Epilobium angustifolium L. extract with high content in oenothein B on benign prostatic hyperplasia: A monocentric, randomized, double-blind, placebo-controlled clinical trial
Abstract
Benign prostatic hyperplasia (BPH) is a common condition in adult men. Especially in Europe, increasing attention has been focused on E. angustifolium extracts (EAEs), which are widely used for their positive effects on the symptoms of BPH, although human
clinical trials are limited.
The aim of this monocentric, randomized, double-blind, placebo-controlled clinical trial is to evaluate if a daily intake of hard, gastric-resistant capsules containing a chemically characterized EAE (500 mg) for 6 months may allow a significant improvement in symptoms in subjects with BPH.
This study was conducted on 128 adult men, randomly assigned to receive either an EAE food supplement (N = 70) or placebo (N = 58), who underwent four visits (baseline = t0, after 15 days = t1, after 2 months = t2 and after 6 months = t3) in an outpatient setting to evaluate post-void residual (PVR) and prostate volume (PV) by means of prostate ultrasound, prostate-specific antigen (PSA) and neutrophil/lymphocyte ratio (N/L), nocturia before the clinical visits and International Prostate-Specific Score (IPSS) registered by the physicians.
EAE food supplement induced a significant decrease in the PVR and consequently nocturia improving the quality of life as suggested by the decrease of IPSS. No subjects reported adverse effects related to oral intake of EAE food supplements.
Moreover, EAE food supplements did not show hepatic or renal toxicity. In conclusion, EAE food supplements can be used in subjects with BPH, to improve their quality of life and general renal function.
Introduction
The American Urological Association Guidelines define benign prostatic hyperplasia (BPH) as a histologic diagnosis referring to the proliferation of smooth muscle and epithelial cells within the prostatic transition zone, often occurring in the second prostate growth phase which starts at about 25 years of age and continues during much of a man’s life.
Gontero et al estimated that BHP is present in 70% of adult males and yet the epidemiology of this condition is not well defined. Through systematic research of major scientific databases, a recent meta-analysis of 30 studies published by Nature in 2017, estimates a global BPH prevalence of 26.6%, ranging from 14.0% in individuals up to 40% and 36.8% in individuals aged 80 and older.
As the prostate enlarges, the gland presses against and pinches the urethra. The bladder wall becomes thicker and may lose the ability to empty completely, leaving some urine in the bladder.
The narrowing of the urethra can cause acute (AUR) and chronic urinary retention (CUR), the most important complications associated with BPH. The first one is a serious complication, which requires hospitalization, while the second may cause other complications including recurrent urinary tract infection, formation of bladder calculi, hematuria, and damage to the bladder wall and kidneys.
The most common symptoms of BHP include incomplete bladder emptying, nocturia (i.e., the need to urinate two or more times per night), dribbling at the end of the urinary stream, incontinence or leakage of urine, the need to strain when urinating, a weak urinary stream, a sudden urge to urinate, a slowed or delayed urinary stream, painful urination, and blood in the urine.
Moreover, there is an important association between benign prostatic hyperplasia/bladder outflow obstruction (BPH/BOO) and male erectile dysfunction. Literature data obtained from clinical trials suggest that the incidence of these complications is low, but, unfortunately, this is enough for them to occur regularly in real life.
Studies
Anti-oxidant activity: Epilobium angustifolium L. pre-treatment of prostate cells (LNCap) enhances cellular antioxidant defense by increasing SOD-1 protein and mRNA levels. SOD-1 is one of the most important endogenous antioxidant defense mechanisms.
[caption id="attachment_144987" align="aligncenter" width="351"]
Anti-Inflammation activity: Epilobium angustifolium L. pre treatment in prostate cells (LNCap) reduces the inflammatory response by decreasing the TNFα protein level. TNFα is one of the most important pro-inflammatory cytokines.[/caption]
Clinical Trial
Monocentric, randomized, double-blind, placebo-controlled clinical trial on Epilobium angustifolium L. extract (EAE) was carried out on 128 subjects with Benign Prostatic Hyperplasia.
The International Prostate-Specific Score (IPSS) is a validated questionnaire to assess BHP symptoms in men with urinary complaints. The score can range from 0 to 35, indicating asymptomatic to very symptomatic subjects. The results are represented by arrows to indicate generally the QoL (Quality of Life) of participants.
IPSS score significantly decreased by nearly 2 points between t0 and t3 in the Epilobium angustifolium L. treated group and slightly increased (0.6 points) in the placebo group, showing an improvement in the quality of life of the subjects treated with the Epilobium angustifolium L. and highlighting the protective effect of this supplementation.
Subjects with BPH may have difficulties in bladder emptying. The narrowing of the urethra may cause acute/chronic urinary retention, which is the most important complication associated with BPH. The bladder post-void residual volume (PVR) was monitored by prostate ultrasound to assess the efficiency of bladder emptying.
Nocturia (the need to urinate two or more times per night) is a serious problem with a high impact on the quality of sleep, leading to sleep disorders, decreased quality of life, and depression.
In the Epilobium angustifolium L.. group the number of subjects with a low residual urine volume in the bladder significantly increased, while there was a decreasing frequency of subjects with residual urine volume higher than 100 ml.
In the Epilobium angustifolium L. group, the frequency of subjects without urination overnight increased by 21,7%, whereas it decreased by 10.2% in the placebo group. Moreover, the number of subjects urinating three or more times per night was completely wiped out in the treated group but remained unchanged in the placebo group.
Conslusions
In conclusion, the metabolic profile of EAE reveals the presence of a rich phytocomplex with different polyphenol species, including many compounds not yet identified in E. angustifolium extracts.
The presence of oenothein A and B, which are converted by gut fermentation into urolithins, whose anti-inflammatory activity is known, suggests that EAE food supplement can exert its beneficial effect against BPH through an anti-inflammatory action.
The results showed that E. angustifolium food supplements can be used in subjects with BPH, to improve their quality of life by reducing post-void residual volume and consequently nocturia and general renal function without hepatic or renal toxicity.
Source
Cristina Esposito, Cristina Santarcangelo, Raffaello Masselli, Giuseppe Buonomo, Giovanna Nicotra, Violetta Insolia, Maria D’Avino, Giuseppe Caruso, Antonio Riccardo Buonomo, Roberto Sacchi, Eduardo Sommella, Pietro Campiglia, Gian Carlo Tenore, Maria Daglia / Epilobium angustifolium L. extract with high content in oenothein B on benign prostatic hyperplasia: A monocentric, randomized, double-blind, placebo-controlled clinical trial, Biomedicine & Pharmacotherapy, Volume 138, 2021, 111414 / ISSN 0753-3322, https://doi.org/10.1016/j.biopha.2021.111414. (https://www.sciencedirect.com/science/article/pii/S0753332221001992)
Translation and Compilation:
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Arerko Kimya
