Transcript You Say - MCE Conferences

Myth-Busting: Forgotten and
Forgettable Medical Management
G. Michael Allan
Associate Professor, Family Med, U of A
Conflict of Interest
• Family Doctor for >10 yrs
• Academic 7 years
• Pay from U of A and Alberta Health
• Research and Speaking Fees
– Non-Profit Sources (ACFP, CEDAC, ENPCN, TI,
TOP, etc)
– No funding from Industry
What we’ll cover
1) Pediatrics
a)
b)
c)
d)
Treating Fever: Acetaminophen or Ibuprofen
Treating Musculoskeletal Pain in Pediatrics
Pediatric Cough
Plus: Sleepless Infant, Vomiting, Croup
2) Dermatology
a) Laceration Repair
b) Plus: Punch Biopsy & Acne
3) Vitamins & Cure-Alls
1) Vitamin D, B12, A&E
2) Motivating patients to move
Fever Fever
• A 5 year old has a nasty fever but otherwise is classic URTI.
His mother wants some advice to treat this fever.
• You say: If you want something, ibuprofen is probably best.
• True: RCT,1 kids, Paracetamol or ibuprofen or both
• 1° outcome time w/o fever 1st 4hr
– Both > para = 55.3mins (p<0.001) but not > than ibuprofen.
– Time w/o fever in 24hrs (ss): para+ibu> para (4.4hr), para + ibu> ibu
(2.5hr)
– Overdosing of meds reported in 33 children.
• Ibu shown previously to be superior to acetaminophen for
relief of fever.2
1. BMJ 2008;337:a13021. 2 Arch Pediatr Adolesc Med 2004;158:521-6.
Are acetaminophen and ibuprofen equivalent
in the treatment of pediatric fever
• Clinical Question: If we provide a
recommendation regarding the treatment
of pediatric fever, is acetaminophen or
ibuprofen superior?
Are acetaminophen and ibuprofen equivalent
in the treatment of pediatric fever
• Meta-analysis & RCT provide some guidance;
• Review of Ibuprofen vs Acetaminophen1
– 10 trials, 1078 patients
– Dose: ibuprofen 5-10 mg/kg & acetaminophen 10-15mg/kg
– Outcome:
• Ibuprofen statistically superior at 2, 4 and 6 hours.
• 4-6 hours ≈15% more will have fever reduction (NNT 7)
Are acetaminophen and ibuprofen equivalent
in the treatment of pediatric fever
• PITCH: RCT, 156 children (age ½ - 6 years), ibuprofen 10mg/kg q6-8
hours, acetaminophen 15mg/kg q4-6 hours or combo2
• Time without fever in first 4 hours: Combo >acetaminophen (55.3mins)
but not ibuprofen.
• Ibuprofen and combination clear fever faster
• Combo had reduced fever time in first 24 hours
• acetaminophen 4.4 hours more
• ibuprofen 2.5 hours more
– Overdosing of medications reported in 33 (21%) children.
– Authors recommended ibuprofen;
• Ibuprofen superior to acetaminophen,
• Combo only slightly > ibuprofen in a few outcomes (but not others),
• Possible risk of excess dosing with a combo.
Are acetaminophen and ibuprofen equivalent
in the treatment of pediatric fever
• Debate:
– No evidence that fever itself is harmful3
– Do not prevent febrile seizures.4
– No evidence treating fever mild harmful.
– Goal should be comfort5 (not adequately studied)
• Adverse events of ibuprofen as compared acetaminophen
– Asthma: Ibuprofen no  risk or perhaps slightly lower6
– Reye Syndrome: No increased risk7,8
– GI Effect & Renal: No evidence of risk.9
• Warning if a child is not “drinking reasonably well.”5
– “Systemic” Reaction: No evidence of risk7
Are acetaminophen and ibuprofen equivalent
in the treatment of pediatric fever
• Bottom-line: Treatment of pediatric fever is
debated and should be discussed with
parents/patients.
• If recommending a treatment, ibuprofen
offers superior fever reduction with no
increase in adverse events.
Opioids always trump NSAIDs
• A 11 year old boy has a rolled ankle. It looks pretty bad but
X-ray is negative. His mom asks about pain medications.
• You say: Here’s acetaminophen with codiene, it’s the best.
• False: Ibuprofen best. 3 trials of pediatric MSK injury
• 336 children; ibuprofen, acetaminophen or codiene.1
– Ibuprofen better than either (for pain score and attaining “adequate”
pain relief.
• 68 children; ibuprofen or aceta+codiene2
– No difference in pain scores.
• 336 children; ibuprofen vs acetaminophen+codeine3
– No difference in mean pain scores
– Ibuprofen less functional limitation & adverse events
1) Pediatrics 2007;119:460-7. 2) Acad Emerg Med 2009;16(8):711-716.
3) Ann Emerg Med 2009 Oct;54(4):553-60. Epub 2009 Aug 19.
ENT: Pediatric cough
• 2 children (age 3 & 5) are in coughing with an
URTI. Mom would like a suggestion about an OTC
cough med or even honey.
• You say: OTC medicines & honey have no effect
on cough in pediatric patients?
• True
– Meta-analysis1,2: 8 studies, 616 kids,
– Statistical improvements were very infrequent, not
consistent and of doubtful clinical significance.
– Honey3: 1 RCT of 105 kids, honey vs DM vs nothing
– Stat sign but never reached clinical significance
1. Cochrane 2008; 1: CD001831. 2. Arch Dis Child 2002;86:170–175. 3. Arch Pediatr
Adolesc Med 2007;161:1140-6.
Pediatric Cough: Do Honey or
OTC cough suppressants help?
• 2 children (age 3 & 5) are in coughing with an
URTI. Mom asks about an OTC cough med or
even honey.
• You say: OTC medicines & honey have no effect
on cough in pediatric patients?
• OTC Cough Suppressants: Cochrane sys review1
– 8 RCTs (poor quality), 616 children, in pediatric/primary
clinics. Mean ages 2 to 7.5 years.
– Outcomes: cough scores, number of patients who were
cough free, patient rated improvement/satisfaction &
parent evaluations.
– Statistical improvements were very infrequent, not
consistent and of doubtful clinical significance.
Pediatric Cough: Do Honey or
OTC cough suppressants help?
• Honey: One RCT of 105 kids, mean age 5: one
night-time dose of honey, Dextromethorphan (DM),
or nothing.2
– Authors report honey best, stat significant improvement
in:
• 5 out of 5 different cough/sleep scores, Honey> DM> nothing.
• In 2 out 5 paired comparison, honey statistically > “nothing”
– BUT: Neither honey or DM got to the study defined
clinically important improvements vs no treatment
– AND randomization not assured & funding=Honey Board
– Cochrane review felt evidence insufficient evidence3
1. Cochran 2008;1:CD001831 2. Arch Pediatr Adolesc Med 2007;161:1140-6. 3. Cochran
2010; 1:CD007094 4. J Fam Pract 2009;58:559a-c. Am Fam Physician 2007;75(4):515-20
Sleepless in Seattle
• A young mother is frazzled by her sleepless
1 y.o. infant. She is considering Benadryl?
• You say: We don’t know if it works
• False: We know it doesn’t!
• RCT 44 kids 6-15 months.
– 3 (14%) placebo vs 1 (5%) in diphenhydramine
got better night-time sleeping.
– No diff in parental happiness
Arch Pediatr Adoles Med. 2006;160:707-712
Holding your Cookies
• A 6 year old is in with his mother. He is vomiting
and looks mild+ dehydrated. Mom is worried that
he ended in ER last time & asks if there is anything.
• You Say: There is nothing we can offer him.
• False: Sys Rev, Ondansetron (6 trials, 745 pts) ER
trials
– Ondansetron usually one dose: IV 0.15-0.3 mg/kg OR
oral 2-8mg or 1.6 – 4 mg (wgt/age based).
• Outcomes
–
–
–
–
Admission: 7.5% vs 14.6% (NNT 14)
Need IVF: 13.9% vs 33.9% (NNT 75)
Still vomiting in ER: 16.9% vs 37.8% (NNT 5)
Caused more diarrhea in 48 hours (No # given)
Arch Pediatr Adolesc Med 2008; 162(9): 858-65.
ENT: Mild Croup
• A 3 year old child is in with his mother. He
has a barking cough and mom reports a
classic stridor episode early today. She is
concerned and would like a medicine.
• You say: Dexamethasone only benefits
patients with moderate to severe croup.
• False
– RCT, 720pts, mild croup, oral 0.6mg/kg, 1 dose
– Return med care: 15% vs 7% (NNT 13)
1. NEJM 2004; 351: 1306-13.
Dermatology
Lacerations: Sterile Gloves & Water?
• Clinical Question: In the management
of simple lacerations, are sterile gloves
and sterile saline required to reduce
infection?
Lacerations: Sterile Gloves & Water?
• Sterile Gloves: RCT, sterile vs non-sterile gloves,
suturing lacerations.1
– 816 patients (age ≥ 1), blinding patients & outcome
assessors.
– Infection rates (23 days): 4.3% non-sterile vs 6% sterile
(no stat diff).
• Sterile Water: Cochrane, 3 RCTs (1338 pts) metaanalysis, tap water vs saline, irrigation.2
– Infection rates: 4.4% tap water vs 7% saline, (stat diff
p=0.045).
– 2 largest RCT (94% of pts) used sterile saline, one small
study (77 pts) used non-sterile saline (so not perfect
sterile vs non)
Lacerations: Sterile Gloves & Water?
• Only RCT of non-sterile gloves but high quality &
reasonable in size.
• 2 older studies (50 & 408 pts),3,4 no gloves vs sterile gloves
– Infections did not increase.
– Significant quality limitations (randomization) & suturing without
gloves is not appropriate.
– However, support that sterile gloves likely offer little advantage.
• In the Cochrane review of tap water, possible saline
increasing infection but
– But includes a small study of non-sterile saline & one of questionable
randomization.
– Focusing on best study - high quality RCT of 713 pts comparing tap
water and sterile saline with no difference in infections.5
Lacerations: Sterile Gloves & Water?
• Bottom-line: The present evidence indicates
simple lacerations can be cleaned with tap
water and repaired with clean non-sterile
gloves without an increased risk of infection.
Punch with or without sutures
• Diagnosis of persistent rash has eluded you. You
take a 4 mm punch biopsy.
• You say: Suturing biopsies <4mm is not helpful
• RCT, 9 Month f/u, 82 (164 wounds) – mean age 47
(70% ♀)1
– 4 mm: Docs VAS score =, pt pref = (slight favor 2nd)
– 8mm: Doc VAS score = (thigh scar size > 2nd), pt pref is
1° (NNT=9 “very satisfied” & NNT=3 preferred 1°)
– 1° healed 3 vs 4 wks, ↓ pain (NNT=9), no diff
bleed/infection
– Can use absorbable.2
Arch Dermatol 2005; 141: 1093-99.
Dermatol surg 2000; 26: 750-2
Acne: What’s on First?
• A 20 y.o. ♂ complains of facial acne, has
moderate severity & wants oral Abx.
• You say: Topical meds are just as effective.
• True: RCT, 650 pts x18 wks, 5 arms
– Oral: Tetracycline 500 BID; Minocycline 100 OD
– Topical: 5% B.P. (BID); 5% B.P. with 3% Erythro (BID);
2% Erythro (am) and 5% B.P. (qhs).
• No Diff (except AE: oral was GI, Topical was skin)
– cost: Minocycline 8x Erythro + BP
– Erythro + B.P. (63-66%) vs oral Abx (54-55%)
•Lancet 2004; 364: 2188-95.
Vitamins &
cure-alls
Fan of Fads: Vitamin D
• A 55 year old woman wonders if she should
take Vitamin D and does she need a test?
• 3 Met-analysis show it helps (stat sign)
– Fracture (19 trials)1: >400IU/day Vitamin D
• Reduced Non-vertebral fractures 1.1%, NNT 93
– Falls (5 trials)2: Reduced 7%, NNT 15
– Mortality (18 trials)3: ↓ Mortality ~ 0.4%, NNT 147
• Study1-3 doses varied but the most common
was 800IU.
Fan of Fads: Vitamin D
• Vitamin D insufficiency is variably defined but
frequently cited at <75nmol/L4-6
• Vitamin D insufficiency is highly prevalent
– Calgary5, 97% had levels <80nmol/L, once/year
– UK6, 87% had levels <75nmol/L, once/year
– USA7, 77% had levels <75nmol/L
• Holik review: screening not recommended but daily
Vitamin D of 800 IU does recommend.4
• Bottom-line: Vitamin D 800 IU (or 1000) daily
reduces fractures, falls and overall mortality in older
patients (likely ≥50 years old). There is currently no
high level evidence to support regular testing older
patients for Vitamin D insufficiency.
What’s the approach to Vitamin D:
Toxicity:
• Review of doses 2,000 – 100,000 IU
- no toxicity BUT
- big doses were 4 days only or bolus q 4 months
- 21 studies: 20 had <250 patients
most < 1 year
• RCT, 2256 pts, ≥70 years, followed 3-5 years
- Given yearly 500,000 IU or placebo
- Falls (≥1): 74% Vit D vs 68% placebo, NNT 18 (Rate ↑)
- Fractures: 4.9%/year Vit D vs 3.9%/year placebo
Am J Clin Nutr 2007;85:6 –18. JAMA. 2010;303(18):1815-1822
Vitamin B12 Deficiency: Monthly
shots or daily pills?
• Mrs Jones, a 73 year old woman has long-standing
B12 def. Last year she lost her license and she
tells you taking a cab is quite pricey for her (for
these B12 shots).
• You say: Why don’t we try B12 pills?
• Evidence: Cochrane Review1 of 2 RCTs2,3
– 38 outpatients & 70 patients:
• 3-4 month oral B12 as effective as IM therapy1 in:
– B12 levels and associated biochemical B12 markers
(total homocysteine and serum methylmalonic acid)
– Hematological and neurological responses.
– Both trials limited: small, short, unblinded & lack ITT
Vitamin B12 Deficiency: Monthly
shots or daily pills?
• 5-20% of elderly patients are B12 deficiency4
• Well-designed, longer (18 months) cohort study
showed that 1000mcg orally a day was effective7
– Review also recommends 1000 mcg orally a day8
• Works in B12 def dietary, pernicious anemia,
gastric or ileal surgery, malabsorption syndrome2,3,7
– Celiac disease and IBD are not well studied.
• Bottom-line: Oral Vitamin B12 is as effective as IM
in most B12 deficient patients. A dose of 1000mcg
(1mg) orally a day appears to be adequate and
most commonly recommended.
– Patients switched to oral should likely have their B12
levels checked to confirm they are not declining.9
Antioxidant vitamin cure-alls
• Case: A 65 year old female is taking vitamin E and Bcarotene (Vit A). She has mild congitive impairment
but is otherwise well.
• Question: Anti-oxidants vitamins (A, E and C)?
• Meta-analysis1,2 of 68 RCT
– 232,606 (70% healthy, 30% pre-existing).1
• Focusing on high-quality RCTs:
– Antioxidants increased mortality: RR1.05 (1.02-1.08)1 & NNH=180.3
– Beta carotene, A and E individually statistically significant
• No statistical diff in mortality for vitamin C or selenium.2
• Previous meta-analyses4,5 & new RCTs find similar results6,7
• Bottom-line: Patients should be dissuaded from using betacarotene and vitamins A & E as may increase mortality.
Motivating Patients to Activity – A
Light at the End of the Couch?
• Clinical Question: How do I motivate my patients to participate
in regular physical activity?
• 2007 review (26 studies, 2767 pts) pedometers  physical
activity levels & improve health.1
–
–
–
–
Pedometers  steps/day 2491 in RCTs & 2183 in observational.
“Step goal” predicted increased activity (work-up to 10,000 steps/day)
Mean intervention duration was 18 weeks.
Heterogeneity in study design & corresponding results (p<0.001).
Motivating Patients to Activity – A
Light at the End of the Couch?
• 2009 lower quality review (32 studies) of pedometers,2
– An increase of approximately 2000 steps per day.
– Benefit of “step goal” (p<0.001)
– Benefits in studies >15 weeks were not less than shorter studies.
• Newer RCTs show pedometers increase steps per day by
approximately 2000 or more.3,4
– Including sustained results up to 1 year.4
Motivating Patients to Activity – A
Light at the End of the Couch?
• Activity reduces mortality, Examples,
– Cohort study (252,925 pts): regular moderate activity (brisk
walking ≥30 minutes most days), 27% relative decrease in
mortality vs no activity5
• Regular vigorous activity reduced mortality 50%.
– Cohort study (9,777 men): mortality rates of active men
33% that of inactive men6
• Active 40/10,000 patient years
• Inactive 122/10,000 patient years
Motivating Patients to Activity – A
Light at the End of the Couch?
• Other benefits of pedometers include
– Weight reductions 1.3 kg (CI 0.7kg-1.8kg) over 16 weeks7
– Reduced systolic BP 3.8 mmHg (p<0.001) over 18 weeks1
– Improved blood sugar readings in patients with impaired
glucose tolerance up to 12 months later4:
• Fasting glucose reduced 0.31 mmol/L (CI 0.03-0.59)
• 2 hour glucose reduced 1.3 mmol/L (CI 0.4-2.2)
– Can cost less than $30.
Motivating Patients to Activity – A
Light at the End of the Couch?
• 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.
Motivating Patients to Activity – A
Light at the End of the Couch?
• Implementation: Written, goal oriented exercise program
increase physical activity levels.8
• A sample “prescription” for pedometer,
– Wear your pedometer every day for one week.
– Calculate your daily steps (feel free to average to the closest 1000
increment).
– Add 500 steps per day to your daily average. Walk that each day
for the next week.
– Repeat step 3, adding 500 steps to last week’s daily goal and walk
that each day for the next week.
– Continue to your target of 10,000 steps per day.
Promise to Disappointment
• Testosterone (transdermal gel) in older men:
– CVD: All (21.7% vs 4.9%, p<0.001, NNH 6),
• Events: increase BP or syncope all the way to stroke/MI & death.
• More serious CVD events: NNH 12 (stat sign)
• Sibutramine in Diabetics and CVD risk:
– Wgt= 1.7kg loss vs 0.7 gain, 1 yr (slow gain after)
• CVD composite: 11.4% sib vs 10% plac, NNH 72
• Nonfatal MI: 4.1% vs 3.2%, NNH 112
• Nonfatal stroke: 2.6% vs 1.9%, NNH 143
• Rimonabant in obese with higher CVD risk
– CVD outcomes: composite not diff (3.9% rim vs 4% placebo),
• Neuropsych (anxiety, dep,…): 32.3% vs 21.4%, NNH 10/y
• Serious Pysch (no clear): 2.5% vs 1.3%, NNH 84
NEJM 2010; 363:109-22. NEJM 2010;363:905-17. Lancet 2010; 376:517-23.
Questions