Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial
| Autor: | Nikolai Lopatkin, Andrey Sivkov, Alexander Medvedev, Udo Engelmann, Petra Funk, Sandra Schläfke |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Urology Prostatic Hyperplasia Placebo Severity of Illness Index Statistics Nonparametric law.invention Double-Blind Method Randomized controlled trial Serenoa law Lower urinary tract symptoms Multicenter trial medicine Humans Adverse effect Aged biology Plant Extracts business.industry Urtica dioica Urination Disorders biology.organism_classification medicine.disease Surgery Urodynamics Treatment Outcome Tolerability Nephrology Disease Progression International Prostate Symptom Score business Follow-Up Studies Phytotherapy |
| Zdroj: | International Urology and Nephrology. 39:1137-1146 |
| ISSN: | 1573-2584 0301-1623 |
| DOI: | 10.1007/s11255-006-9173-7 |
| Popis: | In an open-label extension of a randomized, double-blind clinical trial, the long-term 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) were investigated in elderly men with moderate or severe lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Two hundred and fifty-seven patients were randomly treated with 2 × 1 capsule/day PRO 160/120 or placebo for 24 weeks, followed by a 24-week control period and a 48-week follow-up period in which all patients received PRO 160/120. Efficacy measures included the assessment of LUTS [International Prostate Symptom Score ((I-PSS) self-rating questionnaire] and uroflow and sonographic parameters. Two hundred and nineteen subjects participated in the follow-up. Between baseline and end of observation (week 96) the I-PSS total score was reduced by 53% (P < 0.001), peak and average urinary flow increased by 19% (P < 0.001), and residual urine volume decreased by 44% (P = 0.03). The incidence of adverse events during follow-up was one in 1,181 treatment days; in only one event a causal relationship with intake of PRO 160/120 could not be excluded. Treatment with PRO 160/120 thus provides a clinically relevant benefit over a period of 96 weeks. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink