Randomized Controlled Trials of Ancillary Therapies for Acute Sinusitis

Author (Year)Age (y)Inclusion CriteriaPrimary TherapyLOTOther TreatmentsNMain OutcomeJadad Score
Barlan et al (1997)171–152 major, or 1 major and 2 minor criteria. Duration >7 d; Major criteria: purulent nasal discharge, purulent pharyngeal drainage, cough; Minor criteria: periorbital edema, facial pain, tooth pain, earache, sore throat, wheeze, headache, foul breath, feverIntranasal budesonide (50 µg each nostril) 2 times/day; Intranasal placebo bid21All received amoxicillin/clavulanate (40 mg/kg per day)43No difference in cough or nasal discharge scores at weeks 1 or 3. Budesonide scores statistically lower (less symptomatic) at week 2 for both outcomes2
Yilmaz et al (2000)186–16Specific symptoms not specifiedIntranasal budesonide (2 × 100 µg)10All received cefaclor (40 mg/kg per day)26Budesonide group statistically better improvement in headache, cough, nasal stuffiness, and nasal drainage at day 101
Duration: infection that could take up to 12 wk to resolveOral pseudoephedrine (2 × 30 mg)1026
McCormick et al (1996)191–188–29 d of sinusitis symptomsOxymetazoline nasal spray (0.05%) plus syrup with decongestant-antihistamine14All children received amoxicillin by age/weight: 10–12 kg, 150 mg tid; 12.1–15 kg, 200 mg tid; >15 kg, 250 mg tid34No difference between groups in mean symptom score at enrollment, day 3, or day 144
Placebo nasal spray and syrup14Teenagers: 40 mg/kg per day (maximum: 500 tid)34
Michel et al (2005)202–6“Definition give[n] by the AAP”Intranasal isotonic Ems mineral salts14No additional treatment (including antibiotics) allowed66aNo difference in symptoms at day 14. Ems group had statistically significant less inflammation at day 72
Intranasal xylometazoline (0.05%)14
Wang et al (2009)213–12(1) URI with purulent nasal discharge and/or cough >7 dStandard therapy plus normal saline nasal irrigation, 15–20 mL per nostril 1–3 times/day21“Standard therapy” defined as systemic antibiotics, mucolytics, and nasal decongestants30Saline group had better scores for daytime rhinorrhea and nighttime nasal congestion. No statistically significant differences in quality of life score, nasal smear, or Water's projection1
(2) Abnormal findings of 1 or both maxillary sinuses by Water’s projectionStandard therapy alone2139
Unuvar et al (2010)223–12(1) 10–30 d of URTI symptomsErdosteine syrup (5–8 mg/kg/day orally divided bid)14None49No significant difference in clinical improvement at 14 d between the 2 groups4
(2) Presence of severe symptoms of rhinosinusitisPlacebo1443
  • bid, 2 times per day; LOT, length of therapy; tid, 3 times per day; URTI, upper respiratory tract infection.

  • a Sixty-six patients in trial; numbers in each treatment arm not specified.