Placebo found equivalent to amoxicillin for treatment of acute bronchitis in Nairobi, Kenya: a triple blind, randomised, equivalence trial
- 1Centre for Respiratory Disease Research, Kenya Medical Research Institute, Nairobi, Kenya
- 2Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA
- 3Department of Medicine, University of Washington, Seattle, Washington, USA
- 4Department of Medicine, University of Miami, Miami, Florida, USA
- 5Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, California, USA
- Dr C R Cohen, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, 50 Beale Street, Suite 1200, San Francisco, CA 94105, USA; ccohen{at}globalhealth.ucsf.edu
- Received 7 February 2008
- Accepted 14 May 2008
- Published Online First 17 June 2008
Abstract
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.
Footnotes
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Funding: This study was supported by a grant from the Rockefeller Foundation. VNN was a fellow in the International AIDS Research and Training Program at the University of Washington supported by the Fogarty International Center (T22TW00001). The Rockefeller Foundation did not participate in the development of the study design, implementation or analysis of the data, or in the decision to submit this manuscript for publication.
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Competing interests: None.
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Ethics approval: The procedures followed were approved by the Kenya Medical Research Institute Ethical Review Committee, the University of Washington Human Subjects Review Committee and the University of California, San Francisco Committee on Human Research.
