NICEVIVA
MONOGRAPH SPEC LATEST 2020

Nettle Root (Urtica)

BOTANICALS · Evidence Monograph

Nettle Root (Urtica) is an evidence-graded botanicals monograph evaluated across 11 peer-reviewed PubMed studies (0 meta-analyses, 0 systematic reviews, and 4 randomized controlled trials, encompassing n = 2,716 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 11 Studies
Meta-Analyses · Reviews 0 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 4 RCTs (8 Double-Blind)
Cumulative Participants n = 2,716
Reported Trial Dosages 450 mg · 160 mg · 120 mg
Trial Duration Range 12 weeks · 24 weeks · 96 weeks
Reading Time ~6 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 11 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (450 mg · 160 mg · 120 mg) over a structured 12 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (11 PubMed studies)
Quantitative biomarker & outcome analysis (9 studies with effect-size/sample data)
Randomized controlled trial verification (4 RCTs · 8 double-blind)
Systematic review & meta-analysis synthesis (0 meta-analyses · 0 reviews)
01

What Is Nettle Root (Urtica) & Why Does Form Matter?

Nettle Root (Urtica) is classified under BOTANICALS and has been investigated across 11 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (450 mg, 160 mg, 120 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Nettle Root (Urtica) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (4 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Nettle Root (Urtica) acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Nettle Root (Urtica) an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 11 PubMed studies: 0 meta-analyses, 0 systematic reviews, and 4 randomized controlled trials (8 double-blind, n = 2,716 total participants).

Representative peer-reviewed findings include: • PMID:15330011 (2004) — "Complementary and alternative interventions in asthma, allergy, and immunology." (CONCLUSION: The specialty of allergy and immunology has seen the second largest increase in the popularity of CAM (second only to practitioners who treat lower back pain).) • PMID:12807343 (2003) — "Long-term efficacy and safety of PRO 160/120 (a combination of sabal and urtica extract) in patients with lower urinary tract symptoms (LUTS)." ([email protected] DOI: 10.1078/1433-187x-00352 PMID: 12807343 [Indexed for MEDLINE]) • PMID:32981268 (2020) — "Urtica Dioica Root Extract on Clinical and Biochemical Parameters in Patients with Benign Prostatic Hyperplasia, Randomized Controlled Trial." (CONCLUSION: UDE consumption for 12 weeks among BPH patients had clinically significant effects on IPSS, serum hs-CRP, MDA and SOD activity.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 450 mg · 160 mg · 120 mg · 459 mg over 12 weeks · 24 weeks · 96 weeks · 18 months. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Nettle Root (Urtica), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (450 mg · 160 mg · 120 mg) and re-evaluate efficacy after 12 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (11 Studies) · 9 Quantitative Analyses

01
CLINICAL STUDY Annals of allergy, asthma & immunology (2004) PMID: 15330011 ↗
Complementary and alternative interventions in asthma, allergy, and immunology.
Clinical Trial Synthesis 2004 Clinical Study published in Annals of allergy, asthma & immunology. Key conclusion: CONCLUSION: The specialty of allergy and immunology has seen the second largest increase in the popularity of CAM (second only to practitioners who treat lower back pain).
View Original PubMed Abstract ↓

OBJECTIVE: To review which herbs are most commonly used as complementary and alternative medicine (CAM) for treatment of asthma, allergy, and immunologic conditions. DATA SOURCES: A review of the literature was performed using the PubMed and OVID databases searching the keywords asthma, allergy, and CAM to identify studies published between 1980 and 2003 that focused on Echinacea (Echinacea augustifolia, Echinacea pallida, and Echinacea purpurea); garlic (Allium); angelica; chamomile; ephedra; gingko; grape seed extract; licorice root (Glycyrrhiza); St. John's wort (Hypericum); kava kava (Piper); peppermint oil and leaf (Mentha); stinging nettle (Urtica); and ginseng (Panax) published in the English and German literature. STUDY SELECTION: Studies included in vitro and in vivo clinical trials and case reports selected according to the expert opinion of the author. RESULTS: Echinacea is one of the most common herbs used to treat symptoms of the "common cold" or upper respiratory tract allergies. Although no common drug interactions have been reported, there is a risk of hepatotoxicity, exacerbation of allergies and asthma, and anaphylactic reactions. Garlic is primarily used for cardiovascular health and relief of cough, colds, and rhinitis. Adverse effects commonly include gastrointestinal disturbances, change in body odor through the sweat and breath, and rarely allergic reactions or hypoglycemia. Other CAM agents, including angelica, German chamomile flower, ephedra, gingko, grape seed extract, licorice root, St. John's wort, kava kava rhizome, peppermint, stinging nettle, and ginseng, are also associated with significant adverse effects. CONCLUSION: The specialty of allergy and immunology has seen the second largest increase in the popularity of CAM (second only to practitioners who treat lower back pain). Almost all of the CAM interventions have displayed adverse effects, usually in the form of a hypersensitivity reaction. Allergists and clinical immunologists need to become more knowledgeable about CAM so that they can inform patients about the use and possible abuse of these modalities.

02
CLINICAL STUDY Phytomedicine (2003) PMID: 12807343 ↗
Long-term efficacy and safety of PRO 160/120 (a combination of sabal and urtica extract) in patients with lower urinary tract symptoms (LUTS).
Clinical Trial Synthesis 2003 Clinical Study published in Phytomedicine. Key conclusion: [email protected] DOI: 10.1078/1433-187x-00352 PMID: 12807343 [Indexed for MEDLINE]
View Original PubMed Abstract ↓

190. Phytomedicine. 2003;10 Suppl 4:53-5. doi: 10.1078/1433-187x-00352. Long-term efficacy and safety of PRO 160/120 (a combination of sabal and urtica extract) in patients with lower urinary tract symptoms (LUTS). Bondarenko B(1), Walther C, Funk P, Schläfke S, Engelmann U. Author information: (1)Department of Urology, University Hospital of Cologne, Cologne, Germany. [email protected] DOI: 10.1078/1433-187x-00352 PMID: 12807343 [Indexed for MEDLINE]

03
RANDOMIZED TRIAL (RCT) Pakistan journal of biological sciences (2020) PMID: 32981268 ↗
Urtica Dioica Root Extract on Clinical and Biochemical Parameters in Patients with Benign Prostatic Hyperplasia, Randomized Controlled Trial.
Clinical Trial Synthesis 2020 Randomized Controlled Trial (RCT) published in Pakistan journal of biological sciences involving n = 60 participants. Key conclusion: CONCLUSION: UDE consumption for 12 weeks among BPH patients had clinically significant effects on IPSS, serum hs-CRP, MDA and SOD activity.
View Original PubMed Abstract ↓

1. Pak J Biol Sci. 2020 Jan;23(10):1338-1344. doi: 10.3923/pjbs.2020.1338.1344. Urtica Dioica Root Extract on Clinical and Biochemical Parameters in Patients with Benign Prostatic Hyperplasia, Randomized Controlled Trial. Akbar Karami A, Sheikhsoleimani M, Reza Memarzadeh M, Haddadi E, Bakhshpour M, Mohammadi N, Mehdi Mirhashemi S. BACKGROUND AND OBJECTIVES: Benign Prostatic Hyperplasia (BPH) is a common urological disorder as men get older. BPH can cause uncomfortable urinary tract symptoms. Given the high incidence of the disease, further research is an undeniable necessity for its better management. In this research, the efficacy of Urtica Dioica root extract (UDE) on clinical and biochemical parameters were evaluated in this type of patients. MATERIALS AND METHODS: Participants were 60 men with BPH that randomly allocated to two equal groups (Intervention = 30 and Comparison = 30). Block balanced Randomization method was performed using a computer by a trained nurse. Intervention and comparison groups received 450 mg day-1 UDE and placebo as tablets for 12 weeks, respectively. The main outcome was changes in International Prostate Symptoms Score (IPSS) from baseline to end of treatment. Data were collected by completing a standard questionnaire and performing relevant tests based on common laboratory methods. RESULTS: UDE had an intermediate effect on IPSS, a small effect on serum high-sensitivity C-reactive protein (hs-CRP), intermediate to large effect on malondialdehyde (MDA) levels and intermediate effect on superoxide dismutase (SOD) activity. The magnitude of the effects of UDE on other parameters was overall negligible compared to the comparison and not significant. No side effects were seen in these patients following tablet usage. CONCLUSION: UDE consumption for 12 weeks among BPH patients had clinically significant effects on IPSS, serum hs-CRP, MDA and SOD activity.

04
RANDOMIZED TRIAL (RCT) Planta medica (2017) PMID: 28614869 ↗
A Rosa canina - Urtica dioica - Harpagophytum procumbens/zeyheri Combination Significantly Reduces Gonarthritis Symptoms in a Randomized, Placebo-Controlled Double-Blind Study.
Clinical Trial Synthesis 2017 Randomized Controlled Trial (RCT) published in Planta medica involving n = 46 participants. Key conclusion: There was a trend towards reduced analgesics consumption with MA212, compared to placebo.
View Original PubMed Abstract ↓

The special formulation MA212 (Rosaxan) is composed of rosehip (Rosa canina L.) puree/juice concentrate, nettle (Urtica dioica L.) leaf extract, and devil's claw (Harpagophytum procumbens DC. ex Meisn. or Harpagophytum zeyheri Decne.) root extract and also supplies vitamin D. It is a food for special medical purposes ([EU] No 609/2013) for the dietary management of pain in patients with gonarthritis.This 12-week randomized, placebo-controlled double-blind parallel-design study aimed to investigate the efficacy and safety of MA212 versus placebo in patients with gonarthritis.A 3D-HPLC-fingerprint (3-dimensional high pressure liquid chromatography fingerprint) of MA212 demonstrated the presence of its herbal ingredients. Ninety-two randomized patients consumed 40 mL of MA212 (n = 46) or placebo (n = 44) daily. The Western Ontario and McMaster Universities Arthritis Index (WOMAC), quality-of-life scores at 0, 6, and 12 weeks, and analgesic consumption were documented. Statistically, the initial WOMAC subscores/scores did not differ between groups. During the study, their means significantly improved in both groups. The mean pre-post change of the WOMAC pain score (primary endpoint) was 29.87 in the MA212 group and 10.23 in the placebo group. The group difference demonstrated a significant superiority in favor of MA212 (pU < 0.001; pt < 0.001). Group comparisons of all WOMAC subscores/scores at 6 and 12 weeks reached same significances. Compared to placebo, both physical and mental quality of life significantly improved with MA212. There was a trend towards reduced analgesics consumption with MA212, compared to placebo. In the final efficacy evaluation, physicians (pChi < 0.001) and patients (pChi < 0.001) rated MA212 superior to placebo. MA212 was well tolerated.This study demonstrates excellent efficacy for MA212 in gonarthritis patients. Georg Thieme Verlag KG Stuttgart · New York.

05
CLINICAL STUDY World journal of urology (2014) PMID: 24938176 ↗
Fixed-dose combination PRO 160/120 of sabal and urtica extracts improves nocturia in men with LUTS suggestive of BPH: re-evaluation of four controlled clinical studies.
Clinical Trial Synthesis 2014 Randomized Controlled Trial (RCT) published in World journal of urology involving n = 922 participants; statistical significance reported at p = 0.015. Key conclusion: CONCLUSION: PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.
View Original PubMed Abstract ↓

PURPOSE: To determine the effects of the herbal fixed-dose combination PRO 160/120 (extracts from saw palmetto fruits and stinging nettle roots) on nocturnal voiding frequency, as measured by question 7 of the IPSS questionnaire, in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo, to the α-blocker tamsulosin, or to the 5α-reductase inhibitor finasteride. METHODS: The study is about post hoc evaluation of four published randomized, double-blind clinical trials on PRO 160/120, two compared with placebo, one with finasteride and one with tamsulosin. In addition, a pooled data analysis of the two placebo-controlled trials was conducted. RESULTS: We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1. In the pooled analysis of placebo-controlled trials, nocturnal voids improved by 0.8 (29 %) with PRO 160/120 compared to 0.6 (18 %) with placebo (p = 0.015, Wilcoxon test, one-tailed). The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response (52 %; p = 0.003, χ (2)-test, two-tailed). The majority of responders improved by 1 void/night. Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies. There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates. CONCLUSION: PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.

06
CLINICAL STUDY International urology and nephrology (2007) PMID: 18038253 ↗
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.
Clinical Trial Synthesis 2007 Randomized Controlled Trial (RCT) published in International urology and nephrology; statistical significance reported at p = 0.001. Key conclusion: 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).
View Original PubMed 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.

07
RANDOMIZED TRIAL (RCT) Journal of herbal pharmacotherapy (2005) PMID: 16635963 ↗
Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study.
Clinical Trial Synthesis 2005 Randomized Controlled Trial (RCT) published in Journal of herbal pharmacotherapy involving n = 620 participants; statistical significance reported at p = 0.001. Key conclusion: Further clinical trials should be conducted to confirm these results before concluding that
View Original PubMed Abstract ↓

PURPOSE: To determine the effects of therapy with Urtica dioica for symptomatic relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIAL AND METHODS: A 6-month, double-blind, placebo-controlled, randomized, partial crossover, comparative trial of Urtica dioica with placebo in 620 patients was conducted. Patients were evaluated using the International Prostate Symptom Score (IPSS), the maximum urinary flow rate (Qmax), postvoid residual urine volume (PVR), Serum Prostatic- Specific Antigen (PSA), testosterone levels, and prostate size. At the end of 6-month trial, unblinding revealed that patients who initially received the placebo were switched to Urtica dioica. Both groups continued the medication up to 18 months. RESULTS: 558 patients (90%) completed the study (287/305, 91% in the Urtica dioica group, and 271/315, 86% in the placebo group). By intention- to-treat analysis, at the end of 6-month trial, 232 (81%) of 287 patients in the Urtica dioica group reported improved LUTS compared with 43 (16%) of 271 patients in the placebo group (P < 0.001). Both IPSS and Qmax showed greater improvement with drug than with placebo. The IPSS went from 19.8 down to 11.8 with Urtica dioica and from 19.2 to 17.7 with placebo (P = 0.002). Peak flow rates improved by 3.4 mL/s for placebo recipients and by 8.2 mL/s for treated patients (P < 0.05). In Urtica dioica group, PVR decreased from an initial value of 73 to 36 mL (P < 0.05). No appreciable change was seen in the placebo group. Serum PSA and testosterone levels were unchanged in both groups. A modest decrease in prostate size as measured by transrectal ultrasonography (TRUS) was seen in Urtica dioica group (from 40.1 cc initially to 36.3 cc; P < 0.001). There was no change in the prostate volume at the end of study with placebo. At 18-month follow-up, only patients who continued therapy, had a favorable treatment variables value. No side effects were identified in either group. CONCLUSION: In the present study, Urtica dioica have beneficial effects in the treatment of symptomatic BPH. Further clinical trials should be conducted to confirm these results before concluding that

08
CLINICAL STUDY World journal of urology (2005) PMID: 15928959 ↗
Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms--a placebo-controlled, double-blind, multicenter trial.
Clinical Trial Synthesis 2005 Randomized Controlled Trial (RCT) published in World journal of urology involving n = 257 participants; statistical significance reported at p = 0.003. Key conclusion: In conclusion, PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS.
View Original PubMed Abstract ↓

The 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) was investigated in elderly, male patients suffering from lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia in a prospective multicenter trial. A total of 257 patients (129 and 128, respectively) were randomized to treatment with PRO 160/120 or placebo (127 and 126 were evaluable for efficacy). Following a single-blind placebo run-in phase of 2 weeks, the patients received 2 x 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks. Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120. Outcome measures for treatment efficacy included the assessment of the patients' LUTS by means of the I-PSS self-rating questionnaire and a quality of life index as well as uroflow and sonographic parameters. Using the International Prostate Symptom Score (I-PSS), patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group (6 points vs 4 points; P=0.003, one tailed) with a tendency in the same direction after 16 weeks. This applied to obstructive as well as to irritative symptoms, and to patients with moderate or severe symptoms at baseline. Patients randomized to placebo showed a marked improvement in LUTS (as measured by the I-PSS) after being switched to PRO 160/120 during the control period (P=0.01, one tailed, in comparison to those who had been treated with PRO 160/120 in the double-blind phase). The tolerability of PRO 160/120 was comparable to the placebo. In conclusion, PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS. PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms. The tolerability of the herbal extract was excellent.

09
RANDOMIZED TRIAL (RCT) Der Urologe. Ausg. A (2004) PMID: 15045190 ↗
[Stinging nettle root extract (Bazoton-uno) in long term treatment of benign prostatic syndrome (BPS). Results of a randomized, double-blind, placebo controlled multicenter study after 12 months].
Clinical Trial Synthesis 2004 Randomized Controlled Trial (RCT) published in Der Urologe. Ausg. A involving n = 246 participants; statistical significance reported at p = 0.0233. Key conclusion: A strong increase of Q(max) or reduction of residual urine are not to be expected.
View Original PubMed Abstract ↓

Phytotherapy of BPS has a long tradition in Germany; nevertheless, data referring to single phytotherapeutic agents are rare. We therefore performed a randomized, double-blind, placebo-controlled multicenter study for 1 year with Bazoton uno (459 mg dry extract of stinging nettle roots) with 246 patients. The IPSS decreased on average from 18.7+/-0.3 to 13.0+/-0.5 with a statistically significant difference compared to placebo (18.5+/-0.3 to 13.8+/-0.5; p=0.0233). The median Q(max) increased by 3.0+/-0.4 ml/s in comparison to 2.9+/-0.4 ml/s (placebo), thus not statistically significantly different, as well as the median volume of residual urine, which changed from 35.5+/-3.4 ml before therapy to 20.0+/-2.8 ml and from 40.0+/-4.0 ml to 21.0+/-2.9 ml under placebo application. The number of adverse events (29/38) as well as urinary infections etc. (3/10 events) was smaller under Bazoton uno therapy compared to placebo. Treatment with Bazoton uno can therefore be considered a safe therapeutic option for BPS, especially for reducing irritative symptoms and BPS-associated complications due to the postulated antiphlogistic and antiproliferative effects of the stinging nettle extract. A strong increase of Q(max) or reduction of residual urine are not to be expected.

10
CLINICAL STUDY BJU international (2000) PMID: 10971268 ↗
Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome.
Clinical Trial Synthesis 2000 Randomized Controlled Trial (RCT) published in BJU international involving n = 431 participants; statistical significance reported at p = 0.52. Key conclusion: CONCLUSION: The present analysis showed that the efficacy of both PRO 160/120 and finasteri
View Original PubMed Abstract ↓

OBJECTIVE: To test the hypothesis that in patients with benign prostatic hyperplasia (BPH), the outcome of drug therapy with finasteride may be predictable from the baseline prostate volume and that positive clinical effects might be expected only in patients with prostate volumes of > 40 mL, using a subgroup analysis of results from a previously reported clinical trial of finasteride and phytotherapy. PATIENTS AND METHODS: A subgroup of 431 patients was analysed from a randomized, multicentre, double-blind clinical trial involving 543 patients with the early stages of BPH. Patients received a fixed combination of extracts of saw palmetto fruit (Serenoa repens) and nettle root (Urtica dioica) (PRO 160/120) or the synthetic 5alpha-reductase inhibitor finasteride. The patients assessed had valid ultrasonographic measurements and baseline prostate volumes of either </= 40 mL or > 40 mL. All 516 patients were included in the safety analysis. The results of the original trial showed equivalent efficacy for both treatments. RESULTS: The mean (SD) maximum urinary flow (the main outcome variable) increased (from baseline values) after 24 weeks by 1.9 (5.6) mL/s with PRO 160/120 and by 2.4 (6.3) mL/s with finasteride. There were no statistically significant group differences (P = 0.52). The subgroups with small prostates (</= 40 mL) showed similar improvements, with mean values of 1.8 (5.2) mL/s with PRO 160/120 and 2.7 (7.4) mL/s with finasteride. The mean values for the subgroups with prostates of > 40 mL were similar, at 2.3 (6.1) and 2. 2 (5.3) mL/s, respectively. There were improvements in the International Prostate Symptom Score in both treatment groups, with no statistically significant differences. The subgroup analysis showed slightly better results for voiding symptoms in the patients with prostates of > 40 mL, but there were also improvements in the subgroup with smaller prostates. The safety analysis showed that more patients in the finasteride group reported adverse events and also there were more adverse events in this group than in patients treated with PRO 160/120. CONCLUSION: The present analysis showed that the efficacy of both PRO 160/120 and finasteri

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