Traditional Chinese Medicine for hot flashes & associated symptoms: Evidence from asystematic review

Lisa J Taylor-Swanson, MS, PhD Student

Nancy Fugate Woods, PhD, Professor, Dean Emeritus

Ellen Mitchell, PhD, Associate Professor Emeritus

Janet Schnall, MS, AHI, Librarian

2012 State of the Science Congress on Nursing ScienceSeptember 13-15, 2012Washington, DC

Background

• 80% of women in the US experience menopausal transition (MT) symptoms – usually several symptoms

• Hormone therapy concerns have led to increased utilization of Complementary & Alternative Medicine (CAM)

• Traditional Chinese Medicine (TCM) used to promote women’s health…for awhile

Background

• TCM differential diagnoses vary by clusters of symptoms presented – congruent with study design.

• No systematic review thus far on TCM for multiple MT symptoms.

Purpose

• To review studies of TCM used to treat MT clusters of symptoms (hot flashes, sleep, cognitive function, mood & pain) during the menopausal transition and early post-menopause.

• To generate information useful for clinicians.

Methods

• We reviewed 13 controlled clinical trials (CCTs) of TCM’s effects on HFs & at least 1 other associated symptom including sleep, cognitive function, mood, and pain.

• 8 Acupuncture, 4 Chinese Herbal Medicine (CHM), 1 Moxibustion (“Moxa”) papers.

• Women studied were in the menopausal transition and early post-menopause.

Description of Studies

Study population, location

USA, Norway, Korea, Turkey, Netherlands, China, Hong Kong, Australia

Multi-center trials

Community-based, hospitals

Sample sizes 29 – 267

Age 45-65 years old

Tx 1x - 2x / wk. 4 - 12 wks

Controls Sham acu-puncture, self-care advice, usual care, placebo pills, hormone therapy

Modalities studied

• Acupuncture

• Moxibustion

• Chinese Herbal medicine (CHM)

Results table – CHM & Moxa

Author, Yr

Intervention/Control HFs Sleep Mood Cog. Pain

CHMHaines’08

Dang gui bu xue tang. Control (C) : placebo pill. 6 months.

NS NM NS NM NS

Kwee, 2007

Zhi bai di huang +/- by dx. C: (1) placebo (2) HRT. 16 wks.

+ NM + NM NS

Qian, 2010

Kun bao wan + Xiao yao wan; herbs + psych C: psych only. 6 mos

+ + + NM +

Van der Sluijs, 2009

Er xian tang + zhi bai di huang wan (mod) +Black cohosh C: placebo tablets. 16 wks

NS NM NS NM NS

MOXAPark, ‘09

Moxa –book; moxa-clinical exp. C: wait list. 4 weeks.

+ NM + NM +

Between group findings: + P<0.05 or lower NS non-significant NM Not measured

Acupuncture Results

Author, Yr Intervention/Control HFs Sleep Mood Cog. PainAvis, 2008 2x/week – 8 weeks. Control (C):

usual care; sham acup. NS NS NS NM NM

Borud, ’09 10 sessions, TCM diagnosis (dx), self-care. C: self-care

+ + NM NM +

Borud, ’10 Follow up @ 6 & 12 mos. NS NS NS NM NSHuang, ’06

9 tx in 7 wks. C: off points Streitberger

NS NS NS NM NS

Kim, ’10 3x/wk – 4 wks. C: Usual care. + NM NS NM NMNir, ’07 2x/wk – 7 wks. TCM dx. C:

Streitberger –sham+ NM NS NM NS

Sunay, ’11 2x/wk– 5 wk. C: Streitberger + NM + NM NMVenzke, ’10

16 tx in 12 wks, TCM dx. C: off points.

+ NM NS NM NS

Results

Out of 13 CCTs reviewed – significant between group findings:

• 5 CCTs – HFs and 1+ symptom (sleep, pain, mood). (2 acu, 2 CHM, 1 moxa)

• Acupuncture, Moxibustion and Kun Bao Wan/Xiao Yao Wan plus counseling showed the most broad results. (1 study each)

• 4 CCTs – HFs only

Results - Continued

• Initial findings of significant improvement with 12 weeks’ acupuncture care were no longer present at 6 & 12 months follow-up.

• 5 of 8 CCTs compared acupuncture with sham acupuncture. 1 of these 5 studies found acupuncture and sham acupuncture were both significantly beneficial. (Venzke, 2010).

• No reports of serious harm or adverse events.

Limitations

• Scales used varied: Diary, BDI, MENQOL, Green (HF, psych), WHQ (HF, sleep), MRS (HF, pain, psych)

• Dose – What is an “acupuncture dose”?• Sham acupuncture – it is a sham?• Various CHM formulas, doses, durations studied.• TCM as practiced in clinic was not evaluated (many

tools used simultaneously).• Traditional Chinese Medicine (TCM) differential dx

& others used a standardized protocol.

Conclusions

• TCM offers promise in the management of hot flashes during the menopausal transition and early post-menopause as a safe & possibly effective tx.

• Standardization of study design and methods is needed.

• Longitudinal studies needed – what is the effectiveness trajectory? Booster sessions?

Thank You!

SoN Travel Fund & de Tornyay CenterSchool of Nursing, University of WA

National Institute for Nursing ResearchNIH NR01 04141 and NINR, NIH, P50-NR-02323, P30-NR04001

ARCS Foundation FellowshipSeattle Chapter

Lisa J Taylor-SwansonPhD Student & Licensed Acupuncturist

ljts369@uw.edu

Streitberger needle – sham