The Effect of black cohosh with St. John's wort (Feramin-Q(R)) on climacteric symptoms: multicenter randomized double-blind placebo-controlled trial / 대한산부인과학회지

ABSTRACT

OBJECTIVE: Results of several recent randomized clinical trials and epidemiological studies casted many doubts about the validity and safety of conventional hormone therapy for postmenopausal women. More and more women want to try more natural and safe ways of treating their climacteric symptoms. Black cohosh combined with St. John's wort may be effective in climacteric symptoms alternative to hormone therapy. This multicenter randomized double-blind placebo-controlled prospective clinical trial was carried out to evaluate the effect of the combined preparation of black cohosh and St. John's wort, Feramin-Q(R), on the general climacteric symptoms, hot flushes and climacteric depression. METHODS: Total of 80 postmenopausal women having moderate to severe degree of climacteric symptoms were randomly allocated to receive Feramin-Q(R) (n=40) or placebo (n=40) daily for 12 weeks. Fifty eight subjects completed this clinical study. The primary endpoint, the relief of general climacteric symptom and hot flushes were evaluated by measuring Kupperman index and the secondary endpoint, the relief of climacteric depression by Beck Depression Inventory at 4 and 12 weeks of treatment. RESULTS: After 4 and 12 weeks of treatment, Feramin-Q(R) and placebo groups showed significant decline of Kupperman index and BDI scores compared with baseline scores, but Kupperman index and BDI scores between the groups were not significantly different at 12 weeks. The changes of BDI scores between the groups were different at borderline significant level (p=0.07). Hot flush scores of Feramin-Q(R) groups were significantly decreased after 12 weeks of therapy, which showed significantly different at borderline level (p=0.07) from that of placebo. There was no statistical difference in change of hot flush scores from the baseline between the groups after 12 weeks. Among the 45 postmenopausal women with moderate to severe hot flush, Feramin-Q(R) group showed significant decrease of hot flush scores, which was significantly different compared with placebo group at 12 weeks of therapy. There were more patients (86.4%) in Feramin-Q(R) group, who had much more improvement of hot flushes compared with placebo group (54.6%) (P=0.04). CONCLUSION: There were no significant differences between placebo and Feramin-Q(R) groups concerning the effect on general climacteric symptoms and depression but Feramin-Q(R) was significantly more effective than placebo in relieving of hot flush in postmenopausal women with moderate to severe hot flushes. Therefore Feramin-Q(R) seems to be effective alternative for moderate to severe hot flushes.