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.