Using Traditional Acupuncture for Breast Cancer-Related
Hot Flashes and Night Sweats
Beverley A. de Valois, PhD,1Teresa E. Young, BSc,1Nicola Robinson, PhD,2
Christine McCourt, PhD,3and Elizabeth J. Maher, FRCR, FRCP1
Objectives: Women taking tamoxifen experience hot flashes and night sweats (HF&NS); acupuncture may offer
a nonpharmaceutical method of management. This study explored whether traditional acupuncture (TA) could
reduce HF&NS frequency, improve physical and emotional well-being, and improve perceptions of HF&NS.
Design/settings/location: This was a single-arm observational study using before and after measurements,
located in a National Health Service cancer treatment center in southern England.
Subjects: Fifty (50) participants with early breast cancer completed eight TA treatments. Eligible women were
?35 years old, ?6 months post active cancer treatment, taking tamoxifen ?6 months, and self-reporting ?4
HF&NS incidents/24 hours for ?3 months.
Interventions: Participants received weekly individualized TA treatment using a core standardized protocol for
treating HF&NS in natural menopause.
Outcome measures: Hot Flash Diaries recorded HF&NS frequency over 14-day periods; the Women’s Health
Questionnaire (WHQ) assessed physical and emotional well-being; the Hot Flashes and Night Sweats Ques-
tionnaire (HFNSQ) assessed HF&NS as a problem. Measurements taken at five points over 30 weeks included
baseline, midtreatment, end of treatment (EOT), and 4 and 18 weeks after EOT.
Results for the primary outcome: Mean frequency reduced by 49.8% (95% confidence interval 40.5–56.5,
p<0.0001, n¼48) at EOT over baseline. Trends indicated longer-term effects at 4 and 18 weeks after EOT. At
EOT, seven WHQ domains showed significant statistical and clinical improvements, including Anxiety/Fears,
Memory/Concentration, Menstrual Problems, Sexual Behavior, Sleep Problems, Somatic Symptoms, and Va-
somotor Symptoms. Perceptions of HF&NS as a problem reduced by 2.2 points (standard deviation¼2.15,
n¼48, t¼7.16, p<0.0001).
Conclusions: These results compare favorably with other studies using acupuncture to manage HF&NS, as well
as research on nonhormonal pharmaceutical treatments. In addition to reduced HF&NS frequency, women
enjoyed improved physical and emotional well-being, and few side-effects were reported. Further research is
warranted into this approach, which offers breast cancer survivors choice in managing a chronic condition.
cancer, used to prevent recurrence.1Hot flashes and night
sweats (HF&NS) are the most frequently occurring side-
effects,2,3with up to 80% of women taking tamoxifen
reporting them as troublesome.4With nearly 46,000 new di-
agnoses of breast cancer annually in the United Kingdom and
djuvant hormonal treatments such as tamoxifen are
over 1 million worldwide,5the problem of HF&NS is wide-
spread, with estimates of over 100,000 women in the UK ex-
periencing these symptoms at any given time.
Hot flashes are experienced as subjective sensations of
heat, whose intensity, duration, and associated symptoms
vary according to the individual. A feature of natural men-
opause, the mechanism of HF&NS is not fully understood.
Estrogen withdrawal or reduction, changes in gonadotro-
phin levels, and the action of catecholamines are implicated
1Supportive Oncology Research Team (SORT), Lynda Jackson Macmillan Centre (LJMC), Mount Vernon Hospital, Middlesex, United
2Centre for Complementary Healthcare and Integrated Medicine, Thames Valley University (TVU), Middlesex, United Kingdom.
3Faculty of Health & Human Sciences, Thames Valley University (TVU), Middlesex, United Kingdom.
THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 16, Number 10, 2010, pp. 1047–1057
ª Mary Ann Liebert, Inc.
but no clear mechanisms have been identified.6–8Biological
and psychologic factors such as cultural factors, environ-
ment, and stress may also act as triggers, adding layers of
complexity to the pathophysiology.6,9,10Wide variations in
the manifestation of HF&NS associated with natural meno-
pause make it difficult to identify general population pat-
terns: Prevalence ranges from 24% to 93% in the United
States and northern Europe have been reported.7Frequency
and severity vary from woman to woman, and may fluctuate
within individuals as they progress through the menopause
transition. The challenges of managing and measuring these
variable and subjective symptoms are well documented.6,11
Breast cancer survivors experience HF&NS more fre-
quently than women in natural menopause, and these cancer-
related flashes may be more severe, distressing, and of greater
duration.12,13Occurrences may be accompanied by a range of
physical sensations, including sweating, flashing or redness,
palpitations, dizziness, feelings of suffocation, nausea, tingl-
ing sensations in the hands, and chills before or after the flash.
Accompanying emotional symptoms may include anxiety,
feelings of panic, irritation, annoyance, frustration, and even
suicidal feelings. Night sweats disturb sleep patterns, leading
to fatigue and irritability.6,11HF&NS are disabling and so-
cially embarrassing; their effect on quality of life is serious
and often under-rated.8
In patients with breast cancer, HF&NS may occur re-
gardless of the woman’s natural menopause status: Young
women may experience menopausal symptoms prematurely;
women whose cancer diagnosis coincides with their meno-
pause may have exacerbated symptoms; and postmeno-
pausal women may experience an unwelcome return of
symptoms. Tamoxifen users are often advised that their
symptoms will diminish over time.14,15However, studies
show that women suffer uncomfortable levels of HF&NS at
an average of 3 years into the typical 5-year period of ta-
moxifen therapy,4and these symptoms may continue after
completion of the therapy.16While not life-threatening,
HF&NS may cause nonadherence to adjuvant hormonal
therapy, potentially compromising long-term survival.17
Although hormone replacement therapy (HRT) is consid-
ered the most effective treatment for managing menopausal
symptoms,18its long-term use is controversial, with fears that
it may lead to increased risk of breast cancer, thromboembo-
lism, and endometrial cancer19,20and to increased risk of re-
currence in patients with breast cancer.21Women diagnosed
with breast cancer are usually advised to stop taking HRT,19
and many women stop voluntarily when they receive a breast
cancer diagnosis.22In light of this, women and their medical
professionals are eager to seek alternative means of addres-
sing HF&NS.19,23A range of pharmacological preparations
have been investigated, including antidepressants (especially
the selective serotonin reuptake inhibitors (SSRIs) such as
venlafaxine and paroxetine), antihypertensives such as cloni-
dine, and the anticonvulsant gabapentin.8,23
Many women do not wish to experience further side-
effects of pharmacological preparations, or they simply do
not wish to take medication additional to their adjuvant
hormonal therapy.4For these women, complementary and
alternative medicine approaches may offer choices and may
include vitamin E, plant-derived remedies such as soy and
clover isoflavones, alfalfa, relaxation, cognitive behavioral
treatment, exercise, and lifestyle changes.4,8,24
The treatment of menopausal symptoms is discussed in
the literature of Chinese medicine,24–28and the results of a
number of controlled studies suggest that acupuncture
may be beneficial for managing HF&NS in natural meno-
pause.29–34Therefore, acupuncture might also offer the pos-
sibility of managing HF&NS related to adjuvant hormonal
treatment, and the aim of this study was to investigate this.
At the time of the design of this study, the literature on
using acupuncture to manage HF&NS in women with breast
cancer comprised mainly uncontrolled studies, including
Tukmachi’s35,36case series of 22 women treated with acu-
puncture, diet, and lifestyle; Cumins and Brunt’s37trial of
26 patients (abstract only); and Towlerton’s38study of 12
women treated with semipermanent indwelling studs. More
recently, a number of studies using a range of methods have
contributed to the literature in this area39,40including Por-
zio’s41pilot study using acupuncture to treat 15 women
taking tamoxifen and Filshie’s42audit of long-term man-
agement of vasomotor symptoms using acupuncture and
Nedstrand’s43comparison of electro-acupuncture with re-
laxation (n¼31); Deng’s44comparison of ‘‘true’’ and ‘‘sham’’
acupuncture (n¼72); Frisk’s45long-term follow-up of a
comparison of electro-acupuncture with HRT (n¼45), and
Hervik’s46comparison of traditional Chinese and sham
acupuncture (n¼59). While there are many methodological
problems with these studies, including their small size and
the challenge of finding appropriate placebo controls, there is
consensus that the use of acupuncture in this area warrants
This research investigates whether the traditional acu-
puncture (TA) protocols used to treat the symptoms of nat-
ural menopause could be applied to management of
tamoxifen-related HF&NS. At the time of this study, ta-
moxifen was the criterion standard for preventing recurrence
(although it has been augmented by the aromatase inhibitors
[AIs] for postmenopausal women, and it remains the drug of
choice for the premenopausal). The main research questions
were as follows:
1. Can TA be used to manage HF&NS that are a side-
effect of tamoxifen as an adjuvant treatment for early
2. Does TA affect the overall physical and emotional well-
being of the recipient?
The purpose of the study was to systematically measure
the effects in both the short and longer-terms, to obtain a first
measure of this approach, and to test the suitability of the
outcome measures. It was hypothesized that using TA could
reduce the frequency of hot flashes by 50% at the end of eight
treatments in one third of the study participants, and that
participants would show overall improvements in physical
and emotional well-being.
Materials and Methods
This study is a prospective single-arm observational study
using before and after measurements. It accords with stages
0–2 of the Medical Research Council’s guidelines for devel-
oping and evaluating complex interventions.47,48Participants
attending for eight sessions of TA, delivered on a once-
1048 DE VALOIS ET AL.
weekly basis, were monitored for 30 weeks during which
there were five measurement points: 2 weeks before treat-
ment commenced (Baseline), after the fourth acupuncture
treatment (Mid-tx), at the end of treatment (EOT), 4 weeks
after EOT (Post tx 4), and 18 weeks after EOT (Post tx 18)
(Fig. 1). This permitted measurement of any short and
longer-term effects; however, our primary outcome mea-
surement point was EOT.
The West Hertfordshire Hospitals NHS Trust Local Re-
search Ethics Committee granted ethical approval, and the
study was carried out in the cancer drop-in center associated
with Mount Vernon Cancer Centre (MVCC) in Northwood,
Middlesex, England. Participants were recruited over a 19-
month period from March 2001 through September 2002.
HF&NS frequency was the primary outcome measure,
collected using paper-based hot flash diaries. Designed
in-house, the diary took the form of a small booklet that
showing measurement points.
EOT, end of treatment.
ACUPUNCTURE AND TAMOXIFEN-RELATED HOT FLASHES1049
allowed for 24-hour-a-day recording, for a period of 14 days
per diary. Participants were instructed to record every
HF&NS incident, ideally as it happened.
There is debate about whether objective measures provide
more accurate data about HF&NS than subjective self-
reports.49Objective measures that register changes in skin
temperature, core body temperature, and sweat rates require
use in a controlled, laboratory environment, usually for short
periods oftime.50Thisrestrictedmonitoring time doesnot give
information about ‘‘real-life’’ circumstances, or patterns of
flashing over time. Self-reported measures are perceived by
at night as well as during waking hours,49,51and evidence
of false-positive rates compared with objective measures.12
However, researchers at the Mayo Clinic, after conducting
several clinical studies into HF&NS, argue that daily diaries
exhibit consistency and reliability, with few missing data.52
Physical and emotional well-being were measured using
two validated questionnaires: the Women’s Health Ques-
tionnaire (WHQ) and the Hot Flashes and Night Sweats
The WHQ is a self-administered health-related quality-of-
life measure, designed to assess physical and emotional well-
being in women from the ages of 45–65 undergoing the
natural menopausal transition.54Its 36 statements are di-
vided into the nine domains or subscales shown in Table 1.
Respondents indicate their agreement with the statements
using a 4-point Likert scale. Responses are calculated as
described in the WHQ Women’s Health Questionnaire User
Guide.55The result is a 10-point scale from 0.00 to 1.00, with
lower scores indicating better quality of life, and higher
scores signifying more serious symptoms. Test–retest is re-
liable across a 2-week time interval. The WHQ is sensitive to
change, and a meaningful clinically significant change on the
subscales is a difference of 0.10 to 0.20.54
The HFNSQ is designed to measure the subjective re-
sponses of women to their HF&NS.4,9From it, the Problem
Rating Score (PRS) is derived, using the mean of the sum of
three 10-point scales (problem factors) on which women rate
how much they regard their HF&NS as a problem, how
much distress they cause, and how much they interfere with
daily life. The PRS is a more reliable indicator than hot flash
frequency of how bothersome women find their HF&NS,
and a change of 2 points is clinically significant (M. Hunter,
personal communication, January 8, 2010). Test–retest reli-
ability is high across a 2–3-week interval.9
The frequency of measurements is illustrated in Figure 1.
Three (3) other semistructured questionnaires, designed to
elicit written feedback from participants about their experi-
ence of having acupuncture and participating in the study,
were administered at EOT, Post tx 4, and Post tx 18.
Study population/patient eligibility
The study was open to women taking tamoxifen as adju-
vant treatment for early breast cancer treated at MVCC.
Eligibility criteria included patients aged 35 years or older
with breast cancer; 6 or more months post active cancer
treatment (surgery, chemotherapy, radiotherapy); without
relapse or metastatic disease; taking tamoxifen for 6 or more
months; experiencing HF&NS for 3 or more months and self-
reporting an average of 4 or more HF&NS per 24-hour pe-
riod; and able to speak, read, and understand English.
Concomitant preparations for relieving HF&NS, whether
prescription or over-the-counter, were allowed provided the
participant had taken them for at least 3 months before
joining the study and intended to continue taking them for
the duration of their involvement. Women with advanced
disease were excluded.
Referrals were through the oncology consultant, breast care
nurse, or self-referral via the drop-in center. The research
acupuncturist (BdV) screened referrals by telephone, and sent
eligible women a participant information sheet explaining the
study. Prospective participants attended an intake interview
and signed a consent form after theinterventionand the study
were clarified for them. The research acupuncturist adminis-
tered the baseline questionnaires (including baseline medical
and sociodemographic details), set up future appointments,
and gave the participant a Hot Flash Diary to keep until the
first treatment 2 weeks later.
Table 1. Women’s Health Questionnaire (WHQ) Results for the Primary Measure,
End of Treatment (EOT) Over Baseline
BaselineEOT Paired differences (baseline—EOT)Paired samples t-tests
WHQ scaleMean SDN¼
SD, standard deviation; CI, confidence interval; LL, lower limit; UL, upper limit; ANX, Anxiety/fears; ATT, Attractiveness; DEP, Depressed
Mood; MEM, Memory/Concentration; MEN, Menstrual Symptoms; SEX, Sexual Behavior; SLE, Sleep Problems; SOM, Somatic Symptoms;
VAS, Vasomotor Symptoms.
1050DE VALOIS ET AL.
The acupuncturist practiced ‘‘integrated’’ acupuncture, a
style used extensively in the UK, which draws on both Eight-
principles and Five Elements theoretical frameworks of
TA.56She developed a protocol based primarily on Eight-
principles theories for treating natural menopause symptoms
because there was scant information concerning tamoxifen-
related HF&NS in the literature. The protocol assumed
Kidney Yin Deficiency as the root of the hot flashing,25,26,57
and it included strategies for managing night sweats,26,28,58
and to clear Heat and resolve Damp, which contemporary
colleagues observed to be associated with tamoxifen (G.
Maciocia, personal communication 26 October 26, 1999 and
T. Alræk, personal communication, January 22, 2001).
Drawing on the Five Elements theoretical framework, the
first treatment was an Aggressive Energy (AE) Drain. In
some schools of Five Elements practice, this is the first
treatment administered, and is especially indicated for pa-
tients who have had serious or life-threatening disease, in-
tensive drug therapies, or intense emotions over a period of
time, all of which may apply to women who have been di-
agnosed with and treated for breast cancer.57,59
There is often an expectation in research that acupuncture
protocols will use a fixed or limited set of points; however,
we felt it was important to capture the flexibility of practice
that is characteristic of TA in a usual clinical setting. Thus,
although there was a core protocol at the heart of this ap-
proach, there was also the option to use points for the indi-
vidual participant. The core protocol comprised two steps:
? Treatment 1: AE Drain
? Treatments 2 - 8: Treat HF&NS
Treatments 2–8 were supplemented with acupuncture
points selected for the individual according to traditional
Table 2 shows the treatment principles, points and pro-
cedures used in the core protocol.
The first treatment, lasting 2 hours, comprised taking a full
case history including pulse and tongue diagnosis, after
which the AE Drain was administered. The acupuncturist
analyzed the case history to determine the individualized
points for the patient, and administered these at subsequent
treatments in addition to the core protocol. Individualized
points could be changed as the participant progressed
through treatment. In addition, and according to usual TA
practice, guidance for improving health through practices for
daily living was provided. Advice was given as appropriate
for the individual participant, and addressed a range of as-
pects including eating habits, rest, exercise, and managing
stress.58,59Succeeding treatments lasted 1 hour, and there
was no attempt to limit the therapeutic relationship (estab-
lishing good rapport with the patient is considered an es-
sential part of Five Elements acupuncture).59
Quantitative data were entered into SPSS version 13.
Using data recorded over 14 days in the Hot Flash Diary, the
mean and the median number of HF&NS per day was cal-
culated for each participant at each measurement point.
Missing data were imputed where at least 50% of the data
had been collected and the data appeared to be missing at
random (de Valois B 2006, unpublished PhD thesis).60The
individual participant means were not normally distributed,
Table 2. Treatment Principles, Points, and Procedures for Core Protocol
Treatment 1: Aggressive energy drain
Bl 13 Feishu
Bl 14 Jueyinshu
Bl 15 Xinshu
Bl 18 Ganshu
Bl 20 Pishu
Bl 23 Shenshu
Plus 3 check needles
Insert needles bilaterally using superficial insertion. Do not obtain de qi.
Insert 3 check needles into the muscle nearby, one for each ‘‘group’’ of needles.
Observe for signs of erythema around the needles. Leave all needles for 20 minutes,
or until erythema disappears.
Treatments 2–8: Treat hot flashes and night sweats
Treatment principlePoints Methods
Nourish Kidney Yin Lu 7 Lieque
Kid 6 Zhaohai
Ren 4 Guanyuan
Sp 6 Sanyinjiao
Insert all needles using even technique, and obtain de qi.
All points are used unilaterally.
Stop night sweats He 6 Yanglao
Kid 7 Fuliu
Open the Ren Mai (Directing Vessel): Insert needle into Lu 7 first,
on the side not affected by breast cancer, then Kid 6 on the
opposite side. Retain for a total of 20 minutes.
Clear HeatLI 11 Quchi
Once Lu 7 and Kid 6 are inserted, needle the remaining points.
Do not manipulate the needles.
Resolve DampSp 6 Sanyinjiao
Lu 7 Lieque
LI 11 Quchi
After the 20 minutes, remove all needles. Kid 6 is penultimate
needle removed, and Lu 7 the last.
ACUPUNCTURE AND TAMOXIFEN-RELATED HOT FLASHES 1051
showing a positive skew. Thus, for descriptive purposes the
median data were used, and the mean and median were then
calculated for all participants. Log transformation of the
means for each participant produced a normal distribution,
allowing parametric t tests to be used for comparison with
baseline scores.61,62Data from the WHQ and HFNSQ were
analyzed using Student’s t-tests.
The primary measure was the change in HF&NS fre-
quency at EOT over baseline. We were also interested in
short- and long-term effects, and in this article we present
HF&NS data from all measurement points. WHQ and
HFNSQ data at EOT are also presented, and the data from
the remaining measurement points are detailed elsewhere
(de Valois B 2006, unpublished PhD thesis).
Study participant characteristics
Of the 54 women recruited, 50 completed the course of
eight TA treatments. Two (2) did not proceed beyond the
intake interview (1 stopped taking tamoxifen, the other chose
not to continue beyond the interview); 1 withdrew after three
treatments, citing transportation problems, and 1 after six
treatments, giving no reason. Fifty-two (52) participants
completed baseline questionnaires, 48 completed Mid-tx and
EOT measurements, and 47 completed Post tx 4 and Post tx
18 follow-up questionnaires. The mean age at baseline was
54.3 years (standard deviation [SD]¼7.9, range 37–68). The
mean time since breast cancer diagnosis was 1.9 years
(SD¼0.9, range 1.0 – 4.7), and since starting tamoxifen the
mean time was 1.7 years (SD¼0.9, range 0.5 – 4.6). Table 3
displays the demographic and clinical data for the 52 women
verse effects reported or observed. Mild discomfort on nee-
dling, occasional bleeding or mild bruising at needle sites,
and tiredness after treatment especially in the early stages
were reported (de Valois B 2006, unpublished PhD thesis).63
These effects are consistent with the findings of a large
acupuncture safety study.64
Acupuncture was well tolerated, with few ad-
Hot flash and night sweat frequency.
mean, medians, and ranges of HF&NS per day over the 14
days at baseline and EOT for the 48 participants returning
diaries at EOT.
As discussed above, using log transformations to nor-
malize the data enabled the percentage change in HF&NS
frequency to be calculated. Table 5 shows the results for all
four measurement periods compared with baseline fre-
quencies. Data for the primary endpoint, the change at EOT
over baseline, are highlighted.
The hypothesis for this study was a reduction in HF&NS
frequency of 50% in 33.3% of participants at EOT. To test
this, we ranked the log transformed data per participant in
order of percentage change. This showed that 45.8% (22)
participants reported a reduction of ?50%, 39.6% (20) reported
a reduction of <50%, and 12.5% (6) showed no improvement.
Table 4 shows the
WHQ measurements at EOT.
for the nine domains of the WHQ at baseline and EOT, and
Table 1 shows the results
the paired differences show the changes at EOT over base-
line. Paired samples t tests indicate that at EOT there was a
significant change for all WHQ domains except Attractive-
Table 3. Demographic and Clinical
Characteristics at Baseline
Married (first marriage)
Living with partner
Less than compulsory school education
Compulsory school education
(e.g., school certificate, GCSEs)
Post compulsory school education
below university level
Current employment status
Not working at present
Working part time
Working full time
Cancer treatment history
Time taking tamoxifen
Perimenopause (last period within
Menopause (no period within
previous 1–5 years)
Postmenopause (no period in
over 5 years)
Participants using preparations
to manage HF&NS
Over the counter (including
evening primrose oil, black cohosh,
red clover, Menosan)
Participants with a history of:
Taking hormone replacement therapy
aBased on the stages of reproductive aging workshop (STRAW)
staging system (Soules et al., 2001).
GCSEs, general certificate of secondary education; HF&NS, hot
flashes and night sweats; SSRIs, selective serotonin reuptake inhibi-
tors; HRT, hormone replacement therapy.
1052DE VALOIS ET AL.
Problem rating score (PRS).
in the PRS. The mean difference in the score at EOT over
baseline was 2.22 (SD¼2.15, n¼48, t¼7.16, p<0.0001).
Figure 2 shows the change
The aims of this single-arm observational study were to
explore whether TA could be used to manage tamoxifen-
related HF&NS in women with early breast cancer, and to
identify whether TA treatment could affect physical and
emotional well-being. The data provide promising results,
with a mean reduction in frequency of HF&NS of nearly half
at the end of eight treatments and with 85.4% of participants
experiencing some degree of reduction. Data also indicate a
longer-term benefit, with HF&NS frequency maintaining a
reduction of over 41% at 4 and 18 weeks after EOT. Short-
term data recorded in the 2-week period after the fourth
treatment show that there is already a reduction of just over
40%, while the data at EOT demonstrated that continued
treatment brings a further 10% improvement.
The WHQ data indicate that participants experienced
improvements in a range of aspects of emotional and phys-
ical well-being. Statistically, all of the WHQ subscales except
Attractiveness showed significant improvements at EOT.
Clinically meaningful improvements were observed with
Sleep Problems, Memory/Concentration, Vasomotor Symp-
toms and Anxiety/Fears, Somatic Symptoms and Menstrual
Symptoms, and Sexual Behavior. The 2.2-point reduction in
the Problem Rating Score indicates that participants found
their HF&NS less bothersome, with a change of 2 points on
the scale being clinically significant.
This study has a number of strengths. It is the first study to
our knowledge to systematically measure the application of
a TA protocol based on the Chinese medicine theories of
natural menopause to pharmaceutically induced meno-
pausal symptoms. Although a core standardized protocol
was used, treatments were tailored to the individual partic-
ipants’ presenting symptoms and constitution. Allowing this
individualization, which accords with usual clinical prac-
tice,65was useful to address the variety of syndromes pre-
sented by the participants. As discussed previously, the core
protocol was designed to address Kidney Yin Deficiency,
widely regarded as the predominant syndrome underlying
menopausal hot flashes.66Clinically, a range of syndromes
were encountered, with Yang Deficiency (Kidney and/or
Spleen) presenting frequently, along with forms of Qi Defi-
ciency, Qi Stagnation, Blood Deficiency, and Shen Dis-
turbance. This clinical experience suggests that in designing
future trials, a wide range of syndromes should be accom-
modated in the study design. The incidence of Yang Defi-
ciency also indicates that applying moxibustion (the use of
heat generated by the herb Artemesia vulgaris to stimulate
acupuncture points), often contraindicated in the treatment
of hot flashes, is an appropriate treatment strategy for some
In this study, the wider effects of acupuncture treatment
on physical and emotional well-being were measured, ex-
tending its focus beyond changes in the main complaint only.
This is important, because acupuncturists and their patients
often report improvements in other symptoms and overall
well-being.68–70Additionally, trends suggest long-term im-
This study also shows that it is possible to recruit women
who have had invasive treatments for breast cancer to acu-
puncture studies.63Compliance with acupuncture treatment
suggests they found this intervention acceptable, and most
completed the course of treatments (de Valois B 2006, unpub-
lished PhD thesis).63Keeping repeated daily diaries of HF&NS
occurrence, as well as completing other questionnaires, is
that diary-keeping gave them a feeling of control, enabling
Table 4. Hot Flashes and Night Sweats Frequency
Per Day Over the 14-Day Measurement Periods
Baseline (n¼48) EOT (n¼48)
Mean (standard deviation)
95% Confidence interval
Median (interquartile range)
Minimum mean score
Maximum mean score
EOT, end of treatment.
Table 5. Reductions in Hot Flashes and Night Sweats
Frequency, Using Log Transformed Data
Lower Upper t¼
31.0% 50.0% 6.9 0.0001
40.5% 56.5% 8.7 0.0001
31.0% 49.5% 6.8 0.0001
lnBaseline - lnMid tx 48
lnBaseline – lnEOT
lnBaseline – lnPost
lnBaseline – lnPost
47 41.8% 29.1% 49.5% 6.0 0.0001
‘‘ln’’ as a prefix indicates the log transformed value. CI, confidence
interval; Mid-tx, fourth acupuncture treatment; Post tx 4, 4 weeks
after end of treatment (EOT); Post tx 18, 18 weeks after EOT.
Bolded data indicate the primary endpoint, the change at EOT
treatment (EOT) over baseline.
Changes in the Problem Rating Score at end of
ACUPUNCTURE AND TAMOXIFEN-RELATED HOT FLASHES1053
them to identify hot flash patterns and triggers, and to develop
their own strategies for dealing with them.
The data also contribute to what is known about HF&NS
experienced by women taking tamoxifen. Medical advice is
that symptoms will diminish over time; however, over half
of the participants had been taking tamoxifen for 1–2 years,
and a quarter of the participants on this study were still
experiencing uncomfortable levels of HF&NS during the last
3 years of the 5-year period of their adjuvant hormonal
treatment (Table 3). This confirms that for these women,
HF&NS are a chronic problem, requiring long-term man-
agement. Data collected in the diaries provides further in-
sight into the nature of tamoxifen-related HF&NS. As Table 4
shows, hot flash frequency varied widely across this sample,
ranging from an average of 3.5 to 35 incidents per day in the
2-week baseline measurement. This also suggests that wo-
men with relatively low numbers of flashes find them suf-
ficiently troublesome to seek remedies.
This was an early-stage observational study to evaluate
acupuncture as a complex intervention, to assess the feasi-
bility of this approach for a future randomized controlled
trial.47It has a number of limitations. Its single-arm design
does not control for placebo effects. The challenges of de-
signing appropriate placebo controls for acupuncture studies
are well documented: blinding of acupuncturists and par-
ticipants is problematic, as is finding an inert intervention
with which to compare the acupuncture. It is becoming
widely recognized that the variety of ‘‘sham’’ acupuncture
designs typically used in acupuncture research (from spe-
cially designed nonpenetrating needles to using non-
acupuncture points) generate physiologic effects, and are
therefore not truly inert.72–75Rigid adherence to double-
blinding and sham controls risks distorting acupuncture into
an artificial construct that no longer resembles ‘‘real-world’’
acupuncture, thereby providing research results that have
little clinical relevance.76,77Complementary medicine re-
searchers advocate pragmatic randomized controlled trials
(RCTs), which compare acupuncture treatment with the best
usual treatment for a condition, as an effective way of re-
taining the authenticity of practice and the complexity of the
therapeutic intervention, as well as maintaining scientific
rigor.78–80While pragmatic studies may be a way forward
for acupuncture studies, it remains a tendency for funding
organizations, ethics committees, and other evaluators of
research to insist on blinding and/or sham controls in acu-
puncture research design.81Influencing these views remains
a major challenge to acupuncture researchers.
Similarly, in this study there was no attempt to limit the
therapeutic relationship, also classically regarded part of the
placebo effect. The powerful effect of a strong practitioner–
patient relationship on symptom improvement has been
demonstrated with patients with irritable bowel syndrome,82
and is likely to be a component in the improvements in this
study. However, establishing rapport is an integral part of
many acupuncture styles practiced in the West. This study
aimed to assess normal acupuncture practice as a complex
intervention,76,78and it was not the intention to investigate
individual components of acupuncture treatment.
This study was conducted in a single acupuncture clinic,
which served a mainly white British patient group. They
were treated by a single acupuncturist (BdV) who was also
the investigator. Thus, generalizability of the study results to
the wider population of women with early breast cancer may
Furthermore, a number of study participants did not ad-
here to the study protocol of weekly acupuncture, sometimes
leaving gaps between treatments and extending beyond the
8-week period. Ensuring regular weekly treatment may have
improved the response; however, although future studies
should be designed so participants clearly understand the
need for regular treatment to optimize the effects, some
flexibility should be factored in to allow for life events that
prevent such regular treatment, such as bereavements, ill-
ness, surgery, and holidays—occurrences that interrupted
many participants’ progress through treatment.
Establishing the optimum dose is also an outstanding
issue. The literature does not indicate optimum treatment
frequency or duration, and future research could usefully
investigate increased frequency, as well as extending the
duration of treatment to determine whether the HF&NS
could be further reduced.83At the time of this study, ta-
moxifen was the criterion standard treatment for preventing
recurrence of breast cancer; research into using acupuncture
to manage the HF&NS associated with the AIs that are in-
creasingly prescribed for postmenopausal women could also
Despite these limitations, the results of this exploratory
study showing a mean reduction of 49.8% in HF&NS fre-
quency compares favorably with other acupuncture studies.
A review of the available evidence for using acupuncture to
manage menopausal symptoms concludes that the majority
of women in the studies had a reduction of >50% with
continued effects of up to 6 months.39Although there are
problems with the design and size of these studies, all con-
tribute to the growing body of exploratory evidence for this
approach to manage HF&NS.
The results of this study compare well with research con-
ducted into nonhormonal treatment options for HF&NS in
women with breast cancer. Of the SSRIs, a RCT of venlafaxine
over placebo reduced flashes by a median of 61% compared
with 27% with placebo;84a RCT of paroxetine reduced flashes
by 65% compared with a 38% reduction with placebo,85and
fluoxetine reduced flashes by 50% compared with a 36% re-
duction in the placebo group.86However, side-effects of these
drugs included mouth dryness, decreased appetite, nausea
and constipation, and many women are reluctant to take an-
tidepressants to manage the side-effects of adjuvant hormonal
treatments.4There are also concerns that SSRIs may lower the
effectiveness of tamoxifen.87A RCT of oral clonidine showed
a 38% reduction in hot flashes compared with 24% placebo
after 8 weeks of treatment,88while a study of transdermal
clonidine showed only moderate (20%) reduction.89In both
studies, participants reported side-effects including difficulty
sleeping, mouth dryness, constipation, and drowsiness. In our
study, 12% of participants were using pharmaceutical prod-
ucts to manage tamoxifen side-effects, and were still experi-
encing sufficient discomfort to seek out additional means to
manage their HF&NS.
The data from this exploratory single-arm observational
study suggest that TA may offer an option for managing the
HF&NS associated with adjuvant hormonal treatment in
1054 DE VALOIS ET AL.
women with early breast cancer. TA has few side-effects, and
appears to improve physical and emotional well-being.
Confirmation of these results, using a RCT, could have im-
portant implications for breast cancer survivors to manage
their menopausal side-effects with means that are not phar-
maceutical, thus offering them greater choice and control in
managing their long-term quality of life. Further research is
warranted, both in determining optimum dose, and with
larger-scale studies designed with randomization and con-
trols appropriate to evaluating a complex intervention.
Dr. Richard Ashford, Consultant Clinical Oncologist at the
Mount Vernon Cancer Centre, funded the clinical phase of
this study. This study was part of the author’s doctoral re-
search, and was carried out and supported by the Lynda
Jackson Macmillan Centre and the Centre for Com-
plementary Medicine and Integrated Health at Thames Val-
ley University. We are grateful to the women who
participated in the study and to Richard J. Atkins, who ad-
vised on the statistical methodology.
No competing financial interests exist.
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Address correspondence to:
Beverley A. de Valois, PhD
Supportive Oncology Research Team
Lynda Jackson Macmillan Centre
Mount Vernon Hospital
Northwood, Middlesex HA6 2RN
ACUPUNCTURE AND TAMOXIFEN-RELATED HOT FLASHES1057
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