Table 6.
RCTs examining the effect of fruit and fruit extract supplementation on PSA concentrations among men with PCa, increased PCa risk, or BPH.
| First Author | Origin | Masking | Duration | Patients | Interventions | Results |
|---|---|---|---|---|---|---|
| Student [121] | CZ | Double-blind | 30 d | n = 64 men with PCa prior to surgery | 1. Cranberry fruit powder (1.5 g) (n = 32) 2. Placebo powder (n = 32) |
Serum PSA concentrations decreased by 22.5% in the cranberry intervention arm. |
| Vidlar [122] | CZ | NR | 6 mo | n = 42 men at risk of PCa with LUTS, elevated PSA and negative biopsy | 1. Dried powdered cranberries (0.5 g/d) (n = 21) 2. No cranberry treatment (n = 21) |
The cranberry group experienced a reduction in PSA concentrations on d 180. |
| Spettel [133] | US | Double-blind | 3 mo | n = 113 men (>45 yrs) with significant LUTS | 1. Concord grape juice (240 mL/d) (n = 57) 2. Placebo (n = 56) |
No statistical difference was observed between groups by PSA. |
| Freedland † [134] | US | Double-blind | 4 wks | n = 63 men with PCa, scheduled for prostatectomy (>2 wks) | 1. 2 x 2 POMx caps (each, 0.6 g polyphenols) (n = 30) 2. Placebo (n = 33) |
No differences between arms in pre-surgical PSA or the ratio of baseline/pre-surgery PSA. |
| Stenner-Liewen [135] | CH | Double-blind | 4 wks | n = 87 men with histologically confirmed PCa and PSA ≥ 5 ng/mL | 1. Pomegranate juice 500 mL/d (n = 45) 2. Placebo beverage 500 mL/d (n = 42) |
No differences were detected regarding PSA kinetics. |
| Pantuck [136] | US | Double-blind | 12 mo | N = 166 men with rising PSA concentrations after primary PCa therapy | 1. 8 oz liquid POMx (1.6 mmol polyphenols/d) (n = 102) 2. Matching liquid placebo (n = 64) |
POMx did not prolong PSADT (crude PSA concentrations not compared). |
| Paller † [137] | US | Double-blind | 18 mo | n = 100 men with a rising PSA, without metastases | 1. POMx (1 g/d) (n = 50) 2. POMx (3 g/d) (n = 50) |
POMx was associated with ≥6 mo higher PSADT (no crude PSA concentrations reported). |
| Ryu [129] | KR | Open-label | 1 yr | n = 120 men with symptomatic BPH | 1. Tamsulosin (0.2 mg/d) + saw palmetto (320 mg/d) (n = 60) 2. Tamsulosin (0.2 mg/d) only (n = 60) |
No differences were noted in PSA concentrations among patients between groups. |
| Barry [123,124] | US | Double-blind | 72 wks | n = 357 men (>45 yrs) with an AUA symptom score of 8–24 | 1. Saw palmetto (320 mg, wks 0–24; 640 mg, wks 24–48; 960 mg, wks 48–72) (n = 176) 2. Placebo (n = 181) |
No difference was recorded in the PSA concentrations between groups. |
| Bent [125] | US | Double-blind | 1 yr | N = 225 men (>49 yrs) with mild-to-severe BPH symptoms | 1. Saw palmetto extract (2 × 160 mg/d) (n = 112) 2. Placebo (n = 113) |
No difference in the PSA concentrations between groups. |
| Debruyne [130] | MC | Double-blind | 12 mo | n = 704 men with symptomatic BPH | 1. Tamsulosin (0.4 mg/d) (n = 354) 2. Saw palmetto (320 mg/d) (n = 350) |
PSA remained stable without differences between groups. |
| Carraro [127] | FR | Double-blind | 6 mo | n = 951 men with moderate BPH | 1. Saw palmetto extract (320 mg) (n = 467) 2. Finasteride (5 mg) (n = 484) |
PSA concentrations fell after 13 wks of finasteride but remained stable with saw palmetto. |
| Argirović [128] | RS | NR | 6 mo | n = 265 men with LUTS due to BPH | 1. Tamsulosin (0.4 mg) (n = 87) 2. saw palmetto (320 mg) (n = 97) 3. Tamsulosin (0.4 mg) + saw palmetto (320 mg) (n = 81) |
No differences in the PSA concentrations were recorded between groups. |
AUA, American Urological Association; BPH, benign prostate hyperplasia; eq, equivalent; LUTS, lower urinary tract symptoms; mc, multi-country; PCa, prostate cancer; POMx, pomegranate extract; PSA, prostate-specific antigen; PSADT, prostate-specific antigen doubling time; RCT, randomized controlled trials; † phase II trial.