Open label studies sufficiently demonstrate efficacy in improving sexual function

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I heartily appreciate your interest in our study. As you know, alfuzosin is a selective α-1 blocker given without titration at a dose of 10 mg once daily. Placebo-controlled studies show that it provides a rapid and sustained relief of lower urinary tract symptom (LUTS), with minimal cardiovascular and sexual side effects.1, 2, 3 Furthermore, recent studies, not only in open label studies but also in randomized double-blind, placebo-controlled studies showed that Alfuzosin 10 mg once daily significantly improved LUTS and sexual function.4, 5, 6

As you pointed out, we agree that efficacy in improving sexual function based upon double-blind randomized comparative trial (RCT) are appropriate. Before considering the policy implications of our findings, some methodological aspects of the study need to be considered. In this study, we only included patients with benign prostatic hyperplasia (BPH)/LUTS who reported that they had experienced at least one episode of sexual activity in the past 4 weeks and excluded all ‘sexually inactive’ patients. As you mentioned, overall sexual function may also exhibit considerable improvement upon placebo treatment in men with voiding as well as sexual dysfunction. However, we think that sexually active men with only voiding dysfunction may not exhibit improvement upon placebo treatment because sexual function is not the major issue.

To the best of our knowledge, this study is the first clinical trial concerning the medical treatment of patients with BPH and sexual function assessed by Male Sexual Health Questionnaire (MSHQ). Even though there is no data on how this instrument behaves during placebo treatment, we thought that this is meaningful because the validated questionnaire was first to be applied to clinical practice. We expect that MSHQ will be widely used to show the efficacy of drugs on sexual function.

Conflict of interest

The authors declared no conflict of interest.

References

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Correspondence to B H Chung.

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