| Gerber, et al. (2001)19; 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)21; 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)22; 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)26; 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)23; 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)24; 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)27; 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)28; 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)20; 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)29; 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)30; 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)25; 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|||||. |