[Randomized therapeutic trials of community-acquired lung diseases. Analysis of studies published between 1978 and...

The authors have evaluated the methodology of 21 randomized therapeutic trials concerning community acquired pneumonia. Only 33% of these trials were entirely devoted to community acquired pneumonia; the remainders included various respiratory infections. Only 8 trials were of the double-blind type. The presence of radiological opacity was mentioned as a criterion of inclusion in only 10 trials, and in 9 trials the diagnosis of pneumonia was not defined. The criterion of judgement, which separates success from failure, remained undefined in 6 trials. The number of patients analyzed was much lower than that of patients admitted because of exclusions for negative cultures or for isolation of a bacteria resistant to one of the antibiotics tested. Finally, in only 2 of the 21 trials it was concluded that an antibiotic was superior to the other(s). Clearly then, the quality of these randomized therapeutic trials needs to be improved by a better definition of their purpose and of the criteria of patients' admission, and by analysis of an intention to treat which is the nearest thing to the future use of the drug under study.