LakeMountD
Doctor Science
- Awards
- 1
PRO 160/120 IS 160MG SAW PALMETTO AND 120MG OF NETTLE ROOT (We used similar dosages in cycle support).
Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome
J. Sökeland1
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 5α -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 finasteride was equivalent and unrelated to prostate volume. However, PRO 160/120 had better tolerability than finasteride.
CLINICAL REVIEW
In nineteen studies that included 7,210 participants, all but two
demonstrated positive effects for benign prostatic hyperplasia
(BPH). Numerous studies revealed that saw palmetto improved
symptoms of BPH including one randomized, single-blind,
placebo-controlled, parallel group multicenter study
(R, SB, PC, PG, MC), two open-label (OL), MC studies, a R,
Saw Palmetto
Serenoa repens (W. Bartram) Small (syn. Sabal serrulata [Michx.] Nutt. ex Schult. & Schult. f.;
Serenoa serrulata (Michx.) G. Nichols.)
[Fam. Arecaceae]
Photo © 2003 stevenfoster.com
double-blind (DB), controlled study, a R, comparative study, a
prospective MC study, and a R, PC study. Two OL studies found
positive results, but another OL study failed to find significant
improvement in objective measures of bladder outlet obstruction.
Similarly, one DB, C study found no difference between saw
palmetto and placebo. Several clinical trials have shown that
serum levels of testosterone, dihydrotestosterone (DHT), and
PSA are not changed significantly. One PC study looked at hormone
levels, found no changes in testosterone, luteinizing hormone
(LH), or follicle stimulating hormone (FSH) levels.
It is well accepted that at least 30–50% of BPH patients report an
improvement of their symptoms after treatment with placebo.
This percentage is about the same after simple monitoring. Two
meta-analyses of 18 R, PC studies concluded that saw palmetto
treatment for at least 30 days improved urologic symptoms and
flow measures. Adverse effects were mild and infrequent. The
authors concluded that further research is needed using standardized
preparations to determine saw palmetto’s long-term effectiveness
and ability to prevent BPH complications. Another
meta-analysis focused on 11 R clinical trials and 2 OL trials using
saw palmetto extract on men with BPH. The analysis concluded
that saw palmetto, compared to placebo, provided a significant
improvement in peak urinary flow rate and reduction in nocturia.
Some anecdotal reports have stated that saw palmetto can mask
prostate cancer by lowering PSA levels. However, several large
studies totaling 1,256 patients did not show this effect.
A meta-analysis of recent PC trials included 7 clinical studies. All
trials lasted 3 months and indicated a decrease in nocturia frequency
(0.5 times per night) and an increase in peak urinary flow
rate by 1.5 ml/sec over placebo. A 6-month, DB, PC, R study
comparing Permixon® and finasteride (Proscar®) included 1,809
patients with BPH, and showed equally improved symptom score
in both groups (37% with Permixon® vs. 39% with finasteride),
and equally improved peak urinary flow rate. One of the first trials
conducted in the U.S. reported symptomatic, but not urodynamic,
improvement in 46 men treated for 6 months with a saw
palmetto berry extract.
Five studies focused on the use of the combination of saw palmetto
and nettles to treat the symptoms of BPH. Originally, it
was thought that saw palmetto relieved the symptoms associated
with an enlarged prostate without reducing the enlargement.
However, one R, DB, PC study on the Nutralite® product examined
the use of a saw palmetto, nettles, lemon bioflavonoid
extract, and vitamin A combination and found significant
improvement in prostate epithelial contraction without adverse
effects. Further studies are needed to confirm the finding.
Another trial on the same saw palmetto combination product
suggested a significant reduction in prostate tissue DHT levels, as
determined by needle biopsy. Four well-designed studies on the
fixed combination, PRO 160/120®, ranged from 12 weeks to one
year, and found good efficacy and tolerance.
Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome
J. Sökeland1
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 5α -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 finasteride was equivalent and unrelated to prostate volume. However, PRO 160/120 had better tolerability than finasteride.
CLINICAL REVIEW
In nineteen studies that included 7,210 participants, all but two
demonstrated positive effects for benign prostatic hyperplasia
(BPH). Numerous studies revealed that saw palmetto improved
symptoms of BPH including one randomized, single-blind,
placebo-controlled, parallel group multicenter study
(R, SB, PC, PG, MC), two open-label (OL), MC studies, a R,
Saw Palmetto
Serenoa repens (W. Bartram) Small (syn. Sabal serrulata [Michx.] Nutt. ex Schult. & Schult. f.;
Serenoa serrulata (Michx.) G. Nichols.)
[Fam. Arecaceae]
Photo © 2003 stevenfoster.com
double-blind (DB), controlled study, a R, comparative study, a
prospective MC study, and a R, PC study. Two OL studies found
positive results, but another OL study failed to find significant
improvement in objective measures of bladder outlet obstruction.
Similarly, one DB, C study found no difference between saw
palmetto and placebo. Several clinical trials have shown that
serum levels of testosterone, dihydrotestosterone (DHT), and
PSA are not changed significantly. One PC study looked at hormone
levels, found no changes in testosterone, luteinizing hormone
(LH), or follicle stimulating hormone (FSH) levels.
It is well accepted that at least 30–50% of BPH patients report an
improvement of their symptoms after treatment with placebo.
This percentage is about the same after simple monitoring. Two
meta-analyses of 18 R, PC studies concluded that saw palmetto
treatment for at least 30 days improved urologic symptoms and
flow measures. Adverse effects were mild and infrequent. The
authors concluded that further research is needed using standardized
preparations to determine saw palmetto’s long-term effectiveness
and ability to prevent BPH complications. Another
meta-analysis focused on 11 R clinical trials and 2 OL trials using
saw palmetto extract on men with BPH. The analysis concluded
that saw palmetto, compared to placebo, provided a significant
improvement in peak urinary flow rate and reduction in nocturia.
Some anecdotal reports have stated that saw palmetto can mask
prostate cancer by lowering PSA levels. However, several large
studies totaling 1,256 patients did not show this effect.
A meta-analysis of recent PC trials included 7 clinical studies. All
trials lasted 3 months and indicated a decrease in nocturia frequency
(0.5 times per night) and an increase in peak urinary flow
rate by 1.5 ml/sec over placebo. A 6-month, DB, PC, R study
comparing Permixon® and finasteride (Proscar®) included 1,809
patients with BPH, and showed equally improved symptom score
in both groups (37% with Permixon® vs. 39% with finasteride),
and equally improved peak urinary flow rate. One of the first trials
conducted in the U.S. reported symptomatic, but not urodynamic,
improvement in 46 men treated for 6 months with a saw
palmetto berry extract.
Five studies focused on the use of the combination of saw palmetto
and nettles to treat the symptoms of BPH. Originally, it
was thought that saw palmetto relieved the symptoms associated
with an enlarged prostate without reducing the enlargement.
However, one R, DB, PC study on the Nutralite® product examined
the use of a saw palmetto, nettles, lemon bioflavonoid
extract, and vitamin A combination and found significant
improvement in prostate epithelial contraction without adverse
effects. Further studies are needed to confirm the finding.
Another trial on the same saw palmetto combination product
suggested a significant reduction in prostate tissue DHT levels, as
determined by needle biopsy. Four well-designed studies on the
fixed combination, PRO 160/120®, ranged from 12 weeks to one
year, and found good efficacy and tolerance.
