Amoxicillin/Clavulanate or Ibuprofen No Better Than Placebo for Acute Bronchitis


Am Fam Physician. 2014 Feb 1;89(3):225-226.

Clinical Question

In adults with discolored sputum and acute bronchitis, is treatment with amoxicillin/clavulanate (Augmentin) 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 drug ibuprofen is no more effective than placebo in decreasing symptoms in general or duration of frequent cough. Treatment does, however, produce adverse effects in one in eight 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. (Level of Evidence = 1b)


The investigators enrolled 416 adults presenting for care at one of nine primary care centers in Spain. Patients were eligible for inclusion if they had symptoms of acute bronchitis for less than one week. All patients had cough as the predominant symptom, with discolored sputum and at least one other symptom of lower respiratory tract infection (i.e., dyspnea, wheezing, or chest discomfort or pain). A total of 38% were current smokers. Patients were excluded if they had radiologic evidence of pneumonia or signs of severe infection (e.g., confusion, rapid respiratory rate, rapid pulse). The patients were randomly assigned, using concealed allocation, to receive ibuprofen (600 mg), amoxicillin/clavulanate (500 mg/125 mg), or placebo three 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, Lundgren J, Youngpairoj S. Ann Fam Med. 2013;11(1):5–13). 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 ibuprofen or placebo (5% and 3%, respectively; P < .01).

Study design: Randomized controlled trial (single-blinded)

Funding source: Government Allocation: Concealed

Setting: Outpatient (primary care)

Reference: 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: f5762.

POEMs (patient-oriented evidence that matters) are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com. Copyright Wiley-Blackwell. Used with permission.

For definitions of levels of evidence used in POEMs, see http://www.essentialevidenceplus.com/product/ebm_loe.cfm?show=oxford.

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