| Disease | FIFTY-ONE POSTMENOPAUSAL WOMEN WERE RANDOMIZED TO PLACEBO AND ACTIVE (ONE TABLET PER DAY OF A 40-MG ISOFLAVONE SUPPLEMENT) GROUPS IN A CROSS-OVER DESIGN TRIAL. AFTER A 1-WEEK RUN-IN PERIOD, SUBJECTS WERE COMMENCED ON A 12-WEEK PERIOD OF
TREATMENT (ACTIVE OR PLACEBO), FOLLOWED BY A 1-MONTH PLACEBO WASH-OUT PERIOD, THEN CROSSED OVER TO THE ALTERNATIVE TREATMENT REGIMEN FOR A FURTHER 14 WEEKS. SYMPTON DIARIES WERE MAINTAINED THROUGHOUT THE TRIAL AND AT THE START AND END OF
TREATMENT. PLASMA SEX HORMONE BINDING GLOBULIN (SHBG) ASSAY, FULL BLOOD COUNT, BIOCHEMICAL PROFILES, VAGINAL SWABS AND VAGINAL ULTRASOUND SCANS WERE PERFORMED AND ISOFLAVONES DETERMINED IN 24-H URINE COLLECTIONS BY HPLC ANALYSIS.
THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN ACTIVE AND PLACEBO GROUPS IN THE REDUCTION IN HOT FLUSHES BETWEEN START AND FINISH TIME-POINTS. ANALYSIS PERFORMED ON INTERIM DATA TIME-POINTS REVEALED A SUBSTANTIALLY GREATER REDUCTION IN FLUSHING IN
THE ACTIVE GROUP THAN PLACEBO AT 4 AND 8 WEEKS AFTER COMMENCEMENT OF TREATMENT, BUT THIS WAS NOT STATISTICALLY SIGNIFICANT. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS FOR GREENE SCORES OR IN SHBG LEVELS, HEMATOLOGICAL OR BIOCHEMICAL
PARAMETERS AND VAGINAL SWAB OR ULTRASOUND FINDINGS. THE COMBINED VALUES FOR ALL SUBJECTS, REGARDLESS OF TREATMENT GROUP, REVEALED A STRONG NEGATIVE CORRELATION BETWEEN THE LEVEL OF URINARY ISOFLAVONE EXCRETION AND THE INCIDENCE OF HOT FLUSHES. |