Gerber, et al. (2001)1919. Gerber GS, Kuznetsov D, Johnson BC, Burstein JD. Randomized, double-blind, placebo-controlled trial of Saw Palmetto in men with lower urinary tract symptom. Urology. 2001;58(6):960-3. doi: http://doi.org/10.1016/S0090-4295(01)01442-X https://doi.org/10.1016/S0090-4295(01)01...
; USA |
PhT‡
|
To evaluate the effects of Saw palmetto (S. palmetto) extract on urinary symptoms, sexual function, and urinary flow rate in men with LUTS‡‡‡. |
n: 85 IG||: 41 CG§: 44 |
I-PSS†† score > 8 without history of prostate surgery; 64.5 (±9.9) years old (IG||); 65.3 (±9.7) years old (CG§). |
160 mg S. palmetto capsule (distributed by Nutraceutical), 2x/day (320 mg a day). |
Placebo capsule (extra virgin olive oil, gelatin and glycerin), 2x/day. |
6 |
I-PSS††
|
Qmax||||
|
IG|| had a mean reduction (improvement) of 4.4 (±5.9) points in the I-PSS score††, showing a significant difference (p = 0.038) when compared to the CG§. Qmax|||| improved slightly in both groups, but the changes were not significant (p = 0.75). |
Bent, et al. (2006)2121. Bent S, Kane C, Shinohara K, Neuhaus J, Hudes ES, Goldberg H, et al. Saw Palmetto for benign prostatic hyperplasia. N Eng J Med. 2006;354(6):557-66. doi: http://doi.org/10.1056/NEJMoa053085 https://doi.org/10.1056/NEJMoa053085...
; USA |
PhT‡
|
To determine the efficacy of S. palmetto extract for the treatment of BPH¶. |
n: 225 IG||: 112 CG§: 113 |
BPH determined by AUASI* score > 8, without history of prostate surgery; 62.9 (±8.7) years old (IG||); 63.0 (±7.4) years old (CG§). |
160 mg S. palmetto capsule (distributed by Rexall-Sundown, Inc), 2x/day (320 mg a day). |
Placebo capsule (polyethylene glycol 400, bitter liquid with oily aspect without free fatty acids and brown dye), 2x/day. |
12 |
AUASI* |
Qmax||||||, prostatic volume and PURV |
Slight reduction (improvement) in the AUASI* score, 0.72 (±0.35) points in the CG§ and 0.68 (±0.35) points in the IG||, but without significant difference between the groups (95% CI**: -0.93 to 1.01). Changes were not observed in Qmax||||, prostatic volume or PURV. |
Barry, et al. (2011)2222. Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC, et al. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011;306(12):1344-51. doi: http://doi.org/10.1001/jama.2011.1364 https://doi.org/10.1001/jama.2011.1364...
; United States of America |
PhT‡
|
To determine the effect of S. palmetto extract, up to three times the standard dose, in LUTS‡‡‡ attributed to BPH¶. |
n: 357 IG||: 176 CG§: 181 |
AUASI* score between 8 and 24, without history of prostate surgery; 61.3 ± 8.7 years old (IG||); 60.7 ± 8.1 years old (CG§). |
320 mg S. palmetto capsule (distributed by Rottapharm). Progressive increase in dosage: -1 capsule/day from the 1st to the 23rd week (320 mg a day); -2 capsules/day from the 24th to the 48thweek (640 mg a day); -3 capsules/day from the 48th to the 72thweek (960 mg a day). |
Placebo capsules (375 mg polyethylene glycol, 25 mg glycerol and 75 mg gelatin) following a progressive increase in the number of capsules as in the IG. |
18 |
AUASI* |
Qmax|||| and PURV||||||
|
The mean AUASI* score decreased (improved) by 2.99 points (95% CI**: -3.81 to -2.17) in the CG and by 2.20 points (95% CI: -3.04 to -0.36) in the IG||, a difference of 0.79 points between the two groups in favor of the CG§. The dose-response comparison showed that there was no improvement in the IG|| in any of the doses when compared to the CG§. Changes were not observed in Qmax and PURV||||||. |
Ye, et al. (2019)2626. Ye Z, Huang J, Zhou L, Chen S, Wang Z, Ma L, et al. Efficacy and safety of Serenoa repens extract among patients with benign prostatic hyperplasia in China: a multicenter, randomized, double-blind, placebo-controlled trial. Urology. 2019;129:172-9. doi: http://doi.org/10.1016/j.urology.2019.02.030 https://doi.org/10.1016/j.urology.2019.0...
; China |
PhT‡
|
To assess the efficacy and safety of S. palmetto among patients with LUTS‡‡‡/ BPH¶. |
n: 325 IG||: 159 CG§: 166 |
BPH¶ with I-PSS score < 19; 61.5 (±5.2) years old (IG||); 60.3 (±6.0) years old (CG§). |
160 mg S. palmetto capsule (distributed by Tad Pharma GmbH), 2x/day (320 mg a day). |
Placebo capsule (composition not described), 2x/day. |
6 |
I-PSS††
|
Qmax‡‡, prostate volume and urination frequency |
The I-PSS†† score decreased (improved) in both groups, but the reduction was significantly greater after 24 weeks in the IG|| (p < 0.001). The IG || presented a significant increase (improvement) in Qmax‡‡ from the 4th week (p = 0.011) to the 24th week (p < 0.001). Changes were not observed in prostate volume or urinary frequency. |
Noguchi, et al. (2008)2323. Noguchi M, Kakuma T, Tomiyasu K, Kurita Y, Kukihara H, Konishi K, et al. Effect of an extract of Ganoderma lucidum in men with lower urinary tract symptoms: a double-blind, placebo-controlled randomized and dose-raging study. Asian J Androl. 2008;10(4):651-8. doi: http://doi.org/10.1111/j.1745-7262.2008.00336.x https://doi.org/10.1111/j.1745-7262.2008...
; Japan |
PhT‡
|
To evaluate the safety and efficacy of the Ganoderma lucidum (G. lucidum) extract in men with lower urinary tract symptoms from a dose-escalation study. |
n: 50 IG||/0.6: 12 IG||/6: 12 IG||/60: 14 CG§: 12 |
I-PSS†† score > 5 without history of prostate surgery; 59.1 (51-70) years old (IG||/0.6); 59.2 (50-72) years old (IG||/6); 59.4 (50-70) years old (IG||/60); 59.7 (50-67) years old (CG§). |
IG||/0.6: 0.6 mg G. Lucidum tablet, 1x/day; IG||/6: 6 mg G. Lucidum tablet, 1x/day; IG||/60: 60 mg G. Lucidum tablet, 1x/day. (All tablets distributed by Chlorella Industry). |
Placebo tablet (83.75% maltitol, 10% corn starch, 3% vitamin C, 0.2% yellow gardenia and 3% sucrose fatty acid ester), 1x/day. |
2 |
I-PSS††
|
Qmax||||, prostatic volume and PURV||||||
|
In the 4th week, the mean change in the I-PSS†† score was significantly higher in IG||/60, when compared to the CG§ (p = 0.012) and to the IG||/0.6 (p < 0.001). In the 8th week, the mean change in IG||/0.6 was significantly lower than in IG||/6 (p = 0.016) and IG||/60 (p = 0.005). Slight improvement of Qmax||||, but without significant differences between the groups. No changes were observed in prostatic volume or PURV||||||. |
Noguchi, et al. (2008)2424. Noguchi M, Kakuma T, Tomiyasu K, Yamada A, Itoh K, Konishi F, et al. Randomized clinical trial of an ethanol extract of Ganoderma lucidum in men with lower urinary tract symptoms. Asian J Androl. 2008;10(5):777-85. doi: http://doi.org/10.1111/j.1745-7262.2008.00361.x https://doi.org/10.1111/j.1745-7262.2008...
; Japan |
PhT‡
|
To evaluate the safety and efficacy in men with mild to moderate lower urinary tract symptoms of the G. Lucidum extract, which showed the highest 5α-reductase inhibitory activity among the extracts of 19 edible and medicinal mushrooms. |
n: 88 IG||: 44 CG§: 44 |
I-PSS†† score between 5 and 19, with no history of prostate surgery; 64.0 (±6.9) years old (IG||); 64.0 (±8.0) years old (CG§). |
2 tablets with 3 mg of G. Lucidum (distributed by Chlorella Industry), 1x/day (6 mg a day). |
2 placebo tablets (83.75% maltitol, 10% corn starch, 3% vitamin C, 0.2% yellow gardenia and 3% sucrose fatty acid ester), 1x/day. |
3 |
I-PSS††
|
Qmax||||, Qave‡‡, prostate volume and PURV||||||
|
The I-PSS†† score decreased (improved) more markedly in the IG|| up to the 12th week, showing a significant difference (p < 0.001) in the mean change in the score between the two groups. Qmax|||| (p = 0.400) and Qave‡‡ (p = 0.080) showed an increase (improvement) in the IG|| at the 4th and 8th weeks, but with no significant difference between the groups at the 12th week. Changes were not observed in prostate volume or PURV||||||. |
Vidlar, et al. (2010)2727. Vidlar A, Vostalova J, Ulrichova J, Student V, Stejskal D, Reichenbach R, et al. The effectiveness of dried cranberries (Vaccinium macrocarpon) in men with lower urinary tract symptoms. Br J Nutr. 2010;104(8):1181-9. doi: http://doi.org/10.1017/S0007114510002059 https://doi.org/10.1017/S000711451000205...
; Czech Republic |
PhT‡
|
To evaluate the efficacy and tolerance of cranberry powder in men with lower urinary tract symptoms, elevated PSA§§, BPH¶ and chronic nonbacterial prostatitis. |
n: 42 IG||: 21 CG§: 21 |
Histological findings of nonbacterial, acute or chronic prostatitis; 62.0 (±5.4) years old (IG||); 64.0 (±5.4) years old (CG§); |
500 mg cranberry powder capsule (distributed by Decas Botanical Synergies). 3x/day, (1,500 mg a day). |
Placebo capsule (composition not described), 3x/day. |
6 |
I-PSS††
|
Qmax, Qave and PURV||||||
|
I-PSS†† score significantly lower (better) in the IG|| when compared to the CG§ (p < 0.050). Significant improvement (p < 0.050) of Qmax||||, Qave‡‡ and PURV|||||| in at least 70% of the IG participants||, and significant worsening (p < 0.050) of PURV|||||| in the CG§. |
Vidlar, et al. (2015)2828. Vidlar A, Student V, Vostalova J, Fromentin E, Roller M, Simanek V, et al. Cranberry fruit powder (Flowens(tm)) improves lower urinary tract symptoms in men: a double-blind, randomized, placebo-controlled study. World J Urol. 2016;34(3):419-24. doi: http://doi.org/10.1007/s00345-015-1611-7 https://doi.org/10.1007/s00345-015-1611-...
; Czech Republic |
PhT‡
|
To evaluate the effect of cranberry in men with moderate to severe lower urinary tract symptoms. |
n: 122 IG||/500: 38 IG||/250: 43 CG§: 41 |
I-PSS†† score > 8 without history of prostate surgery; 52.5 (±5.4) years old (IG||/500); 53.3 (±5.2) years old (IG||/250); 54.0 (±5.1) years old (CG§). |
IG||/500: 2 x 250 mg cranberry capsules 1x/day (500 mg a day); IG||/250: 1 250 mg cranberry capsule and 1 placebo capsule, 1x/day (250 mg a day); (all capsules distributed by Decas Botanical Synergies). |
2 placebo capsules (low density maltodextrin, canola oil, sodium aluminum silicate, lake red 40 and lake blue 1), 1x/day. |
6 |
I-PSS††
|
Qmax||||, Qave‡‡, PURV|||||| and bladder emptying volume |
Significant reductions (improvement) in the I-PSS†† score of IG||/500 and IG||/250, of -4.1 (±1.9) (p < 0.001) and -3.1 (±3.0) (p = 0.050) points respectively. Qmax|||| (p = 0.018), Qave‡‡ (p = 0.040), PURV|||||| (p = 0.027) and bladder emptying volume (p = 0.014) significantly improved in IG||/500. |
Johnstone, et al. (2003)2020. Johnstone PA, Bloom TL, Niemtzow RC, Crain D, Riffenburgh RH, Amling CL. A prospective, randomized pilot trial of acupuncture of the kidney-bladder distinct meridian for lower urinary tract symptoms. J Urol. 2003;169(3):1037-9. doi: http://doi.org/10.1097/01.ju.0000044925.03113.ab https://doi.org/10.1097/01.ju.0000044925...
; United States of America |
EA†
|
To assess the response of lower urinary tract symptoms and PSA§§ to EA† in a population of patients with a negative biopsy for prostate cancer. |
n: 30 (It does not specify the sample in each study group) |
I-PSS†† score > 8; 60.7 (±8.2) years old (IG||); 64.7 (±5.2) years old (CG§/EA† placebo); 63.5 (±3.4) years old (CG§/observation). |
AcPts***: R10, B40, B32 and B10. 4-5 Hz electrostimulation on R10 and B40. Sessions 3x/week in the 1st and 2nd weeks, and later 1x/week in the 3rd, 4th and 8th weeks, 20 min/session. |
CG§/EA† placebo: insertion of 5 needles in the posterior region of the shoulders, areas unrelated to AcPts*** and without electrostimulation. CG§/observation: no intervention during the study. |
3 (9 sessions) |
I-PSS††
|
Not evaluated |
No changes were observed in the I-PSS†† score (p = 0.063). |
Ricci, et al. (2004)2929. Ricci L, Minardi D, Romoli M, Galosi AB, Muzzonigro G. Acupuncture reflexotherapy in the treatment of sensory urgency that persists after transurethral resection of the prostate: a preliminary report. Neurourol Urodyn. 2004;23(1):58-62. doi: http://doi.org/10.1002/nau.10105 https://doi.org/10.1002/nau.10105...
; Italy |
EA†
|
To assess whether EA† in reflex therapy/acupuncture is able to treat the sensory irritating components of lower urinary tract symptoms that persist after TURP†††
|
n: 42 IG||:13 CG§/ placebo: 14 CG§/ conv: 15 |
Persistence of sensory irritative symptoms of the lower urinary tract after TURP†††; 64.76 years old (52-78 years old). |
Somatic AcPts: Conception vessel: 1, 2, 4, 5; Bladder 21, 23 and 32; Auricular AcPts***: prostate and external genitalia. 5-10 Hz electrostimulation, with greater intensity tolerated by the patient. 3 sessions/week, plus maintenance sessions every 15 days, starting from the 4th week, 20 min/session. |
CG§/placebo: placebo tablet (it does not define composition, number of tablets, or repetitions per day); CG§/conv: Oxybutynin 5 mg tablet, 2x/day (10 mg a day). |
3 (12 sessions) |
I-PSS††
|
Qmax||||, prostate volume, urination frequency and nocturia |
The I-PSS score†† decreased (improved) in the CG§ and IG|| during the first 3 months, but the difference was only significant in the IG|| (p<0.001). Changes were not observed in Qmax|||| and prostate volume. Reductions in daytime urination frequency of 20% and 8% in the IG|| and CG§, respectively. The nocturia reports were also reduced 60% and 20% in the IG|| and CG§, respectively. |
Yu, et al. (2011)3030. Yu JS, Shen KH, Chen WC, Her JS, Hsieh CL. Effects of electroacupuncture on benign prostate hyperplasia patients with lower urinary tract symptoms: A single-blinded, randomized controlled trial. Evid Based Complement Alternat Med. 2011;2011:303198. doi: http://doi.org/10.1155/2011/303198 https://doi.org/10.1155/2011/303198...
; Taiwan |
EA†
|
To evaluate the effect of EA† on lower urinary tract symptoms in men with BPH¶. |
n: 37 IG||: 18 CG§: 19 |
BPH¶ confirmed by transrectal US§§§ with I-PSS†† score > 8, with no history of prostate surgery; 63.2 (±10.0) years old (IG||); 59.8 (±9.0) years old (CG§). |
AcPts***: Conception Vessels 3 and 4; Stomach 36 and Spleen-Pancreas 6. Needles inserted and handled for 3-5 minutes until reaching Qi. 2 Hz electrostimulation with 2-2.5 mA intensity. 2 sessions/week, 20 min/session. |
Needles inserted superficially (subcutaneous tissue), 1 cm lateral to the AcPt*** of the IG||, without manual handling or electrostimulation. Same frequency of sessions as in the IG||. |
1.5 (12 sessions) |
I-PSS††
|
Qmax||||,Qave‡‡ and bladder emptying volume |
Changes were not observed in the I-PSS†† score between the groups. Increase (improvement) in Qmax|||| (p = 0.030), Qave‡‡ (p = 0.026), significant emptying volume (p = 0.038) in the IG||. |
Wang, et al. (2013)2525. Wang Y, Liu B, Yu J, Wu J, Wang J, Liu Z. Electroacupuncture for Moderate and Severe Benign Prostatic Hyperplasia: A Randomized Controlled Trial. PLoS One. 2013;8(4):e59449. doi: http://doi.org/10.1371/journal.pone.0059449 https://doi.org/10.1371/journal.pone.005...
; China |
EA†
|
To evaluate the effects of EA† on the I-PSS†† score, PURV|||||, and Qmax||||, as well as to explore the differences between AE† in AcPts*** and unrelated points in patients with moderate or severe BPH¶. |
n: 100 IG||: 50 CG§: 50 |
BPH¶ determined by I-PSS†† score > 8; 64.8 (±7.1) years old (IG||); 65.9 (±6.7) years old (CG§); |
AcPts***: Bladder 33, with manipulation until the patient feels a sensation of weight and numbness. 20 Hz electrostimulation, with maximum intensity tolerated by the patient. 1 session/day completing 5 sessions/week during the 1st and 2nd weeks, and then 3 sessions/week in the 3rd and 4th weeks |
Needles inserted at two points approximately 6.7 cm lateral to the AcPts***, without manipulation, with the same electrostimulation as in the intervention group. Same frequency of sessions as in the IG||. |
1 (16 sessions) |
I-PSS††
|
Qmax|||| and PURV||||||
|
The I-PSS†† score had a 3.2-point higher reduction (improvement) in the IG|| than in the CG§at week 18 (p = 0.001). No changes were observed in Qmax|||| or PURV|||||. |