In making treatment decisions for patients with benign prostatic hyperplasia (BPH), physicians have to rely on the efficacy data published in the literature and adapt this to individual patient’s needs. Criticism can be made, however, of the randomised clinical trials (RCTs) that are performed, as the patients enrolled are not an adequate reflection of the general patient population. Although internal validity is high in RCTs with regard to inclusion criteria, external validity is reduced. Another failing of RCTs is the way in which patients are assessed. Typically in many studies, symptom improvement is expressed as a percentage of the Symptom Index improvement. This can be misleading if the results of two trials are compared as this value depends on the pre-treatment Symptom Index. Other methods of evaluation should be considered, such as the presentation of direct symptom outcomes (threshold improvement), the cumulative frequency distribution of threshold improvements or linear regression analysis of individual IPSS. All of these means of expressing the results focus clinical evaluation on the patient himself.

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