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Placebo Medication and Sham Surgery Responses in Benign Prostatic Hyperplasia Treatments: Implications for Clinical Trials

  • Benign Prostatic Hyperplasia (K McVary, Section Editor)
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Abstract

Placebo medications and sham surgeries have long been thought to be inert treatments. These groups served as a threshold to which an active treatment should be compared in a randomized trial to determine the true efficacy of the active treatment. However, surprising changes in subjective symptom scores and objective measures of voiding have been demonstrated in numerous placebo medication or sham surgery arms of trials. The exact mechanisms by which these inactive treatments augment patient outcomes are not clearly defined and multiple theories have been proposed to explain the often pronounced response. It appears that urologic outcomes are particularly prone to these effects and the astute physician should keep these responses in mind when interpreting any trial on a new therapy.

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Conflict of Interest

Igor Sorokin and Adam Schatz each declare no potential conflicts of interest.

Charles Welliver reports other from Sophiris, other from AMS, other from Coloplast, personal fees from American Society of Andrology, other from Antares, other from NexMed, other from Auxilium, and other from Sophiris, and his brother works for Bristol-Myers.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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Authors and Affiliations

  1. Division of Urology, Albany Medical College, Albany, NY, USA

    Igor Sorokin, Adam Schatz & Charles Welliver

  2. Division of Urology, Albany Stratton Veterans Affairs Hospital, Albany, NY, USA

    Charles Welliver

  3. Urological Institute of Northeastern New York, Albany, NY, USA

    Charles Welliver

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  1. Igor Sorokin
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  2. Adam Schatz
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  3. Charles Welliver
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Correspondence to Charles Welliver.

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This article is part of the Topical Collection on Benign Prostatic Hyperplasia

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Sorokin, I., Schatz, A. & Welliver, C. Placebo Medication and Sham Surgery Responses in Benign Prostatic Hyperplasia Treatments: Implications for Clinical Trials. Curr Urol Rep 16, 73 (2015). https://doi.org/10.1007/s11934-015-0544-4

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