A prospective study of the efficacy of Serenoa repens, Tamsulosin, and Serenoa repens plus Tamsulosin treatment for patients with benign prostate hyperplasia
Abstract:Treatment of BPH by both SR and TAM seems to be effective alone. None of them had superiority to another and additionally, combined therapy (SR + TAM) does not provide extra benefits. Furthermore SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH.
“…We found improvement in LUTS-related QL in each group; similarly, it was reported that SR + TAM resulted in equal improvement in QL compared to TAM [20,23]. Although limited studies have evaluated PVR in measuring responses to treatment, we measured PVR to assess the efficacy of treatment regimens and found a mean decrease of 10.6 and 8.3 cc for the TAM and SR + TAM groups at 12 months, respectively.…”
Section: Discussionsupporting
confidence: 76%
“…Hizli and Uygur[20] previously reported in an open-label, prospective 6 months study with 3 arms, including SR 320 mg per day (n = 20), Tamsulosin (TAM) 0.4 mg per day (n = 20), and SR + TAM (n = 20), that treatment of BPH by both SR and TAM alone seems to be effective. None of them had superiority over another and therefore, the combined therapy (SR + TAM) does not provide extra benefits.…”
Introduction: In Korea, increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH. Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies. The present study was designed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH. Materials and Methods: One hundred forty men with symptomatic BPH (IPSS ≥10) were recruited in our hospital for a 12-month, open-label, randomized trial. Patients were randomly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day (n = 60) or tamsulosin 0.2 mg/day only (n = 60). Prostate volume and PSA were measured at baseline and at end-point, whereas total IPSS, and its storage and voiding subscores, LUTS-related QoL, Qmax, and PVR were evaluated at baseline and later every 6 months. Results: Total 103 patients were finally available: 50 in the TAM + SR group and 53 in the TAM group. At 12 months, total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM (p = 0.693); the storage symptoms improved significantly more with TAM + SR (-1.7 vs. -0.8 with TAM, p = 0.024). This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months (-1.9 vs. -0.9, p = 0.024). The changes of voiding subscore, LUTS-related QoL, Qmax, PVR, PSA, and prostate volume showed no significant differences between the TAM + SR and TAM groups. During the treatment period, 8 patients (16.9%) with TAM and 10 (20%) with TAM + SR had drug-related adverse reactions, which included ejaculatory disorders, postural hypotension, dizziness, headache, gastro-intestinal disorders, rhinitis, fatigue and asthenia. Conclusions: The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment.
“…We found improvement in LUTS-related QL in each group; similarly, it was reported that SR + TAM resulted in equal improvement in QL compared to TAM [20,23]. Although limited studies have evaluated PVR in measuring responses to treatment, we measured PVR to assess the efficacy of treatment regimens and found a mean decrease of 10.6 and 8.3 cc for the TAM and SR + TAM groups at 12 months, respectively.…”
Section: Discussionsupporting
confidence: 76%
“…Hizli and Uygur[20] previously reported in an open-label, prospective 6 months study with 3 arms, including SR 320 mg per day (n = 20), Tamsulosin (TAM) 0.4 mg per day (n = 20), and SR + TAM (n = 20), that treatment of BPH by both SR and TAM alone seems to be effective. None of them had superiority over another and therefore, the combined therapy (SR + TAM) does not provide extra benefits.…”
Introduction: In Korea, increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH. Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies. The present study was designed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH. Materials and Methods: One hundred forty men with symptomatic BPH (IPSS ≥10) were recruited in our hospital for a 12-month, open-label, randomized trial. Patients were randomly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day (n = 60) or tamsulosin 0.2 mg/day only (n = 60). Prostate volume and PSA were measured at baseline and at end-point, whereas total IPSS, and its storage and voiding subscores, LUTS-related QoL, Qmax, and PVR were evaluated at baseline and later every 6 months. Results: Total 103 patients were finally available: 50 in the TAM + SR group and 53 in the TAM group. At 12 months, total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM (p = 0.693); the storage symptoms improved significantly more with TAM + SR (-1.7 vs. -0.8 with TAM, p = 0.024). This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months (-1.9 vs. -0.9, p = 0.024). The changes of voiding subscore, LUTS-related QoL, Qmax, PVR, PSA, and prostate volume showed no significant differences between the TAM + SR and TAM groups. During the treatment period, 8 patients (16.9%) with TAM and 10 (20%) with TAM + SR had drug-related adverse reactions, which included ejaculatory disorders, postural hypotension, dizziness, headache, gastro-intestinal disorders, rhinitis, fatigue and asthenia. Conclusions: The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment.
“…The updated search strategy (2008) identified 12 new trials, of which 9 met inclusion criteria (Preuss 2001; Debruyne 2002; Glémain 2002; Willetts 2003; Lopatkin 2005; Engelmann 2006; Bent 2006; Hizli 2007; Shi 2007). Excluded were Pecoraro 2004, Popa 2005, and Vela-Navarrete 2005.…”
Section: Resultsmentioning
confidence: 99%
“…In this update a total of 2053 additional participants were randomized in 9 trials (820 in trials of Serenoa repens alone or in combination ( Urtica dioica , Cernitin®, B-sitosterol, vitamin E, tamsulosin) versus placebo (Preuss 2001; Willetts 2003; Lopatkin 2005; Bent 2006; Shi 2007), and 1233 men in trials of Serenoa repens alone or in combination versus active control (Debruyne 2002; Glémain 2002; Engelmann 2006; Hizli 2007). …”
Background-Benign prostatic hyperplasia (BPH), a nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (also known by its botanical name of Sabal serrulatum), is one of several phytotherapeutic agents available for the treatment of BPH.Objectives-This systematic review aimed to assess the effects of Serenoa repens in the treatment of LUTS consistent with BPH.Search strategy-Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, and The Cochrane Library), by checking bibliographies, and by handsearching the relevant literature.Selection criteria-Trials were eligible if they (1) randomized men with symptomatic BPH to receive preparations of Serenoa repens (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and (2) included clinical outcomes such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers. Data collection and analysis-Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other interventions was the change in urologic symptom-scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects or adverse events was the number of men reporting side effects.Main results-In this update 9 new trials involving 2053 additional men (a 64.8% increase) have been included. For the main comparison -Serenoa repens versus placebo -3 trials were added with 419 subjects and 3 endpoints (IPSS, peak urine flow, prostate size). Overall, 5222 subjects from 30 randomized trials lasting from 4 to 60 weeks were assessed. Twenty-six trials were double blinded and treatment allocation concealment was adequate in eighteen studies.
“…Tacklind wertete 32 Studien aus, die in Tabelle 1 aufgeführt sind [8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39]. …”
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