| Disease | PATIENTS WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) ENTERED A 2-MONTH RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, COMPARATIVE PHASE (GROUP A, 50 MG TWICE DAILY; GROUP B, 100 MG ONCE DAILY), FOLLOWED BY A 10-MONTH, OPEN PHASE (100 MG
ONCE DAILY). MAIN EFFICACY ASSESSMENT PARAMETERS INCLUDED INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), QUALITY OF LIFE (QOL), AND MAXIMUM URINARY FLOW RATE (QMAX). BOTH TREATMENT HAD SIMILAR EFFICACY. IPSS (BASELINE 17 IN BOTH GROUPS) IMPROVED
BY 38% IN GROUP A AND 35% IN GROUP B. QOL IMPROVED BY 28% IN BOTH GROUPS. QMAX INCREASED BY 1.63 ML/S (16%) IN GROUP A AND 2.02 ML/S (19%) IN GROUP B. AFTER 12 MONTHS, THE IPSS FELL FROM 16 (BASELINE) TO 9 (-46%). HALF OF THE PATIENTS HAD AN
IPSS BELOW 8. MEAN QMAX INCREASED BY 1.65 ML/S (15%). THE SAFETY PROFILE WAS SIMILAR BETWEEN GROUPS AND STUDY PHASES. P.AFRINCANA EXTRACT AT 50 MG TWICE DAILY AND 100 MG ONCE DAILY PORVED EQUALLY EFFECTIVE AND SAFE AT 2 MONTHS.
A COMMERCIAL PRODUCT, TADENAN, WAS USED. |