companies More intensive diet counseling control after 3 years

Omega-3 FA Supplements Omega-3 FA and fish oil What we know – recent studies indicating no benefit – cholesterol, dementia, The new Vit E – touted for everything but nothing panning out But wait…

Omega-3 FA Supplements Patients with RA < 12 mo, DMARD – naïve started on triple DMARD therapy 86 on high dose Fish oil supplement and 53 low dose fish oil supplement Previous meta analysis subj & obj benefits High dose fish oil group 22% less failure of triple therapy, remission 2x more in a year 88% f/u, only 122 pts finished, trend SAEs

Diagnostic studies

D-Dimer Very good at excluding DVT and PE if negative (<500) Not good in elderly ADJUST-PE study – JAMA March 19, 2014 Multicenter, consecutive ER patients Age-adjusted D-Dimer level (age x 10 mcg/dl) 3346 patients suspected PE (53-74)

D-Dimer age adjusted 19% PE rate High clinical likelihood – CTA 2898 – D-dimer, 337 in age-adjust 1 of 331 patients had confirmed VTE in 3 months Similar to rates with negative workup No CTA in negative group

Treatment Studies

Migraine Treatment Abortive therapy options – NSAIDS, Ergotamines, Triptans, Combo agents, Narcotics, Barbituates Significant risk of rebound headaches Patients often develop tolerance to meds Have to take meds right away to get benefit OTCs often used, most Rxs expensive

Migraine Treatment Cochrane Database Meta-analysis of 13 RCTs, noted in a PURL in The Journal of Family Practice, Feb aspirin tabs with/without 10 mg metoclopramide 5 placebo studies, 4 against common treatments, 4 both > 3200 patients, 2 hour pain-free, 2 hour headache relief, 24 hour headache relief

Migraine Treatment NNT vs placebo – 9 for pain free status Equivalent to sumatriptan 50 mg 2 hour measures 2/4 studies Metoclopramide reduced nausea and vomiting No GI bleeds, NNH 34 vs placebo for GI upset No comments about rebound headaches

Sore throat Cochrane systematic review 2012 Eight studies, 743 pts 369 kids, 374 adults Antibiotic with/without steroids Studies used one dose oral, three days oral, one dose IM and three days IM One day course oral probably enough – all were similar in effectiveness

Sore throat The Results: Reduced pain faster 8 vs 14 hours Mean time to resolution of pain 14 hours faster More pain resolved at 24 hours (27%) and 48 hours (30%) Not clear if would work without antibiotics No difference in risks, adverse events

Forearm fractures in kids UK study – 317 kids, mostly falls, mostly radius fractures, all minimally displaced Bone Joint Journal Dec 2013 Half fiberglass cast for 3 weeks (std care) Half soft cast tape for 3 weeks 2 patients had increased pain converted No complications at 6 mo f/u (91%)

Forearm fractures

Prevention news

TIAs/Minor Strokes What we know: Patients with TIAs and minor strokes at higher risk or another stroke (10-20% in 3 months) Clopidogrel + asa not better than either alone and increase risk of bleeding Asa benefits post TIA/stroke

TIAs/Minor Strokes Randomized, double-blind, in China 5170 patients with TIA/minor stroke All patients asa first day 75 – 300 mg Had to begin in study in first 24 hours Asa group 75 mg daily and placebo Clopidogrel group – 300 mg load, 75 mg daily + asa day 2-21, then placebo Only 90 day f/u

TIAs/Minor Strokes 8% strokes in 90 days in combined group, 11.7% in aspirin group, no sign difference in bleeding risks NNT 29, stroke rate in China 5x US Only included high risk TIAs – score based on age, blood pressure, clinical features, duration and diabetes Minor stroke < 4 stroke scale