Efficacy and Tolerability of the Hexanic Extract of Serenoa Repens Compared to Tamsulosin in Moderate-Severe LUTS-BPH Patients - Beyond the Abstract

Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (LUTS/BPH) are the primary reason for seeking medical care in men. Medical treatments for LUTS/BPH include alpha-1-adrenergic receptor blockers, 5-alpha-reductase inhibitors, anticholinergics, and a beta-3-adrenergic drug.1 Phytotherapies with anti-inflammatory, antiandrogenic and antiproliferative effects are also emerging as a viable treatment for LUTS/BPH.2,3 When analyzing the efficacy of phytotherapy, however, it is of paramount importance to consider the specific preparation evaluated, as the pharmacokinetic properties and composition of different preparations can vary considerably.1,4-6 Furthermore, different companies use different methods to extract the active ingredient from the same plant, leading to different compositions with distinct biological and clinical effects. This makes it difficult to provide a single recommendation for use covering all phytotherapies that are available to treat LUTS/BPH patients.1,7


The present research evaluates the efficacy of the hexanic extract of Serenoa repens (HESr, 320mg/day) and compares it with results for tamsulosin (TAM, 0.4mg/day) in a total of 737 patients diagnosed with LUTS/BPH (353 TAM, 384 HESr). The analysis was conducted using an iterative matching procedure to ensure maximum comparability at baseline between the two study arms on the International Prostate Symptoms Score (IPSS), IPSS item 8 (QoL), and BII scores, maximum urinary flow, prostate-specific antigen (PSA), and prostate volume. Moreover, a stricter matching procedure (propensity score matching) was also used to ensure individuals in the two groups were comparable according to the baseline characteristics previously described. In the propensity score procedure, each patient in the TAM group was paired with a patient from the HESr group with a similar propensity score, obtaining groups of the same size for comparison, further ensuring the robustness of the results.

Using the iterative matching procedure, at six months follow-up no statistically differences were found for improvement on the IPSS; scores improved by 5.0 (4.3) [mean (standard deviation)] and 4.5 (4.7) points (p=0.117), respectively, for the TAM and HESr groups. Improvements in IPSS scores were greater for both arms (TAM and HESr) in patients with more severe baseline symptoms. The IPSS responder sub-analysis showed 71.6% of patients with a change of more than 3 points (the cut-point for a relevant clinical improvement) in the TAM compared to 65.6% in patients in the HESr group (p=0.100).The percentage of patients with an increase of over 4 points on the IPSS was 1.49% and 2.98% for the TAM and HESr groups (p=0.284), respectively. A higher incidence of side effects was found in the TAM group (14.7% vs 2.1% in the HESr group, p<0.001), and consisted mainly of anejaculation (8.5% TAM vs 0% HESr, p<0.001), reduced ejaculatory volume (5.1% TAM vs 0.5% HESr, p<0.001), and orthostatic hypotension (2.0% TAM vs 0% HESr, p=0.006). The effect of LUTS on quality of life (QoL) was assessed using item 8 of the IPSS score and the Benign Prostatic Hyperplasia Impact Index (BII). IPSS item 8 scores improved by 1.3 (1.2) and 1.1 (1.2) points in the TAM and HESr groups (p=0.129), respectively, while BII scores improved by 2.3 (2.4) and 2.2 (2.5) points in the same groups (p=0.417), respectively. Patients with a higher IPSS baseline score showed greater improvement on the BII for all of its items.  A high correlation was found between mean improvement on the BII score and mean change on question 8 (quality of life) of the IPSS , at r=0.57 for each arm (p<0.001).

As with the iterative matching procedure, there were no statistically significant differences between groups in terms of improvement on the IPSS and BII when applying propensity score matching procedures. Using the latter approach, 128 patients were included in each group (93 with moderate symptoms and 35 with severe symptoms). The propensity matching procedure showed mean (SD) change on the IPSS of 5.1 (4.6) and 4.9 (4.6) points for TAM and HESr, respectively. Mean (SD) improvement on the BII was 2.6 (2.4) for TAM and 2.4 (2.5) points for HESr.

In conclusion, treatment for LUTS/BPH should be tailored to the individual patient, bearing in mind symptoms reported (voiding, storage), quality of life, prostate size, patient expectations, and potential side effects. However, according to the results of the present analysis, the hexanic extract of Serenoa repens (HESr, 320mg/day) is efficacious in managing moderate and severe LUTS/BPH and has better tolerability than TAM.

Written by: José Medina-PoloDepartment of Urology, Health Research Institute i+12, Hospital Universitario 12 de Octubre, HM Hospitals & ROC Clinic, Madrid, Spain

References:

  1. Gravas S, Cornu JN, Gacci M, Gratzke C, Herrmann TRW, Mamoulakis C, et al. EAU Guidelines on Management on Non-neurogenic Male Lower Urinary Tract Symptoims (LUTS), incl. Benign Prostatic Obstruction (BPO). European Association of Urology; 2021. Available at  https://uroweb.org/wp-content/uploads/EAU-Guidelines-on-Management-of-Non-Neurogenic-Male-LUTS-2021.pdf. Accessed on 22 Novembre 2021.
  2. Gravas S, Samarinas M, Zacharouli K, Karatzas A, Tzortzis V, Koukoulis G, et al. The effect of hexanic extract of Serenoa repens on prostatic inflammation: results from a randomized biopsy study. World J Urol. 2019;37(3):539-44.
  3. Sirab N, Robert G, Fasolo V, Descazeaud A, Vacherot F, de la Taille A, et al. Lipidosterolic extract of serenoa repens modulates the expression of inflammation related-genes in benign prostatic hyperplasia epithelial and stromal cells. Int J Mol Sci. 2013;14(7):14301-20.
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  5. Novara G, Giannarini G, Alcaraz A, Cózar-Olmo J-M, Descazeaud A, Montorsi F, et al. Efficacy and Safety of Hexanic Lipidosterolic Extract of Serenoa repens (Permixon) in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Systematic Review and Meta-analysis of Randomized Controlled Trials. Eur Urol Focus. 2016;2(5):553-61.
  6. Debruyne F, Boyle P, Calais Da Silva F, Gillenwater JG, Hamdy FC, Perrin P, et al. Evaluation of the clinical benefit of permixon and tamsulosin in severe BPH patients-PERMAL study subset analysis. Eur Urol. 2004;45(6):773-9.
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