Integrative Cancer Therapies
9(2) 158 –167
© The Author(s) 2010
Reprints and permission: http://www.
Acupuncture as Palliative Therapy
for Physical Symptoms and Quality
of Life for Advanced Cancer Patients
Elizabeth Dean-Clower, MD, MPH,1,5 Anne M. Doherty-Gilman, MPH,1
Aparna Keshaviah, ScM,4 Frank Baker, PhD,2 Chiewkwei Kaw, MS,3
Weidong Lu, MB, PhD, MPH, Lic. Ac,1,5 Judith Manola, MS,1
Richard T. Penson, MD, MRCP, 4,5 Ursula A. Matulonis, MD,1,5
and David S. Rosenthal, MD1,5
Background. Acupuncture is underutilized as an adjunct cancer therapy. The main study objectives were to determine
the feasibility of administering acupuncture as palliative therapy to patients with advanced ovarian or breast cancer and
to assess the effect on symptoms and quality of life (QOL). Methods. This study was a pilot, single-armed prospective
clinical trial for patients with advanced cancer to receive 12 acupuncture sessions over 8 weeks with follow-up at
weeks 9 and 12. Ambulatory patients with advanced ovarian or breast cancer were enrolled to receive treatments at
an outpatient academic oncology center. Symptom severity was measured before and after each acupuncture session.
A composite QOL assessment tool, consisting of validated instruments, was completed at 5 time points. Results.
Forty patients enrolled in the study. Twenty-eight patients (70%; 95% confidence interval [CI] = 53%-83%) completed
4 weeks of treatment, and 26 patients (65%; 95% CI = 48%-79%) completed 8 weeks. Eight patients (20%) withdrew before
receiving acupuncture, and 6 patients (15%) discontinued treatment early because of disease progression or scheduling
demands. Among all 32 assessed patients, there was self-reported improvement immediately post-treatment in anxiety,
fatigue, pain, and depression and significant improvement over time for patients with anxiety (P = .001) and depression
(P = .02). Among patients experiencing baseline symptoms, there was improvement in anxiety (P = .001), fatigue (P = .0002),
pain (P = .0002), and depression (P = .003). QOL measures of pain severity and interference, physical and psychological
distress, life satisfaction, and mood states showed improved scores during treatment, with sustained benefit at 12 weeks.
Conclusions. This pilot study demonstrates that an 8-week outpatient acupuncture course is feasible for advanced cancer
patients and produces a measurable benefit that should be evaluated in controlled trials.
acupuncture, palliative care, symptom management, ovarian cancer, breast cancer
In 2009, the estimated number of new cases of ovarian
cancer was 21,550 and estimated deaths were 14,600.1 Given
the difficulties in early detection, women are often not
diagnosed until they have reached an advanced stage.2 Addi-
tionally, although chemotherapy is quite effective initially,
more than 80% of patients will eventually experience a
recurrence of their cancer. In both situations, palliative treat-
ment is the goal.3 In 2009, the estimated number of new
cases of female breast cancer was 192,370 and estimated
deaths were 40,170.1 Although most breast cancer is diag-
nosed at an early stage and can be cured, a substantial
number of individuals are diagnosed at an advanced stage,
when palliative rather than curative treatments are currently
used. Patients with either advanced ovarian or breast cancer
may experience difficult disease and treatment-related
symptoms and often struggle with diminished quality of life
1 Dana-Farber Cancer Institute, Boston, MA, USA
2 Center for Medical Outcomes Research, School of Health Sciences &
Practice, New York Medical College, Valhalla, NY, USA
3 American Cancer Society, Atlanta, GA, USA
4 Massachusetts General Hospital, Boston, MA, USA
5 Harvard Medical School, Boston, MA, USA
David S. Rosenthal, MD, Leonard P. Zakim Center for Integrative
Therapies, Dana-Farber Cancer Institute, 44 Binney St.,
Boston, MA 02115 USA.
Dean-Clower et al.
These patients face daily physical, psychological, spiri-
tual, and/or emotional challenges. Though their cancer may
be incurable, comprehensive care includes palliative thera-
pies that alleviate symptoms and can improve patients’ QOL.
Nonpharmacological interventions provided by comple-
mentary or integrative therapies, such as acupuncture, may
provide some benefit to patients receiving conventional
treatment.6-9 Cancer patients and survivors have demonstrated
a remarkable interest in complementary and alternative
medicine (CAM), with reported use in the United States
ranging from 34% to 91%, depending on the particular
cancer population studied and whether prayer and exercise
are included.10-13 For clinicians, a lack of familiarity with
these modalities and with the relevant evidence-based
research, safety concerns, and perhaps skepticism may con-
tribute to the overall low recommendation rates.14-17
Among complementary and integrative modalities, acu-
puncture is relatively less used, despite published evidence
of its potential benefits.18,19 Cancer patients’ use of acupunc-
ture is estimated to be from 1.7% to 31%.20-22 In addition to
some clinicians’ lack of familiarity with this therapy, others
may not mention acupuncture because of safety concerns for
cancer patients, despite an excellent track record of patient
safety.23 Additionally, a clear, straightforward biological
mechanism is not yet understood, though acupuncture is an
active field of research interest.19 Acupuncture’s benefit for
cancer patients with chemotherapy-induced nausea and
vomiting was one of the first uses agreed on at the NIH
consensus conference in 199724 and has been reconfirmed in
other studies.9,25 Acupuncture also benefits patients with
other cancer- or treatment-related symptoms, such as pain,7
fatigue,6,26,27 anxiety,27 and overall well-being.27-29 However,
the efficacy of acupuncture as an adjunct to palliative che-
motherapy is not widely recognized; therefore, it is rarely
offered as an adjunct to standard care in the United States.30
The primary aim of this single-arm clinical trial was to
evaluate the feasibility and preliminary effects of acupunc-
ture for patients with advanced ovarian and breast cancer.
Secondary aims were to assess the change in symptom
severity over time and to assess the utility of select QOL
instruments in measuring symptoms in an acupuncture study.
Patients were recruited from the gynecological and breast
oncology programs at 2 academic medical centers:
Dana-Farber/Brigham and Women’s Cancer Center and
Massachusetts General Hospital, in Boston, Massachusetts.
Patients signed consent forms approved by the institutional
review board. The acupuncture treatments were provided
free of charge to study participants; there was no additional
financial incentive provided for patient participation.
The eligibility criteria for this trial were the following:
evidence of metastatic ovarian cancer or other advanced can-
cers in which there had been a failure of adjuvant therapy and
for which there were no curative options; ambulatory status;
use of conventional palliative therapy, including chemother-
apy; complaints of pain, nausea, and/or inadequate QOL;
age > 21years; no acupuncture in the prior 6 months; plate-
lets > 25 000 cells/mL; absolute neutrophil count > 500 cells/
mL; no history of bleeding disorder; no diagnosis of acute
psychosis; Karnofsky performance scale score > 60; and
ability to speak and read English. Patients enrolled in other
complementary medicine or QOL studies were not eligible.
The target enrollment for the study was 40 patients. The
study was open to enrollment in April 2002 and closed to
patient accrual in April 2004, after reaching the target accrual.
Patients received 8 weeks of acupuncture, given twice
weekly during the first 4 weeks and weekly during the last 4
weeks (total of 12 sessions). For twice weekly acupuncture,
the sessions were scheduled at least 1 day apart. All acupunc-
ture treatments were performed on-site at the Leonard
P. Zakim Center for Integrative Therapies at Dana-Farber
Cancer Institute. Three licensed acupuncturists, all trained in
traditional Chinese medicine with at least 10 years clinical
experience, administered the treatments. As part of treatment
follow-up, patients were not to receive any additional
acupuncture until after completion of the study (week 12).
A standard, predetermined acupuncture protocol (SAP)
and symptom-specific acupuncture protocols (SSPs) were
developed based on commonly used points from the medi-
cal literature as well as acupuncturists’ experiences and
consensus. The acupuncture algorithm used was that all
patients received the SAP, and if they were experiencing
nausea, pain, fatigue, depression, anxiety. insomnia, consti-
pation, or cough at the time of the session, they also received
a SSP of preselected points based on specific symptom(s).
The base protocol consisted of the following 10 acu-
puncture points at 17 sites: ST-36, SP-6, LI-11, LI-4, LV-3,
SP-9, Yintang, GV-20, CV-6, and Shenmen. Point selection
under the SSP for each category was made from the follow-
ing: PC-6, CV-12, ST-37 (nausea); Ashi points (pain); K-3,
TW-5, GV-14, LU-9 (fatigue); HT-7, PC-4, LV-5, GV24
(depression/anxiety); GB-20, HT-7, PC-7 (insomnia);
ST-25, TW-6, BL-57 (constipation); LU-7, LU-6, LU-10,
CV-22, BL13 (cough). A study patient received the full SAP
base protocol if there were no specific symptoms. If a
patient reported a specific symptom, a minimum of one
symptom-specific point from that category would be
selected in addition to the SAP. For each additional point
used for a specific symptom, an effort was made to deduct
the same number of points in the SAP to maintain approxi-
mately the same number of acupuncture points for each
Integrative Cancer Therapies 9(2)
treatment session. At each session, stainless steel acupunc-
ture needles (Vinco, Helio Medical Supplies, USA) with a
size 36 gauge, 1 inch (0.20 mm × 25 mm) were inserted into
these points and needles were manually manipulated to
obtain a “De Qi” sensation—a mild, dull aching sensation.
Each session lasted 30 minutes and occurred in a quiet room
with dimmed lights. No electrostimulation was applied.
At each session, data were obtained on the presence and
severity of the specific symptoms noted above; “other”
symptoms reported by patients were recorded, but not
treated. Before each acupuncture session (“pre-session”),
the acupuncturist asked the patient whether or not each
symptom was present, and if so, recorded the symptom
severity (scale of 0-10; 10 = most severe). After the session,
the acupuncturist completed a second form to record the
post-session symptom severity. The patient’s responses
were recorded on a standard form. Information about any
new medical or complementary treatment initiated since the
prior session was also recorded.
The QOL assessment tool consisted of individual assess-
ment tools used in other studies involving cancer patients or
survivors: the Brief Pain Inventory (BPI),31,32 Rotterdam
Symptom Checklist (RSCL),4,33 Satisfaction With Life
Domains Scale–Cancer (SLDS-C),34-36 Profile of Mood
States (POMS),37-40 and Cancer Coping Methods.41
The questionnaires were completed by patients at 5 time
points: baseline before treatment (ranging from 1 week to
immediately prior to the first treatment session), weeks 4
and 8 of treatment (30 minutes after completion of the acu-
puncture session), and weeks 9 and 12 (i.e., 1 week and 4 weeks
after the final acupuncture session). Patients were allowed to
mail in the questionnaires for the final 2 time points.
Brief Pain Inventory. The BPI consists of 2 subscales that
measure (1) the severity of cancer pain (pain severity) and
(2) the impact of pain on the patient’s functioning (pain
interference) in the past 24 hours on a scale from 0 (no pain
or no interference) to 10 (highest level).31,32
Rotterdam Symptom Checklist. The original RSCL
included physical symptom and psychological distress sub-
scales.4 Stein et al.33 developed a shorter version that omitted
the psychological distress items and added some physical
symptom items. The version used here added 3 items to the
Physical Symptom Distress Scale (Drowsiness, Weak All
Over, and Feel Listless [Washed Out]) and dropped 2 items
(Low Back Pain and Burning/Sore Eyes). Respondents
were asked to indicate the extent to which they have been
bothered by each of 32 symptoms during the past week,
using a response format of “not at all” to “very much.”
Satisfaction With Life Domains Scale–Cancer. The SLDS-C
is a broad measure of QOL that asks respondents to indicate
their current satisfaction with 18 different life domains rel-
evant to the QOL of cancer patients.34-36 The scale uses a
picture response format in which satisfaction is indicated
by choosing 1 of 7 faces, ranging from a “terrible” frowning
face to a “delighted” smiling face. Items can be evaluated
individually and a total score calculated.
Profile of Mood States–Short Form (POMS-SF). The POMS
was originally developed to assess transient distinct mood
states using ratings of 65 adjectives that were rated on a
5-point scale from “not at all” to “extremely.” It was
scored using 6 factor-based subscales: Depression-
Dejection, Tension-Anxiety, Anger-Hostility, Fatigue-
Inertia, Confusion-Bewilderment, and Vigor-Activity.37
The POMS-SF that was used in this study is a 37-item ver-
sion of the POMS developed and validated on the responses
of cancer patients and that retains the 6 subscales.38-40
A seventh score of Total Negative Mood Disturbance is cal-
culated by adding together the first 5 subscales and
subtracting the score from the one positively scored sub-
Cancer Coping Methods. The Cancer Coping Methods
instrument used in this study is from the questionnaires
included in the American Cancer Society’s (ACS’s) Studies of
Cancer Survivors.41 The Cancer Coping Methods measure
consists of a list of complementary therapies plus the addi-
tion of some questions regarding talking with other people,
which were included based on what patients listed as “other
methods” on pilot tests of the ACS questionnaires. In the
version used in the large ACS surveys and in our acupunc-
ture study, we used a shorter 32-item list from the original
44-item list that both omitted methods that were little used
and added the items related to talking.41
For the targeted enrollment of 40 patients, feasibility was
defined as 75% of patients completing at least 4 weeks of
treatment and/or 50% of patients completing all 8 weeks of
treatment. If 30 of 40 patients completed 4 weeks of treat-
ment, the 95% confidence interval (CI) for the true 4-week
completion rate would be 58.8% to 87.3%. If 20 patients
completed 8 weeks of treatment, the 95% CI for the true
8-week completion rate would be 33.8% to 66.2%. A patient
was allowed to miss 1 session of treatment at most and still
have completed the treatment protocol.
To determine whether any immediate changes after
acupuncture treatment had occurred, difference scores
(post-treatment minus pre-treatment) were calculated for
each patient at each time point. Means and 95% CIs at each
time point were computed. Given that acupuncture typically
is administered as a course with cumulative benefit, the
effect of acupuncture over time (i.e., the change in symptom
severity across sessions) was tested. Two separate longitu-
dinal analyses were done, one based on all assessed patients
(because symptoms could occur at any time over the dura-
tion of treatment) and another based on patients who were
experiencing a symptom just prior to treatment on day 1.
Dean-Clower et al.
Preacupuncture treatment severity score was modeled as
the dependent variable, and week was the independent vari-
able. If there were 2 sessions in a week, the second session
was treated as occurring one half week after the first ses-
sion. A compound symmetry covariance matrix was used,
and a likelihood ratio test with 11 degrees of freedom was
used to determine whether or not there was a statistically
significant change in symptom severity over time.
Exploratory analyses tested differences in mean symptom
severity by age at study entry (dichotomized as ≤50 vs > 50
years) and years since diagnosis (dichotomized as <2 vs ≥ 2
years) using 2-sample Student’s t tests. To examine whether
the longitudinal effect of acupuncture was altered by these
characteristics, interaction terms between the characteristic
and time were included in the aforementioned repeated-
measures, mixed-effects models. The interactions between
age and session and between years since diagnosis and ses-
sion were tested individually (i.e., in separate models) to
conserve power. However, the tests were anticipated to be
underpowered given the sample size of this small pilot study.
For all analyses, a 2-sided significance level of .05 was
used. Given that this was an exploratory pilot study, P values
were not adjusted for multiple comparisons. Analyses were
conducted by statisticians (JM, AK) using SAS V8.2.
QOL Statistical Considerations
Data analysis on patients’ QOL was conducted (by CK) in
SPSS V13.0 and SAS V8.2. If at least half of the items on an
instrument were completed, the total score was imputed using
the mean of available items. Descriptive statistics were gener-
ated to understand the change in QOL scores across different
time points. Similar longitudinal models with the consider-
ation of demographic and medical characteristic differences
(e.g., age, disease stage, treatment, etc.) among the study par-
ticipants were tested to further evaluate the association between
acupuncture effects and patient’s QOL. Covariance structures
with the best-fit statistics were used in the final analyses.
Twenty-eight of the 40 enrolled patients (70%; 95% CI for
treatment completion rate = 53%-83%) completed at least
4 weeks of acupuncture treatment, and 26 patients (65%; 95%
CI = 48%-79%) completed all 8 weeks of treatment. The
8-week completion rate met the feasibility criteria, whereas the
4-week completion rate was slightly lower than anticipated.
A total of 8 patients (20%) withdrew from the study before
receiving acupuncture because of disease progression (n = 2)
or scheduling difficulties/time commitment (n = 6). Six of
32 patients (15%) began study treatment, but withdrew early
because of progressive disease (n = 4) or withdrawal of
informed consent (n = 2). Therefore, the overall drop-out rate
was 35% (14 of 40 patients). Two acupuncturists adminis-
tered 99% of the treatments (WL, Zhi Ping Li). Among the
26 patients who completed treatment, 21 completed treat-
ment as scheduled, 4 missed 1 treatment session, and 1
completed all 12 sessions but had her final session 3 weeks
later than expected (because of travel). The acupuncture
treatments were well-tolerated. No significant side effects or
adverse events attributable to acupuncture were observed.
Table 1 summarizes baseline patient and disease character-
istics for all 40 registered patients. The median age was 52
Table 1. Baseline Characteristics
Characteristic n Percentage
Gender and race
Female and White
Age at study entry
70 Or older
Karnofsky performance status
Years since diagnosis
Prior chemotherapy regimens
9 Or more
NOTES: aOvarian cancer is used in the text to include other gynecologic
malignancies, specifically Müllarian tumors, which are treated with the
Integrative Cancer Therapies 9(2)
(range, 31-75). All patients had received prior conventional
therapy (surgery, chemotherapy, and/or radiation therapy).
At the time of study entry, 25 patients (63%) were receiving
concurrent palliative chemotherapy. Although all patients
had advanced cancer, 85% had KPS (Karnofsky Perfor-
mance Status) scores greater than 80 at the time of receiving
Seven patients (18%) reported initiating a new form of
medical treatment and/or complementary therapy over the
course of the 8-week acupuncture treatment. These thera-
pies were evenly divided between conventional therapy
(chemotherapy) and CAM therapy (e.g., Chinese herbal mix-
ture); 1 patient began both chemotherapy and vitamins.
Table 2 summarizes the symptom severity scores
reported at baseline for the 32 patients who received any
acupuncture treatment. Of these, 30 patients had at least one
baseline symptom, and many patients were experiencing
multiple symptoms. The most prevalent baseline symptoms
were fatigue, anxiety, and pain, individually or in combina-
tion. For most symptoms, the mean severity experienced
was at a moderate level (4-5 out of 10), though some
patients had higher severity scores of 8 to 10. Two patients
were asymptomatic at baseline, but described experiencing
decreased QOL and therefore were eligible to participate.
There were no significant differences in baseline symptom
severity by age.
Immediate Effects of Acupuncture Treatment
Assessment of change in symptom severity scores (post-
treatment score minus pre-treatment score) was made for all
assessed patients. There was a significant decrease in sever-
ity score at the majority of sessions for anxiety, fatigue,
pain, and depression. Additionally, a total of 31 patients
(97%) reported, following one or more sessions, that acu-
puncture helped their overall sense of well-being.
Figure 1 shows the mean severity score before and
after treatment and over the course of treatment for symp-
tom categories having 13 or more patients affected at
baseline. For insomnia, only pre-treatment scores are clin-
ically relevant. For all other symptoms, post-treatment
scores were lower than pre-treatment scores across all
symptoms and time points, with the exception of depression
at weeks 6 and 7.
Longitudinal Changes in Patients’ Symptoms
Figure 1 also demonstrates that over time, there were statis-
tically significant improvements in 4 of the 5 predominant
symptoms at baseline: anxiety, fatigue, pain, and depression.
The longitudinal changes in anxiety severity differed sig-
nificantly by age at study entry (P = .01), with a greater
decrease in anxiety for patients 50 years or younger.
Quality of Life
QOL questionnaire results generally indicated that acu-
puncture had a positive impact on patients’ QOL. Arithmetic
means and standard deviations for the QOL scores are pre-
sented in Table 3. Model means also were generated and
tested for differences across time points. Patients had better
QOL during the 8-week acupuncture treatment than either
before treatment was initiated or shortly after it was
stopped. Symptom severity decreased over time from the
pre-treatment baseline through the last week of acupuncture
treatment (week 8). Symptoms or other qualitative param-
eters then showed some temporary worsening 1 week later
(week 9). However, the results 1 month after acupuncture
was completed (week 12) continued to show improvement
of QOL compared with baseline values.
Patients’ pain severity and pain interference scores
were significantly improved by 1.26 (P ≤ .0001) and 1.51
Table 2. Baseline Symptom Severity Scores (0-10)
Among Patients with Symptoms
No. With Data No. With Symptoms Percentage With Symptoms Mean Median Range
NOTES: aIn all, 11 patients had severity scores >0 for the following: diarrhea (2), numbness (2), itching/rash, hot flashes, heart burn, neuropathy in feet,
shortness of breath, stiffness, and weakness in arms and hands.
Dean-Clower et al.
Figure 1. Mean symptom severity scores before and after acupuncture treatments for symptom categories having 13 or more
affected patients at baseline among only patients with symptoms just prior to treatment on day 1. Mean severity scores before
treatment were generally higher than after treatment. For insomnia, only pre-treatment scores are applicable. Vertical lines represent
standard errors; dotted line shows model-based estimate of slope; P values indicate significance of change over time among patients
with symptoms just prior to treatment on day 1. Pre-tx = pre-treatment; Post-tx = post-treatment
(P = .0006) units, respectively, at week 8 of treatment
compared to the baseline data (pain severity at baseline =
2.64; pain interference at baseline = 2.30). The study also
revealed that the pain status was better one month after the
treatment was stopped compared with the time before
treatment was given (pain severity and interference one
Integrative Cancer Therapies 9(2)
month after treatment completion were 1.59 and P = .0010,
and 1.32 and P = .0055, respectively).
We also observed significant reduction in the RSCL
physical (PHY) and psychological (PSY) burden by
11.53 units (P ≤ .0001) and 13.95 units (P = .0004) units,
respectively, at week 8 compared with baseline data. Lower
levels of physical and psychological distress were also reported
1 month after the treatment was completed as compared with
the baseline values (PHY P = .0001; PSY P = .0004).
A similar trend of improvement was also observed in
the SLDS-C, in which patients reported significantly
higher life satisfaction at the completion of the acupunc-
ture treatments (week 8) than either before the first
session (14.32, P = .0002) or 1 week after the last treat-
ment (6.52; P = .0013). The improvement in the SLDS-C
score 1 month after the treatment versus the baseline was
7.81 units (P = .0071). For the POMS-SF, significant dif-
ferences were detected for all subscales and for total
mood disturbance, except for the Vigor-Activity subscale
(P = .73). Patients reported 16.10 (P = .0001) and 18.39
(P ≤ .0001) improvement in their mood state at weeks 8
and 12, respectively, compared with baseline.
Regarding patients’ use of various Cancer Coping Meth-
ods at baseline, the most frequent choices encompassed
talking to family or friends (78%), music (68%), prayer or
spiritual practice (65%), and exercise (47%), among other
choices (data not shown). Nutritional supplements were
used by 59% of patients. Other CAM therapies ranged from
3% to 40%, for hypnosis and meditation, respectively. Only
3 patients (10%) indicated that they had used acupuncture
or acupressure as a coping strategy prior to this study.
This study reports that acupuncture is a feasible, safe, and
well-tolerated intervention for patients with advanced ovar-
ian or breast cancer; therefore, the primary study aim was
achieved. There was also a measurable improvement for
certain physical symptoms and subjective QOL. Given that
acupuncture usually requires successive treatments to be
effective, it was important to learn that patients with
advanced cancer, who were naïve to acupuncture, could be
compliant with scheduling demands in an outpatient setting
and could be followed longitudinally.
Studies that have investigated the use of acupuncture
for specific symptom management in palliative care
patients30,42,43 indicate that acupuncture has not yet had an
impact on clinical practice, though efficacy has been dem-
onstrated in 24 of 27 randomized controlled trials.30
Regarding the potential benefit of acupuncture as adjunct
therapy, patients reported positive experiences both during
the treatment phase and at the study’s completion, as indi-
cated by improved symptom scores recorded by the
acupuncturists and patients’ QOL scores from a composite
self-assessment tool. In general, mean symptom scores were
mild to moderate, though some more significant changes
occurred pre-treatment to post-treatment or over time for
specific patients and symptoms.
For the 8-week treatment duration, measures of QOL
showed continued improvement, with sustained improve-
ment at week 12 relative to baseline values. The decrease
in QOL scores 1 week after treatment ended, followed by
improvement 3 weeks later to levels comparable to the
Table 3. Quality of Life Scale Score Arithmetic Means and Standard Deviations (SDs)
Baseline Week 4 Week 8 Week 9 Week 12
Quality of Life Scalea Mean SD Mean SD Mean SD Mean SD Mean SD
Brief Pain Inventory
Rotterdam Symptom Checklist
Physical symptoms distress
Profile of Mood State
Total negative mood
NOTES: SLDS-C = Satisfaction With Life Domains Scale–Cancer.
aEstimated marginal means and P values adjusted for the repeated-measure study design are included in the text.
Dean-Clower et al.
last acupuncture session, could reflect loss of continuity
with the practitioner or simply an independent time
There are several limitations to this study. Without a
control group in this feasibility study, the significant find-
ings cannot be directly attributed to acupuncture treatments,
and all conclusions should be guarded. It is possible that
patients improved because of the attentive presence of the
acupuncturists, the relaxing environment, patients’ desire to
please the practitioners, concurrent cancer treatment, pla-
cebo effect, or a combination of these factors. It is recognized
that expectations of the acupuncture procedure can influ-
ence outcome measurements provided by patients in a
positive way44 and may possibly reflect the Hawthorne
effect,45 that is, patients performing better because they are
participating in a trial.
From a statistical perspective, caution should be exer-
cised in assessing symptoms and QOL over time. Some of
the comparisons were based on fewer than 10 patients and
are therefore likely to be underpowered. It is also possible
that statistically significant differences arose merely by
chance, given the large number of comparisons made.
Additionally, although it is reasonable to evaluate the group
of patients with symptoms at the beginning of the study, this
subset analysis has a small sample size.
Given the positive changes in symptom management
and improved QOL for patients that occurred over the
duration of this acupuncture study, some considerations
for designing future studies are warranted. Performing
randomized trials, which include a control arm for stan-
dard of care, is fundamentally necessary before any firm
conclusions can be drawn about the utility of acupuncture
A. Rotterdam Physical Distress B. Rotterdam Psychological Distress
C. Satisfaction with Life Domain Scale - CancerD. Profile of Mood States - Total Mood Disturbance
Figure 2. Model-based marginal mean estimates and standard errors over time: higher scores indicate a higher level of
symptomatology for RSCL measures (A and B) and Profile of Mood States–Total Mood Disturbance (POMS-TMD, D), whereas higher
scores for Satisfaction of Life Domain Scale–Cancer (SLDS-C) indicate a higher level of life satisfaction (C). Positive QOL change was
observed especially during treatment.
Integrative Cancer Therapies 9(2)
in cancer care. Regarding the acupuncture protocol, a fully
standardized protocol would minimize variability versus
this protocol, which had some individualization. The
choice of standardized versus individualized acupuncture
remains an active topic of interest and debate in research
studies. The required travel to a single urban clinic and the
frequency of sessions were the biggest reported problems
for patients. In future studies, to increase enrollment and
retention, we could investigate the use of satellite loca-
tions and increase patient awareness about the availability
and potential benefits of acupuncture.
In summary, the results of this pilot study indicate that
an 8-week treatment course of acupuncture is feasible for
advanced cancer patients. Patients reported positive changes
in QOL by validated scales, and specific symptoms showed
sustained statistically significant changes, warranting fur-
ther evaluation in controlled trials.
We would like to acknowledge the assistance of the following
people: acupuncturists—Zhi Ping Li, MB, Lic Ac, Grant Hou,
MB, Lic Ac; clinical research coordinators—Kelechi Ohiri, MD,
MPH, Aravind Sugumar, MD, MPH; data management—Alyssa
DellaCroce, MPH, Emily Collins, Donoria Wilkerson, Yajaira
Pagan; statistics—Sabrina Khan, Qian Wang; background—Janet
Abrahm, MD; protocol development—Amy Geng, MD; manu-
script preparation—Katherine Connolly.
Declaration of Conflicting Interests
The authors declared no conflicts of interest with respect to the
authorship and/or publication of this article.
This study was supported by the National Center for Complemen-
tary and Alternative Medicine (NCCAM) [grant # 5 R21
AT01010-02]. Its contents are solely the responsibility of the
authors and do not necessarily represent the official views of the
NCCAM or the National Institutes of Health.
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