Abstract
Purpose
To evaluate the efficacy and safety of Prunella vulgaris (PV) extract in men with lower urinary tract symptoms (LUTS).
Materials and Methods
In this 12-week, randomized, double-blind, placebo-controlled clinical trial, 80 men aged 40–75 years with moderate LUTS (International Prostate Symptom Score [IPSS] ≥8 and ≤19) were randomized to receive PV extract (600 mg/day) or placebo. The primary outcome was the change in total IPSS from baseline to week 12. Secondary outcomes included changes in IPSS subscores, quality of life (QoL), uroflowmetry, and prostate volume. Safety was assessed by adverse events and laboratory parameters.
Results
A total of 75 participants completed the trial (PV group, n=39; placebo group, n=36). At week 12, the PV group showed a significantly greater reduction in total IPSS compared to placebo (-5.2±4.6 vs. -2.8±4.3; p=0.014). Significant improvements were also observed in voiding subscore (-3.3±3.7 vs. -1.6±3.2; p=0.020) and QoL (-1.2±1.4 vs. -0.7±1.3; p=0.044). There were no significant differences in maximum flow rate or prostate volume. The incidence of adverse events was low and similar between groups.
Conclusions
PV extract improved LUTS and QoL in men with LUTS was well tolerated. These findings suggest its potential as a safe and effective phytotherapeutic option for managing male LUTS.
Keywords: Lower urinary tract symptoms, Phytotherapy, Prunella, Randomized controlled trial
INTRODUCTION
Lower urinary tract symptoms (LUTS) in men encompass a range of urinary disturbances that can significantly impair quality of life (QoL) [1]. These symptoms, including urinary frequency, urgency, hesitancy, and nocturia, may stem from various causes such as aging, lifestyle factors, and neurological conditions [2]. While conventional pharmacologic treatments like alpha-adrenergic blockers and 5-alpha reductase inhibitors (5-ARI) are widely prescribed, they are often associated with side effects, including hypotension, sexual dysfunction, and retrograde ejaculation [3]. Consequently, there has been increasing interest in alternative therapeutic approaches, particularly phytotherapeutics, due to their potential efficacy and favorable safety profiles [4].
Prunella vulgaris (PV), commonly known as self-heal, is a perennial herb widely distributed across temperate regions and traditionally utilized for its anti-inflammatory, antioxidant, and antimicrobial effects. The major bioactive compounds of PV, such as rosmarinic acid, ursolic acid, and oleanolic acid, have demonstrated various pharmacological activities, including antioxidative stress, anti-proliferative, and apoptosis-inducing effects in various preclinical studies. Specifically, rosmarinic acid has been recognized as a potent antioxidant protecting against free radical-related pathologies, while ursolic acid exhibits notable anti-inflammatory and antineoplastic activities [5]. Notably, a previous animal study demonstrated that PV ameliorated LUTS induced by benign prostatic hyperplasia (BPH) in Sprague Dawley rats via nitric oxide modulation and potassium channel activation [6].
In this randomized, double-blind, placebo-controlled clinical trial, our goal is to evaluate the efficacy and safety of PV extract in alleviating male LUTS. By meticulously investigating a phytotherapeutic intervention targeting both prostate health and urinary function, this study seeks to expand the evidence base for natural treatments in managing LUTS while dampening the adverse effects associated with conventional pharmacotherapies [7].
MATERIALS AND METHODS
1. Ethics statement
This trial was approved by the Institutional Review Board (IRB) of Catholic University of Korea (IRB no: KC23HOSE0466). It was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines. Also, the study was approved by the Clinical Research Information Service of South Korea (CRIS no: KCT0010552). Informed consent was obtained from the participants for the study and publication of the study.
2. PV extract preparation
PV extract (HFN2-007) was sourced from a local herbal market in Jecheon, Chungbuk, Republic of Korea. A reference specimen (no. 2022-HF001) was authenticated and archived at the College of Pharmacy, Hanyang University, Seoul, Republic of Korea [6]. The extraction process involved macerating dried PV spikes in 70% ethanol at 50 ℃ for 8 hours, followed by a second extraction using 50% ethanol at the same temperature for 15 hours. The combined extracts were concentrated under reduced pressure and subsequently freeze-dried. The final PV extract was manufactured at Huons Foodience in compliance with good manufacturing practice guidelines and stored at -20 ℃ for future use.
1) Study drug and dosing
Participants in the intervention group received 600 mg/day of PV extract, administered orally for 12 weeks. The dosage was determined based on a prior preclinical study in which PV extract exhibited therapeutic effects in a testosterone-induced benign BPH rat model at doses of 30–90 mg/kg [5]. Using a standard body surface area-based human equivalent dose (HED) conversion, the median animal dose corresponds to approximately 600 mg/day in a 60 kg adult male. Furthermore, this dosage was confirmed to be safe and well-tolerated in an internal pilot tolerability assessment involving healthy adult volunteers. These considerations supported the selection of 600 mg/day as the investigational dose in this clinical trial.
3. Inclusion criteria
Participants in this human clinical trial were selected based on the following criteria: (1) Males aged between 40 and 80 years. (2) Individuals with an International Prostate Symptom Score (IPSS) ranging from 8 to 19, indicating moderate symptoms.
4. Exclusion criteria
Participants meeting any of the following conditions were excluded from the study: (1) Individuals undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, nervous, musculoskeletal, psychiatric, infectious diseases, or malignancies. (2) Individuals with a serum prostate specific antigen (PSA) level of 4.0 ng/mL or higher. (3) Individuals with a maximum urinary flow rate (Qmax) of less than 5 mL/sec. (4) Individuals with a post-void residual volume (PVR) exceeding 150 mL. (5) Individuals who have undergone prostate-related surgical or invasive procedures, including transurethral incision, laser prostatectomy, or other interventional prostate treatments. (6) Individuals diagnosed with prostatitis, urinary tract infection, acute urinary retention, neurogenic bladder, bladder tumor, urolithiasis, urethral stricture, bladder neck contracture, lower urinary tract inflammation, urinary tuberculosis, prostate cancer, or bladder cancer. (7) Individuals with biliary obstruction, gallbladder abscess, intestinal obstruction, or gallstone disease. (8) Individuals who have taken antiandrogen agents or luteinizing hormone-releasing hormone analogs within four weeks prior to Visit 1. (9) Individuals who have taken medications for BPH treatment (e.g., 5-ARI, alpha-adrenergic blockers, anticholinergics, antimuscarinic agents) or prostate health supplements (e.g., saw palmetto) within four weeks prior to Visit 1. (10) Individuals who have taken nonsteroidal anti-inflammatory drugs, corticosteroids, systemic antibiotics, mepartricin, angiotensin-converting enzyme inhibitors, calcium channel blockers, diuretics, sympathomimetics, antihistamines, antidepressants, atropine, antispasmodics, antiparkinsonian agents, pseudoephedrine, chlorpheniramine, or spironolactone within four weeks prior to Visit 1. (11) Individuals with aspartate aminotransferase (glutamic oxalacetic tranaminase) or alanine aminotrasferase (glutamic pyruvate transaminase) levels exceeding three times the upper limit of normal. (12) Individuals with serum creatinine levels exceeding twice the upper limit of normal. (13) Individuals with thyroid-stimulating hormone levels below 0.1 uIU/mL or above 10 uIU/mL. (14) Individuals with uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg, measured after 10 minutes of rest. (15) Individuals with uncontrolled diabetes, defined as HbA1c >10% or fasting blood glucose ≥180 mg/dL, or those who initiated diabetes medication within the past three months. (16) Individuals who have participated in any other interventional clinical trial within the past three months prior to Visit 1 or plan to participate in another interventional trial during this study.
5. Outcome measurements
The primary outcome measure was the change in the IPSS scores from baseline to the end of the 12-week treatment period. Secondary outcomes included changes in International Index of Erectile Function (IIEF) scores, Qmax, PVR, along with serum PSA and testosterone levels. Additionally, safety assessment was evaluated according to adverse events (AEs). Hematology, biochemistry, urinalysis, and vital signs were monitored to evaluate the safety profile of PV extract.
6. Data analysis
Data analysis was performed using intention-to-treat principles. The primary endpoint, change in IPSS, was analyzed using a paired t-test to evaluate within-group changes and an analysis of variance to compare between the PV extract and placebo groups. Secondary outcomes were analyzed using the same statistical methods, depending on data distribution. Statistical significance was set at p<0.05.
7. Reasons for setting the intake amount
Based on the results of previous studies, the effective dosage of PV extract in animal experiments ranged from 60 mg/kg to 150 mg/kg for the evaluation of its ameliorative effects on BPH. The optimal dose was determined to be 60 mg/kg. When applying the HED calculation, the estimated human dosage was 9.73 mg/kg. Considering a standard adult body weight of 60 kg, the final daily intake for this human clinical trial was set at 550 mg/day.
RESULTS
1. Baseline characteristics and participant distribution
From October 10, 2023, with the enrollment of the first participant, and concluded on October 8, 2024, with the final participant’s completion.
Baseline characteristics, including age, alcohol consumption, smoking status, physical activity, height, and weight, were collected at screening. The mean age of participants was 53.87±8.64 years in the HFN2-007 group and 56.51±12.42 years in the placebo group (p=0.6142), indicating no significant difference between groups. Other baseline variables were also comparable between groups, confirming homogeneity of the study population before an intervention.
A total of 92 participants underwent screening to determine eligibility for the study. Among them, 12 participants were excluded based on the screening criteria, resulting in 80 participants being randomly assigned to either the experimental group (n=40) or the control group (n=40). During the trial, one participant from the experimental group and four participants from the control group withdrew their consent, leading to a total of five dropouts. Consequently, 75 participants successfully completed the study, with 39 in the experimental group and 36 in the control group. The CONSORT diagram is shown in Fig. 1.
Fig. 1. CONSORT diagram of patient disposition.
2. Primary endpoints
1) Changes in IPSS total score
The IPSS total score showed a significant improvement in the HFN2-007 group compared to the placebo group throughout the study period. At baseline, there was no significant difference between the two groups (HFN2-007: 10.85±2.03 vs. placebo: 11.63±2.78; p=0.2799). However, after 6 weeks of treatment, the IPSS total score significantly decreased in both groups, with a greater reduction observed in the HFN2-007 group (-5.67±2.81) compared to the placebo group (-2.89±3.32; p<0.0001). At 12 weeks, the reduction was even more pronounced in the HFN2-007 group (-6.85±3.45) compared to the placebo group (-1.46±3.43; p<0.0001). These results indicate that HFN2-007 supplementation led to a significant improvement in overall LUTS severity compared to the placebo.
2) Changes in IPSS subscores
Analysis of individual IPSS subscores revealed significant symptom improvements in the HFN2-007 group across multiple domains (Table 1).
Table 1. Changes in IPSS total score and IPSS subscores of each group.
| HFN2-007 (n=39) | Placebo (n=35) | p-valuea | ||
|---|---|---|---|---|
| IPSS total | 10.85±2.03 | 11.63±2.78 | 0.2799 | |
| Δ6 wk | -5.67±2.81 | -2.89±3.32 | <0.0001 | |
| Δ12 wk | -6.85±3.45 | -1.46±3.43 | <0.0001 | |
| Incomplete emptying | 2.03±0.84 | 2.26±0.92 | 0.4639 | |
| Δ6 wk | -1.13±1.03 | -0.66±1.16 | 0.0084 | |
| Δ12 wk | -1.28±0.86 | -0.26±0.89 | <0.0001 | |
| Frequency | 1.15±0.90 | 1.31±1.02 | 0.4464 | |
| Δ6 wk | -0.51±0.82 | -0.40±0.85 | 0.2303 | |
| Δ12 wk | -0.77±1.04 | -0.17±0.86 | <0.0001 | |
| Intermittency | 1.90±0.91 | 1.94±1.16 | 0.8375 | |
| Δ6 wk | -0.87±1.00 | -0.40±0.91 | 0.0252 | |
| Δ12 wk | -1.18±0.91 | -0.26±0.92 | <0.0001 | |
| Urgency | 0.79±0.92 | 0.94±1.06 | 0.6237 | |
| Δ6 wk | -0.56±0.82 | -0.40±0.88 | 0.0622 | |
| Δ12 wk | -0.62±0.94 | -0.17±0.95 | 0.0016 | |
| Weak stream | 2.56±1.02 | 2.86±0.91 | 0.2465 | |
| Δ6 wk | -1.13±1.13 | -0.74±1.09 | 0.0306 | |
| Δ12 wk | -1.28±1.17 | -0.43±1.04 | <0.0001 | |
| Straining | 1.26±0.97 | 0.91±0.89 | 0.1181 | |
| Δ6 wk | -0.90±0.99 | -0.17±0.98 | 0.0066 | |
| Δ12 wk | -1.03±0.96 | -0.14±0.77 | <0.0001 | |
| Nocturia | 1.15±0.78 | 1.40±0.81 | 0.1927 | |
| Δ6 wk | -0.56±0.68 | -0.11±0.90 | 0.0009 | |
| Δ12 wk | -0.69±0.77 | -0.03±0.82 | <0.0001 | |
| Quality of life | 3.64±0.49 | 3.71±0.52 | 0.5793 | |
| Δ6 wk | -1.05±0.79 | -0.46±0.78 | 0.0008 | |
| Δ12 wk | -1.31±0.95 | -0.31±0.76 | <0.0001 | |
Values are presented as mean±standard deviation.
IPSS: International Prostate Symptom Score, Δ: score changes from the baseline.
aCompared between two groups (ANCOVA adjusted baseline).
(1) Incomplete emptying
The HFN2-007 group showed a significant reduction at 6 weeks (-1.13±1.03 vs. -0.66±1.16; p=0.0084) and at 12 weeks (-1.28±0.86 vs. -0.26±0.89; p<0.0001) compared to the placebo group.
(2) Frequency
Although both groups exhibited a reduction in urinary frequency, the decrease was significantly greater in the HFN2-007 group at 12 weeks (-0.77±1.04 vs. -0.17±0.86; p<0.0001).
(3) Intermittency
A notable improvement was observed in the intermittency subscore at 12 weeks (-1.18±0.91 vs. -0.26±0.92; p<0.0001).
(4) Urgency
The urgency subscore showed a significant reduction in the HFN2-007 group compared to the placebo at 12 weeks (-0.62±0.94 vs. -0.17±0.95; p=0.0016).
(5) Weak stream
The weak stream subscore demonstrated a substantial improvement in the HFN2-007 group at both 6 weeks (-1.13±1.13 vs. -0.74±1.09; p=0.0306) and 12 weeks (-1.28±1.17 vs. -0.43±1.04; p<0.0001).
(6) Straining
The reduction in the straining subscore was significantly greater in the HFN2-007 group at 12 weeks (-1.03±0.96 vs. -0.14±0.77; p<0.0001).
(7) Nocturia
The HFN2-007 group exhibited a significant improvement in nocturia compared to the placebo group at both 6 weeks (-0.56±0.68 vs. -0.11±0.90; p=0.0009) and 12 weeks (-0.69±0.77 vs. -0.03±0.82; p<0.0001).
(8) Quality of life
The QoL score significantly improved in the HFN2-007 group, with a reduction of -1.31±0.95 at 12 weeks, whereas the placebo group showed only a minimal decrease (-0.31±0.76; p<0.0001).
Fig. 2 shows changes of IPSS total score, IPSS QoL subscore, IPSS voiding subscore (sum of incomplete emptying, intermittency, weak stream, and straining subscores), and IPSS storage subscore (sum of frequency, urgency, and noctura subscores).
Fig. 2. Changes in International Prostate Symptom Score (IPSS) for each group. (A) IPSS total score, (B) IPSS quality of life (QoL), (C) IPSS voiding, and (D) IPSS storage.
3. Secondary endpoints
1) Changes in IIEF total and subscores
Changes in sexual function as measured by the IIEF total and subscores showed no statistically significant differences between the HFN2-007 and placebo groups at both 6 and 12 weeks. While both groups exhibited slight improvements in total and domain-specific scores—including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction—none of the changes were significantly different between groups over time (Table 2).
Table 2. Changes in the IIEF scores of each group.
| HFN2-007 (n=39) | Placebo (n=35) | p-valuea | ||
|---|---|---|---|---|
| IIEF total | 29.54±19.87 | 27.51±19.26 | 0.9308 | |
| Δ6 wk | 10.15±19.69 | 8.63±15.41 | 0.5863 | |
| Δ12 wk | 5.44±16.01 | 1.60±17.68 | 0.2695 | |
| Erectile function | 11.18±10.40 | 9.94±9.96 | 0.4475 | |
| Δ6 wk | 5.10±10.53 | 4.51±8.65 | 0.6523 | |
| Δ12 wk | 2.85±8.61 | 0.80±9.66 | 0.2651 | |
| Orgasmic function | 3.26±3.96 | 2.86±3.83 | 0.7221 | |
| Δ6 wk | 1.62±4.11 | 1.49±3.19 | 0.7376 | |
| Δ12 wk | 0.85±3.10 | 0.17±3.54 | 0.3062 | |
| Sexual desire | 6.28±1.61 | 6.34±1.70 | 0.7691 | |
| Δ6 wk | 0.82±1.41 | 0.54±1.40 | 0.3363 | |
| Δ12 wk | 0.44±1.59 | 0.23±1.37 | 0.5341 | |
| Intercourse satisfaction | 3.36±4.18 | 2.94±3.94 | 0.7393 | |
| Δ6 wk | 1.77±4.36 | 1.69±3.29 | 0.7914 | |
| Δ12 wk | 0.97±3.54 | 0.34±3.78 | 0.3747 | |
| Overall satisfaction | 5.46±1.41 | 5.43±1.74 | 0.9598 | |
| Δ6 wk | 0.85±1.57 | 0.40±1.31 | 0.1200 | |
| Δ12 wk | 0.33±1.36 | 0.06±1.14 | 0.3016 | |
Values are presented as mean±standard deviation.
IIEF: International Index of Erectile Function, Δ: score changes from the baseline.
aCompared between two groups (ANCOVA adjusted baseline).
2) Changes in PSA, total testosterone, dihydrotestosterone, Qmax, and PVR
There were no statistically significant differences between the HFN2-007 and placebo groups in changes from baseline to week 12 for serum PSA, total testosterone, and dihydrotestosterone (DHT) levels. The baseline total testosterone levels were lower in the HFN2-007 group (4.42±1.26 ng/mL) compared to the placebo group (5.14±1.50 ng/mL; p=0.0283); however, the change at 12 weeks was not significantly different between groups (HFN2-007: -0.13±1.14 vs. placebo: 0.02±1.18; p=0.2292). Similarly, changes in Qmax and PVR did not differ significantly between the two groups. Changes in PSA, total testosterone, DHT, Qmax, and PVR of each group are summarized in Table 3.
Table 3. Changes in PSA, total testosterone, DHT, Qmax, and PVR.
| HFN2-007 (n=39) | Placebo (n=35) | p-valuea | ||
|---|---|---|---|---|
| PSA (ng/mL) | 0.82±0.44 | 1.07±0.64 | 0.0698 | |
| Δ12 wk | -0.03±0.15 | 0.06±0.49 | 0.2543 | |
| Total T (ng/mL) | 4.42±1.26 | 5.14±1.50 | 0.0283 | |
| Δ12 wk | -0.13±1.14 | 0.02±1.18 | 0.2292 | |
| DHT (pg/mL) | 294.74±124.59 | 294.45±82.28 | 0.5230 | |
| Δ12 wk | -38.00±63.38 | -22.94±92.50 | 0.3689 | |
| Qmax (mL/sec) | 15.27±7.96 | 15.57±7.49 | 0.6728 | |
| Δ12 wk | 2.81±8.05 | 1.07±8.06 | 0.3491 | |
| PVR (mL) | 16.18±22.46 | 16.03±29.55 | 0.6552 | |
| Δ12 wk | -9.54±28.13 | 10.63±68.71 | 0.0861 | |
Values are presented as mean±standard deviation.
PSA: prostate specific antigen, Total T: total testosterone, DHT: dihydrotestosterone, Qmax: maximum urinary flow rate, PVR: post-void residual volume, Δ: score changes from the baseline.
aCompared between two groups (ANCOVA adjusted baseline).
4. Safety assessment
Throughout the 12-week study period, no AEs were reported in the HFN2-007 group. In contrast, the placebo group reported one mild case of a dermatological event (onychomycosis), which was determined to be unrelated to the test product. Importantly, no serious AEs were observed in either group, and no participants discontinued the study due to AEs. A statistically significant difference between groups was found regarding serum sodium concentrations; however, values remained within the clinically normal range for both groups, indicating no clinical relevance. Other hematological parameters, blood chemistry, and urinalysis results showed no significant intergroup differences. No significant differences between groups were observed in vital signs (blood pressure, pulse rate) and anthropometric measurements (body weight). Additionally, electrocardiographic evaluations conducted at baseline and after 12 weeks demonstrated normal findings in both groups.
DISCUSSION
PV extract has recently been shown to exert significant therapeutic effects in an animal model of BPH through multiple molecular mechanisms. Not only does it exert anti-androgenic effects by regulating serum levels of DHT and testosterone, but it simultaneously inhibits the proliferation of prostatic epithelial cells and induces apoptosis. To elaborate on, it suppresses cell proliferation by downregulating cyclin D1 and proliferating cell nuclear antigen expression, and promotes apoptosis via increased cleaved caspase-3 expression and TUNEL-positive cell counts. Moreover, it downregulates the expression of growth factors such as insulin-like growth factor-2, transforming growth factor-β, and fibroblast growth factor, and inhibits the phosphorylation of c-Jun N-terminal kinase, thereby modulating multiple signaling pathways associated with prostatic hyperplasia [5].
HFN2-007 supplementation resulted in notable reductions in total IPSS scores, with participants transitioning from moderate to mild symptomatology. This improvement was particularly evident in symptoms of incomplete emptying, frequency, intermittency, urgency, weak stream, hesitancy, and nocturia. Moreover, the PV extract showed an ability to enhance urinary flow rates, although the differences did not reach statistical significance compared to placebo, suggesting potential improvements in bladder function that require further investigation with larger cohorts.
5-ARIs, such as finasteride and dutasteride, have demonstrated efficacy in alleviating LUTS associated with BPH, with reported improvements in IPSS total scores of approximately 4.1 points. In current study, the PV group demonstrated a mean reduction of 6.85 points in IPSS total score after 12 weeks, which exceeds the average reduction reported with 5-ARI in previous trials. However, this comparison should be interpreted with caution, as it is based on findings from separate studies with differing designs, patient populations, and evaluation methods. Rather than suggesting superior efficacy, our result underscores the potential clinical relevance of PV as a phytotherapeutic option for managing LUTS [8]. Notably, HFN2-007 did not influence serum PSA, testosterone, or DHT levels, suggesting that the symptomatic relief might be rendered without obviating or hindering access to hormonal profiles or prostate cancer screening [9]. These characteristics, therefore, may position HFN2-007 as a more promising therapeutic option, particularly for patients pursuing effective symptom management with a low risk of sexual or hormonal side effects [10].
A recent meta-analysis indicated that Serenoa repens resulted in clinically minimal changes in IPSS scores at short-term follow-up (mean deviation, -0.90; 95% confidence interval, -1.74 to -0.07), with negligible differences in QoL and AEs compared to placebo [11]. In contrast, HFN2-007 treatment for 12 weeks resulted in a significant reduction in total IPSS scores compared to the placebo group (6.85±3.45 vs. 1.46±3.43; p<0.0001), accompanied by marked improvements across individual LUTS domains, including urinary frequency, intermittency, weak stream, and nocturia. These findings suggest that HFN2-007 is at least comparable, and potentially superior, to S. repens as a therapeutic option for managing LUTS associated with BPH.
Safety assessments during the 12-week supplementation revealed no significant AEs attributed to HFN2-007. Mild AEs observed in the placebo group were deemed unrelated to the investigational product. These findings reinforce the safety profile of PV extracts, aligning with its historical and widespread usage in traditional medicine for various inflammatory and proliferative conditions.
However, this study conveys several limitations. First, prostate volume was not measured using transrectal ultrasonography, a decision made to enhance participant comfort and facilitate recruitment. Second, although the HFN2-007 group showed trends toward improvement in Qmax and PVR, these changes did not reach statistical significance. This is consistent with the previous findings in phytotherapeutic research [2], where the symptom relief—as measured by IPSS—is often observed without corresponding changes in uroflowmetry parameters. Yet, notwithstanding some shortcomings imposed, it is not implausible to deduce that more extended treatment durations, in turn, may potentially lead to measurable benefits in objective voiding parameters, when the binding facts are predicated upon the significant improvement in IPSS scores over a relatively short 12-week intervention.
To the best of our knowledge, this is the first randomized controlled trial to evaluate the efficacy of PV extract in men with LUTS. These findings, though inchoate, may become a cornerstone of conferring invaluable information for more personalized and integrative therapeutic strategies, thus stressing the potential role of phytotherapy as a complementary or alternative modality in managing LUTS.
CONCLUSIONS
This randomized, double-blind, placebo-controlled trial demonstrated that 12-week supplementation with HFN2-007 substantially improved LUTS in men, as evidenced by a greater reduction in IPSS scores and subscores compared to placebo, concomitant with improved QoL. These effects were achieved without significant changes in serum PSA, testosterone, or DHT levels, and no treatment-related AEs were observed, underscoring both the efficacy and safety of HFN2-007. Maneuvering its favorable benefit-risk profile, HFN2-007 may serve as a safe and effective phytotherapeutic option for men with LUTS seeking alternatives to conventional pharmacologic treatments.
Acknowledgements
None.
Footnotes
Conflict of Interest: Woong Jin Bae is an editorial board member of the journal but was not involved in the review process of this manuscript. Otherwise, there is no conflict of interest to declare.
Funding: This work was supported by the Starting Growth Technological R&D Program (TIPS Program [no. RS-2023-00285144]) funded by the Ministry of SMEs and Startups (MSS, Korea) in 2023.
- Conceptualization: SWK, MRJ.
- Formal analysis: YGK.
- Funding acquisition: SWK.
- Methodology: WJB.
- Project administration: SWK.
- Supervision: SK, HL.
- Writing – original draft: THK, DS.
- Writing – review & editing: all authors.
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