Table 2: Summary of prostate cancer-related clinical trial data (primary and secondary prevention studies) that is available for frequently used complementary alternative medicines (CAMs).

CAM Number of clinical studies, level of evidence, number of patients enrolled (n), and primary clinical outcome measure that was assessed Outcome

Green tea

Two clinical studies;

Clinical study 1: level 1 evidence, n = 97, primary outcome measure was progression of HGPIN to PC [16].

Clinical study 2: level 3 evidence, n = 42, primary outcome measure was 50% reduction in baseline PSA level [17].

None of these studies showed efficacy

Modified citrus pectin (MCP)

Two clinical studies;

Clinical study 1: level 3 evidence, n = 13, primary outcome measure was increase in PSADT [18].

Clinical study 2: level 3 evidence, n = 49, outcome was tumor response per RESIST criteria [24].

Only study 1 showed efficacy

Pomegranate fruit extract (PFE)

Four clinical studies;

Clinical study 1: level 3 evidence, n = 46, outcome measure was reduction in PSA levels [27].

Clinical study 2: level 3 evidence, n = 104, outcome measure was increase in PSADT [30].

Clinical study 3: level 1 evidence, n = 70, outcome measure was a reduction in oxidative stress markers in patient tumors [31].

Clinical study 4: level 1 evidence, n = 102, outcome measure was increase in PSADT [32].

Only studies 1 and 2 showed efficacy

Selenium

Four clinical studies:

Clinical study 1: level 1 evidence, n = 35,533, outcome measure was PC incidence [39].

Clinical study 2: level 1 evidence, n = 423, outcome measure was PC incidence [38].

Clinical study 3: level 1 evidence, n = 699, outcome measure was PC incidence [38].

Clinical study 4: level 1 evidence, n = 1,561, outcome measure was PC incidence [38].

None of these studies showed efficacy

Vitamin E

Two clinical studies:

Clinical study 1: level 1 evidence, n = 35,533, outcome measure was PC incidence [39].

Clinical study 2: level 1 evidence, n = 14,641, outcome measure was PC incidence [45].

None of these studies showed efficacy

Lycopene

Three clinical studies:

Clinical study 1: level 1ii evidence, n = 41, outcome measure was decrease in PSA levels [52].

Clinical study 2: level 1ii evidence, n = 36, outcome measure was decrease in PSA levels [53].

Clinical study 3: level 1ii evidence, n = 71, outcome measure was decrease in PSA levels [54].

Only study 3 showed efficacy

Soy

Eight clinical studies;

Clinical study 1: level 1 evidence, n = 66, outcome measure was decrease in PSA level [67].

Clinical study 2: level 1 evidence, n = 53, outcome measure was decrease in sex hormone-binding globulin [68].

Clinical study 3: level 1 evidence, n = 45, outcome measure was decrease in sex hormone-binding globulin [69].

Clinical study 4: level 1 evidence, n = 47, outcome measure was decrease in PSA levels [70].

Clinical study 5: level 1 evidence, n = 158, outcome measure was decrease in PSA levels [71].

Clinical study 6: level 1 evidence, n = 29, outcome measure was decrease in PSA levels [72].

Clinical study 7: level 1 evidence, n = 66, outcome measure was decrease in circulating androgen levels [73].

Clinical study 8: level 1 evidence, n = 76, outcome measure was decrease in PSA levels [74].

Only studies 4, 6, and 7 showed efficacy. Meta-analysis of all 8 studies was inconclusive

Saw palmetto extract

One clinical study: level 1 evidence, n = 369, outcome measures were AUA symptom score and PSA levels [77].

Did not show efficacy

Vitamin D

Three clinical studies;

Clinical study 1: level 3 evidence, n = 21, outcome measure was decrease in PSA levels [85].

Clinical study 2: level 3 evidence, n = 18, outcome measure was decrease in PSA levels [86].

Clinical study 3: level 1 evidence, n = 52, outcome measures were decrease in PSA levels and Gleason score [85].

Studies 1 and 3 showed efficacy

Sulforaphane

Two clinical studies;

Clinical study 1: level 3 evidence, n = 20, outcome measure was PSADT [93].

Clinical study 2: level 1 evidence, n = 78, outcome measure was decreased PSA level [94].

Study 1 showed efficacy

HGPIN: High Grade Prostatic Intraepithelial Neoplasia; PC: Prostate Cancer; PSADT: PSA Doubling Time.