Does Amoxicillin Improve Outcomes in Patients with Purulent Rhinorrhea?

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Original Research

Does Amoxicillin Improve Outcomes in Patients with Purulent Rhinorrhea?

J Fam Pract. 2002 April;51(4):317-323

By

An I. De Sutter, MD

A Pragmatic Randomized Double-Blind Controlled Trial in Family Practice

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References

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ABSTRACT

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.

POPULATION: The 416 patients included from 69 family practices were 12 years or older, presenting with acute upper respiratory complaints, and having a history of purulent rhinorrhea and no signs of complications of sinusitis.

OUTCOMES MEASURED: Therapy success (disappearance of symptoms that most greatly affected the patient’s health) at day 10 and duration of general illness, pain, and purulent rhinorrhea.

RESULTS: Therapy was successful in 35% of patients with amoxicillin and in 29% of patients with placebo (relative risk [RR] 1.14, 95% confidence interval [CI], 0.92-1.42). There was no effect on duration of general illness or pain. Duration of purulent rhinorrhea 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 POINTS FOR CLINICIANS

In patients with an acute upper respiratory tract infection that includes purulent rhinorrhea, treatment 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 appropriate follow-up is safe.
Patients with purulent rhinorrhea caused by an acute infection of the nose or sinuses can initially be treated with symptomatic therapy, whatever the suspected diagnosis, and instructed to return if symptoms worsen.

Infections of the nasal passages are very common¹ and among the most frequent reasons for the prescription of antibiotics.^2,3 Such infections comprise diagnoses that include upper respiratory tract infection (URTI), rhinitis, rhinopharyngitis, and rhinosinusitis, which are very difficult to distinguish because of the lack of specific clinical features or simple office-based diagnostic tests.^4-7 These diagnostic 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 identify. Three meta-analyses^8-10 on the effect of antibiotics in rhinosinusitis and 5 of 6 recent trials investigating the effect of antibiotics in rhinosinusitis,^11-13 rhinitis, ¹⁴ and bacterial rhinopharyngitis¹⁵ almost exclusively studied patients with a diagnosis established by laboratory or imaging investigation. As a result, implementing the findings is difficult in daily practice, where radiologic or laboratory tests are not obtained for most patients with respiratory infections. Only 1 of the 6 trials¹⁶ included patients with a set of clinical symptoms indicating rhinosinusitis. Because inclusion criteria were rather stringent, however, findings are applicable only to a small group of patients.

The purpose of this trial was to investigate the benefits of antibiotic therapy in a larger group of patients with nose or sinus infections, thereby making the results more widely applicable. Accordingly, we conducted a randomized, double-blind, placebo-controlled trial comparing the effect of amoxicillin with that of placebo in family practice patients with an acute upper respiratory tract infection and presenting with purulent rhinorrhea. Purulent rhinorrhea was chosen as the minimal criterion because it is the symptom most consistently associated with rhinosinusitis in diagnostic studies^5,17-21 and because its presence often leads family physicians (FPs) to prescribe antibiotics.^23-26 The trial was designed as a pragmatic effectiveness trial. Patient inclusion and evaluation were defined on a purely clinical basis to maximize relevance for routine daily practice.

Methods

Study population

Between October 1998 and December 1999, 69 FPs in Flanders, Belgium, agreed to enroll patients meeting the following inclusion criteria: age 12 years or older, presenting with a respiratory tract infection, and having purulent rhinorrhea. Exclusion criteria were allergy to penicillin or ampicillin; having received antibiotic therapy within the previous week; complaints lasting for more than 30 days; abnormality on clinical chest examination; complications of sinusitis (facial edema or cellulitis; orbital, visual, meningeal, or cerebral signs)²⁷; pregnancy or lactation; comorbidity that might impair immune competence; and inability to follow the protocol because of language or mental problems. The Ethics Committee of the Ghent University Hospital (GUH) approved the study. All patients (or their guardians, for those younger than 16 years of age) gave written informed consent.