The effects of Chinese medicinal herbs on postmenopausal vasomotor symptoms of Australian women

Abstract

Objective To evaluate the effects of a defined formula of Chinese medicinal herbs (CMH) on menopausal symptoms. Design A double‐blind randomised placebo‐controlled trial. Methods Between August 1998 and April 1999, 55 postmenopausal Australian women recruited from an urban population completed 12 weeks of intervention with either a defined formula of CMH (n = 28) or placebo (n = 27) taken twice daily as a beverage. Main outcome measures The primary end‐point was change in frequency of vasomotor events (hot flushes and night sweats). The secondary end‐points were changes in score for the domains measured in the Menopause Specific Quality of Life (MENQOL) Questionnaire. Results There was a reduction in average weekly frequency of vasomotor events with CMH (–15%, 95% CI, –31% to +1%) and with placebo (–31%; 95% CI, –42% to –21%). The difference between groups favoured the use of placebo; however, this was not significant (P = 0.09). Although significant reductions in scores for the various domains of the MENQOL Questionnaire were observed for both CMH and placebo, there were no significant differences between the two treatment groups for any domain. There was evidence for effect modification by previous use of natural therapies for the vasomotor, physical and sexual domains of the MENQOL Questionnaire: women with no prior use of natural therapies for their menopausal symptoms responded to therapy, whereas prior users did not. Conclusions The defined formula of CMH was no more effective than placebo in reducing vasomotor episodes in Australian postmenopausal women, or in improving any of the four symptom domains in the MENQOL Questionnaire. Three of the MENQOL Questionnaire domains were modified by prior use of natural therapies. This finding has implications for future studies.

Efficacy and Side Effects of Chinese Herbal Medicine for Menopausal Symptoms: A Critical Review

“…All these 5 studies employed placebo or no treatment as the comparators. Four studies reported substantial but similar improvements in both CHM and placebo groups [34, 53, 55, 56]. One did not find improvement at all in five major domains in CHM, HRT, and no treatment groups [54].…”

Effects of escitalopram on menopause-specific quality of life and pain in healthy menopausal women with hot flashes: A randomized controlled trial

“…The MENQOL was chosen for the MsFLASH trials because of the breadth of the domains covered by its 29 questions, its salutary psychometric properties, its brevity and its sensitivity to change over time. In addition, this measure has been used in previous trials that evaluate hot flash interventions ranging from hormone therapies [20], to dietary supplements [21], to Chinese herbal treatments [22], which facilitates cross-study comparisons. While comparisons between clinical trials must be considered with caution, two trials that evaluated escitalopram [23] or its isomer, citalopram [24], in small samples of symptomatic women (16 and 25 women per group, respectively), reported improvements in the total and domain-specific MENQOL scores as a result of SSRI treatment.…”

Vitex agnus-castus(Chaste-Tree/Berry) in the Treatment of Menopause-Related Complaints

“…The lack of a placebo group is a major limitation, as placebo effects with vasomotor symptoms in menopause studies are substantial, with 51% being the average for studies of HT according to a meta-analysis published in 2004, 116 and generally in the range of 30%-41% in RCTs of medicinal herbs. 11,13,[117][118][119] From baseline to 3 months, a 42% decrease was observed in daily hot flushes, p ¼ 0.0003, and Kupperman Index total symptoms score decreased by 24%, ( p ¼ 0.0028). Due to substantial placebo effects found in studies of vasomotor symptoms, it is possible that the 42% reduction in vasomotor symptoms observed in this study would not be significant over placebo.…”