N20 Tamsulosin with or without serenoa repens in benign prostatic hyperplasia: The Comb TAMSR trial

Argirovic, D.

doi:10.1016/s1569-9056(09)74795-5

Cited by 4 publications

(4 citation statements)

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“…A prospective, randomized trial compared the efficacy of Ser + tamsulosin vs. tamsulosin alone in a 12-mos treatment reporting that the combination was more effective than monotherapy in reducing storage symptoms in BPH patients 14 . In contrast, Argirovic found that the addition of Ser to tamsulosin did not lead to any clinical benefits in terms of IPSS score, Qmax or PVR 19 . Similarly, Hizli et al .…”

Section: Discussionmentioning

confidence: 82%

“…Major strength of the study was a rigorous methodology as compared to previous studies which demonstrated a number of methodological limitations and flaws 12 . Indeed, some studies were limited by a short follow-up (no longer than 6 months) and others failed to report precise data about the extraction modality about the Ser used 13 , 19 . In contrast, our study depicted strict inclusion criteria, with the goal to assess the efficacy of a defined type of Ser extract (namely, hexanic lipidosterolic extract) on LUTS severity after a homogenously relatively long follow-up period (i.e., ≥12 months).…”

Section: Discussionmentioning

confidence: 99%

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Clinically Meaningful Improvements in LUTS/BPH Severity in Men Treated with Silodosin Plus Hexanic Extract of Serenoa Repens or Silodosin Alone

Boeri

Capogrosso

Ventimiglia

et al. 2017

Sci Rep

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To assess the rate and predictors of clinically meaningful improvements (CMI) in patients with lower urinary tract symptoms (LUTS) treated with either silodosin (SIL) alone or with a combination of SIL+ serenoa repens (Ser) hexanic lipidosterolic extract for ≥12 months. Data from 186 patients were collected. Patients completed the International Prostatic Symptoms Score (IPSS) at baseline and at follow-up assessment. Descriptive statistics and logistic regression models tested rates and predictors of CMI. Two CMI were assessed: 1) >3 points improvement in total IPSS from baseline to end (CMI#1); 2) >25% IPSS improvement from baseline to end (CMI#2). Overall, 93 (50%) patients were treated with SIL and SIL+ Ser, respectively. At a mean 13.5-mos follow-up [range: 12–20], mean IPSS scores were significantly lower in patients treated with SIL + Ser compared to those after SIL (p = 0.002). SIL + Ser patients more frequently achieved CMI#1 (69.9% vs. 30.1%, p = 0.001) and CMI#2 (68.8% vs. 31.2%, p < 0.001) compared SIL men. At multivariable analyses, younger age, IPSS severity and SIL + Ser (all p < 0.03) were independent predictors of CMI#1 and CMI#2. In conclusion, SIL + Ser therapy was more effective than SIL alone in improving IPSS scores in men with LUTS. SIL + Ser treatment led to CMIs in up to seven out of ten men.

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Section: Discussionmentioning

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Clinically Meaningful Improvements in LUTS/BPH Severity in Men Treated with Silodosin Plus Hexanic Extract of Serenoa Repens or Silodosin Alone

Boeri

Capogrosso

Ventimiglia

et al. 2017

Sci Rep

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“…In a retrospective study of 100 patients Argirovic of 2009, the addition of SeR to tamsulosin did not have any clinical benefit, such as a change in IPSS, Qmax or PVR.…”

Section: Discussionmentioning

confidence: 92%

Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double‐blinded randomized study between single or combination therapy (PROCOMB trial)

et al. 2014

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BACKGROUND. Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) þ tamsulosin versus single therapies. METHODS. PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, doubledummy multicenter study of 225 patients between 55 and 80 years old, PSA 4 ng/ml, IPSS !12, prostate volume 60 cc, Qmax 15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly þ tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups. RESULTS. The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline This study has been designed and conducted independently. Konpharma provided support for this study. Data collection and management and all statistical analyses were performed and retained by data manager (R.A.). The corresponding author and other co-authors interpreted the data and participated in the preparation, review and approval of the manuscript. to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C. CONCLUSION. SeR-Se-Ly þ tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.

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“…A prospective, randomized trial ex-plored the efficacy of SR + TAM as compared with TAM alone, reporting that the combination was more effective in ameliorating storage symptoms [11]. Conversely, Argirovic [12] proved that combination therapy did not lead to any meaningful clinical advantage regarding IPSS, Q max , or PVR. However, some would argue that these studies were not devoid of several, important limitations, including the lack of any clarification regarding the exact Values denote means ± SD.…”

Section: Discussionmentioning

confidence: 99%

A Prospective, Open-Label Comparison of Tamsulosin plus <b><i>Serenoa repens</i></b> and Bovine Colostrum versus Tamsulosin Alone in the Treatment of Benign Prostatic Hyperplasia

et al. 2019

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Objective: To compare the efficacy and safety of oral supplementation with Serenoa repens (SR) and bovine colostrum (BC) plus tamsulosin (TAM) versus TAM alone over 12 months in men suffering from lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Methods: Between February 2018 and February 2019, men with symptomatic BPH (IPSS ≥10) were prospectively recruited. This prospective, open-label, 12-month study included two different protocols: (1) group A, SR 320 mg/day + BC 30 mg/ day + TAM 0.4 mg/day, and (2) group B, TAM 0.4 mg/day only. Results: Overall, 148 patients entered the study, 76 in group A and 72 in group B. At 12 months, the total IPSS had decreased by 5.5 with TAM + SR + BC and by 5.1 with TAM only (p = 0.21). However, when the total IPSS was divided into storage and voiding subscores, at 6 months the storage symptoms had improved significantly more with TAM + SR + BC (-1.6 vs. -0.9 with TAM only, p = 0.02), with the benefit persisting also at the 1-year evaluation (-1.8 vs. -0.8, p = 0.02). Moreover, the improvement in LUTS-related quality of life (QoL) was significantly different between the groups, with a mean decrease in IPSS QoL subscore of -2.5 ± 0.2 for TAM + SR + BC versus -1.8 ± 0.3 for TAM at 6 months (p = 0.04), and of -2.9 ± 0.4 for TAM + SR + BC versus -2.1 ± 0.4 for TAM at 12 months (p = 0.04). Conversely, no significant differences were found in maximal urinary flow rate (p = 0.38), postvoid residual volume (p = 0.12), prostate-specific antigen (p = 0.41), and prostate volume (p = 0.16). Conclusion: Combination treatment with SR and BC plus TAM was shown to be more effective than treatment with TAM only in improving IPSS storage and QoL subscores in BPH patients after 6 months and up to 12 months of treatment.

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N20 Tamsulosin with or without serenoa repens in benign prostatic hyperplasia: The Comb TAMSR trial

Cited by 4 publications

References 0 publications

Clinically Meaningful Improvements in LUTS/BPH Severity in Men Treated with Silodosin Plus Hexanic Extract of Serenoa Repens or Silodosin Alone

Clinically Meaningful Improvements in LUTS/BPH Severity in Men Treated with Silodosin Plus Hexanic Extract of Serenoa Repens or Silodosin Alone

Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double‐blinded randomized study between single or combination therapy (PROCOMB trial)

A Prospective, Open-Label Comparison of Tamsulosin plus <b><i>Serenoa repens</i></b> and Bovine Colostrum versus Tamsulosin Alone in the Treatment of Benign Prostatic Hyperplasia

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