Evidence map›Paper›PMID 26306400›Full record

Trial reportThe Prostate2015

Effects of hexanic extract of Serenoa repens (Permixon® 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia.

Alain Latil, Marie-Thérèse Pétrissans, Jérôme Rouquet, Grégoire Robert, Alexandre de la Taille

Open access · hybridAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Prostate, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 8% 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

33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Quantification of the Role of TeupolMedicina (Kaunas, Lithuania) · 2025
    Observational
  8. Article
  9. Review
  10. Effects of a proprietary mixture of extracts fromFrontiers in pharmacology · 2024
    Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Efficacy and Safety of the Hexanic Extract ofJournal of clinical medicine · 2022
    Article
  18. Article
  19. Article
  20. Article
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

5 authors at 4 institutions in 2 countries.

Alain LatilInstitut de Recherche Pierre Fabre, Toulouse, France.
Marie-Thérèse PétrissansInstitut de Recherche Pierre Fabre, Toulouse, France.
Jérôme RouquetInstitut de Recherche Pierre Fabre, Toulouse, France.
Grégoire RobertDepartment of Urology, Bordeaux Pellegrin University Hospital, Bordeaux, France.
Alexandre de la TailleDepartment of Urology and INSERM U955 Eq07, CHU Henri-Mondor, Créteil, France.
Pierre Fabre (France) · FRHôpital Pellegrin · FRInserm · FRPierre Fabre (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic prostatic inflammation (CPI) could be a cause of symptomatic or complicated benign prostatic hyperplasia (BPH). In previous in vitro and in vivo studies, Hexanic Extract of Serenoa repens (HESr) namely Permixon(®) has demonstrated potent anti-inflammatory properties. With the aim to provide new insight onto HESr anti-inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms (LUTS) related to BPH using a non-invasive method and investigate links between biomarkers and clinical symptoms.

methodsAn international, randomized, double-blind, parallel-group, tamsulosin-controlled study was carried out in 206 men with BPH-related LUTS. Patients received oral daily HESr 320mg or tamsulosin 0.4 mg during 3 months. The first urine stream after digital rectal examination (DRE) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the glands and seminal plasma fluid after DRE. mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed.

resultsAt D90, a decrease in mean gene expression was observed for 65.4% of the markers detected in the HESr group versus 46.2% in the tamsulosin group. In the 15 most frequently expressed genes, this difference was higher (80% vs. 33% respectively). Three proteins (MCP-1/CCL2, IP-10/CXCL10, and MIF) were detected. At D90, a decrease in the number of patients who expressed MCP-1/CCL2 and IP-10/CXCL10 was observed only in the HESr group. Moreover, MIF expression was significantly reduced by HESr compared with tamsulosin (P = 0.007). Finally, in contrast to tamsulosin, the subgroup of patients treated by HESr and who over expressed MIF at baseline, had a higher response to the International Prostate Symptom Score (I-PSS) than those who did not over express this protein (mean I-PSS change: -6.4 vs. -4.5 respectively). As the study is exploratory, results should be confirmed in a powered clinical study.

conclusionsThese results showed for the first time at clinical level the anti-inflammatory properties of HESr, already indicated in BPH-related LUTS. Thus, HESr could be of interest to prevent unfavourable evolution in patients with CPI.

Indexed as

SerenoaAgedAndrogen AntagonistsBiomarkersDouble-Blind MethodHumansInflammationLower Urinary Tract SymptomsMaleMiddle AgedPlant ExtractsProstatic HyperplasiaSulfonamidesTamsulosinTreatment OutcomeAndrogen AntagonistsBiomarkersPlant Extractssaw palmetto extractSulfonamidesTamsulosinbenign prostatic hyperplasiachronic prostatic inflammationhexanic extract of serenoa repenslower urinary tract symptomspermixon®

Identifiers

PMID26306400
PMCPMC5049653
OpenAlexW1947343385

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.