Elsevier

The Lancet

Volume 349, Issue 9053, 8 March 1997, Pages 683-687
The Lancet

Articles
Primary-care-based randomised placebo-controlled trial of antibiotic treatment in acute maxillary sinusitis

https://doi.org/10.1016/S0140-6736(96)07585-XGet rights and content

Summary

Background

The value of antibiotics in acute rhinosinusitis is uncertain. Although maxillary sinusitis is commonly diagnosed and treated in general practice, no effectiveness studies have been done on unselected primary-care patients. We used a randomised, placebo-controlled design to test the hypothesis that there would be an improvement associated with amoxycillin treatment for acute maxillary sinusitis patients presenting to general practice.

Methods

Adult patients with suspected acute maxillary sinusitis were referred by general practitioners for radiographs of the maxillary sinus. Those with radiographic abnormalities (n=214) were randomly assigned treatment with amoxycillin (750 mg three times daily for 7 days; n=108) or placebo (n=106). Clinical course was assessed after 1 week and 2 weeks, and reported relapses and complications were recorded during the following year.

Findings

After 2 weeks, symptoms had improved substantially or disappeared in 83% of patients in the study group and 77% of patients taking placebo. Amoxycillin did not influence the clinical course of maxillary sinusitis nor the frequency of relapses during the 1-year follow-up. Radiographs had no prognostic value, nor were they an effect modifier. Side-effects were recorded in 28% of patients given amoxycillin and in 9% of those taking placebo (p<0·01). The occurrence of relapses was similar in both groups (21 vs 17%) during the follow-up year.

Interpretation

Antibiotic treatment did not improve the clinical course of acute maxillary sinusitis presenting to general practice. For these patients, an initial radiographic examination is not necessary and initial management can be limited to symptomatic treatment. Whether antibiotics are necessary in more severe cases warrants further study.

Introduction

In the management of patients presenting to general practice with common colds, the question often arises of whether acute maxillary sinusitis is also present. It is widely accepted that acute maxillary sinusitis is a more serious condition than the common cold alone and requires additional treatment with antibiotics. Whether this view is accurate has not been studied in a population representative of primary-care patients.

All published studies about the treament of acute maxillary sinusitis have been done in selected groups of patients who were referred to ear, nose, and throat (ENT) clinics after the discovery of empyema (pus and pathogenic bacteria in the sinus). For such patients, puncture of the sinus is generally thought to be the gold standard for diagnosis. In one study the effectiveness of antibiotic treatment of patients with acute maxillary sinusitis was compared with placebo.1 Antibiotics seemed to accelerate resolution of abnormalities seen on the radiograph, but the differences between antibiotic and placebo resolution rates were small. Other investigators have compared various antibiotics and found no differences.2, 3, 4, 5 In a study of the course of acute maxillary sinusitis without antibiotic treatment, 80% of the patients were found to have completely recovered after 14 days.6

These investigations do not, however, answer the question of whether, in unselected primary-care patients, acute maxillary sinsuitis requires antibiotic treatment. Despite the lack of evidence in favour of antibiotic therapy, throughout the world many primary-care patients with acute maxillary sinusitis are treated with antibiotics. For these patients, it is important to bear in mind that clinical and prognostic spectra, and, consequently, treatment efficacy may differ from those in patients referred to ENT clinics.7

It is difficult in general practice to distinguish clearly between acute rhinitis and acute maxillary sinusitis with only case history and physical examination.8, 9

However, in a primary-care-based study, in patients presenting with a new episode of acute rhinosinusitis, maxillary puncture is too invasive to use as a diagnostic or inclusion criterion in the first stage of primary-care management. Probability of fluid in the maxillary sinus can, however, be estimated with the aid of radiography,9 although it is not yet clear whether the radiographic criterion is useful for the choice of treatment or whether a patient with acute maxillary sinusitis and an abnormal radiograph of the sinus benefits from antibiotic treatment.

We decided to carry out a double-blind, randomised, placebo-controlled trial on the effectiveness of antibiotic treatment for primary-care patients suspected of having acute maxillary sinusitis and with an abnormal radiograph.

Section snippets

Recruitment, baseline measurements, and inclusion

Between March 1, 1993 and March 1, 1994, 53 general practitioners ordered radiographs of the maxillary and frontal sinuses (with Caldwell and Waters' projections) in patients whom they suspected of having acute maxillary sinusitis from case history and after physical examination (acute onset of a common cold with sickness, headache, nose obstruction, discharge, and tapping pain of the maxillary sinus), and for whom antibiotic therapy was considered. The radiographs were made in one of the two

Results

The trial profile (figure) shows the numbers of patients recruited by the general practitioners, included in the trial, and seen after 1 and 2 weeks of follow-up. The results of the 1-year follow-up in general practice are also given.

During the inclusion period, 488 patients were referred by their general practitioners for radiography. 216 patients (32% men, 68% women; mean age 37 years [SD 11·9]) had no radiographic abnormalities and were treated and followed up by their general practitioner.

Discussion

Our evaluation of patient selection suggested that 19% of patients overall were rejected because of exclusion criteria; 41% refused to take part or were left out because they did not meet the inclusion criteria for reasons not related to the severity of the symptoms. The general practitioners considered that 20% of the original 488 patients were not ill enough for antibiotic treatment and did not refer them for a radiograph (table 1). The proportion of patients who were ultimately involved in

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