The Safety of Baduanjin Exercise: A Systematic Review

Objectives Baduanjin exercise is a form of Qigong exercise therapy that has become increasingly popular worldwide. The aims of the current systematic review were to summarize reported adverse events potentially associated with Baduanjin exercise based on currently available literature and to evaluate the quality of the methods used to monitor adverse events in the trials assessed. Methods The English databases PubMed, Cochrane library, and EMbase were searched from inception to October 2020 using the keywords “Baduanjin” or “eight session brocade.” Only studies that included Baduanjin exercise therapy were included. Results Forty-seven trials with a total of 3877 participants were included in this systematic review. Twenty-two studies reported protocols for monitoring adverse events, and two studies reported the occurrence of adverse events during training. The adverse events reported included palpitation, giddiness, knee pain, backache, fatigue, nervousness, dizziness, shoulder pain, chest tightness, shortness of breath, and muscle ache. Conclusions Only two studies reported adverse events that were potentially caused by Baduanjin exercise. Adverse events related to Baduanjin exercise in patients with chronic fatigue syndrome may include muscle ache, palpitation, giddiness, knee pain, backache, fatigue, nervousness, dizziness, shoulder pain, chest tightness, and shortness of breath. Further studies conducted in accordance with the Consolidated Standards of Reporting Trials statement guideline incorporating monitoring of adverse events are recommended. Additional clinical trials in which Baduanjin exercise is used as a main intervention are needed, and further meta-analysis may be required to assess its safety and reach more informed conclusions in this regard in the future.


Introduction
Qigong exercise is a core part of traditional Chinese medicine therapy that has existed for more than 2000 years [1]. Baduanjin is one of the traditional Chinese Qigong exercise therapies of mild to moderate intensity, and it is considered to be an effective approach to promoting health [2]. It emphasizes the mind-body connection, slow movements while breathing deeply, and muscle stretching with mental concentration; it also has profound therapeutic effects in patients with various medical conditions [3][4][5][6][7][8]. Although Baduanjin has been practiced for thousands of years in China, globally it is not as popular as Tai Chi [1,9]. To date, no review has systematically investigated the safety of Baduanjin. e reporting of adverse events (AEs) is vital when introducing and evaluating a new therapy. An AE has been defined as any unwanted experience during a study regardless of whether the AE was directly related to an intervention [10]. Standard reporting of AEs is suggested in the Consolidated Standards of Reporting Trials (CONSORT) statement [11]. It is strongly recommended that AEs should be described in the Results sections of published reports [12]. Despite existing guidelines on the reporting of AEs [11], the degrees to which AEs are described in experimental studies are still inadequate [13,14]. Insufficient reporting of AEs may lead to skepticism, criticism, and even rejection of a therapy.
To address the above-described research gaps with respect to Baduanjin exercise, a systematic review of the available evidence on its safety is needed. Accordingly, the main purpose of the present systematic review was to investigate and summarize the AEs reported in previous studies that included Baduanjin exercise. A secondary aim was to evaluate the quality of the methods used to monitor AEs in the studies assessed.

Guideline Adherence and Eligibility Criteria.
e current analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Only studies published in English were included. Studies involving patients with medical conditions and studies using healthy participants were included. No restrictions on sociodemographic characteristics were applied. Experimental studies that included any type of Baduanjin exercise were included. No restrictions on the types of Baduanjin interventions or control interventions were applied.

Types of Outcome Measures.
e definition of an AE was any undesirable experience during the study period. AEs were categorized as serious, non-serious, and interventionrelated using a prior meta-analytic review as a guide [15]. Serious AEs were defined as those associated with hospitalization or medical or surgical needs, and those that were potentially life-threatening or resulted in death. Other AEs were defined as non-serious. Initial screening to exclude duplicate and irrelevant studies based on article titles was conducted by the first author (Fang). e abstracts of the remaining studies were then independently reviewed by two authors (Fang and Zhang). e remaining full texts were then reviewed by two different independent authors with reference to the eligibility criteria (Wu and Ye). Only research articles that met the selection criteria were included in the subsequent review and assessment. e References sections of relevant articles were also reviewed by the authors. Consensus was reached via discussion if there were disagreements between two reviewers. Only reports published in English were included in the analysis [16].

Data Extraction and Management.
Data extraction from the reports identified included characteristics of the timing, frequency, and types of AEs reported based on the Extension of the CONSORT statement [11], and it was performed by both Fang and Zhang independently. All authors participated in discussion to reach a consensus in cases of disagreements. In two cases in which researchers had not clearly described AEs in their published articles, we emailed the corresponding authors seeking further details on intervention-related AE data and baseline data. Only one of these corresponding authors emailed us back in response to our questions. All of the authors of the current study discussed the AEs that remained unclear in the second study due to the lack of a response from the corresponding author, and made collective judgments with respect to those AEs.

Reports Identified.
A total of 322 records were initially identified. Of these, 112 full-text articles were subsequently obtained based on the predetermined selection criteria, and a total of 47 articles were ultimately included in the current review.
e flow of the literature search is presented in Figure 1.

Characteristics of Intervention Groups and Control
Groups.

Discussion
Baduanjin exercise is becoming increasingly popular around the world as it has been associated with therapeutic benefits for various medical conditions. It is now offered in hospital and community settings across China to reduce clinical symptoms and improve quality of life. e risk of harm from Baduanjin exercise may be minor, as suggested by the current systematic review, and older adults or patients with chronic illness are more likely to experience benefits associated with its clinical effects and affordability.
In the present systematic review, the reporting of AEs in Baduanjin exercise studies was insufficient, and this limits the conclusions that can be drawn to date about its safety [10]. A total of 47 studies with a combined total of 3877 participants were included in the current systematic review. Of the 47 studies, 22 reported the utilization of protocols to monitor AEs, and 2 reported the actual occurrence of AEs.
e AEs reported included palpitation, giddiness, knee pain, backache, fatigue, nervousness, dizziness, shoulder pain, chest tightness, shortness of breath, and muscle ache. Some studies reported AEs at the end of the study, which may have resulted in recall bias. More frequent measures to identify AEs, and the incorporation of multiple modalities via which to report AEs throughout the study (interviews, questionnaires, and tests), may contribute to the generation of more reliable evidence [12].
None of the studies in the current systematic review reported any serious AEs. e most commonly reported AE related to Baduanjin exercise was muscle ache [44,52], which is consistent with previous observations in other exercise studies [61][62][63][64][65]. Notably, some Baduanjin exercises entail a semi-squat position, for example, "Session 2, Open the Arms as an Archer Shooting Both Left-and Right-Handed"; "Session 5, Sway the Head and Shake the Tail"; and "Session 7, Grip the Palms to Improve Strength" [25]. In such sessions, participants are required to coordinately move upper limbs and trunks while in a semi-squat position, which may greatly improve muscle strength, particularly that of the lower extremities.
ese types of Baduanjin exercises may have contributed to the mild muscle aches reported during the first 2 weeks of practice [44,52].
In one trial that included participants with chronic fatigue syndrome (CFS), 24 AEs were reported after Baduanjin exercise [44], which is consistent with other physical exercise studies in individuals with CFS [66].
is suggests that patients with CFS may experience some non-serious AEs after standard Baduanjin exercises. Notably however, that report [44]   Evidence-Based Complementary and Alternative Medicine

Conclusion
Estimation of any potential harm related to a novel therapy is a vital consideration when promoting that therapy. Poor reporting of AEs may substantially limit the conclusions that can be drawn relating to Baduanjin exercise. e number of trials with strict reporting of AEs is small. One of the studies in the current analysis suggests that AEs related to Baduanjin exercise in patients with CFS may include muscle ache, palpitation, giddiness, knee pain, backache, fatigue, nervousness, dizziness, shoulder pain, chest tightness, and shortness of breath. It is recommended that in future studies AEs are rigorously monitored and strictly reported in accordance with the CONSORT guideline. Further metaanalysis may enhance understanding of the safety of Baduanjin exercise in the future.
Data Availability e datasets used and analyzed during the current study are available from the corresponding author upon reasonable request. Disclosure e funder had no role during the entire process of this study.

Conflicts of Interest
e authors declare that there are no conflicts of interest regarding the publication of this article.