BMC Emergency Medicine Journal Club

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BMC Emergency MedicineJournal Club

• But doctor, I always get antibiotics for my
  sinus infections
• When are antibiotics needed for acute
  rhinosinusitis?
• January 2009

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Todays Agenda

• Curriculum Topic Head and ENT
• Morsal Tahouni, MD (EM2)
• Shane Ruter, MD (EM1)

BMC EM Journal Club
BMC EM Journal Club
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BMC Emergency MedicineJournal Club

• But doctor, I always get antibiotics for my
  sinus infections
• When are antibiotics needed for acute
  rhinosinusitis?
• Shane Ruter, MD
• January 2009

BMC EM Journal Club
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Got sinusitis?
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Supportive Therapy

• Reassurance
• Oral decongestants
• Topical decongestants
• Saline nasal spray
• Antihistamines
• Mucolytics

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• The nighttime sniffling, sneezing, coughing,
  aching, so-you-can-rest antibiotics?

ANTIBIOTICS
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J Fam Pract 200554144-151
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Background

• 31 million people annually
• Fifth most common diagnosis for which antibiotics
  are prescribed in outpatient settings
• 1 in 5 antibiotic prescriptions
• 6 billion spent annually on prescription and OTC
  medications

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Objective 1

• To determine whether patients with sinusitis-like
  symptoms improved with antibiotics
• Null hypothesis antibiotics placebo

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Objective 2

• To test the validity of a clinical prediction
  rule
• At least 3 out of 4 cardinal clinical features
• (1) One-sided purulent nasal discharge
• (2) One-sided local facial pain
• (3) Bilateral purulent nasal discharge
• (4) Pus in the nasal cavity
• 76 sensitivity, 79 specificity

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Methods

• Population
• Recruited from a suburban primary care office
• Enrolled from Oct 1, 2001 March 31, 2003
• At least 1 cardinal feature of clinical
  prediction rule
• At least 7 days of symptoms
• Exclusion criteria
• Children (lt 18 years) prior h/o antibiotic
  treatment (past month), allergy to PCN, sinus
  surgery, pneumonia, streptococcal pharyngitis,
  compromised immunity

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Methods

• Exposure and Control
• Amoxicillin 1000 mg twice daily or placebo taken
  for 10 days

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Methods

• Outcome (1) improved vs not improved by 2
  weeks
• On what day were you entirely improved?
• Rates of improvement (Kaplan-Meier curve)
• Patients self-rating (Likert scores)
• Outcome (2) Clinical Prediction Rule
• Do more signs and symptoms (i.e., 3 or 4 cardinal
  features) show differences in clinical outcome?

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Results

• Primary Outcome Complete improvement in 32 (48)
  amoxicillin group compared with 25 (37) placebo
  group (P0.26) after 2 weeks

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Figure Kaplan-Meier curve for improvementamoxici
llin (n67) vs placebo (n68)
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Table 2 Likert scoresHow sick do you feel
today?
Likert score of 1 represents perfect health to
10 representing worst condition data shown
represent mean and standard deviation (SD) NS,
Not Significant
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Table 3 Clinical Prediction Rule
Mean number of days to improvement by group and
number of signs and (at baseline) for patients
who improved
Signs and symptoms are purulent nasal discharge
predominating on 1 side, local facial pain
predominating on 1 side, purulent nasal discharge
on both sides, and pus in the naval cavity
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Authors Conclusion

• Overall antibiotics offered no greater
  improvement in patients with sinusitis-like
  symptoms
• However, among those who improved, there may
  exist a subset of patients for whom antibiotics
  may be beneficial

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Strengths of Article

• Study design
• Blinded personnel conducting follow-up
• Clinical improvement as a primary outcome
• Intention-to-treat analysis
• Study groups are compared in terms of the
  treatment to which they are randomly allocated,
  irrespective of the treatment they actually
  receive
• Preserves the value of randomization and
  minimizes bias

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Limitations of Article

• Determining primary outcome and its endpoint
• Limited power to find differences between groups
  based on the number of signs and symptoms
• Single study site

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Further Questions

• Inter-rater variability (e.g., detecting purulent
  nasal discharge)
• Assessment of outcomes
• What were the twelve follow-up questions asked?
• What other sinusitis treatments did the patients
  get?

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Survey Results Part I

• Results
• No respondent would prescribe antibiotics at 2
  days
• 1 respondent would prescribe antibiotics at 8
  days
• One-third would prescribe antibiotics at 15 days
• Most respondents prescribe some form of
  symptomatic relief (decongestant or nasal
  saline)

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3 out of 4 Joes!
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BMC Emergency MedicineJournal Club

• But doctor, I always get antibiotics for my
  sinus infections
• When are antibiotics needed for acute
  rhinosinusitis?
• Morsal Tahouni, MD
• January 2009

BMC EM Journal Club
25
Arch Intern Med 20031631793
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Background

• Acute rhinosinusitis is one of the most common
  diagnoses and most frequent reasons for
  prescribing antibiotics in general practice
• Lack of simple diagnostic test
• Few studies that reflect routine clinical
  practice
• Unclear benefit of antibiotics
• Complicated by
• Viral etiology
• High rate of spontaneous resolution (80)
• Patient requests
• Antibiotic resistance

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Objective

• To assess effects of antibiotic treatment in
  uncomplicated acute rhinosinusitis in the general
  practice setting
• Intervention
• Augmentin 875mg/125mg bid for 6 days
• Null hypothesis antibiotics placebo

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Methods

• Placebo-controlled, Double-blind, Randomized
  Trial
• Enrollment Adult patients during winter months
  in Switzerland -November 1 to April 30 1997 to
  2001
• Repeated purulent nasal discharge, sinus pain for
  48 hours
• Pus under rhinoscopy (subject to change)
• Excluded
• lt18 years old
• Fever, URI, or antibiotic use in the last 4 weeks
• Immuno-compromised
• History of ENT pathology
• Pregnant or breastfeeding
• No German, French, Italian and Romansh fluency

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Methods II

• Baseline clinical exam with questionnaire
• Rhinoscopy by trained physician
• Sinus x-ray, C-reactive protein, and WBC obtained
• Randomized in blocks of 6
• Antibiotic and placebo group
• All subjects received xylometazolin and
  acetaminophen
• Follow-up
• Repeat exam at 7 days
• Telephone interview at 14 and 28 days

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Methods III

• 1o Outcome Time to cure (days)
• Restriction of Activities
• 1 to 10 scale
• 2o Outcomes
• Number of days restricted activity
• Adverse events
• Recurrence at 28 days

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Key Results

• 1565 eligible
• 252 randomized
• 68 women
• No significant difference between groups
• Two subgroups
• Positive rhinoscopy
• Restriction of activities at baseline

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Key Results

• No significant difference in time to cure
• HR 0.99 (CI 0.68 to1.45)
• Same findings in subgroups

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Hazard Ratio (HR)

• The risk of an individual reaching a certain
  event (hazard) at any point in time
• In other words, similar to odds ratio
• i.e. if I drove this car, HR for speeding ticket
  would be gtgt1.0

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Key Results

• No difference in days of restriction in any group
• No difference in recurrence at 28 days
• Increased diarrhea in treatment group at 7 and 14
  days
• Trend towards increase in other adverse events

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Authors Conclusion

• No difference in time to cure
• Treatment group more likely to have adverse events

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Study Strengths

• Double-blind, placebo-controlled, random
• High follow-up rate (98)
• Replicated clinical setting
• High number of sites (24)

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Strength - Disclosure
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Study Limitations

• Authors
• 1o outcome insensitive
• Only one follow-up visit
• Other follow-up by phone
• Low prevalence of bacterial etiology
• Ignored 7-day guideline
• Changed inclusion criteria
• Mine
• 433 subjects not included for other reasons
• Diarrhea at 14 days
• Confidence interval includes 1.0
• Enrollment only during winter months

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Further Questions

• What was the enrollment per site?
• Average enrollment per site 2.4/year
• What about the 3rd subgroup symptoms for 7
  days?
• Are there other clinical diagnostic methods
  available?

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Survey Results

• Enrollment 9 attendings, 5 residents
• Results
• No one would prescribe antibiotics at 2 days
• 21 would prescribe antibiotics at 8 days
• 22 attendings, 20 residents
• 71 would prescribe antibiotics at 15 days
• 89 attendings, 40 residents

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Final Comments

• Study supports current practice patterns
  regarding utility of early antibiotics for acute
  rhinosinusitis
• Further studies could focus on
• Best time to prescribe antibiotics
• Isolating 20 of cases that will not resolve with
  supportive care

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Upcoming Journal Clubs

• February 10 Hematology
• David Meguerdichian (EM2)
• Nadia Huancahuari (EM1)
• March 10 Immune Disorders Lopez and Dresden
• April 14 Infectious Disorders Levenberg and
  DeLong

BMC EM Journal Club
BMC EM Journal Club