■ OBJECTIVE To compare the efficacy of amoxicillin vs placebo in patients with an acute upper respiratory tract infection and purulent rhinorrhea. ■ STUDY DESIGN Double-blind randomized placebo-controlled trial. ■ POPULA TION The 416 patients included from 69 family practices were 12 years or older, pre- senting with acute upper respiratory complaints, and having a history of purulent rhinorrhea and no signs of complications of sinusitis. ■ OUTCOMES MEASURED Therapy suc- cess (disappearance of symptoms that most greatly affected the patient’s health) at day 10 and duration of general illness, pain, and purulent rhinorrhea. ■ RESUL TS Therapy was successful in 35% of patients with amoxicillin and in 29% of patients with placebo (relative risk [RR] 1.14, 95% confidence inter- val [CI], 0.92-1.42). There was no effect on duration of general illness or pain. Duration of purulent rhin- orrhea was shortened by amoxicillin (9 days vs 14 for clearing of purulent rhinorrhea in 75% of patients; P = .007). Diarrhea was more frequent with amoxicillin (29% vs 19%, RR 1.28, 95% CI, 1.05-1.57). No complications were reported. One patient (0.5%) receiving amoxicillin and 7 (3.4%) receiving placebo discontinued trial therapy because of exacerbation of symptoms (RR 0.25, 95% CI 0.04-1.56, P = .07). All 8 patients recovered with antibiotic therapy. ■ CONCLUSIONS Amoxicillin has a beneficial effect on purulent rhinorrhea caused by an acute infection of the nose or sinuses but not on general recovery. The practical implication is that all such patients, whatever the suspected diagnosis, can be safely treated with symptomatic therapy and instructed to return if symptoms worsen. ■ KEY WORDS Respiratory tract infections; sinusitis; antibiotics; therapeutics; family practice. (J Fam Pract 2002; 51:317-323) I nfections of the nasal passages are very common 1 and among the most frequent reasons for the pre- scription of antibiotics. 2,3 Such infections comprise diagnoses that include upper respiratory tract infec- tion (URTI), rhinitis, rhinopharyngitis, and rhinosi- nusitis, which are very difficult to distinguish because of the lack of specific clinical features or simple office-based diagnostic tests. 4-7 These diag- nostic difficulties probably explain why it remains unclear whether and when antibiotics should be used for such patients in clinical practice. Although evidence shows that a small minority of patients benefit from antibiotic therapy, these patients are extremely difficult to recognize or iden- tify. Three meta-analyses 8-10 on the effect of antibi- otics in rhinosinusitis and 5 of 6 recent trials investi- gating the effect of antibiotics in rhinosinusitis, 11-13 The Journal of Family Practice • APRIL 2002 • VOL. 51, NO. 4 ■ 317 Does Amoxicillin Improve Outcomes in Patients with Purulent Rhinorrhea? A Pragmatic Randomized Double-Blind Controlled Trial in Family Practice AN I. DE SUTTER, MD; MARC J. DE MEYERE, MD, PHD; THIERRY C. CHRISTIAENS, MD; MIEKE L. VAN DRIEL, MD, MSC; WIM PEERSMAN; AND JAN M. DE MAESENEER, MD, PHD Ghent, Belgium ● In patients with an acute upper respiratory tract infection that includes purulent rhinorrhea, treat- ment with amoxicillin has no effect on general recovery and increases the frequency of diarrhea. ● In most patients, symptoms of acute respiratory tract infection last for more than 10 days. ● Treatment without antibiotics and with appropri- ate follow-up is safe. ● Patients with purulent rhinorrhea caused by an acute infection of the nose or sinuses can initial- ly be treated with symptomatic therapy, whatev- er the suspected diagnosis, and instructed to return if symptoms worsen. KEY POINTS FOR CLINICIANS From the Department of General Practice and Primary Health Care (A.I.DeS., M.J.DeM., T.C.C., M.L.v.D., J.M.DeM.) and the Department of Population Studies and Social Sciences Research Methods (W.P.P.), University of Ghent, Belgium. This study was presented at the 28th annual meeting of the North American Primary Care Research Group, Amelia Island, Fla., November 2000, and at the European meeting of the World Organization of National Colleges, Academies, and Academic Associations of General Practitioners/Family Physicians (WONCA), Tampere, Finland, June 2001. Competing interest: This trial was financed by a grant by Eurogenerics NV, Brussels. Reprint requests should be addressed to An De Sutter, MD, Department of General Practice UG.UZG–1K3, De Pintelaan, 185, B 9000 Ghent, Belgium. E-mail: an.desutter@rug.ac.be. ORIGINAL RESEARCH online