CLIMACTERIC 2015;18:142–156

Effects of traditional Chinese medicine on symptom clusters during the menopausal transition L. Taylor-Swanson*, A. Thomas*, R. Ismail*,†, J. G. Schnall‡, L. Cray**, E. S. Mitchell†† and N. F. Woods* *Biobehavioral Nursing, University of Washington, USA; †Ministry of Health, Republic of Indonesia; ‡Information Management Librarian, Health Sciences Library, University of Washington, USA; **College of Nursing, Seattle University, USA; ††Family and Child Nursing, University of Washington, USA

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Key words:  MENOPAUSE, MENOPAUSAL TRANSITION, TRADITIONAL CHINESE MEDICINE, SYMPTOM CLUSTER, ACUPUNCTURE, SYSTEMATIC REVIEW, CHINESE HERBAL MEDICINE, MOXIBUSTION, HOT FLUSHES

ABSTRACT Aims  To review controlled clinical trials of traditional Chinese medicine (TCM) therapies for hot flushes and at least one other co-occurring symptom among sleep, cognitive function, mood, and pain. Methods  An experienced reference librarian performed an extensive search of PubMed/Medline, CINAHL Plus, PsycInfo, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Web of Science, EMBASE, AMED, and Alt-Health Watch for randomized, controlled trials reported in English between 2004 and July 2011. Of 1193 abstracts identified, 58 trials examined effectiveness of therapies for hot flushes and at least one additional co-occurring symptom. Results  Eleven trials (13 publications) examined TCM therapeutics of acupuncture, Chinese herbal medicine (CHM) or moxibustion. Acupuncture trials (eight) yielded mixed results; five trials significantly reduced hot flushes. Of those five trials, one also showed benefit for sleep and pain and two trials found benefit for mood symptoms. Of three CHM trials, three trials had significant findings: one for hot flushes and mood, one for hot flushes and pain, and one for hot flushes, sleep, mood symptoms and pain. Moxibustion and counseling (one trial) significantly reduced hot flushes, mood symptoms and pain. None of the trials reported any serious adverse events. Conclusions  TCM therapeutics of acupuncture, CHM and moxibustion show promising results for the treatment of mood and pain symptoms co-occurring with hot flushes. Although the controlled clinical trials of TCM therapeutics reviewed here measured multiple symptom outcomes, few report treatment effects in ways that allow clinicians to consider symptom clusters when prescribing therapies. Future studies need to measure and report results for individual symptoms or group like symptoms together into subscales. Controlled clinical trials with larger numbers of participants are essential to allow evaluation of these therapies on hot flushes and multiple co-occurring symptoms.

INTRODUCTION The menopausal transition is a normal transition in a woman’s life and some 80% of women in the US experience symptoms during this time and the early postmenopause. Reported symptoms include hot flushes and several co-occurring symptoms including awakening at night, forgetfulness and difficulty concentrating, depressed mood and pain symptoms1. Multiple co-occurring symptoms, or symptom clusters, vary

by severity and stage of the menopausal transition and early postmenopause. A cluster of moderate to severe hot flushes and moderately severe sleep, mood, cognitive and pain symptoms was observed more frequently in the early and late menopausal transition stages and postmenopause than during the late reproductive stage2. Recent hormone therapy concerns have led to increased utilization of complementary and alternative medicine (CAM), including traditional Chinese medicine (TCM). TCM is

Correspondence: Dr L. Taylor-Swanson, 8005, 2211 Pacific Avenue, Tacoma, WA, 98402, USA; E-mail: [email protected] REVIEW © 2014 International Menopause Society DOI: 10.3109/13697137.2014.937687

Received 05-04-2014 Revised 18-06-2014 Accepted 19-06-2014

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Traditional Chinese medicine and symptom clusters documented to have promoted women’s health for at least 2000 years (the earliest extant written documentation on traditional Chinese medicine is the Huang Di Nei Jing or Yellow Emperor’s Cannon of Internal Medicine. It is thought to be the oldest medical textbook in the world, dating back to between 400 bce and 260 ce3). While menopausal transition symptoms as such are defined in modern TCM textbooks only4, TCM has a long track record of treating individual symptoms such as a feeling of feverishness, sweating, pain, vaginal dryness, and cognitive, sleep and mood symptoms experienced by many women during the menopausal transition. This systematic review included three specific TCM modalities – acupuncture, Chinese herbal medicine (CHM) and moxibustion – and their effect on menopausal transition symptoms as evidenced in controlled clinical trials (CCTs). This work focused on multiple symptoms as this is what women typically experience1 and TCM differential diagnoses vary by clusters of symptoms presented – essentially a person’s entire list of symptoms at any given point in time is assessed in order to make a TCM diagnosis. This TCM diagnosis is called pattern differentiation5. The specific cluster of symptoms studied in this review is based on prior research to identify symptom clusters experienced by women during the late reproductive through the early postmenopause stage2 and includes hot flushes, sleep, mood, pain and cognitive symptoms2. Systematic reviews of TCM therapeutics for symptoms experienced by women during the menopausal transition and early postmenopause have focused on hot flushes exclusively, even though women report experiencing co-occurring symptoms. As of this publication, the treatment of hot flushes plus other co-occurring symptoms with TCM has not been evaluated in a systematic review and this project is the first to do so. Four previously published reviews specifically examined acupuncture for hot flushes experienced during a natural menopausal transition6–9. The reviews examined slightly different sets of papers and arrived at varying interpretations. Alfhaily and colleagues reviewed 17 papers and concluded that, while acupuncture was shown to decrease hot flushes by more than 50%, the results were not trustworthy due to methodological flaws including small sample sizes and inadequate controls6. Borud, Grimsgaard and White reviewed 16 papers and concluded that acupuncture needling decreased hot flushes7. However, they found that the data did not support acupuncture requiring use of acupoints (acupoints are specific locations on the body, defined classically and in modern practice as where acupuncture needles should be inserted). Use of sham acupuncture, the needling of non-acupoints, reduced hot flushes with similar strength to verum acupuncture7. Cho and Whang reviewed 11 trials and concluded that there was no evidence indicating that acupuncture was effective in reducing hot flushes when compared to sham acupuncture8. These different views illustrate the challenges of finding a suitable sham for acupuncture and how to interpret current findings of sham acupuncture as a control. Mainly, the types of sham used to date do elicit a mild to moderate physiological effect and are not inert10. Borud, Grimsgaard and White noted an essential clarification of sham acupuncture stimulating some type of

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Taylor-Swanson et al. physiologic response and that it is not inert7. The authors concluded that acupuncture, whether real or sham, decreased hot flushes and that future work must demonstrate clearly whether individualized treatment is necessary, or whether systematic/non-individualized acupuncture sufficiently reduces hot flushes. Lastly, Lee, Shin and Ernst concluded that shamcontrolled, randomized, controlled trials of acupuncture did not show specific effects of acupuncture on hot flushes9. A Cochrane Collaboration report recently reviewed 16 trials of acupuncture for hot flushes and concluded over the whole that the evidence does not demonstrate acupuncture as an effective treatment for menopausal vasomotor symptoms11. With pooled data from eight trials that compared acupuncture to sham acupuncture, the paper reports that acupuncture decreased hot flush severity as compared to sham. Acupuncture compared to hormone therapy was inferior in reducing hot flush frequency. Electro-acupuncture compared to relaxation in one study demonstrated no significant differences between groups. Four studies compared acupuncture to wait list or no intervention, and acupuncture was significantly more effective in reducing hot flush frequency and severity. One systematic review of CHM for hot flushes evaluated one herbal formula, Er-xian-tang12. This CHM is used to treat amenorrhea, hypertension, insomnia, irregular menstruation, irritability and night sweats13. It is comprised of six herbs (Baji-tian, Dang-gui, Huang-bai, Xian-mao, Yin-yang-huo and Zhi-mu) and is a common first choice for clinicians treating women experiencing menopausal transition symptoms with a TCM diagnosis of Kidney Yin and Yang deficiency. The review found that, while the formula showed promising findings in the reduction of hot flushes, the studies reviewed were of such poor methodological quality that the authors recommended more studies on this herbal formula to determine its efficacy, or lack therein. No published reviews in English were located regarding the use of moxibustion for the treatment of hot flushes during the menopausal transition and early postmenopause. To date, there are no published systematic reviews of the effects of TCM therapeutics on hot flushes and co-occurring symptoms in women experiencing a natural menopausal transition. The purpose of this systematic review is to fill that gap by identifying reported therapeutic effects of TCM interventions including acupuncture, CHM and moxibustion on hot flushes and co-occurring symptoms, including sleep, mood concerns, cognitive concerns, and pain symptoms.

METHODS Even though symptom clusters are of increasing interest to researchers and clinicians, and they are also a part of the TCM diagnostic framework, no models exist in the literature for examining symptom clusters as outcomes. This study focused on published reports of studies that included symptoms that co-occurred with hot flushes, that is, when hot flushes and at least one other symptom group were measured in the same study as primary or secondary outcomes. Symptom groups

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Traditional Chinese medicine and symptom clusters and their representative symptoms consist of mood disturbance (depressed mood, mood changes, crying, irritability, anxiety or melancholia), sleep disturbances (awakening at night, difficulty getting to sleep, early morning awakening, or sleep disorders), cognitive disturbances (problem concentrating, forgetfulness or poor memory) and pain symptoms (joint aches or pains, backache or pain, headache or arthralgias). As long as hot flushes and one of those symptoms were measured, we considered that a symptom cluster. Therefore, a symptom cluster was composed of hot flushes and at least one symptom from one of the four symptom groups of sleep, mood, sleep disturbances or pain. These symptom clusters were identified by factor analysis in a prior study2. Both between- and within-group findings are examined in this study. Extensive details of the methods are published elsewhere, including the electronic search criteria and search strategy, and selection criteria for abstracts as well as full-text articles, inclusion and exclusion criteria and the data extraction procedure14. The overall method is summarized below.

Procedure The study was conducted in four phases: an electronic search to identify eligible CCTs and comparative effectiveness studies, abstract and full text selection, data extraction and then evaluation of the eligible studies. Included in this review were original CCTs published in peer-reviewed scientific literature regarding the effects of TCM therapies on hot flushes and at least one additional symptom from one of the four symptom groups (sleep, mood, cognitive and pain symptoms). For this project, inclusion criteria included: randomized trials in which women in the menopausal transition or early postmenopause participated; masking was used as appropriate; non-pharmacologic therapies were studied as the treatment with one or more comparison groups; hot flushes and at least one additional symptom from at least one of the symptom clusters was reported as an outcome (from sleep, mood, cognition, pain symptom groups). The symptom groups were defined as follows: sleep disturbances (awakening during the night, difficulty getting to sleep, early morning awakening, and sleep disorders); mood disturbances (depressed mood, mood changes, crying, irritability, anxiety, melancholia); cognitive disturbances (problem concentrating, forgetfulness, poor memory); and pain symptoms (joint aches or pains, backache or pain, headache, arthralgias). The exclusion criteria were: trials in which pharmaceutical treatments were studied unless they constituted a comparison condition; trials studying only women who were breast cancer survivors or in active treatment for breast cancer; reports not available in English; full text not available; and if it was impossible to determine the effects of treatments on the individual symptoms of interest (e.g. hot flushes, depressed mood), for example when only a total scale score was reported that included multiple types of symptoms. An extensive electronic search of databases was conducted by Janet G. Schnall, Health Sciences Librarian at the University

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Taylor-Swanson et al. of Washington. The databases included PubMed/Medline, CINAHL Plus, PsycInfo, Cochrane Database of Systematic Reviews, Cochrane Central Registry of Clinical Trials, Web of Science, EMBASE, AMED (Allied and Complementary Medicine Database), and Alt-Health Watch, from January 2004 to July 6, 2011 for clinical trials14. This search strategy yielded 1193 abstracts that were initially reviewed (N.F.W.) to inspect the clinical trial design, including: non-pharmacologic therapy tested; inclusion of a control group; randomization; a full-length publication in English was available. This yielded 153 abstracts which were further reviewed by the co-investigators to obtain final agreement that the abstract met inclusion and exclusion criteria. After individual reviewers (E.S.M., N.FW., R.I., L.T.S., A.J.T.) reconciled differences in coding and final inclusion recommendations, N.F.W. reviewed each of the studies selected for inclusion and the basis for the exclusion decisions for consistency across reviewers. Based on this review process, 59 unique trials were identified that met the inclusion and exclusion criteria of the study. Of these, 19 focused on herbal preparations, 17 on soy/isoflavones/amino acids, 13 papers on 11 trials of TCM, and ten on mind–body interventions. This paper reports on the 11 trials of TCM. The papers were organized according to the type of intervention (acupuncture, CHM or moxibustion) because none of the studies investigated more than one TCM intervention. Data extraction was performed by two authors and recorded in a standardized table. Discrepancies were resolved by discussion and consensus. No meta-analyses were performed due to the heterogeneity of the different interventions and scales. Data were extracted that included the following elements, as shown in Table 1: (1) Study – name of first author, year and location of trial; (2) Study population – sample size and characteristics, including number screened, randomized, completing treatment, completing follow-up data collection; (3) Design – should be randomized, controlled clinical trial or a randomized comparative effectiveness study; masking where relevant; (4) Intervention and duration of treatment; (5) Comparison or control group, including placebo, usual care; (6) Outcome measures for hot flushes and how measured; (7) Outcome measures: other symptoms and how measured; (8) Major findings – efficacy of the intervention for hot flushes and other symptoms, including significant differences between the treatment and control groups or multiple treatment groups.

Measures Many measures were used in this review to determine symptom outcomes, including: Green Climacteric Scale (GCS)15,16, Short Form (SF) 3617, Beck Depression Index (BDI)15,

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Borud, 2009, Norway22

Acupuncture Avis, 2008, USA18

Author, year, study location Study design

Two-site CT 3-arm PMP 3  months ameno, prospective, PM 12  months randomized, ameno; 4  HF/day; age single-blind, 42–55. Exclude: HRT, sham-control SERM, antidep Rx, chemo, mental illness, Acup last 4 weeks, rx ↑bleeding. Surg MP OK. 86% white. 95% HS educ. Age 51.1 (0.6) UC, 52.2 (0.7) SA, 51.3 (0.6) TA. BMI: 25.9 (5.5) UC, 30.3 (9.3) SA, 28.0 (1.0) TA 246 screened; 105 eligible; 64 baseline diaries; 56 random; 19 UC, 18 SA, 19 TA Pragmatic, multicenter Multicenter pragmatic RCT with 2 parallel RCT with 2 parallel arms (Acup   arms. Age: 53.5 1  4.4 2 self-care info; Acup; 54.1 1  3.7 C. PM 2 self-care info as C). 7  HFs/24 h during 7 All researchers consecutive days. All blinded. Acup ethnic Norwegian. providers unblinded 535 screened; 428 received baseline diary; 399 returned baseline diary; 267 randomized; 131 analyzed Acup, 117 control

Study population, sample size (screened, enrolled, completed, followed)

Outcome Outcome measures: hot measures: other symptoms flushes Results: hot flushes

Primary: mean # hours of sleep 10 Acup txs plus – diary. HF self-care advice. 2nd  WHQ frequency Clinicians chose (depressed, per 24 h Acup points somatic, baseline to according to TCM memory/ 12 weeks. dx, but standardized concentration, Diary. points. 4 study, sleep 2nd  WHQ moxa OK. No dimensions) VM herbs. dimension C  self-care advice only

NS all questionnaires

Results: other symptoms

baseline: 4 weeks: 21.8 (2.1); 8 weeks: -2.7 (2.4); 12 weeks: 23.2 (2.5) C WGRP: HF int***. Diff from baseline: 4 weeks: 21.1 (1.9); 8 weeks: 21.4 (2.0);12 weeks: 21.8 (2.2) 2nd WHQ: VM Acup ↓. BGRP: 20.24*** (Continued)

BGRP: Acup ↓ HF freq 2.1*** to C. # hours sleep: BGRP Acup ↑ HF int ↓ 1.4*** to C. 0.28** to C. Acup WGRP: HF frequency** (95% CI Difference from baseline: 4 weeks: 0.05–0.50; 23.3 (3.7); 8 weeks: 25.1 (4.6); BGRP 2nd: 12 weeks: 25.8 (4.6); WHQ C WGRP: HF frequency***; Difference from baseline: 4 weeks: Acup  C Sleep: 20.13**; 22.4 (3.2); 8 weeks: 23.1 (3.7); Somatic: 12 weeks: 23.7 (3.7) 20.07* Acup WGRP: HF int***. Diff from

WGRP: HF frequency ↓ significant Main intervention: 11 Daily diary of Sleep: WHI all 3 groups**; BGRP: NS Insomnia HF needles (5 bilat, 1 difference between TA and SA frequency & Rating Scale. on midline  others MENQOL severity. HF according to TCM Physical, Related dx.   16 needles Psychological, Daily total. De Qi. 20” Psychosocial Interference ant Acup, 10” post General Scale Acup. Well-Being Two groups: UC told Index: no new txs; SA 12 depression, needles (6L, 6R) anxiety non-Acup points, no De Qi. NOT Streitberger

Main intervention and comparison/control

Table 1 Trials of traditional Chinese medicine for hot flushes and co-occurring symptoms: study population, design, interventions, outcomes, and results

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Huang, 2006, CA, USA25

Borud, 2010, Norway23

Author, year, study location Study design

Main intervention and comparison/control

Outcome Outcome measures: hot measures: other symptoms flushes Results: hot flushes

# hours of sleep BGRP: NS Pragmatic, multicenter Acup was given for 12 Mean HF Multicenter pragmatic – diary. frequency weeks only; C: RCT with 2 parallel RCT with 2 parallel 2nd  WHQ per 24 h advice on self-care arms (Acup  arms. Age: 53.5 1  4.4 2 (depressed, baseline to only self-care info; Acup; 54.1 1  3.7 C. PM 2 somatic, 12 weeks. self-care info as C). 7  HFs/24 h during 7 memory/ Diary. This study reports consecutive days. All concentration, 2nd  WHQ follow-up results @ 6 ethnic Norwegian sleep VM & 12 months 535 screened; 428 received dimensions) dimension baseline diary; 399 returned baseline diary; 267 randomized; analyzed 131 Acup, 117 C PSQI – sleep BGRP: HF severity: A ↓28%, Prospective randomized Acup (A) 9 sessions in Diary re: PM 7  HF/24 h age PA↓6%*. HF frequency: NS frequency & 7 weeks. 2/week placebo-controlled 45–65. Ameno difference severity first 2 weeks, then study 6  months. Exclude: 2/week for 5 serious dz, psych dz, tx weeks. (HRT, SSRIs, phyto). Placebo Acup (PA) 9 BSO and CA NR. sessions in 7 weeks. 100% caucasian Acup, Same schedule as A. 94% caucasian placebo. Streitberger on sham BMI 24.62 1  3.70 2 points acup, 23.27 1  3.16 2 placebo 244 assessed for eligibility; 29 randomized; analyzed 12 Acup, 17 placebo. (137 did not meet study criteria, other reasons listed)

Study population, sample size (screened, enrolled, completed, followed)

Table 1  (Continued)

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PSQI – NS

BGRP: NS

Results: other symptoms

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Kim, 2010, Korea27

51.4 Acup, 51.2 C years Prospective, randomized, open, – NS. Recruited from 3 controlled clinical hospitals. Multicenter trial, 2 parallel arms trial (4 cities). PM or (patients in C could PMP daily HF scores ask for Acup at end 10  for 1 week b4; of study). screen Randomized when PM  irregularity or signed up; 2nd amenorrhea 3–11 randomization months. PMP  (1) 12 computer-generated months ameno, (2) 6 @ coordinating months ameno with center; block of 3 FSH  40 (3) 6 weeks assigned: 2 Acup, 1 post-op BSO; (4) hyst C. Patients with at least 1 intact Unblinded; assessor ovary. Excluded: HTN, unblinded; DM, thyroid dz, statistician & data malignant tumor, entry blinded dyslipidemia, infectious dz, systemic dz. No HRT, antidepressants, gabapentin, sedatives 205 screened; 175 eligible; 175 randomized; 116 Acup, 59 Usual; 2 weeks: 111/51; 4 weeks: 108/58; ITT: 116/59

Acup 3/week  4 weeks & heat on abdo  usual care (OTCs) Usual care alone (OTCs)

MRS-psych, Mean subscales reduction in HF score – diary – and HF frequency. Assessed 24 h, day & night

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(Continued)

MRS psych**: Week 8 mean (SD) change in HF *** BGRP: Acup BGRP: 24 h score 23.56 (2.94); Acup: -17.58 (18.24); C: 27.57 C: 22.62 (10.15). (2.93) Change in frequency 8 weeks: Acup: 27.20 (7.44); C: 22.95 (4.36)

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Sunay, 2011, Turkey24

Nir, 2007, CA, USA26

Author, year, study location Study design

Randomized, placeboEligible: PM age 45–65 controlled, 3 phases ameno 6  months. (screen, tx, 1 month BSO   6 months  follow-up – 1 tx and ago  OK. told tx they had 7  moderate/severe received) HFs/24 h. Excluded: thyroid dz, E2dependent cancer, psych dz. 100% caucasian Acup, 94% caucasian placebo. BMI 24.62 1 2 3.70 Acup, 23.27 1 2 3.16 placebo 244 assessed for eligibility; 29 randomized; analyzed 12 Acup, 17 placebo (137 did not meet study criteria, other reasons listed) Sham, RCT, single53 PM (6 surgically) blind 12  months ameno. No HRT. Age: 50.3 1  4.5 2 Acup, 48.5 1 2 7.9 SA. BMI 29.1 1 2 3.9 A, 30.6 1 2 5.1 SA.

Study population, sample size (screened, enrolled, completed, followed)

Table 1  (Continued)

Acup (A) 2/week 10 sessions. St 36, Li4, Ki3, Liv3. R3. De qi. 20” no estim. Control: Sham Acup (SA). 2/week 10 sessions same points, same LAc. Streitberger

Acup (A): 2/week first 2 weeks, then 2/week for 5 weeks. 5–7 acupoints by TCM dx. De qi

Main intervention and comparison/control

Results: other symptoms

BGRP: MRS Psych: A↓*** (last session 4.1 1 2 2.3 A, 8.3 1 2 3.3 SA***)

MSQL NS BGRP: HF severity: A↓ * difference in 24.5 1 2 30.72% , any subscale PA↓4.41 1  17.14%; HF frequency: 2 NS difference

Results: hot flushes

BGRP: A↓ somatic scale*** (last MRS Somatic MRS session 3.2 1 (4 items) Psychological 2 2.1 A, 8.8 1 2 2.3 SA***) (4 items)

MSQL: Logs re: frequency & psychosocial & physical severity subscales

Outcome Outcome measures: hot measures: other symptoms flushes

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Climacteric MENQOL Dang Gui Bu Xue Tang (5: 1 huang qi: dang gui) TCM herbal rx. 3 g/day in 6 capsules. Control: Placebo 6 capsules/day matched for color, taste

Green VM RA: Acup 2 tx/ Prospective, Rural or healthy. Age: score week  4 weeks then randomized, 54.1 Acup, 52.6 C. All baseline & 1 tx/week  8 weeks. single-blind. One but 3 C white. Early 16 weeks. n  16 tx in 12 LAc gave real Acup PM (12  months Diary weeks. Estimated @ (RA) and sham Acup ameno). FSH  30 IU. 2 hz on SP6 4” sup (SA) & could not be No HRT 3  months. to med malleolus & blinded HF 14  any severe/ UB23 2” lateral to week or 5/week L2. Tx by TCM dx. moderate to severe HF. PA: Acup 2 tx/ 4 C took antidepressant week  4 weeks then rx, none in RA group 1 tx/week  8 weeks. (text says 2C, table says n  16 tx in 12 4C) weeks. Estimated @ 80 screened; 56 eligible; 2 hz on leg and 56 randomized; 51 back completed; Acup 27, Placebo Acup 24

Chinese herbal medicine (CHM) Haines, 2008, 6-month double-blind 84 PM any age allowed; Hong Kong20 RCT LMP   12 months ago.  Exclude CHM or HRT within 8 weeks, serious dz, undiagnosed vaginal bleed. NR BSO, cancer. Age 52.8 1 2 4.9, 51.3 1  4.6 C. Age at 2 menopause 47.1 1 2 5.8, 46.1 1  4.5 C. FSH, LH, 2 E2 measures for inclusion. NR ethnicity/ race, BMI. Ratio height/ weight for groups only 103 enrolled; 100 randomized 50 herbal, 50 C. Analyzed 45 herbal, 39 C.

Venzke, 2010, Oregon, USA15

Green psych ↓tx* and ↓C* Green soma ↓tx* and ↓C* No BGRP results

No BGRP results

(Continued)

MENQOL psychosocial NS. Physical BGRP*

WGRP: BDI dep ↓Tx*, dep ↓ C*

WGRP: Flush scores HF ↓tx*, HF ↓C* Green VM: HF ↓tx*, HF ↓C*.

MENQOL ↓ WGRP Mild HF MENQOL frequency Acup 18.9 1 psychosocial, 2 23.5 to **, C 8.6 1  17.1 @ 6 months physical 2 26.0 1 2 43.5 to 12.4 1 2 17.6 @ 6 months, p  0.062. BGRP: Moderate HFs*. MENQOL VM NS

Green psych, Green soma, BDI

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Study population, sample size (screened, enrolled, completed, followed) Study design

Main intervention and comparison/control Results: hot flushes

‘Markedly effective, effective, SCL-90 re: ineffective’. ME  26.42% A, somatic, 18.18% B, 53.57% C, total eff mental. They rates (ME  E)  64.15% A, do have data 50.91% B, 87.50% C** on TCM sxs, including S2 anxiety/bad temper, S4 sore loin/knee, S5 insomnia (sleep)

SF 36 – bodily WGRP: P 30% effective ↓HFs. BGRP: CHM 29% higher than pain (BP) & P*; HRT 50% higher than P** mental health (MH)

Outcome Outcome measures: hot measures: other symptoms flushes

Diary re CHM adjusted to Double-blind, Kwee, 2007, Include: 20  HF/week, frequency TCM dx at visits 0, double-dummy Netherlands17 age 45–65, PMP 2, 4, 12. randomized, irregular. Exclude: HRT, 16  follow-up w/o placebo-controlled cancer, serious dz, HBP, rxs. Zhi bai di trial. All dx’d  2: BMI  30% normal. Age: huang wan jia wei. biomedicine & TCM. 53.6 (50.0–57.3) HRT; Comparison: 1 HRT; 2 Evaluated weeks 0, 53.2 (51.5–55.0) CHM; placebo 2, 4, 12, 16. 4 weeks 54.9 (51.6–58.2) P. BMI afterwards w/o tx 22.3 (20.7–24.0) HRT; 23.8 (21.9–25.6) CHM; 23.3 (20.8–25.8) P. 50 screened, 31 enrolled; randomized: 11 HRT, 10 CHM, 10 placebo (P). Completed: 11 HRT, 9 CHM, 10 P Qian, 2010, KI and TCM RCT. Blinding NR. 3 Group A – n  53 Beijing Hospitals. Age China19 indices arms: Group analyzed (59 41–60, PMP not S1  HF A  CHM; Group randomized) CHM. defined. Age: Group A B  psychological Kun Bao Wan 5 g 51.25 1  6.96; B 2 intervention; Group qd. Xiao Yao Wan 6 52.87 1 2 6.98; C C  CHM  g bid. 51.43 1  7.01. Inclusion: 2 psychological Group B – n  55 lipid labs. Ethnicity/ intervention analyzed (65 race, BMI NR. randomized) Screened NR; eligible NR; psychological 185 enrolled, intervention (est randomized; 164 rapport, counsel analyzed effectiveness of CHM, critically assess mental condition, qwk 30–40”) Group C – n  56 analyzed (63 randomized)  CHM  psychological intervention

Author, year, study location

Table 1  (Continued)

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SL90 -Total scores only. Mood, pain & sleep all ↓ WGRP, BGRP (C:A, C:B) SL 1, 2, 4, 5 all decreased in Group C*

HRT 62.5 (54.3–70.8); CHM 55.2 (50.4–60.0); P 75.6 (64.7– 86.5)

SF36 BP: NS HRT 25.5 (11.6–3.3); CHM 31.0 (15.8–46.2); P 22.0 (5.5– 38.5). SF36 MH: BGRP CHM & placebo**

Results: other symptoms

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RCT. Blinded: data 51 PM or PMP. Any age analysis. NR blinded OK. BSO OK. Excluded moxa providers. All cancer, HRT, DM, HTN. patients received Age: 51.05 1  2.31 M1; 2 moxa, so assume 50.00 1 2 3.03 M2; blinded 52.40 1  2.99 C. BMI NR 2 69 screened; 11 excluded d/t exclusion criteria; 58 eligible, 7 declined; 51 randomized; 10 C, 21 Moxa1, 20 Moxa2; completed study: 10 C, 19 Moxa1, 18 Moxa2

MENQOL Moxa (see comments). Frequency, (psychsocial, severity by Moxa1  clinically physical diary. based (CV12, CV4, subscores) MENQOL, ST36, SP6). MRS Moxa2  lit based points (GV4, CV4, CV6, UB23). 14 sessions over 4 weeks, follow-up @ 2 weeks Wait-list control

GCS, HFRDI Intervention: Suan zao Daily HF Randomized to 2 Advertised (newspaper, Scale total diary; GCS ren  Zhi bai di groups: Intervention/ magazine articles, score only Hot Flush huang wan  Er Placebo (46/46); television, radio Related Xian Wan  parallel-design interviews), referral Daily Cimifuga racemosa clinical trial (4 weeks from health service and Interference (L.) NUTTALL baseline, 16 weeks hospitals; Scale ( 2.5% triterpene treatment, 8 weeks postmenopausal women (HFRDI glycosides calculated follow-up) Mean age 55.68/55.66 Scale) total as 27-deoxyactein). (Intervention/Placebo); score only Two 955-mg tablets BMI 25.23/26.07; (3150 mg of dry previously taken HRT herb), twice orally/day 26%/24%; previously Control: Placebo taken CAM 28%/26% (calcium and 413 eligible, 122 screened, magnesium salts, 93 randomized, 72 cellulose, colors, and completed licorice flavor) BGRP: psychological, anxiety, and depression score: NS Somatic score NS. WGRP: NR

BGRP: 4 weeks: M1*** & M2** ↓ BGRP: Psychosocial: Freq HF to C. M2 & C** BGRP Severity HF 4 weeks: ↓M1** ** M2 to C*; M2↓ to C. Physical: M2 BGRP: MENQOL VM subscale & C** M1** & M2** ↓ to C. MRS NS @ 2, 4 weeks & follow-up

BGRP: HF frequency and severity score NS WGRP – trend of decreasing HFs 8 weeks after cessation of CHM

­*, p  0.05; **, p  0.01; ***, p  0.001 Acup, acupuncture; BGRP, between-group; WGRP, within-group; BMI, body mass index; MT, menopausal transition; PMP, premenopause; PM, postmenopause; surg MP, surgically menopausal; BSO, bilateral salpingo-oophorectomy; E2, estradiol; FSH, follicle stimulating hormone, LH, luteinizing hormone; HF, hot flushes; HRT, hormone replacement therapy; NS, not significant; NR, not reported; dx, diagnosis; dz, disease; rx, prescription; tx, treatment; VAS, Visual analog scale; GCS, Greene Climacteric Scale; WHI, Women’s Health Initiative; KI, Kupperman Index; BDI, Beck Depression Inventory; RCT, randomized, controlled trial; HS educ, high school education; UC, usual care; SA, sham; TA, traditional acupuncture; ill, illness; ameno, amenorrhea; SERM, selective estrogen receptor modulator; SSRI, selective serotonin reuptake inhibitor; phyto, phytoestrogen; DM, diabetes mellitus; HBP, high blood pressure; HTN, hypertension; LMP, last menstrual period; LAc, licensed acupuncturist

Park, 2009, South Korea21

Moxibustion

van der Sluijs, 2009, Australia16

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Traditional Chinese medicine and symptom clusters Women’s Health Initiative Insomnia Rating Scale18, Kupperman Index (KI)19, Menopause Related Quality of Life (MENQOL)18,20,21, Daily Diaries of hot flushes18,22,23, Menopausal Rating Scale (MRS)15,21,24, WHQ – QoL22,23, Pittsburgh Sleep Quality Index (PSQI) Global Score25, Menopause-Specific Quality of Life (MSQL)26, Beck Anxiety Inventory (BAI)15 and Hot Flush Related Daily Interference Scale (HFRDI Scale)16. Results of each study were analyzed to determine whether they measured symptoms that indicated the five symptom groups and/or the 17 acceptable symptoms that comprised our symptom groups. See the Supplementary Appendix (to be found online at http://informahealthcare. com/doi/abs/10.3109/13697137.2014.937687) for a list of measures utilized by studies in this review.

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Analysis Data were analyzed by reviewing patterns of between-group and within-group effects on individual symptoms for the therapies included in the studies.

RESULTS This review focused on a total of 13 reports of 11 trials related to the effects of traditional Chinese medicine on menopausal

Taylor-Swanson et al. transition symptoms (hot flushes, sleep, mood, cognitive concerns, pain) representing a total of 1009 participants from seven countries. Two papers were reviewed from one acupuncture trial, one paper reported the initial findings, and a second reported on the 6- and 12-month follow-up results. Also, two papers were reviewed for another acupuncture trial. The interventions tested included acupuncture, five different CHM formulations, and moxibustion, a warming therapy rendered by burning mugwort (Artemesia vulgaris) and holding it either indirectly over or directly on the skin, depending on the technique employed.

Acupuncture, hot flushes and co-occurring symptoms As seen in Table 2, acupuncture was effective at decreasing hot flushes in five of six trials22,24–27. Acupuncture was delivered in 9–16 sessions over 4–12 weeks. Various acupuncture points were used in the studies, and three of the six studies used acupoints according to individual participants’ TCM diagnosis. Two acupuncture papers demonstrated improvement in mood symptoms24,27. Treatments were given two to three times per week for 4–5 weeks. Acupuncture rendered according to differential diagnosis that changed over time as indicated by the patient’s presentation resulted in improvement in hot flushes, pain and sleep symptoms, but not in cognition22. Note that the study by Borud and colleagues was

Table 2  Summary of treatment outcomes (between-group differences for treatment vs. control or comparison) for all symptoms according to intervention and study symptoms Type of intervention/study Acupuncture Avis 2008: 16 sessions over 8 weeks vs. usual care vs. sham Borud 2009: 10 sessions by TCM diagnosis and self care vs. self care Borud 2010: Follow-up of Borud 2009 at 6 and 12 months Huang 2006: Nine real acupuncture treatments in 7 weeks vs. off channel points Streitberger sham Kim 2010: 12 acupuncture treatments in 4 weeks vs. usual care Nir 2007: 14 acupuncture treatments in 7 weeks by TCM diagnosis vs. Streitberger sham Sunay 2011: 10 acupuncture treatments in 5 weeks vs. Streitberger sham Venzke 2010: 16 acupuncture treatments in 12 weeks by TCM diagnosis vs. off-channel points Chinese herbal medicine Haines 2008 6 months: Dang gui bu xue tang vs. placebo pill Kwee 2007: 16 weeks: Zhi bai di huang modified by TCM diagnosis vs. placebo pills vs. HRT Qian 2010: 6 months: Kun bao wan  Xiao yao wan vs. counseling vs. herbs plus counseling Van der Sluijs 2009: 16 weeks: Er xian wan  Zhi bai di huang wan modified  black cohosh tablets vs. placebo tablets Moxibustion Park 2009: 4 weeks: Moxa by the book and counseling vs. moxa by clinical experience and counseling vs. wait list

Hot flushes

Sleep

Mood

Cognitive

Pain

NS  NS 

NS  NS NS

NS NS NS NM

NM NS NS NM

NM  NS NM

   NS

NM NM NM NM

 NS  NS

NM NM NM NM

NM NS NA NA

 

NM NM

NS 

NM NM

 NS







NM



NS

NM

NS

NM

NS



NM



NM



­ S, not significant; NM, not measured; NA, not applicable – MRS Somatic subscale used (contains heterogeneous symptoms); , significant N positive treatment effect, symptoms improved; 2, significant negative treatment effect, symptoms did not improve and improvement was greater in the control or comparison group

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Traditional Chinese medicine and symptom clusters the single study that included measurement of cognitive symptoms of all studies reviewed22. The effects of acupuncture were no longer present in a follow-up study at 6 and 12 months23. Three studies reported all non-significant effects15,18,23.

Chinese herbal medicine, hot flushes and co-occurring symptoms

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Decreased hot flushes were noted in three of four studies of CHM. Five different Chinese herbal formulas were studied in the four papers reviewed. Zhi-bai-di-huang-wan showed a significant decrease in hot flushes and mood17. Kun-bao-wan  Xiao-yao-wan showed significant improvement in symptoms related to hot flushes, mood, sleep and pain19. Dang-guibu-xue-tang showed improvement for moderate hot flushes and pain20. One study reported all non-significant effects16.

Moxibustion, hot flushes and co-occurring symptoms Moxibustion significantly decreased hot flushes in the one study analyzed. The moxibustion study showed positive findings for hot flushes in two groups when moxibustion was delivered according to clinical experience or according to literary references that guided acupoint selection. Moxibustion also showed positive findings for mood and for pain21. Overall, the effects of TCM on hot flushes and mood were beneficial in two acupuncture studies, two CHM studies, and one moxibustion study. TCM was beneficial for hot flushes and pain in one acupuncture study, two CHM studies, and one moxibustion study. Only Qian’s paper on CHM showed positive results for four of five symptoms studied19. The formulas used were Kun-bao-wan and Xiao-yao-wan and counseling was provided as well. Only one acupuncture study measured hot flushes and cognitive symptoms, and the findings were non-significant22.

DISCUSSION Based on this review, acupuncture, CHM and moxibustion all appear to provide promising treatment effects for hot flushes and mood and for hot flushes and pain. The most robust findings were for hot flushes and mood, of which five trials found significant improvement of symptoms. Acupuncture and CHM show promise for the treatment of hot flushes, sleep and pain symptoms. Safety is an utmost concern for clinicians and patients alike. Regarding adverse events, there were no reports of serious harms or adverse events in any of the 11 studies (13 papers) reviewed. The few minimal and moderate adverse events noted in each paper are summarized in Table 3. These data raise several key questions. First and most prominent is sham acupuncture and the question of how to

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Taylor-Swanson et al. render a truly inert sham acupuncture28 and how to interpret findings of previously reported trials using sham interventions. The central question is, ‘Have prior sham acupuncture interventions been an inert control?‘ The answer appears to be that they are not inert. As was noted in the Introduction, four reviews reported both sham and verum acupuncture to decrease hot flushes – some authors interpreted this as verum acupuncture being ineffective6,8,9 while others concluded that acupuncture decreases hot flushes but the treatments need not be acupoint-specific (when off-channel points are used for sham acupuncture)7. Interpreting verum acupuncture as ineffective when compared to a non-inert sham acupuncture underestimates treatment effects due to the sham being active, not inert. One key question is whether acupoints are necessary or not – in essence, can acupuncture needles be inserted anywhere and elicit a physiologic response? Borud, Grimsgaard and White conclude that, since verum and sham acupuncture both elicit a decrease in hot flushes, perhaps acupuncture is not point-specific7. Others conclude that acupoints do indeed exist and matter29. An extensive literature regarding acupoint specificity and mechanisms of acupuncture action exists, including increased degranularization of mast cells at acupoints, which leads to analgesia30, increased net-like formations of collagen and increased microcirculation at acupoints31 as well as decreased electrical resistance at acupoints compared with non-points32. It appears that acupoints may have a specific physiologic effect, but further research is certainly warranted to clarify whether or not these physiologic changes occur only at acupoint sites. A second key question is the selection of therapeutics in the studies we reviewed. Specifically, Dang-gui-bu-xue-tang is a formula comprised of only two herbs (Dang-gui (Radix Angelicae Sinesis) and Huang-qi (Radix Astragali)) and strongly nourishes both Qi and Blood and is given to patients with Blood deficiency. Biomedically, this formula has been shown to increase the production of erythropoietin in cultured liver cells33, so this herbal formula is appropriate for anemic individuals (this parallels some aspects of Blood deficiency in TCM). It is not indicated if one is sweating due to Yin deficiency unless there is concurrent Blood deficiency13, so one would not typically use it for menopausal women with hot flushes that are often accompanied by a sweat due to Yin deficiency. It is plausible to use for women with a Qi and Blood deficiency diagnosis, yet the authors did not make this differential diagnosis an inclusion criterion20. There are several questions regarding studies of CHM and outcomes measured or observed. First, neither Kwee and colleagues17 nor van der Sluijs and colleagues16 measured sleep concerns yet the formula used (Zhi-bai-di-huang-wan) is clinically used to promote sleep, among treating other symptoms. It would have been useful to measure changes in sleep quality given the intervention applied13. Second, CHM formulas used in the two studies with non-significant findings for mood are not commonly used clinically to address mood concerns, so it is unsurprising they had non-significant findings for mood symptoms16,20. Third, the study by van

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Table 3  Trials of traditional Chinese medicine for hot flushes and associated symptoms: details of intervention and controls Name, year Acupuncture Avis 200818 Borud 200922 Borud 201023 Huang 200625

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Kim 201027

Intervention type

TEAM diagnosis UB 23, R 4, HT 6, Sp 6, KI 7, Ki3 Points not listed TEAM diagnosis  leaflet of information TEAM diagnosis Variety from a long list of points according to diagnosis TEAM diagnosis Many points according to diagnosis

Nir 200726

Traditional Korean medicine TEAM diagnosis

Sunay 201124

Protocol acupoints

Venzke 201015

TEAM diagnosis

Chinese herbal medicine (CHM) Haines 200820 Dang gui bu xue tang

Kwee 200717

Qian 201019

van der Sluijs 200916

Moxibustion Park 200921

Intervention detail (acupoints or individual herbs used)

St 36, Sp 6, Li 4, Pc 6, Ht 7, Ht 8, CV 4  TDP heat on abdomen Many points according to diagnosis

Control type

Adverse events

Off channel sham: 1–6 Not recorded Self-care leaflet of None information Self-care Not recorded Streitberger off channel placebo Usual care

None None

Sham Streitberger off channel St 36, Ki 3, LR 3, CV 3, EX-HN3 Streitberger sham on acupoints Off channel sham: Selection from points and electrical electrical stimulation used: UB 23, UB 15, UB 17. Du stimulation with 9, Du 4, Sp 9, Sp6, Right Lu7, Left Ki 6. Ki Streitberger needle 3, Ki7, Ht 7, Ht 6, Liv 3, Du 24, GB 20

None

Encapsulated granules of Dang gui: Huang qi – 5 : 1 ratio

Two serious adverse events neither thought to be treatment-related No serious adverse events

Placebo encapsulated granules

Zhi bai di huang wan Base formula modified according to TEAM Two controls: placebo tablets of diagnosis – specific herbs not listed in modified over time herbal formula; paper. 12 weeks according to TEAM HRT tablets diagnosis Counseling only Kun bao wan and Jia Kun bao wan: Fructus Ligustri lucidi, Fructus Rubi, Semen Cuscutae, Fructus wei xiao yao wan Lycii, Radix Polygoni multiflori, Carapax  counseling. et Plastrum Testudinis, Cortex Lycii, Inclusion criteria: Radix Adenophorae, Radix women diagnosed Ophiopogonis, Semen Zizyphi spinosae, with Kidney & Rdix Scutellariae. Modified XiaoYao deficiency  Liver Pill: Radix Bupleuri, Radix Angelicae Qi stagnation sinensis, Radix Paeoniae alba, Rhizom Atractylodes alba, Poria, Radix Glycyrrhizae, Cortex Moutn, Fructus Gardeniae, and Herba Menthae Placebo tablets Suan zao ren, Sheng di huang, Zhi mu, Er Xian wan  Zhi Tian Men Dong, Yin Yang Huo, Xian bai di huang wan  Mao, Huang Bai. Black cohosh. 16 weeks black cohosh tablets

Wait list for both 18 mm moxa pillar. 4 treatments/week  2 Group 1  Point groups weeks, then 3 treatments/week  2 weeks. location determined Group 1  CV 12, CV4, ST 36, SP6. by experts; Group Group 2  GV4, CV 4, CV6, UB23 2  determined by textbooks

None None

None

Adverse events were reported by 48% in placebo, 57% in CHM. All adverse events were mild to moderate: headache and gastrointestinal complaints Four people discontinued trial due to general fatigue, stomach upsets, flare-ups and headaches caused by smoke; five participants reported burns on their skin but all remained in trial

­Italics, additions to formulas

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Traditional Chinese medicine and symptom clusters der Sluijs and colleagues16 included Suan-zao-ren (Zizyphus jujube) as the highest dose ingredient in their CHM plus black cohosh trial, yet did not measure sleep changes in their study. In contrast, appropriate CHM formulas and measures were applied by Qian and colleagues19. This paper reported on the use of Kun-bao-wan and Jia-wei-xiao-yao-wan, which contain several herbs that tend to be analgesic in effect (Dang-gui (Angelica polymorpha), Ji-xue-teng (Spatholobus suberectus), Bai-shao (Paeonia lactiflora)) and pain was reduced significantly in this study34. Three of the five formulas included Dang-gui (Angelica sinensis), a herb studied for its phytoestronergic effects35. It is worth noting the seemingly novel use of a warming therapeutic, moxibustion, for women experiencing various symptoms during the menopausal transition, which often includes hot flushes. Moxibustion is indicated here as the authors utilized acupoints to be warmed with moxibustion according to theory indicated in textbooks and according to clinical experience (two arms). In each arm, acupoints were used that tonify Kidney Yang and Kidney Yin. Of the points used in the two moxibustion treatment groups, each group used Conception Vessel points that are typically used to calm and relax the mind36. Moxibustion is well known for its analgesic effects, as it invigorates the blood, moves stagnation, and increases local circulation and decreases inflammation37. Only one of the studies examined the impact of TCM therapeutics on cognitive symptoms and hot flushes and reported non-significant findings22. TCM texts38,39 instruct clinicians how to promote cognitive health (yet there is a dearth of published literature on this topic). This is a topic that would benefit from rigorous study and evaluation. In summary, this review of TCM therapeutics including acupuncture, CHM, and moxibustion evaluated outcomes for women traversing the menopausal transition and early postmenopause. We found that one study of CHM including Kun-bao-wan  Xiao-yao-wan and counseling benefitted hot flushes, mood, pain and sleep symptoms. Of the other treatments that focused on hot flushes plus at least one other symptom, acupuncture and CHM were found to have significant improvement in hot flushes and mood, pain or sleep in nine of 13 publications. There are several limitations to this review, including the small number of trials that met our criteria for inclusion in

Taylor-Swanson et al. the review and the size of those trials: most of the studies had enrolments of fewer than 100 participants. This made it challenging to identify statistically significant outcomes between groups. Furthermore, additional challenges were presented by the heterogeneity of measures used, making it difficult to compare across studies. Recommendations for future research would include focusing on multiple symptoms including hot flushes, mood, cognitive, sleep and pain symptoms often experienced by women traversing the menopausal transition and early postmenopause. It is critical to utilize scales that are homogeneous with respect to symptoms, and to report individual scale scores, so that clinicians may evaluate findings in a way that is relevant to practice, and researchers may also compare findings with extant literature. Furthermore, given that TCM theory posits that examining the whole-person, including all existing symptoms, it would make sense to measure relevant symptoms when designing trials of TCM therapeutics. Lastly, while the trials examined here are CCTs, it is worth noting that clinical practice typically involves the combined application of acupuncture and moxibustion and CHM to an individual patient. Attempts should be made to study TCM in its entirety as a whole system of medicine, including CCTs. These whole-medicine CCTs could be followed up with effectiveness trials which would more closely match individualized treatment as in a clinical setting.­­­

ACKNOWLEDGEMENT The first author would like to thank her patients for motivating her to evaluate research. Conflict of interest    The authors report no conflict of interest. The authors alone are responsible for the content and writing of this paper. Source of funding    This work was supported by grants from the National Institute of Nursing Research (NINR 1R21NR012218 Menopause Symptom Clusters: Refocusing Therapeutics; NR 04141 – Menopausal Transition: A Biobehavioral Model of Symptoms; P30 NR 04001, P50-NR02323 – Center for Women’s Health and Gender Research).

References 1. Woods NF, Mitchell ES. Symptoms during the perimenopause: prevalance, severity, trajectory and significance in women’s lives. Am J Med 2005;118(Suppl 2):14–24 2. Cray L, Woods NF, Herting JR, Mitchell ES. Symptom clusters during the late reproductive stage through the early menopause: observations from the Seattle Midlife Women’s Health Study. Menopause 2012;19:864–9

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3. Unschuld PU. Huang Di Nei Jing Su Wen: Nature, Knowledge, Imagery in an Ancient Chinese Medical Text. Berkeley: University of California Press, 2003 4. Scheid V, Ward T, Cha WS, Watanabe K, Liao X. The treatment of menopausal symptoms by traditional East Asian medicines: review and perspectives. Maturitas 2010;66: 111–30

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Traditional Chinese medicine and symptom clusters 5. Maciocia G. Diagnosis in Chinese Medicine: A Comprehensive Guide. London: Churchill Livingstone, 2004 6. Alfhaily F, Ewies AA. Acupuncture in managing menopausal symptoms: hope or mirage? Climacteric 2007;10:371–80 7. Borud E, Grimsgaard S, White A. Menopausal problems and acupuncture. Auton Neurosci 2010;157:57–62 8. Cho SH, Whang WW. Acupucture for vasomotor menopausal symptoms: a systematic review. Menopause 2009;16:1065–73 9. Lee MS, Shin BC, Ernst E. Acupuncture for treating menopausal hot flushes: a systematic review. Climacteric 2009;12:16–25 10. Vincent C, Lewith G. Placebo controls for acupuncture studies. J R Soc Med 1995;88:199–202 11. Dodin S, Blanchet C, Marc I, et al. Acupuncture for menopausal hot flushes. Cochrane Database Syst Rev 2013;7:CD007410 12. Chen HY, Cho WC, Sze SC, Tong Y. Treatment of menopausal symptoms with Er-xian decoction: a systematic review. Am J Chin Med 2008;36:233–44 13. Scheid V, Bensky D, Ellis A, Barolet R, eds. Chinese Herbal Medicine: Formulas & Strategies. 2nd edn. Seattle: Eastland Press, 2009 14. Woods NF, Mitchell ES, Schnall JG, et al. Effects of mind–body therapies on symptom clusters during the menopausal transition. Climacteric 2014;17:10–22 15. Venzke L, Calvert JF Jr, Gilbertson B. A randomized trial of acupuncture for vasomotor symptoms in post-menopausal women. Complement Ther Med 2010;18:59–66 16. van der Sluijs CP, Bensoussan A, Chang S, Baber R. A randomized placebo-controlled trial on the effectiveness of an herbal formula to alleviate menopausal vasomotor symptoms. Menopause 2009;16:336–44 17. Kwee SH, Tan HH, Marsman A, Wauters C. The effect of Chinese herbal medicine (CHM) on menopausal symptoms compared to hormone replacement therapy (HRT) and placebo. Maturitas 2007;58:83–90 18. Avis NE, Legault C, Coeytaux RR, et al. A randomized, controlled pilot study of acupuncture treatment for menopausal hot flashes. Menopause 2008;15:1070–8 19. Qian LQ, Wang B, Niu JY, Gao S, Zhao DY. Assessment of the clinical effect of Chinese medicine therapy combined with psychological intervention for treatment of patients of peri-menopausal syndrome complicated with hyperlipidemia. Chin J Integr Med 2010;16:124–30 20. Haines CJ, Lam PM, Chung TK, Cheng KF, Leung PC. 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. Climacteric 2008;11:244–51 21. Park JE, Lee MS, Jung S, et al. Moxibustion for treating menopausal hot flashes: a randomized clinical trial. Menopause 2009;16:660–5 22. Borud E, Alraek T, White A, et  al. The Acupuncture on Hot Flushes Among Menopausal Women (ACUFLASH) study, a randomized controlled trial. Menopause 2009;16:484–93

Taylor-Swanson et al. 23. Borud EK, Alraek T, White A, Grimsgaard S. The Acupuncture on Hot Flashes Among Menopausal Women study: observational follow-up results at 6 and 12 months. Menopause 2010; 17:262–8 24. Sunay D, Ozdiken M, Arslan H, Seven A, Aral Y. The effect of acupuncture on postmenopausal symptoms and reproductive hormones: a sham controlled clinical trial. Acupunct Med 2011;29:27–31 25. Huang MI, Nir Y, Chen B, Schnyer R, Manber R. A randomized controlled pilot study of acupuncture for postmenopausal hot flashes: effect on nocturnal hot flashes and sleep quality. Fertil Steril 2006;86:700–10 26. Nir Y, Huang MI, Schnyer R, Chen B, Manber R. Acupuncture for postmenopausal hot flashes. Maturitas 2007;56:383–95 27. Kim KH, Kang KW, Kim DI, et  al. Effects of acupuncture on hot flashes in perimenopausal and postmenopausal women – a multicenter randomized clinical trial. Menopause 2010;17: 269–80 28. White P, Lewith G, Hopwood V, Prescott P. The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trial. Pain 2003; 106:401–9 29. Zhao L, Chen J, Liu CZ, et al. A review of acupoint specificity research in China: status quo and prospects. Evid Based Complement Alternat Med 2012:543943 30. Zhang D, Ding G, Shen X, et al. Role of mast cells in acupuncture effect: a pilot study. Explore 2008;4:170–7 31. Yu X, Ding G, Huang H, Lin J, Yao W, Zhan R. Role of collagen fibers in acupuncture analgesia therapy on rats. Connect Tissue Res 2009;50:110–20 32. Shen XY, Wei JZ, Zhang YH, et al. Study on Volt-ampere (V-A) characteristics of human acupoints. Zhonogguo Zhen Jiu 2006; 26:267–71 33. Gao QT, Cheung JK, Choi RC, et al. A Chinese herbal decoction prepared from Radix Astragali and Radix Angelicae Sinensis induces the expression of erythropoietin in clutured Hep3B cells. Planta Med 2008;74:392–5 34. Bensky D, Clavey S, Stoger E. Chinese Herbal Medicine: Materia Medica. 3rd edn. Seattle: Eastland Press, 2004 35. Kim SH, Park MJ. Effects of phytoestrogen on sexual development. Korean J Pediatr 2012;55:265–71 36. Deadman P, Al-Khafaji M, Baker K. A Manual of Acupuncture. 2nd edn. East Sussex: Journal of Chinese Medicine Publications, 2007 37. Maciocia G. The Foundations of Chinese Medicine: A Comprehensive Text for Acupuncturists and Herbalists. 2nd edn. London: Churchill Livingstone, 2005 38. Maciocia G. The Practice of Chinese Medicine: The Treatment of Diseases with Acupuncture and Chinese Herbs. 2nd edn. London: Churchill Livingstone, 2007 39. Moss CA, Eckman P. Power of the Five Elements: The Chinese Medicine Path to Healthy Aging and Stress Resistance. Berkeley: North Atlantic Books, 2010

Supplementary materials available online Supplementary Appendix.

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Effects of traditional Chinese medicine on symptom clusters during the menopausal transition.

To review controlled clinical trials of traditional Chinese medicine (TCM) therapies for hot flushes and at least one other co-occurring symptom among...
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