COCHRANE FOR CLINICIANS: PUTTING EVIDENCE INTO PRACTICE
How Should We Treat Acute Maxillary Sinusitis?
Am Fam Physician. 2001 Sep 1;64(5):837-841.
An adult patient presents with purulent nasal discharge and maxillary facial pain. Symptoms have been present for 10 days and initially started as cold symptoms.
Are antibiotics indicated for treatment of acute maxillary sinusitis and, if so, which classes of antibiotics are most effective?
If acute maxillary sinusitis is defined as positive radiographs or positive sinus aspiration cultures, limited evidence indicates that therapy with either amoxicillin or penicillin for seven to 14 days is modestly effective.
Objectives. Among adults seeking care in ambulatory practices, sinusitis is the most common diagnosis treated with antibiotics. The objective of this review was to see whether antibiotics are indicated for treatment of acute sinusitis and, if so, which antibiotic classes are most effective.
Search Strategy. Relevant studies were identified from searches of Medline and Embase in October 1998, contacts with pharmaceutical companies and bibliographies of included studies.
Selection Criteria. Randomized trials that compared antibiotic with control or antibiotics from different classes in the treatment of acute maxillary sinusitis were eligible. Additional criteria were diagnostic confirmation by radiograph or sinus aspiration, outcomes that included clinical cure or improvement, and a sample size of 30 or more adults. Of 1,784 potentially relevant studies, two or more reviewers identified 32 studies that met selection criteria.
Data Collection and Analysis. Data were abstracted independently by two persons and synthesized descriptively. Some data were analyzed quantitatively using a random effects model. Primary outcomes were (A) clinical cure and (B) clinical cure or improvement. Secondary outcomes were radiographic improvement, relapse rates and dropouts related to adverse effects.
Primary Results. Thirty-two trials involving 7,330 subjects evaluated antibiotic treatment for acute maxillary sinusitis. Major comparisons were antibiotic versus control (n = 5); newer, nonpenicillin antibiotic versus penicillin class (n = 10); and amoxicillin-clavulanate versus other extended-spectrum antibiotics (n = 10). Most trials were conducted in otolaryngology settings. Only five trials described adequate allocation and concealment procedures; 10 were double blind. Compared to control, penicillin improved clinical cures (relative risk [RR] 1.72, 95 percent confidence interval [CI] 1.00 to 2.96). Treatment with amoxicillin did not significantly improve cure rates (RR 2.06; 95 percent CI 0.65 to 6.53), but there was significant variability between studies.
Radiographic outcomes were improved by antibiotic treatment. Comparisons between classes of antibiotics showed no significant differences: newer nonpenicillins versus penicillins (RR for cure 1.07; 95 percent CI 0.99 to 1.17); newer nonpenicillins versus amoxicillin-clavulanate (RR for cure 1.01, 95 percent CI 0.97 to 1.04). Dropouts related to adverse effects were significantly lower among those taking cephalosporin antibiotics when compared to those taking amoxicillin-clavulanate. Relapse rates within one month of successful therapy were 5 percent.
Reviewers' Conclusions. For acute maxillary sinusitis confirmed radiographically or by aspiration, current evidence, although limited, supports penicillin or amoxicillin therapy for seven to 14 days. Clinicians should weigh the moderate benefits of antibiotic treatment against the potential for adverse effects.1
These summaries have been derived from Cochrane reviews published in the Cochrane Database of Systematic Reviews in the Cochrane Library. Their content has, as far as possible, been checked with the authors of the original reviews, but the summaries should not be regarded as an official product of the Cochrane Collaboration; minor editing changes have been made to the text (http://www.cochrane.org)
The authors addressed a specific clinical question of tremendous importance in ambulatory medical practice. In an effort to clearly define the clinical entity of sinusitis and exclude self-limited viral syndromes, only articles that confirmed the diagnosis of sinusitis with either radiographs or sinus aspiration were reviewed. This led to an exclusion of the vast majority of otherwise eligible articles. Unfortunately, plain radiographs and sinus computed tomographic (CT) scans are nonspecific and insensitive to the presence or absence of clinical sinusitis.2–4 A significant number of asymptomatic patients have mucosal thickening on sinus CT scan. In addition, clinically infected patients often have normal CT scans or radiographs.
The Agency for Health Care Policy and Research, now the Agency for Healthcare Research and Quality (AHRQ), sponsored another systematic review of the diagnosis and treatment of acute bacterial sinusitis that used more liberal inclusion criteria. That review also concluded that most studies were flawed. The AHRQ concluded that sinus radiographs were moderately sensitive (76 percent) and specific (79 percent). Sinus aspirations are accurate but infrequently used (only three of the more than 1,700 eligible studies used aspiration). The AHRQ also concluded that sinus puncture was both costly and invasive.5
The individual articles' validity was evaluated. Because of the low number of articles and the selection criteria for confirming sinusitis, there was variation in article results, most dramatically in the evaluations of amoxicillin versus placebo. In an effort to apply stringent diagnostic criteria, the resulting analysis showed modest benefit from penicillin therapy and little benefit from newer, broad-spectrum antibiotics. The AHRQ gathered similar conclusions but discovered slightly more compelling support for the limited use of antibiotics. Their study showed that more patients were cured or improved more quickly with antibiotic therapy compared to placebo, but also that two thirds of patients receiving placebo recovered spontaneously. In addition, serious complications of bacterial sinusitis were rare.
No evidence could be found in the AHRQ review to indicate that newer antibiotics were more effective than either amoxicillin or trimethoprim-sulfamethoxazole. A reasonable conclusion was to approach most patients with an initial seven- to 10-day course of watchful waiting and, if treatment appeared to be required, to initiate therapy with either amoxicillin or trimethoprim-sulfamethoxazole. The data on adjunctive therapies are too poor to allow conclusions to be drawn.
Random Effects Model.
Randomization is the allocation of individuals to groups, based on chance. Although the distribution is random, it is not haphazard but predetermined, usually based on a table of random numbers. This randomization of eligible participants of a study into groups helps in minimizing observer bias and making the groups more comparable—even for unknown factors. The negative effects of randomization are its expense and the fact that it may not be appropriate in all instances for ethical or practical reasons.
The effort to clarify the best treatment for acute maxillary sinusitis is extremely important and timely. Sinusitis results in 22 to 25 million patient visits in the United States each year, at a direct and indirect cost of $6 billion per year. As clinicians continue their attempt to curtail antimicrobial resistance by limiting inappropriate antibiotic prescribing, it is crucial that we clarify the appropriate use of antibiotics in the treatment of acute maxillary sinusitis, which is the most frequent diagnosis resulting in an antibiotic prescription.
Because radiographic diagnosis of sinusitis is both expensive and inaccurate, clinicians would benefit most from focused clinical criteria that would help in the diagnosis of acute maxillary sinusitis. Additional evaluation of the benefits of antibiotics for clinically diagnosed acute maxillary sinusitis may yield results that could guide clinicians.
According to the AHRQ, a strong history for acute sinusitis is present when a patient has two or more of the following major factors: facial congestion or fullness, nasal obstruction or blockage, nasal discharge, purulence or discolored postnasal discharge, facial pressure or pain, hyposmia or anosmia, purulence in the nose on examination, or fever (in acute episodes only); or one major and two minor factors, consisting of the following: headache; fever (chronic episodes); halitosis; fatigue; dental pain; cough; or ear pain, pressure or fullness. If patients fulfill the above criteria, antibiotic therapy should be considered.
The AHRQ also concluded that clinical criteria (i.e., the presence of three of the following four symptoms: purulent rhinorrhea with unilateral predominance; local pain with unilateral predominance; bilateral purulent rhinorrhea; and the presence of pus in the nasal cavity) had a diagnostic sensitivity similar to that of sinus radiographs. The evidence as reviewed by the Cochrane Collaboration and the AHRQ suggests that the initial antibiotic choice can be either amoxicillin or a folate inhibitor. The length of therapy and the use of adjunctive treatments, decongestants, mucolytics or saline irrigations have not been adequately studied. The current recommendations are for 10 to 14 days of antibiotic therapy and adjunctive treatment to improve drainage.
Despite the overwhelming frequency with which acute maxillary sinusitis is seen in clinical practice, review of the evidence reveals few rigorous studies that can guide clinicians in recognition and appropriate treatment. The most cost-effective way to diagnose sinusitis appears to be through the application of strict clinical guidelines. There is no evidence to indicate that newer and more expensive antibiotics offer additional benefits over the use of either amoxicillin or folate inhibitors. Although patients with bacterial sinusitis improve more rapidly when treated with antibiotics, the vast majority of patients improve with no therapy. Adjunctive therapies, although commonly used, have never been adequately studied.
1. Williams JW Jr, Aguillar C, Makela M, Cornell J, Hollerman DR, Chiquette E, et al. Antibiotics for acute maxillary sinusitis. Cochrane Database Syst Rev. 2000;(2):CD000243.
2. Havas TE, Motbey JA, Gullane PJ. Prevalence of incidental abnormalities on computed tomographic scans of the paranasal sinuses. Arch Otolaryngol Head Neck Surg. 1988;114:856–9.
3. Bhattachryya T, Piccirillo J, Wippold FJ II. Relationship between patient-based descriptions of sinusitis and paranasal sinus computed tomographic findings. Arch Otolaryngol Head Neck Surg. 1997;123:1189–92.
4. Stewart MG, Sicard MW, Piccirillo JF, Diaz-Marchan PJ. Severity staging in chronic sinusitis: are CT scan findings related to patient symptoms? Am J Rhinol. 1999;13:161–7.
5. Diagnosis and treatment of acute bacterial rhinosinusitis. Summary, evidence report/technology assessment: number 9, March 1999. Agency for Health Care Policy and Research, Rockville, Md.: AHCPR publication no. 99-E015. Retrieved August 2001, from: http://www.ahrq.gov/clinic/sinussum.htm.
Copyright © 2001 by the American Academy of Family Physicians.
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