Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms—a placebo-controlled, double-blind, multicenter trial

Abstract

The efficacy and tolerability of a fixed combination of 160 mg sabal fruit extract WS 1473 and 120 mg urtica root extract WS 1031 per capsule (PRO 160/120) was investigated in elderly, male patients suffering from lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia in a prospective multicenter trial. A total of 257 patients (129 and 128, respectively) were randomized to treatment with PRO 160/120 or placebo (127 and 126 were evaluable for efficacy). Following a single-blind placebo run-in phase of 2 weeks, the patients received 2 x 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks. Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120. Outcome measures for treatment efficacy included the assessment of the patients' LUTS by means of the I-PSS self-rating questionnaire and a quality of life index as well as uroflow and sonographic parameters. Using the International Prostate Symptom Score (I-PSS), patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group (6 points vs 4 points; P=0.003, one tailed) with a tendency in the same direction after 16 weeks. This applied to obstructive as well as to irritative symptoms, and to patients with moderate or severe symptoms at baseline. Patients randomized to placebo showed a marked improvement in LUTS (as measured by the I-PSS) after being switched to PRO 160/120 during the control period (P=0.01, one tailed, in comparison to those who had been treated with PRO 160/120 in the double-blind phase). The tolerability of PRO 160/120 was comparable to the placebo. In conclusion, PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS. PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms. The tolerability of the herbal extract was excellent.

Effects of Leaf Extract of Urtica pilulifera L. on Male Reproductive System of Streptozotocin-Diabetic Rats

“…This plant is also commonly known in Roman as Nettle and in Jordan as Qurraus [1,2] . For decades, crude extracts of plant species of U. pilulifera have long been used in many countries around the world as a traditional medicine for the treatment of various diseases including Diabetes Mellitus (DM) [3,4] . DM is mainly due to relatively low level of insulin production or an inability of the body to use insulin properly which, in turn, leads to hyperglycemia [5] .…”

Urtica ferox neuropathy

“…9,21 By contrast, nettles have been used as a herbal remedy since antiquity, 5 and most of the medical Urtica literature concerns their use in conditions such as prostatism and colitis. 17,19 Lignans or steroids from Urtica roots may mediate effects on the prostate. 15,24 The water-soluble extract of U. dioica has been shown to have antioxidant properties, 13 and stimulates the proliferation of T-lymphocytes and suppresses nitric oxide (NO) production in lipopolysaccharide-stimulated macrophages.…”

Risks and benefits of commonly used herbal medicines in Mexico

“…There is contradictory evidence about the effectiveness of stinging nettle for symptoms of BPH. In one study, taking a combination product (PRO 160/120, Willmar Schwabe GmbH, Germany) containing a specific extract of stinging nettle (WS 1031) 120 mg plus a specific extract of saw palmetto (WS 1473) 160 mg twice daily for 24 weeks seemed to significantly improve urinary tract symptoms in men with BPH (Lopatkin et al, 2005). In another trial, an herbal product containing stinging nettle root extract 80 mg, saw palmetto lipoidal extract 106 mg, pumpkin seed oil extract 160 mg, lemon bioflavonoid extract 33 mg, and vitamin A (100% as beta-carotene) 190 IU taken three times daily for 6 months did not significantly improve symptoms of BPH (Marks et al, 2000).…”

“…Nair B, 2001;Inoue et al, 2002 Allergic reactions and conjunctivitis (Paulsen, 2002;De Smet, 2002) Warfarin Citochrome P450 (Segal and Pilote, 2006) Nettle Osteoarthritis. BPH Allergic rhinitis (hayfever) (Mittman, 1990;Lopatkin et al, 2005) Uterine-stimulant effects, it can induce abortion (Heinrich, 2003;Gagnier et al, 2006) None reported…”