Largest randomised European study confirms antibiotics ineffective for treating coughs
A European study of 2,061 adults with lower respiratory tract infections (LRTI) has proved that prescribing antibiotic amoxicillin is no more effective at relieving symptoms than the use of no medication, even in older patients. The findings from the largest randomised placebo controlled trial of antibiotics for acute uncomplicated LRTI are published in The Lancet Infectious Diseases.
The EU's Sixth research framework programme FP6 funded the GRACE (Genomics to Combat Resistance against Antibiotics in Community-acquired LRTI in Europe) project with EUR 11.5 million as part of the 'Life Sciences, genomics and biotechnology for Health' theme. Additional funding came from the United Kingdom's National Institute for Health Research (NIHR), Barcelona's Ciber de Enfermedades Respiratorias (CIBERES), Spain and Research Foundation Flanders (FWO), Belgium.
Professor Paul Little from the University of Southampton in the United Kingdom, who led the research, noted, 'Patients given amoxicillin don't recover much quicker or have significantly fewer symptoms. Indeed, using amoxicillin to treat respiratory infections in patients not suspected of having pneumonia is not likely to help and could be harmful. Overuse of antibiotics (which is dominated by primary care prescribing), particularly when they are ineffective, can lead to side effects (eg, diarrhoea, rash, vomiting) and the development of resistance.'
A cough that is accompanied by lower respiratory tract symptoms is one of the most common acute illnesses treated in primary care in developed countries. According to Health Guidance, seeking treatment for a common cold is one of the leading causes for doctor visits, though doctors can do little to treat the illness. It is thought that viruses cause most of these infections, and whether or not antibiotics are beneficial in the treatment of LRTI, particularly in older patients, is still hotly debated. Research so far has produced conflicting results.
The study involved primary care practices based in 12 European countries (Belgium, England, France, Germany, Italy, the Netherlands, Poland, Spain, Slovakia, Slovenia, Sweden and Wales). Study subjects, aged 18 years and older, were randomly assigned to receive either amoxicillin or a placebo 3 times a day for 7 days, with doctors assessing symptoms while participants completed a daily symptom diary for the duration of their illness to a maximum of 28 days. Each symptom was scored on a scale from 0 to 6 (with 0 being no problem and 6 being as bad as it could be).
The outcome of the study showed that there was very little difference in the severity or duration of symptoms reported between the two groups. This was also the case for the older patients aged 60 or more who were generally healthy.
However, the research significantly found that more patients in the placebo group experienced new or worsening symptoms (19.3 % vs. 15.9 %), with 30 people needing treatment and a further 3 requiring hospitalisation (2 patients in the placebo group and 1 in the antibiotic group).
A surprising factor of the study found that patients taking antibiotics reported significantly more side-effects, including nausea, rash and diarrhoea, than those given the placebo (28.7 % vs. 24 %).
According to Professor Little, 'Our results show that most people get better on their own. But, given that a small number of patients will benefit from antibiotics the challenge remains to identify these individuals.'
Writing in a linked comment, Philipp Schuetz from the University of Basel in Switzerland said, 'Professor Little and colleagues have generated convincing data that should encourage physicians in primary care to refrain from antibiotic treatment in low-risk patients in whom pneumonia is not suspected. Whether this one-size-fits-all approach can be further improved remains to be seen. Guidance from measurements of specific blood biomarkers of bacterial infection, such as procalcitonin, might help to identify the few individuals who will benefit from antibiotics despite the apparent absence of pneumonia and avoid the toxic effects and costs of those drugs and the development of resistance in the other patients.'
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