Amoxicillin for Acute Rhinosinusitis: A Randomized Controlled Trial | Clinical Pharmacy and Pharmacology | JAMA | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
Hickner JM, Bartlett JG, Besser RE, Gonzales R, Hoffman JR, Sande MA.American Academy of Family Physicians; American College of Physicians-American Society of Internal Mediciine; Centers for Disease Control; Infectious Diseases Society of America.  Principles of appropriate antibiotic use for acute rhinosinusitis in adults: background.  Ann Intern Med. 2001;134(6):498-50511255528PubMedGoogle ScholarCrossref
Agency for Healthcare Research and Quality.  Diagnosis and treatment of community-acquired acute bacterial rhinosinusitis: AHCPR evidence report 1998. Accessibility verified January 13, 2012
Hughes JM. Preserving the lifesaving power of antimicrobial agents.  JAMA. 2011;305(10):1027-102821343545PubMedGoogle ScholarCrossref
Axelsson A, Chidekel N, Grebelius N, Jensen C. Treatment of acute maxillary sinusitis: a comparison of four different methods.  Acta Otolaryngol. 1970;70(1):71-764989705PubMedGoogle ScholarCrossref
Lindbaek M, Hjortdahl P, Johnsen UL. Randomised, double blind, placebo controlled trial of penicillin V and amoxycillin in treatment of acute sinus infections in adults.  BMJ. 1996;313(7053):325-3298760738PubMedGoogle ScholarCrossref
van Buchem FL, Knottnerus JA, Schrijnemaekers VJ, Peeters MF. Primary-care-based randomised placebo-controlled trial of antibiotic treatment in acute maxillary sinusitis.  Lancet. 1997;349(9053):683-6879078199PubMedGoogle ScholarCrossref
Wald ER, Chiponis D, Ledesma-Medina J. Comparative effectiveness of amoxicillin and amoxicillin-clavulanate potassium in acute paranasal sinus infections in children: a double-blind, placebo-controlled trial.  Pediatrics. 1986;77(6):795-8003520469PubMedGoogle Scholar
Falagas ME, Giannopoulou KP, Vardakas KZ, Dimopoulos G, Karageorgopoulos DE. Comparison of antibiotics with placebo for treatment of acute sinusitis: a meta-analysis of randomised controlled trials.  Lancet Infect Dis. 2008;8(9):543-55218718440PubMedGoogle ScholarCrossref
de Ferranti SD, Ioannidis JP, Lau J, Anninger WV, Barza M. Are amoxycillin and folate inhibitors as effective as other antibiotics for acute sinusitis? a meta-analysis.  BMJ. 1998;317(7159):632-6379727991PubMedGoogle ScholarCrossref
Garbutt JM, Goldstein M, Gellman E, Shannon W, Littenberg B. A randomized, placebo-controlled trial of antimicrobial treatment for children with clinically diagnosed acute sinusitis.  Pediatrics. 2001;107(4):619-62511335733PubMedGoogle ScholarCrossref
Merenstein D, Whittaker C, Chadwell T, Wegner B, D’Amico F. Are antibiotics beneficial for patients with sinusitis complaints? a randomized double-blind clinical trial.  J Fam Pract. 2005;54(2):144-15115689289PubMedGoogle Scholar
Williamson IG, Rumsby K, Benge S,  et al.  Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial.  JAMA. 2007;298(21):2487-249618056902PubMedGoogle ScholarCrossref
Ahovuo-Saloranta A, Borisenko OV, Kovanen N,  et al.  Antibiotics for acute maxillary sinusitis.  Cochrane Database Syst Rev. 2008;(2):CD00024318425861PubMedGoogle Scholar
Gill JM, Fleischut P, Haas S, Pellini B, Crawford A, Nash DB. Use of antibiotics for adult upper respiratory infections in outpatient settings: a national ambulatory network study.  Fam Med. 2006;38(5):349-35416673197PubMedGoogle Scholar
Rosenfeld RM, Andes D, Bhattacharyya N,  et al.  Clinical practice guideline: adult sinusitis.  Otolaryngol Head Neck Surg. 2007;137(3):(suppl)  S1-S3117761281PubMedGoogle ScholarCrossref
Anderson ER, Murphy MP, Weymuller EA Jr. Clinimetric evaluation of the Sinonasal Outcome Test-16: Student Research Award 1998.  Otolaryngol Head Neck Surg. 1999;121(6):702-70710580223PubMedGoogle ScholarCrossref
Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20).  Otolaryngol Head Neck Surg. 2002;126(1):41-4711821764PubMedGoogle ScholarCrossref
Garbutt J, Spitznagel E, Piccirillo J. Use of the modified SNOT-16 in primary care patients with clinically diagnosed acute rhinosinusitis.  Arch Otolaryngol Head Neck Surg. 2011;137(8):792-79721844413PubMedGoogle ScholarCrossref
Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific quality of life questionnaire.  J Clin Epidemiol. 1994;47(1):81-878283197PubMedGoogle ScholarCrossref
Tan T, Little P, Stokes T.Guideline Development Group.  Antibiotic prescribing for self limiting respiratory tract infections in primary care: summary of NICE guidance.  BMJ. 2008;337:a43718650239PubMedGoogle ScholarCrossref
Stalman W, van Essen GA, van der Graaf Y, de Melker RA. The end of antibiotic treatment in adults with acute sinusitis-like complaints in general practice? a placebo-controlled double-blind randomized doxycycline trial.  Br J Gen Pract. 1997;47(425):794-7999463979PubMedGoogle Scholar
Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D, Holman H. Capturing the patient's view of change as a clinical outcome measure.  JAMA. 1999;282(12):1157-116210501119PubMedGoogle ScholarCrossref
Aseltine RH Jr, Carlson KJ, Fowler FJ Jr, Barry MJ. Comparing prospective and retrospective measures of treatment outcomes.  Med Care. 1995;33(4):(suppl)  AS67-AS767536868PubMedGoogle Scholar
Garbutt J, Rosenbloom I, Wu J, Storch GA. Empiric first-line antibiotic treatment of acute otitis in the era of the heptavalent pneumococcal conjugate vaccine.  Pediatrics. 2006;117(6):e1087-e109416740811PubMedGoogle ScholarCrossref
Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpreting treatment effects in randomised trials.  BMJ. 1998;316(7132):690-6939522799PubMedGoogle ScholarCrossref
Juniper EF. Quality of life questionnaires: does statistically significant = clinically important?  J Allergy Clin Immunol. 1998;102(1):16-179679842PubMedGoogle ScholarCrossref
Martin CL, Njike VY, Katz DL. Back-up antibiotic prescriptions could reduce unnecessary antibiotic use in rhinosinusitis.  J Clin Epidemiol. 2004;57(4):429-43415135847PubMedGoogle ScholarCrossref
Cals JW, Schot MJ, de Jong SA, Dinant GJ, Hopstaken RM. Point-of-care C-reactive protein testing and antibiotic prescribing for respiratory tract infections: a randomized controlled trial.  Ann Fam Med. 2010;8(2):124-13320212299PubMedGoogle ScholarCrossref
Zalmanovici A, Yaphe J. Steroids for acute sinusitis.  Cochrane Database Syst Rev. 2007;(2):CD00514917443574PubMedGoogle Scholar
Dolor RJ, Witsell DL, Hellkamp AS, Williams JW Jr, Califf RM, Simel DL.Ceftin and Flonase for Sinusitis (CAFFS) Investigators.  Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis: the CAFFS Trial: a randomized controlled trial.  JAMA. 2001;286(24):3097-310511754675PubMedGoogle ScholarCrossref
Kassel JC, King D, Spurling GK. Saline nasal irrigation for acute upper respiratory tract infections.  Cochrane Database Syst Rev. 2010;(3):CD00682120238351PubMedGoogle Scholar
Original Contribution
February 15, 2012

Amoxicillin for Acute Rhinosinusitis: A Randomized Controlled Trial

Author Affiliations

Author Affiliations: Division of General Medical Sciences (Dr Garbutt), Departments of Medicine (Dr Garbutt), Pediatrics (Drs Garbutt and Ms Banister), Mathematics (Dr Spitznagel), and Otolaryngology-Head and Neck Surgery (Dr Piccirillo), Washington University School of Medicine, St Louis, Missouri.

JAMA. 2012;307(7):685-692. doi:10.1001/jama.2012.138

Context Evidence to support antibiotic treatment for acute rhinosinusitis is limited, yet antibiotics are commonly used.

Objective To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with clinically diagnosed acute rhinosinusitis.

Design, Setting, and Participants A randomized, placebo-controlled trial of adults with uncomplicated, acute rhinosinusitis were recruited from 10 community practices in Missouri between November 1, 2006, and May 1, 2009.

Interventions Ten-day course of either amoxicillin (1500 mg/d) or placebo administered in 3 doses per day. All patients received a 5- to 7-day supply of symptomatic treatments for pain, fever, cough, and nasal congestion to use as needed.

Main Outcome Measures The primary outcome was improvement in disease-specific quality of life after 3 to 4 days of treatment assessed with the Sinonasal Outcome Test-16 (minimally important difference of 0.5 units on a 0-3 scale). Secondary outcomes included the patient's retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, and satisfaction with and adverse effects of treatment. Outcomes were assessed by telephone interview at days 3, 7, 10, and 28.

Results A total of 166 adults (36% male; 78% with white race) were randomized to amoxicillin (n = 85) or placebo (n = 81); 92% concurrently used 1 or more symptomatic treatments (94% for amoxicillin group vs 90% for control group; P = .34). The mean change in Sinonasal Outcome Test-16 scores was not significantly different between groups on day 3 (decrease of 0.59 in the amoxicillin group and 0.54 in the control group; mean difference between groups of 0.03 [95% CI, −0.12 to 0.19]) and on day 10 (mean difference between groups of 0.01 [95% CI, −0.13 to 0.15]), but differed at day 7 favoring amoxicillin (mean difference between groups of 0.19 [95% CI, 0.024 to 0.35]). There was no statistically significant difference in reported symptom improvement at day 3 (37% for amoxicillin group vs 34% for control group; P = .67) or at day 10 (78% vs 80%, respectively; P = .71), whereas at day 7 more participants treated with amoxicillin reported symptom improvement (74% vs 56%, respectively; P = .02). No between-group differences were found for any other secondary outcomes. No serious adverse events occurred.

Conclusion Among patients with acute rhinosinusitis, a 10-day course of amoxicillin compared with placebo did not reduce symptoms at day 3 of treatment.

Trial Registration Identifier: NCT00377403