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Urological Oncology

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ACUPUNCTURE FOR VASOMOTOR SYMPTOMS ASSOCIATED WITH LHRH AGONIST TREATMENT FOR PROSTATE CANCER
HARDING
et al.

BJUI

Auricular acupuncture: a novel treatment

for vasomotor symptoms associated with
luteinizing-hormone releasing hormone agonist
treatment for prostate cancer

BJU INTERNATIONAL

Christopher Harding, Andrea Harris and David Chadwick

Department of Urology, James Cook University Hospital, Middlesbrough, UK
Accepted for publication 15 May 2008

Study Type Therapy (case series)

Level of Evidence 4
OBJECTIVES
To evaluate the role of auricular acupuncture
(AA) in men receiving luteinizing-hormone
releasing hormone (LHRH) analogues for
carcinoma of the prostate, as vasomotor
symptoms can affect the quality of life
in such men, and similar symptoms in
postmenopausal women have been
successfully treated with AA.
PATIENTS AND METHODS

(median age 74 years, range 5883)

consented to weekly AA for 10 weeks. The
validated Measure Yourself Concerns and
Well-being questionnaire (a six-point scale
to assess symptom severity) was used to
assess concerns and well-being before and
after treatment.
RESULTS
All men completed the treatment with no
adverse events recorded, apart from
transient exacerbation of symptoms in two
men; 95% of patients reported a decrease in
the severity of symptoms, from a mean 5.0
to 2.1 (Students t-test, P < 0.01).

CONCLUSIONS
The symptomatic improvement was at
levels comparable with that from
pharmacotherapy, and cost analysis
showed AA to be a viable alternative.
Larger randomized studies are needed
to fully evaluate AA against more
conventional treatments, and these are
planned.

KEYWORDS
prostate cancer, vasomotor symptoms,
acupuncture

In all, 60 consecutive patients with prostate

cancer and on LHRH agonist treatment

INTRODUCTION
Prostate cancer is the most commonly
diagnosed cancer in UK men [1], with 35 000
new cases in 2004. This disease represents
almost a quarter of new cancer diagnoses in
males [1] and many men (about a quarter) will
have advanced disease at presentation [2]. The
treatment of choice for metastatic prostate
cancer remains androgen-deprivation therapy
(ADT) [3]. This type of treatment is associated
with significant side-effects, including
osteoporosis, loss of libido and psychological
illness [4]. Perhaps the most common and
bothersome side-effect from ADT is hot
flushes, that consist of a sudden perceived
increase in temperature, with erythema of the
skin, sweating and tachycardia, experienced
by 5080% of men on ADT for prostate cancer
[4].

186

The mechanism underlying hot flushes is not

completely understood but current theories
centre around a disturbance of the
hypothalamic thermoregulatory processes [5].
Much of the work in this area has examined
hot flushes in the postmenopausal women,
and it is suggested that low levels of
oestrogen are responsible. Circulating
oestrogens and their metabolites lead to
production of -endorphins in the
hypothalamus, which have a negative
feedback effect on the production of
hypothalamic noradrenaline. The loss of this
negative feedback results in higher levels of
noradrenaline and an up-regulation of
serotonin receptors in the hypothalamus,
causing a resetting of the thermoregulation
process [5]. In men the precise mechanism is
not understood and the contribution of low
circulating testosterone is unclear.

Auricular acupuncture (AA) was first reported

in the mid-1950s, by Nogier, but probably
dates back to the Stone Age [6]. Nogier
hypothesized that all internal organs are
represented in the external ear and found
distinct measurable changes in the radial
pulse of patients when certain points on the
ear were stimulated [7]. Further research
suggested an effect on both the sympathetic
and parasympathetic nervous systems after
acupuncture. Knardahl et al. [8] found an
increase in sympathetic nerve activity and in
pain threshold after electro-acupuncture, and
Haker et al. [9] reported a series of 12 healthy
volunteers in which there was increased
activity of the parasympathetic nervous
system after auricular stimulation.
Furthermore, the analgesic effect of AA has
been shown to be obliterated by naloxone (an
opioid antagonist), implicating a role for the

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ACUPUNCTURE FOR VASOMOTOR SYMPTOMS ASSOCIATED WITH LHRH AGONIST TREATMENT

FIG. 1. Diagram showing the five points on the

external ear corresponding to the NADA protocol
for AA.

FIG. 2. The MYCAW questionnaire.

Concern or problem 1:
0

Kidney

Not bothering
me at all

Autonomic

6
bothers me
greatly

Shen Men
Concern or problem 2:
0
1
2
3
4
5
Not bothering
me at all

6
bothers me
greatly

Wellbeing: How would you rate your general feeling of well-being now?
(How do you feel in yourself?)
0

As good
as it could be

Liver
Lung

endorphinergic system [10]. Despite these

data the precise mechanism of action of AA
has yet to be fully elucidated.
AAA has been used clinically in several
different settings and has been shown to be
effective in the treatment of insomnia [11],
smoking cessation and alcohol withdrawal
[12,13] and perioperative anxiety [14,15]. In
addition there is some evidence of its efficacy
for treating drug-induced hot flushes. De
Valois et al. [16] examined the effect of AA on
women with tamoxifen-induced hot flushes
after treatment for early breast cancer. That
study reported an improvement in symptoms
of hot flushes and a 30% reduction in the
frequency of these episodes after eight
sessions of AA at 1-week intervals. As well as
the reduction in hot flushes there was also a
reported improvement in emotional and
physical well-being. The aim of the current
pilot study was to examine the effect of AA on
men with hot flushes after ADT for advanced
prostate cancer.

PATIENTS AND METHODS

Sixty consecutive men (mean age 74 years,
range 5883) receiving ADT for advanced
prostate cancer and having troublesome hot

flushes were recruited to the study. Patients

were fully counselled before inclusion and
were provided with printed information
sheets. Written consent was obtained before
starting the study protocol. Most patients had
received no previous treatment for their hot
flushes, and all had been receiving LHRH
analogues for 6 months before inclusion,
and at entry to the study were not taking any
medications or other preparations as a
treatment for hot flushes.
AA was administered in accordance with
the National Acupuncture Detoxification
Association (NADA) protocol. This involves the
insertion of 0.20 G sterile single-use needles
(Helio Medical Supplies, Fairford, UK) to five
points on the external ear bilaterally. The five
points are shown in Fig. 1. The needles were
left in-situ for 40 min and the treatments
were given in a group setting for most
patients; these treatments were scheduled
weekly for 10 weeks.
All patients were asked to complete the
Measure Yourself Concerns and Well-being
(MYCAW) questionnaire [17] at their initial
visit and then again at 10 weeks (end of
study protocol). This is the only outcome
questionnaire to have been exclusively
developed in the cancer-care setting and has
been previously validated in terms of its
appropriateness, acceptability and response
to change [17]. The MYCAW questionnaire
asks the patients to name their primary and
secondary health concerns and to grade their
severity. The MYCAW scale is a six-point
analogue scale with 0 representing no
concerns and 6 representing maximum
concern. In addition, a question on

6
As bad
as it could be

generalized well-being is also asked and

graded from 0 (representing good overall
well-being) to 6 (well-being as bad as it could
be; Fig. 2).
In addition to the validated questionnaire
we also asked the patients to record the
frequency of hot flush episodes both during
the day and at night, and recorded this at 0, 4
and 10 weeks. Finally patients were asked to
grade the intensity of their hot flushes on
a 06 scale, with 6 representing maximum
intensity and recorded these data at 0, 4 and
10 weeks.
The responses to the MYCAW questionnaires
and the scores for frequency and intensity of
hot flushes were analysed to confirm that
these data were normally distributed.
Differences in scores at 0, 4 and 10 weeks
were examined for statistical significance
using ANOVA and paired Students t-tests. The
significance level was set at 5% for twogroup comparisons and 1% for multiple
group comparison.

RESULTS
All 60 men completed the study protocol; the
side-effects of the treatment were limited
to transient exacerbation of vasomotor
symptoms in two men, that lasted only
seconds. All patients were able to selfcomplete the MYCAW questionnaire (Fig. 2)
and at the outset the primary concern was
hot flushes and night sweats in 37 (62%) men,
night sweats alone in 18 (30%), hot flushes
alone in three (5%) and depression in two
(3%). Secondary concerns were sleep

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187

H A R D I N G ET AL.

disturbance in 24 (40%) men, exhaustion/

fatigue in 13 (22%), depression/emotional
anxiety in eight (13%), insomnia in three (5%),
panic attacks in three (5%), night sweats in
one (2%), headaches in one (2%) and poor
mobility in one (2%); six (10%) did not have a
secondary health concern.
The mean (SD) MYCAW primary concern score
for the group at the beginning of the study
protocol was 5.0 (0.8), which was reduced to
2.1 (1.2) at the end of the study protocol
(10 weeks). Of the 60 men, 57 (95%) showed a
reduction in the magnitude of their primary
concern, with the three remaining patients
reporting no change. The difference between
MYCAW primary concern scores for weeks 0
and 10 was statistically significant (paired
Students t-test, P < 0.05). The mean (SD)
MYCAW secondary concern score for the
group at the beginning of the study protocol
was 4.8 (1.8), which reduced to 2.1 (1.6) by the
end of the study. Again no patient reported an
increase in secondary concern, with the vast
majority (92%) reporting a decrease. The
difference between MYCAW secondary
concern scores for weeks 0 and 10 was
statistically significant (paired Students
t-test, P < 0.05).
The general well-being of the patients was
assessed using the third question from the
MYCAW questionnaire. At the beginning of
the study the mean (SD) well-being score was
4.6 (0.7). At 10 weeks this was reduced to
2.5 (1.1), and was statistically significant
(paired Students t-test, P < 0.05). Again most
patients (95%) reported an improvement in
their general well-being, with none reporting
deterioration. Thus all of the individual
domains of the MYCAW questionnaire
showed a significant change after the 10week course of AA.
All patients were encouraged to keep a record
of the frequency and intensity of their hot
flushes during the period of study; the results
are shown in Table 1. The ANOVA showed
statistically significant reductions in
frequency and intensity of both daytime and
night-time hot flushes over the study period,
by 69% and 50%, and 70% and 63%,
respectively.
For each patient in the study the total cost of
treatment, including consumables, was 3 per
patient per session, i.e. 30 per patient for the
duration of the study protocol. This is based
on delivering acupuncture within the group

188

Mean (SD)
Frequency
Daytime
Night-time
Intensity
Daytime
Night-time

Weeks
0

10

P, ANOVA

7.2 (4.9)
6.3 (3.9)

3.8 (3)
3.0 (1.9)

2.2 (2.1)
1.9 (1.4)

<0.05
<0.05

3.2 (0.8)
4.3 (0.9)

2.7 (1.5)
3.1 (1.6)

1.6 (1.4)
1.6 (1.3)

<0.05
<0.05

setting consisting of on average 10 patients.

Compared to the cost of medical therapy for
the same period it was substantially less
expensive, e.g. the cost of 10 weeks of
treatment with cyproterone acetate (CPA) at
50 mg twice daily would be over 78.

DISCUSSION
The results from this pilot study suggest that
standardized AA is a safe, inexpensive and
effective treatment for troublesome
vasomotor symptoms experienced by men
taking ADT for advanced prostate cancer. We
provided 10 weekly sessions for 60 patients
(600 treatments) and found minimal adverse
events. On just two (0.3%) occasions patients
reported a transient increase in their
vasomotor symptoms which subsided in a few
seconds. The treatments were carried out by
one practitioner within the group setting
of up to 12 patients. This highlights the
economic benefit of this therapy, which is
relatively inexpensive when compared with
the potential costs of other treatments,
especially pharmacotherapy. The efficacy of
AA is highlighted by the results; the vast
majority of men had a reduction in both the
frequency and intensity of their hot flushes. In
addition to this, all domains of the validated
MYCAW questionnaire [17] showed a mean
improvement across the study group as a
whole. No patient reported any deterioration
in any of these three domains and there were
no patients reporting increases in either
frequency or intensity of hot flushes
throughout the duration of the study
protocol.
We found that the MYCAW questionnaire was
an excellent tool to use for this group of
patients (predominantly elderly men). All
patients were able to self-complete this
simple three-domain questionnaire with no
difficulty. Patients found the questions
unambiguous and the scoring system easy to
understand. Furthermore, the questionnaire

TABLE 1
The mean (SD) frequency
and intensity of day and
night-time hot flushes at 0,
4 and 10 weeks; the
intensity is scored out of 6
(with 6 representing
maximum intensity)

showed response to change after the

intervention, and this adds further validity to
the use of this tool as a method of assessing
health concerns and general well-being in
patients with cancer. In addition, most
patients were able to record the frequency of
hot flushes and provide an estimate of their
intensity. The use of logbooks or diaries to
record frequency and intensity of hot flushes
was shown to be a useful way to monitor
vasomotor symptoms in previous studies [18],
and we found this method complemented the
use of the validated MYCAW questionnaire
[17].
There are several theories of the possible
mechanism of action of AA but precise details
remain unclear. A recent randomized trial
comparing AA at anxiety-relieving points vs
sham points showed a significantly higher
anxiolytic effect over the sham group [19]. It
is possible that AA relieves the symptoms
of hot flushes by causing a release of endorphins [20] which act to maintain the
negative feedback on the production of
hypothalamic noradrenaline. This is thought
to be partially responsible for the vasomotor
symptoms experienced during a hot flush. In
addition to this there appears to be a role for
calcitonin gene-related peptide (CGRP); a
small study by Wyon et al. [21] showed that
CGRP was released into the circulation during
a hot flush. In that study an increase in serum
CGRP of 73% was reported during hot flushes
in postmenopausal women. -endorphins
have an inhibitory effect on CGRP [22] and
further supportive evidence is provided in
another study by Wyon et al. [23], which
showed that the urinary excretion of CGRP
was reduced after acupuncture, and it is
possible that this effect is mediated by endorphin release. Despite these findings the
same group failed to detect an increase in
urinary CGRP in men with vasomotor
symptoms after castration therapy for
prostate cancer [24]. Currently, the potential
use of CGRP antagonists for treating hot
flushes remains theoretical and further work

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ACUPUNCTURE FOR VASOMOTOR SYMPTOMS ASSOCIATED WITH LHRH AGONIST TREATMENT

is needed to establish a potential role for this

type of treatment.
Another neurotransmitter, 5hydroxytryptophan (5-HT), a precursor of
serotonin, has also been implicated in the
pathophysiology of hot flushes. In a recent
paper, Curcio et al. [25] hypothesized a central
role for 5-HT; it was shown that decreased
levels of circulating oestrogens lead to a
lowering of serum endorphin and serotonin
concentrations and an increase in serotonin
receptors [26,27]. Serotonin is thought to
inhibit the production of hypothalamic
noradrenaline. Therefore it is logical that
agents that increase circulating serotonin
would be expected to reduce hot flushes.
Several studies report the successful
treatment of hot flushes with selective
serotonin re-uptake inhibitors (SSRIs), adding
support to this theory [2830]. Perhaps the
highest level of evidence comes from a
randomized controlled trial by Loprinzi et al.
[28], showing that venlafaxine, an SSRI,
produced a significant reduction in hot
flushes in postmenopausal women, compared
with placebo. Despite these encouraging
results, SSRI therapy might not be the answer
to treating hot flushes, as these agents have
fairly common bothersome side-effects, such
as insomnia, nausea, vomiting, anorexia and
decreased libido [25].
Hormonal changes are unquestionably
responsible for the occurrence of vasomotor
symptoms, and hormonal treatments have
also been investigated. Atala et al. [31] studied
14 patients with vasomotor symptoms after
orchidectomy treated with low-dose
diethylstilbestrol vs placebo in a double-blind
crossover trial. Their results showed a
significant reduction in vasomotor symptoms
after administration of diethylstilbestrol, and
they claimed that low doses avoided the
potential cardiovascular or thromboembolic
complications of oestrogen therapy. In
another study, Wyon et al. [32] compared
electro-acupuncture with oestrogen
treatment in a randomized trial; their results
showed that both treatments significantly
reduced the frequency of hot flushes.
However, the potential side-effects of
oestrogen treatment might prevent its
widespread acceptance as a treatment for hot
flushes [33].

to be effective in several studies.

Charig and Rundle [34] gave 5 mg of
medroxyprogesterone acetate twice daily to
men after orchidectomy and found that hot
flushes were alleviated in five of the seven
patients studied. In addition, a retrospective
study of 48 men on LHRH analogue therapy
for prostate cancer was reported by
Langenstroer et al. [35], showing an
improvement in vasomotor symptoms in 91%
and complete resolution in 46%.

4
A recent review by Spetz et al. [36] detailed
the evidence for the antiandrogen CPA in the
treatment of hot flushes. A decrease in
vasomotor symptoms is described in two
double-blind, placebo-controlled studies of
castrated men [37,38]. Eaton and McGuire
[37] found significant symptom reduction in
12 patients given CPA 100 mg three times
daily, but found that significantly many
patients (42%) complained of increasing
tiredness whilst on the treatment.
There are therefore various pharmacological
therapies which have confirmed efficacy
in reducing vasomotor symptoms. Each of
these has well described side-effects and
furthermore many men with advanced
prostate cancer are on multiple medical
therapies, and are reluctant to add to their list
of drugs.
In conclusion, the present pilot study showed
that AA might be a useful treatment for
vasomotor symptoms in men on LHRH
analogue treatment for advanced prostate
cancer. It reduces the frequency and severity
of these symptoms and significantly improves
well-being. The treatment is inexpensive and
has no side-effects. Further studies are
necessary and a randomized controlled
trial assessing AA against a conventional
pharmacological therapy is planned,
comparing AA with CPA in the treatment of
hot flushes in men on long-term LHRH
analogue treatment for prostate cancer. This
will provide useful pilot data before a larger
multicentre study in collaboration with the
National Cancer Research Institute.

10

11

12

13

CONFLICT OF INTEREST
14
None declared.
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Correspondence: David Chadwick, James Cook

University Hospital, Middlesbrough TS4 3BW,
UK.
e-mail: david.chadwick@stees.nhs.uk
Abbreviations: ADT, androgen-deprivation
therapy; AA, auricular acupuncture; NADA,
National Acupuncture Detoxification
Association; MYCAW, Measure Yourself
Concerns and Well-being; CPA, cyproterone
acetate; CGRP, calcitonin gene-related
peptide; 5-HT, 5-hydroxytryptophan; SSRI,
selective serotonin re-uptake inhibitor.

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