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. 2008 Mar 10;2008:0511.

Sinusitis (acute)

Kim Ah-See 1
PMCID: PMC2907938  PMID: 19450327

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 1−5% 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 with radiologically or bacteriologically confirmed acute sinusitis? We searched: Medline, Embase, The Cochrane Library and other important databases up to August 2007 (BMJ 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, co-amoxiclav, doxycycline, cephalosporins, macrolides, different doses [amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides], long-course regimens), antihistamines, cephalosporins or macrolides, decongestants (xylometazoline, phenylephrine, pseudoephedrine), doxycycline, saline nasal washes, steam inhalation, and topical corticosteroids (intra-nasal).

Key Points

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 1−5% of the adult population each year in Europe.

In clinically, and in radiologically/bacteriologically diagnosed, acute sinusitis, corticosteroids (intra-nasal 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, co-amoxiclav (amoxicillin-clavulanate), or doxycycline over placebo in terms of clinical cure rate.

In people with acute sinusitis that has been radiologically or bacteriologically confirmed as caused by a bacterial infection, antibiotics seem to be effective.

  • Amoxicillin and co-amoxiclav improve early clinical cure rates, but are associated with adverse gastrointestinal effects.

  • Cephalosporins and macrolides also seem as effective as amoxicillin, and with fewer adverse effects.

  • We found insufficient evidence to judge the efficacy of doxycycline.

  • Long-term antibiotic regimens (6−10-day courses) do not seem any more effective than short-term treatments (3−5-day courses), but 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: Since the last update of this review, the acute sinusitis indication for telithromycin has been withdrawn by the FDA as the risks benefits ratio is no longer favourable (12 February 2007).

We found no 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 less than 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 more than 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 1-5% 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

Symptom scores; time to self-reported symptom resolution; time to clinical resolution (defined by examiner). 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

BMJ Clinical Evidence search August 2007. The following databases were used to identify studies for this systematic review: Medline 1966 to August 2007, Embase 1980 to August 2007, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2007, Issue 3. Additional searches were carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) — for Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA), Turning Research into Practice (TRIP), and NICE. 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 author for additional assessment, using pre-determined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews and RCTs in any language, at least single blinded, and containing more than 20 individuals of whom more than 80% were followed up. There was a minimum of one week follow-up required to include studies. We excluded all studies described as "open", "open label", or not blinded unless blinding was impossible. In addition we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table ).

Table.

GRADE evaluation of interventions for sinusitis (acute)

Important outcomes Symptom improvement, cure rates, time to return to normal activities, adverse effects
Number of studies (participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of treatments in people with clinically diagnosed acute sinusitis?
1 (730) Symptom improvement Corticosteroids (intra-nasal) v placebo 4 0 0 –1 0 Moderate Directness point deducted for different methods used to assess symptom improvement
1 (416) Cure rates Amoxicillin v placebo 4 0 0 0 0 High
1 (192) Cure rates Doxycycline v placebo 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (252) Time to return to normal activities Co-amoxiclav v placebo 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results
1 (1018) Cure rates 5-day course of cephalosporin v 10-day course 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results
What are the effects of treatments in people with radiologically or bacteriologically confirmed acute sinusitis?
10 (1590) Cure rates Cephalosporins or macrolides v amoxicillin or co-amoxiclav 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results
12 (5260) Cure rates Macrolides v co-amoxiclav 4 –2 0 0 0 Low Quality points deducted for per-protocol analysis and for incomplete reporting of results
2 (448) Cure rates Macrolides v cephalosporins 4 0 0 0 0 High
1 (356) Cure rates 5-day course of telithromycin v 10-day course ofcefuroxime 4 –1 0 0 0 Moderate Quality point deducted for randomisation flaws
1 (303) Symptom improvement Amoxicillin v placebo 4 0 0 0 0 High
1 (298) Cure rates Different doses of cephalosporins compared with each other 4 0 0 0 0 High
1 (283) Cure rates Once-daily extended-release clarithromycin v twice-daily immediate release 4 –2 0 0 0 Low Quality points deducted for no intention-to-treat analysis and incomplete reporting of results
1 (76) Cure rates Doxycycline v placebo 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and for not stating method of randomisation
2 (1062) Symptom improvement Intranasal corticosteroids v placebo 4 0 0 –1 0 Moderate Consistency point deducted for conflicting results and added for dose–response effect. Directness point deducted for inclusion of people with clinically diagnosed sinusitis
3 (1694) Cure rates Longer v shorter courses of macrolides 4 –2 0 –1 0 Very low Quality points deducted for incomplete reporting of results and for per- protocol analysis. Directness point deducted for no direct comparison between groups
1 (401) Cure rates Longer v shorter courses of cephalosporins 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results
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Type of evidence: 4 = RCT; 2 = Observational; 1 = Non-analytical/expert opinion. Consistency: similarity of results across studies Directness: generalisability of population or outcomes Effect size: based on relative risk or odds ratio

Glossary

High-quality evidence

Further research is very unlikely to change our confidence in the estimate of effect

Hyposmia

Reduced, 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.

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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BMJ Clin Evid. 2008 Mar 10;2008:0511.

Corticosteroids (intra-nasal)

Summary

SYMPTOM IMPROVEMENT Compared with placebo: Intra-nasal mometasone seems to be 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 ).

Benefits

Corticosteroids versus placebo:

We found one systematic review (search date 2006), which identified four 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 the individual RCTs here. The RCT(981 people with clinically diagnosed acute sinusitis in a primary-care setting) identified by the review compared mometasone furoate nasal spray (200 mcg once or twice daily), oral amoxicillin (500 mg 3 times daily), and placebo for 15 days. The systematic review found no significant difference in the proportion of people with resolution or improvement in symptoms between mometasone furoate (at either dose) and placebo, although more people taking mometasone had improved symptoms (442/478 [93%] with 200 or 400 mcg daily v 225/252 [89%] with placebo; RR 1.04, 95% CI 0.99 to 1.09). However, the RCT assessed symptom improvement differently: the primary end point 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. It found significantly lower major-symptom scores with mometasone (200 mcg twice daily) compared with placebo (mean reduction of major-symptom score with mometasone v placebo 0.81, CI not reported; P less than 0.001; absolute numbers not reported).

Harms

Corticosteroids versus placebo:

The RCT identified by the review found that treatment-related adverse events were similar throughout all treatment groups (36% with mometasone furoate twice daily v 35% with mometasone furoate once daily v 38% with placebo; absolute numbers not reported). The most common adverse effects were headache and epistaxis. Fourteen-day follow-up 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

Corticosteroids (intra-nasal) for clinically diagnosed acute sinusitis One systematic review added;categorisation unchanged (Likely to be beneficial).

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Antibiotics (amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides)

Summary

CURE RATES Amoxicillin compared with placebo: Amoxicillin is no more effective at increasing treatment success rates in people with clinically diagnosed acute sinusitis ( high-quality evidence ). Doxycycline compared with placebo: Doxycycline may be no more effective at increasing cure rates at 10 or 42 days in people with acute sinusitis ( low-quality evidence ). Different treatment durations of cephalosporin compared with each other: A 5-day course of cephalosporin is as effective as a 10-day course at increasing cure rates in people with acute sinusitis ( moderate-quality evidence ). TIME TO RETURN TO NORMAL ACTIVITIES Co-amoxiclav compared with placebo: Co-amoxiclav is no more effective at reducing the time to return to normal activities in people with acute sinusitis (moderate-quality evidence).

Benefits

We found no systematic review.

Amoxicillin or doxycycline versus placebo:

We found three RCTs in people with an exclusively clinical diagnosis of acute sinusitis, without reliance on radiological or bacteriological investigations. The first RCT (416 people in a primary-care setting) compared amoxicillin (500 mg 3 times daily) versus placebo for 10 days. It found no significant difference in treatment success at the end of treatment between amoxicillin and placebo (treatment success [defined by absent or mild symptoms]: 59/170 [35%] with amoxicillin v 47/164 [29%] with placebo; RR 1.14, 95% CI 0.92 to 1.42). The second RCT (150 people with clinically diagnosed acute maxillary sinusitis in a primary-care setting) compared three antibiotics (amoxicillin, doxycycline, and penicillin) versus placebo.It found that both amoxicillin and doxycycline increased recovery rates at 2 weeks compared with placebo, but the statistical significance of the individual antibiotics compared with placebo was not reported (recovery assessed by telephone: 18/23 [78%] with amoxicillin v 26/33 [79%] with doxycycline v 39/59 [66%] with placebo; significance not reported). The third RCT (192 people with acute sinusitis in a primary-care setting, clinically diagnosed) compared doxycycline (100 mg once daily) versus placebo for 10 days.Both groups were also given xylometazoline nose drops and steam inhalation. The RCT provided limited evidence suggesting no difference between groups in cure rate at 10 days or at 42 days (10 days: 60% cure in all people overall in trial; 42 days: 90% cure in all people overall in trial; reported as no difference between groups, statistical analysis between groups not provided). It found no significant difference between groups in time to resolution of facial pain (median: 4 days with doxycycline v 5 days with placebo; HR 1.17, 95% CI 0.87 to 1.57) or in time to return to daily activities (median: 5 days with doxycycline v 6 days with placebo; HR 1.31, 95% CI 0.96 to 1.78).

Co-amoxiclav (amoxicillin–clavulanate) versus placebo:

We found one RCT (252 adults recruited from general practices and outpatient clinics). It found no significant difference for time to return to normal activities between 6 days of co-amoxiclav and placebo (HR adjusted for specified variables 0.99, 95% CI 0.68 to 1.45).

Cephalosporins or macrolides versus placebo:

We found no RCTs.

Cephalosporins (5-day v 10-day course):

One RCT (1018 people in a primary-care setting) compared a 5-day versus a 10-day course of cefotiam in people with acute sinusitis (radiology and bacteriology were not required for the diagnosis to be made). The RCT found no significant difference in cure rate between groups (418/489 [85.5%] with 5-day course v 418/490 [85.3%] with 10-day course; P value not reported; reported as not significant).

Antibiotics versus each other:

We found no RCTs.

Harms

Amoxicillin or doxycycline versus placebo:

The first RCT found that diarrhoea was significantly more common with amoxicillin compared with placebo (29% with amoxicillin v 19% with placebo; RR 1.28, CI 1.05 to 1.57). The second RCT did not report adverse effects separately for amoxicillin or doxycycline compared with placebo. The third RCT found that 17/98 [17%] people had adverse effects in the doxycycline group (including nausea, vomiting, abdominal pain, diarrhoea, and rash) compared with 2/94 [2%] people (both nausea) in the placebo group (significance not reported).

Co-amoxiclav versus placebo:

The RCT found that co-amoxiclav significantly increased diarrhoea at 7 days and non-significantly increased diarrhoea at 14 days compared with placebo (7 days: OR 3.89, 95% CI 2.09 to 7.25; 14 days: OR 1.71, 95% CI 0.91 to 3.23).

Cephalosporins or macrolides versus placebo:

We found no RCTs.

Cephalosporin (5-day v 10-day course):

The RCT reported a low rate of overall adverse effects (42/1018 [4%]).

Antibiotics versus each other:

We found no RCTs.

Comment

Clinical guide:

In clinically diagnosed acute sinusitis, there is currently little evidence from RCTs to support the use of amoxicillin, 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

Antibiotics (amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides) Evidence reassessed; recategorised as Unlikely to be beneficial.

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Antihistamines

Summary

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

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Decongestants (xylometazoline, phenylephrine, pseudoephedrine)

Summary

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

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Saline nasal washes

Summary

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

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

Saline nasal washes for clinically diagnosed acute sinusitis New option for which we found no RCTs.

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Steam inhalation

Summary

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

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

Steam inhalation for clinically diagnosed acute sinusitis New option for which we found no RCTs.

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Cephalosporins or macrolides

Summary

CURE RATES Cephalosporins or macrolides compared with amoxicillin: Penicillin-type antibiotics (including amoxicillin) and non-penicillins (cephalosporins or macrolides) seem to be equally effective at improving clinical resolution rates in people with radiologically or bacteriologically confirmed acute maxillary sinusitis ( moderate-quality evidence ). Macrolides compared with co-amoxiclav: Macrolides and co-amoxiclav may be equally effective at improving clinical resolution rates, and cure rates, in people with radiologically or bacteriologically confirmed acute maxillary sinusitis ( low-quality evidence ). Macrolides compared with cephalosporins: Macrolides and cephalosporins seem to be equally effective at increasing cure rates, and at improving clinical resolution rates, in people with radiologically confirmed sinusitis ( high-quality evidence ). 5-day course of macrolides compared with 10-day course of cephalosporins: A 5-day course of telithromycin and a 10-day course of cefuroxime seem to be equally effective at increasing clinical cure rates in people with bacteriologically or radiologically confirmed sinusitis (moderate-quality evidence). ADVERSE EFFECTS Cephalosporins and macrolides are associated with fewer adverse effects compared with amoxicillin or co-amoxiclav. NOTE We found no clinically important results about cephalosporins compared with no active treatment or macrolides.

Benefits

Cephalosporins or macrolides versus placebo:

We found two systematic reviews (search dates 1998 and 2001). 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:

The second systematic review found 10 RCTs (1590 adults), which compared penicillin antibiotics (including amoxicillin) versus cephalosporins, macrolides (clarithromycin, spiramycin, azithromycin, roxithromycin, and erythromycin), or minocycline in people with radiologically or bacteriologically confirmed acute maxillary sinusitis. It found no significant difference in clinical resolution rate between non-penicillins and penicillin antibiotics (OR 0.85, 95% CI 0.70 to 1.08).

Macrolides versus co-amoxiclav (amoxicillin–clavulanate):

The second review (10 RCTs, 3957 adults) and two subsequent RCTs compared co-amoxiclav versus macrolides or cephalosporins. The second systematic review found no significant difference in clinical resolution rate between co-amoxiclav and the other antibiotics (OR 0.90, 95% CI 0.76 to 1.08). The first subsequent RCT (941 adults) found no significant difference in cure rates between co-amoxiclav (500 mg amoxicillin–125 mg clavulanate 3 times daily for 10 days) and azithromycin (500 mg daily for 3 or 6 days) at 28 days (206/288 [71.5%] with co-amoxiclav v 213/298 [71.5%] with 3 days of azithromycin v 218/294 [74%] with 6 days of azithromycin; difference from co-amoxiclav: ARR 0%, 97.5% CI –8.4% to +8.3% for 3 days and ARR +2.6%, 97.5% CI –5.6% to +10.9% for 6 days of azithromycin). The second subsequent RCT (607 adults with acute maxillary sinusitis at baseline, 423 people analysed on a per-protocol basis) found no significant difference in cure rate between co-amoxiclav and telithromycin (800 mg for 5 or 10 days) at 17–24 days' follow-up (102/137 [74.5%] with co-amoxiclav v 110/146 [75.3%] with 5 days of telithromycin v 102/140 [72.9%] with 10 days of telithromycin; difference from co-amoxiclav: ARR +0.8%, 95% CI –9.9% to +11.7% with 5 days and –1.6%, 95% CI –12.7% to +9.5% with 10 days of telithromycin). 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 co-amoxiclav v 55/201 [27%] with 5 days of telithromycin v 64/204 [31%] with 10 days of telithromycin).

Cephalosporins or macrolides versus doxycycline:

We found no systematic review or RCTs.

Macrolides versus cephalosporins:

The second systematic review identified two RCTs, and we found one subsequent RCT.The first included RCT (78 people, diagnosis confirmed radiologically and evaluable for clinical response) found no significant difference between azithromycin (500 mg once daily for 3 days) and cefaclor (250 mg 3 times daily for 10 days) in clinical improvement or resolution of symptoms after 11–15 days (clinical improvement or clinical resolution: 38/41 [93%] with azithromycin v 35/37 [95%] with cefaclor; P = 0.187). The second included RCT (370 people, multicentre design, diagnosis confirmed radiologically) compared 10 days of clarithromycin (250 mg twice daily) versus 10 days of cefuroxime (250 mg twice daily). It found no significant difference between groups in cure rates at 1–3 days after completion of treatment (cured or improved: 172/185 [93%] with clarithromycin v 169/185 [91%] with cefuroxime; difference ARR 2%, 95% CI –8% to +4%). The subsequent RCT (385 people, diagnosis confirmed by bacteriological/radiological findings) compared a 5-day course of telithromycin versus a 10-day course of cefuroxime. People were randomised in a 2:1 ratio. It found no significant difference between groups in clinical cure rate (193/240 [80%] with telithromycin v 84/116 [72%] with cefuroxime; difference in proportions ARR 8%, 95% CI –2.2% to +18.2%). Of 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.

Harms

Cephalosporins or macrolides versus placebo:

We found no RCTs.

Cephalosporins or macrolides versus amoxicillin:

The systematic review found that the risk of stopping treatment because of adverse effects was lower with cephalosporins and macrolides (clarithromycin, spiramycin, azithromycin, roxithromycin, and erythromycin) than with penicillins (withdrawal rate owing to adverse effects: 15/852 [2%] with non-penicillins v 26/822 [3%] with penicillins; OR 0.54, 95% CI 0.29 to 1.00).

Cephalosporins or macrolides versus co-amoxiclav:

The systematic review found that the risk of stopping treatment because of adverse effects was significantly lower with cephalosporins and macrolides than with co-amoxiclav (withdrawal rate owing to adverse effects: 46/2428 [2%] with cephalosporins and macrolides v 104/2343 [4%] with co-amoxiclav; OR 0.44, 95% CI 0.32 to 0.61). The first subsequent RCT found that co-amoxiclav significantly increased adverse effects compared with azithromycin (51% with co-amoxiclav v 31% with 3 days of azithromycin v 38% with 6 days of azithromycin; P value not reported). The most common adverse effect was diarrhoea, which was more frequent with co-amoxiclav (32% with co-amoxiclav v 17% with 3 days of azithromycin v 21% with 6 days of azithromycin; P value not reported). The second subsequent RCT found similar rates of adverse effects between co-amoxiclav and 5 or 10 days of telithromycin (43% with co-amoxiclav v 42% with 5 days of telithromycin v 47% with 10 days of telithromycin; P value not reported). It found no significant difference between treatments for diarrhoea (24% with co-amoxiclav v 19% with 5 days of telithromycin v 21% with 10 days of telithromycin; P value not reported).

Cephalosporins or macrolides versus doxycycline:

We found no RCTs.

Macrolides versus cephalosporins:

The first included RCT comparing azithromycin versus cefaclor found no significant difference in adverse effects between treatments (11% with azithromycin v 10% with cefaclor; P = 0.82). The most common adverse effects were gastrointestinal symptoms (9% with azithromycin v 6% with cefaclor; P value not reported). These figures included people with otitis media, pharyngitis/tonsillitis, and sinusitis: the RCT did not report adverse effects of sinusitis alone. The second included RCT found similar rates of adverse effects between clarithromycin and cefuroxime (about 10% in each group, mainly gastrointestinal in nature; significance not reported).The subsequent RCT comparing telithromycin versus cefuroxime found similar rates of people with one or more severe adverse effects between groups, with nausea and diarrhoea the most common adverse effects reported (at least 1 severe effect: 11/252 [4%] with telithromycin v 4/121 [3%] with cefuroxime; significance not reported).

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).

Comment

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. Co-amoxiclav seems to produce higher rates of adverse events compared with the other antibiotics we have searched for.

Substantive changes

No new evidence

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Corticosteroids (intra-nasal)

Summary

SYMPTOM IMPROVEMENT Compared with placebo: Intra-nasal corticosteroids are more effective at increasing the number of people with an improvement or with resolution of symptoms of clinically diagnosed or radiologically or bacteriologically confirmed sinusitis ( moderate-quality evidence ).

Benefits

We found one systematic review (search date 2006), which identified four 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 the individual RCTs here.The first RCT (967 people) found no significant difference in the proportion of people with resolution or improvement of symptoms between mometasone furoate 400 mcg daily for 21 days and placebo (160/325 [49%] with corticosteroids 400 mcg v 178/318 [56%] with placebo; RR 1.14, 95% CI 0.98 to 1.32). However, the RCT found a significant difference in the proportion of people with resolution or improvement of symptoms between mometasone furoate 200, 400, or 800 mcg for 21 days and placebo (371/642 [58%] with mometasone 200, 400, or 800 mcg v 160/325 [49%] with placebo; RR 1.07, 95% CI 1.03 to 1.24).The second RCT (95 people) found that mometasone furoate 200 mcg daily significantly increased the proportion of people with resolution or improvement of symptoms compared with placebo (39/47 [83%] with mometasone 200 mcg v 30/48 [63%] with placebo; RR 1.33; 95% CI 1.03 to 1.71). The withdrawal rate in the third RCT (89 people) was high (41%), so the review provided no data from it.

Harms

In the first RCT there were similar rates of adverse effects in each group (12% with mometasone 400 mcg v 15% with mometasone 200 mcg v 15% with placebo; significance not assessed). The most common adverse effect considered related to treatment was epistaxis, which occurred equally frequently in each group (5% with mometasone 400 mcg v 6% with mometasone 200 mcg v 6% with placebo; significance not assessed).The second RCT found no significant difference in adverse effects in each group (37% with fluticasone 200 mcg v 20% with placebo; P = 0.07). The third RCT reported that there "were no adverse effects attributed to use of corticosteroids".

Comment

None.

Substantive changes

Corticosteroids (intra-nasal) (in addition to oral antibiotics) for radiologically or bacteriologically confirmed acute sinusitis One systematic review added;categorisation changed from Unknown effectiveness to Likely to be beneficial.

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Amoxicillin or co-amoxiclav

Summary

CURE RATES Amoxicillin compared with placebo: A 7–10-day course of amoxicillin is more effective than placebo at increasing clinical cure rates in people with acute uncomplicated sinusitis, but is associated with more adverse effects, mainly gastrointestinal ( high-quality evidence ). Amoxicillin compared with cephalosporins or macrolides: Penicillin-type antibiotics (including amoxicillin) and non-penicillins (cephalosporins or macrolides) seem equally effective at improving clinical resolution rates in people with radiologically or bacteriologically confirmed acute maxillary sinusitis ( moderate-quality evidence ). Co-amoxiclav compared with macrolides: Co-amoxiclav and macrolides may be equally effective at improving clinical resolution rates, and cure rates, in people with radiologically or bacteriologically confirmed acute maxillary sinusitis ( low-quality evidence ). ADVERSE EFFECTS Cephalosporins and macrolides are associated with fewer adverse effects compared with amoxicillin or co-amoxiclav.

Benefits

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 2001, 2 RCTs, 344 adults with acute sinusitis). The first review did not report separately on amoxicillin compared with placebo. The second review found that 7–10 days of amoxicillin significantly increased complete symptom resolution compared with placebo (clinical cure: 88/153 [58%] with amoxicillin v 58/150 [39%] with placebo; OR 2.24, 95% CI 1.41 to 3.56).

Co-amoxiclav (amoxicillin–clavulanate) versus placebo:

The first review did not report separately on the effects of co-amoxiclav compared with placebo. The second review found no RCTs.

Amoxicillin or co-amoxiclav versus cephalosporins or macrolides:

See benefits of cephalosporins and macrolides.

Amoxicillin or co-amoxiclav versus doxycycline:

We found no RCTs.

Harms

Amoxicillin versus placebo:

Both RCTs included in the second review found that antibiotics significantly increased adverse effects (mainly gastrointestinal) compared with placebo (first RCT; diarrhoea: 47% with amoxicillin v 11% with placebo; P = 0.001; second RCT, all adverse effects: 28% with amoxicillin v 9% with placebo; P less than 0.001).

Amoxicillin or co-amoxiclav versus cephalosporins or macrolides:

See harms of cephalosporins or macrolides.

Comment

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

Substantive changes

No new evidence

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Antihistamines

Summary

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

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Decongestants (xylometazoline, phenylephrine, pseudoephedrine)

Summary

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

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Different dosages of antibiotics (amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides)

Summary

CURE RATES Different doses of cephalosporins compared with each other: Two and three daily doses of cefaclor seem to be equally effective at 14 days at improving clinical resolution rates in people with confirmed acute sinusitis ( high-quality evidence ). Once-daily extended-release clarithromycin compared with twice-daily immediate release: Once-daily extended-release clarithromycin and twice-daily immediate-release clarithromycin may be equally effective at 10–17 days at increasing clinical cure rates in people with radiologically confirmed acute sinusitis ( low-quality evidence ). NOTE We found no direct information about other antibiotics comparing different daily dosage regimens.

Benefits

Amoxicillin, co-amoxiclav (amoxicillin–clavulanate), and doxycycline:

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

Cephalosporins:

One RCT (298 people with confirmed acute sinusitis) compared different daily dose regimens of the same cephalosporin. It found no significant difference in clinical resolution rates at 14 days' follow-up between cefaclor 500 mg three times daily and cefaclor 750 mg twice daily (96% with 500 mg 3 times daily v 97% with 750 mg twice daily; CI not reported; P = 0.333).

Macrolides:

One RCT (283 people, setting not clearly reported, diagnosis confirmed radiologically) compared an extended-release formulation of clarithromycin (2 x 500 mg tablets once daily for 14 days) versus an immediate release formulation (500 mg tablet twice daily for 14 days). It found no significant difference between groups in clinical cure rates 10–17 days after completion of treatment (104/122 [85%] with extended release v 97/123 [79%] with immediate release; reported as not significant, P value not reported). The analysis was not by intention to treat.

Harms

Amoxicillin, co-amoxiclav, and doxycycline:

We found no RCTs.

Cephalosporins:

The RCT found no significant difference in adverse-effect rates between cefaclor 500 mg three times daily and cefaclor 750 mg twice daily (25% with 750 mg twice daily v 32% with 500 mg 3 times daily; CI not reported, P = 0.162).

Macrolides:

The RCT of clarithromycin comparing an extended- versus an immediate-release formulation found no significant difference in adverse-effect rate between groups (40/141 [28%] with immediate release v 45/142 [32%] with extended release; P = 0.6). However, it found that the immediate-release (500 mg tablet twice daily) formulation significantly increased the proportion of people who discontinued treatment because of gastrointestinal symptoms or abnormal taste compared with the extended-release (2 x 500 mg tablets once daily) formulation (withdrawal rate: 10/141 [7%] with immediate release v 2/142 [1%] with extended release; P = 0.02).

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Doxycycline

Summary

CURE RATES Compared with placebo: Doxycyline 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 ). NOTE We found no clinically important results about doxycycline compared with amoxicillin, with or without clavulanate, macrolides, or cephalosporins, in the treatment of people with radiologically or bacteriologically confirmed acute sinusitis.

Benefits

Doxycycline versus placebo:

We found one systematic review (search date 2001), which identified no RCTs. We found one additional RCT (61 people with acute maxillary sinusitis, 15 people with bilateral sinusitis, 76 sinuses in total, diagnosis confirmed by bacteriological/radiological findings), which compared 6 days of doxycycline (200 mg on the first day and 100 mg on subsequent days) versus placebo. Both groups also had irrigation of the maxillary sinus once weekly, and nose drops three times daily. The RCT reported outcomes in terms of sinuses rather than by people. It found no significant difference in recovery rate between groups after 2 weeks (recovered: 24/32 [75%] of sinuses with doxycycline v 36/44 [82%] of sinuses with placebo; reported as not significant, P value not provided). 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.

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

We found no RCTs.

Harms

Doxycycline versus placebo:

The RCT gave no information on adverse effects.

Doxycycline versus amoxicillin, co-amoxiclav, cephalosporins, and macrolides:

We found no RCTs.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Saline nasal washes

Summary

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

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

Saline nasal washes for radiologically or bacteriologically confirmed acute sinusitis New option added for which we found no RCTs.

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Steam inhalation

Summary

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

Benefits

We found no systematic review or RCTs.

Harms

We found no RCTs.

Comment

None.

Substantive changes

Steam inhalation for radiologically or bacteriologically confirmed acute sinusitis New option added for which we found no RCTs.

BMJ Clin Evid. 2008 Mar 10;2008:0511.

Long-course antibiotic regimens (amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides)

Summary

CURE RATES Longer courses of macrolides compared with shorter courses: Longer courses (6–10 days) of macrolides may be more effective than shorter courses (3–5 days) at increasing cure rates in people with radiologically confirmed sinusitis ( very low-quality evidence ). Longer courses of cephalosporins compared with shorter courses: Longer courses (10 days) and shorter courses (5 days) of cephalosporins seem to be equally effective at increasing clinical resolution rates in people with confirmed sinusitis ( moderate-quality evidence ). NOTE Longer and shorter courses of the macrolides azithromycin and telithromycin have been associated with similar rates of adverse effects and diarrhoea. Longer courses of the cephalosporins cefuroxime have been associated with more adverse effects, mainly gastrointestinal, compared with shorter courses.

Benefits

Macrolides:

We found two RCTs that compared longer versus shorter courses of azithromycin or telithromycin. Neither RCT was designed to compare longer versus shorter courses of the same antibiotic directly, but compared the different doses versus control. However, we found a third RCT which compared a 5- and 10-day course of the same antibiotic (telithromycin) directly. The first RCT (936 adults) compared 3 and 6 days of azithromycin versus co-amoxiclav. It found similar cure rates between the shorter compared with longer courses of azithromycin (72% with 3-day course v 74% with 6-day course; P value not reported). The second RCT (607 adults with acute maxillary sinusitis at baseline, 423 people analysed on a per-protocol basis) compared 5 and 10 days of telithromycin versus co-amoxiclav. It found similar cure rates between the shorter compared with longer courses of telithromycin (75% with 5-day course v 73% with 10-day course; P value not reported). The third RCT (341 adults, diagnosis confirmed radiologically) found no significant difference in clinical cure rates between a 5- and 10-day course of telithromycin measured at 17–21 days after starting treatment (138/167 [83%] with 5-day course v 147/168 [88%] with 10-day course; difference –4.9%, 95% CI –13.1% to +3.3%).

Cephalosporins:

One RCT (401 people with confirmed sinusitis) found no significant difference in clinical resolution rates between a 10- and 5-day course of cefuroxime 11–18 days after treatment (73% with 10-day course v 74% with 5-day course; ARR with shorter course +1.0%, 90% CI –7.5% to +8.5%).

Harms

Macrolides:

The RCT comparing 3 and 6 days of azithromycin found similar rates of overall adverse effects (31% with 3-day course v 38% with 6-day course) and diarrhoea (17% with 3 days v 21% with 6 days, P values not reported) between the shorter and longer courses. The RCT comparing 5 and 10 days of telithromycin found similar rates of overall adverse effects (42% with 5-day course v 47% with 10-day course) and diarrhoea (19% with 5 days v 21% with 10 days; P values not reported) between the shorter and longer courses. The third RCT comparing 5 versus 10 days of telithromycin reported that the overall frequency of adverse effects was comparable between groups (further statistical analysis not reported). The most common adverse effects reported in both groups were diarrhoea, nausea, gastrointestinal pain, and vaginal moniliasis.

Cephalosporins:

The RCT found that a larger proportion of people on the 10-day course of cefuroxime reported minor adverse effects, mainly gastrointestinal, compared with the 5-day course (12% with 10-day course v 6% with 5-day course; significance not reported).

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).

Comment

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

Long-course antibiotic regimens: amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides Evidence reassessed; recategorised as Unknown.

Articles from BMJ Clinical Evidence are provided here courtesy of BMJ Publishing Group

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