PhD Candidate, Centre for Research in Evidence-Based Practice Bond University
Alternative treatment may reduce the current high antibiotic prescribing in acute otitis media cases
Acute otitis media (AOM) is an inflammation of the middle ear commonly found in children, resulting from infection, commonly viral, but also bacterial, or both. Its pathophysiology involves an inflammatory process of both cellular and chemical inflammatory mediators in the middle ear. AOM is a painful condition, with approximately 75% of children have an episode of AOM before the age of 5 years (the peak incidence at age 6-12 months). Antibiotics are frequently prescribed, even though it is often self-limiting. However, antibiotics do not relieve pain symptoms in most cases, and it has been estimated that only one-third of cases benefit from them (generally the more severe). Frequent use of antibiotics leads to increased risk of antibiotic resistance, a serious threat to health globally. Therefore, alternatives for relieving the distressing pain of AOM are needed.
Proposed alternatives or additions to antibiotics include paracetamol, non-steroidal anti-inflammatory drugs, various herbal preparations, and corticosteroids. However, the evidence for these is too weak to recommend for clinical practice. The anti-inflammatory effect of corticosteroids suggests it could be a viable treatment alternative for AOM. We conducted a systematic review of randomised placebo-controlled trials (RCTs) of steroids for AOM: only two small trials (low to moderate quality), indicated corticosteroids could be useful in this condition, but our confidence in the results is low, due to small sample size and very wide confidence intervals around the observed results. Therefore, we propose an adequately powered clinical trial to address this uncertainty.
If corticosteroids prove effective in relieving pain and distress in children, and are safe, they would become a useful alternative to antibiotics in mild cases of AOM, and an adjunct to antibiotics in severe cases. The treatment is relatively cheap, easy to dispense and administer. Along with other interventions to reduce antibiotic prescribing, these study results could lead to a reduction in antibiotic resistance, thus saving precious antibiotics for severe diseases where rapid response to antibiotics is critical.
Abstract: To determine whether the adjunctive drugs antihistamine and corticosteroid improve immediate and long-term outcomes of acute otitis media (AOM).Children with AOM (3 mos-6 y) were enrolled in a randomized, double-blind, placebo-controlled trial. All 179 children received one dose of intramuscular ceftriaxone and were assigned to receive either chlorpheniramine maleate (0.35 mg/kg/d) and/or prednisolone (2 mg/kg/day) or placebo for 5 days. Main outcome measures were rate of treatment failure during the first 2 weeks, duration of middle ear effusion, and rate of recurrences of AOM to 6 months.Clinical outcomes and recurrence rates did not differ significantly with treatment. Children who received antihistamine alone had significantly longer duration of middle ear effusion (median, 73 days) than subjects in other treatment groups (median, 23 to 36 days, P=.04). Temporary normalization of tympanometric findings on day 5 occurred more frequently in the corticosteroid-treated group (P=.04).Five-day treatment with antihistamine or corticosteroid, in addition to antibiotic, did not improve AOM outcomes. Antihistamine use during an acute episode of OM should be avoided, since the drug may prolong the duration of middle ear effusion. The efficacy of 7- to 10-day treatment of AOM with corticosteroid, in addition to antibiotic, deserves further investigation.
Pub.: 01 Oct '03, Pinned: 24 Aug '17
Abstract: When prescribing antibiotics for common indications, clinicians need information about both harms and benefits, information that is currently available only from observational studies. We quantified the common harms of the most frequently prescribed antibiotic, amoxicillin, from randomized placebo-controlled trials.For this systematic review, we searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials, without language restriction, for any randomized, participant-blinded, placebo-controlled trials of amoxicillin or amoxicillin-clavulanic acid for any indication, in any setting. Our main outcome was any reported adverse event.Of 730 studies identified, we included 45 trials: 27 involving amoxicillin, 17 involving amoxicillin-clavulanic acid and 1 involving both. The indications for antibiotic therapy were variable. The risk of bias was low, although only 25 trials provided data suitable for assessment of harms, which suggested under-reporting. Diarrhea was attributed to amoxicillin only in the form of amoxicillin-clavulanic acid (Peto odds ratio [OR] 3.30, 95% confidence interval [CI] 2.23-4.87). The OR for candidiasis (3 trials) was significantly higher (OR 7.77, 95% CI 2.23-27.11). Rashes, nausea, itching, vomiting and abnormal results on liver function tests were not significantly increased. The results were not altered by sensitivity analyses, nor did funnel plots suggest publication bias. The number of courses of antibiotics needed to harm was 10 (95% CI 6-17) for diarrhea with amoxicillin-clavulanic acid and 27 (95% CI 24-42) for candidiasis with amoxicillin (with or without clavulanic acid).Diarrhea was caused by use of amoxicillin-clavulanic acid, and candidiasis was caused by both amoxicillin and amoxicillin-clavulanic acid. Harms were poorly reported in most trials, and their true incidence may have been higher than reported. Nevertheless, these rates of common harms associated with amoxicillin therapy may inform decisions by helping clinicians to balance harms against benefits.
Pub.: 19 Nov '14, Pinned: 24 Aug '17