In a retrospective study with data from over 70 000 elderly male patients, the effects of the phytotherapeutic PRO 160/120 with
the 5α-reductase inhibitors finasteride and dutasteride, and with the
α1-adrenoceptor antagonists tamsulosin and with tamsulosin/dutasteride.
compared in terms of incidence of various prostate complaints. The Sabal Urtica preparation (PRO 160/120) performed very well.
One of the main causes of lower urinary tract symptoms ( LUTS), which are common in older men, is an enlarged prostate due to benign prostatic hyperplasia (BPH). BPH results in subvesical obstruction and thus bladder outlet obstruction and associated symptoms. Depending on the severity of BPH, there are different treatment options. The indication for drug therapy is usually given for mild to moderate symptoms.
Based on data from the Germany-wide representative Disease Analyzer database IQVIA**, a retrospective analysis was performed to analyze the effects of PRO 160/120 on the incidence of urinary incontinence, polyuria (including nocturia), urinary retention, and erectile dysfunction in a “real-world” setting in Germany and to compare it with the 5-α-reductase inhibitors (5-ARI) finasteride and dutasteride, as well as the α1-adrenoceptor antagonists tamsulosin and the fixed combination tamsulosin/dutasteride [1]. The phytopharmacological preparation PRO 160/120 (box) contains 160 mg of sabal extract (WS® 1473) and 120 mg of urtica extract (WS® 1031) and is available as a fixed combination Prostaplant®-F(WS® 1541) in capsule form [2].
** The physician transmits anonymized data from the practice computer to IQVIA™. The course of disease and therapy can be evaluated anonymously. Over 2500 medical practices in Germany provide data to IQVIA™, www.iqvia.com.
| Prostaplant®-F(PRO 160/120): Combination preparation with anti-inflammatory effect The drug Prostaplant®-F is approved in Switzerland by Swissmedic for the treatment of prostate disorders, it is a combination preparation PRO 160/120, which contains as main pharmacological active ingredients a lipidosterol extract of saw palmetto (Sabal serrulata, Fig. 1) and an extract of the large nettle (Urtica dioica, Fig. 2) contains [2]. PRO 160/120 targets the conversion of testosterone to dihydrotestosterone and aromatase activity to balance estrogen levels [1]. The active ingredients also relax the swollen prostate tissue and thus reduce the pressure on the urethra. Due to its anti-inflammatory effect, PRO 160/120 reduces prostate irritation [3]. Several in vitro and in vivo studies have confirmed the beneficial effect of Sabal Urtica extracts on the inflammatory process in the prostate [3–7]. |
Results of the retrospective analysis
All male patients enrolled in the IQVIA database who had received an initial prescription of PRO 160/120, dutasteride, finasteride, tamsulosin, or a dutasteride/tamsulosin combination from a urologist or primary care physician between January 2010 and September 2020 were included in the analysis [1]. A total of 77 923 patients were enrolled in the study. 3035 of participants received PRO 160/120, 3133 finasteride, 418 dutasteride, 64 962 tamsulosin, and 3375 tamsulosin/dutasteride fixed combination. Of patients treated with PRO 160/120, 71.3% (n=2168) had a documented diagnosis of BPH (ICD-10: N40), which is comparable to patients in the other treatment groups (finasteride: 68.5%; dutasteride: 81.6%; tamsulosin: 76.8%; tamsulosin/dutasteride: 84.4%). The mean age of patients treated with PRO 160/120 was 66.0 years, slightly lower than the mean age of the other groups: Finasteride (71.0 years), Dutasteride (73.0 years); Tamsulosin (70.0 years) or Tamsulosin/Dutasteride (74.0 years).
Table 1 shows the results of the multivariable logistic regression models (follow-up time from 1 day after the index prescription) [1]. PRO 160/120 was significantly associated with a lower incidence of urinary incontinence (OR: 1.48; 95% CI: 1.10-1.98; p=0.010) and urinary retention (OR: 3.39; 95% CI: 1.75-6.57) compared to tamsulosin. In addition, PRO 160/120 reduced the risk of erectile dysfunction compared to dutasteride (OR: 2.79; 95% CI: 1.49-5.25; p=0.001). At the same time, the other complications occurred as frequently in patients receiving PRO 160/120 as in patients taking the comparators.
Literature:
- Madersbacher S, et al: Association between PRO 160/120 prescriptions and incidence of benign prostatic hyperplasia complications in Germany: a retrospective cohort study. Postgrad Med 2023;135(2): 149-154.
- Drug Information, www.swissmedicinfo.ch,(last accessed 03/07/2023).
- Koch E: Extracts from fruits of saw palmetto (Sabal serrulata) and roots of stinging nettle (Urtica dioica): viable alternatives in the medical treatment of benign prostatic hyperplasia and associated lower urinary tracts symptoms. Planta Med 2001; 67(6): 489-500.
- Koch E, Biber A: Pharmacological effects of sabal and urtica extracts as a basis for rational drug therapy of benign prostatic hyperplasia. Urologist B 1994; 34(2): 3-8.
- Pigat N, et al: Combined sabal and urtica extracts (WS® 1541) exert anti-proliferative and anti-inflammatory effects in a mouse model of benign prostate hyperplasia. Front Pharmacol 2019; 10: 311.
- Saponaro M, et al: Serenoa repens and urtica dioica fixed combination: in vitro validation of a therapy for benign prostatic hyperplasia (BPH). Int J Mol Sci 2020; 21(23): 9178.
- Kirschner-Hermanns R, Funk P, Leistner N: WS PRO 160 I 120 mg (a combination of sabal and urtica extract) in patients with LUTS related to BPH. Ther Adv Urol 2019; 11: 1756287219879533.
HAUSARZT PRAXIS 2023; 18(3): 47-48
