Fixed combined herbal drug for therapy of menopausal complaints – a placebo-controlled randomised trial

Objective

For many women with menopausal complaints herbal drugs play an even more important role provided they have proven quality, efficacy and tolerability. Black cohosh has demonstrated both by open and controlled clinical trials.

Because many women suffer from pronounced psychological menopausal complaints such as nervousness, irritability, anxiety and depressive mood, a preparation was developed combining the advantages of black cohosh directed against neurovegetative complaints (hot flushes, sweating) with the proven efficacy on psychological symptoms of St John’s wort: Remifemin Plus (Schaper & Bruemmer, Salzgitter, Germany). The aim of this randomised controlled trial was to assess efficacy and tolerability of this combination.

Materials and methods

A total of 179 women were randomised into two groups receiving active (one coated tablet twice daily, n = 87) or matching placebo (n = 92). Study duration was of 6 weeks assessing Kupperman Menopause Index and CGI Scores for ‘Anxiety’, ‘Impaired drive’, ‘Depressive Mood’ and ‘Nervousness/Irritability’. For tolerability, adverse events were recorded.

Results

A decrease in Kupperman Index total score demonstrated significant superiority of the active to placebo(P < 0.001). In all CGI items referring to psychological symptoms Remifemin Plus was also superior (P < 0.001). Results are also clinically relevant: response (Kupperman score < 15 or at least 50% reduction) was reached by 36 patients respective 19 women (P < 0.01). In each group five adverse effects were recorded (not serious).

Conclusion

In this first placebo controlled trial assessing efficacy and tolerability of a fixed combination of black cohosh and St John’s wort an excellent benefit risk ratio could be proven. Remifemin Plus offers effective and safe treatment for women with menopausal complaints suffering from pronounced psychological symptoms.