Trial reportJournal of translational medicine2021
Improvement of urinary tract symptoms and quality of life in benign prostate hyperplasia patients associated with consumption of a newly developed whole tomato-based food supplement: a phase II prospective, randomized double-blinded, placebo-controlled study.
Trial report in Journal of translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.
- Potential Efficacy of Polyphenols and Isothiocyanates in the Management of Genitourinary Diseases: A Systematic Review of Preclinical and Clinical Studies.International journal of molecular sciences · 2026Pooled it
- Influence of Lycopene Intake on Mental Health: A Systematic Review of Randomized Controlled Trials (RCTs).Nutrients · 2025Pooled it
- A step forward in enhancing the health-promoting properties of whole tomato as a functional food to lower the impact of non-communicable diseases.Frontiers in nutrition · 2025Review
- Prostogrit mitigates testosterone/estradiol induced prostatic enlargement/remodeling in rat model of benign prostatic hyperplasia and fine-tunes prostatic expression ofFrontiers in endocrinology · 2025Article
- Improving Whole Tomato Transformation for Prostate Health: Benign Prostate Hypertrophy as an Exploratory Model.International journal of molecular sciences · 2023Review
- Overview of BPH: Symptom Relief with Dietary Polyphenols, Vitamins and Phytochemicals by Nutraceutical Supplements with Implications to the Prostate Microbiome.International journal of molecular sciences · 2023Review
- Lipidic extract of whole tomato reduces hyperplasia, oxidative stress and inflammation on testosterone-induced BPH in obese rats.International urology and nephrology · 2023Article
- FruHis significantly increases the anti-benign prostatic hyperplasia effect of lycopene: A double-blinded randomized controlled clinical trial.Frontiers in nutrition · 2022Article
- Treatment of Benign Prostatic Hyperplasia by Natural Drugs.Molecules (Basel, Switzerland) · 2021Review
- Tomato and Olive Bioactive Compounds: A Natural Shield against the Cellular Effects Induced by β-Hexachlorocyclohexane-Activated Signaling Pathways.Molecules (Basel, Switzerland) · 2021Article
- Prostate Artery Embolization Using N-Butyl Cyanoacrylate Glue for Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Valid Alternative to Microparticles?Journal of clinical medicine · 2021Article
Corrections and comments
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Authors and funding
12 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBenign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients' quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH.
methodsForty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for 2 months a sachet (5 g) of a newly developed whole tomato food supplement (WTFS) (treatment = Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score (IPSS) questionnaire before and after treatment.
resultsAll but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (P < 0.0002) LUTS since mean IPSS decreased from 9.05 ± 1.15 to 7.15 ± 1.04 (paired t-test, two-tailed P-value < 0.001), and improved life quality (P < 0.0001). A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/mL ± 1.52 vs 6.95 ± 0.76, P = 0.065), with changes being statistically significant only in the subgroup of patients with baseline levels above 10 ng/mL (18.5 ng/mL ± 2.7 vs 10.3 ± 2.1, P = 0.009).
conclusionsThe new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients.
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Registered trials
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.