Menopause & Chinese Herbal Medicine Research

It is still uncertain whether Chinese Herbal Medicine (CHM) for the treatment of vasomotor symptoms in menopausal women is effective or safe. Menopausal women are seeking natural therapies due to concerns associated with adverse effects (AE) of hormone replacement therapy (HRT). I am a Holistic Health Health expert in Melbourne, Australia and am very passionate about supporting women with menopause in clinic.

What is Menopause?

Menopause is the cessation of reproductive ability and cyclic production of ovarian sex steroids due to loss of ovarian function in a woman that produces vasomotor, somatic, sexual and psychological symptoms (Gartoulla, Islam, Bell & Davie, 2014). Almost 80% of women in western nations and more than 60% of Chinese women experience menopausal symptoms that interfere with their quality of life ((Kronenberg (1994), Nelson (2008)). Diagnosis is confirmed by the cessation of menstruation (excluding hormonal contraceptive use) for more than 12 months (Goolsby, 2001).
Currently, doctors treat menopause with custom-compounded bioidentical HRT, non-hormonal pharmalogics such as (e.g. SSRIs), gabapentin and clonidine (Pace, 2017). There are various HRT brands, preferably a woman will find other options given there are serious side effects that HRT carries. As a guide, the costs of HRT may initially seem lower than seeking naturopathy and Chinese medicine for menopause, however the severity of side effects can outweigh both cost and benefit of HRT.

Symptoms of Menopause

Menopause can present numerous symptoms such as weight gain, hot flashes, night sweating and dryness. Chinese medicine offers numerous remedies to not necessarily reverse the menopause but to support the body to return the body to balance so that hot flash frequency and severity are reduced, metabolism is supported to prevent further weight gain, the excess heat is cleared from the body to reduce the night sweating and dryness. Premature menopause can be supported too for symptomatic reasons but is difficult to treat with Chinese medicine for fertility.

What is Premature Menopause?

Premature menopause is defined as a woman going through menopause before the age of 40 years. Chinese medicine can support premature menopause to reduce the severity of the condition and ease symptoms but it cannot be cured. It can be diagnosed medically, usually through FSH analysis.

What is Perimenopause?

Is when a woman transitions into menopause, she may not be completely menopausal but on the cusp and it can occur for a few years. She may get occasional symptoms such as changes in regularity of menstruation and bleeding quantity. The beginning so hot flashes and night sweating that comes and goes. This occurs as the body makes less oestrogen, in Chinese medicine oestrogen is considered a yin hormone as it makes the body moist and young, so when oestrogen levels drop a woman can become dry and present with heat symptoms such as night sweating and hot flashes. Although taking HRT or synthetic oestrogen alleviates these symptoms, when taken over a long period of time they have been linked to serious side effects such as breast cancer. This is why a course of acupuncture and Chinese herbal medicine with an experienced practitioner is worth doing before trying stronger medications.

How To Self-Helf Naturally During Menopause

If you want to understand and learn ways to help your menopause symptoms yourself, read my article here on Natural Support for Menopause.

Definition of Menopause in Traditional Chinese Medicine

CHM is based on traditional Chinese medicine (TCM). TCM theory regards menopause as a natural event in a woman’s life that occurs around 49 years of age. The signs and symptoms experience by a woman at this time vary from night sweating, hot flushes, exhaustion, vaginal dryness to severe hormonal changes (Zhou & Qu, 2007). Menopause is thought to occur after the very gradual decline of kidney jing (essence) over a woman’s life, and manifested in the deficiency of kidney yin or yang, or both, along with the physiological decline of tian gui (heavenly water). An ancient Chinese medicine text, the Huang di Nei Jing Su Wen depicts that this “tian gui” arrives at 14 years of age and is exhausted by the age of 49;
“At the age of 14 the Tian Gui arrives,
the Ren Mai begins to flow,
the Chong Mai is flourishing,
the periods come regularly and she can conceive…
At the age of 49,
the Ren Mai is empty,
the Chong Mai depleted,
the Tian Gui dries up,
the Earth Passage [uterus] is not open,
so weakness and infertility set in”
(Unschuld, 2003, p.84).
TCM treats menopause with either CHM or acupuncture, or both together. Treatment principles generally aim to nourish both the kidney yin and yang, while clearing any deficient heat and addressing any related organ imbalances (Maciocia,1998).

Chinese Medicine Menopause Melbourne

Chinese medicine has been used for thousands of years to improve the annoying and uncomfortable symptoms of menopause. Located in Fairfield, Melbourne, Ilana is experienced at using Chinese herbs, Moxa and acupuncture to effectively treat menopause give you much desired relief.
To make an appointment for in Clinic Acupuncture or online Holistic Health coaching Book Online or contact us on 0466 866 450.
Copyright © 2020 Ilana Sowter · All Rights Reserved

Rationale for Another Systematic Review

HRT is currently the most effective and prescribed medical treatment for vasomotor symptoms of menopause, however numerous AE and associations have been reported especially for long-term application; ranging from endometrial hyperplasia, endometrial carcinoma, breast cancer to stroke and venous embolism (Lumsden, 2016, Beral et. al., 2001).
In consequence, a significant proportion of menopausal women are unwilling to use hormone therapy and some have contraindications to the therapy making not only patients, but also physicians progressively curious in complimentary therapies which offer good efficacy and fewer AE (Kang, Ansbacher & Hammoud, 2002).
Problematic symptoms, specifically vasomotor of menopause in Australia affected 50% of women (Gartoulla, Islam, Bell & Davie, 2014). Australia has an ever-growing ageing population; many menopausal women are in the workplace and need alleviation (Davis et. al., 2008). Many Australian women prefer to take and try alternative medicines to ease their menopausal signs and symptoms (Gartoulla, Islam, Bell & Davie, 2014).
This raises questions to the safety and efficacy of complimentary therapies for vasomotor symptoms in menopause.Chinese herbal medicine (CHM) is one of these therapies that has been commonly used in Asia (Scheid, Ward, Cha, Watanabe & Liao, 2010). However, in Australia and other western countries, the evidence for CHM’s effectiveness for menopause remains as sceptical and unconvincing (Huntley & Ernst, 2003)(Lin et al, 2017).
Chinese herbal medicine (CHM) has been used for hundreds of years by women in China to manage these symptoms, however how truly effective are they? The Australian media is sceptical of the quality and safety of Chinese herbs.
For this reason, we aim to assess research pertaining to the efficacy and safety of CHM for the management of vasomotor symptoms in menopausal women. Only two systematic reviews have specifically evaluated CHM for vasomotor symptoms in menopause.
Xu et al (2012) evaluated 23 randomised-controlled trials (RCTs) for the efficacy and side effects of CHM. Their critical analyses found that studies were of low to moderate quality, CHM is effective at least for some symptoms, CHM has less side effects than HRT and need to be confirmed through further well-designed comprehensive research.
Zhu, Liew & Liu (2016) used 22 RCTs and found insufficient evidence that Chinese herbal medicines were any more or less effective than placebo or HRT for the alleviation of vasomotor symptoms. The safety of CHM was inconclusive and they called for better designed RCTs given the quality of evidence ranged from very low to moderate.
Despite the limitation of RCTs on CHM and menopause available (Zhu, Liew & Liu, 2016),the author decided to see whether any better RCTs on the topic had been since conducted, and include any relevant RCTs with an Australian population. It was evaluated how CHM purely compares to a placebo and the effects on vasomotor symptoms given only three high quality RCTs were considered.

Objectives

To evaluate the quality of the available literature in the treatment of menopausal-related vasomotor signs and symptoms with internal Chinese herbal medicine to establish the efficacy and safety of treatment outcomes for menopausal women.

METHODS

Search Methods for Identification of Studies

PICOS was utilised to convert the information into a high-level clinical question here (Table 1). The author used a MeSH search for menopause in the PubMed database (Table 2). The suggestions from the MeSH analysis (Table 2) clarified that menopause, and premenopause would be used for the search terminology along with perimenopause. Postmenopause and premature menopause were omitted and would be classified as exclusion criteria.

Search Strategy

The results of this with various combinations of Boolean operator were queried (Table 5). A comprehensive retrieval for studies that evaluated the efficacy and safety of CHM in patients with menopausal vasomotor symptoms was performed in the major English medical database; PubMed. The following subject terms and key words were used in the search: (‘Chinese herb’ OR ‘herbal formula’ OR ‘Chinese herbal medicine’) AND (‘Randomized clinical trial’ OR ‘randomized controlled trial’ OR ‘randomized trial’) AND (‘menopause’ OR ‘premenopause’ OR ‘perimenopause’). The most appropriate search strategy was number 11 (Table 5), given the Boolean Operator combination in American English provided the greatest result of articles. This result of 52 articles were then considered according to inclusion and exclusion criteria (Table 6).

Types of Outcome Measures for Outcome Data

The primary outcome measure considered from the assessed RCTs were the change in vasomotor symptoms, specifically the frequency and severity of hot flushes as this is a standard in menopausal studies (Zhu, Liew & Zhao, 2016). The secondary outcome required was a quality of life assessment for participants, such as the menopause-specific quality of life (MENQOL) Questionnaire (Radtke, Terhorst & Cohen, 2011).

Study Characteristics

Three RCTs were analysed. A total of 256 patients were used for the analysis (128 in the intervention group and 128 in the comparator group). Two studies were conducted on women from Hong Kong and one study on non-Asian Australian women. The duration of trials selected in this review varied from 12 to 24 weeks (Table 7).

Bias

All three studies were parallel-design randomised controlled trials (RCTs).
Only two studies reported that allocation concealment was implemented, and therefore on this count were considered to have a low risk of selection bias (Haines et. al. 2008; Zhong et. al. 2013). 

RESULTS

When CHM (95% CI 57.2 to 19.6 +- 5.225) was compared with placebo (95% CI 63.83 to 73.97 +- 5.065) for all 3 RCTs, there was no evidence of a difference between groups for MENQOL (scale 0 to 6). There was also no evidence between groups for frequency of hot flushes (95% CI -2.08 to 0.45 +- 0.75) (Table 14). There was no difference across studies for age or sample size (Table 15). Adverse effects were fully reported in the included RCTs and participants in the CHM were found to be less likely to have AE than the placebo (RR=0.84, Table 15). Adverse effects included numerous symptoms such as per rectum bleeding, headache, bloating, stomach-ache and insomnia across both groups (Table 7). It was also 7% less likely for there to be dropouts in the CHM when compared to placebo (RR=0.93, Table 15). Adverse effects were found in both placebo and intervention groups.

Data Extraction & Quality Evaluation

A total of 52 articles were found to have potential relevance for the research question regarding menopause. From these 52, 17 were excluded for the following reasons; there were 2 articles without text or abstract available, 6 were specifically not related to vasomotor symptoms, 1 was duplicate and 8 were not related to Chinese herbal medicine. The remaining 35 articles were assessed for eligibility and 33 were excluded for the following reasons, 2 were premature ovarian failure, 3 only studied a single herb, 1 was not translated into English, 10 were reviews and systemic reviews, 5 had more than one intervention, 3 were pilot studies, 5 studies analysed a patent product and 3 were protocol studies. Thus, 49 trials were excluded after analysis. Only 3 RCTs met all inclusion criteria and were thus considered for qualitative and quantitative analysis for this review (Diagram 1).
The analysed characteristics of the 3 chosen studies (Zhong et. al., 2013; Haines et. al., 2008; Davis et. al., 2001) are presented in Table 2. Two studies were conducted in Hong Kong and one in Australia. Participants were recruited from the outpatient wards of hospitals, and a menopausal society magazine. The sample size of groups ranged from 27 from 51.
Given the condition analysed was vasomotor symptoms of menopause, gender composition of participants was exclusively female. Average age of participants ranged from 46.7 to 57.7. Notably, none of the included studies considered traditional Chinese medicine (TCM) syndrome differentiation. Participants were classified according to vasomotor symptoms medically.

Results of Individual Studies

Zhong et. al. (2016) tested the efficacy and safety of er xian tang (EXD), given previous studies presented insufficient evidence to support this CHM formula for the management of menopausal vasomotor symptoms against a placebo for 24 weeks for 108 patients. It was found to be the most superior study analysed in this systematic review, measuring as low risk on all counts in the risk of bias (Table 3). Overall, EXD was found to significantly reduce the frequency and severity of hot flushes, even both menopause rating scale (MRS) (p<0.05) and MENQOL scores (p<0.01) faired favourably when compared with the comparator. One hundred and one participants finished the treatment.
Haines et. al. (2008) examined the effect of dang gui buxue tang against a placebo on menopausal vasomotor symptoms for 12 weeks in Hong Kong Chinese women with 103participants enrolled. Overall risk of bias here was measured as moderate (Table 7) given there were two unclear and one high risks (Table 8). Overall, there was a significant reduction in the number of mild hot flushes per month in the treatment group (p<0.05) but not in the placebo group (p=0.107). Regarding moderate flushes, there was a significant reduction in the placebo group (p<0.05) compared to the treatment group (p=0.471). Regarding vasomotor symptoms in the MENQOL questionnaire, there was also a significant reduction in scoring in the placebo group (p<0.01) but not in the treatment group (p=0.247). Thus, there was no overall difference between the intervention and placebo group, except for dang gui buxue tang being statistically superior to the placebo for mild hot flushes. One hundred subjects finished the treatment.
Davis et. al. (2001) evaluated the effects of their own CHM formula against a placebo for menopausal symptoms in 78 enrolled participants. Overall risk of bias here was measured as high (Table 7) given blinding and allocation as significant items were both unclear, plus another high risk was found (Table 8). There was a reduction in frequency of vasomotor symptoms for the CHM group and also with placebo and although the difference between groups favoured the use of placebo, this was not significant (p=0.09). There were significant reductions in scores for the various domains of the MENQOL questionnaire, however there were no significant differences between the two treatment groups for any domain. Fifty-five menopausal Australian women recruited from an urban population completed 12 weeks of CHM intervention against a placebo.
Regarding vasomotor symptoms in the MENQOL questionnaire, there was also a significant reduction in scoring in the placebo group (p<0.01) but not in the treatment group (p=0.247). Thus, there was no overall difference between the intervention and placebo group, except for dang gui buxue tang being statistically superior to the placebo for mild hot flushes. Hence it was concluded that the defined formula of CHM was no more effective than placebo in reducing vasomotor episodes in Australian menopausal women.

Funding

All three studies declared their funding sources. Zhong et. al. (2016) was supported by the Liu Hao Tsing Foundation and HKU Small Project Funding. Haines et. al. (2008) was funded by the Area of Excellence Grant of the University Grants Committee in Hong Kong. Davis et. al. (2001) was supported by a research grant from the Australasian Menopause Society. There was absence of any potential conflict of interest.

Risk of Bias Across Studies

Only one study (Zhong et. al., 2016) reported that the overall monthly vasomotor symptom scores were lower in the CHM group compared to the placebo (95% CI -5.52 to -4.06). 

Risk of bias in Individual Studies

The risk ratio was calculated for age, sample size, AE and dropouts across all three RCTs. All RCTs were found to have no difference between intervention and comparator groups for age and sample size. The risk ratio for Davis et. al. (2001) suggested that the number dropouts was likely to have affected the study results whereas those for Haines et. al. (2008) and Zhong et. al. (2016) would not (Table 10).

Limitations

Self-selection bias was present given participants agreed to trial a herbal intervention, expressed negative views on HRT and had high prior expectations to the efficacy of CHM. These kinds of expectations may lead to inaccuracies in reporting in the MENQOL Questionnaire for example. Secondly dosage of Chinese herbs vary and modern dosages are not necessarily correct or the equivalent to the classical prescription. For example Zhong et. al. (2016) prescribed 30g daily whereas Haines et. al. (2008) prescribed 3g daily (Table 7). Thirdly, participant ethnicity varied given two studies were a Hong Kong population and one was an Australian, hence findings may not be generalised. The greatest limitation amongst all three studies was that all forms of CHM were prescribed without considering the participants’ Chinese medicine diagnosis given in TCM a CHM formula is always specified to diagnosis.

DISCUSSION

All RCTs were found to have no difference between intervention and comparator groups for age and sample size. It was slightly less likely for there to be more adverse effects or dropouts in the CHM group compared to placebo. Ultimately, it was inconclusive as to whether MENQOL scores and hot flush frequency faired better in the CHM groups (Table 14).

Strength and Weaknesses of Evidence

Zhong et. al. (2016) resembled a well-designed and thought out study providing low risk of bias on all counts as the authors had extensively researched flaws and needs of past, similar studies. Haines et. al. (2008) was also a well-designed study however the author pertains that its’ major weakness was the dosage of Chinese herbs as being too low to have any significant effect. Across all three RCTs, evidence was not strong enough to support that CHM was superiorly effective to a placebo.

Implications for Clinical Practice

Implications for clinical practice are prescribing an appropriate dosage, 30g of powdered CHM daily is quite high and 3g daily is potentially too low. In clinical practice, the herbalist will almost always prescribe a formula specific to the patients TCM presentation, whereas this was not considered in any of the RCTs. In clinical practice, there is no blinding for patient nor practitioner in clinical practice, and the patient usually decides how long they will take the herbal formula for.

Implications for Research

As always, the major implication for research with TCM is to create a large enough study to have patients in a group of one syndrome, for example liver qi stagnation and then prescribe a general formula for this group. Funding is an issue (what is the purpose of funding a CHM classical formula that cannot be patented?) and the time and effort to create such an RCT is exhaustive.

Limitation of This Systematic Review Project

Two of the studies had the same length of treatment for 12 weeks (Haines et. al., 2008; Davis et. al., 2001) whereas one (Zhong et. al., 2016) went for 24 weeks. Dosages varied from 3g to 30g daily. As always in menopausal studies, the placebo group always responds well, meaning that it is difficult truly to compare the intervention to the placebo.

Comparison with Existing Literature

The author finds that the studies used were of generally high quality when compared to the majority of CHM menopausal studies. Most of which have very small sample sizes, are not blinded nor randomised. Like existing literature, it was found that the efficacy CHM for vasomotor menopausal symptoms is inconclusive and studies with a greater sample size are to be made.

CONCLUSIONS

Despite extensive analysis and consideration, we found insufficient evidence that Chinese herbal medicine was any more or less effective for the relief of vasomotor symptoms for menopausal women. In regards to safety, there were no serious or dangerous effects and although AE appeared lower in the CHM group when compared to the placebo (RR=0.84), the evidence was inconclusive and not clear enough. The quality of evidence ranged from low to moderate quality; there is need for large-scale, well-designed randomised controlled trials.

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APPENDICES

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