Amoxicillin / clavulanate or ibuprofen no better than placebo for acute bronchitis

Clinical Question

In adults with discolored sputum and acute bronchitis, is treatment with either amoxicillin / clavulanate or ibuprofen more effective than placebo in decreasing the number of days with frequent cough?

Bottom Line

Treating acute bronchitis with amoxicillin / clavulanate or the nonsteroidal anti-inflammatory ibuprofen is no more effective than placebo in decreasing symptoms in general or duration of frequent cough. Treatment does, however, produce adverse effects in 1 in 8 patients. To quote Osler: “The desire to take medicine is perhaps the greatest feature which distinguishes man from animals.” In that case, prescribing ibuprofen rather than an antibiotic may be the better way to allow patients to take medicine while their cough resolves. (LOE = 1b)


Llor C, Moragas A, Bayona C, et al. Efficacy of anti-inflammatory or antibiotic treatment in patients with non-complicated acute bronchitis and discoloured sputum: randomised placebo controlled trial. BMJ 2013;347:15762. doi: 10.1136/bmj.f5762.

Study Design Randomized controlled trial (single-blinded)

Funding Government

Setting Outpatient (primary care)

Allocation Concealed


The Spanish investigators enrolled 416 adults presenting for care at 1 of 9 primary care centers with symptoms of acute bronchitis for less than 1 week. All patients had cough as the predominant symptom, along with discolored sputum, and at least one other symptom of lower respiratory tract infection (ie, dyspnea, wheezing, or chest discomfort or pain). Thirty-eight percent were current smokers (this is Spain, after all). Patients were excluded if they had radiologic evidence of pneumonia or signs of severe infection (eg, confusion, rapid respiratory rate, or rapid pulse). The patients were randomly assigned, using concealed allocation, to receive ibuprofen 600 mg, amoxicillin/clavulanate 500 mg/125 mg, or placebo 3 times daily for 10 days. The mean time to complete resolution of cough was 14.6 days, which is slightly shorter than the average duration of 18 days reported in other studies (Ebell MH, et al. Ann Fam Med 2013 doi: 10.1370/afm.1430). Using intention-to-treat analysis, the median number of days of frequent cough, recorded by patient diary, was approximately 10 days in each group. The results were similar when analyzing only those patients who adhered to the complete treatment. Symptom scores during treatment did not differ among the groups. Adverse effects were more common with antibiotic treatment (12%) as compared with treatment with ibuprofen or placebo (5% and 3%; P < .01)

Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA


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