Is amoxicillin beneficial in acute maxillary sinusitis? - Journal Club

Journal of Family Practice, July, 1997 by Mark Zamorski

Reference Van Buchem FL, Knottnerus JA, Schrijinemaekers VJJ Peeters ME Primary-care-based randomised placebo-controlled trial of antibiotic treatment in acute maxillary sinusitis. Lancet 1997; 349:683-7.

Clinical question Does amoxicillin benefit patients with acute maxillary sinusitis?

Background Acute maxillary sinusitis is ordinarily treated with oral antibiotics Several recent observational trials have demonstrated that this condition resolves spontaneously in many patients, but the possibility of a specific, incremental benefit to antibiotic therapy has not been addressed. This study sought to examine the effect of amoxicillin therapy in acute maxillary sinusitis.

Population studied Two hundred fourteen adults with radiographic abnormalities suggesting acute maxillary sinusitis were recruited among patients with respiratory symptoms presenting to the practices of 53 general practitioners in the Netherlands. Patients had been ill for an average of 2.2 weeks before treatment.

Study design and validity This was a classic, randomized, double-blind, placebo-controlled clinical trial. In most such trials, the principal threat to validity is the patient selection. In this case, the authors estimate that the patients enrolled represented about 20% of patients who presented to the general practitioners' offices with upper respiratory symptoms. Even this estimate seems generous, given that it took 53 general practitioners 1 year to recruit 214 patients for the trial. Also, the average patient was sick for over 2 weeks, which seems somewhat long. Subjects were randomized to treatment with either oral amoxicillin, 750 mg 3 fumes a day for 7 days, or an identical placebo. Amoxicillin was chosen because beta-lactamase producing Haemophilus influenzae is rare in the Netherlands.

Outcomes measured The principal study outcomes were cure rates after 2 weeks and symptom scores after 1 and 2 weeks. Secondary outcomes included the resolution of radiographic abnormalities at 2 weeks and the incidence of side effects, relapses, and evolution into chronic sinusitis.

Results After 2 weeks, 65% of amoxicillin-treated patients had been cured and had no residual symptoms, compared with 52% of placebo-treated patients (P=.06). Symptom scores at 1 and 2 weeks showed essentially no difference, with 83% of amoxicillin-treated patients and 77% of placebo-treated patients showing greatly decreased symptoms (P=.20). Stratification failed to identify any specific subgroup of patients who benefited from amoxicillin, and multivariate analysis failed to demonstrate any effect modification by clinically important covariates.

Patients treated with amoxicillin were more likely to have resolution of the radiographic abnormalities (74% vs 60%, P=.03), but the authors attribute this to the chance occurrence of more abnormal radiographs in the placebo group at the time of randomization. Side effects were substantially more common among amoxicillin-treated patients. No differences were observed with respect to the incidence of relapse or evolution to chronic sinusitis.

Recommendations for clinical practice Antibiotics should be withheld in patients with symptoms most suggestive of a viral illness. This study supports the expectant management of even those patients suspected of having acute maxillary sinusitis--antibiotic therapy benefits few, if any, of these patients, and expectant management does not increase the risk of developing sinusitis relapses or chronic sinusitis.

Integrating the results of this study into clinical practice will not be easy. Physicians' and patients' beliefs about the efficacy of antibiotics may be deeply ingrained. Nevertheless, one recent study' demonstrated that even though the majority of patients presenting to their family physician for upper respiratory symptoms expected an antibiotic, many did not share this expectation. Physicians were not always correct at guessing which patients wanted antibiotics, and patient satisfaction with the visit was independent of whether or not antibiotics were prescribed, even among those who expected one. Furthermore, physicians were able to change patient expectations about antibiotics during the visit. Physicians might start by identifying the substantial minority of patients who do not expect antibiotics, and try managing these patients expectantly. Additional patients without strong expectations might be talked into expectant management. When a decision to initiate antibiotic therapy for acute sinusitis is made, safe, inexpensive, first-line antibiotics (amoxicillin or trimethoprim/sulfamethoxazole) should be selected, and using these agents for 3 to 7 days may be sufficient.[2]

References

[1.] Hamm RM, Hicks, RJ, Bemben DA. Antibiotics and respiratory infections: are patients more satisfied when expectations are met? J Fam Pract 1996; 43:56-62.

[2.] Williams JW, Holleman DR, Samsa GP, Simel DL. Randomized controlled trial of 3 vs 10 days of trimethoprim/sulfamethoxazole for acute maxillary sinusitis. JAMA 1995; 273:1015-21.