IDSA Clinical Practice Guideline For Acute Bacterial Rhinosinusitis in Children and Adults
IDSA Clinical Practice Guideline For Acute Bacterial Rhinosinusitis in Children and Adults
IDSA Clinical Practice Guideline For Acute Bacterial Rhinosinusitis in Children and Adults
Institute, Cleveland Clinic, Ohio; 3Department of Pediatrics, Georgetown University School of Medicine, Washington, D.C.; 4Department of Clinical
Evidence-based guidelines for the diagnosis and initial management of suspected acute bacterial rhinosinusitis
in adults and children were prepared by a multidisciplinary expert panel of the Infectious Diseases Society
of America comprising clinicians and investigators representing internal medicine, pediatrics, emergency
medicine, otolaryngology, public health, epidemiology, and adult and pediatric infectious disease specialties.
Recommendations for diagnosis, laboratory investigation, and empiric antimicrobial and adjunctive therapy
were developed.
Strength of
Recommendation Clarity of Balance Between
and Quality of Desirable and Undesirable Methodological Quality of Supporting
Evidence Effects Evidence (Examples) Implications
Strong Desirable effects clearly Consistent evidence from well-performed Recommendation can apply to most
recommendation, outweigh undesirable RCTs or exceptionally strong evidence patients in most circumstances.
high-quality effects, or vice versa from unbiased observational studies Further research is unlikely to change
evidence our confidence in the estimate of effect.
Strong Desirable effects clearly Evidence from RCTs with important Recommendation can apply to most patients
recommendation, outweigh undesirable limitations (inconsistent results, in most circumstances. Further research
moderate-quality effects, or vice versa methodological flaws, indirect, or (if performed) is likely to have an important
evidence imprecise) or exceptionally strong impact on our confidence in the estimate
evidence from unbiased observational of effect and may change the estimate.
studies
Strong Desirable effects clearly Evidence for at least 1 critical outcome Recommendation may change when
prescribed for patients presenting with symptoms of acute placebo-controlled randomized clinical trials [18]. Thus,
rhinosinusitis, being the fifth leading indication for anti- overprescription of antibiotics is a major concern in the
microbial prescriptions by physicians in office practice [15]. management of acute rhinosinusitis, largely due to the dif-
The total direct healthcare costs attributed to a primary ficulty in differentiating ABRS from a viral URI. To address
medical diagnosis of sinusitis in 1996 were estimated to ex- these issues, several practice guidelines for the treatment of
ceed $3 billion per year [16]. A recent national survey of ABRS have been published by various professional organ-
antibiotic prescriptions for URI in the outpatient setting izations in the United States and Canada within the past
showed that antibiotics were prescribed for 81% of adults decade, including the American College of Physicians (2001)
with acute rhinosinusitis [17, 18], despite the fact that ap- [19, 20], the American Academy of Pediatrics (2001) [21],
proximately 70% of patients improve spontaneously in the Rhinosinusitis Initiative (representing the American
may lead to an erroneous conclusion that some patients with clear exceptions, the laboratory designation of antimicrobial
a clinically important question [1]. This implies a careful desirable effects of an intervention outweigh the undesirable
selection of the important clinical questions to be addressed effects. A weak recommendation denotes that the desirable
and the key outcomes to be evaluated. Other factors that de- effects of adhering to a recommendation probably outweigh
termine the strength of recommendation are the resource the undesirable effects, but the panel is less confident. The
implications and variability in values and preferences for or GRADE approach offers a structured, systematic, and trans-
against an alternative management strategy considered by the parent process to formulate recommendations based on ex-
guideline panel. Only 2 grades are assigned for the strength plicit criteria that go beyond just the quality of available
of recommendation in GRADE: strong or weak. A strong rec- evidence (please visit the GRADE website at http://www.
ommendation reflects a high degree of confidence that the gradeworkinggroup.org/ for more information).
Abbreviations: CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development and Evaluation; OR, odds ratio.
a
The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
b
Self-reported history may not be reliable.
c
Purulent rhinorrhea with unilateral predominance (symptom).
d
Facial pain with unilateral predominance (symptom).
e
Bilateral purulent rhinorrhea (sign).
f
Presence of pus in nasal cavity (sign).
g
Pus as surrogate for positive bacterial cultures.
(Table 3). A fourth RCT [63] was not included in this analysis criterion was not included in the AAO-HNS guideline for
as patients were treated with inadequate dosing of anti- adult rhinosinusitis [13], but was included in the consensus
microbials. In contrast, among placebo-controlled RCTs in recommendations by Meltzer et al [42].
adults in which duration of symptoms $7–10 days was Benefits. More stringent criteria of patient selection based
the primary inclusion criteria, the beneficial effect of anti- on duration as well as characteristic progression of the clinical
microbial therapy was less prominent (73% vs 65%; OR, course should improve the differentiation of ABRS from viral
1.44 [95% CI, 1.24–1.68], and NNT of 13). rhinosinusitis and identify the patient population most likely
The criteria of persistent symptoms $10 days duration and to benefit from empiric antimicrobial therapy.
worsening symptoms or signs within 5–10 days after initial Harms. Adoption of more stringent clinical criteria for
improvement (double-sickening) were based on earlier studies the diagnosis of ABRS may result in delay of appropriate
of the natural history of rhinovirus infections [40] (Figure 2). antimicrobial therapy in some patients. However, more ac-
Although 25% of patients with rhinovirus infection pro- curate distinction will be made between bacterial vs viral
spectively studied by Gwaltney et al [40] had symptoms longer rhinosinusitis, and the overuse of antibiotics will be mini-
than 14 days, their clinical course was improving before the mized. Reserving antimicrobial therapy for patients with
10-day mark. severe or prolonged manifestation of ABRS fails to address
The criterion of severe symptoms or signs of high fever quality of life or productivity issues in patients with mild or
($39°C [102°F]) and purulent nasal discharge or facial pain moderate symptoms of ABRS.
lasting for 3–4 days at the beginning of illness identifies a sub- Other Considerations. Radiographic confirmation of sinus
population with severe disease in whom antimicrobial therapy disease for patients with uncomplicated ABRS is not necessary
is clearly warranted before the 10-day ‘‘waiting’’ period. This and is not advised.
Abbreviations: CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development and Evaluation; OR, odds ratio.
a
The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
b
Self-reported history may not be reliable.
Conclusions and Research Needs. The clinical differentia- findings of RCTs in which approximately 70% of patients in
tion of bacterial from viral acute rhinosinusitis remains prob- the placebo arm improved spontaneously by 7–12 days [25],
lematic without direct sinus aspiration and culture. Additional and that a strategy of delaying antimicrobial prescriptions for
RCTs of antibiotic vs placebo in adult patients meeting patients with mild upper respiratory tract infections is an ef-
stringent clinical criteria as outlined above are urgently needed. fective means of reducing antibiotic usage [83]. However, as
Such studies should incorporate both pre- and posttherapy discussed earlier in this review, the high spontaneous resolu-
sinus cultures to provide critical information regarding the tion rate in these placebo-controlled RCTs is most certainly
natural history of sinus infection and efficacy of antimicrobial due to less stringent patient selection and the inclusion of pa-
therapy. The use of endoscopic middle meatus cultures in tients who had viral rather than true ABRS. In contrast, when
lieu of sinus aspiration should be further evaluated for this more stringent inclusion criteria such as those outlined in
purpose. recommendation 1 were employed, Wald et al [61] reported
a considerably lower spontaneous improvement rate of only
II. When Should Empiric Antimicrobial Therapy Be Initiated 32% at 14 days in children receiving placebo, compared with
in Patients With Signs and Symptoms Suggestive of ABRS? 64% in those treated with amoxicillin-clavulanate, giving an
Recommendation NNT of 3 (95% CI, 1.7–16.7; P , .05). This RCT is notable
2. It is recommended that empiric antimicrobial therapy be not only for its stringent inclusion/exclusion criteria for ini-
initiated as soon as the clinical diagnosis of ABRS is established tiating antimicrobial therapy, but also for its adoption of
as defined in recommendation 1 (strong, moderate). a clinical severity score for monitoring patient progress. Thu-
Evidence Summary s, a watchful waiting strategy is only reasonable if one is un-
Because adoption of more stringent clinical criteria based on certain about the diagnosis of ABRS owing to mild symptoms
characteristic onset and clinical presentations is more likely to but cannot be recommended when more stringent clinical
identify patients with bacterial rather than acute viral rhinosi- criteria for the diagnosis of ABRS are applied.
nusitis, withholding or delaying empiric antimicrobial therapy Benefits. Prompt antimicrobial therapy for patients more
is not recommended. Prompt initiation of antimicrobial therapy likely to have acute bacterial rather than viral rhinosinusitis
as soon as the clinical diagnosis of ABRS is established as should shorten the duration of illness, provide earlier symptom
defined in recommendation 1 should shorten the duration relief, restore quality of life, and prevent recurrent infection
of illness, provide earlier symptomatic relief, restore quality or suppurative complications.
of life, and prevent recurrence or suppurative complications. Harms. Prompt antimicrobial therapy may result in over-
This recommendation contravenes a popular management use of antibiotics, enhanced cost, and risk of adverse effects
strategy of ‘‘watchful waiting’’ in which antibiotic therapy is in those patients who do have true bacterial infection but
withheld unless patients fail to respond to symptomatic man- mild disease. However, the patient selection criteria specified
agement [13, 82]. The proponents of this approach cite the in recommendation 1 make this possibility less likely.
Susceptible Breakpoint
(lg/mL) Harrison et al (2005–2007) [94] Critchley et al (2005–2006) [93] Sahm et al (2005) [95]
MIC90 MIC90 MIC90
Antimicrobial CLSI PK/PD (lg/mL) CLSI (% Susceptible) PK/PD (% Susceptible) (lg/mL) CLSI (% Susceptible) (lg/mL) CLSI (% Susceptible)
Abbreviations: Amox, amoxicillin; amox-clav, amoxicillin-clavulanate; BLP, b-lactamase positive; CLSI, Clinical Laboratory Standards Institute; MIC90, minimum inhibitory concentration for 90% of isolates; N, no. of isolates
CLSI (% Susceptible)
antimicrobial susceptibility profiles of all respiratory pathogens
(both regional and national) should be performed at regular
Sahm et al (2005) [95]
99
99
100
100
NA
NA
NA
NA
NA
intervals to guide initial empiric antimicrobial therapy.
tested; NA, not available; PD/PK, pharmacodynamic/pharmacokinetic; PI, penicillin-intermediate; PR, penicillin-resistant; PS, penicillin-susceptible; TMP/SMX, trimethoprim-sulfamethoxazole.
Adults?
0.03
0.06
0.25
(lg/mL)
Recommendation
MIC90
NA
NA
NA
NA
NA
2
4. Amoxicillin-clavulanate rather than amoxicillin alone is rec-
ommended as empiric antimicrobial therapy for ABRS in adults
(weak, low).
CLSI (% Susceptible)
Evidence Summary
Critchley et al (2005–2006) [93]
#0.12
#0.06
MIC90
0.5
0.5
NA
NA
NA
NA
97
98
7
100
98
97
100
NA
NA
NA
NA
NA
0.06
MIC90
NA
NA
PK/PD
#0.12
#0.5
#0.5
#1
#1
#1
#2
#2
NA
NA
NA
#8
#4
#2
#2
#2
Cefuroxime axetil
Levofloxacin
Ceftriaxone
TMP/SMX
Cefdinir
Illustrative Comparative
Risksa (95% CI)
Assumed Risk Corresponding Risk
Relative Effect, No of Participants Quality of the
Outcomes b-Lactam FQ OR (95% CI) (No. of Studies) Evidence (GRADE) Reference
b,c,d,e
Clinical response Study population (low-risk) 1.09 (.85–1.39) 2133 (5 studies) 4442 moderate Karageorgopoulos
follow-up: et al [115]
10–31 days
861 per 1000 871 per 1000 (840–896)
Patient or population: patients with acute sinusitis. Settings: initial therapy. Intervention: FQ. Comparison: b-lactam.
Abbreviations: CI, confidence interval; FQ, fluoroquinolone, GRADE, Grading of Recommendations Assessment, Development and Evaluation; OR, odds ratio.
a
The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
b
Only 5 of 11 studies included; only those comparing respiratory fluoroquinolones are included.
amoxicillin-clavulanate, until clear evidence of high failure rates serotype 19A and is expected to dramatically reduce PNS
($10%) from standard-dose amoxicillin-clavulanate emerges, S. pneumoniae disease. Protection against serotype 19A disease
the panel consensus is to reserve high-dose amoxicillin- has been documented in a PCV13 vaccine effectiveness study
clavulanate for patients from geographic regions with high [99]. Thus, decisions regarding appropriate dosing regimens
endemic rates of PNS S. pneumoniae ($10%, using 2008 should be guided by antimicrobial susceptibility profiles of
CLSI revised breakpoints), those seriously ill with evidence prevalent pathogens through diligent surveillance by local or
of systemic toxicity (eg, fever of 39°C [102°F] or higher) and national reporting agencies.
threat of suppurative complications, those who are immuno- Conclusions and Research Needs. More studies are needed
compromised, and those with risk factors for acquiring PNS to directly compare the cost-effectiveness of high-dose vs
S. pneumoniae as outlined above. standard-dose amoxicillin-clavulanate as initial empiric an-
Benefits. Until a clear need for high-dose amoxicillin- timicrobial therapy of presumed ABRS in both adults and
clavulanate is demonstrated by unacceptably high failure children.
rates from standard-dose amoxicillin-clavulanate, delaying the
use of high-dose amoxicillin-clavulanate as empiric therapy for VI. Should a Respiratory Fluoroquinolone vs a b-Lactam
all patients with presumed ABRS may be more cost-effective Agent Be Used as First-line Agents for the Initial Empiric
and result in fewer adverse effects and less antibiotic selection Antimicrobial Therapy of ABRS?
pressure for resistance. Recommendation
Harms. Standard-dose amoxicillin-clavulanate is inadequate 6. A b-lactam agent (amoxicillin-clavulanate) rather than a re-
for the treatment of ABRS caused by PNS S. pneumoniae and spiratory fluoroquinolone is recommended for initial empiric
the rare occurrence of ampicillin-resistant b-lactamase–negative antimicrobial therapy of ABRS (weak, moderate).
H. influenzae. Evidence Summary
Other Considerations. It should be noted that the preva- The respiratory fluoroquinolones (both levofloxacin and
lence of resistant or intermediate S. pneumoniae in a given moxifloxacin) have remained highly active against all common
community may vary not only geographically but also tem- respiratory pathogens, including PNS S. pneumoniae and
porally. This is evidenced by the shift in S. pneumoniae b-lactamase–producing H. influenzae or M. catarrhalis [105,
susceptibility profiles in some communities following the 106]. Nevertheless, respiratory fluoroquinolones were not
introduction of the 7-valent pneumococcal conjugate vaccine superior to b-lactam antibiotics in 8 RCTs of the treatment
(PCV7), which resulted in the subsequent emergence of highly of ABRS [107–114]. A meta-analysis of these trials confirmed
virulent and resistant nonvaccine serotypes of S. pneumoniae that initial treatment with the newer fluoroquinolones con-
such as serotypes 14 and 19A [86, 103]. In 2010, PCV13 ferred no benefit over b-lactam antibiotics [115]. The com-
replaced the PCV7 for all children [104]. PCV13 contains parator agents in these trials were amoxicillin-clavulanate
6 additional pneumococcal serotype antigens including in 5, cefuroxime in 2, and cefdinir in 1. Specifically, in
for placebo in one study [47], and 85% for both groups in the Oral Cephalosporins. The in vitro activity of second-
second study [46]. Of the 3 comparative trials, only the and third-generation oral cephalosporins (such as cefaclor,
Scandinavian study enrolled sufficient patients [135]. In this cefprozil, cefuroxime axetil, cefpodoxime, cefdinir, and
double-blind, randomized study, 662 patients were enrolled cefixime) are highly variable particularly against penicillin-
and both pre- and posttreatment sinus punctures were per- intermediate and resistant S. pneumoniae. Among these
formed. However, only 50% yielded positive pretreatment oral cephalosporins, cefpodoxime, cefuroxime axetil, and
cultures and were evaluable for bacteriological eradication. cefdinir are moderately active against penicillin-intermediate
In the intent-to-treat analysis, the clinical success rate was S. pneumoniae (,50% susceptible) followed by cefixime,
91% in both groups (300 of 330 for doxycycline vs 303 of 332 whereas cefaclor and cefprozil are inactive [95, 136, 137].
for loracarbef). In the evaluable patients, the clinical success Oral cephalosporins including cefpodoxime and cefdinir
rate was 93% (153 of 164) in the doxycycline group vs 98% are inactive against penicillin-resistant S. pneumoniae [136,
(165 of 168) in the loracarbef group (P 5 .05 with Yates’s 138]. Intravenous ceftriaxone and cefotaxime remain active
against nearly all S. pneumoniae, including penicillin-resistant
correction) within 3 days posttreatment, and 92% for both
strains, and are preferred as second-line empiric therapy (in
groups at follow-up 1–2 weeks posttreatment (121 of 131 for
place of high-dose amoxicillin-clavulanate) for hospitalized
doxcycline vs 129 of 140 for loracarbef). The microbio-
patients with severe infections. Cefpodoxime is the most active
logical eradication rate posttreatment was 81% (133 of 164)
oral cephalosporin against both H. influenzae and M. catar-
for doxycycline and 80% (135 of 168) for loracarbef. Mi-
rhalis (both b-lactamase positive and negative), followed by
crobiological failure due to presence of the same pathogen
cefixime, cefuroxime, and cefdinir [138, 139]. Cefaclor and
in the posttreatment cultures occurred in 27 (16%) of
cefprozil are least active (Table 7). Based on these in vitro
doxycycline-treated patients and 21 (13%) of loracarbef- data, it is clear that considerable variability exists in the activity
treated patients. A different organism was isolated from of second- and third-generation oral cephalosporins, par-
posttreatment cultures in 4 (2.4%) of doxcycline vs 12 ticularly against S. pneumoniae and H. influenzae. For this
(7.1%) of loracarbef patients. The significance of these reason, these agents are no longer recommended as mono-
posttreatment cultures is difficult to interpret since they therapy for the initial empiric treatment of ABRS in children
do not always correlate with the clinical response. Never- or adults. If an oral cephalosporin is to be used, a third-
theless, the available clinical as well as microbiological and generation cephalosporin (eg, cefixime or cefpodoxime) in
PK/PD data do support the use of doxycycline as an alter- combination with clindamycin is recommended for patients
native to amoxicillin-clavulanate for empiric antimicrobial with ABRS from geographic regions with high endemic rates
therapy of ABRS in adults at low risk for acquisition of PNS of PNS S. pneumoniae ($10% using 2008 CLSI revised
S. pneumoniae. breakpoints). However, clindamycin resistance is reported
frequently among S. pneumoniae serotype 19A isolates (31%) 19A [86, 103]. The introduction of PCV13, which contains
[94]. In such instances, a fluoroquinolone (levofloxacin or 6 additional serotype antigens including serotype 19A, is an-
moxifloxacin) is recommended as an alternative. The rec- ticipated to decrease both overall and resistant invasive
ommended first-line and second-line regimens for empiric pneumococcal disease [99]. However, ongoing surveillance
antimicrobial therapy of ABRS in children and adults are is required to detect the possibility of other emerging non-
summarized in Tables 9 and 10, respectively. vaccine serotypes of PNS S. pneumoniae.
Benefits. The respiratory fluoroquinolones are active Conclusions and Research Needs. Doxycycline should be
against both b-lactamase–positive and –negative respiratory included in national and regional surveillance studies of re-
pathogens common in ABRS and can be administered with spiratory pathogens, and more RCTs with this antimicrobial
once- or twice-daily dosing regimens and improved com- agent in the empiric treatment of adults with ABRS are war-
pliance. Doxycycline appears more cost-effective than the ranted. Among the third-generation oral cephalosporins, cef-
respiratory fluoroquinolones. Third-generation oral cepha- ditoren appears to have the best intrinsic activity against all
losporins (eg, cefixime or cefpodoxime) are well tolerated common respiratory pathogens including PNS S. pneumoniae
with minimal adverse effects. However, their coverage for [137, 142]. More RCTs with this agent for the treatment of
S. pneumoniae is variable. ABRS are warranted in both adults and children.
Harms. The respiratory fluoroquinolones are more costly VIII. Which Antimicrobial Regimens Are Recommended for
than doxycycline, and escalating resistance with increased the Empiric Treatment of ABRS in Adults and Children With
usage is a concern. Similar to other fluoroquinolones, moxi- a History of Penicillin Allergy?
floxacin has been associated with severe hepatotoxicity Recommendations
[140, 141]. Doxycycline is not recommended for children 11. Either doxycycline (not suitable for children) or a respiratory
#8 years of age due to staining of teeth. Oral third-generation fluoroquinolone (levofloxacin or moxifloxacin) is recom-
cephalosporins are relatively costly and may cause diarrhea or mended as an alternative agent for empiric antimicrobial
hypersensitivity reactions. Clindamycin is an important cause therapy in adults who are allergic to penicillin (strong,
of Clostridium difficile–associated enterocolitis, and clinda- moderate).
mycin resistance is common among S. pneumoniae serotype 12. Levofloxacin is recommended for children with a history
19A isolates (31%). of type I hypersensitivity to penicillin; combination therapy
Other Considerations. The introduction and large-scale with clindamycin plus a third-generation oral cephalosporin
implementation of PCV7 has led to the emergence of more (cefixime or cefpodoxime) is recommended in children with
virulent and resistant nonvaccine serotypes such as serotype a history of non–type I hypersensitivity to penicillin (weak, low).
(3–7 days) vs long-course (6–10 days) antibiotic therapy (OR, literature recommendations, which varies from 3–5 days, to
0.95 [95% CI, .81–1.12]). In addition, no differences in mi- 5–7 days, to 6–10 days [164]. This recommendation is
crobiological efficacy (OR, 1.30 [95% CI, .62–2.74]), relapse considered reasonable since in most patients with confir-
rates (OR, 0.95 [CI .63–1.37]) or adverse effects (OR, 0.88 mation of ABRS by sinus puncture, both symptomatic
[CI, .71–1.09]) were found. However, if only the studies that improvement and bacteriological eradication from the
compared 5 days (short-course) vs 10 days (long-course) were maxillary sinus can be expected within 72 hours after ini-
included (5 RCTs), adverse effects were significantly fewer in tiation of appropriate antimicrobial therapy (see question
the short-course treatment groups (OR, 0.79 [95% CI, .63– XIV following). In any event, duration of antimicrobial
.98]). This meta-analysis has a number of limitations. The therapy beyond 10 days in adult patients with un-
study population was heterogeneous with respect to the entry complicated ABRS is likely excessive. Data in pediatric
criterion of symptom duration (any patient with symptoms patients, however, are inconclusive because the efficacy of
,30 days with positive radiologic findings). There was shorter courses of therapy has not been specifically studied
overlap in the duration of short-course (3–7 days) vs long- in a rigorous randomized fashion [165].
course (6–10 days) treatment groups. Last, the concomitant Benefits. Short courses of antimicrobial therapy may
administration of adjunctive medications may have minimized offer several advantages over longer courses of therapy in-
any real differences between the treatment groups in the vari- cluding improved patient compliance, fewer adverse events,
ous trials (Table 11). A major concern raised from earlier decreased bacterial antibiotic resistance, and lower cost
published RCTs is that the favorable outcome of shorter [159, 160, 166–168].
duration of treatment might be attributed to inclusion of Harms. Shorter courses of antimicrobial therapy may
patients without microbiological confirmation of ABRS. result in relapse or recurrent infection, particularly among
However, a recent study suggested that even among the elderly and those with underlying disease or who are
patients with confirmation of ABRS by sinus puncture, the immunocompromised.
clinical cure rate of treatment with 5 days of moxifloxacin Other Considerations. None.
was not significantly better than placebo (78% vs 67%, Conclusions and Research Needs. Most clinical trials of
respectively) [45]. antimicrobial therapy in ABRS have excluded severely ill pa-
The duration of treatment for 5–7 days is chosen some- tients and have focused exclusively on acute maxillary sinus-
what arbitrarily and is intermediate in the range of itis with little information on patients with involvement of
other sinuses. Further research is needed regarding the opti- observed in some symptom scores (nasal secretion, nasal pa-
mal duration of antimicrobial treatment in children and tency, and overall health status), these changes were relatively
adults in whom the likelihood of a viral URI has been mini- minor (Table 12). The authors concluded that the trials were
mized by adhering to stringent clinical inclusion criteria. too small and had too high a risk of trial bias to be confident
that the benefits were meaningful. Nevertheless, there was
XI. Is Saline Irrigation of the Nasal Sinuses of Benefit as a trend toward reduced antibiotic use in one study as well as
Adjunctive Therapy in Patients With ABRS? a significant reduction in time lost from work [172].
Recommendation The value of intranasal saline irrigation in young children is
16. Intranasal saline irrigations with either physiologic or less certain. In a small clinical trial, 69 children with acute si-
hypertonic saline are recommended as an adjunctive treat- nusitis (mean age, 6 years [range, 3–12]) were randomized to
ment in adults with ABRS (weak, low-moderate). receive either saline irrigation or no irrigation [173]. The Total
Evidence Summary Nasal Symptom Scores as well as the Pediatric Rhino-
There is limited evidence in support of physiologic or hy- conjunctivitis Quality of Life Questionnaire were significantly
pertonic saline irrigations as adjunctive therapy for patients improved in the saline group. More important, the nasal peak
with ABRS. A recent Cochrane review evaluated the efficacy of expiratory flow rate was significantly improved in the saline
saline nasal irrigations in treating acute URIs including acute irrigation group compared with no irrigation. However, it is
rhinosinusitis [169]. Three RCTs (total of 618 participants) unclear how well the saline irrigation procedure was tolerated
were included for analysis and various nasal symptom scores particularly among the younger children. Minor discomfort is
were assessed. Although significant improvements were common during saline irrigation, and installation of nasal drops
Illustrative Comparative
Risksa (95% CI)
Assumed Risk Corresponding Risk
No. of
Intranasal Relative Effect Participants Quality of the
Outcomes Placebo Corticosteroids (95% CI) (No. of Studies) Evidence (GRADE) Reference
b,c
Symptom Study population (medium-risk) RR, 01.10 (1.02–1.18) 1130 (2 studies) 4444 high Meltzer et al,
resolution or Nayak et al
improvement [182, 183]
(MFNS
400 lg/day)
Follow-up: 667 per 1000 734 per 1000 (680–787)
3 weeks
Symptom Study population (medium-risk) RR, 1.04 (.98–1.11) 590 (2 studies) 4444 moderateb,c Dolor et al,
Patient or population: patients with adults and children with ABRS. Setting: outpatient clinic. Intervention: intranasal corticosteroids. Comparison: placebo.
Abbreviations: ABRS, acute bacterial rhinosinusitis; BDSN, budesonide nasal spray; CI, confidence interval; GRADE, Grading of Recommendations Assessment,
Development and Evaluation; MFNS, mometasone furoate nasal spray; OR, odds ratio; RR, relative risk.
a
The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
b
Mometazone 400 lg/day vs 200 lg/day for 21 days.
c
A 400-lg dose was superior to 200-lg dose.
d
Symptom duration was relatively short at enrollment (median, 7 days [range, 4–14 days]).
Further studies in larger populations with these agents are objective rhinometric findings do not support this impres-
clearly needed. sion [185]. There have been several RCTs that assessed the
possibility of an additive effect of topical or oral decon-
XIII. Should Topical or Oral Decongestants or Antihistamines gestants or antihistamines to antimicrobial therapy in adults
Be Used as Adjunctive Therapy in Patients With ABRS? with ABRS [175, 186, 187]. Inanli et al [175] prospectively
Recommendation evaluated the effect of topical decongestants (oxymetazoline)
18. Neither topical nor oral decongestants and/or antihist- vs hypertonic (3%) or isotonic (0.9%) saline or no topical
amines are recommended as adjunctive treatment in patients treatment on mucociliary clearance in patients with ABRS. All
with ABRS (strong, low-moderate). patients received 625 mg amoxicillin-clavulanate 3 times daily
Evidence Summary for 3 weeks. At 20 minutes after application, statistically sig-
Although decongestants and antihistamines are frequently nificant improvements in mucociliary clearance compared with
prescribed in patients with ABRS, there is scant evidence basal levels were only observed in the oxymetazoline and 3%
to support that they hasten recovery. Although patients saline treatment groups. At 3 weeks, significant improvement
may subjectively feel improvement in nasal airway patency, from basal levels was observed in all treatment groups as well as