| Disease | IN A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY, THE CLINICAL EFFICACY AND SAFETY OF TWO DIFFERENT EXTRACTS OF ST. JOHN'S WORT WERE INVESTIGATED IN 147 MALE AND FEMALE OUTPAITNETS SUFFERING FROM MILD TO MODERATE DEPRESSION
ACCORDING TO DSM-IV CRITERIA. FOLLOWING A PLACEBO RUN-IN PERIOD OF THREE TO SEVEN DAYS, THE PATIENTS WER RANDOMIZED TO ONE OF THREE TREATMENT GROUPS: DURING THE 42-DAY TREATMENT PERIOD, THEY RECEIVED 3 X 1 TABLETS OF EITHER PLACEBO, HYEPRICUM
EXTRACT WS 5573 (300 MG, WITH A CONTENT OF 0.5% HYPERFORIN), OR HYPERICUM EXTRACT WS 5572 (300 MG, WITH A CONTENT OF 5% HYPERFORIN). THE MANUFACTURING PROCESS FOR THE TWO HYEPRICUM PREPARATIONS WAS IDENTICAL SO THAT THEY DIFFERED ONLY IN THEIR
HYPERFORIN CONTENT. EFFICACY REGARDING DEPRESSIVE SYMPTOMS WAS ASSESSED ON DAYS 0, 7, 14,28, AND 42, USING THE HAMILTON RATING SCALE FOR DEPRESSION (HAMD, 17-TIEM VERSION) AND THE DEPRESSION SELF-RATING SCALE (D-S) ACCORDING TO VON ZERSSEN.
IN ADDITION, THE SEVERITY OF ILLNESS WAS ALSO RATED BY THE INVESTIGATORS ON DAY 0 AND 42 USING THE CLINCAL GLOBAL IMPRESSION (CGI) SCALE. THE LAST OBSERVATION OF PATIENTS WITHDRAWN FROM THE TRIAL PREMATURELY WAS CARRED FORWARD. AT THE END OF THE
TREATMENT PERIOD (DAY 42), THE PATIENTS RECEIVING WS 5572 (5% HYPERFORIN) EXHIBITED THE LARGEST HAMD REDUCTION VERSUS DAY O (10.3+4.6 POINTS; MEAN+SD), FOLLOWED BY THE WS 5573 GROUP (0.5% HYPERFORIN; HAM REDUCTION 8.5+6.1 POINTS) AND THE PLACEBO
GROUP (7.9+5.2 POINTS). AS REGARDS THE CHANGE IN THE HAMD TOTAL SCORE BETWEEN DAY 0 AND TREATMENT END AND ITS RELATIONSHIP TO THE HYPERFORIN DOSE, A SIGNIFICANT MONOTONIC TREND WAS DEMOSTRATED IN THE JONCHEERE-TERPSTRA TEST (P=0.017). IN
PAIRWISE COMPARISON, WS 5572 (5% HYPERFORIN) WAS SUPERIOR TO PLACEBO IN ALLEVIATING DEPRESSIVE SYMPTOMS ACCORDING TO HAMD REDUCTION (MANN-WHITNEY U-TEST: P=0.004), WHEREAS THE CLINICAL EFFECTS OF WS 5573 (0.5% HYPERFORIN) AND PLACEBO WERE
DESCRIPTIVELY COMPARABLE. ETC. |