Sabal-Urtica combination: an evidence-based treatment option

The extracts from saw palmetto fruits (Sabal serrulata) and nettle roots (Urtica dioica) have a synergistic effect that has been proven to alleviate BPH-associated LUTS symptoms. This is shown by the results of several randomized and placebo-controlled studies. A decisive advantage over many synthetic medications is the low risk of side effects of the Sabal-Urtica combination.

In men, hyperplasia of connective tissue, epithelial and/or smooth muscle cells occurs in the transitional zone from around the fourth decade of life [1]. Benign prostatic hyperplasia (BPH) is exclusively a histological diagnosis, while LUTS (lower urinary tract symptoms) describes a clinical picture of symptoms of the lower urinary tract caused by various causes [2]. If LUTS occurs in connection with BPH, this is referred to as “LUTS suggestive of BPH” or in German-speaking countries as “benign prostate syndrome” (BPS) [2]. LUTS are divided into bladder storage symptoms, bladder emptying symptoms and symptoms after micturition (Fig. 1) [3,4].

Sabal-Urtica fixed combination: convincing cost-benefit profile

Phytopharmaceuticals are an established and evidence-based drug treatment option for BPH [5]. The fixed combination ^{Prostaplant®-F}(^WS® 1541) contains 160 mg Sabal extract ^WS® 1473 and 120 mg Urtica extract ^WS® 1031 in one capsule [6]. This proprietary combination of active ingredients is also known as PRO 160/120 and is characterized by a multifactorial mechanism of action with synergistic effects [6]. The efficacy of the phytopreparation in relieving BPH-associated LUTS symptoms has been proven in several clinical studies in comparison to placebo and in comparison to tamsulosin and finasteride:

In a randomized controlled trial, the PRO 160/120 arm showed an improvement in the IPSS (International Prostate Symptom Score) from 18.6 to 11.1 points after six months, while the corresponding values in the placebo group were 19 and 17.6 points respectively (p=0.002) [7].

In another placebo-controlled study, the IPSS was reduced by an average of 53% after 96 weeks of PRO 160/120 therapy compared to the placebo, residual urine was reduced by 44% and the quality of life index increased by 50% [8,9].

In a randomized study of 489 patients, PRO 160/120 showed similar efficacy compared to finasteride: In the phyto group, the IPSS decreased from 11.3 to 6.5 points and in the finasteride arm from 12.6 to 6.9 points [10].

In a randomized, double-blind, multi-center comparative study over a treatment period of 60 weeks, PRO 160/120 (2×/d 1 capsule) achieved a comparable reduction in IPSS values to 0.4 mg tamsulosin [11].

The extracts of Sabal serrulata and Urtica dioica have a synergistic effect, which is characterized on the one hand by anti-inflammatory effects and on the other by a reduction in growth factors [12]. Recent data show that PRO160/120 inhibits proinflammatory signaling pathways involved in the development and progression of BPH [13]. The anti-inflammatory effects are due, among other things, to a downregulation of the cytokines IL-6 and IL-8, which are correlated with the state of hyperplasia [16,17]. One advantage over synthetics is the low risk of side effects of PRO160/120; there is no drop in blood pressure, dizziness or sexual disorders.

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