Top POEMs of 2013: Respiratory Disease

Amox/Clav 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)

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;347:15762. doi: 10.1136/bmj.f5762.

Study design: Randomized controlled trial (single-blinded)

Funding source: Government

Allocation: Concealed

Setting: Outpatient (primary care)

Synopsis: 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

Mean Duration of Cough Is 18 Days; Patients Expect About 1 Week

Clinical question: Doc, how long will this cough last and when are you gonna give me some antibiotics?

Bottom line: In published studies of patients with cough not treated with antibiotics, the average cough duration is approximately 18 days, although patients anticipate coughing for only 5 days to 7 days. Physicians can educate patients about this discrepancy to reduce inappropriate antibiotic use. (LOE = 1a)

Reference: Ebell MH, Lundgren J, Youngpairoj S. How long does a cough last? Comparing patients' expectations with data from a systematic review of the literature. Ann Fam Med 2013;11(1):5-13.

Study design: Other

Funding source: Other

Setting: Population-based

Synopsis: These authors conducted a mixed methods study in which they compared the duration of cough reported in a systematic review of the published literature with patients' expectations of cough duration. To establish the literature-base for cough duration in patients not receiving antibiotics, they searched MEDLINE and the reference list of the most recent Cochrane review of antibiotics for acute bronchitis. They obtained their data from observational studies and from the placebo-treated control patients of clinical trials. To obtain data on patients' expectations, they used random digit dialing to survey residents of Georgia. The researchers identified 19 studies with between 23 and 1230 patients. The mean duration of any cough was 17.8 days (range = 15.3 - 28.6) and for productive cough was 13.9 days (range = 13.3 - 17.4). In contrast, the 493 survey respondents (44% response rate) expected the duration of cough to be from 5 days to 7 days. Patients who were nonwhite, had less education (some college or less), or had previous antibiotic treatment for acute cough illness more often felt that antibiotics were always helpful. One major limitation of the study is that the random patient survey was conducted entirely in the state of Georgia; the culture and beliefs regarding cough duration may vary with regional location.

Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI

5-Day Steroid Treatment Effective for Acute COPD Exacerbation

Clinical question: Is a 5-day course of systemic glucocorticoids effective in the treatment of adults with acute exacerbations of chronic obstructive pulmonary disease?

Bottom line: A 5-day course of systemic glucocorticoids is at least as effective as a 14-day course in the treatment of adults with acute exacerbations of chronic obstructive pulmonary disease (COPD). (LOE = 1b)

Reference: Leuppi JD, Schuetz P, Bingisser R, et al. Short-term vs. conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease. The REDUCE randomized clinical trial. JAMA 2013;309(21):2223-2231.

Study design: Randomized controlled trial (double-blinded)

Funding source: Government

Allocation: Concealed

Setting: Inpatient (any location)

Synopsis: Glucocorticoid therapy reduces the length of hospital stay in adults with acute exacerbations of COPD, but the optimal dose and duration of treatment is unknown. These investigators identified adults (N = 314) who presented to 1 of 5 emergency departments in Switzerland and met standard clinical criteria for acute exacerbations of COPD. Eligible patients randomly received (concealed allocation assignment) either 5 days or 14 days of systemic glucocorticoids, beginning with 40 mg intravenous methylprednisolone on day 1, followed by 40 mg oral prednisone daily for days 2 through 5, and then either 40 mg oral prednisone daily or matched placebo for days 6 through 14. Individuals assessing outcomes remained masked to treatment group assignment. All patients received antibiotic therapy for 7 days and an inhaled, nebulized, short-acting bronchodilator as clinically indicated during hospitalization. Additional standard treatments included inhaled glucocorticoids, beta-agonists, and tiotropium given throughout the study duration. Approximately 8% of patients in each treatment group were discharged directly from the emergency department; the remaining patients were hospitalized. Complete follow-up occurred for 99% of patients at 6 months. Using intention-to-treat analysis, there were no significant differences in recurrent COPD exacerbations between the short-term and conventional treatment groups: 35.9% vs 36.8%, respectively, met the primary end point of no exacerbations within 180 days. The median time to exacerbation was 43.5 days in the short-term treatment group and 29 days in the conventional group. In subgroup analyses the authors found no differences in results by differing severities of COPD. There were also no treatment group differences in the need for mechanical ventilation, quality of life assessments, hypertension or hyperglycemia worsening, infection rates, gastronintestinal bleeding, or all-cause mortality.

David Slawson, MD
Director of Information Sciences
University of Virginia Health System
Charlottesville, VA

Amox-Clavulanate During COPD Exacerbations Decreases Sx and Delays Subsequent Exacerbations

Clinical question: Does amoxicillin-clavulanate improve outcomes in patients with exacerbations of mild to moderate chronic obstructive pulmonary disease?

Bottom line: Patients with exacerbations of their mild to moderate chronic obstructive pulmonary disease (COPD) have a higher rate of cure when given amoxicillin-clavulanate compared with placebo. (LOE = 2b)

Reference: Llor C, Moragas A, Hernández S, Bayona C, Miravitlles M. Efficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2012;186(8):716-723.

Study design: Randomized controlled trial (double-blinded)

Funding source: Foundation

Allocation: Concealed

Setting: Outpatient (primary care)

Synopsis: The 2010 update to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline on managing patients with COPD limits the role of antibiotics in patients with infectious exacerbations; it recommends that patients have purulent sputum plus increased dyspnea or increased sputum volume before receiving antibiotics. However, the data on the role of antibiotics in patients with mild disease is quite limited. The researchers for this study randomly assigned patients with mild to moderate COPD with exacerbations (at least ONE of the following: increased dyspnea, increase in sputum volume, or purulent sputum) to receive either amoxicillin-clavulanate (500/125 mg 3 times daily) or placebo. The treating physicians could prescribe corticosteroids in addition to the antibiotic (which happened in approximately 17% in each group). Each patient was evaluated 9 days to 11 days after treatment for clinical cure by the treating physician. The authors used intention-to-treat to evaluate the outcomes. Approximately 75% of antibiotic-treated patients were "cured" compared with 60% of those treated with placebo (number needed to treat = 8; 95% CI, 5 - 27). Additionally, patients taking antibiotics had a longer time to the next exacerbation compared with patients receiving placebo (233 vs 160 days). Two patients stopped taking the antibiotics because of gastrointestinal distress.

Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI

POEMs 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(www.essentialevidenceplus.com).

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