Arthur Jeske DMD, PhD; James Zahrowski DMD, MS, PharmD
Antibiotic treatment conferred a small benefit in patients who had symptoms of uncomplicated acute maxillary sinusitis symptoms beyond seven days.
In adult patients with acute maxillary sinusitis, does an antibiotic, in comparison with placebo, safely improve the outcome of sinusitis?
The authors searched three data bases up to June 2007 for additional evidence since the review by Williams et al in 2003.(1) All included studies were randomized controlled trials (RCTs) of at least 30 adults. The studies compared antibiotics to a placebo, or two different classes of antibiotics for acute sinusitis. The authors calculated risk ratios (RR) for differences in the intervention. Primary outcome measure was a lack of cure or improvement at seven to 15 days. They reported adverse effects from antibiotics as clinical signs, symptoms and drop-out rates.
The review included 57 studies, six of which were placebo-controlled studies and 51 of which compared different classes of antibiotics. In five trials (631 participants), there was a lack of cure or improvement at seven to 15 days' follow-up. In these studies, the authors found a slight, statistical difference favoring antibiotics as compared to placebo, with a RR of 0.66 (95 percent confident interval [CI] 0.44 to 0.98). The cure or improvement rate was high in both the placebo group (80 percent) and the antibiotic group (90 percent). When clinical failure was defined only as a lack of total cure, the authors found in six trials (747 participants) a significant difference favoring antibiotics compared to placebo, with a pooled RR of 0.74 (95 percent CI 0.65 to 0.84) at seven to 15 days' follow-up. Only one controlled study evaluated 15- to 60-day primary outcome with a nonsignificant result. The authors evaluated 51 studies that compared different classes of antibiotics (penicillin, macrolides, cephalosporins, amoxicillin-clavulate). They found none as being superior to another. The most common adverse effects from antibiotics were gastrointestinal disorders and skin rashes, with drop-out rates varying from 2 percent (penicillin, macrolides, cephalosporins) to 10 percent (amoxicillin-clavulate).
Antibiotic treatment has a small beneficial effect in patients with uncomplicated acute sinusitis whose symptoms have lasted for more than seven days. Ninety percent of patients taking antibiotics improved while 80 percent of patients not taking antibiotics improved in seven to 15 days.
Source of Funding:
Finnish Office for Health Technology Assessment / FinOHTA, National Research and Development Centre for Welfare & Health / STAKES, Finland.
Importance and Context:
Sinusitis affects 35 million adults in the United States. As one of the most common health problems, it accounts for 12 percent of all antibiotic prescriptions.(2) Acute bacterial maxillary sinusitis often is preceded by an acute viral upper respiratory tract infection. Signs and symptoms can last more than one week, which increases the likelihood the patient will develop sinusitis, purulent nasal discharge, sinus pain with palpation, poor response to decongestants, unilateral facial pain, and maxillary toothache. Expert opinions vary on the appropriate role of antibiotics in treating acute maxillary sinusitis for symptom relief, to prevent both complications and the development of chronic sinusitis. Other maxillary sinusitis treatments include the use of decongestants, steroid drops or sprays, mucus-clearing drugs (mucolytics), antihistamines, or sinus puncture and lavage. A systematic review of better RCTs is needed to quantify the effectiveness and safety of antibiotic therapy for acute sinusitis.
Strengths and Weaknesses of the Systematic Review:
This high-quality systematic review included a comprehensive search, defined inclusion and exclusion criteria, and had no language restrictions. Two authors independently assessed study quality and extracted data with disagreements resolved by consensus among the four authors. Standard guidelines for data analysis and heterogeneity were performed. The authors assessed each study for risk of bias.
Strengths and Weaknesses of the Evidence:
The six placebo-controlled studies included inadequate random allocation (four studies), lack of blinding (one study) and moderate- to high-risk of bias (four studies). The 51 studies that compared antibiotics included inadequate random allocation in 42 studies, lack of blinding in 18 studies, single-blinding only in 10 studies, and moderate to high bias in 46 studies. Thirty-six studies were supported by pharmaceutical companies. Nasal decongestants and analgesics were allowed but not prescribed in three studies, and one study used a decongestant as a supplementary therapy and control group treatment. The authors failed to provide standardized information about side effects in almost half of the studies. To better assess the efficacy and adverse effects of antibiotic therapy, longer-term studies with longer follow-up periods are needed. Ideally, these studies also would identify subgroups of patients that may benefit from antibiotics.
Implications for Dental Practice:
Dental infections may coexist or possibly be the cause of maxillary sinusitis. When making the differential diagnosis of maxillary tooth pain, a clinician should suspect maxillary sinus infection if there are no signs of dental infection, sinus pain at palpation or when head is lowered, unilateral facial pain, nasal discharge or obstruction with poor response to decongestants, or a recent history of upper respiratory infection. When considering antibiotics to treat maxillary sinusitis, clinicians should assess the potential benefits and risks. This Cochrane systematic review currently is being updated and will report similar results supported by an improved quality of evidence.(3)
1. Williams Jr JW, Aguilar C, Cornell J, Chiquette E. Dolor RJ, Makela M, Holleman DR, Simel DL. Antibiotics for acute maxillary sinusitis. Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD000243. DOI: 10.1002/14651858.CD000243.
2. Piccirillo JF, Mager DE, Frisse ME, Brophy RH, Goggin A. Impact of First-Line vs Second-Line Antibiotics for the Treatment of Acute Uncomplicated Sinusitis J Amer Med Assoc. October 17, 2001; Vol 286 (15): 1849-56.
3. Ahovuo-Saloranta A. Personal communication 9/22/10.