n engl j med 363;8 nejm.org august 19, 2010 743
original article
A Randomized Trial of Tai Chi
for Fibromyalgia
Chenchen Wang, M.D., M.P.H., Christopher H. Schmid, Ph.D., Ramel Rones, B.S.,
Robert Kalish, M.D., Janeth Yinh, M.D., Don L. Goldenberg, M.D.,
Yoojin Lee, M.S., and Timothy McAlindon, M.D., M.P.H.
From the Division of Rheumatology (C.W.,
R.K., J.Y., T.M.) and the Institute for Clinical
Research and Health Policy Studies
(C.H.S., Y.L.), Tufts Medical Center, Tufts
University School of Medicine; and Mind–
Body Therapies (R.R.) — both in Boston;
and Newton–Wellesley Hospital, Newton,
MA (D.L.G.). Address reprint requests to
Dr. Wang at the Division of Rheumatology,
Tufts Medical Center, 800 Washington
St., Box 406, Tufts University School
of Medicine, Boston, MA 02111, or at
cwang2@tuftsmedicalcenter.org.
N Engl J Med 2010;363:743-54.
Copyright © 2010 Massachusetts Medical Society.
ABSTRACT
Background
Previous research has suggested that tai chi offers a therapeutic benefit in patients
with fibromyalgia.
Methods
We conducted a single-blind, randomized trial of classic Yang-style tai chi as compared
with a control intervention consisting of wellness education and stretching
for the treatment of fibromyalgia (defined by American College of Rheumatology
1990 criteria). Sessions lasted 60 minutes each and took place twice a week for 12
weeks for each of the study groups. The primary end point was a change in the Fibromyalgia
Impact Questionnaire (FIQ) score (ranging from 0 to 100, with higher
scores indicating more severe symptoms) at the end of 12 weeks. Secondary end
points included summary scores on the physical and mental components of the
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). All assessments
were repeated at 24 weeks to test the durability of the response.
Results
Of the 66 randomly assigned patients, the 33 in the tai chi group had clinically
important improvements in the FIQ total score and quality of life. Mean (±SD)
baseline and 12-week FIQ scores for the tai chi group were 62.9±15.5 and 35.1±18.8,
respectively, versus 68.0±11 and 58.6±17.6, respectively, for the control group (change
from baseline in the tai chi group vs. change from baseline in the control group,
−18.4 points; P<0.001). The corresponding SF-36 physical-component scores were
28.5±8.4 and 37.0±10.5 for the tai chi group versus 28.0±7.8 and 29.4±7.4 for the
control group (between-group difference, 7.1 points; P = 0.001), and the mentalcomponent
scores were 42.6±12.2 and 50.3±10.2 for the tai chi group versus
37.8±10.5 and 39.4±11.9 for the control group (between-group difference, 6.1 points;
P = 0.03). Improvements were maintained at 24 weeks (between-group difference in
the FIQ score, −18.3 points; P<0.001). No adverse events were observed.
Conclusions
Tai chi may be a useful treatment for fibromyalgia and merits long-term study in
larger study populations. (Funded by the National Center for Complementary and
Alternative Medicine and others; ClinicalTrials.gov number, NCT00515008.)
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Th e new england journal o f medicine
744 n engl j med 363;8 nejm.org august 19, 2010
Fibromyalgia is a common and complex
clinical syndrome characterized by
chronic and widespread musculoskeletal
pain, fatigue, sleep disturbance, and physical
and psychological impairment.1,2 Evidence-based
guidelines suggest that fibromyalgia is typically
managed with multidisciplinary therapies involving
medication, cognitive behavioral therapy, education,
and exercise.3-5
Although exercise is beneficial for fibromyalgia
and has been advocated as a core component
of its treatment,6-8 most patients continue to be
in considerable pain years after the original diagnosis
and require medication to control symptoms;
they also remain aerobically unfit, with
poor muscle strength and limited flexibility.9
New approaches are needed to reduce musculoskeletal
pain in patients with fibromyalgia and
to improve their physical and emotional functioning
and quality of life.
Tai chi is a mind–body practice that originated
in China as a martial art. It combines meditation
with slow, gentle, graceful movements, as
well as deep breathing and relaxation, to move
vital energy (or qi) throughout the body. It is
considered a complex, multicomponent intervention
that integrates physical, psychosocial, emotional,
spiritual, and behavioral elements.10 Because
of its mind–body attributes, tai chi could
be especially well suited to the treatment of fibromyalgia.
In fact, tai chi is practiced preferentially
in the United States by persons with musculoskeletal
and mental health conditions.11,12 A
small, nonrandomized study showed that tai chi
reduced symptoms and improved quality of life
in patients with fibromyalgia,13 and it has also
been shown to have potential therapeutic benefits
in patients with other chronic rheumatic
conditions, such as rheumatoid arthritis and
osteoarthritis.14,15
We conducted a single-blind, randomized, controlled
trial to compare the physical and psychological
benefits of tai chi with those of a control
intervention that consisted of wellness education
and stretching. We hypothesized that at the end
of the 12-week intervention period, patients in
the tai chi group would have a greater reduction
in musculoskeletal pain and greater improvements
in sleep quality, physical and psychological
function, and health-related quality-of-life
scores than those in the control group.
Methods
Study Participants
We conducted the trial from July 2007 through
May 2009 at Tufts Medical Center, a tertiary care
academic hospital in Boston. The institutional
review board of the Tufts University Health Sciences
Campus approved the study protocol. Eligible
patients were 21 years of age or older and
fulfilled the American College of Rheumatology
1990 diagnostic criteria for fibromyalgia. These
criteria include a history of widespread musculoskeletal
pain on the right and left sides of the
body as well as above and below the waist, with a
minimum duration of 3 months, and tenderness
on pressure at 11 or more of 18 specific sites
(tender points), with moderate or more severe
tenderness reported on digital palpation.16 We
excluded persons who had participated in tai chi
training within the past 6 months; those with
serious medical conditions that might limit their
participation; those with other diagnosed medical
conditions known to contribute to fibromyalgia
symptoms, such as thyroid disease, inflammatory
arthritis, systemic lupus erythematosus, systemic
sclerosis, rheumatoid arthritis, myositis, vasculitis,
or Sjögren’s syndrome; women who had a
positive pregnancy test or who were planning to
become pregnant during the study period; and
persons who were unable to pass the Mini–Mental
State Examination (i.e., those with a score less
than or equal to 24 [out of 30] points).17 Participants
were allowed to continue routine medications
and maintain usual visits with their primary
care physicians or rheumatologists throughout
the study. All patients provided written informed
consent.
Study Design
We assigned participants to tai chi or the control
intervention in three randomization cycles, using
computer-generated numbers. The randomized
treatment assignments were sealed in opaque
envelopes and were opened individually for each
patient who agreed to be in the study.
The sponsors had no role in the design and
conduct of the study; the collection, management,
analysis, or interpretation of the data; or the
preparation, review, or approval of the manuscript.
The study was conducted in accordance
with the trial protocol.
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A Randomized Trial of Tai Chi for Fibromyalgia
n engl j med 363;8 nejm.org august 19, 2010 745
Tai Chi Intervention
The tai chi intervention took place twice a week
for 12 weeks, and each session lasted for 60 minutes.
Classes were taught by a tai chi master with
more than 20 years of teaching experience. In the
first session, he explained the theory behind tai
chi and its procedures and provided participants
with printed materials on its principles and techniques.
In subsequent sessions, participants practiced
10 forms from the classic Yang style of tai
chi18 under his instruction. Each session included
a warm-up and self-massage, followed by a review
66 Underwent randomization
90 Underwent baseline evaluation
24 Were excluded
1 Did not have fibromyalgia
4 Were physically unable to participate
17 Had scheduling conflicts
1 Was currently practicing tai chi
1 Had preexisting medical condition
124 Were within the Boston area
34 Were excluded
19 Had scheduling conflicts
4 Had practiced tai chi in the past 6 mo
11 Did not report fibromyalgia
356 Patients were prescreened by telephone
232 Were outside the Boston area
33 Were assigned to the tai chi group 33 Were assigned to the control group
1 Had a scheduling conflict
3 Declined to participate
1 Was outside the U.S.
32 Completed the 12-wk evaluation 29 Completed the 12-wk evaluation
1 Was lost to follow-up
1 Moved out of Boston area
30 Completed the 24-wk evaluation 29 Completed the 24-wk evaluation
Figure 1. Screening, Randomization, and Completion of 12-Week and 24-Week Evaluations.
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746 n engl j med 363;8 nejm.org august 19, 2010
of principles, movements, breathing techniques,
and relaxation in tai chi. Throughout the intervention
period, participants were instructed to
practice tai chi at home for at least 20 minutes
each day. At the end of the 12-week intervention,
participants were encouraged to maintain their
tai chi practice, using an instructional DVD, up
until the follow-up visit at 24 weeks.
Control Intervention
Our wellness education and stretching program
similarly included 60-minute sessions held twice
a week for 12 weeks.19 At each session, a variety
of health professionals provided a 40-minute
didactic lesson on a topic relating to fibromyalgia,
including the diagnostic criteria; coping strategies
and problem-solving techniques; diet and
nutrition; sleep disorders and fibromyalgia; pain
management, therapies, and medications; physical
and mental health; exercise; and wellness and
lifestyle management.20 For the final 20 minutes
of each class, participants practiced stretching exercises
supervised by the research staff. Stretches
involved the upper body, trunk, and lower body
and were held for 15 to 20 seconds. Participants
were instructed to practice stretching at home for
20 minutes a day.
Adherence to Programs
Participants in both groups were encouraged to
continue their routine activities during the 12-
week intervention period but were asked not to
take part in any new, additional exercise programs.
Adherence was maximized by an oral and
written commitment from all participants at the
baseline evaluation. The research staff asked
participants who missed a class to attend a makeup
class. Throughout the 12-week intervention
period, we tracked the number of missed sessions
and asked subjects to complete daily logs indicat-
Table 1. Baseline Characteristics of the Study Participants.*
Variable
Tai Chi Group
(N = 33)
Control Group
(N = 33)
Female sex — no. of patients (%) 28 (85) 29 (88)
Age — yr 49.7±11.8 50.5±10.5
White race — no. of patients (%)† 20 (61) 17 (52)
High-school or higher education — no. of patients (%) 31 (94) 30 (91)
Body-mass index‡ 33.9±8.9 31.5±7.4
Duration of fibromyalgia-related pain — yr 11.8±6.9 10.0±7.2
Medications taken before intervention — no. of patients (%)
Analgesics 29 (88) 24 (73)
Antidepressants 17 (51) 15 (45)
Anticonvulsants 9 (27) 5 (15)
Muscle relaxants 9 (27) 4 (12)
Benzodiazepines 5 (15) 3 (9)
Self-reported coexisting illness — no. of patients (%)
Heart disease 0 0
Hypertension 12 (36) 6 (18)
Diabetes 6 (18) 1 (3)
FIQ score§ 62.9±15.5 68.0±11
Visual-analogue scale¶
Patient’s global assessment 5.8±2.3 6.3±1.8
Physician’s global assessment 5.7±1.9 5.6±2.4
PSQI score‖ 13.9±3.1 13.5±3.7
SF-36 score**
Physical component 28.5±8.4 28.0±7.8
Mental component 42.6±12.2 37.8±10.5
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A Randomized Trial of Tai Chi for Fibromyalgia
n engl j med 363;8 nejm.org august 19, 2010 747
ing the amount of time they practiced tai chi or
stretching exercises.
Outcome Measures and Follow-Up
The primary outcome measure was the change in
the Fibromyalgia Impact Questionnaire (FIQ)
score from baseline to the end of the 12-week
intervention. The FIQ is a well-validated, multidimensional
measure of the overall severity of fibromyalgia
as rated by patients. Categories include
the intensity of pain, physical functioning, fatigue,
morning tiredness, stiffness, depression, anxiety,
job difficulty, and overall well-being.21 The total
score ranges from 0 to 100, with higher scores
indicating more severe symptoms.
Secondary outcomes during the 12-week intervention
included FIQ scores (obtained weekly).
Global pain status was assessed separately by the
participant and the study physician, who was
unaware of the group assignment, with the use
of a visual-analogue scale (VAS) (range, 0 to 10,
with higher scores indicating greater pain). The
study physician also determined the number of
tender sites (of 18 sites in total) according to the
standardized protocol.16,22 The research staff, who
were also unaware of the group assignments,
evaluated participants’ physical performance by
measuring the time to completion of the 6-minute
walk test (measured in yards).23 Additional
measures included the score on the Pittsburgh
Sleep Quality Index (PSQI) (range, 0 to 21, with
higher scores indicating worse sleep quality),24
the score on the depression scale of the Center
for Epidemiologic Studies (CES-D) (range, 0 to
60, with higher scores indicating more severe
depression),25 the score on the Outcome Expectations
for Exercise Scale (range, 1 to 5, with 1 indicating
no expectations for exercise and 5 the
highest expectations for exercise),26 the score on
the Chronic Pain Self-Efficacy Scale (CPSS) (range,
1 to 10, with higher scores indicating greater
self-efficacy with respect to the management of
chronic pain),27 and the summary scores for the
physical and mental quality-of-life components
of the Medical Outcomes Study 36-Item Short-
Form Health Survey (SF-36) (range, 0 to 100, with
higher scores indicating better health status).28
Participants continued to take their regular
medications, and we recorded any changes in the
use of analgesics, antidepressants, anticonvul-
Table 1. (Continued.)
Variable
Tai Chi Group
(N = 33)
Control Group
(N = 33)
CES-D score†† 22.6±9.2 27.8±9.2
CPSS score‡‡ 5.2±1.9 4.6±2.2
6-Minute walk test — yd§§ 522.1±102.7 501.2±106.6
Outcome Expectations for Exercise score¶¶ 3.7±0.8 3.9±0.7
* Plus–minus values are means ±SD unless otherwise noted.
† Race was reported by the patients.
‡ The body-mass index is the weight in kilograms divided by the square of the height in meters. This value was missing
for one patient in the tai chi group.
§ The Fibromyalgia Impact Questionnaire (FIQ) assesses physical function, common symptoms, and general well-being
in fibromyalgia. Scores range from 0 to 100, with higher scores indicating more severe symptoms.
¶ Patient global status was assessed separately by the participant and the study physician with the use of a visual-analogue
scale. Scores range from 0 to 10, with 0 equaling no pain.
‖ Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
** The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is a self-administered, 36-item questionnaire
that assesses the concepts of physical functioning, role limitations due to physical problems, social function, bodily
pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. Note
that both the physical and mental component summaries can be combined. Scores range from 0 to 100, with higher
scores indicating better health status.
†† Scores on the Center for Epidemiologic Studies Depression (CES-D) index range from 0 to 60, with higher scores indicating
more dysphoria. The difference between the scores of the two treatment groups was significant (P<0.05).
‡‡ The Chronic Pain Self-Efficacy Scale (CPSS) reflects the patients’ confidence in their ability to perform a particular behavior
or task and is believed to be a determinant of fibromyalgia symptoms. Scores range from 1 to 10, with higher
scores indicating better status.
§§ The 6-minute walk test measures the distance covered during the 6-minute walk (in yards) as an objective assessment
of mobility. It was considered to be a proxy for physical function, with higher scores indicating improved functional
conditioning in fibromyalgia. To convert yards to meters, multiply by 0.9144.
¶¶ Scores on the Outcome Expectations for Exercise Scale range from 1 to 5, with higher scores indicating high outcome
expectations.
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sants, muscle relaxants, benzodiazepines, dopamine
agonists, or 5-hydroxytryptamine agonists.
To test durability of the response, outcome measurements
were repeated at the 24-week follow-up
visit.
Throughout the entire intervention period,
we monitored adverse events, using a standard
adverse-event case report form at each visit. This
form included a description of all unanticipated
benefits and undesirable experiences, particularly
falls and exacerbations of fibromyalgia symptoms.
Lack of an effect with tai chi or with
stretching and wellness education was not considered
an adverse event. By the nature of an
exercise program, delayed muscle soreness (mild
muscle pain or discomfort that occurred after
exercise, did not require medical intervention,
and resolved within 72 hours) was an expected
outcome and thus was not considered an adverse
event.
Statistical Analysis
A trial conducted in Sweden, in which 58 participants
were assigned to 32 weeks of either aquatic
exercise or education (control), showed a significant
effect size (i.e., standardized mean difference
between groups) of 0.7 points in the FIQ score
(mean [±SD] change, –0.9±1.3 in the exercise
group vs. 0.0±1.4 in the control group).29 Guided
by these results, we randomly assigned 66 patients
to two groups (33 patients to each), which
provided 78% power to detect a difference between
means at a significance level of 5% with
the use of a two-sided t-test.
We compared between-group changes in outcomes
at 0, 12, and 24 weeks (and weekly FIQ
Table 2. Changes in Primary and Secondary Outcomes.*
Variable Mean Change from Baseline (95% CI) Between-Group Difference (95% CI)
Tai Chi Group
(N = 33)
Control Group
(N = 33)
Tai Chi Group vs.
Control Group P Value†
FIQ score‡
Week 12 −27.8 (−33.8 to −21.8) −9.4 (−15.5 to −3.4) −18.4 (−26.9 to −9.8) <0.001
Week 24 −28.6 (−34.8 to −22.4) −10.2 (−16.4 to −4.0) −18.3 (−27.1 to −9.6) <0.001
Patient’s global assessment score§
Week 12 −2.5 (−3.3 to −1.7) −0.6 (−1.4 to 0.2) −1.9 (−3.1 to −0.7) 0.002
Week 24 −2.4 (−3.1 to −1.7) −0.7 (−1.4 to 0.01) −1.7 (−2.7 to −0.8) 0.001
Physician’s global assessment score§
Week 12 −1.0 (−1.7 to −0.4) 0.02 (−0.6 to 0.7) −1.1 (−1.9 to −0.2) 0.02
Week 24 −0.5 (−1.2 to 0.1) 0.6 (0.03 to 1.2) −1.1 (−2.0 to −0.2) 0.02
PSQI score¶
Week 12 −3.6 (−4.8 to −2.4) −0.7 (−1.9 to 0.5) −2.9 (−4.6 to −1.2) 0.001
Week 24 −4.2 (−5.8 to −2.7) −1.2 (−2.7 to 0.4) −3.0 (−5.2 to −0.9) 0.007
6-Minute walk test (yd)‖
Week 12 60.6 (37.9 to 83.3) 16.3 (−6.4 to 38.9) 44.4 (12.3 to 76.4) 0.007
Week 24 49.8 (25.9 to 73.8) 23.2 (0.8 to 47.1) 26.7 (−7.2 to 60.5) 0.12
Body-mass index**
Week 12 0.02 (−0.4 to 0.4) −0.2 (−0.5 to 0.2) 0.2 (−0.3 to 0.7) 0.47
Week 24 −0.2 (−0.7 to 0.3) −0.3 (−0.8 to 0.2) 0.1 (−0.6 to 0.8) 0.76
SF-36 score††
Physical component
Week 12 8.5 (5.7 to 11.3) 1.4 (−1.5 to 4.2) 7.1 (3.1 to 11.1) 0.001
Week 24 8.4 (5.6 to 11.3) 1.5 (−1.4 to 4.3) 7.0 (2.9 to 11.0) 0.001
Mental component
Week 12 7.7 (3.9 to 11.6) 1.6 (−2.2 to 5.4) 6.1 (0.7 to 11.6) 0.03
Week 24 8.5 (4.6 to 12.4) 1.2 (−2.7 to 5.0) 7.3 (1.9 to 12.8) 0.009
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A Randomized Trial of Tai Chi for Fibromyalgia
n engl j med 363;8 nejm.org august 19, 2010 749
scores during the 12-week intervention) with
mixed models, using time and group as categorical
fixed factors, interactions between time and
group, random intercepts, and an unstructured
covariance matrix. Effects were evaluated on an
intention-to-treat basis, and participants who did
not complete the follow-up period were considered
not to have had any changes in scores. We
tested for potential interactions between treatment
and covariates, including age, sex, bodymass
index, fibromyalgia duration, pain-severity
score, coexisting illnesses, health status, and
medication use. A two-sided P value of less than
0.05 indicated statistical significance. Results are
presented as between-group differences with 95%
confidence intervals.
Results
Between July 2007 and December 2008, we
screened 356 patients by telephone. Of the 124
patients who resided near Boston, 90 qualified
for the baseline evaluation; 24 patients in this
group were excluded for various reasons, and the
66 eligible participants were randomly assigned
in equal numbers to either the tai chi intervention
or the control intervention (Fig. 1).
Baseline Characteristics of the Patients
Table 1 shows baseline data for the 66 participants
before randomization. Participants had a
mean age of 50 years, 86% were women, and
56% were white; the mean body-mass index (the
weight in kilograms divided by the square of the
height in meters) was 32.7. On average, participants
had had fibromyalgia for 11 years. Baseline
characteristics were reasonably well balanced
between the two groups, except that the tai chi
group had a lower CES-D score. The average score
on the physical component of the SF-36 was
about 2 SD below normal, indicating a cohort
with poor health.
The rate of attendance during the 12-week
intervention was 77% for the tai chi group and
70% for the control group. Five patients withdrew
from the study by 12 weeks, and seven by
24 weeks (Fig. 1).
Table 2 and Figure 2 show changes from base-
Table 2. (Continued.)
Variable Mean Change from Baseline (95% CI) Between-Group Difference (95% CI)
Tai Chi Group
(N = 33)
Control Group
(N = 33)
Tai Chi Group vs.
Control Group P Value†
CES-D score‡‡
Week 12 −8.1 (−10.9 to −5.3) −2.3 (−5.1 to 0.6) −5.9 (−9.8 to −1.9) 0.005
Week 24 −6.5 (−9.4 to −3.6) −2.4 (−5.3 to 0.5) −4.1 (−8.2 to 0.1) 0.05
CPSS score§§
Week 12 1.5 (0.7 to 2.2) 0.5 (−0.3 to 1.2) 1.0 (−0.03 to 2.0) 0.06
Week 24 1.2 (0.4 to 1.9) 0.6 (−0.2 to 1.4) 0.6 (−0.5 to 1.6) 0.28
* All values are means, with the 95% confidence intervals.
† P values were calculated with repeated-measures analysis of variance.
‡ The Fibromyalgia Impact Questionnaire (FIQ) assesses physical function, common symptoms, and general wellbeing
in patients with fibromyalgia. Scores range from 0 to 100, with higher scores indicating more severe symptoms.
§ Global status was assessed separately by the study participant and the study physician with the use of a visual-analogue
scale ranging from 0 to 10, with higher scores indicating greater pain.
¶ Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep
quality.
‖ The 6-minute walk test measures the distance covered during the 6-minute walk (in yards) as an objective assessment
of mobility. It was considered to be a proxy for physical function, with higher scores indicating improved functional
conditioning. To convert yards to meters, multiply by 0.9144.
** The body-mass index is the weight in kilograms divided by the square of the height in meters. This value was missing
for one patient in the tai chi group.
†† Scores on the mental and physical components of the Medical Outcomes Study 36-Item Short-Form Health Survey
(SF-36) range from 0 to 100, with higher scores indicating better health status. Values were obtained by means of
repeated-measures analysis of variance, which accounts for slight differences from values given in the text.
‡‡ Scores on the Center for Epidemiologic Studies Depression (CES-D) index range from 0 to 60, with higher scores indicating
greater dysphoria.
§§ Scores on the Chronic Pain Self-Efficacy Scale (CPSS), which measures patients’ confidence in their ability to perform
a particular behavior or task, range from 1 to 10, with higher scores indicating improved status.
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750 n engl j med 363;8 nejm.org august 19, 2010
line to 12 and 24 weeks in the two groups for all
outcomes.
At 12 weeks, the tai chi group had a significantly
greater decrease in the total FIQ score
than did the control group (−27.8 points [95%
confidence interval {CI}, −33.8 to −21.8] vs. −9.4
points [95% CI, −15.5 to −3.4]). The mean betweengroup
difference was −18.4 points (95% CI, −26.9
to −9.8). Figure 3 shows that the mean betweengroup
difference in FIQ scores gradually increased
during the intervention. Similarly, at 24 weeks the
tai chi group had a significant reduction in symptoms
(change in the total FIQ score from baseline
to 24 weeks, −28.6 points [95% CI, −34.8 to
−22.4]), which was greater than the improvement
in the control group; the mean between-group difference
in the change from baseline to 24 weeks
was −18.3 points (95% CI, −27.1 to −9.6; P<0.001).
At 12 weeks, the tai chi group had greater
mean improvement in sleep quality than the control
group, as measured by the change in the
PSQI score (mean between-group difference, −2.9
points [95% CI, −4.6 to −1.2]; P = 0.001). In addition,
the tai chi group had greater improvement
as measured by the change in the patient’s global
assessment (mean between-group difference, −1.9
FIQ Score
100
80
90
70
60
40
30
10
50
20
0
P<0.001
PSQI Score
21
18
12
9
3
15
6
0
P=0.002
Patient’s Global Assessment
of Pain
10
8
6
4
2
0
P=0.001
Physician’s Global
Assessment of Pain
10
8
6
4
2
0
P=0.02
CES-D Score
60
50
30
20
40
10
0
P=0.02
6-Min Walk (yd)
700
600
500
400
200
300
100
0
P=0.02
SF-36 Physical-Component
Score
100
80
90
70
60
40
30
10
50
20
0
100
80
90
70
60
40
30
10
50
20
0
Baseline 12 Wk 24 Wk Baseline 12 Wk 24 Wk Baseline 12 Wk 24 Wk
P=0.001
SF-36 Mental-Component
Score
P=0.03
CPSS Score
10
8
6
4
2
0
P=0.15
Tai chi group
Control group
Tai chi group
Control group
Tai chi group
Control group
Tai chi group
Control group
Tai chi group
Control group
Tai chi group
Control group
Tai chi group
Control group
Tai chi group
Control group
Tai chi group
Control group
Figure 2. Mean Changes in Nine Secondary Outcomes at 12 and 24 Weeks, According to Treatment Group.
Outcome scores are shown for the tai chi group (squares) and the control group (triangles). The values shown are unadjusted means;
I bars indicate 95% confidence intervals. Measurements were obtained at baseline, 12 weeks, and 24 weeks, but data points are slightly
offset for clarity. Scores on the Fibromyalgia Impact Questionnaire (FIQ) range from 0 to 100, with higher scores indicating more severe
symptoms. Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Global assessments of pain were made on a visualanalogue
scale (VAS) from 0 to 10, with 0 equaling no pain. Scores on the Center for
Epidemiologic Studies Depression (CESD)
index range from 0 to 60, with higher scores indicating more severe depression. The 6minute
walk test is measured in yards (to convert values to meters, multiply by 0.9144). Summary scores on the physical and mental components
of the Medical Outcomes Study 36Item
ShortForm
Health Survey (SF36)
range from 0 to 100, with higher scores indicating better health
status. Scores on the Chronic Pain SelfEfficacy
Scale (CPSS) range from 1 to 10, with higher scores indicating greater selfefficacy
with
respect to the management of chronic pain. In summary, for the FIQ, the PSQI, the patient and physician assessments on the VAS, and the
CESD,
lower scores indicate improvement in outcome. For the SF36
physical and mental components, the 6minute
walk test, and the CPSS,
higher scores indicate improvement in outcome.
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A Randomized Trial of Tai Chi for Fibromyalgia
n engl j med 363;8 nejm.org august 19, 2010 751
points [95% CI, −3.1 to −0.7]; P = 0.002). The
change from baseline to 12 weeks in the physician’s
objective global assessment also differed
significantly between the two groups (mean
between-group difference, −1.1 points [95% CI,
−1.9 to −0.2]; P = 0.02). The 6-minute walk test
was significantly better with tai chi at 12 weeks
(mean between-group difference, 44.4 yd [95%
CI, 12.3 to 76.4]; P = 0.007). At 12 weeks, the tai
chi group also had greater improvement in the
scores for the SF-36 physical component (mean
between-group difference, 7.1 points [95% CI, 3.1
to 11.1]; P = 0.001), the SF-36 mental component
(mean between-group difference, 6.1 points
[95% CI, 0.7 to 11.6]; P = 0.03), and the CES-D
(mean between-group difference, −5.9 points
[95% CI, −9.8 to −1.9]; P = 0.005). The tai chi
group had greater improvement in the CPSS
score, but the difference was not significant
(mean between-group difference, 1.0 point [95%
CI, −0.03 to 2.0]; P = 0.06). The body-mass index
remained stable in both groups.
Improvements with tai chi were maintained
at 24 weeks for sleep quality, the patient’s and
physician’s global assessments, the scores for the
SF-36 physical and mental components, and the
CES-D score. The changes from baseline to 24
weeks in the 6-minute walk test and the CPSS
score also favored tai chi over the control intervention,
but the between-group difference was
not significant.
Table 3 shows that, with a clinically meaningful
change in the FIQ score defined as 8.1
points,30 significantly more patients in the tai chi
group than in the control group had improvement:
79% versus 39% (P = 0.001) at 12 weeks, and 82%
versus 53% (P = 0.009) at 24 weeks. The tai chi
group also met standards for clinically meaningful
improvement in the patient’s VAS score for pain
and in sleep-quality, CES-D, and SF-36 scores significantly
more often than did controls (Table 3).
All treatment effects remained significant
after adjusting for the baseline CES-D score,
and no interactions with treatment were found.
No adverse events were noted during the study
interventions.
Medication Use
At 12 weeks, more subjects had discontinued
medication used to treat fibromyalgia in the tai
chi group than in the control group, but the difference
was not significant (11 of 31 patients vs.
4 of 26, P = 0.09).
Discussion
This randomized, controlled trial shows that tai
chi is potentially a useful therapy for patients
with fibromyalgia. The effect was evident in the
FIQ score, a well-validated, multidimensional instrument
for the assessment of fibromyalgia, and
in other measures of pain and quality of life and
was consistent with both subjective and objective
assessments. The observed benefits exceeded the
specified thresholds for clinically significant improvement
in the FIQ score30 and in the measures
used to assess pain,31 sleep quality,24 depression,
32 and quality of life,28,33 and these benefits
were sustained at 24 weeks. No adverse events
were reported in the study participants, indicating
that tai chi is probably a safe therapy for patients
with fibromyalgia.
Our results are consistent with those of a
previous, nonrandomized trial of tai chi for
fibromyalgia, as well as with the findings in
other studies showing the benefits of tai chi
with regard to musculoskeletal pain, depression,
and quality of life.13,34 Our findings are also
consistent with observations from other clinical
trials and meta-analyses that support the
benefits of physical exercise and mind–body
FIQ Score
70
60
80
40
30
10
50
20
0
1 2 3 4 5 6 7 8 9 10 11 12
Weeks
Control group
Tai chi group
AUTHOR:
FIGURE:
RETAKE:
SIZE
Line Combo 4-C H/T
Revised
AUTHOR, PLEASE NOTE:
Figure has been redrawn and type has been reset.
Please check carefully.
1st
2nd
3rd
Wang
3 of 3
ARTIST:
TYPE:
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JOB: 36308 ISSUE: 08-19-10
4 col
22p3
Figure 3. Fibromyalgia Impact Questionnaire (FIQ) Scores during the 12-Week
Intervention Period, According to Treatment Group.
FIQ scores, measured weekly over the 12-week intervention period, are shown
for the tai chi group and the control group. The FIQ scores range from 0 to
100, with higher scores indicating more severe symptoms and lower scores
indicating improvement in outcomes. The values shown are unadjusted
means; the data points are slightly offset for clarity. I bars indicate 95%
confidence intervals.
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Th e new england journal o f medicine
752 n engl j med 363;8 nejm.org august 19, 2010
practice for symptom management in fibromyalgia.
35-41
The biologic mechanisms by which tai chi
might affect the clinical course of fibromyalgia
remain unknown. As a complex, multicomponent
intervention, tai chi may act through many intermediate
variables along the pathway to improved
health outcomes. Physical exercise has been
shown to increase muscle strength and blood
lactate levels in some patients with fibromyalgia.
42 Mind–body interventions may improve psychosocial
well-being, increase confidence, and
help patients overcome fear of pain.43 Furthermore,
controlled breathing and movements promote
a restful state and mental tranquility, which
may raise pain thresholds and help break the
“pain cycle.” 44 All these components may influence
neuroendocrine and immune function as
well as neurochemical and analgesic pathways
that lead to enhanced physical, psychological,
and psychosocial well-being and overall quality
of life in patients with fibromyalgia.40,45,46
Our study had some limitations. We did not
use a double-blind study design, since this would
have required the use of sham tai chi, for which
no validated approach currently exists. Devising
a sham mind–body intervention poses a set of
unique challenges when one attempts to separate
the various mind and body components. Nevertheless,
the development of some form of sham
intervention for use in future studies of tai chi is
a desirable goal. To minimize the influence of
preexisting beliefs and expectations with respect
to tai chi (e.g., its possible placebo effect), we
informed participants only that the study was
designed to test the effects of two different
types of exercise training programs, one of which
was combined with education. Deemphasizing
tai chi may have lessened participants’ expectations
and minimized biases. Notably, the baseline
outcome expectations of benefit from an exercise
intervention were similar in the tai chi
and control groups (3.7±0.8 and 3.9±0.7, respectively),
indicating that our neutral presentation
of the interventions may have been successful.
The fact that treatment was delivered by a
single tai chi master at a single center also potentially
limits the generalizability of our results.
However, the group of patients with poor health
status at baseline may in general resemble patients
with fibromyalgia. For these reasons, it
would be prudent to further explore the benefits
of tai chi for fibromyalgia in other settings with
other instructors. Since tai chi is a complex
mind–body intervention with a variety of active
ingredients, such as social support, relaxation,
and cognitive behavioral elements,47 assessment
of its placebo effect might require separate evaluations
of these ingredients. Finally, we followed
participants for only 24 weeks, so the long-term
effectiveness of tai chi in patients with fibromyalgia
remains to be determined.
In conclusion, our preliminary findings indi-
Table 3. Patients with Clinically Meaningful Improvement.
Variable
Tai Chi Group
(N = 33)
Control Group
(N = 33) P Value*
no. of patients (%)
FIQ score†
Week 12 26 (78.8) 13 (39.4) 0.001
Week 24 27 (81.8) 17 (51.5) 0.009
Patient’s global assessment‡
Week 12 18 (54.5) 9 (27.3) 0.02
Week 24 18 (54.5) 9 (27.3) 0.02
PSQI score§
Week 12 13 (39.4) 4 (12.1) 0.01
Week 24 15 (45.5) 6 (18.2) 0.02
CES-D score¶
Week 12 24 (72.7) 16 (48.5) 0.04
Week 24 23 (69.7) 13 (39.4) 0.01
SF-36 scores‖
Physical component
Week 12 18 (54.5) 5 (15.2) 0.001
Week 24 17 (51.5) 5 (15.2) 0.002
Mental component
Week 12 14 (42.4) 8 (24.2) 0.12
Week 24 16 (48.5) 8 (24.2) 0.04
* P values were calculated with the use of the chi-square test.
† A change in the score on the Fibromyalgia Impact Questionnaire (FIQ) of 14%
(or 8.1 units) indicates clinically meaningful improvement.30
‡ A reduction of 30% (or 2 points) on a visual-analogue scale indicates clinically
meaningful improvement.31
§ A change of greater than 5 in the total score of the Pittsburgh Sleep Quality
Index (PSQI) indicates clinically meaningful disturbed or poor sleep.24
¶ A reduction of 10% (or 6 points) on the Center for Epidemiologic Studies
Depression (CES-D) index indicates a clinically significant change.32
‖ On follow-up, changes of 6.5 points on the SF-36 physical-component scale
and of 7.9 points on the mental-component scale indicate clinically meaningful
improvement.28,33
The New England Journal of Medicine as published by New England Journal of Medicine.
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Copyright © 2010 Massachusetts Medical Society. All rights reserved.
A Randomized Trial of Tai Chi for Fibromyalgia
n engl j med 363;8 nejm.org august 19, 2010 753
cate that tai chi may be a useful treatment in the
multidisciplinary management of fibromyalgia.
Longer-term studies involving larger clinical samples
are warranted to assess the generalizability
of our findings and to deepen our understanding
of this promising therapeutic approach.
The contents of this article are solely the responsibility of the
authors and do not necessarily represent the official views of the
National Center for Complementary and Alternative Medicine or
the National Institutes of Health.
Supported by a grant (R21AT003621) from the National Center
for Complementary and Alternative Medicine of the National
Institutes of Health, the American College of Rheumatology
Research and Education Foundation Health Professional Investigator
Award, and the Boston Claude D. Pepper Older Americans
Independence Center Research Career Development Award.
Disclosure forms provided by the authors are available with
the full text of this article at NEJM.org.
We thank the data and safety monitoring board members,
Drs. Daniel S. Rooks, Karen H. Costenbader, and Lee-Jen Wei,
for their insightful suggestions concerning the study protocol;
Marcie Griffith, Judith L. Ramel, Melynn Nuite, Xiaogang Gao,
and Drs. Irwin Rosenberg, John Griffith, Ronenn Roubenoff,
Raveendhara Bannuru, Aghogho Okparavero, and Paola DePablo;
the Clinical Research Center nurses for their help with various
aspects of the study and Drs. Haewook Han and Harry Pino for
their expertise in teaching the control group; and the study participants,
whose cooperation, encouragement, and enthusiasm
were an inspiration to us.
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The New England Journal of Medicine as published by New England Journal of Medicine.
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