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BMJ Clin Evid. 2011; 2011: 0511.
Published online 2011 December 2.
PMCID: PMC3275132

Sinusitis (acute)

Kim Ah-See, Consultant Otolaryngologist-Head and Neck Surgeon

Abstract

Introduction

Acute sinusitis is defined pathologically, by transient inflammation of the mucosal lining of the paranasal sinuses lasting less than 4 weeks. Clinically, it is characterised by nasal congestion, rhinorrhoea, facial pain, hyposmia, sneezing, and, if more severe, additional malaise and fever. It affects 1% to 5% of the adult population each year in Europe.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments in people with clinically diagnosed acute sinusitis, and in people with radiologically or bacteriologically confirmed acute sinusitis? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2011 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 19 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review we present information relating to the effectiveness and safety of the following interventions: antibiotics (amoxicillin, amoxicillin–clavulanic acid [co-amoxiclav], doxycycline, cephalosporins, macrolides; different doses, long-course regimens), antihistamines, decongestants (xylometazoline, phenylephrine, pseudoephedrine), saline nasal washes, steam inhalation, and topical corticosteroids (intranasal).

Key Points

Acute sinusitis is defined pathologically by transient inflammation of the mucosal lining of the paranasal sinuses lasting <4 weeks.

  • Clinically, it is characterised by nasal congestion, rhinorrhoea, facial pain, hyposmia, sneezing, and, if more severe, additional malaise and fever.
  • It affects 1% to 5% of the adult population each year in Europe.

In clinically diagnosed and in radiologically/bacteriologically diagnosed acute sinusitis, corticosteroids (intranasal spray) may reduce symptoms compared with placebo.

In clinically diagnosed acute sinusitis, there is currently little evidence from RCTs to support the use of amoxicillin, amoxicillin–clavulanic acid (co-amoxiclav), or doxycycline over placebo in terms of clinical cure rate.

  • We found no RCTs on the effects of cephalosporins or macrolides compared with placebo in clinically diagnosed acute sinusitis.
  • Amoxicillin and amoxicillin–clavulanic acid are no more effective than placebo at reducing treatment failure rates, and they are associated with adverse gastrointestinal effects.
  • Cephalosporins and macrolides seem no more effective than amoxicillin, but they have fewer adverse effects.
  • We found insufficient evidence to judge the efficacy of doxycycline.
  • Long-term antibiotic regimens (6- to 10-day courses) seem no more effective than short-term treatments (3- to 5-day courses), but they do seem to produce more adverse effects.
  • We found insufficient evidence to draw conclusions on which is the most effective dosage regimen for antibiotics.
  • CAUTION: the FDA has withdrawn the acute sinusitis indication for telithromycin, as the risks:benefits ratio is no longer favourable (12 February 2007).

We found no good-quality studies examining the effectiveness of antihistamines, decongestants, steam inhalation, or saline nasal washes in sinusitis diagnosed either clinically or based on radiological or bacteriological results.

About this condition

Definition

Acute sinusitis is defined pathologically, by transient inflammation of the mucosal lining of the paranasal sinuses lasting <4 weeks. Clinically, it is characterised by nasal congestion, rhinorrhoea, facial pain, hyposmia, sneezing, and, if more severe, by additional malaise and fever. The diagnosis is usually made clinically (on the basis of history and examination, but without radiological or bacteriological investigation). Clinically diagnosed acute sinusitis is less likely to be caused by bacterial infection than acute sinusitis confirmed by radiological or bacteriological investigation. In this review, we have excluded studies in children, in people with symptoms for >4 weeks (chronic sinusitis), and in people with symptoms after facial trauma. We have made it clear in each section whether we are dealing with clinically diagnosed acute sinusitis or acute sinusitis with clinical symptoms that have also been confirmed by bacteriological or radiological investigation, because the effects of treatment may be different in these groups.

Incidence/ Prevalence

Each year in Europe 1% to 5% of adults are diagnosed with acute sinusitis by their general practitioners. Extrapolated to the British population, this is estimated to cause 6 million restricted working days a year. Most people with acute sinusitis are assessed and treated in a primary-care setting. The prevalence varies according to whether diagnosis is made on clinical grounds or on the basis of radiological or bacteriological investigation.

Aetiology/ Risk factors

One systematic review (search date 1998) reported that about 50% of people with a clinical diagnosis of acute sinusitis have bacterial sinus infection. The usual pathogens in acute bacterial sinusitis are Streptococcus pneumoniae and Haemophilus influenzae, with occasional infection with Moraxella catarrhalis. Preceding viral upper respiratory-tract infection is often the trigger for acute bacterial sinusitis, with about 0.5% of common colds becoming complicated by the development of acute sinusitis.

Prognosis

One meta-analysis of RCTs found that up to two-thirds of people with acute sinusitis had spontaneous resolution of symptoms without active treatment. One non-systematic review reported that people with acute sinusitis are at risk of chronic sinusitis and irreversible damage to the normal mucociliary mucosal surface. One further non-systematic review reported rare life-threatening complications, such as orbital cellulitis and meningitis, after acute sinusitis. However, we found no reliable data to measure these risks.

Aims of intervention

To relieve symptoms as quickly as possible, with minimal adverse effects.

Outcomes

Improvement in sinusitis: includes symptom improvement (symptom scores), cure rates (time to self-reported symptom resolution and time to clinical resolution [defined by examiner]), and time to return to normal activities; and adverse effects of treatment. In the identified studies, clinical improvement and clinical cure were often used as outcome measures. "Clinical improvement" was defined as improvement in clinical state as rated by the assessor or by the participant. "Clinical cure" was defined as resolution of symptoms as rated by assessor or participant.

Methods

Clinical Evidence search June 2011. The following databases were used to identify studies for this systematic review: Medline 1966 to June 2011, Embase 1980 to June 2011, and The Cochrane Database of Systematic Reviews, 2011, Issue 2 (1966 to date of issue). An additional search within The Cochrane Library was carried out for the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the contributor for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language, at least single blinded, and containing >20 individuals of whom >80% were followed up for a minimum of 1 week. We excluded all studies described as "open", "open label", or not blinded unless blinding was impossible. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied applying the same study design criteria for inclusion as we did for benefits. In addition we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).

Table
GRADE Evaluation of interventions for Sinusitis (acute).

Glossary

High-quality evidence
Further research is very unlikely to change our confidence in the estimate of effect.
Hyposmia
Reduced, although not absent, sense of smell.
Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Orbital cellulitis
Inflammation of the soft tissues in and around the eye socket.
Rhinorrhoea
Discharge from the nasal cavity.
Very low-quality evidence
Any estimate of effect is very uncertain.

Notes

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

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13. De Sutter AI, De Meyere MJ, Christiaens TC, et al. Does amoxicillin improve outcomes in patients with purulent rhinorrhea? A pragmatic randomized double-blind controlled trial in family practice. J Fam Pract 2002;51:317−323. [PubMed]
14. Varonen H, Kunnamo I, Savolainen S, et al. Treatment of acute rhinosinusitis diagnosed by clinical criteria or ultrasound in primary care: a placebo-controlled randomised trial. Scand J Prim Health Care 2003;21:121−126. [PubMed]
15. Stalman W, van Essen GA, van der Graaf Y, et al. The end of antibiotic treatment in adults with acute sinusitis-like complaints in general practice? A placebo-controlled double-blind randomized doxycycline trial. Br J Gen Pract 1997;47:794−799. [PMC free article] [PubMed]
16. Bucher HC, Tschudi P, Young J, et al. Effect of amoxicillin−clavulanate in clinically diagnosed acute rhinosinusitis: a placebo-controlled, double-blind, randomized trial in general practice. Arch Intern Med 2003;163:1793−1798. [PubMed]
17. Gehanno P, Loncle-Provot V, Le Kerneau J. Efficacy of cefotiam hexetil in acute maxillary sinusitis, with a short five day vs ten day treatment. Med Mal Infect 2004;34:455−459. [In French] [PubMed]
18. Ahovuo-Saloranta A, Rautakorpi U, Borisenko O, et al. Antibiotics for acute maxillary sinusitis. In: The Cochrane Library, Issue 2, 2011. Chichester, UK: John Wiley & Sons, Ltd. Search date 2010.
19. O'Doherty B. An open comparative study of azithromycin versus cefaclor in the treatment of patients with upper respiratory tract infections. J Antimicrob Chemother 1996;37(suppl C):71−81. [PubMed]
20. Stefansson P, Jacovides A, Jablonicky P, et al. Cefuroxime axetil versus clarithromycin in the treatment of acute maxillary sinusitis. Rhinology 1998;36:173−178. [PubMed]
21. Buchanan PP, Stephens TA, Leroy B. A comparison of the efficacy of telithromycin versus cefuroxime axetil in the treatment of acute bacterial maxillary sinusitis. Am J Rhinol 2003;17:369−377. [PubMed]
22. Lindbaek M, Hjortdahl P, Johnsen ULH. Randomised, double blind, placebo controlled trial of penicillin V and amoxycillin in treatment of acute sinus infections in adults. BMJ 1996;313:325−329. [PMC free article] [PubMed]
23. Van Buchem FL, Knottnerus JA, Schrijnemaekers VJJ, et al. Primary-care-based randomised placebo-controlled trial of antibiotic treatment in acute maxillary sinusitis. Lancet 1997;349:683−687. [PubMed]
24. Turik M, Watkins M, Johns D Jr. Double-masked, randomized, parallel-group comparison of cefaclor AF and cefaclor in the treatment of acute bacterial sinusitis. Curr Ther Res Clin Exp 1997;58:227−239.
25. Murray JJ, Solomon E, McCluskey D, et al. Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of adult patients with acute maxillary sinusitis. Clin Ther 2000;22:1421−1432. [PubMed]
26. Rantanen T, Arvilommi H. Double-blind trial of doxycycline in acute maxillary sinusitis. Acta Otolaryngol 1973;76:58−62. [PubMed]
27. Kassel JC, King D, Spurling-Geoffrey, KP. Saline nasal irrigation for acute upper respiratory tract infections. In: The Cochrane Library, Issue 2, 2011. Chichester, UK: John Wiley & Sons, Ltd. Search date 2009.
28. Henry DC, Riffer E, Sokol WN, et al. Randomized double-blind study comparing 3- and 6-day regimens of azithromycin with a 10-day amoxicillin−clavulanate regimen for treatment of acute bacterial sinusitis. Antimicrob Agents Chemother 2003;47:2770−2774. [PMC free article] [PubMed]
29. Luterman M, Tellier G, Lasko B, et al. Efficacy and tolerability of telithromycin for 5 or 10 days vs amoxicillin/clavulanic acid for 10 days in acute maxillary sinusitis. Ear Nose Throat J 2003;82:576−590. [PubMed]
30. Roos K, Brunswig-Pitschner C, Kostrica R, et al. Efficacy and tolerability of once-daily therapy with telithromycin for 5 or 10 days for the treatment of acute maxillary sinusitis. Chemotherapy 2002;48:100−108. [PubMed]
2011; 2011: 0511.
Published online 2011 December 2.

Corticosteroids (intranasal)

Summary

In clinically diagnosed acute sinusitis, corticosteroids (intranasal spray) may reduce symptoms compared with placebo.

Benefits and harms

Corticosteroids versus placebo:

We found one systematic review (search date 2006), which identified 4 RCTs: one RCT in people with clinically diagnosed sinusitis and three RCTs in people with radiologically or biologically confirmed sinusitis. The review did not perform separate analyses in people with clinically or laboratory-confirmed sinusitis; therefore, we report the results of only the RCT in clinically confirmed sinusitis. Assessment of symptom improvement in the review differed from that in the RCT, and so we report both here.

Improvement in sinusitis

Compared with placebo Intranasal mometasone seems no more effective at 15 days at increasing the number of people with an improvement in symptoms of clinically diagnosed acute sinusitis (moderate-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Symptom improvement

Systematic review
981 people with clinically diagnosed acute sinusitis in a primary-care setting
Data from 1 RCT
Resolution or improvement in symptoms 15 days
442/478 (93%) with mometasone furoate nasal spray 200 micrograms once or twice daily
225/252 (89%) with placebo

RR 1.04 for mometasone furoate nasal spray (200 micrograms once or twice daily) v placebo
95% CI 0.99 to 1.09
Not significant

RCT
4-armed trial
981 people with clinically diagnosed acute sinusitis in a primary-care setting
In review
Mean reduction of major-symptom score 15 days
with mometasone (200 micrograms twice daily)
with placebo
Absolute results not reported

Mean difference: 0.81
P <0.001 for mometasone furoate nasal spray (200 micrograms twice daily) v placebo
Effect size not calculatedmometasone furoate nasal spray

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
4-armed trial
981 people with clinically diagnosed acute sinusitis in a primary-care setting
In review
Treatment-related adverse effects 15 days
36% with mometasone furoate (200 micrograms twice daily)
35% with mometasone furoate (200 micrograms once daily)
38% with placebo
Absolute numbers not reported

Significance not assessed

Further information on studies

The primary endpoint of the RCT of major symptom score was based on the sum of the individual symptom scores (0 = none, 1 = mild, 2 = moderate, 3 = severe) for rhinorrhoea, postnasal drip, nasal congestion, sinus headache, and facial pain. Follow-up at 14 days after treatment suggested no greater risk of recurrence or exacerbation in the mometasone furoate group compared with placebo (significance not assessed).

Comment

Clinical guide:

In clinically diagnosed acute sinusitis, 15 days of topical corticosteroid spray may confer a treatment benefit in terms of symptom reduction when compared with placebo. The RCT did not report analysis of amoxicillin compared with placebo.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Antibiotics (amoxicillin, amoxicillin–clavulanic acid [co-amoxiclav], doxycycline, cephalosporins, macrolides)

Summary

In clinically diagnosed acute sinusitis, there is currently little evidence from RCTs to support the use of amoxicillin, amoxicillin–clavulanic acid (co-amoxiclav), or doxycycline over placebo in terms of clinical cure rate.

We found no RCTs on the effects of cephalosporins or macrolides compared with placebo in clinically diagnosed acute sinusitis.

Benefits and harms

Amoxicillin versus placebo:

We found two RCTs in people with an exclusively clinical diagnosis of acute sinusitis, without reliance on radiological or bacteriological investigations.

Improvement in sinusitis

Compared with placebo Amoxicillin seems no more effective at increasing treatment success rates in people with clinically diagnosed acute sinusitis (moderate-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

RCT
416 people in a primary-care setting Treatment success (defined by absent or mild symptoms) 10 days (end of treatment)
59/170 (35%) with amoxicillin (500 mg 3 times daily)
47/164 (29%) with placebo

RR 1.14
95% CI 0.92 to 1.42
Not significant

RCT
4-armed trial
150 people with clinically diagnosed acute maxillary sinusitis in a primary-care setting Recovery rates (assessed by telephone) 2 weeks
18/23 (78%) with amoxicillin
39/59 (66%) with placebo

Significance not reported

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
416 people in a primary-care setting Diarrhoea
29% with amoxicillin
19% with placebo
Absolute numbers not reported

RR 1.28
95% CI 1.05 to 1.57
Small effect sizeplacebo

No data from the following reference on this outcome.

Doxycycline versus placebo:

We found two RCTs in people with an exclusively clinical diagnosis of acute sinusitis, without reliance on radiological or bacteriological investigations.

Improvement in sinusitis

Compared with placebo Doxycycline may be no more effective at increasing cure rates at 10 or 42 days, at improving the mean time to resolution of facial pain, or at improving the time to return normal activities in people with acute sinusitis (low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

RCT
4-armed trial
150 people with clinically diagnosed acute maxillary sinusitis in a primary-care setting Recovery rates (assessed by telephone) 2 weeks
26/33 (79%) with doxycycline
39/59 (66%) with placebo

Significance not assessed

RCT
192 people with acute sinusitis in a primary-care setting, clinically diagnosed Cure rate 10 days
with doxycycline (100 mg once daily) for 10 days
with placebo for 10 days
Absolute results not reported

Significance not assessed

RCT
192 people with acute sinusitis in a primary-care setting, clinically diagnosed Cure rate 42 days
with doxycycline (100 mg once daily) for 10 days
with placebo for 10 days
Absolute results not reported

Significance not assessed
Symptom improvement

RCT
192 people with acute sinusitis in a primary-care setting, clinically diagnosed Median time to resolution of facial pain
4 days with doxycycline (100 mg once daily) for 10 days
5 days with placebo for 10 days

HR 1.17
95% CI 0.87 to 1.57
Not significant
Time to return to normal activities

RCT
192 people with acute sinusitis in a primary-care setting, clinically diagnosed Median time to return to normal activities
5 days with doxycycline (100 mg once daily) for 10 days
6 days with placebo for 10 days

HR 1.31
95% CI 0.96 to 1.78
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
192 people with acute sinusitis in a primary-care setting, clinically diagnosed Adverse effects
17/98 (17%) with doxycycline (100 mg once daily) for 10 days
2/94 (2%) with placebo for 10 days

Significance not assessed

No data from the following reference on this outcome.

Amoxicillin–clavulanic acid (co-amoxiclav) versus placebo:

We found one RCT.

Improvement in sinusitis

Compared with placebo Amoxicillin–clavulanic acid (co-amoxiclav) seems no more effective at reducing the time to return to normal activities in people with acute sinusitis (moderate-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Time to return to normal activities

RCT
252 adults recruited from general practices and outpatient clinics Time to return to normal activities
with amoxicillin–clavulanic acid (co-amoxiclav) for 6 days
with placebo for 6 days
Absolute results not reported

HR (adjusted for specified variables) 0.99
95% CI 0.68 to 1.45
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Diarrhoea

RCT
252 adults recruited from general practices and outpatient clinics Diarrhoea 7 days
with amoxicillin–clavulanic acid (co-amoxiclav) for 6 days
with placebo for 6 days
Absolute results not reported

OR 3.89
95% CI 2.09 to 7.25
Moderate effect sizeplacebo

RCT
252 adults recruited from general practices and outpatient clinics Diarrhoea 14 days
with amoxicillin–clavulanic acid for 6 days
with placebo for 6 days
Absolute results not reported

OR 1.71
95% CI 0.91 to 3.23
Not significant

Cephalosporins or macrolides versus placebo:

We found no RCTs.

Different treatment durations of cephalosporins versus each other:

We found one RCT.

Improvement in sinusitis

Different treatment durations of cephalosporins compared with each other A 5-day course of cephalosporin seems as effective as a 10-day course at increasing cure rates in people with acute sinusitis (moderate-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

RCT
1018 people in a primary-care setting with acute sinusitis (radiology and bacteriology were not required for the diagnosis to be made) Cure rate
418/489 (85.5%) with 5-day course of cefotiam
418/490 (85.3%) with 10-day course of cefotiam

Reported as not significant
P value not reported
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
1018 people in a primary-care setting with acute sinusitis (radiology and bacteriology were not required for the diagnosis to be made) Adverse effects
with 5-day course of cefotiam
with 10-day course of cefotiam
Absolute results not reported

Different antibiotics versus each other:

We found no RCTs.

Further information on studies

None.

Comment

Clinical guide:

In clinically diagnosed acute sinusitis, there is currently little evidence from RCTs to support the use of amoxicillin, amoxicillin–clavulanic acid (co-amoxiclav), or doxycycline over placebo in terms of clinical cure rate. We found no RCTs on the effects of cephalosporins or macrolides compared with placebo in this group.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Antihistamines

Summary

We found no direct information from RCTs about antihistamines in the treatment of people with clinically diagnosed acute sinusitis.

Benefits and harms

Antihistamines:

We found no systematic review or RCTs.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Decongestants (xylometazoline, phenylephrine, pseudoephedrine)

Summary

We found no direct information from RCTs about decongestants (xylometazoline, phenylephrine, pseudoephedrine) in the treatment of people with clinically diagnosed acute sinusitis.

Benefits and harms

Decongestants:

We found no systematic review or RCTs.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Saline nasal washes

Summary

We found no direct information from RCTs about saline nasal washes in the treatment of people with clinically diagnosed acute sinusitis.

Benefits and harms

Saline nasal washes:

We found no systematic review or RCTs.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Steam inhalation

Summary

We found no direct information from RCTs about steam inhalation in the treatment of people with clinically diagnosed acute sinusitis.

Benefits and harms

Steam inhalation:

We found no systematic review or RCTs.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Cephalosporins or macrolides

Summary

We found no RCT evidence comparing cephalosporins or macrolides versus placebo in people with radiologically or bacteriologically confirmed acute sinusitis, but we found equivalence between these drugs and amoxicillin or amoxicillin–clavulanic acid. We found insufficient data to draw firm conclusions on the effectiveness of cephalosporins or macrolides.

Cephalosporins and macrolides seem to have fewer adverse effects than amoxicillin.

Benefits and harms

Cephalosporins or macrolides versus placebo:

We found two systematic reviews (search dates 1998 and 2010). The first review did not report separately on the effects of cephalosporins and macrolides compared with placebo. The second review found no RCTs comparing these antibiotics with placebo. We found no subsequent RCTs.

Cephalosporins or macrolides versus amoxicillin:

We found one systematic review (search date 2010), which compared penicillin antibiotics (including amoxicillin) versus cephalosporins, macrolides (clarithromycin, spiramycin, azithromycin, roxithromycin, and erythromycin), or minocycline.

Improvement in sinusitis

Cephalosporins or macrolides compared with amoxicillin Penicillin-type antibiotics (including amoxicillin) and non-penicillins (cephalosporins or macrolides) seem equally effective at reducing failure rates in people with radiologically or bacteriologically confirmed acute maxillary sinusitis (high-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

Systematic review
1083 adults with radiologically or bacteriologically confirmed acute maxillary sinusitis
7 RCTs in this analysis
Proportion of people failing treatment 7 to 15 days
36/546 (7%) with non-penicillins
52/537 (10%) with beta-lactamase-sensitive penicillins

RR 0.70
95% CI 0.47 to 1.06
P = 0.092
Not significant

Systematic review
169 adults with radiologically or bacteriologically confirmed acute maxillary sinusitis
Data from 1 RCT
Proportion of people failing treatment 16 to 60 days
9/87 (10%) with non-penicillins
10/82 (12%) with beta-lactamase-sensitive penicillins

RR 0.85
95% CI 0.36 to 1.98
P = 0.70
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

Systematic review
1208 adults with radiologically or bacteriologically confirmed acute maxillary sinusitis
7 RCTs in this analysis
Withdrawal owing to adverse effects
8/604 (1%) with non-penicillins
14/604 (2%) with penicillin antibiotics

OR 0.58
95% CI 0.25 to 1.35
Not significant

Macrolides or cephalosporins versus amoxicillin–clavulanic acid (co-amoxiclav):

We found one systematic review (search date 2010, 17 RCTs) comparing amoxicillin–clavulanic acid versus macrolides or cephalosporins.

Improvement in sinusitis

Macrolides or cephalosporins compared with amoxicillin–clavulanic acid (co-amoxiclav) Cephalosporins are modestly less effective than amoxicillin–clavulanic acid at reducing treatment failure at 7 to 15 days in people with radiologically or bacteriologically confirmed acute maxillary sinusitis, but they are equally effective at 16 to 60 days. Macrolides and amoxicillin–clavulanic acid are equally effective at reducing treatment failure at 7 to 60 days (high-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

Systematic review
1887 adults with radiologically or bacteriologically confirmed acute maxillary sinusitis
6 RCTs in this analysis
Proportion of people failing treatment 7 to 15 days
110/944 (12%) with cephalosporins
80/943 (8%) with amoxicillin–clavulanic acid (co-amoxiclav)

OR 1.37
95% CI 1.04 to 1.80
P = 0.025
Small effect sizeamoxicillin–clavulanic acid

Systematic review
1415 adults with radiologically or bacteriologically confirmed acute maxillary sinusitis
7 RCTs in this analysis
Proportion of people failing treatment 16 to 60 days
124/724 (17%) with cephalosporins
109/691 (16%) with amoxicillin–clavulanic acid

OR 1.08
95% CI 0.85 to 1.37
P = 0.52
Not significant

Systematic review
1807 adults with radiologically or bacteriologically confirmed acute maxillary sinusitis
7 RCTs in this analysis
Proportion of people failing treatment 7 to 15 days
78/950 (8%) with macrolides
82/857 (10%) with amoxicillin–clavulanic acid

OR 0.83
95% CI 0.62 to 1.13
P = 0.24
Not significant

Systematic review
908 adults with radiologically or bacteriologically confirmed acute maxillary sinusitis
4 RCTs in this analysis
Proportion of people failing treatment 16 to 60 days
44/486 (9%) with macrolides
43/422 (10%) with amoxicillin–clavulanic acid

OR 0.85
95% CI 0.57 to 1.27
P = 0.42
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

Systematic review
2973 adults with radiologically or bacteriologically confirmed acute maxillary sinusitis
9 RCTs in this analysis
Proportion of people who withdrew owing to adverse effects
19/1486 (1%) with cephalosporins
66/1487 (4%) with amoxicillin–clavulanic acid (co-amoxiclav)

OR 0.32
95% CI 0.21 to 0.49
P <0.00001
Moderate effect sizecephalosporins

Systematic review
2250 adults with radiologically or bacteriologically confirmed acute maxillary sinusitis
8 RCTs in this analysis
Proportion of people who withdrew owing to adverse effects
28/1315 (2%) with macrolides
59/1235 (5%) with amoxicillin–clavulanic acid

OR 0.47
95% CI 0.30 to 0.72
P = 0.0005
Moderate effect sizemacrolides

Cephalosporins or macrolides versus doxycycline:

We found no systematic review or RCTs.

Macrolides versus cephalosporins:

We found one systematic review (search date 2010), which identified three RCTs. The review did not perform a meta-analysis for this comparison, so we present data from individual RCTs.

Improvement in sinusitis

Macrolides compared with cephalosporins Macrolides and cephalosporins seem equally effective at increasing cure rates, and at improving clinical resolution rates, in people with radiologically confirmed sinusitis (moderate-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

RCT
78 people, diagnosis confirmed radiologically and evaluable for clinical response
In review
Clinical improvement or resolution of symptoms 11 to 15 days
38/41 (93%) with azithromycin (500 mg once daily for 3 days)
35/37 (95%) with cefaclor (250 mg 3 times daily for 10 days)

P = 0.19
Not significant

RCT
370 people, diagnosis confirmed radiologically
In review
Cure rates (cure or improved) 1 to 3 days after completion of treatment
172/185 (93%) with 10 days of clarithromycin (250 mg twice daily)
169/185 (91%) with 10 days of cefuroxime (250 mg twice daily)

ARR +2%
95% CI –8% to +4%
Not significant

RCT
385 people, diagnosis confirmed by bacteriological/radiological findings
In review
Clinical cure rate
193/240 (80%) with 5-day course of telithromycin
84/116 (72%) with 10-day course of cefuroxime

ARR +8.0%
95% CI –2.2% to +18.2%
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
78 people, diagnosis confirmed radiologically and evaluable for clinical response
In review
Adverse effects
11% with azithromycin (500 mg once daily for 3 days)
10% with cefaclor (250 mg 3 times daily for 10 days)
Absolute numbers not reported

P = 0.82
Not significant

RCT
78 people, diagnosis confirmed radiologically and evaluable for clinical response
In review
Gastrointestinal symptoms
9% with azithromycin (500 mg once daily for 3 days)
6% with cefaclor (250 mg 3 times daily for 10 days)
Absolute numbers not reported

P value not reported

RCT
370 people, diagnosis confirmed radiologically
In review
Adverse effects
About 10% with 10 days of clarithromycin (250 mg twice daily)
About 10% with 10 days of cefuroxime (250 mg twice daily)
Absolute numbers not reported

Significance not reported

RCT
385 people, diagnosis confirmed by bacteriological/radiological findings
In review
At least 1 severe adverse effect
11/252 (4%) with 5-day course of telithromycin
4/121 (3%) with 10-day course of cefuroxime

Significance not assessed

Further information on studies

Of the 593 people initially enrolled at study entry, 385 were actually randomised. Reported reasons for failure of randomisation after enrolment included failure to return after enrolment, failure to meet inclusion criteria, lack of radiological or bacteriological confirmation, screening failure, non-compliance with protocol, and symptom resolution before trial.

Comment

Drug safety alert:

The FDA has withdrawn the acute sinusitis indication for telithromycin as the risks:benefits ratio is no longer favourable (www.fda.gov/medwatch).

Clinical guide:

There is no clear evidence from RCTs of benefit in cure rates for radiologically or bacteriologically confirmed acute sinusitis between the different antibiotics we have searched for. It may be that local factors and cost will influence choice. Amoxicillin–clavulanic acid (co-amoxiclav) seems to produce higher rates of adverse events compared with the other antibiotics we have searched for.

Substantive changes

Cephalosporins or macrolides One Cochrane systematic review updated. New evidence added. Categorisation changed from Likely to be beneficial to Unknown effectiveness.

2011; 2011: 0511.
Published online 2011 December 2.

Corticosteroids (intranasal)

Summary

In radiologically/bacteriologically diagnosed acute sinusitis, corticosteroids (intranasal spray) may reduce symptoms compared with placebo.

Benefits and harms

Corticosteroids versus placebo:

We found one systematic review (search date 2008, 3 RCTs).

Improvement in sinusitis

Compared with placebo Intranasal corticosteroids seem modestly more effective at increasing the proportion of people with improvement or with resolution of symptoms of clinically diagnosed or radiologically or endoscopically confirmed sinusitis (moderate-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Symptom improvement

Systematic review
1130 people
2 RCTs in this analysis
Proportion of people with resolution or improvement of symptoms
402/553 (73%) with mometasone furoate 400 micrograms daily for 15 to 21 days
385/577 (67%) with placebo

RR 1.10
95% CI 1.02 to 1.18
P = 0.0093
Small effect sizemometasone furoate 400 micrograms

Systematic review
1792 people
3 RCTs in this analysis
Proportion of people with resolution or improvement of symptoms
852/1167 (73%) with mometasone 200, 400, or 800 micrograms for 15 to 21 days
415/625 (66%) with placebo

RR 1.11
95% CI 1.04 to 1.18
P = 0.0011
Small effect sizemometasone furoate

Systematic review
590 people
2 RCTs in this analysis
Proportion of people with resolution or improvement of symptoms
257/290 (89%) with mometasone furoate 200 micrograms daily for 15 to 21 days
255/300 (85%) with placebo

RR 1.04
95% CI 0.98 to 1.11
P = 0.19
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

Systematic review
1130 people
2 RCTs in this analysis
Proportion of people who withdrew owing to adverse effects
56/553 (10%) with mometasone 400 micrograms
68/577 (12%) with placebo

RR 0.86
95% CI 0.61 to 1.20
P = 0.37
Not significant

Systematic review
590 people
2 RCTs in this analysis
Proportion of people who withdrew owing to adverse effects
26/290 (9%) with mometasone 200 micrograms
36/300 (12%) with placebo

RR 0.75
95% CI 0.46 to 1.21
P = 0.23
Not significant

Systematic review
1792 people
3 RCTs in this analysis
Proportion of people who withdrew owing to adverse effects
114/1167 (10%) with mometasone 200, 400, or 800 micrograms
71/625 (11%) with placebo

RR 0.85
95% CI 0.64 to 1.12
P = 0.24
Not significant

Further information on studies

None.

Comment

None.

Substantive changes

Corticosteroids (intranasal) (in addition to oral antibiotics) for radiologically or bacteriologically confirmed acute sinusitis One Cochrane systematic review updated. New evidence added. Categorisation unchanged (Likely to be beneficial).

2011; 2011: 0511.
Published online 2011 December 2.

Amoxicillin or amoxicillin–clavulanic acid (co-amoxiclav)

Summary

Amoxicillin is no more effective than placebo at reducing treatment failure rates, and it is associated with gastrointestinal adverse effects.

Benefits and harms

Amoxicillin versus placebo:

We found two systematic reviews (search date 1998, number of relevant RCTs not reported, 761 adults with acute uncomplicated sinusitis; and search date 2010, 3 RCTs). The first review did not report separately on amoxicillin compared with placebo. As the second review did not report extensive meta-analyses of adverse effects, we report some harms data from individual RCTs.

Improvement in sinusitis

Compared with placebo Amoxicillin is no more effective at reducing treatment failure at 7 to 15 days in people with acute uncomplicated sinusitis (high-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

Systematic review
206 adults with acute sinusitis
Data from 1 RCT
Proportion of people failing treatment 7 to 15 days
18/105 (17%) with amoxicillin
23/101 (23%) with placebo

RR 0.75
95% CI 0.43 to 1.31
Not significant

Systematic review
116 adults with acute sinusitis
Data from 1 RCT
Proportion of people failing treatment 7 to 15 days
24/56 (43%) with amoxicillin
35/60 (58%) with placebo

RR 0.73
95% CI 0.51 to 1.06
Not significant

No data from the following reference on this outcome.

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
Adults with acute sinusitis
In review
Diarrhoea
47% with amoxicillin
11% with placebo
Absolute numbers not reported

P = 0.001
Effect size not calculatedplacebo

RCT
Adults with acute sinusitis
In review
All adverse effects
28% with amoxicillin
9% with placebo
Absolute numbers not reported

P <0.001
Effect size not calculatedplacebo

No data from the following reference on this outcome.

Amoxicillin–clavulanic acid (co-amoxiclav) versus placebo:

We found two systematic reviews (search date 1998, number of relevant RCTs not reported, 761 adults with acute uncomplicated sinusitis; and search date 2010). The first review did not report separately on the effects of amoxicillin–clavulanic acid compared with placebo. The second review found no RCTs.

Amoxicillin or amoxicillin–clavulanic acid (co-amoxiclav) versus cephalosporins or macrolides:

See option on cephalosporins and macrolides.

Amoxicillin or amoxicillin–clavulanic acid (co-amoxiclav) versus doxycycline:

We found no RCTs.

Further information on studies

None.

Comment

One of the RCTs that compared amoxicillin with placebo was a three-armed trial, which also examined the effects of penicillin. We have not reported results in the penicillin group.

Substantive changes

Amoxicillin or amoxicillin–clavulanic acid (co-amoxiclav) One Cochrane systematic review updated. New evidence added. Categorisation changed from Trade-off between benefits and harms to Unlikely to be beneficial.

2011; 2011: 0511.
Published online 2011 December 2.

Antihistamines

Summary

We found no direct information from RCTs about antihistamines in the treatment of people with radiologically or bacteriologically confirmed acute sinusitis.

Benefits and harms

Antihistamines:

We found no systematic review or RCTs.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Decongestants (xylometazoline, phenylephrine, pseudoephedrine)

Summary

We found no direct information from RCTs about decongestants (xylometazoline, phenylephrine, pseudoephedrine) in the treatment of people with radiologically or bacteriologically confirmed acute sinusitis.

Benefits and harms

Decongestants:

We found no systematic review or RCTs.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Different dosages of antibiotics (amoxicillin, amoxicillin–clavulanic acid [co-amoxiclav], doxycycline, cephalosporins, macrolides)

Summary

We found insufficient evidence to draw conclusions on which is the most effective dosage regimen for antibiotics.

Benefits and harms

Amoxicillin, amoxicillin–clavulanic acid [co-amoxiclav], and doxycycline:

We found no RCTs comparing different daily dosing regimens of the same antibiotic.

Different doses of cephalosporins versus each other:

We found one RCT.

Improvement in sinusitis

Different doses of cephalosporins compared with each other Two and three daily doses of cefaclor are equally effective at 14 days at improving clinical resolution rates in people with confirmed acute sinusitis (high-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

RCT
298 people with confirmed acute sinusitis Clinical resolution rate 14 days
96% with cefaclor 500 mg 3 times daily
97% with cefaclor 750 mg twice daily
Absolute numbers not reported

P = 0.333
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
298 people with confirmed acute sinusitis Adverse effects
32% with cefaclor 500 mg 3 times daily
25% with cefaclor 750 mg twice daily
Absolute numbers not reported

P = 0.162
Not significant

Different doses of macrolides versus each other:

We found one RCT.

Improvement in sinusitis

Once-daily extended-release clarithromycin compared with twice-daily immediate-release clarithromycin Once-daily extended-release clarithromycin and twice-daily immediate-release clarithromycin may be equally effective at 10 to 17 days at increasing clinical cure rates in people with radiologically confirmed acute sinusitis (low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

RCT
283 people, setting not clearly reported, diagnosis confirmed radiologically Clinical cure rates 10 to 17 days after completion of treatment
97/123 (79%) with immediate-release clarithromycin (500 mg tablet twice daily) for 14 days
104/122 (85%) with extended-release clarithromycin (2 x 500 mg tablets once daily) for 14 days

Reported as not significant
P value not reported
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
283 people, setting not clearly reported, diagnosis confirmed radiologically Adverse effects
40/141 (28%) with immediate-release clarithromycin (500 mg tablet twice daily) for 14 days
45/142 (32%) with extended-release clarithromycin (2 x 500 mg tablets once daily) for 14 days

P = 0.6
Not significant

RCT
283 people, setting not clearly reported, diagnosis confirmed radiologically Withdrawal because of gastrointestinal symptoms or abnormal taste
10/141 (7%) with immediate-release clarithromycin (500 mg tablet twice daily) for 14 days
2/142 (1%) with extended-release clarithromycin (2 x 500 mg tablets once daily) for 14 days

P = 0.02
Effect size not calculatedextended-release clarithromycin

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Doxycycline

Summary

We found insufficient evidence to judge the efficacy of doxycycline.

Benefits and harms

Doxycycline versus placebo:

We found one systematic review (search date 2001), which identified no RCTs. We found one additional RCT.

Improvement in sinusitis

Compared with placebo Doxycycline may be no more effective at 2 weeks at increasing recovery rates of sinuses in people with radiologically or bacteriologically confirmed acute sinusitis (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rate

RCT
61 people with acute maxillary sinusitis, 15 people with bilateral sinusitis, 76 sinuses in total, diagnosis confirmed by bacteriological/radiological findings Recovery rate 2 weeks
24/32 (75%) of sinuses with doxycycline (200 mg on first day followed by 100 mg on subsequent days)
36/44 (82%) of sinuses with placebo

Reported as not significant
P value not reported
RCT has weak methods; see further information on studies for full details
Not significant

Adverse effects

No data from the following reference on this outcome.

Doxycycline versus amoxicillin, amoxicillin–clavulanic acid (co-amoxiclav), cephalosporins, and macrolides:

We found no RCTs.

Further information on studies

The RCT was conducted before 1973. Although the trial stated that a double-blind method was used, the method of randomisation was not described. Recovery rate was defined with respect to clinical picture, sinus irrigation findings, and ostium function.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Saline nasal washes

Summary

We found no direct information from RCTs about saline nasal washes in the treatment of people with radiologically or bacteriologically confirmed acute sinusitis.

Benefits and harms

Saline nasal washes:

We found one systematic review (search date 2009) of saline douches with acute upper respiratory tract infections, a subgroup of whom had acute rhinosinusitis. However, as the review did not perform a subgroup analysis, we cannot draw conclusions on the effectiveness of saline douches in people with acute sinusitis.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Steam inhalation

Summary

We found no direct information from RCTs about steam inhalation in the treatment of people with radiologically or bacteriologically confirmed acute sinusitis.

Benefits and harms

Steam inhalation:

We found no systematic review or RCTs.

Further information on studies

None.

Comment

None.

Substantive changes

No new evidence

2011; 2011: 0511.
Published online 2011 December 2.

Long-course antibiotic regimens (amoxicillin, amoxicillin–clavulanic acid [co-amoxiclav], doxycycline, cephalosporins, macrolides)

Summary

Long-term antibiotic regimens (6- to 10-day courses) do not seem any more effective than short-term treatments (3- to 5-day courses), but they do seem associated with more adverse effects.

Benefits and harms

Long-course versus short-course macrolides:

We found three RCTs that compared longer versus shorter courses of azithromycin or telithromycin.

Improvement in sinusitis

Longer courses of macrolides compared with shorter courses Longer courses (6–10 days) of macrolides may be no more effective than shorter courses (3–5 days) at increasing cure rates in people with radiologically confirmed sinusitis (very low-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

RCT
3-armed trial
936 adults Cure rates
72% with 3 days of azithromycin
74% with 6 days of azithromycin
Absolute numbers not reported

Significance not assessed
RCT not designed to compare directly longer versus shorter courses of antibiotics

RCT
3-armed trial
607 adults with acute maxillary sinusitis at baseline Cure rates
75% with 5 days of telithromycin
73% with 10 days of telithromycin
Absolute numbers not reported

Significance not assessed
RCT not designed to compare directly longer versus shorter courses of antibiotics

RCT
341 adults, diagnosis confirmed radiologically Clinical cure rates 17 to 21 days after starting treatment
138/167 (83%) with 5-day course of telithromycin
147/168 (88%) with 10-day course of telithromycin

Difference –4.9%
95% CI –13.1% to +3.3%
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
3-armed trial
936 adults Adverse effects
31% with 3 days of azithromycin
38% with 6 days of azithromycin
Absolute numbers not reported

Significance not assessed
RCT not designed to compare directly longer versus shorter courses of antibiotics

RCT
3-armed trial
936 adults Diarrhoea
17% with 3 days of azithromycin
21% with 6 days of azithromycin
Absolute numbers not reported

Significance not assessed
RCT not designed to compare directly longer versus shorter courses of antibiotics

RCT
3-armed trial
607 adults with acute maxillary sinusitis at baseline Adverse effects
42% with 5 days of telithromycin
47% with 10 days of telithromycin
Absolute numbers not reported

Significance not assessed
RCT not designed to compare directly longer versus shorter courses of antibiotics

RCT
3-armed trial
607 adults with acute maxillary sinusitis at baseline Diarrhoea
19% with 5 days of telithromycin
21% with 10 days of telithromycin
Absolute numbers not reported

Significance not assessed
RCT not designed to compare directly longer versus shorter courses of antibiotics

RCT
341 adults, diagnosis confirmed radiologically Adverse effects
with 5-day course of telithromycin
with 10-day course of telithromycin

Long-course versus short-course cephalosporins:

We found one RCT.

Improvement in sinusitis

Longer courses of cephalosporins compared with shorter courses Longer courses (10 days) and shorter courses (5 days) of cephalosporins seem equally effective at increasing clinical resolution rates in people with confirmed sinusitis (moderate-quality evidence).

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Cure rates

RCT
401 people with confirmed sinusitis Clinical resolution rates 11 to 18 days after treatment
73% with 10-day course of cefuroxime
74% with 5-day course of cefuroxime

ARR with shorter course +1.0%
90% CI –7.5% to +8.5%
Not significant

Adverse effects

Ref (type)PopulationOutcome, InterventionsResults and statistical analysisEffect sizeFavours
Adverse effects

RCT
401 people with confirmed sinusitis Adverse effects
12% with 10-day course of cefuroxime
6% with 5-day course of cefuroxime
Absolute numbers not reported

Significance not assessed

Further information on studies

The high exclusion rate of the RCT was the result of major protocol violations (insufficient duration of treatment, incorrect diagnosis, or missing data). However, exclusion rates were similar among treatment groups (65/202 [32%] with amoxicillin–clavulanic acid [co-amoxiclav] v 55/201 [27%] with 5 days of telithromycin v 64/204 [31%] with 10 days of telithromycin).

Comment

Drug safety alert:

The FDA has withdrawn the acute sinusitis indication for telithromycin, as the risks:benefits ratio is no longer favourable (www.fda.gov/medwatch).

Clinical guide:

From available RCT evidence comparing short with longer courses of the antibiotics we searched for, there seems to be no difference in outcome in cure rate for acute sinusitis confirmed radiologically or bacteriologically.

Substantive changes

No new evidence


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