Traditional Chinese medicine formula (Er-xian decoction) for menopausal symptoms: literature review andclinical trial

Abstract

More than half of the women aged from 45-55 suffer from menopausal symptoms

which can seriously affect the quality of life of the midlife women. The menopause

transition has become a very active research area in healthy aging in the last several

decades. In recent years, more and more women have turned to traditional Chinese

medicine (TCM) to manage their menopausal symptoms. Among various Chinese

medicine formulae, Er-Xian Decoction (EXD) is one of the most acceptable Chinese

medicine formulae to relieve menopausal symptoms. Although EXD is popular in the

management of menopausal symptoms, its effectiveness has not been evaluated by

strictly designed clinical study.

A systematic review was conducted to evaluate the current evidence to assess the

efficacy and safety of EXD as a basic formula for menopausal symptoms. A total of

12 randomized controlled trials (RCTs) were included for further analysis. The results

of these studies suggested that EXD was more effective than the control interventions,

which included various HRT and other Chinese herbal medicine. Seven of the studies

compared EXD with HRT and the meta-analysis seemed to suggest that EXD as a

basic formula was superior to hormone replacement therapy. However, the included

studies were insufficient in methodological quality and had a high probability of bias.

A double-blind randomized controlled clinical trial was then conducted to assess the

efficacy and safety of EXD for menopausal symptoms. Of 557 recruited women, 108

subjects were eligible to participate in the study and 101 subjects finished the study.

Comparisons between placebo and EXD groups were conducted by using an analysis

of covariance (ANCOVA) with baseline as covariate. EXD granules when compared

with placebo significantly reduced the frequency and severity of hot flushes and night

sweats. EXD compared with placebo significantly reduced the frequency of hot flushes (P=0.041) and the hot flush severity score (P=0.016). Superiority of EXD over

placebo was also observed in greater improvement in total scores of MRS (P=0.028)

and MENQOL questionnaires (P=0.021). There were no differences between EXD

and placebo group in serum hormones and bone markers. There were no serious

adverse events and the safety indices of whole blood counts, renal and liver functions

were normal before and after the treatment. Both EXD and placebo were well

tolerated.

In summary, this Chinese herbal formula EXD was found to be superior to placebo in

reducing hot flushes and improving menopausal symptoms in Hong Kong

perimenopausal women. It was well tolerated, with no serious adverse events noted

during the study period.