Clinical Benefit of Tamsulosin and the Hexanic Extract of Serenoa Repens, in Combination or as Monotherapy, in Patients with Moderate/Severe LUTS-BPH: A Subset Analysis of the QUALIPROST Study

Abstract

To investigate whether tamsulosin (TAM) and the hexanic extract of Serenoa repens (HESr) are more effective in combination than as monotherapy in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Subset analysis of data from a 6-month, multicenter observational study. Patients received either tamsulosin (0.4 mg/day) or HESr (320 mg/day) alone or in combination. Primary endpoints were change in symptoms and quality of life. Tolerability was also assessed. Seven hundred and nine patients were available for intention to treat (ITT) analysis, 263 treated with tamsulosin, 262 with HESr, and 184 with TAM + HESr. After 6 months, International Prostate Symptom Score (IPSS) scores improved by a mean (standard deviation) of 7.2 (5.0) points in the TAM + HESr group compared to 5.7 (4.3) points with TAM alone and 5.4 (4.6) points with HESr (p < 0.001). Quality of life showed greatest improvement with combination therapy (p < 0.02). Adverse effects were reported by 1.9% of patients receiving HESr, 13.3% receiving TAM, and 12.0% receiving TAM + HESr (p < 0.001). In men with moderate/severe LUTS/BPH, combination treatment with TAM + HESr produced more effective symptom relief and greater improvement in quality of life than with either treatment alone, with acceptable tolerability.

A randomized placebo-controlled study: Phellodendron Bawei tablets combined with standard management can improve storage symptoms, sleep quality, and medication compliance in patients with benign prostatic hyperplasia compared to placebo with standard management

“…This aligns with our research results. However, previous studies did not subdivide the improvement of symptoms into storage and voiding, nor did they discuss the impact on sleep quality (27,28).…”

Serenoa Repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part III

“…In 2020, Alcaraz et al [12] reported their follow-up to the QUALIPROST study of 2016 [16] that compared HESr (Permixon) vs. tamsulosin vs. a combination of the two agents. The combination arm results were statistically superior related to IPSS, QoL, BII at p values of 0.002, 0.001, and 0.007, respectively (supplementary document at https: //www.mdpi.com/2077-0383/9/9/2909/sl, accessed on 30 July 2021).…”

“…This issue of degree of efficacy of LSESr based on the severity of the baseline IPSS warrants further scrutiny and, perhaps in a followup study, the authors of QUALIPROST will clarify this issue by comparing IPSS changes in the severe with the moderate LUTS cohorts. Notwithstanding, the 2020 QUALIPROST publication [12] and its supplement (URL provided earlier) are valuable contributions and raise the possibility of a synergistic effect of LSESr with the alpha-blocker tamsulosin.…”

Serenoa repens (saw palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part III

“…In 2020, Alcaraz et al [9] reported their follow-up to the QUALIPROST study of 2016 [11] that compared HESr (Permixon) vs tamsulosin vs. a combination of the two agents. The combination arm results were statistically superior at p < 0.001.…”

“…This issue of degree of efficacy of LSESr based on the severity of the baseline IPSS warrants further scrutiny, and hopefully the corresponding author of the QUALIPROST study will clarify this issue by comparing the severe with the moderate LUTS cohorts. Notwithstanding, the 2020 QUALIPROST publication [9] and its supplement are valuable contributions and raise the possibility of a synergistic effect of LSESr with the alpha-blocker tamsulosin.…”