'Hypericum perforatum' with 'Vitex angus-castus' in menopausal symptoms: a randomized, controlled trial

Objective: To evaluate the effectiveness to a phytotherapeutic intervention comprimising a combination of 'Hypericum perforatum' (St. John's wort) and 'Vitex agnus-castus' (Chaste tree/berry) in the management of menopausal symptoms. Design: A double-blind, randomized, placebo-controlled, parrallel trial was performed over 16 weeks in 100 eligible late-perimenopausal or postmenopausal women experiencing hot flushes and other menopausal symptoms. Herbal combination therapy or placebo tablets were administered twice daily. The primary endpoint was hot flush episodes. Secondary endpoints included Greene Climacteric Scale scores, Hamilton Depression Inventory scores, and Utian Quality of Life Scale scores. Results: Ninety-three women completed the study. Data analysis on an intent-to-treat basis found no significant differences between the two groups for any of the endpoints. Analyses performed at interim data points revealed no significant differences at week 3, 8, or 12 for daily weighted flushes or scores on the Greene Climacteric Scale or Hamilton Depression Inventory. However, significant improvements across the treatment phase were observed in both the placebo and active treatment groups for these endpoints. No significant change was found for either group on quality of life. Conclusion: the herbal combination of 'H. Perforatum' and 'V. agnus-castus' was not found to be superior to placebo for the treatment of menopausal symptoms. The herbal combination was well tolerated and no significant adverse effects noted in the short term. Robust findings from quality studies such as this are important for informing the community, healthcare providers, and regulatory authorities.