Abstract
A double-blind, placebo-controlled clinical trial was performed to investigate the efficacy and safety of 12-week intake of honeybee-collected pollen lump extract (HPLE)-supplemented food in 47 patients with benign prostatic hyperplasia (BPH). The participants were randomly assigned to 3 study food trial groups: a placebo group (0 mg HPLE per day); a lower-dose group (160 mg HPLE per day); and a high-dose group (320 mg HPLE per day) (Groups P, L, and H, respectively). Outcome measures were the change during the 12-week intervention period in subjective symptom scores and 2 urodynamic parameters, maximum flow rate (Qmax) and residual urine volume. Qmax values were significantly increased in Group H (P<0.05) but not in Groups L or P. While residual urine volume was significantly increased in Groups L and P (P<0.05 each), the level in Group H decreased, although the difference between Groups H and P did not reach statistical significance (P=0.052). No HPLE-related health hazards or laboratory abnormalities of clinical significance were encountered.