| Disease | OPEN THREE-CENTER EFFICACY AND SAFETY STUDY WAS CONDUCTED ACCORDING TO COMMON PROTOCOL AT UROLOGY CLINICS, IN ORDER TO CONFIRM THE THERAPEUTIC PROFILE OF PYGEUM AFRICANUM IN CONDITIONS OF DAILY PRACTICE, USING INTERNATIONAL PROSTATE SCORE (IPSS)
AND FLOWMETRY ASSESSMENTS. MEN AGED 50-75 YEARS AND IN COMPLIANCE WITH THE SELECTION CRITERIA (INCLUDING IPSS > 12, QUALITY OF LIFE(QOL) SCORE >3, AND MAXIMUM URINARY FLOW > 15 ML/S) WERE FIRST EXAMINED THEN RECALLED AFTER TWO WEEKS DURING WHICH
NO TREATMENT WAS PROVIDED (WASHOUT AND CHECK OF STABILITY). IF STILL COMPLIANT, THEY WERE ENTERED AT THIS POINT INTO A TWO-MONTH PEROID OF TREATMENT WITH PYGEUM AFRICANUM EXTRACT 50 MG TWICE DAILY. THERE FOLLOWED A FURTHER ONE-MONTH PEROID WHTH
OUT TREATMENT, THE OBJECTIVE BEING TO EVALUATE THE PERSISTENCE OF ANY EFFECTS OBSERVED DURING THE PREVIOUS TWO MONTHS OF PYGEUM AFRICANA ADMINISTRATION. THE PRIMARY EFFICACY PARAMETER INVESTIGATED WAS IPSS; THE OTHER EFFICACY PARAMETERS WERE QOL
NOCTURNAL FREQUENCY; MAXIMUM URINARY FLOW, AVERAGE URINARY FLOW, POST-VOIDING RESIDUAL VOLUME AND PROSTATIC VOLUME, AFTER ONE AND TWO MONTHS OF PYGEUM AFRICANUM TREATMENT AND ONE MONTH AFTER STOPPONG TREATMENT. A TOTAL OF 85 PATIENTS WERE EVENLY
DISTRIBUTED BETWEEN THE THREE CENTERS AND COMPLETED THE ENTIRE STUDY. AT INCLUSION THEIR MEAN IPSS WAS 16.17, QOL WAS 3.60 AND NOCTURIA WAS 2.6 TIMES PER NIGHT. THE CHANGES IN SUBJECTIVE SCORES, IPSS AND QOL AFTER THE TWO-MONTHS TREATMENT PERIOD
WERE HIGHLY STATISTICALLY SIGNIFICANT WITH MEAN IMPROVEMENTS OF 40% AND 31%, RESPECTIVELY. NOCTURNAL FREQUENCY WAS REDUCED BY 32% AND THE MEAN REDUCTION WAS AGAIN HIGHLY STATISTICALLY SIGNIFICANT. MEAN MAXIMUM URINARY FLOW, AVERAGE URINARY FLOW
AND URINE VOLUME WERE ALSO STATISTICALLY SIGNIFICANTLY IMPROVED, BUT THE MODEST IMPROVEMENT IN POST-VOIDING VOLUME DID NOT REACH STATISTICAL SIGNIFICANCE. THE IMPROVEMENTS, WHICH EXCEEDED THOSE OBSERVED WITH PLACEBO IN EARLIER STUDIES, WERE
MAINTAINED AFTER ONE MONTH WITHOUT TREATMENT INDICATING AN INTERESTING PERSISTENCE OF CLINICALLY USEFUL ACTIVITY. PROSTATIC VOLUME AND QUALITY OF SEXUAL LIFE REMAINED UNCHANGED THROUGHOUT. NO TREATMENT-RELATED-ADVERSE EFFECTS WAS OBSERVED |