Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia (BPH).
Because benign prostatic hyperplasia (BPH) is relatively common, it is important to discover safe and effective means to treat this often debilitating perturbation. Accordingly, we examined the effectiveness of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) in treating symptoms of BPH. We undertook a randomized, placebo-controlled, double-blind study. Patients were enrolled from 3 urological practices in the USA. 144 subjects were randomized for study. 17 subjects eventually withdrew, leaving 70 patients in the test group and 57 in the placebo group to complete the study. Inclusion criteria consisted of a diagnosis of BPH, no evidence of cancer, and a maximal urinary flow rate between 5 and 15 ml/second. Patients received either placebo or the combined natural products for 3 months. Evaluations were performed via the American Urological Association (AUA) Symptom Index score, urinary flow rate, PSA measurement, and residual bladder volume. Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo (p < 0.001). Daytime frequency was also lessened significantly (p < 0.04). When the average individual total AUA Symptom Index score in the test group was compared to that in the placebo group at the end of the study, the difference proved highly significant (p < 0.014). PSA measurements, maximal and average urinary flow rates, and residual volumes showed no statistically significant differences. When taken for 3 months, a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score. The combination of natural products caused no significant adverse side effects.
Preuss
H G
HG
Department of Physiology and Biophysics, Georgetown University Medical Center, Washington, DC 20007, USA. preusshg@georgetown.edu
Marcusen
C
C
Regan
J
J
Klimberg
I W
IW
Welebir
T A
TA
Jones
W A
WA
D000726:Androgen Antagonists / Q000627:therapeutic use*; D001688:Biological Products / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D010936:Plant Extracts / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000503:physiopathology / Q000628:therapy*; D012434:Secale; D028024:Serenoa; D012855:Sitosterols / Q000627:therapeutic use*; D014563:Urodynamics; D014810:Vitamin E / Q000627:therapeutic use*
D000726:Androgen Antagonists; D001688:Biological Products; D010936:Plant Extracts; D012855:Sitosterols; D014810:Vitamin E; C025473:gamma-sitosterol; C010070:cernilton; C040972:saw palmetto extract