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Efficacy and safety of the hexanic extract of serenoa repens vs. watchful waiting in men with moderate to severe LUTS-BPH: Results of a paired matched clinical study

  • Antonio Alcaraz,
  • Mauro Gacci,
  • Vincenzo Ficarra,
  • José Medina-Polo,
  • Andrea Salonia,
  • Jesús M. Fernández-Gómez,
  • Alexandru Ciudin,
  • David Castro-Díaz,
  • Alfredo Rodríguez-Antolín,
  • Joaquín Carballido-Rodríguez,
  • José M. Cózar-Olmo,
  • Santiago Búcar-Terrades,
  • Noemí Pérez-León,
  • Francisco J. Brenes-Bermúdez,
  • José M. Molero-García,
  • Antonio Fernández-Pro Ledesma,
  • Michael Herdman,
  • José Manasanch,
  • Javier C. Angulo,
  • on behalf of the QUALIPROST Study Group

Publication: Journal of Clinical Medicine, February 2022

We investigated changes in symptoms and quality of life (QoL) in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of Serenoa repens (HESr) and compared results with a matched group on watchful waiting (WW). Data was from a real-world, open-label, prospective, multicenter study. This sub-group analysis included patients with moderate-to-severe symptoms receiving either the HESr 320 mg/daily for six months (HESr) or who remained untreated for LUTS/BPH (WW). Changes in urinary symptoms and QoL were measured by IPSS and BII questionnaires. Two statistical approaches (iterative matching and propensity score pairing) were used to maximize between-group comparability at baseline. Tolerability was assessed in the HESr group. After iterative matching, data for analysis was available for 783 patients (102 WW, 681 HESr). IPSS scores improved by a mean (SD) of 3.8 (4.4) points in the HESr group and by 2.2 (4.5) points in the WW group (p = 0.002). Changes in BII score were 1.8 (2.4) points and 1.0 (2.2) points, respectively (p < 0.001). Three patients (0.9%) treated with the HESr reported mild adverse effects. Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.