Evidence map›Paper›PMID 18038253›Full record

Trial reportInternational urology and nephrology2007

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.

Nikolai Lopatkin, Andrey Sivkov, Sandra Schläfke, Petra Funk, Alexander Medvedev, Udo Engelmann

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International urology and nephrology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. American palm ethnomedicine: a meta-analysis.Journal of ethnobiology and ethnomedicine · 2009
    Pooled it
  3. Effects of a proprietary mixture of extracts fromFrontiers in pharmacology · 2024
    Article
  4. Review
  5. Review
  6. International journal of molecular sciences · 2020
    Article
  7. CombinedFrontiers in pharmacology · 2019
    Article
  8. Article
  9. Article
  10. Phytotherapy: emerging therapeutic option in urologic disease.Translational andrology and urology · 2012
    Review
  11. Review
  12. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Nikolai LopatkinInstitute of Urology, 3rd Parkovaya Street 51, 105425, Moscow, Russia, avsivkoff@yandex.ru.
Andrey Sivkov
Sandra Schläfke
Petra Funk
Alexander Medvedev
Udo Engelmann
Dr Willmar Schwabe (Germany) · DEInstitute of Experimental Cardiology · RUUniversity Hospital Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 x 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.

Indexed as

SerenoaUrtica dioicaAgedDisease ProgressionDouble-Blind MethodFollow-Up StudiesHumansMalePhytotherapyPlant ExtractsProstatic HyperplasiaSeverity of Illness IndexStatistics, NonparametricTime FactorsTreatment OutcomeUrination DisordersPlant Extracts

Identifiers

PMID18038253
OpenAlexW2013305107

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.