Tools for Practice: Jeopardy Edition. Mike Allan (part of the) ACFP Evidence & CPD Team

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1 Tools for Practice: Jeopardy Edition Mike Allan (part of the) ACFP Evidence & CPD Team

2 Guidelines Presenter Disclosure: G Michael Allan has no potential for conflict of interest with this presentation He wrote or was the editor for these Tools for Practice. The Tools for Practice is sponsored by a grant from the Alberta College of Family Physicians

3 Jeopardy AOM & small miracles All Benefit, No harm Hormones The Bell Tolls Lot Clot OCP? HDL Cure-All Best Thiazide Diet Vs Health BMD tests Lubricant wrecks a PAP test Old Iron Doses TCA 4 Smoking Exercise 2 4-letter words Need a little, take a lot OTC (antihistamines) for cold Coffee: Nice Vice Dual Anti-platelet: To Stop or not Omega-3: Igloo Fix Fasting?: A1c Dx Need a little, take a multi-lot Delaying Abx Burning for a UTI answer Osteoporosis Screening Test Calcium: +/-/= Flashes of Evidence Menopause Insulin: Is longer better Bisphosphonates To infinite &, Paediatric Fever: If yes, what drug Hold on Honey: Cough Ezetimibe: still waiting Elderly BP: careful Start Insulin at the end Old #1: Atenolol

4 Amoxil will help 1 in 4 young kids with AOM? Evidence: 2 RCTs & a systematic review. Avoid treatment failure day 8-12: NNT 3-9 Adverse events up: particularly diarrhea (NNH 5-7) At 7-14 days, AOM will resolve in approximately 70% untreated children. Poor Prognostic: Bilateral AOM, age <24 months, exposure to more children (day-care), and more severe symptom scores Bottom-line: Although most children will recover from Acute Otitis Media without complications, antibiotics will improve outcomes for 1 in 3 to 1 in 10, depending on outcome and complicating factors. They will cause adverse events, particularly diarrhea, in up to 1 in every 5. #42 Feb 22, 2011

5 Do antiviral medications provide any benefit to patients with Bell s Palsy? Evidence: Meta-analysis, 2 high-quality RCTs Unsatisfactory recovery at 4 months: corticosteroid 16% vs Placebo 26% (NNT 10) Antivirals, with or without steroid, no additional benefit Bottom-line: The best evidence indicates that corticosteroids (in doses of prednisolone 25 mg BID or 60 mg x5 days then tapered by 10 mg/day) improve the odds of complete recovery from Bell s Palsy. Antivirals (used either alone or in addition to prednisolone) seem to offer no advantage (although research continues in severe Bell s Palsy). #4 July 9, 2009 Updated July 8, 2013

6 Newer Contraceptive have a clearly higher risk of Venous Thromboembolism (VT)? Evidence: cohort studies 4-5/10,000 for non-users or progestin only 10/10,000 for older OCP (like levonorgestrel).1,7 20/10,000 for transdermal or vaginal ring, newer OCP8 29/10,000 for pregnancy (for comparison).1 Bottom-line: Due to limits in the evidence, there is real uncertainty whether the risks of VT vary with different hormonal contraceptives. If they do, the increased risk appears to be about 1 extra VT per year for 2000 women. #70 July 23, 2012

7 Adding Niacin to statins has a small benefit in patients with CVD (+ low HDL levels)? Evidence: AIM-HIGH, 3-yr RCT 3414 patients (and new 25,000 pt Merck trial stopped early) Still, niacin may be better than ezetimibe Bottom-line: In patients with cardiovascular disease already on statin therapy, adding niacin does not improve cardiovascular events. Among lipid treatments, only statin monotherapy has strong evidence for CVD prevention (regardless of lipid levels). #65 April 10, 2012

8 Bioidentical hormone micronized progesterone has lower risks vs synthetic medroxyprogesterone? Evidence: RCTs of surrogate markers. Cohorts of without results or multiple flaws, and surveys. Compounding compounds uncertainty. Bottom-line: The theory behind bioidentical hormone use is appealing; however its clinical advantage is not supported by reliable evidence. Long-term safety is largely unknown. #63 March 5, 2012

9 When choosing a thiazide diuretic for hypertension, is hydrochlorothiazide (HCTZ) the best choice? Evidence: Meta-analysis showing Chlor > HCTZ NNT over 5 yrs (even when office BP same) BP (24 hour 5-7mmHg) better, MRFIT, all best trials Bottom-line: The available data suggest that chlorthalidone is at least equal to and very likely superior to HCTZ in reducing BP and improving clinical outcomes. Consider prescribing chlorthalidone (12.5mg increasing to 25mg daily) when initiating thiazide diuretic therapy for hypertension. #61 February 6, 2012; Hypertension. 2012;59(6):

10 Is any diet better for weight loss or preventing -ve health outcomes like heart disease or mortality? Evidence: No difference in low vs high carb, No evid: DASH, very low cal ( 800 cal), & cohort wgt loss Med diet: CVD NNT 12-14, mortality NNT 25 x2-3 yrs Bottom-line: Weight loss for all diets is best at 6 months, regain is common, and by two years there is no consistent difference between diets. Only the Mediterranean diet has demonstrated positive results in hard outcomes like mortality, despite not having differences in weight or surrogate markers like lipid profiles. #46 April 18, 2011

11 Once we have initiated bisphosphonate therapy, how frequently should we check bone mineral density (BMD)? Evidence: Too much variance for frequent testing Over 2 weeks, BMD variance = 2.4-5% Over 3 yrs BMD improves on Tx by 1-6%. Bottom-line: Repeating BMD in the first three years after starting treatment with a bisphosphonate is unnecessary and potentially confusing. The vast majority of patients taking a bisphosphonate will get an adequate increase in BMD after three years and have a reduced fracture risk regardless of BMD changes. #32 September 8, 2010

12 Does Lubricant disrupt the cytology of a PAP test? Evidence: 4 RCTs Lubricant has no effect on the cytology quality. Liquid based studies also find little effect One study found applying a cm 'ribbon' of lubricant gel directly to the cervical os might disrupt the cytology 2 studies show reduced pain/discomfort with lubricant Bottom-line: A small amount of water soluble lubricant on a speculum does not reduce the quality of the PAP test and probably does not affect microbiologic results either. The present evidence suggests the adequacy of liquid-based PAP tests would be minimally affected or not at all. #21 April 22, 2011

13 In elderly adults with iron deficiency anemia, what is the appropriate dose of iron? Evidence: 15 vs 150mg elemental iron = Hgb (14) Drop-out NNH 5, Abdo cramps or N/V=2, constipation=5 Ferrous Sulfate 300mg = elemental iron Bottom-line: In elderly patients with iron deficiency anemia, low doses of iron raise hemoglobin similar to higher doses with considerably less adverse events in most patients. Options for dosing include ½ of a 300mg ferrous gluconate per day or 2.5ml of Fer-In-Sol syrup a day. Clinicians should work-up the cause of anemia as appropriate. #30 July 6, 2010

14 In patients ready for smoking cessation, how effective are first-line medications and what are the potential concerns? Evidence: Assuming 10% placebo cessation rates: NTT: Varenicline 8, nortriptyline 10, bupropion 10, NRT 16 Buproprion 150mg 300mg; Varenicline: 0.5mg 1mg BID Nortriptyline: 25mg qhs, 25 mg q3-4d, mg max Bottom-line: In addition to nicotine replacement, buproprion, nortriptyline (off-label) and varenicline are all effective in smoking cessation, perhaps the latter more so. Adverse events vary and may in part relate to quitting smoking, but are important and require monitoring. #27 May 26, 2010

15 How do I motivate my patients to participate in regular physical activity? Evidence: 2 Sys Rev + RCTs: steps/day. Also reduce BP, Weight, glucose at $30/pedometer. Bottom line: Pedometers, used with specific exercise goals, provide an inexpensive, tangible measure of a patient s physical activity, and have been demonstrated to increase physical activity levels at least in the short term. #5 July 14, 2009

16 How do I motivate my patients to participate in regular physical activity? 1 Wear your pedometer every day for 1 week. 2 Calculate your daily steps. 3 Add 500 steps per day to your daily average. Walk that each day for the next week. 4 Repeat step 3, adding 500 steps to last week s daily goal, and walk that each day for the next week. 5 Continue until you reach steps per day. #5 July 14, 2009

17 Does daily supplementation with antioxidant vitamins (A, E and C) decrease mortality in the general population? Evidence: Meta-analysis with 296,707 patients Beta-carotene (pro-vitamin A): RR 1.05 ( ) Vitamin E (RR 1.03, ) Vitamin A all doses (RR 1.07, ) High dose vitamin A (? 5000IU) does increase mortality (p=0.002) NNH likely over 3.5 years or so. Bottom-line: The current evidence does not support the use of antioxidant supplementation, and patients should be dissuaded from using beta-carotene, vitamin E and perhaps high dose vitamin A, as they appear to increase mortality. #10 September 22, 2009 Updated June 28, 2013

18 Do antihistamines (alone or combo) improve cold Sx? Evidence: 3 Systematic rev (mostly moderate to poor RCTs) Antihistamine alone: no meaningful effect. Antihistamine with decongestants and/or decongestants improved global symptoms NNT 4-7. Limited evidence of benefit in peds Antihistamines and cold and cough preparations are 2nd and 6 th most common substances involved in (age 5 years) pediatric deaths. Bottom-line: Antihistamines alone have no meaningful impact on the common cold. Although evidence is at moderate to high risk of bias, antihistamines combined with decongestants and/or analgesia may have a small impact on improving symptoms for one in 4-7 patients but should not be used in children under 6. #80 January 7, 2013

19 Does drinking coffee impact mortality or other health outcomes in the general population? Evidence: 400,000 (US) x 14 yrs (+ other cohorts) Increased mortality with coffee (but lots of confounders) Men: About 10% relative reduction for 2 cups/day Women: About 15% relative reduction for 2 cups/day Bottom-line: Coffee consumption is associated with no change or a small reduction in mortality in cohort studies. While the evidence is not strong enough to recommend non-drinkers to start consuming coffee, coffee drinkers can be reassured that it does not appear to result in excess harm (except in pregnancy). #74 October 1, 2012

20 In CAD with stent placement or ACS, should dual antiplatelet therapy, like clopidogrel plus ASA, >12 months? Evidence: 12 vs months, 2-RCTs, 2701 pts Increased MI, stroke & death (12 months 1.3% vs months 2.7%, p=0.048). Meta-analysis cohort: no clear benefit beyond 12 months. Bottom-line: Current evidence and guidelines suggest that it is reasonable to continue dual antiplatelet therapy for 12 months following stent placement or acute coronary syndrome. After 12 months, one antiplatelet (example clopidogrel) may be stopped and low-dose ASA continued. #72 September 4, 2012

21 Do omega-3 fatty acid supplements reduce the risk of recurrent CVD in patients with existing CVD? Evidence: 3 RCTs ( ): No effect Meta-analysis (20,000): No effect RCT 12,000 diabetics (60% with CVD): no effect Bottom-line: Although guidelines recommend increased dietary omega-3 consumption, evidence does not support using omega-3 fatty acid supplements to prevent recurrent CVD events in patients with cardiovascular disease. #69 July 3, 2012

22 What are the advantages and disadvantages of using A1c as a diagnostic test for Type II DM? Evidence: A1c predicts outcomes fasting glucose Screening A1c Dx agreement: 22-33% fasting & OGTT A1c 6.5%: sensitivity and specificity = 44% and 79%, Bottom-line: While Hemoglobin A1c can be used for diagnosis of diabetes, controversy remains around appropriate cut-offs and agreement with other tests. Using the 6.5% cut-off recommended by the American Diabetes Association and the WHO may give inconsistent results from other glucose tests. #68 June 11, 2012

23 Daily multivitamins reduce mortality? Evidence: Meta-analysis of 21 RCTs (91,074 patients) x3.5 years. Most are primary prevention studies from Europe or North America. No effect on overall mortality: RR 0.98 ( ) No effect on cancer mortality: RR 0.96 ( ) No effect on CVD mortality: RR 1.01 ( ) Bottom-line: Present evidence does not support the routine use of multivitamins to reduce mortality, cardiovascular disease or cancer for people in developed countries. #87 April 15, 2013

24 What are the advantages and limitations of delayed prescriptions of antibiotics for URTI? Evidence: Meta-analysis of 9 RCTs Filled scripts: 32% delayed vs 93% immediate. Filled scripts for no antibiotics was 14% Delayed scripts slight reduce pt satisfaction (87% vs 92%) Bottom-line: Delayed antibiotic prescriptions versus immediate prescriptions substantially reduce antibiotic use but may slightly worsen some symptomatic outcomes. Delayed prescriptions may also reduce return to care rates and for mild URTI, are not associated with important negative consequences. #53 October 3, 2011

25 Does Cranberry juice or extract prevent recurrent urinary tract infections (UTI)? Evidence: 2 Systematic Rev & 1 additional RCT One no diff & another found NNT 12 (but only if excluded negative study) TMP-SMX (40/200 mg daily) or ciprofloxacin (125 mg daily), generally for 6 to 12 months. NNT =2 to 3 /yr. Bottom-line: Available evidence does not support cranberry products for reduction of UTIs. The overall quality of evidence is poor. #84 4 March 2013

26 What is the most efficient way to determine who is at high risk of osteoporosis and requires BMD? Evidence: 4 systematic reviews, up 72,000 women OST as good or better than all others Simple application of OST: Age - Weight (kg) If > -5, increased risk of osteoporosis, BMD is warranted. A cut-off of >5 should be used for Asian patients. Bottom-line: The OST is simple, quick and predicts osteoporosis as reliably as other more complicated instruments. It is a reasonable screening tool to identify those who would benefit from bone mineral density testing. #44 March 21, 2011

27 Does calcium (Ca+) supplementation contribute to increased risk of MI and other CVD? Evidence: Sys Rev 15 RCT Calcium increased MI risk: RR 1.27 ( ) NNT 135 to 211 x4 years. Others find no effect or NNT 240 (x5yr) Bottom-line: The present evidence suggests that calcium supplementation, particularly 1000mg/day, may lead to an increase risk of MI. This evidence is poor and the risk, if present, is likely <1%. #21 February 7, 2011

28 Hot flash treatment with SSRI as good as HRT? Evidence: Well-designed Meta-analysis of 43 RCT s SSRI/SNRI (mid dose)= 1.13 Hot Flashes/d (vs placebo) Clonidine ( 0.075mg BID) = Hot flashes/d Gabapentin (300mg TID) = 2.05 Hot flashes/d Soy Isoflavone Extract (50-70mg/d)= Endometrial safety with Isoflavone still unresolved. Estrogen best (2.5-3 Hot flashes/d) Bottom-line: All drugs for hot flashes are generally equivalent in effectiveness except HRT which is better. Select based on side-effects and patient preference. JAMA 2006; 295:

29 In diabetics, how do the long-acting insulin analogues (glargine and detemir) compare to NPH? Evidence: Sys Rev 49 RCT, A1c similar (? NPH lower) Severe hypoglycemia no diff, Some diff in nocturnal or overall (NNT 7-12) BUT hypo not confirmed, blinded, or specific Bottom-line: Compared to NPH insulin, long-acting insulin analogues have no advantage in A1c, no evidence for hard outcomes, and no difference in severe hypoglycemia. The small reductions in other hypoglycemic symptoms have a high risk of bias. #35 October 26, 2010

30 Can osteoporosis patients on bisphosphonates for 5 yrs d/c meds without increasing future fracture risk? Evidence: FLEX RCT, bisphosphonate x 5 yrs, off 5 yrs No difference in fractures HORIZON-Pivotal Fracture Trial (PFT) Extension: Zoledronic Also, no effect on preventing fractures. Bottom-line: Available evidence suggests that after 5 years of treatment, discontinuation of bisphosphonates carries little to no increased future fracture risk. Choosing appropriate patients to continue therapy beyond 5 years and determining when or if to reinitiate therapy in those discontinued, remains uncertain. #33 September 20, J Bone Miner Res Feb;27(2):

31 When recommending regarding paediatric fever treatment, is acetaminophen or ibuprofen superior? Evidence: Meta-analysis of 10 trials, Ibuprofen superior at 2, 4, and 6 hours; NNT 7 RCT: ibuprofen, acetaminophen, or both combo fever in 24 hrs vs Aceta 4.4 hrs more, ibu 2.5 Bottom-line: Treatment of paediatric fever is debated and should be discussed with parents/patients. If clinicians are going to recommend a treatment, ibuprofen offers superior fever reduction with no increase in adverse events. #28 June 7, 2010

32 Do OTC cough suppressants or Honey improve cough due to URTI in children? Evidence: 3 RCTs if Honey, all find the same At 24 hrs: 59% honey, 45% DM and DPH, 31% no-drug 8 RCTs with 616 children: No effect Health Canada recommends against OTC cough in <6 Bottom-line: OTC cough suppressants should not be used in children under 6 and do not appear to be effective in older children. There is sufficient evidence to consider the use of honey in acute pediatric cough. #24 April 12, 2010

33 Does Ezetimibe (Ezetrol) modify clinical outcomes? Evidence: Trials: Enhance, Arbiter-Halts, SEA, SHARP, Improve-IT* Combo: statin + Ezetimibe vs nothing, useless study Ezetimibe vs placebo (background statin): No effect Inferior to niacin (5% CVD vs 1%). Also? cancer Bottom-line: Eight years after being licensed by the FDA, there is still no evidence that ezetimibe reduces cardiovascular outcomes. It may be worse than niacin and there is concern about a potential increased cancer mortality risk. #23 March 29, 2010

34 In patients over age 80, what are risks and benefits of treating hypertension (& different targets)? Evidence: RCT 3845 pts x 2.1 yrs, BP > 160 Outcomes: mortality - NNT 47, CVD - NNT 34 Healthy: ( 12% CVD history, < 7% DM, no dementia) RCT, 3260 patients, aged 70-84, <150 = <140 mm Hg. Bottom-line: Treating hypertension in healthy elderly patients age 80 is effective. Exact targets are uncertain but the primary trial used 150/90 as a target. The benefit of treating the frail elderly or those with orthostasis and/or a standing systolic pressure of <140 remains uncertain. #22 March 15, 2010

35 What is the optimal regimen for initiating insulin in type 2 diabetes? Evidence: 4 RCTs (primarily 1 or 708 pts x 3 yrs) A1C similar but basal has less hypo & wgt gain Family Doctors just as effective with A1c Basal NPH, 10 units qhs, add 1 unit qhs, until fasting 4-7 Bottom-line: In type 2 diabetes poorly controlled with oral agents, initiating basal insulin results in similar HbA1c reductions compared to prandial or biphasic insulin and may cause less weight gain and hypoglycemia. Family practitioners who start insulin are as effective as specialists. #20 February 16, 2010

36 Are beta-blockers, particularly atenolol, equal to other antihypertensive meds in preventing hypertensive outcomes? Evidence: Atenolol, meta-analysis, 5 RCT No effect vs placebo Vs other meds: more strokes (NNH 79), deaths (NNH 110) Other Beta-blockers: Less clear,? Worse if older. Bottom-line: Atenolol is an inferior choice for blood pressure treatment. Beta-blockers in general should not be considered first line in age 60 and some have suggested they should not be first line in any patient with uncomplicated hypertension. #15 November 30, 2009

37 End