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).
| Important outcomes | Improvement in sinusitis | ||||||||
| 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) | Improvement in sinusitis | Corticosteroids versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for different methods used to assess symptom improvement |
| 2 (416) | Improvement in sinusitis | Amoxicillin versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (284) | Improvement in sinusitis | Doxycycline versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for use of co-intervention |
| 1 (252) | Improvement in sinusitis | Amoxicillin–clavulanic acid (co-amoxiclav) versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (1018) | Improvement in sinusitis | Different treatment durations of cephalosporins versus each other | 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? | |||||||||
| 7 (1083) | Improvement in sinusitis | Cephalosporins or macrolides versus amoxicillin | 4 | 0 | 0 | 0 | 0 | High | |
| 17 (at least 1887) | Improvement in sinusitis | Macrolides or cephalosporins versus amoxicillin–clavulanic acid (co-amoxiclav) | 4 | 0 | 0 | 0 | 0 | High | |
| 3 (804) | Improvement in sinusitis | Macrolides versus cephalosporins | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for inclusion of improvement in outcome measured |
| 3 (1792) | Improvement in sinusitis | Corticosteroids versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Consistency point deducted for conflicting results but added back for dose–response effect. Directness point deducted for inclusion of people with clinically diagnosed sinusitis |
| 1 (322) | Improvement in sinusitis | Amoxicillin versus placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (298) | Improvement in sinusitis | Different doses of cephalosporins versus each other | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (283) | Improvement in sinusitis | Different doses of macrolides versus each other | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for no intention-to-treat analysis and incomplete reporting of results |
| 1 (76) | Improvement in sinusitis | Doxycycline versus placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and not stating method of randomisation |
| 3 (1694) | Improvement in sinusitis | Long-course versus short-course 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) | Improvement in sinusitis | Long-course versus short-course cephalosporins | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.
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.
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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