It can be confusing when you are going through menopause as to know what is happening, what is normal and what you can do.
When I was studying for my Chinese herbal medicine masters thesis, I finally decided that the only research I would consider for my systematic review would be high-quality randomised controlled trials (RCTs) for menopause.
RCTs that use a Chinese herbal medicine formula not just an isolated herb or constituent, and measure the outcomes of the participants according to their vasomotor symptoms such as frequency and severity of hot flushing and night sweating.
The other outcome measure I was interested in was lifestyle, how did the participants feel after having taken the Chinese herbal medicine? What areas of their life improved or didn’t?
Many women in Melbourne don’t want to use Hormone Replacement Therapy (HRT) after all the bad press it’s had, especially with links to causing breast cancer who would. So here is how you can research whether a natural medicine like Chinese herbs can improve the signs and symptoms of menopause and check the safety and real stats…
TITLE: Developing a protocol for a systematic review assessing the efficacy of Chinese herbal medicine (CHM) reducing vasomotor symptoms in menopausal women.
Can Chinese herbal medicine (CHM), not just an isolated Chinese herb or constituent, but a traditional Chinese medicine formula be effective in treating vasomotor symptoms in menopausal women? Specifically, can CHM reduce the severity of hot flushes? Can CHM reduce night sweating? Can CHM improve the quality of life of menopausal women when assessed through a questionnaire such as the Menopause-Specific Quality of Life (MENQOL) (Radtke, Terhorst & Cohen, 2011)? The aim of this systematic review is to determine the effectiveness of CHM in reducing the severity in menopause-related signs and symptoms.
DEFINITION OF MENOPAUSE (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 yin, yang 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 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).
DEFINITION OF MENOPAUSE (WESTERN MEDICINE)
Menopause is medically defined as 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). Diagnosis is established by the cessation of menstruation (without hormonal contraceptive use) for more than 12 months (Goolsby, 2001). Current medical treatments for menopause include Custom-compounded bioidentical HT, non-hormonal pharmalogics such as selective serotonin reuptake inhibitors (SSRIs), gabapentin and clonidine (Pace, 2017). The main treatment option available now is menopause hormone therapy (MHT) (Lumsden, 2016).
JUSTIFICATIONS FOR THE TOPIC
All women go through menopause with a varied degree of signs and symptoms. Australia has an ever-growing ageing population, and many menopausal women are in the workplace. Past trends of taking hormone replacement therapy (HRT) have dramatically dropped since associations of the drug with breast cancer (Lumsden, 2016). Many Australian women prefer to take and try alternative medicines to ease their menopausal signs and symptoms (Gartoulla, Islam, Bell & Davie, 2014).
Chinese herbs have been used for hundreds of years by women in China to manage this life stage, however how truly effective are they? The Australian media is sceptical of the quality and safety of Chinese herbs. In a systematic review on problematic symptoms of menopause in Australia; vasomotor symptoms affected 50% of women (Gartoulla, Islam, Bell & Davie, 2014).
We aim to assess the efficacy and safety of CHM for the management of vasomotor symptoms in menopausal women. Numerous systemic reviews have assessed menopause and CHM. Despite the limitation of randomised controlled trials (RCTs) on CHM and menopause available (Zhu, Liew & Liu, 2016), we will evaluate how CHM compares to a placebo and the effects on vasomotor symptoms given only three high quality RCTs will be considered.
PICOS was utilised to convert the information into a high-level clinical question here (Table 1).
|Table 1. PICOS|
|POPULATION||Female participants diagnosed as premenopausal, perimenopausal or menopausal|
|INTERVENTION||A traditional Chinese herbal medicine (CHM) formula|
|OUTCOME MEASURE||Vasomotor symptoms (e.g. hot flushes or night sweats)|
|STUDIES||Double-blinded randomised controlled trials (RCTs)|
The author used a MeSH search for menopause in the PubMed database (Table 2). Given seemingly sufficient RCTs of the topic were retrieved, PubMed was the only databased considered. Grey literature and hard-copy searches were not pursued.
|Table 2. MeSH Search Results|
|WORD SEARCHED||SUGGESTIONS FROM MeSH SEARCH|
The suggestions from the MeSH analysis (Table 2) helped clarify 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.
CLEARLY DEFINED SEARCH TERMS IN BLOCKS
|Table 3. Preparing to perform the Search regarding Chinese Herbal Medicine for Menopause|
|menopause||Chinese herb||randomised/randomized controlled trials|
|premenopause||Chinese herbal formula||randomised/randomized clinical trials|
|perimenopause||Chinese herbal medicine||randomised/randomized trial|
The search terms in Table 3 were used to conduct the PubMed Advanced Search Builder and were then applied as a search strategy in PubMed (Table 4). Note that both Australian and American spelling are considered.
|Table 4. Search Strategy used in PubMed Database|
|4||or 1 to 3|
|7||Chinese herbal medicine|
|8||or 5 to 7|
|9||randomized controlled trial|
|10||randomized clinical trial|
|12||or 9 to 11|
The results of this with various combinations of Boolean operator were queried (Table 5). A comprehensive retrieval for studies that evaluate the efficacy and safety of CHM in patients with menopause vasomotor symptoms will be performed in the major English medical database, PubMed. The following subject terms and key words will be 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’).
|Table 5. Search Strategy Results with the Boolean Operator (OR, AND, NOT) in the PubMed Advanced Search Builder|
|Search Number||Search terms used for the Query||Number of Articles Found|
|1||((Menopause) AND Chinese Herbs) AND Randomised Controlled Trial||8|
|2||((Menopause) AND Chinese Herbal Medicine) AND Randomised Controlled Trial||38|
|3||((Menopause) AND Herbal Medicine) AND Randomised Controlled Trial||55|
|4||((Menopause) AND Chinese Medicine) NOT Acupuncture) AND Randomised Controlled Trial||75|
|5||((Premenopause) AND Chinese Herbal Medicine) AND Randomised Controlled Trial||1|
|6||((Premenopause) AND Chinese Herb) AND Randomised Controlled Trial||0|
|7||((Premenopause) AND Herbal Medicine) AND Randomised Controlled Trial||2|
|8||((Perimenopause) AND Chinese Herb) AND Randomised Controlled Trial||1|
|9||((Menopause) OR Chinese Herbal Medicine) OR Randomised Controlled Trial||665,471|
|10||(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)||48|
|11||(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)||52|
The most appropriate search strategy applied was number 11 (Table 5), due to the Booleon Operator combination given in American English provided a greater result of articles than number 10 which was in Australian English. These 52 articles will then be considered according to inclusion and exclusion criteria (Table 6).
|Table 6. Study Inclusion and Exclusion Criteria regarding Chinese Herbal Medicine (CHM) and Menopause-related Signs and Symptoms|
|Study published within the last twenty years (1998-2018)||Study older than twenty years (1998 or older)|
|Participants diagnosed as any stage and type of premenopause, perimenopause or menopause||Participants diagnosed as postmenopausal, ovarian insufficiency, premature menopausal: ovarectimized, primary amenorrhoea or no diagnosis|
|Participants are adult and females||Participants that are men, teenagers or paediatric|
|Study must be published in English||Studied published in Chinese or any language other than English|
|Full text studies||Conference Abstracts|
|Data Type: Must Include Primary Data||Data Type refers to Secondary or other data|
|Study Design must be original, a RCT. Must have a placebo as the control group.||Reviews, Editorials, Letters and Pilot studies, non-randomised controlled trials, theoretical protocols, evidence-based and systematic reviews.|
|Outcome measures analyse vasomotor symptoms such as hot flushes and night sweats||Non-vasomotor outcome measures such as emotional (depression), cholesterol, bone density, functional dyspepsia or cardiovascular disease.|
|Uses the MENQOL questionnaire to analyse outcomes of the intervention.||Studies analysing patented prescription formula that are a brand name, are not traditional or are combined with supplements.|
|The main intervention is to be CHM vs placebo||Other interventions such as acupuncture, hormone therapy and psychotherapy|
|CHM that consist of a formula using Chinese medicine classified herbs.||Studies analysing single herbs or herbs pertaining from a Western formula or origin.|
|Intervention is a CHB formula and comparator is placebo||three or four arm studies comparing 3 to 4 interventions|
|Sample size per group at least 20||Sample size of each group less than 20|
PROTOCOL OF DATA EXTRACTION & QUALITY EVALUATION
The author will extract and double-check the data from the included articles. Any discrepant data will be reviewed by discussion with a senior research member at RMIT. The details of the study selection will be completed in a PRISMA flow chart (Diagram 1).
The author will individually go through each article found on the PubMed search strategy result (number 11 of Table 5) and assess each article according to inclusion and exclusion criteria (Table 6).
STUDY QUALITY ASSESSMENT
All 52 articles were individually analysed and assessed, along with being checked to remove duplications. Forty-nine were found unsuitable and three were considered acceptable and are listed in Table 7. Table 7 includes the data on age, year the study was published, interventions, comparators, sample size, incidence of primary and secondary outcome measures, randomisation, blinding, outcomes, study dropouts, usage of MENQOL questionnaire (or equivalent), the incidence and details of adverse effects.
|Table 7. STUDY QUALITY ASSESSMENT||RCT 1||RCT2||RCT3|
|YEAR STUDY PUBLISHED||2013||2008||2001|
|AUTHORS||Zhong LL, Tong Y, Tang GW, Zhang ZJ, Choi WK, Cheng KL, Sze SC, Wai K, Liu Q, Yu BX||Haines CJ, Lam PM, Chung TK, Cheng KF, Leung PC||Davis SR, Briganti EM, Chen RQ, Dalais FS, Bailey M, Burger HG.|
|OUTCOME MEASURE||Hot flushes frequency and severity, MENQOL||Hot flushes, night sweats, MENQOL||Hot flushes, MENQOL|
|INTERVENTION||Chinese herbal formula Er-Xian Decoction||Chinese herbal formula Dang Gui BuXue Tang||Chinese herbal medicine granule formula. See Appendix for ingredients|
|INCIDENCE OF HOT FLUSHES||INTERVENTION||P=0.04||p<0.01||p<0.05|
|INCIDENCE OF SWEATS||INTERVENTION||not measured||p<1.07||not measured|
|COMPARATOR||not measured||p,0.05||not measured|
|ADVERSE EFFECTS||INTERVENTION||none||none||Abdominal bloating by 1 subject. 2 women reported lower abdominal pain and loose stools. 6 women reported headache, joint pain or dizziness|
|COMPARATOR||none||none||Abdominal bloating by 3 subjects. 9 women reported headache, joint pain or dizziness|
The main characteristics and outcome measures identified from the assessed RCTs will be vasomotor symptoms, specifically how hot flushes and/or night sweats have been monitored and quality of life, such as the MENQOL Questionnaire. 985
RISK OF BIAS ASSESSMENT
We propose that the methodological quality of the three selected RCTs will be assessed by means of ‘risk of bias assessment tool’ as described in the Cochrane Handbook 5.1 by the author IS. Any different views will be considered with senior research staff at RMIT. The risk of bias in these RCTs will be analysed by the following eight domains: randomisation sequence generation, randomisation allocation concealment, blinding of participants, blinding of personnel, blinding of outcome assessors, incomplete outcome data, selective outcome reporting and other sources of impending bias.
PROTOCOL OF DATA SYNTHESIS & STATISTICAL ANALYSES
Data analysis will be calculated manually using BMJ formulae (LINK). For continuous data collected using the same measurement scale, we will calculate the weighted mean difference and 95%CIs. Continuous data collected using a similar measurement scale for the same outcome will require calculating the standardised mean differences with 95% CIs. A standard χ2 and I2 statistic will be used to test heterogeneity between groups. Data will be analysed with a fixed-effect model if no statistical heterogeneity is observed between groups. Data will be analysed with a fixed-effect model if no statistical heterogeneity was observed between subgroups (p≥0.1, I2≤50%). In the presence of heterogeneity (p<0.1, I2>50%), a random-effect model will be used and the possible causes of heterogeneity will be examined. This protocol has is completely based on a protocol for a systematic review by Feng et al (2018).
Davis, S.R., Briganti, E.M., Chen, R.Q., Dalais, F.S., Bailey, M. & Burger, H.G. (2001). The effects of Chinese medicinal herbs on postmenopausal vasomotor symptoms of Australian women. A randomised controlled trial. Med. J. Aust., 174(2), 68.
Feng, M., Lu, J., May, B.H, Liu, S., Guo, X., Zhang, A.L., Xue, C.C. & Lu, C. (2016). Chinese herbal medicine for patients with vascular cognitive impairment no dementia: protocol for a systematic review. BMJ Open, 6. doi:10.1136/bmjopen-2015- 010295
Gartoulla, P., Davies, S.R., Worsley, R. & Bell, R.J. (2015). Use of complementary and alternative medicines for menopausal symptoms in Australian women aged 40-65 years. Med. J. Aust., 203(3), 146-146e.
Gartoulla, P., Islam, M.R., Bell, R.J. & Davis S.R. (2014). Prevalence of menopausal symptoms in Australian women at midlife: a systematic review. Climeractic, 17(5), 529-539. doi: 10.3109/13697137.2013.865721
Goolsby, M.J. (2001). Management of menopause. J. Am. Acad. Nurse Pract., 13(4), 147-50. doi: 10.1111/j.1745-7599.2001.tb00237
Haines, C.J., Lam, P.M., Chung, T.K.H., Cheng, K.F. & Leung, P.C. (2008). A randomized, double-blind, placebo-controlled study of the effect of a Chinese herbal medicine preparation (dang gui buxue tang) on menopausal symptoms in Hong Kong Chinese women. Climeractic, 11(3), 244-251. doi: 10.1080/13697130802073029
Lumsden, M.A. (2016). The NICE Guideline – Menopause: diagnosis and management. Climeractic, 19(5), 426-429.
Maciocia, G. (1998). Obstetrics and gynaecology in Chinese medicine. London, UK; Churchill Livingstone.
Monteleone, P., Mascagni, G., Ginanini, A., Genazzini, A.R. & Simonicini, T. (2018). Symptoms of menopause – global prevalence, physiology and implications. Nature Reviews Endicrinology, 2. doi: 10.1038/nrendo.2017.180
Pace, D. (2017). The menopausal woman: the need for an individualized plan of care. The Nurse Practitioner, 42(12), 43-49.
Radtke, J.V., Terhorst, L. & Cohen, S.M. (2011). The Menopause-Specific Quality of Life (MENQOL) Questionnaire: Psychometric Evaluation among Breast Cancer Survivors. Menopause. 18(3), 289-295. doi: 10.1097/gme.0b013e3181ef975a
Unschuld, P.U. (2003) Huang di nei jing su wen: nature, knowledge, imagery in an ancient Chinese medical text. Berkeley, USA: University of California Press.
Van der Sluijs, C.P., Bensoussan, A., Chang, S., & Baber, R. (2009). A randomized placebo-controlled trial on the effectiveness of an herbal formula to alleviate menopausal vasomotor symptoms. Menopause. 16(2), 336-344. doi: 10.1097/gme.0b013e3181883dc1
Zhong, L.L., Tong, Y., Tang, G.W., Zhang, Z.J., Choi, W.K., Cheng, K.L, Sze, S.C., Wai, K., Liu, Q. & Yu, B.X. (2013). A randomized, double-blind, controlled trial of a Chinese herbal formula (Er-Xian decoction) for menopausal symptoms in Hong Kong perimenopausal women. Menopause, 20(7), 767-76. doi: 10.1097/GME.0b013e31827cd3dd.
Zhou, J. & Qu, F. (2007). The effect of Chinese medicinal herbs in relieving menopausal symptoms in ovariectomized Chinese women. Journal of Science and Healing, 3(5), 478-484. doi: https://doi.org/10.1016/j.explore.2007.06.002
Zhu, X., Liew, Y. & Zhao, L.L. (2016). Chinese herbal medicine for menopausal symptoms. Cochrane Gynaecology and Fertility Group. doi: 10.1002/14651858.CD009023.
Chinese Herbal Formula Ingredients
|1: Chinese Herbal Formula Ingredients|
|Pharmaceutical name||Pin yin name||Dose*|
|Shu Di Huang|
Shan Zhu Yu
Di Gu Pi
He Huan Pi
Suan Zao Ren
Han Lian Cao
Nu Zhen Zi
|*Dose in grams of dried herb per day.|
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