To evaluate the effectiveness of a phytotherapeutic intervention comprising a combination of Hypericum perforatum (St. John's wort) and Vitex agnus-castus (Chaste tree/berry) in the management of menopausal symptoms.
A double-blind, randomized, placebo-controlled, parallel 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.
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 time points revealed no significant differences at week 4, 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.
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 with no significant adverse events noted in the short term. Robust findings from quality studies such as this are important for informing the community, healthcare providers, and regulatory authorities.
In this randomized, controlled trial, 100 late-perimenopausal or postmenopausal women received either 5,400mg Hypericum perforatum and 1,000mg Vitex agnus-castus or placebo daily for 16 weeks. No significant differences were observed between groups for hot flushes or other menopausal symptoms, although both groups improved significantly.
From the 1Royal Melbourne Institute of Technology-University, Bundoora, Victoria, Australia; 2Prince Henry's Institute of Medical Research, Clayton, Victoria, Australia; 3MediHerb, Warwick, Queensland, Australia; University of New England, Armidale, New South Wales, Australia; 4Jean Hailes Foundation, Monash Institute of Health Services Research, Monash University, Clayton, Victoria, Australia.
Received March 26, 2008; revised and accepted May 12, 2008.
Funding/support: MediHerb Australia Pty Ltd. provided active and placebo formulations. Financial support was also provided by the Australian College of Phytotherapy and Jean Hailes Foundation for Women's Health.
Financial disclosure: Kerry Bone is a founder and director of research and development of MediHerb Australia Pty Ltd.
Address correspondence to: Diana van Die, School of Health Sciences (Comp Med), RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia. E-mail: email@example.com