International Journal of Clinical Medicine, 2011, 2, 51-55
doi:10.4236/ijcm.2011.21010 Published Online February 2011 (http://www.SciRP.org/journal/ijcm)
51
Acupuncture for the Treatment of Hot Flashes in
Men with Advanced Prostate Cancer
Jillian L. Capodice, Philippa Cheetham, Mitchell C. Benson, James M. McKiernan, Aaron E. Katz
Department of Urology, Columbia University Medical Center, New York, USA.
Received December 14th, 2010; revised January 6th, 2011; accepted January 11th, 2011.
ABSTRACT
PURPOSE: To test the safety and efficacy of acupuncture in reducing hot flashes in men with advanced prostate cancer
(CaP) undergoing androgen deprivation therapy. METHODS: A single-arm, pilot study was undertaken to evaluate
acupuncture treatment for hot flashes experienced by CaP patients undergoing hormonal therapy. Sixteen advanced
CaP patients und ergoing androgen deprivation therapy (ADT) received standard ized full body and auricular acupunc-
ture 1x/week for 14 weeks. Patients were evaluated at 0, 7, 14, and an additional 14-wk follow-up (F/U) (28-wks).
Safety was measured by monitoring for adverse events over the treatment period. Serum testosterone was measured at 0
and 14-wks. Quality of life (QOL) was measured by the hormone domain of the Expanded Prostate Index Composite
(EPIC), at the 0, 7, 14, and 28-wks and patient reported hot flash frequency was assessed weekly. Safety endpoints were
serum testosterone and analysis of adverse events. Efficacy endpoints were scores on the EPIC and the number of pa-
tient reported hot flashes. RESULTS: 17 patients were enrolled and 15 completed the trial. Of 15 evaluable patients the
median age was 68 ± 8.19. Serum analysis demonstrated no change in testosterone at baseline 9.5 ng/ml ± 8.9 vs. end-
point 14 ± 8.78 (p = 0.101). No adverse events were reported. Data analysis of the EPIC demonstrated a trend toward
improvement after 7 wks and a significant improvement following 14 wks of acupuncture (p = 0.01). Analysis of patient
reported frequency showed a significant reduction in the number of hot flashes at 7-wk (6, p = 0.04), 14-wk (2.6, p =
0.001), and 28-wk F/U (3.2, p = 0.01) as compared to baseline 9.57 ± 3.98. CONCLUSIONS: The administration of
acupuncture in men with advanced CaP appears to significantly decrease the frequency of hot flashes. No serious ad-
verse events were noted and serum testosterone levels were unchanged from baseline suggesting that the mechanism of
action of acupuncture for hot flash amelioration is not via increase in testosterone.
Keywords: Prostate Cancer, Ac u puncture, Hot Flashes
1. Background
Prostate cancer (CaP) is the most commonly diagnosed
cancer in American men and the second leading cause of
cancer deaths. More than 217,730 men will be diagnosed
with prostate cancer in 2010, and an estimated 32,050
patients will die of this disease [1,2]. Factors including
family history and race/ethnicity account for increased
risk of prostate cancer. Age-specific incidence rates are
also a factor in CaP, and advanced age accounts for about
60% all newly diagnosed prostate cancer cases. Addi-
tionally, 80% of all CaP deaths occur in men greater than
70 years of age [2].
However, prostate cancer (CaP) patients are living
longer largely due to the benefits of androgen deprivation
therapy (ADT) including androgen ablation utilizing lu-
teinizing hormone-releasing hormone (LHRH) agonists
alone or in combination with anti-androgens. This treat-
ment has become a standard option for men with metas-
tatic CaP (Stage 3 or 4) but frequently cause multiple
side effects including gyencomastia, fatigue, hair loss
and hot flashes. The cause of hot flashes is thought to be
due to the decrease in circulating leutinzing hormone
(LH) and follicle stimulating hormone (FSH) [3-5] and
the incidence of hot flashes in men with CaP is close to
80% over the course of treatment and often continues for
years even after ADT is stopped [3]. The severity of hot
flashes impact quality of life and often interfere with
patient compliance. The most commonly prescribed me-
dication to ameliorate hot flashes are estrogens which
also cause undesirable side effects [4] and in the man-
agement of patients with advance cancers, maintaining
treatment compliance, minimizing side effects and pre-
serving quality of life (QOL) are of extreme importance

Acupuncture for the Treatment of Hot Flashes in Men with Advanced Prostate Cancer
52
[3,4]. Based on these facts we hypothesize that acupunc-
ture, a popular complementary and alternative medicine
(CAM) modality may offer a non-pharmacologic ap-
proach to the amelioration of hot flashes in men with
advanced prostate cancer.
2. Materials and Methods
2.1. Subjects
Men with a history of prostate cancer (CaP) Stage 3 (T3,
N0, M0, any G) or Stage 4 (T4, N0, M0, any G or any T,
N1, M0 any G), currently taking any hormonal therapies
including leuprolide acetate or goserelin acetate (± flu-
tamide, nilutamide, or bicalutamide), reporting four or
more hot flashes/day, able to walk, able to lie prone for
the duration of treatment and able to sign the informed
consent in English were eligible for the study. Excluded
from the study were men with the presence of any bleed-
ing disorder or skin infection, any acupuncture treatment
within the past 6 months, initiation or cessation of other
hormonal therapy during or for the 3 weeks prior to the
start of the study, current use or introduction of any
pharmacological treatment for hot flashes, current che-
motherapy or chemotherapy within the past 3 months,
current radiation or completed radiation within the past
month, and current use of any of the following dietary
supplements including non-dietary soy, Cimicifuga ra-
cemosa (black cohosh), Trifolium pretense (red clover),
or vitamin E (> 800 IU daily). The protocol for this pilot
study was approved by the Institutional Review Board of
Columbia University Medical Center and the Herbert
Irving Comprehensive Cancer Center (New York, NY,
USA).
2.2. Study Procedures
Consecutive subjects were assessed at their initial
enrollment and if they met the eligibility criteria were
instructed to read, understand and sign the written in-
formed consent Subjects were then assigned to once-
weekly 30-minute acupuncture sessions for 14 weeks. At
baseline subjects were asked to complete demographic
information. During each weekly visit, the subject was
asked to report their average number of hot flashes per
day. At baseline (week 0), week 7 and 14, blood draws
were taken. At weeks 0, 7, 14, and 28 the EPIC ques-
tionnai r e wa s a dminist e r e d.
2.3. Acupuncture Intervention
The acupuncture treatment protocol and procedure were
devised according to Standard for Reporting of Con-
trolled Trials in Acupuncture (STRICTA) [6]. Our acu-
puncture rationale included standardized body and auri-
cular treatment and the protocol consisted of a standar-
dized set of acupuncture pointes given weekly for 30
minutes over the 14 week period. Points were selected
based on standard texts, informal practitioner query, and
previous studies on acupuncture for hot flashes [7-9] and
all points were applied to standard needle depths. All
acupuncture points were administered with the patient
lying in the prone position, with feet elevated by a pillow.
Stainless steel acupuncture needles were single-use, ste-
rile and disposable. Full body acupuncture needles were
32 and 34 gauge (Cloud and Dragon, Wujiang City
Cloud and Dragon Medical Device Co. Ltd, China). Au-
ricular acupuncture needles were 15 mm and 38 gauge
(Seirin, Seirin-America Inc., Weymouth, MA). All
needles were inserted and a de qi sensation was ob tained
at each point [10]. The needles remained in situ for 30
minutes during which time the acupuncturist returned to
stimulate the needles once (light rotation of the needle
back and forth up to six times). The full body acupunc-
ture point prescription was: SP 6, UB 15, UB 23, UB 43,
LR 3, KD 6, LU 7, HT 7. The Auricular Acupuncture
Point Prescription was: Shen Men, Brain, Kidney, Liver,
and Upper Lung. All treatments were provided by a sin-
gle acupuncturist licensed in New York State, USA
throug ho ut the study pe riod.
2.4. Statistics
The primary safety outcome was the incidence of adverse
effects, complication/illness and/or serious medical
events most likely due to the acupuncture treatment.
Other safety measurements included measurement serum
testosterone levels. The primary efficacy outcome of this
study was change in the score of the hormone domain of
the EPIC questionnaire. Secondary outcomes were re-
duction in self-reported hot flashes and hot flash fre-
quency based on self-reported daily diaries. The acu-
puncture treatment effect was assessed by a paired t- test
comparing measurements of the symptom survey at
baseline to weeks 7, 14 and 28 for all applicable meas-
ures. Descriptive analyses were performed for demo-
graphics utilizing characteristic measures such as mean,
standard deviation, range etc. Analyses were performed
using SPSS Version 9.0 fo r W indows (Chica go , IL).
3. Results
3.1. Subjects
Seventeen men with advanced prostate cancer were
enrolled in the trial. The mean ± SD age was 68.06 ±
8.19. Demographics and baseline characteristics are
summarized in Table 1. Eighty-eight point two percent
of the men (15/17) completed the trial. The reasons for
premature withdrawal were presence of a second cancer
[1] and moving [10].

Acupuncture for the Treatment of Hot Flashes in Men with Advanced Prostate Cancer
53
Table 1. Demographics.
Characteristic
Frequency
N
17
Median age, years ± SD
68.06 ± 8.19
Race, no (%)
White
Black
Hispanic/Latino
Asian
10 (58.8)
5 (29.4)
1 (5.9)
1 (5.9)
LHRH agonist (%)
Anti-androgen (%) 17/17 (100) 11/17 [64.7]
Baseline hot flash frequency
9.57 ± 3.98
3.2. Safety and Tolerability Outcomes
No serious side effects were reported throughout treat-
ment and follow-up including no reports of bleeding,
bruising at any needle site, dizziness or vasovagal re-
sponse(s) that may have been directly related to adminis-
tration of full body or auricular acupuncture treatment.
Testosterone levels at 0 and 14 weeks showed no change
in testosterone at baseline 9.5 ng/ml ±8.9 ng/ml from the
endpoint average of 14.0 ± 8.78, p = 0.101 (Table 2).
3.3. EPIC Data and Hot Flash Frequency
3.3.1. EPIC
Analysis of the EPIC questionnaire (hormonal domain)
demonstrated a trend toward improvement following 7
weeks of treatment and a significant improvement fol-
lowing 14 weeks of acupuncture (p = 0.006). However
after an additional 14 weeks of follow up the trend was
reduced (p = 0.055), see Figure 1.
3.3.2. Hot Flash Frequency
At the 7-wk follow-up patients reported a significant
decrease in hot flashes (p = 0.04) with an average of 6.00
± 2.4 hot flashes per day as compared to 9.57 ± 3.98 at
baseline. The trend in de c re a sing frequency of hot flashes
continued at the 14-wk follow-up, with patients reporting
an average of 2.63 ± 1.2 hot flashes per day. The 14-wk
numbers represent a significant improvement from the
baseline frequency of hot flashes (p = 0.001) (Table 2).
The decrease in hot flush frequency was maintained over
the following 14 weeks without acupuncture treatments,
and at the 28-wk follow-up while the value was slightly
increased, the subjects still reported decreased hot flash
frequenc y as compa re d to baseline 3.2 ± 1.7 (p = 0.01).
4. Discussion
The results of our study demonstrate that acupuncture
was safe, well tolerated, and significantly reduced the
frequency and severity of hot flashes experienced by men
Figure 1. Results of the EPIC-hormone domain *. Student’ s
t-test week 0 versus weeks 7, 14 and 28 (p=0.028, p=0.006,
p=0.055 respectively), * Higher values represent a better
outcome, ** p < 0.05.
Table 2. Change in weekly reported hot flashes and testos-
terone.
Description Baseline
mean (SD)
After acu-
puncture, week
14 (SD) P-value
Self-reported
hot flashes 9.57 ± 3.98 2.63 ± 1.2 P = 0.001
Testosterone
(ng/ml)
9.5 ± 8.9 14.0 ± 8.78 P = 0.101
undergoing hormonal therapy for advanced prostate can-
cer as measured by a standardized questionnaires and
other self reported outcomes. Moreover, the administra-
tion of acupuncture did not affect testosterone levels
throughout the study period, an additional safety bench-
mark for pa tients being treated by andro gen ablat i on.
Our results demonstrate that acupuncture significantly
affected scores on the hormonal portion of the EPIC
questionnaire after 14 weeks of treatment (p = 0.10) but
only trended toward improvement at 7 weeks (p = 0.288).
This suggests that the treatment dosage with regard to
application of acupuncture for hot flashes may be longer
than dosages of acupuncture for other conditions. For
example, studies of acupuncture for post-operative or
chronic osteoarthritic pain demonstrate that amelioration
of pain (measured by standardized questionnaires) may
occur as quickly as 2-3 weeks [11]. Our second measure
of weekly patient reported hot flash frequency was also
significant at weeks 7, 14 and 28 and these data were
consistent with previous reports [12].
After the 14 week study period, serum testosterone
remained unchanged despite significant amelioration of
hot flashes by full body and auricular acupuncture. This
finding is extremely important as it demonstrates that
acupuncture is safe when administered to patients re-
ceiving hormonal therapy and that the potential mechan-
ism of action is not via testosterone increase, an outcome
which would be contraindicated in this patient population.
Interestingly the most recent data analyzing the effect of
acupuncture for hot flashes in both men with prostate

Acupuncture for the Treatment of Hot Flashes in Men with Advanced Prostate Cancer
54
cancer and women with breast cancer imply a neuromo-
dulatory mechanism via neurotransmitter release [13-15].
This hypothesis is also suppor ted by recent clinical trials
on selective serotonin reuptake inhibitors for the treat-
ment for ho t flashes in both men and women [14,15] and
recent in vitro data demonstrating that acupuncture may
increase circulating serotonin in a murine model [16].
A handful of other studies of acupuncture for hot
flashes induced by hormonal therapy in men also suggest
a potential neuromodulatory mechanism of action in-
cluding b-endorphin release and potential effect on cal-
citonin gene-related peptide immunoreactivity [7,13].
Based on our original hypothesis and current research,
we also suggest that the action of acupuncture in men
with hot flashes may be due to a neuromodulatory effect
that targets noradrenergic and serotonergic pathways that
are thought to be involved with hypothalamic thermore-
gulation following the reduction of testosterone and
hormonal fluctuations as a result of androgen ablation.
Moreover, fMRI research has recently implied that acu-
puncture modulates cortical activity and may powerfully
modulate human subjective experiences including res-
ponses to pain, hunger, and memory [17].
Limitations of our study include lack of a placebo or
sham control. However at the time of study design only
one case report existed in the literature and we felt that
pilot data needed to be collected first in order to support
a hypothesis for a larger trial.
Our study clearly demonstrates that acupuncture is
safe and effective in reducing hot flashes in men with
advanced prostate cancer undergoing androgen depriva-
tion therapy following 14 weeks of acupuncture treat-
ment. It is warranted for further controlled studies that
should investigate the potential mechanism of action of
acupuncture and may be a powerful treatment for a debi-
litating symptom in which there is limited medical ar-
mamentarium.
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