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The lipidosterolic extract ofSerenoa repens in the treatment of benign prostatic hyperplasia: A comparison of two dosage regimens

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Abstract

This 6-month double-blind, randomized, parallel-group study compared two dose regimens of Libeprosta®, the lipidosterolic extract ofSerenoa repens in 100 male outpatients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH). The patients received two 80-mg tablets twice daily or two 80-mg tablets three times daily. Baseline evaluations included maximum and mean urinary flow rates, postvoid residual urine volume, and International Prostate Symptom Score (I-PSS) total and quality-of-life scores. Both regimens significantly reduced the I-PSS mean total score from baseline values (P < .001); improvements achieved statistical significance after month 3 and were maintained for the duration of the study. Significant improvements from baseline also occurred in quality-of-life scores, maximum and mean urinary flow rates, and residual urine volume (P < .05). The decrease in residual urine with both regimens was highly significant (P < .001). No significant differences in efficacy were noted between the two dose groups, and no treatment-related complications or clinical adverse events occurred. In this clinical study, the lipidosterolic extract ofSerenoa repens was a well-tolerated agent that may significantly improve lower urinary tract symptoms and flow measurements in men with BPH.

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Authors and Affiliations

  1. Department of Urology, Ioannina University School of Medicine, Ioannina, Greece

    X. Giannakopoulos M.D., Ph.D., D. Baltogiannis M.D., Ph.D., D. Giannakis M.D., Ph.D., A. Tasos M.D. & N. Sofikitis M.D., Ph.D., D.M.Sci.

  2. Laboratory of Physiology (Clinical Unit), Ioannina University School of Medicine, Ioannina, Greece

    K. Charalabopoulos M.D., Ph.D. & A. Evangelou M.D., Ph.D.

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  1. X. Giannakopoulos M.D., Ph.D.
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  2. D. Baltogiannis M.D., Ph.D.
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  3. D. Giannakis M.D., Ph.D.
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  4. A. Tasos M.D.
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  5. N. Sofikitis M.D., Ph.D., D.M.Sci.
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  6. K. Charalabopoulos M.D., Ph.D.
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  7. A. Evangelou M.D., Ph.D.
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Giannakopoulos, X., Baltogiannis, D., Giannakis, D. et al. The lipidosterolic extract ofSerenoa repens in the treatment of benign prostatic hyperplasia: A comparison of two dosage regimens. Adv Therapy 19, 285–296 (2002). https://doi.org/10.1007/BF02853174

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  • DOI: https://doi.org/10.1007/BF02853174

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