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Safety of Qigong
Protocol for an overview of systematic reviews
Yu Guo, MD, PhD
a,b
, Mingmin M. Xu, MD, PhD
c
, Yuchang Huang, MM
d
, Meiqi Ji, MD, PhD
d
, Zeren Wei, BS
a
,
Jialei Zhang, MS
b
, Qingchuan Hu, MD, PhD
a,b
, Jian Yan, MM
a,b
, Yue Chen, MM
a,b
, Jiaxuan Lyu, MD, PhD
a
,
Xiaoqian Shao, MS
b
, Ying Wang, MM
a
, Jiamei Guo, MM
a
, Yulong Wei, MD, PhD
a,∗
Abstract
Background: Qigong, as one of the essential elements of Traditional Chinese exercises, has been used to improve physical and
psychological health and combat diseases in China for thousands of years. In recent years, the beneficial effects of Qigong on
different medical conditions are becoming more accepted by both patients and health care providers. Although it is a common
impression that Qigong and related therapies are generally safe procedures, but the current understanding of its adverse events is
fragmented. Thus, we conducted this overview to synthesize comprehensively existing systematic reviews on adverse events
associated with Qigong and related therapies, and our findings can be used to informing clinicians, Qigong practitioner, and patients
alike on applying such treatments or interventions in clinical treatment and daily life training mindful manner, and provide a guideline for
researchers in future.
Methods: A systematic review of reviews will be performed. A literature search strategy designed by a number of specialists in the
fields of Traditional Chinese Medicine (TCM), sports medicine, health information, and Qigong training will be carried out in relevant
English and Chinese electronic database. The date range of search will start from inception to the search date. Two reviewers will
identify relevant studies, extract data information, and then assess the methodical quality by Assessment of Multiple Systematic
Reviews (AMSTAR) tool. Any types of systematic review that summarized adverse effects related to Qigong and related therapies in
human will be included. Any safety-related outcomes will be considered as the primary outcomes of this overview. Where objectives
from 2 or more reviews overlap, we will assess the causes of any noted discrepancies between reviews. An overall summary of results
will be performed using tabular and graphical approaches and will be supplemented by narrative description.
Results: This overview will identify any adverse events associated with nonstandardized Qigong and related therapies procedures
based on current relevant literature evidence of safety for Qigong.
Conclusion: Our overview will provide evidence to help synthesize the broad degree of information available on furthering the
knowledge, safety, and application of Qigong.
Ethics and dissemination: Formal ethical approval is not required, as this study is an overview based on the published
systematic reviews. The result of this overview of systematic reviews will be published in a peer-reviewed journal or disseminated at
national and international conferences.
PROSPERO registration number: PROSPERO CRD42018109409
Abbreviations: AMSTAR =Assessment of Multiple Systematic Reviews, CNKI =China National Knowledge Infrastructure, DARE
=Database of Abstracts and Reviews, Development and Evaluation, GRADE =Grading of Recommendations Assessment, HTA =
Health Technology Assessment, MeSH =Medical Subject Heading, PICOS =Participants-Intervention/Comparator-Outcomes-
Study design, PRISMA-P =Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol, PROSPERO =
Prospective Register of Systematic Reviews, TCM =Traditional Chinese Medicine, VIP =China Science and Technology Journal
database.
Keywords: adverse event, overview of systematic review, protocol, Qigong, safety
Both YG and MMX have contributed equally to this study as the first author.
Funding/support: This work was supported by the National Natural Science Foundation of China (NO.81674043).
This study is independent from the sponsor and competing interests.
The authors declare that they have no conflicts of interest to disclose.
a
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing,
b
Ovation Health Science and Technology Co. Ltd, ENN Group,
Langfang,
c
School of Acupuncture-Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu,
d
Department of Ophthalmology, China-
Japan Friendship Hospital, Beijing, China.
∗
Correspondence: Yulong Wei, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No.11, Bei San Huan Dong Lu, Chao Yang
District, Beijing 100029, China. (e-mail: wylbucm@163.com)
Copyright ©2018 the Author(s). Published by Wolters Kluwer Health, Inc.
This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Medicine (2018) 97:44(e13042)
Received: 1 October 2018 / Accepted: 9 October 2018
http://dx.doi.org/10.1097/MD.0000000000013042
Study Protocol Systematic Review Medicine®
OPEN
1
1. Introduction
Qigong, translates from Chinese to mean,
[1]
Qi means vital life-
energy that flows in channels (meridians) in the body and Gong
means training or cultivation of the Qi.
[2,3]
Qigong, as a gentle
low-impact mind-body aerobic exercise, has been recognized as a
“medical”exercise and used to improve physical and psycholog-
ical health and combat diseases in China for thousands of
years.
[3–6]
The characteristic of Qigong is self-directed and basic
components of that include concentration, relaxation, medita-
tion, rhythmic breathing regulation, body posture, and gentle
movement.
[5–8]
The definition can be understood to practice
Qigong is to practice the 3 adjustments, and the aim is to achieve
the state of oneness by integrating the adjustments.
[9]
As we
know, as one of the essential elements of Traditional Chinese
exercises, earliest forms of Qigong make up one of the historic
roots of contemporary Traditional Chinese Medicine (TCM)
theory and practice.
[3,4,10,11]
There are hundreds of forms of
Qigong exercises developed in different regions of China that
have been created by specific teachers, some designed to benefit
certain diseases while most others have general health bene-
fits.
[3,9]
Such as “The Five-Animal Frolics (Wuqinxi),”“The
Eight-Section Brocades (Baduanjin),”“The Six Syllable Formula
(Liuzijue),”“Muscle/Tendon Changing Classic (Yijinjing),”
“Five Elements Plam (Wuxinzhang),”“Health Preserving
Qigong(Baojiangong),”“Post Standing Qigong(Zhanzhuang-
gong),”“Relaxation Qigong(Fangsonggong),”“Internal Nour-
ishing Qigong(Neiyanggong),”“meditation,”“mindfulness,”
“mind concentration,”and“Guolin New Qigong.”According to
the philosophy of TCM, Qigong is based on the theory that the
body is a small universe where “Qi”circulates, illness or injury
disturbs the harmony of vital energy circulation. Qigong is
believed to be a method of achieving a harmonious flow of vital
energy and regulate the functional activities of meridians and
visceral organs.
[3,12–14]
With regular practice and rehearsal of the
structured postures or movements, as well as concentration on
mind and breath, practitioners can achieve an efficiency of “body
relaxation and mind calm”and Tian Ren He Yi (the theory that
mankind is an integral part of nature) so as to experience mood
stabilization and improved strength and fitness.
[3,15–18]
From the
perspective of western thought and science, this combination of
self-awareness with self-correction of the posture and movement
of the body, the flow of breath, and stilling of the mind are
thought to comprise a state that activates naturally occurring
physiological and psychological mechanisms of self-regulatory
(self-healing) capacity, stimulating the balanced release of
endogenous neurohormones and a wide array of natural health
recovery mechanisms, which are seen as affecting the balance and
flow of energy, enhancing functionality in the body and the mind,
and intently integration of body and mind.
[4,12,19–21]
Besides, Qigong is an easily adaptable form of aerobic exercise
that can be practiced any place and any time and can be learned
by almost anyone of any age or physical condition without any
special equipment.
[3–6,14,17,22]
It is widely practiced by Chinese
not only to improve their physical health but also to control their
emotions, manage their stress or depressive/anxiety symptoms,
and enhance overall well-being.
[1,10,14,18,23,24]
There are many
qigong clinics, and in some hospitals, Qigong is integrated with
TCM and with conventional western biomedicine. Several
complementary medical therapies with some similarities to
Qigong are practiced in hospitals in the west and are paid for
by insurance. In recent years, existing systematic reviews have
examined the clinical evidence of the beneficial effects of Qigong
exercise on different medical conditions, such as tumor and
cancer,
[25–27]
hypertension,
[2,28,29]
diabetes mellitus,
[30–32]
obe-
sity,
[33,34]
chronic heart diseases,
[35,36]
Parkinson’s disease,
[37–39]
dementia,
[40,41]
chronic fatigue syndrome,
[42–44]
menopause
syndrome,
[45,46]
insomnia,
[47–49]
lower back pain,
[50–52]
chronic obstructive pulmonary disease,
[53–55]
fibromyalgia,
[56–58]
metabolic disease,
[20,59]
osteoarthritis,
[60–62]
mental disease,
[14,19,63,64]
and so on.
The wide use of Qigong in clinical treatment and daily life
training require continual safety evaluation. In China, although it
is a common impression that Qigong and related therapies are
generally safe procedures and the risk of receiving Qigong
training may be lower, but the question has not yet been
definitively investigated. Thus, we conducted this overview of all
identifiable peer-reviewed relevant publications and critically
examine the safety of Qigong in patients or practitioners
receiving regular training. And then, this overview of systematic
reviews will provide a comprehensive picture of both the evidence
needed to make decisions regarding this topic and the research
gaps in this area.
2. Objectives
As the goal of this overview, based on the methods for Cochrane
overviews, will be designed to synthesize comprehensively
existing systematic reviews and then summarize systematically
the best current evidence on adverse events associated with
Qigong and related therapies, thus our findings can be used to
informing clinicians, Qigong practitioner, and patients alike on
applying such treatments or interventions in clinical treatment
and daily life training mindful manner, and provide a guideline
for researchers in future.
3. Study methods and analysis
This protocol of overview describes the methods will be
performed according to recommendations of the Cochrane
Collaboration and “Preferred Reporting Items for Systematic
Review and Meta-Analysis Protocols”(PRISMA-P) statement
guidelines.
[65]
This review has been registered on the Interna-
tional prospective register of systematic reviews (PROSPERO),
registration number: CRD42018109409. (https://www.crd.york.
ac.uk/prospero/display_record.php?RecordID=109409).
3.1. Research questions to be addressed
The main purpose of this overview is to evaluate the frequency
and type of adverse event occurrences of Qigong and related
therapies for all populations. A secondary aim is to evaluate the
consistency and quality of adverse events monitoring protocols
used in the included trials. This study has been designed to answer
the following primary research question: How many kinds of
adverse events and what are the main adverse events in Qigong
training, besides, what is the incidence of adverse Qigong events
in clinical treatment and daily life training? Then on the base of
these, how should we avoid and prevent the occurrence of
adverse events regarding Qigong and related therapies? In the
context of the review, a series of secondary objectives will also be
addressed. These will include assessment of Qigong adverse
events and incidence within different practitioner age groups
(e.g., teenager, adult, and elderly practitioners), different
practitioner sex groups (e.g., male and female), settings (e.g.,
community, home, school, professional institutions, and hospi-
Guo et al. Medicine (2018) 97:44 Medicine
2
tals), durations and frequencies of Qigong training (e.g., acute,
continuing, and long-term training, or often, once in a while),
types or forms of Qigong training (e.g., dynamic Qigong and
static Qigong), assessment of the different cited types and causes
of preventable adverse Qigong events (both with their corre-
sponding distribution of frequency), and the severity of
practitioner outcomes associated with their occurrence. We
conclude with recommendations for improving our understand-
ing of the safety of Qigong and related therapies, including
guidelines for reporting adverse events in future training of
Qigong and related therapies.
3.2. Study eligibility criteria
Eligibility criteria have been prepared in terms of the participants:
intervention/comparator-outcomes-study design (PICOS) frame-
work, which is helpful and form the basis to establish eligibility
criteria, with this additional component, the types of study
design. We will consider systematic reviews and primary studies
included in those reviews according to the following criteria
defined below.
3.2.1. Type of reviews. The current study is designed to be an
overview of existing reviews because systematic reviews rather
than original trials utilize the widest range of relevant evidence,
and thus, any types of systematic review that summarized adverse
effects related to Qigong and related therapies in human patients
or volunteers, including Baduanjin Qigong, Wuqinxi Qigong,
Liuzijue Qigong, Tai Chi Qigong, Yijinjing Qigong, Meditation
Qigong, Mindfulness Qigong, Post Standing Qigong,Guo Lin
New Qigong Therapy, Relaxation Qigong, Internal Nourishing
Qigong, Health Preserving Qigong, and other forms of Qigong,
were considered eligible for this overview. Those reporting on the
occurrence of adverse Qigong events where Qigong were
adequately administered will not be eligible.
To be included, the systematic reviews must have a primary
objective of identifying adverse events instead of investigating its
treatment efficacy or effectiveness. However, systematic reviews
on adverse effects specifically caused by self-psychosomatic
problems, failure to follow the principles of Qigong training, lack
of concentration and attention in Qigong training, and were
excluded.
We will consider publications to be peer-reviewed systematic
reviews as full text as well as any published as abstract only if they
were clearly described in the report as being based on an explicit
and systematic search strategy of one or more electronic literature
databases, clearly specified the review question and methodology
with explicit eligibility criteria, involved study selection and data
collection by 2 or more reviewers, performed some form of risk
of bias appraisal of included studies, provide a systematic
presentation and summaries of the characteristics and findings of
the included reviews, and synthesized all information using a
quantitative or qualitative approach. Review articles not meeting
these criteria or animal research and in vitro studies will be also
excluded.
3.2.2. Type of population. We had no restriction for the type of
patients or practitioner included, as long as they received Qigong
or related therapies for the management of physical and
psychological wellbeing, or any diseases and symptoms. Thus,
we will include systematic reviews that summarizes studies
target patients or practitioner receiving various forms of
Qigong training intervention from community, home, school,
professional institutions, or hospitals and being treated and
prevented with Qigong will be sought.
3.2.3. Types of intervention. No specific Qigong intervention is
required for a study to be eligible for this overview. Systematic
reviews covering all types of Qigong intervention aimed at the
management of physical and psychological wellbeing, or any
diseases and symptoms will be identified. No restriction on
duration and frequency (if applicable) of Qigong training will be
imposed.
3.2.4. Types of comparisons. We did not set any restriction on
the control treatment or intervention as long as adverse effects of
Qigong or related therapies were reported. These Qigong
interventions can either be compared with control interventions
(standard or usual treatment/care), no intervention (treatment or
exercise), or alternative conventional physical exercise such as
jogging or walking, and so on.
3.2.5. Types of outcomes. To be included, the systematic
review must have a primary objective of identifying adverse
events instead of investigating its treatment or intervention
efficacy or effectiveness. Any safety-related outcomes will be
considered as the primary outcomes of this overview.
Adverse events were further divided into 2 types, “Serious”and
“Other (not including Serious).”In accordance with its definition
of an adverse event and the definition of Qigong-related adverse
events in the previous literature, the following definition of
Qigong-related adverse events will be defined
[9]
:“a variety of
undesirable experience or any slightly unfavorable and unin-
tended sign, feeling, symptom, physical and mental changes or
disease that participants endure during or after treatment or
intervention with Qigong training regardless of causal relation-
ship, but are not serious to the point of affecting normal life and
work.”And serious adverse events are defined that the event led
to serious outcomes such as being life-threatening, permanent
damage, require either in-patient hospitalization or the pro-
longation of hospitalization, results in persistent or significant
disability/incapacity or death.
[9]
Thus, serious adverse events in
the Qigong training refer to Qigong “deviation,”also known as
“overrunning”of fire and entrance of demons, or deviation for
short, which is the serious negative somatic or mental reactions in
the course of practicing Qigong. Deviation is represented by
functional, psychological, emotional, or behavioral disorders
that affect the practitioner’s normal life or work and is unlikely to
disappear spontaneously. Qigong deviation differs from adverse
event that do not interfere with the activities of daily and will
mostly disappear spontaneously or be relieved by proper medical
intervention.
[9]
After pre-retrieval and repeated discussion, the range of
Qigong-related adverse events include headache, dizziness or
vertigo, distension of head, tinnitus, stuffiness in the chest and
worsening shortness of breath, heart-pounding or palpitations,
muscular soreness or pain, and so on. At the same time, Qigong
deviation occurs with a variety of serious negative physiological
or psychological changes and symptoms, which can be divided
into 2 categories: somatic symptoms (e.g., compression at the top
of the head, difficulty in breathing, emission or spermatorrhea,
shaking in the arms or legs, profuse cold perspiration of whole
body, or intensified and strange ceaseless body and limb
movement due to Qi disorder, etc) and mental and emotional
symptoms (e.g., neurasthenia, affective disorder, disorder of self-
consciousness, hallucination and paranoia, or psychological
stress, etc).
Guo et al. Medicine (2018) 97:44 www.md-journal.com
3
3.3. Literature search and search strategy
A purposive literature search strategy has been established with
the assistance and reviewed of a number of experts in the fields of
TCM and sports medicine. The health information specialist and
Qigong specialist will be consulted for the development of the
search strategies, and this person will help for performing the
searches.
Two reviewers will independently conduct sensitive search for
eligible systematic reviews through the following relevant
electronic databases, such as PubMed Database, Embase
Database, Cochrane Library, Web of Science database, Medline,
Chinese BioMedical Literature Database, China National
Knowledge Infrastructure (CNKI), China Science and Technolo-
gy Journal database (VIP), and Wanfang Data Chinese database
without study type and publication (publication date or
publication status) restrictions of systematic review. The date
range of search will start from inception to the search date. We
will also search for the following sources, which contain
systematic reviews and overviews of publications: Database of
Abstracts and Reviews (DARE), Health Technology Assessment
(HTA) database, TRIP Database, PDQ-Evidence, Epistemoni-
kos, and Health Systems Evidence. The search will be limited to
the English and Chinese language literature. This electronic
search will be supplemented by a search for unpublished,
ongoing, or recently completed systematic reviews in PROS-
PERO. In addition, we will also conduct hand searches in the
reference lists of all included systematic reviews that might meet
inclusion for the current overview.
Structured search strategies will be developed using the
thesaurus terms of each database and targeting the “title”and
“abstract”fields. We will conduct searches in electronic data-
bases using a combination of free text keywords and Medical
Subject Heading (MeSH) terms; as we were concerned that most
articles poorly report adverse events and are poorly indexed, we
decided not to combine search terms for adverse events at the cost
of sensitivity. The following search terms were used: Qigong, Ch’i
Kung, Qigong therapeutics, Qigong exercise, traditional Chinese
exercise, complementary therapies, mind–body exercise, mind-
body therapies, breathing exercises, breathing training, breathing
technique, respiratory training, respiratory exercise, physical
therapy modalities, exercise movement techniques,
Five-Animal Frolics, Wuqinxi, Eight-Section Brocades,
Baduanjin, Six Syllable Formula, Liuzijue, Muscle Changing
Classic, Tendon Changing Classic, Yijinjing, Five Elements Plam,
Wuxinzhang, Health Preserving Qigong, Baojiangong, Post
Standing Qigong, Zhanzhuanggong, Relaxation Qigong, Fang-
songgong, Internal Nourishing Qigong,Neiyanggong, meditation,
mindfulness, mind concentration, Guolin New Qigong, Tai Chi,
Taiji,Taijichuan, adverse event, adverse reaction, adverse effect,
adverse experience, Qigong deviation, overrunning of fire and
entrance of demons, overrunning of fire, entrance of demons,
adverse health care event, incident, accident, complication, side
effect, error, safe, safety, risk, and an in-depth list of text words
given the nature of varyingterminology in this area. The equivalent
search terms will be translated into Chinese while searching in the
Chinese databases. An example of a search strategy in PubMed is
presented in Table 1. This strategy will be adapted and refined
according to the specificities of the other databases.
3.4. Data collection and analysis
The methodology for data extraction and synthesis for this
overview will be based on the guidance from PRISMA-P
[65]
statement and the Cochrane Handbook of Systematic Reviews of
Interventions.
[34]
The chapters give criteria for conducting
overviews of systematic reviews.
Table 1
Search strategy for the PubMed database.
Number Search terms
1 Qigong
2Ch’i Kung
3 Qigong therapeutics
4 Qigong exercise
5 traditional Chinese exercise
6 complementary therapies
7 mind–body exercise
8 mind-body therapies
9 breathing exercises
10 breathing training
11 breathing technique
12 respiratory training
13 respiratory exercise
14 physical therapy modalities
15 exercise movement techniques
16 Five-Animal Frolics
17 Wuqinxi
18 Eight-Section Brocades
19 Baduanjin
20 Six Syllable Formula
21 Liuzijue
22 Muscle Changing Classic
23 Tendon Changing Classic
24 Yijinjing
25 Five Elements Plam
26 Wuxinzhang
27 Health Preserving Qigong
28 Baojiangong
29 Post Standing Qigong
30 Zhanzhuanggong
31 Relaxation Qigong
32 Fangsonggong
33 Internal Nourishing Qigong
34 Neiyanggong
35 meditation
36 mindfulness
37 mind concentration
38 Guolin New Qigong
39 Tai Chi
40 Taiji
41 Taijichuan
42 adverse event
43 adverse reaction
44 adverse effect
45 adverse experience
46 Qigong deviation
47 overrunning of fire and entrance of demons
48 overrunning of fire
49 entrance of demons
50 adverse health care event
51 incident
52 accident
53 complication
54 side effect
55 error
56 safe
57 safety
58 risk
Guo et al. Medicine (2018) 97:44 Medicine
4
3.4.1. Process of study selection. One reviewer will download
all of the reviews and will remove any obviously irrelevant titles.
Following removal of duplicate material, 2 reviewers will
independently screen the search output for results (based on
keywords, abstract, and title) of the remaining systematic reviews
from the literature search described above in order to assess their
eligibility for inclusion in this overview. After initial selection, all
citations judged potentially eligible systematic reviews or
systematic review protocols will then be further obtained and
screened in full-text copies of reports to assess eligibility for final
inclusion in the overview. Criteria for inclusion will be based on
the type of studies, type of participants, type of interventions, and
type of outcome measures. If any ongoing or unpublished study is
identified, we will contact the corresponding author for
information on the current status of the systematic review
(ongoing vs completed) and whether any preliminary data may be
included in our overview. Any discrepancies in the inclusion of
abstracts or full-text articles will be resolved by discussion and
reaching a consensus. If a consensus cannot be reached,
consultation of a third member of the review team where
necessary. In case of lack of consensus, a third author (TT) will
arbitrate. Reviewers will not be blinded to journal titles, study
authors, or institutions. Both stages of screening will be preceded
by a piloting exercise to ensure that reviewers have a similar
understanding of the eligibility criteria. A flow diagram will be
presented to describe the process of study selection (Fig. 1).
3.4.2. Data collection and extraction. According to the
inclusion, 2 independent reviewers will summarize all included
reviews and perform data extraction from the included systematic
reviews using an electronic standardized spreadsheet data
extraction form to record descriptive characteristics of included
reviews. We will extract the following information from the
included systematic reviews: features of the review(first author
name and institutions, country/countries of origin, journal title,
year of publication, review title, date of last search, number of
included studies and participants, source of financial support (if
any), registration details of the review protocol, if applicable, type
of included primary studies, type of adverse event and causality,
number of cases, qualification of Qigong trainers); characteristics
of population demographics and setting (e.g., healthy people,
patient with different diseases, age, gender, total sample size,
health condition, primary disease, prognosis, community, home,
school, professional institutions, and hospitals), type of inter-
ventions (e.g., types or forms, durations and frequencies of
training), comparisons(e.g., standard or usual treatment/care, no
treatment or exercise, or alternative conventional physical
exercise), description of results and conclusions that are relevant
to our overview question in adverse event (follow-up period,
details about the specific aspects of adverse event, the way
outcomes have been measured, different types of outcomes), the
key findings, method of assessing quality of studies, reported
limitations of review, and the likelihood of causality between the
event and acupuncture was assessed in each individual case. We
will systematically synthesize the individual studies included
within all identified reviews to explore whether any reviews
covered the same studies. If an overlap between reviews is
identified, 2 overview authors will discuss the overlap with
consideration of each review question, comparisons explored,
and date of the last search and key aspects of methodological
quality (e.g., types of studies included, risk of bias assessment).
We will use these details to reach agreement regarding which data
from which review comparisons should be included within the
overview. Any overlaps between included reviews or compar-
Figure 1. Flowchart of literature selection on systematic reviews of Qigong-related adverse events.
Guo et al. Medicine (2018) 97:44 www.md-journal.com
5
isons will be transparently reported. Any disagreements arising
during the data extraction process will be resolved by discussion
and consensus involving the 2 reviewers or will involve a third
review author as needed to establish consensus in the presence of
disagreements. In case of lack of consensus, a third author (MQJ)
will arbitrate, if needed. If any information is missing or
incomplete, we will try to contact the review authors. If any data
cannot be obtained, then the review will be recorded as an
“Included review”without data. To ensure consistency, we will
conduct calibration exercises before the review. A data collection
form will be drafted and piloted on a small number of studies and
discussed among the team to incorporate any necessary refine-
ments before completion of data collection from all relevant
studies.
3.4.3. Certainty of evidence in included reviews. We will
report the certainty of evidence as assessed by the systematic
review authors. If the systematic review authors did not assess the
certainty of the evidence, we will assess the certainty of the
evidence reported by the review authors using the Grading of
Recommendation Assessment, Development, and Evaluation
(GRADE) approach as outlined in the GRADE handbook.
[66]
3.4.4. Quality assessment/methodological quality of includ-
ed reviews. Two reviewers will independently evaluate the
methodological quality/risk of bias for each included systematic
review that meets the eligibility criteria, using validated
Assessment of Multiple Systematic Reviews (AMSTAR) mea-
surement tool.
[67,68]
This is most commonly used to assess the
quality of systematic reviews included in overviews. AMSTAR
includes 11 items, with each of the 11 criteria given a rating of
“yes”(definitely done), “no”(definitely not done), “can’t
answer”(unclear if completed), or “not applicable”based on
information provided by the systematic reviews on which
reviewers put a score of 1 point when the criterion is met. Each
systematic review will be assigned to 1 of 3 quality levels (0–3
points—low quality, 4–7 points —medium quality, and 8–11
points—high quality). Disagreements between assessors were
discussed to reach consensus, and where this is not achieved,
arbitration by a third review author (MQJ) will be sought.
3.4.5. Dealing with missing data. Reasons for missing data will
be recorded by the original reviews. If the original reviews
included this detail, we will try our best to obtain requisite
information by contacting the corresponding author of the
referenced articles for the missing data whenever possible. If the
missing data cannot be obtained, we will report the number of
studies that performed the analysis based on the available data to
decrease the potential influence of the missing data. The potential
impact of the effect of missing data on the final findings of the
overview will be addressed in the discussion.
3.4.6. Data synthesis. Adverse effects of Qigong and related
therapies were narratively reported of the relevant results for the
individual systematic reviews. To summarize findings, a
descriptive approach will be performed that will provide a series
of summary tables to characterize key features, quality assess-
ment, and major conclusions, and variations of the research,
supplemented with graphics to highlight diversity and enhance
the clarity in study results and other aspects. This will also include
a focused effort to map gaps between reviews in relation to many
aspects of adverse Qigong events described. For reviews
addressing the same objectives and endpoints, their findings will
be compared. In exploring the rationale for variations in findings
between the reviews, several strategies will be employed. First, a
comparison of review methods will be performed in relation to
eligibility criteria (i.e., assessment of variations in criteria used
to identify eligible patients or practitioners, study designs, and
endpoints of interest), literature search details (dates, databases,
and key differences in strategies employed, language restrictions
employed), endpoint definitions used, statistical approaches to
meta-analysis (if performed), and rigor of review methods (as
reflected by variations in AMSTAR assessments and other aspects
of study methodology). Second, the evidence base included in
different reviews will be evaluated in terms of their degree of
overlap; this will involve comparison of date ranges of studies
covered by the review, the numbers of studies and volunteers
across reviews, and development of a citation matrix to establish
the similarity of included study lists. Lastly, comparison of review
findings (e.g., meta-analytic findings regarding pooled incidence
rates or other related measures) and conclusions drawn by review
teams will also be performed. For studies examining the same
Qigong interventions, we will state whether the reported
conclusions are concordant.
3.5. Sensitivity analysis
If applicable, we will conduct sensitivity analysis and summarize
the quality of the evidence in relation to the most important
outcomes by using the GRADE approach.
[67]
3.6. Subgroup analysis
Depending on sufficiency of reviews, we will explore subgroup
analyses according to types or forms of Qigong training,
durations and frequencies of Qigong training, settings, different
practitioner age groups, different practitioner sex groups,
assessment of the different cited types, causes of preventable
adverse Qigong events, and so on.
4. Ethics and dissemination
The result of this overview of systematic reviews will be published
in a peer-reviewed journal or disseminated at relevant confer-
ences presentations. Formal ethical approval is not required
because we will search and evaluate only existing sources of
literature. Due to the paucity of related publications in the field,
this review article will, by adding more recent studies into the
analysis, provide more robust evidence of safety of Qigong to
clinicians, Qigong practitioner, and patients who apply for such
treatments or interventions in clinical treatment and daily life
training for the management of physical and psychological
wellbeing, or any diseases and symptoms.
5. Discussion
In China, Qigong and related therapies have been as modality of
treatment for various ailments and medical diseases.
[1,3,4,6]
It is
said that the popularity of Qigong and related therapies is
partially attributed to its convenience and safety, and in some
oriental countries, Qigong and related therapies are usually
conducted by Qigong professionals. However, this kind of
intervention is not entirely risk-free, where adverse events, such as
distension of the head, palpitation, shortness of breath,
hypochondriac distension, muscular soreness or pain, self-feeling
of Qi leakage through perineum or anus, intensified and strange
ceaseless body and limb movement due to Qi disorder,
Guo et al. Medicine (2018) 97:44 Medicine
6
neurasthenia, affective disorder, and hallucination and paranoia
are also reported in the literature
[3,9,69–73]
; meanwhile, when
applying Qigong and related therapies to special populations
with psychiatric disorder, particularly patients suffering from
severe schizophrenia, mania, obsessive-compulsive disorder,
unwanted adverse reactions, or Qigong “deviation”could have
occurred.
[9,70–73]
In addition, people who have a family history or
personal complications when Qigong and related therapies are
implemented, as improper or overexuberant practice may induce
further occurrence of psychotic episodes. On the contrary, people
who do not suffer psychosis but present with personality
disturbance, eccentric conduct, and irrational thinking are not
suitable for Qigong and related therapies, because they are at a
high risk of trigger-undesired Qi deviation (physical or more
often emotional disorientation) during Qigong practice.
[9,70–73]
Both minor and serious adverse events refer to physical and
mental changes or special sensations can occur during Qigong
training and they could last some while after practicing.
[3,9,69–73]
Many publications have reported these adverse events, but they
are hard for clinicians or practitioners to digest, as they were
written in inconsistent formats. To minimize potential adverse
effects and harms caused by Qigong and related therapies,
practitioners need to strictly follow standardized procedures of
Qigong and related therapies administration as well as fully
understand the potential adverse events associated with it. It is
important to assess the safety of Qigong and related therapies in
clinical practice and daily life training. Different from other
traditional therapies such as acupuncture,
[74,75]
moxibustion,
[76]
massage,
[77]
and cupping,
[78,79]
whose safety is well analyzed in
surveys and/or overview of systematic reviews. Currently, despite
preliminary scoping of the literature in this area suggests that
there exist a number of review articles that have sought to
characterize adverse events associated with Qigong and related
therapies in different populations and settings,
[69–73]
there is no
overview in existing literature synthesizing the information
provided by systematic reviews and meta-analyses on safety or
adverse events associated with Qigong and related therapies, and
evidence on the safety of Qigong and related therapies have not
been clearly established to date. In such situations, this overview
serves as an important step toward furthering the knowledge,
safety, and application of Qigong. The overview may inform
practitioners around the world about and modify the way they
practice Qigong, given that many Qigong practitioners and
masters may not be fully aware of the full breadth and depth of
risk their training can pose. The aim of this study was to evaluate
the type and frequency of Qigong and therapies related to adverse
events, to identify any avoidable adverse events associated with
nonstandardized Qigong and related therapies procedures, and
to provide recommendations for improving our understanding of
the safety of Qigong and related therapies, including guidelines
for reporting adverse events in potential future research.
Some limitations of this overview should be noted. Due to
language barriers, our study only included systematic reviews
published in the English language, so a language bias may exist.
Future studies might include other languages for a better global
estimate of adverse event of Qigong training reporting. Second,
because of the small number of studies as well as the
heterogeneity of both interventions and controls, our study only
employed descriptive statistics and narrative summaries of
adverse event reports. As the literature evolves, future studies
with more formal meta-analyses for assessing relative harms of
Qigong when compared with other control interventions may be
helpful. Finally, most of systematic reviews only included adverse
events reported in randomized trials. And data from audits and
cross-sectional studies, especially of longer-term practitioners, as
well as uncontrolled longitudinal studies may better inform long-
term safety.
Acknowledgments
The authors would like to deeply acknowledge Professor Tianjin
Liu and Haibo Zhang from BUCM, Professor Qing Tang and
Weibo Zhang from Ovation Health Science and Technology Co.
Ltd, ENN Group for providing valuable suggestions to conduct
this overview.
Author contributions
YG and MMX, YCH and YLW contributed to conceived the idea
of research, developed the search strategy, and drafted the
manuscript. JLZ and QCH critically revised the manuscript and
provided valuable advice on the protocol. YG is in charge of
coordination and direct implementation. YLW is responsible for
monitored the process of overview. YG and MMX will screen the
titles, abstracts, keywords of all retrieved records, and extract
data independently. ZRW and JY will assess the risk of bias
independently. YC and JXL will deal with the missing data. YW
and JMG will conduct statistical analysis, XQS and MQJ will
arbitrate any disagreements in the review. All review authors
approved the publication of the protocol. All authors participat-
ed in the protocol design, commented on drafts of this paper, and
read and approved the publication of the final manuscript.
Conceptualization: Yu Guo, Mingmin Xu, Yuchang Huang,
Yulong Wei.
Data curation: Jialei Zhang, Yue Chen, Xiaoqian Shao.
Formal analysis: Jian Yan, Ying Wang, Jiamei Guo.
Investigation: Yu Guo, Meiqi Ji, Zeren Wei.
Methodology: Yu Guo, Mingmin Xu, Meiqi Ji.
Project administration: Yu Guo, Mingmin Xu, Meiqi Ji, Yulong
Wei.
Supervision: Yu Guo, Mingmin Xu, Yulong Wei.
Validation: Mingmin Xu, Qingchuan Hu, Jiaxuan Lyu.
Visualization: Yu Guo, Mingmin Xu, Yuchang Huang, Meiqi Ji,
Zeren Wei, Jialei Zhang, Qingchuan Hu, Jian Yan, Yue Chen,
Jiaxuan Lyu, Xiaoqian Shao, Ying Wang, Jiamei Guo, Yulong
Wei.
Writing –original draft: Yu Guo, Mingmin Xu.
Writing –review & editing: Yuchang Huang, Meiqi Ji, Yulong
Wei.
Yu Guo: orcid 0000-0002-1752-1254.
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