eCAM Advance Access published February 2, 2009
Acupuncture and Auricular Acupressure in RelievingMenopausal Hot Flashes of Bilaterally OvariectomizedChinese Women: A Randomized Controlled Trial
Jue Zhou1,*, Fan Qu2,*, Xisheng Sang3, Xiaotong Wang4 and Rui Nan5
1Sino-Britain Joint Laboratory, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, Zhejiang310058, 2Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310006, 3HeilongjiangUniversity of Chinese Medicine, Harbin, Heilongjiang, 150040, 4The First Affiliated Hospital, Liaoning University ofChinese Medicine, Shenyang, Liaoning, 110032, P. R. China and 5Colorado School of Traditional ChineseMedicine, 1441, York Street, Denver, CO 80206, USA
The objective of this study is to explore the effects of acupuncture and auricular acupressure inrelieving menopausal hot flashes of bilaterally ovariectomized Chinese women. Between May2006 and March 2008, 46 bilaterally ovariectomized Chinese women were randomized into anacupuncture and auricular acupressure group (n ¼ 21) and a hormone replacement therapy(HRT) group (Tibolone, n ¼ 25). Each patient was given a standard daily log and was requiredto record the frequency and severity of hot flashes and side effects of the treatment felt daily,from 1 week before the treatment started to the fourth week after the treatment ended. Theserum levels of follicle stimulating hormone (FSH), LH and E2 were detected before and afterthe treatment. After the treatment and the follow-up, both the severity and frequency of hotflashes in the two groups were relieved significantly when compared with pre-treatment(P50.05). There was no significant difference in the severity of hot flashes between them aftertreatment (P40.05), while after the follow-up, the severity of hot flashes in the HRT group wasalleviated more. After the treatment and the follow-up, the frequency of menopausal hot flashesin the HRT group was reduced more (P50.05). After treatment, the levels of FSH decreasedsignificantly and the levels of E2 increased significantly in both groups (P50.05), and theychanged more in the HRT group (P50.05). Acupuncture and auricular acupressure can be usedas alternative treatments to relieve menopausal hot flashes for those bilaterally ovariectomizedwomen who are unable or unwilling to receive HRT.
Keywords: acupuncture – auricular acupressure – hormone replacement therapy (HRT) –hot flashes – menopausal
Hot flashes are episodic and usually accompanied bynausea, dizziness, headache, palpitations, diaphoresis or
Hot flashes occur in the vast majority of post-menopausal
night sweats (3). Having hot flashes may decrease a
women (1). An extensive questionnaire study of 506
woman’s quality of life by decreasing the quality of sleep
women found that 87% had daily hot flashes (2).
and aggravating fatigue and depression (4,5). Menopausalhot flashes make most of women seek medical care during
*These authors contribute equally to this work.
the menopausal transition (2). Menopausal hot flashes are
For reprints and all correspondence: Fan Qu, No. 604 Room in
related to a psychological or mental disorder in meno-
B Building, School of Medicine, Zhejiang University, 388 Yuhang Tang
pausal women and the hormonal changes in these women
Road, Hangzhou, Zhejiang 310058, P. R. China. Tel: þ86-13429119143;E-mail: [email protected]
may be the underlying mechanism (6,7). ß 2009 The Author(s). This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work isproperly cited.
Acupuncture and auricular acupressure in relieving menopausal hot flashes
For those bilaterally ovariectomized pre-menopausal
not manifest any perimenopausal symptoms before the
women, the estradiol (E2) contents in their serum were
bilateral ovariectomy and had not taken any drugs
reduced by 80% (8). The abrupt decline in E2 usually
containing hormones or affecting the cardiovascular
leads to more frequent and severe menopausal symptoms,
system during the previous 6 months; the level of
especially hot flashes. Menopausal hot flashes are also
thyroid-stimulating hormone (TSH) was normal and the
related to enhanced norepinephrine (NE) activity in the
E2 concentration was 550 pg/ml; a gynecologic examina-
hypothalamus, resulting in an abrupt, transient, down-
tion and laboratory tests showed that the patient did not
ward resetting of the normal thermoregulatory response
suffer from other organic diseases of the reproductive
set point (9, 10). Most of the bilaterally ovariectomized
system after the bilateral ovariectomy; written consent
Chinese women have difficulty in stopping hormone
was obtained from the subject stating that the subject
replacement therapy (HRT) due to the severe menopausal
would complete the study. To have been considered for
symptoms. Although HRT historically has been used
the study, patients must have met all criteria.
as the standard treatment for hot flashes (11), many
Exclusion criteria were as follows: the subject was
women choose not to initiate or adhere to HRT because
under other medical treatment during the research period,
of its potential health risks and side effects (12,13).
had metabolic, renal, anaphylactic or endocrine disease,
In recent years, non-pharmacological alternative treat-
or suffered from primary hypertension, primary hypoten-
ments are being requested by more bilaterally ovariecto-
sion, chronic anemia, tuberculosis, a mental disorder or
mized women to relieve their menopausal symptoms,
a chronic affection; the body mass index (BMI) of the
especially menopausal hot flashes. A study has demon-
subject was more than 24 or she was a cigarette smoker.
strated that acupuncture could induce accumulation of
Patients were excluded from the study if they fit any of
vaginal exfoliative cells, increase the weight of adrenal,
and raise the level of serum corticosterone in ovariecto-
The women were informed of the short- and long-term
mized model rats (14). It is deduced that estrogen levels
benefits of HRT and were informed about the aim and
may be elevated using acupuncture to create compensa-
methodology of the study. Ethical approval and permis-
tory hyperplasia of the adrenal cortex, thereby enhancing
sion to conduct the study were obtained from the local
the transferring of androgen into estrogen in peripheral
ethical committee and the administration of the study
tissues (14). In as early as 1995, the acupuncture’s
was based on international ethical guidelines. Voluntary
efficacy in relieving menopausal symptoms has been
participation was requested and informed consent was
demonstrated (15). Alternative and complementary thera-
pies, including acupuncture, have been used increasingly
Subjects were randomized to either the acupuncture
and auricular acupressure group or the HRT group
(16–23), although one of them suggested that the used
with the use of a randomization chart constructed in
medical acupuncture was not any more effective for
Microsoft Excel that randomized numbers into two
reducing menopausal hot flashes than was the chosen
groups. Having been divided, the acupuncture and auric-
sham acupuncture (16). As hot flashes are the most
ular acupressure group had 21 cases and HRT group
common menopausal symptoms in bilaterally ovariecto-
had 25. In the statistical analysis, 43 of the women were
mized women, it is important to find effective, non-
included. Three subjects were considered missing cases
pharmacological treatments to relieve their menopausal
during the study (Fig. 1). There was no significant differ-
hot flashes. This study was designed to explore the effects
ence in baseline characteristics between the two groups
of acupuncture and auricular acupressure in relieving
menopausal hot flashes of bilaterally ovariectomized
Each patient was given a standard daily log and was
required to record the frequency and severity of hotflashes and side effects of the treatment felt daily, from1 week before the treatment started to the fourth week
after the treatment ended. The patients were required torecord the items before going to bed in the evening.
The standard daily log was made in a structured way by
Between May 2006 and March 2008, 46 bilaterally
the hospitals and all the possible side effects of the
ovariectomized Chinese women were recruited through
treatment had been listed on it, which had been validated
advertisement to complete 12 weeks of intervention with
either acupuncture and auricular acupressure or Livial
Each participant received a physical examination,
a routine blood examination, a routine uronoscopy, a
Inclusion criteria were as follows: the subject had
liver function test and a renal function test, respectively,
received a bilateral ovariectomy in the previous 2 years
1 day before the treatment started and 1 day after the
and suffered from menopausal hot flashes; the patient did
Table 1. The baseline characteristics of the participants
Assessed for eligibility (n = 46) Excluded (n = 0) Randomized (n = 46) Acupuncture & auricular acupressure group HRT group (n = 21) (n = 25) Received oral Livial (Tibolone) Simultaneously received one tablet a day (2.5mg/tab) for acupuncture and auricular twelve consecutive weeks acupressure treatment for twelve consecutive weeks Missing cases Missing cases excluded from analysis excluded from analysis (n = 2) (n = 1) lost to follow-up (n = 1) no explanation (n = 1) no explanation (n = 1) Analysed (n = 19) Analysed (n = 24)
Acupuncture and Auricular Acupressure Group
Each patient randomized into the acupuncture and
auricular acupressure group received both acupuncture
and auricular acupressure treatments.
The selected acupoints: Sanyinjiao (SP6),
Fengchi (GB20), Hegu (LI4), Quchi (LI11), Guanyuan
The patient was in a comfortable, supine position.
After the skin was routinely disinfected and the acupointswere carefully localized, filiform 0.35 mm Â 40 mm ster-
time and manipulated twice during that time using
ilized, disposable needles (provided by Suzhou Hua Tuo
a twirling technique in a small range. The manipulation
Medical Instruments Co. Ltd, Suzhou, China) were
lasted 30 s for each acupoint. The acupuncture treatment
inserted using the double hand-needle insertion techni-
consisted of two sessions each week for 12 consecutive
que. The depth of insertion was adjusted based on the
patient’s body size and the permissible depth of insertionof the specific acupoint. A technique using lifting, thrust-
ing and twirling in a small range was performed until the
sympathetic (AH6a), shenmen (TF4), adrenal gland
appearance of De-qi, an obtained needle sensation, when
(TG2p), subcortex (AT4), endocrine (CO18), kidney
there emerge a soreness, numbness and a feeling of
(CO10), heart (CO15) and liver (CO12).
distension around the point after the needle is inserted to
After the above acupoints were sterilized with 75%
a certain depth, and tenseness around the needle felt by
alcohol, pieces of plaster with magnetic beads of proper
the operator. Then, an even reinforcing-reducing techni-
size and good quality were stuck to the acupoints, which
que was applied. The needle was retained for 40 min each
were then pressed slightly until the patient had an
Acupuncture and auricular acupressure in relieving menopausal hot flashes
aching pain, numbness, distention and a warm sensation.
The patients were asked to press the acupoints by
acupressure group and the HRT group were determined.
themselves six times a day for a 3 min duration eachtime. It was explained that the strength of the pressingshould make the local auricle congestive, flushed, hot
and achy. The auricular acupressure was alternativelyconducted on the two ears every 2 days. The plaster with
magnetic beads was exchanged for a fresh set once
There were no significant difference between the two
groups’ baseline characteristics (P40.05) (Table 1).
The acupuncture process adhered to the Standards for
Reporting Interventions in Controlled Trials of Acu-puncture (STRICTA) criteria (24).
There was no significant difference between the two
groups’ severity of hot flashes before treatment. After the
The patients were prescribed with oral Livial (Tibolone,
12 weeks of treatment, both groups’ severity of hot
made by Nanjing Oujianong Pharmaceutical Company
flashes decreased significantly (P50.05) with no signifi-
Limited, Nanjing, China), in the dosage of one tablet
cant difference between the groups (P40.05). The 4-week
a day (2.5 mg/tablet) for 12 consecutive weeks.
follow-up showed that both groups were alleviated signif-
One day before the treatment and at the end of the
icantly when compared with pre-treatment (P50.05) and
treatment, the levels of follicle stimulating hormone
HRT had greater effects (P50.05) (Table 2).
(FSH) and luteinizing hormone (LH) were measuredwith enzyme-linked immunosorbent assay (ELISA) and
the levels of E2 were measured with double antibioticELISA. All the reagents were provided by Lianxing
There was no significant difference between the two
Biological Technology Company, Tianjin, China.
groups before treatment. After the 12 weeks of treatment,the frequency of the menopausal hot flashes in bothgroups were reduced significantly (P50.05) and HRT
had greater effects (P50.05) (Table 2). The 4-week
The severity of hot flashes was defined as follows: mild—
follow-up showed that the frequency of hot flashes in the
a fleeting, warm sensation without sweating or disruption
two groups both decreased significantly when compared
of normal activities; moderate—a warm sensation asso-
with pre-treatment (P40.05) and the patients in the HRT
ciated with sweating, and disruption of normal activities;
group were alleviated more (P50.05) (Table 2).
severe—a hot sensation associated with sweating and thediscontinuation of normal activities (16,19,23,25,26).
The score of the hot flash severity for a particular day
is calculated by adding 1 Â the number of mild hot
Before treatment, there was no significant difference
flashes þ 2 Â the number of moderate hot flashes þ 3 Â
in the serum levels of FSH, LH and E2 between the
the number of severe hot flashes (16,19,23,25,26).
acupuncture and auricular acupressure group and the
The frequency of hot flashes is the total number of
HRT group. After treatment, the levels of FSH decreased
the mild, moderate and severe hot flashes occurred
significantly and the levels of E2 increased significantly in
both of the two groups and the levels of LH decreasedsignificantly in the HRT group (P50.05) (Table 2). Theserum levels of FSH, LH and E2 in the HRT group
Results were analyzed by an independent universitystatistician using Statistical Package for Social Sciences
(SPSS 13.0 for Windows), a computer software. Non-parametric Mann–Whitney tests were used to analyze the
No side-effect was reported in either group during the
inter-group and intra-group differences of the severity
period of the research or in the follow-up phase.
and frequency of menopausal hot flashes. Analysis ofvariance (ANOVA) was used to compare the inter-group
and intra-group differences of the serum levels of FSH,LH and E2. A 5% significance level (P50.05) and two-
Although menopause is associated with changes in
tailed tests were used for all hypothesis tests. Ninety-
the hypothalamic and pituitary hormones that regulate
five percent confidence intervals (CI) for the median
Table 2. The severity and frequency of hot flashes and the serum levels of FSH, LH and E2
Acupuncture and auricular acupressure group (n ¼ 19)
FSH, follicle stimulating hormone; LH, luteinizing hormone; E2, estradiol; CI, Confidence intervals. *P50.05, compared with pre-treatment in the same group.
#P50.05, compared with the HRT group.
event, but rather primary ovarian failure (27). As the
elevated plasma LH due to ovariectomy (36); in addition,
hypothalamic-pituitary-ovarian axis remains intact during
acupuncture also restored the number of gonadotropin-
the menopausal transition, FSH levels rise in response to
releasing hormone (GnRH) neurons in the ovariecto-
ovarian failure and the absence of negative feedback
mized rats (35). In another study, acupuncture was found
from the ovary (27). Atresia of the follicular apparatus,
in particular the granulosa cells, results in the reduced
ovariectomy in rats through modulating the blood E2
production of estrogen and inhibin, which leads to the
levels (37). Acupuncture may improve the function of the
reduced inhibin levels and the elevated FSH levels, a
hypothalamic-pituitary-ovarian axis, increase blood adre-
cardinal sign of menopause (27). Correlations between
nogenous androgen level and facilitate its transformation
endocrine levels and symptom severity ratings over time
into estrogen by aromatic enzyme in the brain, liver and
revealed that hot flash severity was significantly and
positively related to FSH (28). Investigations of hormo-
The present study showed that acupuncture and auric-
nal connections between hot flash severity and reproduc-
ular acupressure significantly relieve the severity and
tive hormones in Study of Women’s Health Across the
frequency of menopausal hot flashes. The levels of FSH
Nation (SWAN), Melbourne Midlife Women’s Health
decreased significantly and the level of E2 increased
Project (MMWHP) and Penn Ovarian Aging Study
significantly in both of the two groups after treatment.
cohorts found that decreased serum E2 and increased
As the increased levels of FSH and the lowered level of E2
serum FSH were associated with the increases in hot
are mainly associated with hot flashes during the
flash severity (29–31). In an analysis of SWAN data,
menopausal transition (29–31), it may be partly through
which modeled the effects of FSH and E2 (and other
decreasing the levels of FSH and increasing the levels of
reproductive hormones) together, Randolph and collea-
E2 that acupuncture and auricular acupressure alleviate
gues noted that FSH was associated with hot flash
the severity and frequency of menopausal hot flashes of
the bilaterally ovariectomized Chinese women. In com-
It is well known that acupuncture is associated with
parison with HRT, although acupuncture did not change
homeostatic regulation, and possess effects such as
hormone levels as significantly as HRT in this study, the
buffering hormonal disturbance, modulating ovulation,
bilaterally ovariectomized women’s own functions may be
as well as improving psychological or behavioral abnor-
regulated with the use of acupuncture, while HRT restores
mity (32–34). Acupuncture in specific acupoints has been
the body’s hormone level by exogenous hormones.
found to significantly increase blood concentrations of E2
The protocol of the acupuncture treatments comes from
in the ovariectomized rats (35), while reducing the
a combination of literatures and clinical experiences.
Acupuncture and auricular acupressure in relieving menopausal hot flashes
There is no corresponding name to menopausal hot
acupuncture treatment was also found to significantly
flashes in ancient books of traditional Chinese medicine
decrease the severity of hot flashes in symptomatic post-
(TCM). Based on Zang-fu organs in TCM, disorders of
menopausal women when compared with placebo acu-
the kidney and liver are generally considered as the main
puncture of equal duration (23). Another study showed
pathogenesis. According to the principle of reinforcing
that acupuncture and applied relaxation significantly
the kidney and regulating the liver, the main acupoints
reduced the number of menopausal hot flashes (22).
selected were Sanyinjiao (SP6), Fengchi (GB20), Hegu
The present study showed that acupuncture and auricular
(LI4), Quchi (LI11), Guanyuan (CV4), Dazhui (GV14),
acupressure significantly relieve the severity and fre-
Fuliu (KI7) and Zigong (EX-CA1). Among them,
quency of menopausal hot flashes. However, as the
Sanyinjiao (SP6), Fengchi (GB20), Hegu (LI4) and
sample size of the present study was small and the sham-
Quchi (LI11) have been selected as the main acupoints
acupuncture was not used, the conclusion may be
in most of the clinical researches on menopausal hot
flashes (19,23). Sanyinjiao (SP6) is an important acupoint
Although the double-blind randomized controlled trial
to treat disorders of the spleen, liver and kidney (41).
(RCT) has been known as the gold standard in clinical
It is able to soften and harmonize the Liver and to
researches, the biggest challenges and the difficulties to
benefit the kidney Qi, based on the ancient classics of
the researchers in the fields of clinical acupuncture and
acupuncture (42). Fengchi (GB20) works to regulate the
moxibustion are the design of an ideal placebo-control
function of liver and remove heat from the head and eye,
method and the credibility and ethics behind sham
based on the ancient acupuncture records and the
acupuncture (47–52). An ideal acupuncture placebo that
Meridian Theory of TCM (41). Hegu (LI4) functions to
avoids the necessity of penetration of the skin and shows
clear heat in the Upper and Middle Jiao (41). Quchi
the same psychological impact has not yet been found.
(LI11) has been acknowledged to produce hypothermia in
A study has shown that for non-drug interventions
normal subject (42). Guanyuan (CV4) is an important
including acupuncture, it was difficult to establish a
acupoint on the Conception Vessel and functions to
placebo or sham control that is both inert and indistin-
reinforce kidney Qi and replenish Qi and blood (41).
guishable (53). It concluded that although randomized
Sanyinjiao (SP6) and Guanyuan (CV4) have been found
trials investigating the specific effects of acupuncture
to increase the gonadal hormone levels (43). Dazhui
have used a great variety of sham interventions as
(GV14) has been found to produce hypothermia in
controls, the sham interventions as ‘placebo’ controls
normal adult (44). Fuliu (KI7) can regulate kidney Qi
seem misleading and scientifically unacceptable (53).
and sweating (41). Zigong (EX-CA1) is an important
Another study demonstrated that the control interven-
empirical one for treating female disorders (41).
tions were equally as effective as acupuncture in
According to the theory of TCM, all channels of the
alleviating pain in conditions that are predominantly
body and all 12 meridians are closely connected with
associated with affective components such as migraines
the ear (45). The earliest record of ear acupuncture is
or lower back pain, but not those with a more pro-
in Huangdi Neijing (The Yellow Emperor’s Classic ofInternal Medicine). In the famous Chinese medical
nounced sensory component, such as osteoarthritis of
classics, a great number of acupuncture treatments were
the knee or lateral epicondylalgia (54). Some previous
summarized, among which, there are the specific acu-
research also showed that nearly 40% of the participants
puncture points on the external ear for relief of certain
in clinical research were able to detect a difference
disorders. Auricular acupressure could associate the
between the active and placebo needles at active points
meridians of the body, regulate Qi and activate blood,
(55). In a clinical study on the effect of acupuncture in
regulate Zang-fu organs and promote good metabolism
treating post-menopausal hot flashes, although they
according to the Meridian Theory of TCM (45). There
combined the use of placebo needles with sham points
are 200 acupoints on the outer ear. Auricular acupres-
in the placebo treatment, a difference in the patients’
sure’s effectiveness and non-invasiveness make it easily
accepted by both patients and doctors (45,46). Auricular
considered finding an optimal placebo for acupuncture
acupressure works by stimulating the central nervous
remained a challenge for future studies (23). In addition,
system through the cranial and spinal nerves on the
as most of the middle-aged Chinese people have had
auricle of the ear. This stimulation results in increasing
experiences receiving acupuncture treatments, it is even
neurotransmitters within the pituitary and spinal cord of
more difficult to simulate real acupuncture in clinical
the central nervous system (45). All the auricular acu-
researches. This is why the study did not attempt to use
points selected in the study were associated with enforc-
sham-acupuncture as a control. Although this may
ing kidney Qi and regulating liver Qi.
introduce bias into trials, extensive details regarding the
Acupuncture has been found to significantly reduce the
baseline characteristics of the recruited women were
severity of nocturnal hot flashes in post-menopausal
collected before treatment and between the two groups,
women (19). Standardized and individually tailored
no significant difference in the patients’ detailed baseline
characteristics existed. Further research with larger
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Received May 8, 2008; accepted January 12, 2009
ACTA DEL TRIBUNAL CALIFICADOR En la Sede Social del Consorcio de Transportes de Bizkaia sito en la c/. Ugasko. 5-bis-1º Dcha de Bilbao, siendo las 9.30 horas del día 17 de mayo de 2004, se reunió el Tribunal Calificador de la Oposición Concurso convocado para cubrir una plaza de Auxiliar Administrativo de Administración General Funcionario de Administración General, por el sis