Antibiotics and Topical Nasal Steroid for Treatment of Acute Maxillary Sinusitis

Clinical Question

• In adults with acute rhinosinusitis, is the routine use of antibiotics safe and effective at reducing the severity and duration of the symptoms?

Bottom Line

• In patients with acute rhinosinusitis, the routine use of antibiotic was not safe and effective at reducing the severity and duration of the symptoms.

Major Points

Currently, the use of antibiotics for the treatment of…is debated and the effectiveness of anti-inflammatory drugs, such as topical steroids, has been minimally studied. This study evaluates the usefulness of antibiotics and topical steroids for the relief and resolution of symptoms caused by acute sinusitis in patients presenting to a primary care setting.

This study was a double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged ≥16 years) with acute nonrecurrent sinusitis that were positive for at least 2 diagnostic criteria who were seen and monitored by 74 family physicians between November 2001 and November 2005. Each patient was randomized to 1 of 4 treatment groups: antibiotic and nasal steroid; placebo antibiotic and nasal steroid; antibiotic and placebo nasal steroid; placebo antibiotic and placebo nasal steroid. The primary outcome of this study observed the proportion of patients clinically cured at day 10 using patient symptom diaries of duration and severity of symptoms as the indicator.

There was no clinically significant difference in achieving the primary outcome between any of the four treatment groups. The study concluded that neither the use of an antibiotic nor a topical steroid alone or both in combination was effective in treating adult patients with acute nonrecurrent sinusitis. Due to the strict exclusion criteria, this study has minimal external validity in populations where patients have comorbidities or severe symptoms and should not be the sole predictor in determining treatment. The use of these findings in practice would have to be in conjunction with other studies and based on patient specific factors and symptoms.

Guidelines

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Design

• Double-blinded, randomized, placebo-controlled factorial trial
• N = 240 patients
• 53 active antibiotic and active steroid
• 60 active antibiotic and placebo steroid
• 64 placebo antibiotic and active steroid
• 63 placebo antibiotic and placebo steroid
• Setting: 58 family practices in the United Kingdom
• Enrollment: November 2001 through November 2005
• Mean follow up: 14 days
• Analysis: Intention-to-treat
• Primary Outcome: Proportion of patients clinically cured at day 10

Population

Inclusion Criteria

• >15 years of age with uncomplicated acute illness (<28 days duration) who presented to a primary care practice
• Positive for at least 2 of the following Berg and Carenfelt criteria:

    -purulent nasal discharge with unilateral predominance
    -local pain with unilateral predominance
    -purulent nasal discharge bilaterally
    -pus on inspection inside the nose 

Exclusion Criteria

• Cases with a low probability of acute bacterial sinusitis that had less than 2 of the Berg and Carenfelt criteria
• Patients with a history of recurrent sinusitis (defined by >2 attacks of acute rhinosinusitis in the previous 12 months)
• Patients with significant comorbidities, such as poorly controlled diabetes or heart failure
• Patients who are pregnant or breastfeeding
• Patients with allergies to or a history of adverse reactions to either medication
• Patients who received antibiotics or steroids in the previous month

Baseline Characteristics

• Only clinically significant between groups in this study was the initial temperature. 107 patients had initial temp of 36.5C in antibiotic group and 119 patients with 36.5C in no antibiotic group.
• Mean age: 42.1
• Sex:

    -Male:12/53
    -Female: 41/53

• Smoking history:

    -Never: 15/41
    -Past: 18/41
    -Current: 8/41

• Asthma:

    -No: 38/41
    -Yes: 3/41

• Eczema:

    -No: 34/41
    -Yes: 7/41

• Hay fever:

    -No: 36/44
    -Yes: 8/44

• Sinusitis before:

    -No: 40/53
    -Yes: 38/44

• Pus on infection:

    -No: 40/53
    -Yes: 13/53

• Initial temp: 36.5 C
• No. of days had symptoms: 7
• Berg and Carenfelt criteria:

    -2: 35/49
    ->3: 14/49

Interventions

• Patients in the antibiotic group were treated with a dose of 500 mg of amoxicillin 3 times per day for 7 days.
• Patients in the steroid group were treated with a dose of 200 mcg of budesonide in each nostril once per day for 10 days.
• Patients were asked to report their symptoms in symptom diaries that were returned after 14 days.
• Indicators for clinical cure were the duration of symptoms and the severity of symptoms.

Outcomes

Comparisons are intensive therapy vs. standard therapy.

Primary Outcomes

• Patients clinically cured at day 10.

       -Symptoms >10 days: 29 of 100 (29%) for amoxicillin vs 36 of 107 (33.6%) for no amoxicillin (AOR, 0.99; 95% CI, 0.57-1.73). 
       -Symptoms >10 days: 32 of 102 (31.4%) for topical budesonide vs 33 of 105 (31.4%) for no budesonide (AOR, 0.93; 95% CI, 0.54-1.62).
       -Amoxicillin vs placebo (hazard ratio for resolution, 1.08 [95% CI, 0.79-1.48]; P = .63) 
       -Budesonide vs placebo (hazard ratio, 1.05 [95% CI, 0.77-1.44]; P = .75).

Secondary Outcomes

• Nasal steroids were significantly more effective in patients who had less severe symptoms when presented at the physician’s office.

Subgroup Analysis

• There were no clinically relevant subgroups presented in the study that would have impacted the outcome.

Adverse Events

• No adverse events or hospitalization were encountered in the study.

Criticisms

• There was a low recruitment rate for the study.
• Diagnostic criteria were strict and many patients initially screened failed to meet those criteria.
• The study had limited power to detect any clinical effects of an antibiotic. Minor improvements in symptoms were not included in the clinical analysis and, therefore, were not observed.
• Excessive work pressure on busy family physicians posed an additional obstacle to recruitment for this study.
• This study has limited external validity due to strict and highly specific exclusion criteria.

Funding

• The study was funded and supported by the UK Department of Health.

Further Reading

1. Williamson I, Rumsby K, Benge S, Moore M, Smith P, Cross M et al. Antibiotics and Topical Nasal Steroid for Treatment of Acute Maxillary Sinusitis. JAMA. 2007;298(21):2487(1).