Qigong Exercise for the Treatment of Fibromyalgia: A Systematic Review of Randomized Controlled Trials

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1 THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 18, Number 7, 2012, pp ª Mary Ann Liebert, Inc. DOI: /acm Review Articles Qigong Exercise for the Treatment of Fibromyalgia: A Systematic Review of Randomized Controlled Trials Cecilia L. W. Chan, PhD, 1,2 Chong-Wen Wang, PhD, 1 Rainbow T. H. Ho, PhD, 1,2 Siu-Man Ng, PhD, 1,2 Eric T. C. Ziea, MD, PhD, 3 and Vivian Taam Wong, FRCP 4 Abstract Objectives: The study objective was to summarize and critically assess the evidence available from randomized controlled trials (RCTs) of qigong exercise for patients with fibromyalgia (FM). Methods: Thirteen (13) databases were searched up to February RCTs testing the effects of qigong exercise among patients with FM were included. For each included study, data were extracted and study quality was evaluated using the Jadad Scale. Results: Four (4) RCTs met the inclusion criteria. One (1) RCT demonstrated beneficial effects of qigong exercise for FM. Two (2) RCTs testing the effectiveness of qigong as a part of a treatment package compared with group education or daily activities failed to show favorable effects of qigong exercise for adult patients with FM. Another RCT comparing qigong with aerobic exercise among children with FM showed effects in favor of aerobic exercise. Conclusions: Given methodological flaws in the included studies, it is still too early to draw a conclusion about the effectiveness of qigong exercise for FM. Further rigorously designed RCTs are warranted. Introduction Fibromyalgia (FM) is a chronic pain disorder characterized by widespread musculoskeletal pain, chronic fatigue, muscle tenderness, sleep disorder, paresthesia, migraine headache, functional impairments, and psychologic distress. 1 It is estimated that FM affects between 1% and 4% of the population, and its incidence is sevenfold higher among women. 2,3 It is speculated that input from peripheral tissues and central sensitization contribute to overall FM pain, 4 and research has demonstrated dysfunction of pain modulatory systems including pain inhibition and pain facilitation in FM patients. 5 Symptom management and functional improvement are the main goals in the treatment of FM. 6,7 Although recent clinical trials have demonstrated favorable impacts of some medications on FM-related pain 8 and pharmacological treatments are consistently recommended, higher ratings to multidisciplinary approaches and multicomponent therapies for management of FM symptoms have been assigned in recent evidence-based guidelines. 9 Studies have demonstrated benefits of regular low-impact aerobic-only exercise for FMrelated symptoms and function, but compliance or adherence to the exercise programs is a serious problem for patients with FM. 10 The use of complementary and alternative medicine to manage their symptoms has been preferred by a large number of patients with FM. 11 Qigong, a general term for a large range of traditional Chinese energy exercises and therapies, is a form of traditional Chinese medical practice. It is popularly practiced by a large number of people in Chinese communities. Qi means vital energy and gong refers to discipline. It is believed that qi circulates throughout the body along its own channels in the way that blood circulates in the arteries and veins; if its flow is obstructed, specific symptoms such as pain may be felt. 12 Qigong aims to achieve a harmonious flow of energy (qi) in the body through gentle movements integrating body with mind so as to improve physical fitness and overall wellbeing, and is thus potentially helpful for pain relieving. Moreover, controlled breathing and structured movements promote a restful state and mental tranquility that may raise pain thresholds. 13 Basically, there are two categories of qigong: internal qigong versus external qigong. Internal qigong or qigong exercise is self-directed and involves the use of movements, meditation, and control of breathing pattern, whereas external qigong or emitted qi is usually performed by a trained practitioner using their hands to direct qi energy 1 Centre on Behavioral Health, The University of Hong Kong, Hong Kong, China. 2 Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong, China. 3 Chinese Medicine Department, Hospital Authority, Hong Kong, China. 4 School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China. 641

2 642 CHAN ET AL. onto the patient for treatment. Their underlying mechanisms for potential benefits are different. Because of its mind body attributes, qigong exercise has been applied in some clinical studies for the treatment of FM. However, no systematic review of the subject has been published to date. The purpose of this systematic review was to summarize and critically assess the evidence of the effectiveness of qigong exercise in the treatment of FM and the management of relevant symptoms. Methods The following electronic databases were searched: PubMed/MEDLINE, Ò Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (Embase), Allied and Complementary Medicine (AMED), Qigong and Energy Medicine Database, China Journals Full-text Database-Medicine/Hygiene Series, China Proceedings of Conference Full-text Database, Chinese Master Theses Full-text Database, China Doctor Dissertations Full-text Database, Electronic Theses and Dissertation System (Taiwan), Taiwan Electronic Periodical Services, and Index to Taiwan Periodical Literature System. The search terms used for this systemic review include the following: qigong, qi-gong, qi gong, chi kung, chi chung, chi gong, qi chung, qi-training, fibromyalgia, and fibrositis. Both traditional and simplified Chinese translations of these terms were used in Chinese databases. No limits were imposed on characteristics of participants, study design, intervention, and language. Studies in foreign languages other than English and Chinese were also examined where available. Reference lists of all included studies, relevant reviews, and other archives of the located publications were hand-searched for further relevant reports. All controlled clinical trials testing the effects of qigong exercise in the patients with FM were included. Randomized controlled trials (RCTs) were preferred and nonrandomized controlled clinical trials were also examined due to the limited number of RCTs in the field. Uncontrolled observational studies were excluded due to their susceptibility to bias and lack of significant evidence. For all included studies, the primary data from the original sources were reviewed and analyzed. To assess the effectiveness of qigong exercise in the treatment of FM, all clinical outcome measures relevant to FM were considered. For each included study, data were extracted by one main researcher and then verified by another researcher. Any discrepancies were resolved by discussion. The quality or validity of the included studies were evaluated and summarized using the Jadad Scale, 14 which is based on three criteria: description of randomization, blinding, and withdrawals or dropouts (the score ranges from 0 to 5). This scale has been extensively used in systematic reviews. Risk of bias for all included trials was assessed using the framework for methodological quality recommended by Jüni and colleagues. 15 Results The searches identified 30 potentially relevant articles. Of these, 26 articles were excluded because they were not based on a clinical trial, not related to qigong, related to external qigong, not related to or did not focus on FM, or were uncontrolled observational studies (Fig. 1). Four (4) RCTs met the inclusion criteria. No nonrandomized controlled trials were successfully identified. Of the four included studies, three focused on adult patients and one 19 focused on children with FM. Sample sizes among the included studies ranged from 30 to 128. In total, these studies covered 251 subjects including 128 subjects in the qigong groups and 123 subjects in the control groups. All of the included studies were conducted with a two-armed parallel group design. Durations of intervention ranged from 7 weeks to 3 months. The outcome measures that emerged in the included studies included FM symptoms, functional capacity, pain, quality of life (QOL), psychologic distress, and fitness measures. These studies were conducted in the United States, 16 Sweden, 18,19 and Canada. 19 All of the included studies were published in peer-review journals in English. Jadad Scores for these RCTs ranged from 2 to 4. Characteristics of the included studies are displayed in Table 1. Details of Included Studies Astin et al. 16 tested the health benefits of mindfulness meditation plus qigong exercise therapy for individuals with FM. One hundred and twenty-eight (128) individuals with FM were randomly assigned to either the intervention group receiving mindfulness meditation plus qigong exercise therapy once a week for 8 weeks or an education support group as a control. Outcome measures included pain, disability, tender points count, total myalgic score, 6-minute walk time test, depression, and coping strategies, which were assessed at baseline and at 8, 16, and 24 weeks. No significant difference was found between the two groups for all of the outcomes, though significantly positive changes were observed in the score of disability, total myalgic score, pain, and depression in both groups and were maintained throughout the 6-month follow-up period. Haak and Scott 17 conducted a RCT to examine the effects of qigong exercise on individuals with FM. Fifty-seven (57) female subjects were randomly assigned either to the intervention FIG. 1. Selection process for included studies. RCTs, randomized controlled trials.

3 Table 1. Summary of Randomized Controlled Trials of Qigong Exercise for Fibromyalgia Studies Ages (years) N Intervention (frequency) Control Duration & follow-up Outcome measures Intergroup differences Jadad Score Astin et al QG:64 Qigong (Dance of the Phoenix) and mindfulness meditation training, (2.5 hrs, group meetings, once a week) Education/support (2.5 hrs, group sessions, once a week) 8 weeks, followed up at 16 and 24 weeks CG:64 2. Total myalgic score 1. Tender point count NS for all outcome measures. 3. FIQ 4. 6-minute walk time test 5. MOS SF-36 bodily pain score 5. BDI 6. Coping strategies questionnaire 7. Medical care history 4 Haak & Scott QG:29 Internal Qigong (He Hua Waiting-list control 7 weeks, followed up 1. Anxiety (STAI) 1 p < CG:28 Qigong, 20 min 9 at 4 months 2. Depression (BDI) 2 p < 0.01 group sessions within 7 3. Quality of life 3 p < 0.05 weeks plus homebased (WHOQOL-BREF) a. p < 0.05 exercise 20 min a. Psychologic health b. NS twice a day) and external b. Physical health Qigong (2 times) 4. Daily self-recordings (VNS) 4 Daily self-recordings a. Intensity of pain (VNS) a. p < 0.05 b. Degree of inconvenience as a result of pain b. p < 0.01 c. Ability to control pain c. p < 0.05 d. Degree of restoration following sleep d. p = 0.11, Cohen s d = 0.44 e. Sleep quality e. NS f. Harmony f. p < g. Energy level g. p < h. Ability to concentrate h. p < 0.01 Mannerkorpi & Arndorw Daily activities 3 months (14 1. BARS 1. p = CG:17 sessions) 2. FIQ 2. NS QG:19 Qigong (style not reported) plus body awareness therapy, (1.5 hrs, group sessions, once a week) 3. Hand grip test 3. NS 4. Chair test 4. NS (continued) 643

4 Table 1. (Continued) Studies Ages (years) N Intervention (frequency) Control Duration & follow-up Outcome measures Intergroup differences Jadad Score 12 weeks 1. Tender points 1. NS 3 CG:14 2. C-HAQ score 2. C-HAQ score Stephens et al QG: 16 Qigong exercise (18 postures) (30 min, super- vised session once a week plus unsupervised session twice a week) Structured aerobic exercise (30 min, supervised session once a week plus unsupervised session twice a week) a. Total a. p = 0.05* b. Pain VAS b. p < 0.01* c. Illness VAS c. p < 0.05* 3. Overall QOL 3. p = 0.01* 4. HRQOL 4. NS 5. PedsQL fatigue 5. p = 0.01* 6. PedsQL pain 6. NS 7. FSSQ 7. FSSQ a. Symptom score a. NS b. Mean score b. NS 8. CDI 8. NS 9. HAES total 9. NS QG, Qigong group; CG, control group; n.s., not significant; FIQ, Fibromyalgia Impact Questionnaire; MOS SF-36, Medical Outcome Study Short-form-36, BDI, Beck s Depression Inventory; STAI-S, State Anxiety Inventory; WHOQOL-BREF, World Health Organization Quality of Life BREF; VNS, Visual Numerological Scale; BARS, Body Awareness Rating Scale; C-HAQ, Childhood Health Assessment Questionnaire; VAS, Visual Analog Scale; NS, no significance; HRQOL, health-related quality of life; QOL, quality of life; PedsQL, Pediatric Quality of Life Inventory; FSSQ, Functional Status and Symptom Questionnaire; CDI, Childhood Depression Inventory; HAES, Habitual Activity Estimation Scale. *Significant improvements were observed in the aerobic excercise group. 644

5 QIGONG FOR THE TREATMENT OF FIBROMYALGIA 645 group (n = 29) or a waiting-list control group (n = 28). Participants in the intervention group received nine sessions of group qigong exercise training plus two sessions of external qigong therapy during a 7-week period. After completion of the experimental part, participants in the control group also received the same intervention. All participants were followed up for 4 months. The outcome measures included anxiety, depression, QOL, pain, sleep, harmony, energy level, and the ability to concentrate. Compared to the control group, significant improvements in the qigong group were observed for the majority of these outcomes except for physical health and sleep quality. Almost identical results were observed for all of the participants in the control group after receiving similar intensity of qigong intervention. The majority of the favorable results were maintained at the 4-month follow-up. Mannekorpi and Arndorw 18 evaluated the effects of qigong exercise plus body awareness therapy on individuals who had FM for a very long history of symptoms (an average of 10 years). Thirty-six (36) female patients were randomly assigned to either the intervention group receiving qigong exercise plus body awareness therapy once a week for 3 months (n = 19) or a control group with normal daily activities (n = 17). Outcome measures included the Body Awareness Rating Scale (BARS), the Fibromyalgia Impact Questionnaire, and two tests of physical function. Although a significant difference in the BARS total score between the two groups was observed at postintervention, no improvement was found for physical function and FM symptoms. Stephens et al. 19 conducted a RCT to compare the effects of qigong and aerobic exercise on children with FM. Thirty (30) children with FM aged 8 18 years were randomly assigned to either the qigong exercise group or the aerobic exercise group. Participants in both groups received one supervised session and two unsupervised sessions of qigong exercise or structured aerobic exercise every week over a period of 12 weeks. Each session lasted for 30 minutes. The outcome measures included FM symptoms, functional capacity, pain, QOL, and fitness measures. Significant improvements in physical function, FM symptoms, QOL, and pain were observed in both groups, with better performance in several outcome measures at postintervention in the aerobic exercise group. Discussion Overall, the number of controlled clinical trials on the effectiveness of qigong exercise for the treatment of FM is limited and the findings are inconsistent across the studies included in this systematic review. Of the four included RCTs, only one 17 demonstrated beneficial effects of qigong exercise for the treatment of FM. Two RCTs 16,18 testing the effectiveness of qigong exercise as a part of a treatment package in adult patients with FM failed to generate significant differences between the qigong group and the control group. In contrast, one RCT 19 comparing qigong with aerobic exercise among children with FM showed effects in favor of aerobic exercise. The risk of bias inherent in these studies was assessed using a standard scoring system. Of the four included RCTs, only two 16,19 reported adequate concealment of treatment allocation. Blinding of patients for qigong exercise is generally impossible. Blinding of assessors to reduce detection bias was applied in three RCTs. 16,18,19 Details of dropouts and withdrawals were described in all included RCTs, but intent-to-treat analysis was used only in one RCT. 19 In two RCTs, 16,18 intent-to-treat analysis was planned but was not performed due to high dropout rates. Thus, the probability of bias might exist in these studies. An examination of the included studies also reveals a great variability of the dosage and the quality of qigong exercise across these studies. In the two RCTs 16,18 that failed to generate a significant intergroup difference, qigong was taken as a part of a treatment package involving mindfulness meditation training or body awareness therapy and was performed only once a week. Although the patients were encouraged to perform qigong exercise at home, but the frequency of practicing qigong at home is unclear. Qigong is designed to achieve a harmonious flow of energy (qi) in the body through gentle movements and postures of the exercise, and its health benefits rely on long-term rehearsal of structured body exercise and skillful stress management practice. A frequency of once a week of qigong exercise may not be sufficient to generate health benefits. In another RCT 19 among children with FM, qigong was taught by trained instructors rather than a master of qigong. It is thus possible that the full benefits of qigong training have not been realized. In the sole RCT 17 that showed significant results, a combination of internal and external qigong was applied. It was difficult to attribute all effects to internal qigong. Another issue is related to the quality of qigong exercise intervention. Practically, many forms or styles of qigong exercise (e.g., Guo-Lin Qigong, Chinese Taiji Five-Element Qigong, and Chan-Chuang Qigong) have been developed. Basically, qigong exercise can be divided into different types including meditative qigong or quiescent qigong (known as jing gong in Chinese), dynamic qigong or active qigong (dong gong in Chinese), and a combination of the two (jing dong gong in Chinese). The intensity of exercise is often different for these types of qigong. However,theqigong styles varied greatly across the included studies. Thus, some of these studies might be subject to performance bias. Furthermore, most of the included studies have a small sample size and therefore their results are prone to type II error. Although most of the included studies did not show a desirable effect of qigong exercise over the control group with education/support or aerobic exercise, improvements of FM symptoms, pain, fatigue, function, and QOL were observed in the qigong group in pre-/postcomparison in all of these studies. Several uncontrolled observational studies 20 23,a c also showed positive effects of qigong exercise for the patients with FM. Unfortunately, these data were highly susceptible to bias and provided little scientific evidence on the beneficial effects of qigong exercise as an alternative therapy for FM. The current review may have some limitations. Similar to any systematic review, one major limitation is the potential a Berglund E, Perman GB, Westerlind M. Medical treatment and rehabilitation with the aid of qigong. An unpublished project within Lilla Edet Primary Health Care system [in German] b Berglund E, Perman GB, Westerlind M. Medical treatment and rehabilitation with the aid of qigong. An unpublished project within Lilla Edet Primary Health Care system [in German] c Jendenäs N. How to break the negative circle in fibromyalgia. An unpublished project within Salems Primary Health Care [in German]

6 646 CHAN ET AL. incompleteness of the evidence reviewed. The aim was to identify all controlled clinical trials in the field. A large number of databases were searched with relevant terms in title, abstract, and keywords. The authors are confident that all relevant data have been located with this search strategy. However, a degree of uncertainty remains. It was not possible to perform meta-analyses due to heterogeneity of outcome measures in the included studies. Moreover, selective publishing and reporting can also be a major cause of bias in the included studies. Despite these limitations, this review is the first to critically assess the evidence of the effects of qigong exercise in the treatment of FM and reveals some methodological flaws in existing studies, such as expertise of qigong practitioners, the pluralism of qigong frequency and duration of intervention, and heterogeneous comparison groups and outcome measures, as pointed out by other reviews on qigong. 24,25 Future RCTs of qigong for FM should adhere to accepted standards of trial methodology. Well-designed RCTs with rigorous interventional strategies are important for reducing bias. Taking qigong as a part of an intervention package involving mindfulness meditation training and insufficient amount of qigong exercise may underestimate the effects of qigong for FM. Moreover, quiescent qigong focusing on meditation may be inappropriate for FM because resting and focusing inwards can amplify pain by bringing a patient s attention to it. The effects of internal qigong and external qigong should also be differentiated. Conclusions In conclusion, it is still too early to draw a conclusion about the effectiveness of qigong exercise for FM. Further rigorously designed RCTs are required to test the effectiveness of qigong as a complementary and alternative therapy in the treatment of FM. Acknowledgments This review was supported by the Hospital Authority of Hong Kong (HA105/48 PT5). Disclosure Statement No competing financial interests exist. References 1. Wolfe F, Smythe HA, Yunus MB, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia: Report of the multicentre criteria committee. Arthritis Rheum 1990;33: Branco JC, Bannwarth B, Failde I, et al. Prevalence of fibromyalgia: A survey in five European countries. Semin Arthritis Rheum 2010;39: Lawrence RC, Felson DT, Helmick CG, et al. 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Integr Cancer Ther 2002;1: Lee MS, Pittler MH, Ernst E. Internal qigong for pain conditions: A systematic review. J Pain 2009;10: Address correspondence to: Chong-Wen Wang, PhD Centre on Behavioral Health The University of Hong Kong 5 Sassoon Road Pokfulam, Hong Kong China wangcw@hku.hk