The effect of acupuncture on postmenopausal symptoms and reproductive hormones: a sham controlled clinical trial
Didem Sunay,1 Muruvvet Ozdiken,1 Huseyin Arslan,2 Ali Seven,3 Yalcin Aral4
system, accompanied with a series of psycho-
Background Acupuncture is commonly used to
logical symptoms.1 Oestrogen, either by itself
or with progestins is the most consistently
gynaecological conditions. In this study, the authors
Ministry of Health, Ankara Training and Research Hospital,
aimed to investigate whether acupuncture has an
However, the Women’s Health Initiative and
effect on menopausal symptoms and to explore
Million Women Study have identiﬁ ed impor-
whether this effect is related to changes in hormone
tant risk factors (coronary heart disease, stroke,
breast and endometrial cancer) associated
with hormone replacement therapy (HRT).3–6
Materials and methods A total of 53
postmenopausal women were alternately assigned
Those ﬁ ndings have led to an expanded inter-
into two treatment groups: acupuncture (n=27)
est in non-hormonal therapies for managing
symptoms were assessed using the Menopause
only limited data to support their use. The
Rating Scale (MRS). The serum oestradiol, follicular
common conclusion in reviews regarding to
stimulating hormone (FSH) and luteinising hormone
complementary and alternative therapies for
(LH) levels were measured at baseline and again
the management of menopause related symp-
after the fi rst and last sessions. The Student t test
toms was that the data were insufﬁ cient to
was used for normally distributed data and the
recommend any alternative therapy and fur-
Wilcoxon signed rank test for not normally
ther investigation was still needed.7 8 In the
distributed data. The group differences in MRS
area of complementary and alternative thera-
scores were assessed using non-parametric
pies, acupuncture and acupressure treatments
are promising, however, the results of pub-
Results After treatment, total MRS, and the
lished randomised controlled trials of the
somatic and psychological subscale scores were
effect of acupuncture on hormone levels and
signifi cantly lower in the acupuncture group than
the sham group (all p=0.001). The severity of hot
fl ushes was found to be signifi cantly decreased
after treatment in acupuncture group (p=0.001). In
the acupuncture group LH levels were lower and
multiple biological responses.16 17 These
oestradiol levels were signifi cantly higher than sham
responses can occur at or close to the site of
group (p=0.046 and p=0.045, respectively) after
application, or at a distance, mediated mainly
treatment, but there was no difference in FSH
by sensory neurons to many structures within
the central nervous system. This can lead to
Conclusion Acupuncture was effective in reducing
activation of pathways affecting various phys-
menopausal complaints when compared to sham
iological systems in the brain as well as in the
periphery. Stimulation by acupuncture may
alternative therapy in the treatment of menopausal
also activate the hypothalamus and the pitu-
itary gland, resulting in a broad spectrum of systemic effects. Alteration in the secretion of neurotransmitters and neurohormones and
changes in the regulation of blood ﬂ ow, both
Perimenopause syndrome, referred also as cli-
macteric syndrome, results from the changing documented.18of relationship among the hypothalamus,
pituitary and ovary during women’s ageing aimed to investigate whether acupuncture has process. Those changes take place ﬁ rst in the an effect on menopausal symptoms and to ovary, then in the hypothalamus and pituitary,
explore whether this effect is related to
which are reﬂ ected as the functional changes changes in levels of reproductive hormones. in the endocrinological and central nervous
Acupunct Med 2011;29:27–31. doi:10.1136/aim.2010.003285
Original paper MATERIALS AND METHODS
The secondary outcome measures were hormone lev-
After obtaining approval of the local ethical committee,
els. Hence, the baseline serum E2 (E2b), FSH (FSHb) and
56 postmenopausal women (50 naturally and six surgi-
luteinising hormone (LH; LHb) levels were recorded.
cally), who had been referred to the outpatient clinic of
These parameters were measured again after the ﬁ rst
menopause at Ankara Training and Research Hospital,
(E2fs, FSHfs, LHfs) and last sessions (E2ls, FSHls, LHls) to
Ankara, Turkey, between October 2009 and December
evaluate whether the effect of intervention was cumula-
2009, for follow-up or treatment and who agreed to par-
tive. The ﬁ rst session of interventions was applied 2–7 days
ticipate were included in this, single-blind, sham-con-
trolled study. All participants were informed about the
The acupuncture group received traditional Chinese med-
study and written consents were received. Participants
icine acupuncture twice a week for a total of 10 sessions by
were alternately assigned into two treatment groups: acu-
a licensed acupuncturist with 6 years experience. Sterile, dis-
puncture (n=28) and sham acupuncture (n=28). The age,
posable, silver needles with a length of 0.25×25 mm (Wujiang
menopausal age, body weight and height of all partici-
Jia Chan, Wujiang City, China) were used. The needles were
pants were recorded. Body mass index (BMI) was calcu-
inserted bilaterally at four acupuncture points (ST36, depth
lated by the formula body weight (kg)/height (m2).
1 cun; LI4, 0.5 cun; KI3, 0.2 cun; LR3, 0.3 cun) and also in the
The term postmenopausal was deﬁ ned as: 12 months
points EX-HN3 at 0.1 cun depth and CV3, 0.5 cun; de qi sen-
spontaneous amenorrhea for women who still had a uterus,
sation was obtained with manipulation and the needles
and serum oestradiol (E2) levels lower than 50 pg/ml and
were then left for 20 min without any manual or electrical
serum follicular stimulating hormone (FSH) levels higher
stimulation. The points were located by the acupuncturist
than 40 IU/ml for women who had surgical menopause
according to WHO Standard Acupuncture Point Locations
and had no uterus. None of the participants had taken HRT
Sham acupuncture was performed on the sham group
The primary outcome of the study was an assessment
twice a week for a total of 10 sessions at the same points
of improvement in menopausal symptoms. Hence, meno-
by the same acupuncturist. Sham acupuncture needles
pausal symptoms were assessed using an 11 item Turkish
developed by Streitberger and Kleinhenz22 (Asia Med,
version of the Menopause Rating Scale (MRS).19 20 Three
Munich, Germany) were used. The blunted needles were
aspects were assessed from the menopausal symptoms:
inserted by using an O ring and adhesive dressing to avoid
somatic (four items), psychological (four items) and uro-
penetration to the skin. No other interventions were
genital (three items) symptom complexes. A 5-point rating
scale allowed the women to describe the perceived sever-
In relation to the reproductive hormones, we hypothe-
ity of symptoms for each item (severity: 0=no complaints
sised that the interventions would be considered effective
to 4=very severe symptoms). The composite scores for
if FSH and LH levels decreased and oestradiol levels
each dimension (subscale) are based on adding the item
scores in the respective dimensions. The composite score
Data were analysed using SPSS V.12. G-Power V.3.1
(total score) is the sum of the dimension scores.
software was used to evaluate sample size and power of
• Received allocated intervention (n=28)
• Received allocated intervention (n=27)
• Did not receive allocated intervention (n=0)
• Did not receive allocated intervention (n=0)
Lost to follow-up (unable to contact) (n=1)
Discontinued intervention (private reasons)
Figure 1 Flow diagram of the progress through the phases of the randomised trail. Acupunct Med 2011;29:27–31. doi:10.1136/aim.2010.003285
the present study. Theoretical power was taken as 0.80 in
psychological and urogenital subscale scores (p=0.132,
planning the study and the power actually achieved was
p=0.066 and p=0.461, respectively). However, all subscale
calculated to be 0.71 at the end of the study. Descriptive
scores were signiﬁ cantly decreased after therapy in the
statistics were expressed as mean±SD for continuously
measured variables. Student t test was used for normally
When the severity of hot ﬂ ushes in somatic subscale
distributed data, and Wilcoxon signed rank test for not
was evaluated alone, a signiﬁ cant difference was found
normally distributed data for comparisons in dependent
between groups, with scores in the acupuncture group sig-
groups. The group differences in MRS scores were assessed
niﬁ cantly lower than the sham group (p=0.001) after the
using non-parametric Mann–Whitney U test. Multivariate
last session. For the within group changes in severity of
analysis with Bonferroni correction was used posthoc to
hot ﬂ ushes no signiﬁ cant difference was observed in the
explore changes in FSH levels. A pvalue of 0.05 was con-
sham group (p=0.317), but there was a signiﬁ cant decrease
The comparisons of hormone levels (baseline, after the
ﬁ rst and last sessions) of groups are shown in table 3. In
In the acupuncture group, one patient left the study for
the acupuncture group, FSHb levels were higher than
personal reasons, in the sham group, one patient did not
sham group before treatment (p=0.002), which was con-
come to follow-ups and one patient did not meet the
inclusion criteria (she had surgical menopause with FSH
FSH levels of the acupuncture group were higher than
levels lower than 40 IU/ml). Hence, the study was com-
the sham group (p=0.009) after the ﬁ rst treatment but not
pleted with 53 participants (27 in the study group, 26 in
at the end of the course of acupuncture (p=0.659). LH lev-
the sham group) analysed (ﬁ gure 1). No adverse effects
els in the acupuncture group were signiﬁ cantly lower after
were observed in any of the patients.
the ﬁ rst treatment (p=0.036) and also at the end of the
The groups were similar in terms of mean age, mean
course (p=0.046). Oestrogen levels were signiﬁ cantly
menopausal age and mean duration of menopause higher than in the sham group at the end of treatment (p=0.633, p=0.991 and p=0.760, respectively). Mean BMI
of the groups were also similar (p=0.186) (table 1).
Considering the changes within the groups before and
The MRS scores for the two groups are shown in table 2.
after interventions, no signiﬁ cant differences were found
When total MRS scores of the groups were compared, no
between FSHbs and FSHls, LHb and LHls, E2b and E2ls
differences were found between the total scores of the
levels in acupuncture and sham groups (p=0.853, p=0.245,
groups after the ﬁ rst session (p=0.115), but the total score
p=0.138, p=0.043, p=0.904 and p=0.695, respectively).
of the acupuncture group after the last treatment was sig-niﬁ cantly lower than the sham group (p=0.001). The uro-
genital subscale and hot ﬂ ush severity scores were In the present study, total MRS scores as well as somatic signiﬁ cantly different between groups at baseline, which
and psychological (but not urogenital) subscale scores of
was considered a random ﬁ nding. Somatic subscale scores
acupuncture group were lower than sham group after
after the ﬁ rst and last sessions were signiﬁ cantly lower in acupuncture group than the sham group (both p=0.001). The psychological subscale scores after the ﬁ rst session
Table 2 Menopause Rating Scale scores of the two groups
were similar in the two groups (p=0.626) whereas the scores after the last session were signiﬁ cantly lower in
acupuncture group than placebo group (p=0.001).
Urogenital subscale scores of the groups were no different
after the ﬁ rst and last sessions (p=0.447 and p=0.153,
When the scores were compared before and after the
interventions (within groups), no signiﬁ cant differences
were found in sham group in terms of somatic, Psychological
Table 1 The mean age, menopausal age, duration of
menopause and mean body mass index (BMI) of the groups
Acupuncture Mean±SD Mean±SD (Min–Max) (Min–Max)
bs, baseline; fs, fi rst session; ls, last session. Acupunct Med 2011;29:27–31. doi:10.1136/aim.2010.003285
Original paper Table 3 Hormone levels of groups at baseline and after the fi rst and the last sessions Acupuncture Mean±SD (Min–Max) Mean±SD (Min–Max)
Follicular stimulating hormone (FSH) FSH bs
*Multivariate analysis: no signifi cant effect of time (p=0.464) or group × time interaction (p=0.659). bs, baseline; fs, fi rst session; ls, last session.
treatment. LH levels were reduced and oestradiol levels
symptoms, such as vasomotor symptoms and vaginal or
were raised after treatment with acupuncture group, but
genital dryness, but also contributed to treatment-related
those we believe that those changes in hormone levels are
effects, such as bleeding and breast tenderness.26 27 Also
not sufﬁ ciently large to explain the changes in symptoms.
different results have been reported in studies comparing
Most acupuncture studies in this topic have used similar
HRT with acupuncture for the treatment of menopausal
time frames for acupuncture sessions, but it is not clear
symptoms. In some of those, it was reported that symp-
whether the length of time chosen for treatment was suf-
toms decreased signiﬁ cantly with both treatments,11 28 in
ﬁ cient to reﬂ ect acupuncture’s complete effect. Therefore
some of them better results with HRT,10 and in others
we assessed MRS scores and the hormone levels after the
with acupuncture12 13 have been reported.
ﬁ rst session of interventions, to explore whether the effect
Among menopausal symptoms, the most prominent
of acupuncture was cumulative: we found that the differ-
symptom—and the one on which most studies have been
ences were greater after the last session than the ﬁ rst
conducted—is hot ﬂ ushes. The symptoms are characteris-
tic of a heat-dissipation response and consist of sweating
It was suggested in 1976 that acupuncture stimulation in
on the face, neck and chest, as well as peripheral vasodila-
normal ovulatory women may affect endocrine func-
tion. Although hot ﬂ ushes clearly accompany oestrogen
tions.23 Later, the effect of acupuncture on ovulation induc-
withdrawal at menopause, oestrogen alone is not respon-
tion was investigated by Yu et al24 who found that ovulation
sible since levels do not differ between symptomatic and
was induced in ﬁ ve of 11 women with chronic anovula-
asymptomatic women. Until recently, it was thought that
tory cycles, three of whom conceived. However, different
hot ﬂ ushes were triggered by a sudden, downward reset-
results have been reported in studies examining the effect
ting of the hypothalamic thermoregulatory set-point, since
of acupuncture on postmenopausal hormone levels. In
there was no evidence of increased core body tempera-
some studies, where different acupuncture techniques and
ture. Evidence obtained using a rapidly responding
different HRT procedures were applied, signiﬁ cantly
ingested telemetry pill indicates that the thermoneutral
decreased FSH and LH levels and increased oestradiol lev-
zone, within which sweating, peripheral vasodilation and
els were reported with acupuncture10–12 15 while in some, a
shivering do not occur, is virtually non-existent in symp-
signiﬁ cant decrease in menopausal symptoms but no tomatic women but normal in asymptomatic women. The change in hormone levels were reported.9 Especially in
results suggest that small temperature elevations preced-
studies with electroacupuncture, more signiﬁ cant results
ing hot ﬂ ushes acting within a reduced thermoneutral
were obtained in hormone levels.12 25 Since we observed
zone constitute the triggering mechanism. Central sympa-
small changes in hormone levels similar to some studies,
thetic activation is also elevated in symptomatic women,
we speculate that acupuncture might have an effect on
which reduces the thermoneutral zone in animal studies.
reproductive hormones through some mechanisms that
Oestrogen virtually eliminates hot ﬂ ushes but its mecha-
we could not explain. It is certain that further studies are
nism of action is not known.29 Acupuncture has been sug-
gested as an alternative to HRT, based on the fact that
In the present study somatic, psychological and urogen-
acupuncture increases central β-endorphin activity and
ital symptom subscale scores of MRS decreased with acu-
therefore may make the thermoregulation more stable
puncture therapy. In studies that have investigated the
and decrease hot ﬂ ushes and sweating.28 In some studies
effect of HRT in treatment of menopausal symptoms, it
signiﬁ cant decrease has been reported not in frequency
was reported that HRT relieved some menopausal but in severity of hot ﬂ ushes with acupuncture.14 30 Like
Acupunct Med 2011;29:27–31. doi:10.1136/aim.2010.003285
several other studies, in this study the severity of hot
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Ethics approval This study was conducted with the approval of the local ethical
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Provenance and peer review Not commissioned; externally peer reviewed.
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