Intranasal Corticosteroids in Management of Acute Sinusitis: A Systematic Review and Meta-Analysis

Gail Hayward; Carl Heneghan; Rafael Perera; Matthew Thompson

doi:10.1370/afm.1338

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Figure 1
Flow diagram of search results.
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Figure 2
Effect of intranasal steroids on resolution of symptoms of acute sinusitis at (A) 14 to 15 days and (B) 21 days.

INCS=intranasal steroid.
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Figure 3
Dose-response relationship of mometasone furoate and likelihood of symptom resolution.

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Table 1

Characteristics of Trials Included in the Meta-Analysis

Study (Year and Location)	Age Range (Mean), y	No. Analyzed		Criteria for Sinusitis; Duration of Symptoms at Entry	Treatment		Other Medications Used	Analgesia	Outcomes and Definition of Symptom Resolution

		Intervention	Control		Intervention^a	Control
Williamson et al¹⁴ (2007; United Kingdom, general practice)	≥16 (42.5)	102^a	105^b	2 of following: predominantly unilateral purulent nasal discharge and local pain, bilateral purulent nasal discharge, pus on inspection Median duration of symptoms 7 days (IQR 10)	400 μg budesonide once daily for 10 days	Placebo spray	Amoxicillin 500 mg 3 times a day for 7 days or placebo, factorial design used	Not restricted, not reported	Symptom scores assessed on 7-point scales Time to resolution of symptoms Percent with complete resolution of symptoms up to day 14 Resolution = patient reporting 0 or 1 on 7-point scale for 11 individual symptom scores
Meltzer et al¹⁷ (2005; 14 countries, medical centers)	≥12 (35.3)	478	252	Symptoms score ≥5/15 (scores of 0 = none to 3 = severe for facial pain, nasal congestion, headache, rhinorrhea, and postnasal drip) Clinical signs/symptoms for >7 days but <28 days	2 arms:^c,^d MFNS 200 μg twice daily or MFNS 200 μg once in the morning with placebo spray in the evening Each given for 15 days	Placebo spray	Separate study arm received amoxicillin	Prohibited	Major symptom score = sum of individual symptom scores over days 2-15 of treatment Time to onset of MSS being statistically different from placebo Global response to treatment at day 15 Adverse events Recurrence Resolution = absence of failure of treatment
Nayak et al¹⁸ (2002; United States, 61 treatment centers)	≥12 (39.1)	642	325	Coronal CT evidence of sinusitis Total symptom score of ≥6/18 (scores of 0 = none to 3 = severe for facial pain, nasal congestion, headache, rhinorrhea, cough, and postnasal drip) No information on duration given	2 arms:^c MFNS 200 μg twice daily or MFNS 400 μg twice daily Each given for 21 days	Placebo spray	Amoxicillin–clavulanate potassium 875 mg twice daily for 21 days	Not specifically commented on; not recorded	Change from baseline in total symptom score CT appearance of sinuses at 21 days Percent of patients with resolution of symptoms Adverse events Resolution = patient reporting complete or marked relief of symptoms
Dolor et al²⁰ (2001; United States, 12 primary care and 10 otorhinolaryngology clinics)	≥18	47	48	History of recurrent sinusitis Clinical criteria: 2/5 of headache; facial pain and pressure; nasal congestion; purulent nasal discharge; and olfactory disturbance; and Water radiographic or endoscopic evidence of sinusitis No information on duration given	400 μg fluticasone propionate once daily for 21 days	Placebo spray	Cefuroxime axetil 250 mg twice daily for 10 days 2 puffs of xylometazoline hydrochloride in each nostril 10 min before the study nasal spray for the first 3 days	Allowed, unregulated	Overall symptom score Percent of patients with resolution of symptoms Work attendance Work performance Quality of life (SNOT-20 score) Adverse events Recurrences Additional attendances Resolution = patient report of symptoms much improved or resolved
Meltzer et al²¹ (2000; United States, 29 medical centers, outpatient)	≥12 (40.4)	200	207	History of sinusitis episodes separated by symptom-free periods Symptom score >6/18 (scores of 0 = none to 3 = severe on facial pain, nasal congestion, headache, rhinorrhea, cough, and postnasal drip) and coronal CT evidence of sinusitis Mean duration of symptoms 13.5 days	MFNS 400 μg twice daily for 21 days	Placebo spray	Co-amoxiclav 875 mg twice daily for 21 days	Paracetamol only; unregulated, unrecorded	Symptom scores assessed on 6-point scale (individual symptoms and total scores) Percent with complete resolution of symptoms at 21 days CT scoring of sinusitis (10-point scale) Adverse events Resolution = patient reporting complete or marked relief of symptoms
Barlan et al¹⁹ (1997; Turkey, pediatric outpatient clinic)	≤15 (6.95)	43	46	Clinical criteria: 2/3 of purulent nasal discharge, purulent pharyngeal drainage, and cough, or 1/3 of the above plus 2 of facial or tooth pain, edema, earache, sore throat, wheeze, headache, fever, and foul breath No information on duration given	100 μg budesonide twice daily for 21 days	Propellant- only spray	Amoxicillin–clavulanate potassium 40 mg/kg daily for 21 days	Not reported	Symptoms scores: median score of cough and nasal discharge for first, second, and third weeks Relapse Resolution (no overall measure reported)

CT = computed tomography; IQR = interquartile range; MFNS = mometasone furoate nasal spray; MSS = mean symptom score; SNOT-20 = 20-item Sino-Nasal Outcome Test.²⁴
↵a Total dose both nostrils.
↵b Factorial design means that each group included patients receiving both active and placebo antibiotics.
↵c Results of the 2 arms were combined for the overall analysis.
↵d A third arm evaluated amoxicillin 500 mg 3 times a day; therefore, these patients also received placebo capsules as a control for amoxicillin.

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Table 2

Methodologic Quality of Included Studies

Study (Year)	Allocation Concealment	Randomization	Comparability of Groups at Baseline	Blinding^a	Provision of Care Apart From the Intervention	Percentage Participation
Williamson et al¹⁴ (2007)	Adequate	Random number table, block randomization	Comparable	Double blind	Equal	86
Meltzer et al¹⁷ (2005)	Adequate	Computer-generated randomization stratified by duration of symptoms at presentation	Comparable	Double blind	Equal	90
Nayak et al¹⁸ (2002)	Adequate: matching placebo used	Randomized, method not reported	Comparable	Double blind	Equal	89
Dolor et al²⁰ (2001)	Adequate	Permuted block randomization scheme stratified by site	Comparable	Double blind	Equal	94
Meltzer et al²¹ (2000)	Adequate: matching placebo used	Randomized, method not reported	Comparable	Double blind	Equal	100
Barlan et al¹⁹ (1997)	Adequate	Randomized, method not reported	Comparable	Double blind	Equal	59

↵a Williamson et al was the only study to specifically describe the method of double blinding.

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Supplemental Appendix

Supplemental Appendix. Mean Individual Symptom Scores Reported for Study and Dosage Arm

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Supplemental data: Appendix - PDF file, 2 pages, 238 KB
The Article in Brief

Gail Hayward, and colleagues

Background Acute sinusitis is often treated with antibiotics, although there is little evidence for their benefit. This analysis of existing research examines the effects of intranasal corticosteroids on acute sinusitis symptoms.

What This Study Found After 14 to 21 days of intranasal corticosteroid use, patients show a small increase in the resolution or improvement of symptoms; the most consistently significant benefits are relief of face pain and congestion. The effect is most marked when patients are given longer durations of treatment (21 days) and higher doses of medication.

Implications

The authors call for additional research comparing intranasal corticosteroids with placebo and without antibiotics to clarify the time-course of clinical benefit and the impact on work and quality of life.