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BMJ 2011; 342 doi: (Published 11 May 2011) Cite this as: BMJ 2011;342:d2841

Real world trials challenge asthma guidelines

Randomised trials tell us that established treatments for asthma relieve symptoms and improve lung function for selected people treated under ideal conditions. But they tell us next to nothing about the real world effectiveness of asthma treatments for the heterogeneous group of people who come through the doors of primary care doctors every day. Two new pragmatic trials from the UK go some way to bridging the gap by including diverse patients, treated by their usual doctor, in their usual clinic.

Both trials aimed to improve long term quality of life. The first compared an oral leukotriene receptor antagonist (usually montelukast) with an inhaled corticosteroid (usually beclometasone) as first line treatment for adults needing regular control for their asthma. The second compared an oral leukotriene receptor antagonist (again, usually montelukast) with a long acting β adrenoceptor agonist (usually salmeterol) for adults poorly controlled by inhaled glucocorticoids alone. Both trials found little to choose between the two treatments after two months, or two years. Comparator groups reported improvements in quality of life and asthma control that were essentially equivalent, although not always in the strict statistical sense specified in the protocol. Both trials included mostly adults aged 16-80 (n=306 and n=352). More than half were current or former smokers.

These trials challenge current guidelines, says an editorial (p 1769). Leukotriene receptor antagonists seem to compare more favourably with inhaled treatments in the real world than they do in traditional trials—possibly because people are better at taking pills than they are at using inhalers. Adherence rates were 65% and 74% for the two groups assigned a leukotriene inhibitor, compared with just 41% and 46% for controls assigned an inhaled treatment.

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