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A randomized placebo-controlled trial on the effectiveness of an herbal formula to alleviate menopausal vasomotor symptoms

van der Sluijs, Corinne Patching Dip Ed, BSc, BHlth Sc1; Bensoussan, Alan PhD1; Chang, Sungwon BSc, MStat1; Baber, Rodney MB, BS, BPharm2,3

doi: 10.1097/gme.0b013e3181883dc1
Articles

Objective: To evaluate the effectiveness of a formula containing Chinese herbs and Cimicifuga racemosa in alleviating vasomotor symptoms and improving quality of life.

Methods: Between September 2004 and October 2005, 93 healthy women aged 45 to 65 years who reported six or more vasomotor symptoms per 24 hours were recruited into a 20-week randomized, double-blind, placebo-controlled trial. Women were consulted in clinics conducted within the Sydney metropolitan area. After a 4-week baseline period, women were randomly allocated to receive herbal (equivalent to 3,150 mg dry herb) or identical placebo tablets for 16 weeks. Women recorded the number and severity (1 = mild to 4 = very severe) of vasomotor symptoms in a daily hot flash diary and completed the Greene Climacteric and Hot Flash Related Daily Interference scales at each monthly consultation.

Results: Intention-to-treat and per-protocol analyses found no statistically significant differences in mean hot flash scores (product of frequency and intensity), Greene Climacteric Scale scores, and Hot Flash Related Daily Interference Scale scores between the placebo and herbal treatment groups after 16 weeks of intervention.

Conclusions: This herbal formula containing Chinese herbs and Cimicifuga cannot be recommended to alleviate menopausal vasomotor symptoms or improve quality of life.

This randomized double-blind placebo-controlled trial found that a herbal formula comprising of seven traditional Chinese medicinal herbs and Cimicifuga racemosa was no more effective than placebo in alleviating menopausal vasomotor symptoms and improving quality of life.

From 1CompleMED, Centre for Complementary Medicine Research, University of Western Sydney, Sydney, Australia; 2Department of Obstetrics and Gynaecology, University of Sydney, Sydney, Australia; and 3Menopause Clinic, Royal North Shore Hospital, Sydney, Australia.

Received June 3, 2008; revised and accepted July 28, 2008.

Funding/support: Research funding and supply of herbal and placebo treatments were supplied by Global Therapeutics.

Financial disclosure: None reported.

Address correspondence to: Corinne Patching van der Sluijs, Dip Ed, BSc, BHlth Sc, CompleMED, Centre for Complementary Medicine Research, University of Western Sydney, Locked Bag 1797, Penrith South DC, New South Wales 1797, Australia. E-mail: corinne@xactsolutions.com.au

©2009The North American Menopause Society