TY - JOUR
T1 - Placebo found equivalent to amoxicillin for treatment of acute bronchitis in Nairobi, Kenya
T2 - A triple blind, randomised, equivalence trial
AU - Nduba, V. N.
AU - Mwachari, C. W.
AU - Magaret, A. S.
AU - Park, D. R.
AU - Kigo, A.
AU - Hooton, T. M.
AU - Cohen, C. R.
PY - 2008/11
Y1 - 2008/11
N2 - Background: Antibiotic treatment is not recommended for acute bronchitis in immunocompetent patients in industrialised countries. Whether these recommendations are relevant to the developing world and to immunocompromised patients is unknown. Design, setting and participants: Randomised, triple blind, placebo controlled equivalence trial of amoxicillin compared with placebo in 660 adults presenting to two outpatient clinics in Nairobi, Kenya, with acute bronchitis but without evidence of chronic lung disease. Main outcome measure: The primary study end point was clinical cure, as defined by a ≥75% reduction in a validated Acute Bronchitis Severity Score by 14 days; analysis was by intention to treat with equivalence defined as ≤ 8% difference between study arms. Results: Clinical cure rates in the amoxicillin and placebo arms were 81.7% and 84.0%, respectively (difference 2.3%, 95% CI -8.6% to 4.0%). Of 131 HIV infected subjects (19.8%), cure rates for those randomised to amoxicillin (77.2%) and placebo (83.8%) differed by 6.6% (95% CI -21.7% to 8.6%). Among HIV uninfected subjects, the difference in cure rates was 1.6% (95% CI -8.5% to 5.3%). Potential drug side effects were similar in the two arms. No subjects required hospitalisation or died. Conclusion: Antibiotic treatment of acute bronchitis is unhelpful, even in populations with a high prevalence of HIV infection.
AB - Background: Antibiotic treatment is not recommended for acute bronchitis in immunocompetent patients in industrialised countries. Whether these recommendations are relevant to the developing world and to immunocompromised patients is unknown. Design, setting and participants: Randomised, triple blind, placebo controlled equivalence trial of amoxicillin compared with placebo in 660 adults presenting to two outpatient clinics in Nairobi, Kenya, with acute bronchitis but without evidence of chronic lung disease. Main outcome measure: The primary study end point was clinical cure, as defined by a ≥75% reduction in a validated Acute Bronchitis Severity Score by 14 days; analysis was by intention to treat with equivalence defined as ≤ 8% difference between study arms. Results: Clinical cure rates in the amoxicillin and placebo arms were 81.7% and 84.0%, respectively (difference 2.3%, 95% CI -8.6% to 4.0%). Of 131 HIV infected subjects (19.8%), cure rates for those randomised to amoxicillin (77.2%) and placebo (83.8%) differed by 6.6% (95% CI -21.7% to 8.6%). Among HIV uninfected subjects, the difference in cure rates was 1.6% (95% CI -8.5% to 5.3%). Potential drug side effects were similar in the two arms. No subjects required hospitalisation or died. Conclusion: Antibiotic treatment of acute bronchitis is unhelpful, even in populations with a high prevalence of HIV infection.
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U2 - 10.1136/thx.2008.097311
DO - 10.1136/thx.2008.097311
M3 - Article
C2 - 18559367
AN - SCOPUS:56049106852
VL - 63
SP - 999
EP - 1005
JO - Thorax
JF - Thorax
SN - 0040-6376
IS - 11
ER -