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RESEARCH ARTICLE
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Abstract
Introduction: Our objective was to compare the effectiveness and safety of traditional Chinese moxibustion to that
of sham moxibustion in patients with chronic knee osteoarthritis (KOA) pain.
Methods: We conducted a randomized placebo-controlled trial involving 110 patients with KOA who met the
inclusion criteria. These patients randomly received either active moxibustion (n = 55) or sham moxibustion control
(n = 55) at acupoints Dubi (ST 35), extra-point Neixiyan (EX-LE 4), and an Ashi (tender) point three times a week for
6 weeks. Effects were evaluated with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC VA
3.1) criteria at the end of the course of treatment and 3, 12, and 24 weeks after the initial treatment.
Results: The WOMAC pain scores showed greater improvement in the active treatment group than in control at
weeks 3 (P = 0.012), 6 (P <0.001), 12 (P = 0.002), and 24 (P = 0.002) as did WOMAC physical function scores of the
active treatment group at week 3 (P = 0.002), 6 (P = 0.015), and 12 (P <0.001) but not 24 (P = 0.058). Patients and
practitioners were blinded successfully, and no significant adverse effects were found during the trial.
Conclusions: A 6-week course of moxibustion seems to relieve pain effectively and improve function in patients
with KOA for up to 18 weeks after the end of treatment. Moxibustion treatment appears to be safe, and the
usefulness of the novel moxa device was validated.
Trial registration: Current controlled trial: ISRCTN68475405. Registered 4 April 2014.
Introduction
Knee osteoarthritis (KOA), common among the elderly,
significantly affects patient quality of life because of pain
and physical activity limitations [1,2]. Today, in Chinese
who are at least 60 years old, the prevalence of symptomatic KOA is 19.4% [3]. Pharmacological therapies are
often ineffective, and agents such as non-steroidal antiinflammatory drugs can cause undesired side effects.
* Correspondence: sxy1@shutcm.edu.cn
Equal contributors
1
Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road,
Shanghai 201203, China
2
Shanghai Research Center of Acupuncture & Meridian, 199 Guoshoujing
Road, Shanghai 201203, China
Full list of author information is available at the end of the article
2014 Zhao et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication
waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise
stated.
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Methods
Random assignment
Research design
Procedures
Blinding
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Figure 1 Real and sham moxibustion pillar. The real and sham moxibustion devices appear to be identical. (A) The real device has holes at
the bottom to allow heat and smoke to radiate to the acupoints. (B) The sham device has a metal membrane at its base to block the smoke and
minimize the heat.
Treatment procedure
treatment they thought that they had administered. Patient blinding was assessed at the end of the 6-week
course of treatment by using a previously validated questionnaire [19].
Statistical considerations
Results
In total, 124 eligible patients were screened and enrolled
between August 2009 and October 2011; 14 were excluded: 6 because of insufficient pain, 4 for other clinically
significant diseases, and 4 because they showed no radiographic evidence of an osteophyte. Of the 110 randomly
assigned patients, all completed the 6-week course of
treatment and 105 were assessed at 12 weeks (52 from the
active group and 53 from the sham group). A total of 99,
49 from the active group and 50 from sham, completed
the full 24 weeks (Figure 2). There was no difference between the two groups in age, gender, or course and severity of disease (P >0.05). Before treatment, there was no
difference in WOMAC scores for knee pain or physical
function between the groups (P >0.05). Baseline characteristics of the patients are presented in Table 1.
Pain
In all post-baseline assessments, WOMAC pain scores improved more in patients receiving active moxibustion than
in those receiving sham (Table 2). Pain score at baseline
was 6.69 2.41 in the active group and decreased to 4.80
2.47 at week 3; pain score at baseline was 6.27 2.72 in the
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Figure 2 Flow diagram of the progress through the phases of the RCT.
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Sham group
Total
(n = 55)
(n = 55)
(n = 110)
65.80 7.45
64.55 8.38
65.17 7.89
Male
16 (29.09)
21 (38.18)
37 (33.63)
Female
39 (70.90)
34 (61.81)
73 (66.36)
1 knee
12 (21.82)
18 (32.73)
30 (27.27)
Both knees
43 (78.18)
37 (67.27)
80 (72.72)
<5 years
30 (54.55)
37 (67.27)
67 (60.90)
6-10 years
18 (32.73)
12 (21.82)
30 (27.27)
>10 years
7 (12.73)
6 (1.090)
13 (11.82)
Weight, kg
64.06 9.02
66.01 5.21
65.04 6.33
Height, cm
1.63 5.28
1.62 1.45
1.62 7. 98
24.11 1.08
25.15 2.41
24.63 5.52
Characteristics
Age, years
Gender, n (%)
Outcomes (baseline)
WOMAC pain score
WOMAC function score
6.73 2.35
6.29 2.70
6.51 2.53
33.47.0 15.37
30.99 17.82
32.23 16.61
There were no differences between the groups in age, gender, course of disease, or condition of the diseased knee (P >0.05). There were no differences between
the groups in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain or physical function scores (P >0.05).
Blinding
The dropout rate was low; by the end of the trial, it was
10% (11 out of 110). In the active moxibustion group,
six of the 55 patients were lost to follow-up: three at
week 12; one felt the treatment was ineffective, and two
Endpoint
Week
Pain
24.65 43.42
2.63 57.87
52.87 31.57
12
57.90 31.77
24
Function
Z value
P value
2.513
0.012a
24.43 50.03
3.806
<0.001a
18.37 62.38
3.052
0.001a
50.75 35.03
20.47 57.30
3.111
0.002a
21.71 79.25
7.23 96.90
3.080
0.002a
39.03 71.26
13.14 111.49
2.423
0.015a
12
50.84 43.67
14.51 89.63
3.543
<0.001a
24
43.58 53.51
11.28 114.82
1.898
0.058
x SD
x SD
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score reduction change (post-treatment baseline)/baseline 100%. P <0.05 for
purpose of comparison. SD, standard deviation.
a
Discussion
In this double-blind RCT, a 6-week course of moxibustion
treatment significantly reduced pain and improved function in patients with KOA compared with sham control.
Although the effectiveness of moxibustion treatment has
been reported by others, the results of most of those studies were inclusive: the studies were of low quality and had
high risks of bias [26,27]. In a systematic review on moxibustion for KOA, Choi and colleagues [27] found that the
modality might be effective for symptom management in
patients with KOA: 83% of the studies reviewed (39 out of
47) reported an effective rate. However, owing to the limited number of studies, their poor quality, and their inadequate use of controls and high risk of bias, the authors
concluded that these RCTs provided little supporting evidence for their use in KOA [27].
In contrast, in the present trial, we addressed such limitations by using rigorous double-blinded, placebo-controlled
methods with adequate random assignment. Another
strength of our study is that the compliance rate in the
first 6 weeks of the trial was high (100%), possibly because
most of the participants were elderly and retired, with
more time for treatment than those still working. Additionally, they all lived close to our hospitals, and many of
them said that they found the treatment and the setting
comfortable. Our trial is characterized as an effectiveness
study, as defined by Gartlehner and colleagues [28]. The
trial was conducted in a primary-care setting, the outcome
was a condition-relevant health outcome, follow-up time
was sufficient, and an intention-to-treatment statistical
analysis was used.
To minimize the risk of bias, we adopted a novel sham
moxibustion device first reported by Zhao and colleagues
[15] in 2006. Similar sham moxibustion methods have
been reported by several other investigators [29,30]. The
uniqueness of our trial is the validated double-blinding.
The nature of the moxibustion procedure makes blinding
difficult, as patients might expect warmth to radiate from
the burning moxa. In our trial, blinding was successful in
part because all of the patients were nave to moxibustion
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Conclusions
The findings of the present trial show that moxibustion,
like acupuncture, can be a useful adjunctive treatment for
patients with KOA. Moxibustion treatment is simple, easy
to perform, and cost-effective. This modality is also more
easily replicable than acupuncture, which is subject to
variation caused by the different needling techniques of individual practitioners. Our findings suggest that traditional
moxibustion is a safe, effective, and easy-to-use therapy
that can be a useful adjunct to conventional medicine for
alleviating pain and improving function in patients with
KOA. A larger RCT using this double-blinded, placebocontrolled, multi-centered approach is warranted to confirm and generalize our findings.
Abbreviations
KOA: knee osteoarthritis; OA: osteoarthritis; RCT: randomized controlled trial;
WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index.
Competing interests
The authors declare that they have no competing interests.
Authors contributions
LZ carried out the data collection and analysis, participated in the trial
coordination, and drafted the manuscript. KC carried out the random
assignment, allocation, and trial registration and drafted the manuscript.
LW participated in trial coordination. FW and HD participated in data
collection. MT carried out the data analysis. LL participated in the trial design
and critically revised the manuscript. XS conceived of the trial and
participated in its design and helped to draft the manuscript. All authors
read and approved the final manuscript.
Authors information
LZ and KC should be considered co-first authors.
Acknowledgments
This study was supported by the National Basic Research Program of China
(2009CB522901), the Key Program of the State Administration of traditional
Chinese medicine (TCM) of China (ZYSNXD-CC-ZDXK-07), the National
Natural Science Foundation of China (NSFC) (81320108028 and 81202648),
the Shanghai Municipal Science Foundation (11DZ1973300), and 2014
Innovation Program of the Shanghai Municipal First-Class Field of Traditional
Chinese Medicine of Shanghai.
Author details
1
Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road,
Shanghai 201203, China. 2Shanghai Research Center of Acupuncture &
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