Abstract
Objectives
To assess efficacy and tolerability of a special extract of Vitex agnus castus (VAC, BNO 1095) in the treatment of women suffering from premenstrual syndrome (PMS)
with moderate to severe complaints.
Methods
Prospective, open, non-comparative, monocentre study. After a run-in phase lasting
three cycles, eligible patients were treated for up to three cycles with VAC extract.
Efficacy was assessed using a PMS-Diary (primarily) and the PMTS score.
Results
One hundred and twenty-one patients were enrolled, 118 provided efficacy data (full
analysis set), and 109 completed the treatment phase. The severity of the PMS symptoms
consistently decreased during treatment, on average from 22.8 score points during
the baseline cycle to 10.2 during the third cycle. The mean decrease was 12.6 score
points (95% CI: 10.9–14.4, p < 0.0001, Student's t-test). Response to treatment was found in 67.8% of the women during the third treatment
cycle (95% CI: 58.6–77.0). Results for the PMTS were similar with a decrease on average
from 22.5 to 11.0 score points, i.e. mean change −11.4 (95% CI: 10.1–12.8, p < 0.0001).
Conclusion
Vitex agnus castus extract BNO 1095 is effective and well tolerated in the treatment of moderate to
severe PMS.
Keywords
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Article info
Publication history
Published online: July 20, 2006
Identification
Copyright
© 2006 Elsevier Ireland Ltd. Published by Elsevier Inc. All rights reserved.
