Complementary Therapies in Clinical Practice 40 (2020) 101210

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Complementary Therapies in Clinical Practice

journal homepage: http://www.elsevier.com/locate/ctcp

The effectiveness of cupping therapy on chronic fatigue syndrome: A

single-blind randomized controlled trial
xiu-dong Meng 1, Hao-ran Guo 1, Qing-ying Zhang , Xin Li , Yong Chen , Mu-yang Li ,
Xue-mao Zhuo , Mei-juan Wang , Kai Shan , Yi-nan Gong , Ning-cen Li , Bo Chen **, Ze-lin Chen *,
Yi Guo
Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China

A R T I C L E I N F O A B S T R A C T

Keywords: Background: and purpose: We investigated the effectiveness of cupping therapy with three different pressures in
Chronic fatigue syndrome patients with chronic fatigue syndrome (CFS).
Cupping therapy Materials and methods: The participants were randomly assigned to three groups, as follows: cupping pressure of
Regularity of effect
0.02 mpa (n ¼ 38), 0.03 mpa (n ¼ 38), or 0.05 mpa (n ¼ 36). Each group received cupping treatment that
consisted of 10 sessions over 5 weeks (2 sessions per week). The primary outcomes were Fatigue Scale (FS-14)
score and Fatigue Assessment Instrument (FAI) score after 5 and 10 sessions. The secondary outcomes were the
Self-Rating Anxiety Scale (SAS) score, the Self-Rating Depression Scale (SDS) score, and the Pittsburgh Sleep
Quality Index (PSQI) score.
Results: There were 91 participants who completed the trial. After five sessions of treatment, the primary
outcome of FS-14 score decreased by 3.20 (2.19, 4.21) in the 0.02 mpa group, by 2.39 (1.51, 3.27) in the 0.03
mpa group, and by 3.40 (2.28, 4.52) in the 0.05 mpa group (P ¼ 0.667). After 10 sessions of treatment, the
outcome of FS-14 score decreased by 5.00 (3.79, 6.21) in the 0.02 mpa group, by 4.06 (3.07, 5.05) in the 0.03
mpa group, and by 4.77 (3.52, 5.94) in the 0.05 mpa group (P ¼ 0.929). And, the results were statistically
different between 5 sessions and 10 sessions of treatment (P < 0.01). However, there were no statistical dif­
ferences in FAI, SAS, SDS, and PSQI scores between the three groups after 5 sessions and 10 sessions of treatment.
Conclusions: In conclusion, cupping therapy has significantly relieved fatigue symptoms and improved emotion
and sleep condition of CFS patients, and 10 sessions of treatment had superior results compared with 5 sessions in
each group. Moreover, in 5 sessions of treatment, cupping with high pressure showed better improvement in
fatigue syndromes and sleep condition according to effective rates.
Trial registration: Chinese clinical trial registry (ChiCTR1800017590); Ethical approval number: ChiECRCT-
20180085.

1. Introduction throat, tender cervical or axillary lymph nodes, muscle pain, pain in
several joints, new headaches, unrefreshing sleep, and malaise after
Chronic fatigue syndrome (CFS), also known as myalgic encephalo­ exertion [1,2]. The overall incidence of CFS in the United Kingdom and
myelitis (ME), is a complicated disorder characterized by extreme fa­ the United States is 0.19%–0.50% [3,4]. At present, clinical treatments
tigue that cannot be explained by any underlying medical condition. are mainly focused on symptomatic therapies, including drugs, exercise
Accompanying symptoms include impaired memory or attention, sore therapy, cognitive behavioral therapy, and complementary

* Corresponding author.
** Corresponding author.
E-mail addresses: [email protected] (x.-d. Meng), [email protected] (H.-r. Guo), [email protected] (Q.-y. Zhang), [email protected]
(X. Li), [email protected] (Y. Chen), [email protected] (M.-y. Li), [email protected] (X.-m. Zhuo), [email protected] (M.-j. Wang),
[email protected] (K. Shan), [email protected] (Y.-n. Gong), [email protected] (N.-c. Li), [email protected] (B. Chen), chenzelin328@163.
com (Z.-l. Chen), [email protected] (Y. Guo).
1
Equal contributor: These authors contributes to the work equally and should be regarded as co-first authors.

https://doi.org/10.1016/j.ctcp.2020.101210
Received 25 October 2019; Received in revised form 4 June 2020; Accepted 8 June 2020
Available online 20 June 2020
1744-3881/© 2020 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
x.-d. Meng et al. Complementary Therapies in Clinical Practice 40 (2020) 101210

preparations, to alleviate symptoms and improve life quality due to the (6) patient has had four or more of the following symptoms, concur­
unknown etiology and pathophysiology. Traditional Chinese medicine rently present for 6 months or longer: impaired memory or concentra­
(TCM) including acupuncture and massage are also recommended in the tion, sore throat, tender cervical or axillary lymph nodes, muscle pain,
clinical manual developed by the International Association of Chronic pain in several joints, new headaches, unrefreshing sleep, or malaise
Fatigue Syndrome (IACFS) [5]. after exertion.
Cupping therapy is one of the TCM treatments that acts on an acu­ The exclusion criteria are as follows: (1) medical condition
point to remove stagnation and stimulate the flow of Qi [6]. Cupping explaining fatigue; (2) patients with cardiovascular and cerebrovascular
therapy is the process of adsorbing the cup (usually made of glass) onto diseases, blood diseases, or infectious diseases; (3) psychiatric disorders
skin by creating negative pressure. The negative pressure is created by including anxiety, psychosis, depressive disorder (psychotic features),
warming or suctioning the air within the cup that draws local tissue into bipolar disorder, schizophrenia, dementia, or delusional disorder; (4)
the cup. The inner-cup negative pressure also increases blood flow and pregnant and lactating women; (5) anorexia nervosa, bulimia nervosa;
loosens fascia or connective tissue as well as accelerating the healing (6) alcohol or substance abuse; (7) taking vasoactive drugs that affect
process in clinical practice [6]. Previous studies have proved that the microcirculation within the last 6 months; (8) infectious skin dis­
cupping therapy could ease the symptoms of CFS by improving the re­ ease, skin allergy, or skin lesion at the site of surgery; (9) severe obesity
sults of the Fatigue Scale (FS-14) and the Fatigue Assessment Instrument [body mass index (BMI) > 28]; and (10) using other therapies unrelated
(FAI), the Self-Rating Anxiety Scale (SAS), and the Self-rating Depres­ to this study, and those patients who are unable to evaluate the efficacy
sion Scale (SDS), among others [7–11]. However, most of these clinical of, understand the significance of, or tolerate the treatment measures of
trials lacked standardized results due to a low level of clinical evidence. the study.
There are various cupping methods such as retention cupping, moving
cupping, and pricking cupping. In addition, cupping therapy is often 2.3. Study interventions
combined with acupuncture, moxibustion, herbal medicine, massage,
and other methods. As a result, there are many influencing factors on the The study protocol was developed by an expert panel experienced in
indicators of outcome. Moreover, there is a lack of research on the the treatment of CFS using cupping therapy. After randomization, each
relationship between cupping pressure and efficacy; thus, our study participant received 10 cupping sessions (10 min each session, twice a
focused on the observation of the efficacy of cupping therapy for CFS week) over 5 weeks with a cupping device (JingLuo GuanTong Instru­
with different negative pressures. ment, JLG-3. Beijing Hai Ao Si Kai technology co., LTD, China). This
cupping device is capable of generating pulsating pressures by using a
2. Materials and methods micro-vacuum pump to generate negative pressure based on the Ber­
noulli principle to realize the stability and adjustment of pressure [12].
2.1. Design We set the pressures at 0.2 mpa, 0.3 mpa, and 0.5 mpa, respec­
tively. The cup was a transparent plastic cup with an inner diameter of
This study was designed as a three-armed, parallel, and participant 46 mm, and the therapy was performed on the same acupoints: Da Zhui
blinded single-centre randomized controlled clinical trial. All partici­ (DU14), Gan Shu (BL18), Pi Shu (BL20), and Ming Men (DU4) in all
pants provided written informed consent before inclusion, and the study three groups. The cupping therapy was performed at four points
was performed at the outpatient department of Acupuncture and Mox­ simultaneously. The effectiveness of this cupping therapy method was
ibustion of Baokang Hospital affiliated with Tianjin University of TCM in validated by pre-experiment [13]. The cupping was performed by the
Tianjin, China. The participants were recruited from August 5 to TCM physicians, who were trained in cupping and were not involved in
December 12, 2018, and all the study interventions and follow-up as­ the data collection. The patients were blinded to their study interven­
sessments were completed by June 2019. The participants who fulfilled tion; although they could feel that they were being cupped, they did not
the pre-screening criteria were asked to meet with the physician for know the specific pressure value.
further information, and then they signed informed consent and baseline
assessment after meeting the inclusion and exclusion criteria. The allo­ 2.4. Outcome parameters
cation to the three groups followed a 1:1:1 block randomization process
that was generated by SPSS 22.0 Software (SPSS Inc. USA). A random 2.4.1. Primary outcomes
intervention allocation was concealed in sequentially numbered, sealed Although there is no consensus on objective indicators for measuring
envelopes, and only the data analyst could access it. The patients were fatigue, the FS-14 [14] and the FAI [15] are widely used in CFS mea­
assigned to the corresponding group according to chronological order surement [16,17]. The FS-14 is a 14-item questionnaire, and it was used
when they met the enrolment criteria. with a Likert-like score in this study. The participants responded ‘Yes’ or
’No’ for each question, and the total scale ranged from 0 to 14 points.
2.2. Participants Higher scores indicated more severe fatigue symptoms. The FAI is a
27-item questionnaire, and each item is scored using a 0- to 7-point scale
The participants were recruited through the WeChat application (0 means disagree at all, 7 means totally agree). The total score of the
(Tencent co., LTD, China) and posters. The recruitment location was the scale ranged from 0 to 189 points, and higher scores indicated more
outpatient department of Acupuncture and Moxibustion of Baokang severe fatigue symptoms. In this study, the primary outcomes were the
Hospital affiliated with the Tianjin University of TCM in Tianjin. FS-14 and FAI scores at 5 sessions and 10 sessions of cupping.
Recruitment posters were placed in the outpatient departments of the
hospital, and online recruitment was facilitated via web links. Interested 2.4.2. Secondary outcomes
patients were pre-screened by post-graduate students for inclusion. Usually, CFS patients have many concomitant symptoms such as bad
The inclusion criteria were as follows: (1) men and women, (2) aged mood and poor sleep. We choose several instruments to measure mood
18–34 years, and (3) with a clinical diagnosis of CFS. and sleep. The SAS [18] was used to measure anxiety and includes 20
The diagnostic criteria for CSF were as follows: characterized by items (scored from 0 to 4). The total score of 20 items is multiplied by
persistent or relapsing unexplained chronic fatigue; (1) fatigue lasting 1.25 to obtain the standard score: 0 to 50 ¼ no anxiety, 50 to 59 ¼ mild
for at least 6 months; (2) fatigue is of new or definite onset; (3) fatigue is anxiety, 60 to 69 ¼ moderate anxiety, and >69 ¼ severe anxiety [19].
not the result of an organic disease or of continuing exertion; (4) fatigue The SDS [20] was used to measure depression and includes 20
is not alleviated by rest; (5) fatigue results in a substantial reduction in questions (scored from 0 to 4). The total score of 20 items is multiplied
previous occupational, educational, social, and personal activities; and by 1.25 to obtain the standard score: 0 to 53 ¼ no depression, 53 to 62 ¼

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x.-d. Meng et al. Complementary Therapies in Clinical Practice 40 (2020) 101210

mild depression, 63 to 72 ¼ moderate depression, and >73 ¼ severe < 90%); effective ¼ disappearance of clinical main symptoms and
depression [21]. comorbidities > 1/3 (30% < reduction rate < 70%); invalid ¼ clinical
The Pittsburgh Sleep Quality Index (PSQI) was used to measure the main symptoms and comorbidities disappeared <1/3, or no improve­
quality of sleep [22] and consists of 19 self-assessments and 5 “other” ment (minus 30%); reduction rate ¼ (pre-treatment points-post-
assessment items, of which the 19th self-assessment item and 5 “other” treatment points)/pre-treatment points � 100%.
assessment items do not contribute to scoring. We used only 18 The statistical analysis was performed with IBM SPSS Statistics
self-assessment items that were composed of seven components in this Version 22.
study. Each component was scored on a scale of 0–3, and the total score Data description: X [95% confidence interval (CI)]. Statistical
ranged from 0 to 21, with higher score representing poorer sleep quality methods: repeated measure analysis of variance (ANOVA) was used for
[23]. scale scores measured at different sessions during the study. One-way
ANOVA was used when the scale scores of different pressures between
2.5. Statistical analysis groups met the normal distribution and homogeneity of variance. The
intergroup comparison scale score was non-normal in distribution. The
The sample size calculation was performed for the primary compar­ rank sum test was used to test in cases of variance inhomogeneity. A chi-
ison between the cupping groups. In the preliminary experiment, the FS- square test was used for comparison between valid numbers in each
14 score decreased from 10.63 � 2.37 (before) to 6.38 � 3.03 under the group. The results were reported as adjusted means with 95% CIs, and
pressure of 0.03 mpa [13]. According to experts, the estimates were 10 the p-value for the group comparison. The adverse events included
� 2.5 for the 0.02 mpa group and 9 � 2.5 for the 0.05 mpa group bruising, pain, and blistering and are presented descriptively by fre­
P
�
Pk
� quency for each treatment group.
according to the formula: n ¼ Ψ2 ð ki¼1 σ2i ∕kÞ∕ 2
i¼1 ðui μÞ =ðk , The study protocol was registered on the Chinese Clinical Trial
1Þ
κ ¼ 3, given a significance level of α ¼ 0.05, β ¼ 0.1, so ϕ ¼ 2.52, n ¼ Registry (ChiCTR; http://www.chictr.org.cn/enindex.aspx) with the
30.91. Based on these assumptions and drop-outs, a total of 112 patients registration number of ChiCTR 1800017590 and approved by the China
were needed. ethics committee of registering clinical trials (ChiECRCT-20180085).
According to Effectiveness Standards for TCM Diagnosis and Treat­
ment of Chronic Fatigue Syndrome, the treatment effectiveness was 3. Results
categorized as follows: cured ¼ clinical main symptoms and comorbid­
ities completely disappeared, able to adapt to normal social life and A total of 295 patients were screened for eligibility, and 183 were
work rhythm (minus rate > 90%); significant effect ¼ disappearance of excluded for not meeting the inclusion criteria (n ¼ 132), refusing to
clinical main symptoms and comorbidities > 2/3 (70% < reduction rate participate after being informed about the trial (n ¼ 28), taking other

Fig. 1. Participant flow diagram.

3
x.-d. Meng et al. Complementary Therapies in Clinical Practice 40 (2020) 101210

drugs (n ¼ 6), unwilling to accept cupping treatment (n ¼ 8), not suit­ 3.3. Follow-up study
able for cupping (n ¼ 6), or receiving acupuncture treatment (n ¼ 3).
Altogether 112 patients were randomized and allocated to groups of The FS-14 and FAI were used to evaluate the fatigue status of patients
0.02 mpa (n ¼ 38), 0.03 mpa (n ¼ 38), and 0.05 mpa (n ¼ 36) with CFS at 1, 2, 3, 4, 5, and 6 months after the end of cupping therapy. A
(Fig. 1). The patient baseline characteristics, including age, gender, total of 77 patients were followed up, 25 for the 0.02 mpa group, 26 for
weight, height, BMI, and FS-14 score, are shown in Table 1. The fatigue the 0.03 mpa group, and 26 for the 0.05 mpa group. No serious
measure by the FS-14 was higher in the 0.02 mpa group [9.74 (8.90, adverse events were observed during the entire study period.
10.57)] compared with the 0.03 mpa group [9.05 (8.27, 9.83)] and the We compared the FS-14 score among the different pressure groups at
0.05 mpa group [9.08 (8.17, 10.00)]. 1 month (P ¼ 0.625), 2 months (P ¼ 0.963), 3 months (P ¼ 0.576), 4
After 5 weeks, 21 patients ( 0.02 mpa n ¼ 8, 0.03 mpa n ¼ 7, months (P ¼ 0.904), 5 months (P ¼ 0.573), and 6 months (P ¼ 0.774).
0.05 mpa n ¼ 6) had dropped out of the trial. The reason for with­ We also compared the FAI scores among the different pressure groups at
drawal from the study was identified as “inconvenient time” (n ¼ 15), 1 month (P ¼ 0.090), 2 months (P ¼ 0.390), 3 months (P ¼ 0.219), 4
noncompliance (n ¼ 4), and “health problems” (n ¼ 2). months (P ¼ 0.626), 5 months (P ¼ 0.712), and 6 months (P ¼ 0.808)
(Table 3).
3.1. Primary outcomes
3.4. Adverse events
The patients randomized to the 0.02 mpa, 0.03 mpa, and 0.05
mpa groups had no statistically significant difference noted between the
The most common adverse events reported by people who receive
different pressures after five cupping sessions according to the FS-14
cupping therapy are bruises and blisters. In our study, no patient expe­
score (P ¼ 0.667 > 0.05) and the FAI score (P ¼ 0.450 > 0.05). There
rienced these adverse reactions.
were no statistically significant between-group differences for the
different pressure groups after 10 sessions of cupping according to the
4. Discussion
FS-14 score (P ¼ 0.929 > 0.05) and FAI score (P ¼ 0.145 > 0.05)
(Table 2).
To our knowledge, this is the first clinical trial using different
There was a significant decrease in the 0.02 mpa group after
cupping pressures generated by a cupping instrument. In our study, each
cupping, according to the FS-14 score (P < 0.01) and FAI score (P <
group showed beneficial effects within 10 sessions, and there was sig­
0.01). There was also a significant decrease in the 0.03 mpa group after
nificant improvement in fatigue scores, anxiety scores, depression
cupping, according to the FS-14 score (P < 0.01) and the FAI score (P <
scores, and sleeping scores. Moreover, there was a statistical difference
0.01). There was a significant decrease in the 0.05 mpa group after
in the FS-14 and the PSQI scores with different cupping pressure at five
cupping, according to the FS-14 score (P < 0.01) and the FAI score (P <
sessions.
0.01) (Table 2).
According to the criteria for determining the efficacy of TCM, we
defined “effective” as 30% reduction of FS-14 score. After cupping under
3.2. Secondary outcomes
different pressures, the effective rates at five sessions (P ¼ 0.038) were
53.33% ( 0.02 mpa group), 32.26% ( 0.03 mpa group), and 66.67%
The patients randomized to the 0.02 mpa, 0.03 mpa, and 0.05
( 0.05 mpa group). However, there was almost no difference between
mpa groups had no statistically significant differences noted after five
groups at 10 sessions (P ¼ 0.999), with effective rates of 73.33% ( 0.02
sessions of cupping according to the SAS score (P ¼ 0.726 > 0.05), SDS
mpa group), 70.97% ( 0.03 mpa group), and 70.00% ( 0.05 mpa
score (P ¼ 0.421 > 0.05), and PSQI score (P ¼ 0.868 > 0.05). There was
group). These results showed that higher pressure took shorter time to
no statistically significant difference between the groups after 10 ses­
take effect and that different cupping pressures might show an equal
sions of cupping, according to the SAS score (P ¼ 0.902 > 0.05), SDS
curative effect through more sessions. The results indicate that cupping
score (P ¼ 0.820 > 0.05), and PSQI score (P ¼ 0.849 > 0.05) (Table 2).
as a complementary therapy could relieve fatigue but that achieving a
There was a significant decrease of 0.02 mpa after cupping, ac­
higher efficiency is difficult. The effective rate according to the FAI score
cording to the SAS score (P < 0.01), SDS score (P < 0.01), and PSQI score
was 23.33% ( 0.02 mpa group), 32.25% ( 0.03 mpa group), and
(P < 0.01). There was a significant decrease of 0.03 mpa after cupping,
10.00% ( 0.05 mpa group) over 10 sessions (P ¼ 0.130), which were
according to the SAS score (P < 0.01), SDS score (P < 0.01), and PSQI
lower than the FS-14 score. The FS-14 is a dichotomy different from FAI
score (P < 0.01). There was a significant decrease of 0.05 mpa after
with grades between 1 and 7. We can speculate that cupping therapy
cupping, according to SAS score (P < 0.01), SDS score (P < 0.01), and
could improve the symptoms related to fatigue to a relatively small
PSQI score (P < 0.01) (Table 2).
extent. The curative effect of cupping therapy has been confirmed to
treat fatigue in CFS patients [9,24], and our results also supported that.
Our study found that cupping therapy could alleviate anxiety and
depression in CFS patients, and the SAS scores decreased by 11.01 points

Table 1
Baseline characteristics for patients in the 0.02mpa,-0.03mpa and 0.05mpa group.
Group 0.02mpa 0.03mpa 0.05mpa
Mean (95%CI)/n (%) Mean (95%CI)/n (%) Mean (95%CI)/n (%)

No. of Patients 38 38 36
Age (years) 24.72 (23.55,25.89) 25.62 (24.29,26.96) 24.44 (23.39,25.49)
Gender (Male) 11 (36.7) 8 (25.8) 12 (40)
Hight (cm) 165.14 (162.35,167.94) 168.43 (166.18,170.68) 167.16 (165.21,169.11)
Weight (kg) 59.10 (55.76,62.45) 62.70 (59.99,65.41) 60.01 (57.39,62.63)
Fatigue Scale 9.74 (8.90,10.57) 9.05 (8.27,9.83) 9.08 (8.17,10.00)
Fatigue Assessment Instrument 127.05 (118.62,135.48) 126.32 (117.75,134.88) 131.39 (123.65,139.13)
Self-Rating Anxiety Scale 41.34 (38.81,43.87) 40.84 (38.67,43.02) 41.11 (37.82,44.41)
Self-Rating Depression Scale 42.76 (40.50,45.02) 40.68 (38.41,42.96) 41.69 (38.06,45.33)
Pittsburgh Sleep Quality Index 6.05 (4.90,7.21) 6.29 (5.18,7.40) 7.44 (6.29,8.60)

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 x.-d. Meng et al. Complementary Therapies in Clinical Practice 40 (2020) 101210

( 0.02 mpa group), 10.81 points ( 0.03 mpa group), and 12.58 points
( 0.05 mpa group) after 5 weeks of cupping. And, the SDS scores
decreased by 10.21 points ( 0.02 mpa group), 10.53 points ( 0.03 mpa
0.05mpa different

group), and 12.54 points ( 0.05 mpa group) after 5 weeks of cupping.
Although the effect for anxiety and depression was significantly
different after a different number of sessions, the effect among different
sessions

cupping pressures showed no obvious difference. The effective rate was

P value

<0.01

<0.01

<0.01

<0.01

<0.01
26.67% ( 0.02 mpa group), 16.12% (-0.03 mpa group), and 23.33%
( 0.05 mpa group) for anxiety (P ¼ 0.638) and 30.00% ( 0.02 mpa
group), 22.58% ( 0.03 mpa group), and 23.33% ( 0.05 mpa group) for
depression (P ¼ 0.835) after 5 weeks of cupping, which was lower than
0.03mpa different

the effective rate of the Fatigue Scale. The change in emotional state of
patients with CFS in this research was mild change or very close to
normal; thus, the SAS and SDS scores decreased just 30% of participants.
The improvement of sleep condition in this study was obvious, and
sessions
P value

<0.01

<0.01

<0.01

<0.01

<0.01
the scores for the FS-14 and the PSQI decreased 3.17 points ( 0.02 mpa
group), 3.19 points ( 0.03 mpa group), and 4.17 points ( 0.05 mpa
group) after 5 weeks of cupping. The effective rates after 10 sessions
reached 73.33% ( 0.02 mpa group), 70.97% ( 0.03 mpa group), and
0.02mpa different

80.00% ( 0.05 mpa group) (P ¼ 0.674). There was no obvious differ­

ence between different cupping pressures, but the effective rates were
significantly different after five sessions: 30.00% ( 0.02 mpa group),
45.16% ( 0.03 mpa group), and 53.33% ( 0.05mpa group) (P ¼
sessions
P value

<0.01

<0.01

<0.01

<0.01

<0.01

0.039). The regularity of the sleeping state measured by the PSQI was
the same as that for fatigue measured by the FS-14. The cupping therapy
effective rates were positively correlated with cupping pressure in the
areas of fatigue and sleeping. Although these studies used different in­
different pressure

terventions including combinations with acupuncture or drugs, much

research has confirmed that cupping therapy improves the mood and
sleep status of patients with CFS [25,26]. Previous studies of cupping
P value
groups

therapy to improve fatigue, emotion, and sleep mostly included

0.480
0.667
0.929
0.730

0.450

0.145

0.863
0.726
0.902
0.732
0.421
0.820
0.252
0.868
0.849

acupuncture or medications, leading to more factors that could poten­

tially affect the results [27,28]. In our study, we used controlled pressure
of cupping through the instrument and found that cupping can improve
52.33 (48.91; 55.76)
44.25 (41.17; 47.33)
39.75 (36.20; 43.30)
53.54 (49.45; 57.64)
44.08 (40.16; 48.01)
41.00 (37.04; 44.96)
9.40 (8.46; 10.34)

fatigue and sleep status. And, because we used only cupping as an

6.00 (4.75; 7.25)
4.67 (3.40; 5.94)

8.20 (7.07; 9.33)

5.13 (4.19; 6.07)
4.03 (3.20; 5.27)
130.47 (121.49;

116.03 (108.56;

112.70 (104.27;
Mean (95%CI)

intervention in treating CFS patients, the impact of other treatments on

the outcome is reduced.
0.05mpa

139.45)

123.51)

121.13)

We have found a relationship between the number of cupping ses­

sions and the curative effect, in that 10-session cupping therapy showed
30

superior improvement compared with 5-session therapy on symptoms

such as fatigue, emotional disorders, and sleeping problems. Further­
51.13 (48.21; 43.24)
45.97 (43.29; 48.64)
40.32 (36.43; 44.22)
51.65 (48.46; 54.85)
46.01 (42.51; 49.50)
41.12 (37.02; 45.24)
Observed mean results for scale scores at 5 sessions and 10 sessions in each group.

more, higher cupping pressure showed better efficacy in relieving fa­

9.03 (8.18; 9.88)
6.65 (5.63; 7.66)
4.97 (4.01; 5.93)

7.13 (6.04; 8.22)

5.29 (4.25; 6.33)
3.94 (3.18; 4.69)
125.97 (116.24;

113.42 (105.46;

tigue and sleep disorders. However, we have not found a relationship

100.13 (89.26;
Mean (95%CI)

between pressure and a curative effect on emotion disorder. First, our

0.03mpa

study applied 0.02 mpa and 0.03 mpa as the low-pressure groups,
135.70)

121.38)

111.00)

which only differ by 0.01 mpa, and the small gap could not cause a
31

difference in efficacy. Second, the scale of emotion was evaluated sub­

jectively, which might lead to a less sensitive outcome. Cupping can
51.88 (48.50; 55.25)
45.29 (41.71; 48.87)
40.87 (37.70; 44.05)
52.79 (49.69; 55.89)
47.58 (43.56; 51.60)
42.58 (38.63; 46.54)

dilate blood vessels [29] and improve local immune status, including
9.77 (8.94; 10.60)
6.57 (5.45; 7.68)
4.77 (3.54; 6.00)

7.10 (6.08; 8.12)

5.50 (4.50; 6.50)
3.93 (3.14; 4.72)

co-regulation of cellular immunity [30,31] and cytokines [32,33]. These

130.30 (121.06;

120.33 (111.91;

109.80 (100.51;
Mean (95%CI)

factors may be closely related to the symptoms of fatigue in patients with

0.02mpa

CFS treated by cupping. Several studies have found that serotonin [34],
139.54)

128.76)

119.09)

dopamine [35], epinephrine [36], and neuropeptides are closely related

30

to the onset of anxiety and depression, and cupping can regulate these
substances by changing the local metabolic state of the acupoint area.
sessions

The metabolism regulates depression, anxiety, and sleep states [37].

10

10

10

10

10

However, the mechanisms of depression, anxiety, and poor sleep quality

0
5

0
5

0
5

0
5

are still unknown; thus, further experimental verification is needed.

Self-Rating Depression Scale

In this study, we chose participants according to the standard of the

Self-Rating Anxiety Scale

Pittsburgh Sleep Quality

China National Bureau of Statistics, which defines “adults” as in­

dividuals older than 18 years of age, and defines “youth” as individuals
Fatigue Assessment

between 15 and 34 years old; thus, we selected people between 18 and

No. of Patients
Fatigue Scale

Instrument

34 years old, which is different from the standard of the World Health
Organization (WHO) (15–24 years old). The age-screening standards
Index
Table 2

was set considering the common onset age of CFS and demographic
characteristics of hospitals and universities. The cupping device

5
x.-d. Meng et al. Complementary Therapies in Clinical Practice 40 (2020) 101210

Table 3
Fatigue follow up after treatment.
time 0.02mpa 0.03mpa 0.05mpa different pressure groups
Mean (95%CI) Mean (95%CI) Mean (95%CI) P value

No. of Patients 25 26 26
Fatigue Scale 14 1 month 6.12 (4.86; 7.38) 5.73 (4.74; 6.72) 5.35 (4.13; 6.56) 0.625
2 month 9.08 (8.11; 10.05) 8.92 (7.74; 10.11) 9.12 (8.04; 10.20) 0.963
3 month 9.68 (8.77; 10.59) 9.00 (8.08; 9.92) 9.38 (8.40; 10.37) 0.576
4 month 9.12 (8.38; 9.86) 8.85 (8.02; 9.67) 8.96 (7.91; 10.02) 0.904
5 month 9.28 (8.48; 10.08) 8.65 (7.74; 9.57) 8.92 (8.07; 9.78) 0.573
6 month 9.08 (8.39; 9.77) 8.88 (7.95; 9.82) 9.31 (8.37; 10.25) 0.774
Fatigue Assessment Instrument 1 month 117.16 (107.95; 126.37) 104.31 (95.42; 113.19) 112.96 (105.41; 120.52) 0.090
2 month 126.80 (119.20; 134.40) 118.96 (110.16; 127.76) 122.69 (114.45; 130.93) 0.390
3 month 129.64 (122.47; 136.81) 119.23 (109.35; 129.11) 125.31 (116.77; 133.84) 0.219
4 month 127.36 (118.84; 135.88) 122.00 (112.21; 131.79) 122.12 (113.13; 131.10) 0.626
5 month 122.92 (114.69; 131.15) 121.12 (111.62; 130.61) 125.92 (117.89; 133.96) 0.712
6 month 124.92 (117.58; 132.26) 121.19 (112.19; 129.92) 123.50 (114.61; 132.39) 0.808

(JingLuo GuanTong Instrument) has five cups with inner diameters of Ethics approval and consent to participate
20, 28, 46, 54, and 62 mm, respectively, for different acupoints, and the
size (46 mm) we applied is suitable for the skin on the back [13,38]. We The Ethics Committee of Chinese Clinical Trial Registry reviewed the
chose acupoints of Da Zhui (DU14), Gan Shu (BL18), Pi Shu (BL20), and study protocol and approved the study (ChiECRCT-20180085). All
Ming Men (DU4), because they can invigorate Qi and promote Qi ac­ participants gave written informed consent.
tivity. The preliminary experiments have verified that the cup size and
acupoints we chose had good efficacy and safety [13]. Consent for publication
For further study of the influencing factors of negative pressure in
cupping therapy, it is necessary to further adjust the pressure differences Not applicable.
and select more sensitive outcome indicators for research studies.
Declaration of competing interest
5. Conclusion
The authors declare that they have no competing interests.
Among patients with CFS, cupping therapy has significantly relieved
fatigue symptoms and improved emotion and sleep condition of CFS CRediT authorship contribution statement
patients, and 10 sessions of treatment had superior results compared
with 5 sessions in each pressure group. Moreover, in five sessions of xiu-dong Meng: Writing - review & editing. Hao-ran Guo: Meth­
treatment, cupping with high pressure showed better improvement in odology. Qing-ying Zhang: Validation. Xin Li: Data curation. Yong
fatigue syndromes and sleep condition according to the effective rates. Chen: Investigation. Mu-yang Li: Software. Xue-mao Zhuo: Method­
ology. Mei-juan Wang: Data curation. Kai Shan: Resources. Yi-nan
5.1. Limitations Gong: Formal analysis. Ning-cen Li: Data curation. Bo Chen: Super­
vision. Ze-lin Chen: Project administration, Funding acquisition. Yi
This study also has several limitations. First, blinding was not tested Guo: Validation.
at the end of the experiment. Second, many participants failed to com­
plete the trial due to changes in the test site of the hospital during the Acknowledgements
experiment, leading to a 18.75% dropout rate. Third, all of the outcomes
were based on relatively short-term measurements, and long-term We thank all participating patients and our study members. We
follow-up beyond 6 months was not available. Fourth, the study thank the National Natural Science Foundation of China, Youth foun­
design did not set a no-treatment (control) group, although it has been dation of the National Natural Science Foundation of China, the Na­
proved that cupping can improve fatigue symptoms clinically. tional Science Foundation of Tianjin, and Scientific Research Project of
Tianjin Educational Committee.
Funding
Abbreviations
This study was funded by the National Natural Science Foundation of
China: (NO.81573882), Youth foundation of the National Natural Sci­ CFS Chronic fatigue syndrome
ence Foundation of China (81603679), the National Science Foundation FS-14 Fatigue Scale
of Tianjin (18JCQNJC82400), Scientific Research Project of Tianjin FAI Fatigue Assessment Instrument
Educational Committee (2017KJ143), and National Key R&D Program SAS Self-Rating Anxiety Scale
of China (2019YFC1712200-2019YFC1712204). SDS Self-Rating Depression Scale
All funders had no influence on the design or methodology of the PSQI Pittsburgh Sleep Quality Index.
study, the data collection, analysis or interpretation, or the drafting of
the manuscript. Appendix A. Supplementary data

Availability of data and materials Supplementary data to this article can be found online at https://doi.
org/10.1016/j.ctcp.2020.101210.
The datasets generated and analyzed during the current study are not
publicly available as participants were not asked to provide consent
regarding such use of their data. The manuscript benefits from a stan­
dard CONSORT flow diagram.

6
x.-d. Meng et al. Complementary Therapies in Clinical Practice 40 (2020) 101210

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