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 | Interventiona | Control | ||||||
| Williamson et al14 (2007; United Kingdom, general practice) | ≥16 (42.5) | 102a | 105b | 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.