| Disease | PROSTAGLUTT FORTE (COMBINATION OF S. REPENS AND U. DIOICA) WERE RECENTLY REPORTED. THE RANDOMIZED, PLACEBO-CONTROLLED STUDY INCLUDED ONLY 20 PATIENTS IN EACH ARM. AFTER A 2-WEEK PLACEBO LEAD-IN PERIOD, THERE WAS 6 MONTHS OF DOUBLE-BLIND
TREATMENT, FOLLOWED BY 6 MONTHS OF OPEN-LABEL TREATMENT. IN THAT STUDY, BOTH IPSS AND PEAK FLOW RATE SHOWED GREATER IMPROVEMENT WITH TREATMENT THAT WITH PLACEBO. THE IPSS WENT FROM 18.6 DOWN TO 11.1 WITH PROSTAGLUTT AND FROM 19 TO 17.6 WITH
PLACEBO (P=0.002). DURING THE OPEN-LABEL EXTENSION PHASE, THE PLACEBO GROUP IMPROVED FROM 17.6 TO 13.3; SURPRISINGLY, THE PRSTAGLUTT-TREATED GROUP ALSO CONTINUED TO IMPROVE, DROPPING FROM 11.1 TO 9.8. IN TERMS OF PEAK FLOW RATES, THE PROSTAGLUTT
-TREATED PATIENTS IMPROVED BY 2.3 ML/S OVER THE OPEN-LABEL SECOND 6-MONTH PERIOD. THE PLACEBO GROUP SHOWED MINMAL CHANGE DURING THE INITIAL PLACEBO PERIOD (0.45 ML/S); HOWEVER, DURING ACTIVE TREATMENT THERE WAS A 2-ML/S IMPROVEMENT. THUS, THIS
STUDY INDICATED THAT FURTHER IMPROVEMENT WITH PROSTAGLUTT THERAPY CAN BE ACHIEVED WITH LONGER TREATMENT (FROM 6 TO 12 MONTHS). THIS FINDING FURTHER SUPPORTS THE NEED FOR DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES OF AT LEAST 1 YEAR IN DURATION
TO EVLALUATE PLANT EXTRACT THERAPY. |