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Safety of Qigong: Protocol for an overview of systematic reviews.

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.

SUBMITTER: Guo Y

PROVIDER: S-EPMC6221731 | biostudies-other | 2018 Nov

REPOSITORIES: biostudies-other

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Safety of Qigong: Protocol for an overview of systematic reviews.

Guo Yu Y Xu Mingmin M MM Huang Yuchang Y Ji Meiqi M Wei Zeren Z Zhang Jialei J Hu Qingchuan Q Yan Jian J Chen Yue Y Lyu Jiaxuan J Shao Xiaoqian X Wang Ying Y Guo Jiamei J Wei Yulong Y

Medicine 20181101 44

<h4>Background</h4>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 adve ...[more]

PMID: 30383671

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Project description:Background In 2009, a new influenza A H1N1 virus emerged causing a global pandemic. A range of monovalent influenza A H1N1pdm09 vaccines with or without adjuvants were developed. After the mass vaccination campaigns safety concerns related to H1N1pdm09 vaccines were reported. More than a decade later, reported AEFIs are still under scrutiny. We performed a systematic review aiming to synthesize the evidence on the safety of the H1N1pdm09 vaccines on reported outcomes from existing systematic reviews. Methods Four electronic databases, PubMed, EMBASE, Epistimonikos and the Cochrane Database of Systematic Reviews were searched for articles on H1N1pdm09 vaccination published from 2009 to January 2021. Systematic reviews assessing short- or long-term adverse events after H1N1pdm09 vaccination were considered for inclusion. Data was extracted from all selected reviews. Outcomes were grouped and results from each included review were presented narratively and in tables. Results 16 systematic reviews met the inclusion criteria. Reported outcomes were short-term events (3 reviews), fetal/pregnancy outcomes (8 reviews), Guillain-Barré syndrome (GBS) (4 reviews), narcolepsy (2 reviews) demyelinating diseases (1 review based on one study only) and inflammatory bowel disease (IBD) (1 review). Short-term serious adverse events were rare, 3 cases amongst 16725 subjects in 18 randomized controlled trials (0.018%). No deaths were reported. The risks of local events were generally higher for adjuvanted vaccines as compared to unadjuvanted vaccines. Maternal H1N1pdm09 vaccination in any trimester was not associated with an increase in preterm birth, small for gestational age, congenital malformations or fetal death. For GBS, results were conflicting. The main systematic review on narcolepsy found a 5-14-fold increased risk in children, and a 2-7- fold increased risk in adults after vaccination with Pandemrix. The attributable risk of narcolepsy one year after vaccination was 1 case per 18 400 vaccine doses in children/adolescents, and 1 case per 181 000 vaccine doses in adults. Conclusion Adjuvanted vaccines had more local but not serious adverse events compared to unadjuvanted vaccines. Vaccination with Pandemrix was strongly associated with narcolepsy, particularly in children. No increased risks of pregnancy outcomes were seen after pandemic vaccination. The findings on GBS were inconclusive.

Project description:Background:Migraine is a common neurological disease, which burdens individuals and society all over the world. Acupuncture, an important method in Traditional Chinese Medicine, is widely used in clinical practice as a treatment for migraine. Several systematic reviews (SRs) have investigated the effectiveness and safety of acupuncture for migraine. Objective:To summarize and critically assess the quality of relevant SRs and present an objective and comprehensive evidence on the effectiveness and safety of acupuncture for migraine. Data Sources. MEDLINE, Embase, Cochrane Library, PROSPERO database, Chinese National Knowledge Infrastructure (CNKI), Chinese Biological Medicine (CBM), China Science and Technology Journal (SCTJ), and WanFang database (WF) were searched from inception to December 2019 and grey literatures were manually searched. Selection Criteria. SRs which meet the criteria were independently selected by 2 reviewers according to a predetermined protocol. Data Extraction. Characteristics of included SRs were independently extracted by 2 reviewers following a predefined data extraction form. Review Appraisal. The methodological quality, risk of bias, and reporting quality of included SRs were assessed, respectively, by a Measurement Tool to Assess Systematic Reviews (AMSTAR) 2, the Risk of Bias in Systematic reviews (ROBIS) tool, and the Preferred Reporting Item for Systematic Review and Meta-analysis-Acupuncture (PRISMA-A) statement. The quality of outcomes was evaluated by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Results:A total of 15 SRs were included. All the SRs were published between 2011-2019. Based on AMSTAR 2, 14 out of 15 SRs were rated critically low quality and 1 was rated low quality. According to ROBIS tool, 9 SRs (60%) were low risk of bias. With the PRISMA-A checklist, we found 11 out of 15 SRs were found adequately reported over 70%. With the GRADE tool, we found high quality of evidence indicated that the effective rate of acupuncture was superior to western medicine in treatment of migraine. Besides, acupuncture reduced more headache days and the times of using painkiller and was more effective in reducing the frequency and degree of headache than western medicine and sham acupuncture. Limitations. There might be some missing information. The accuracy of the conclusions may be decreased reduced since we were unable to synthesis all the evidence. Conclusions:Based on high quality of evidence, we concluded that acupuncture may be an effective and safe therapy for migraine. However, the quality of SRs in acupuncture for migraine still needs more improvement.

Project description:BackgroundKnee osteoarthritis (KOA), known as severe degenerative arthritis, commonly occurs in middle-aged and elderly people all over the world. Acupuncture as traditional oriental intervention is getting widely used and several systematic reviews (SRs) have reported the effectiveness of acupuncture on pain relief and functional recovery in patients with KOA.ObjectiveConducting an overview of SRs to provide more reliable evidence-based medical references for clinical practitioners and researchers of the effectiveness and safety of acupuncture for KOA.Data sourcesEMBASE, Medline, Web of science, the Cochrane library, China National Knowledge Infrastructure, the Chinese Science and Technology Periodical Database, China Biology Medicine, Wan Fang Digital Journals, and PROSPERO databases from inception to December 2018, magazines, websites, and unpublished sources.Selection criteriaPotential SRs were independently selected by 2 reviewers following a predetermined protocol.Data extractionData information of included SRs were independently extracted by 2 reviewers following a predetermined standardized data extraction form.Review appraisalThe risk of bias and reporting quality of included SRs were evaluated by the Risk of Bias in Systematic reviews (ROBIS) tool and the Preferred Reporting Item for Systematic Review and Meta-analysis (PRISMA) statement. The quality of evidence of outcomes was evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE).ResultsA total of 12 SRs were included. All the SRs were published in recent 12 years, ranging from 2006 to 2017. According to ROBIS, 4 SRs were in low risk in domain 1 and 7 in domain 3 of phase 2, and 2 SRs were low risk in phase 3. Among 27 items of PRISMA, 19 items were reported over 70% of compliance. Using GRADE assessment, of 34 outcomes, high quality of evidence was found in 5 outcomes, 17 outcomes were rated moderate quality, and 11 outcomes were low quality. According to high-quality outcomes, acupuncture had more total effective rate, short-term effective rate, and less adverse reactions than western medicine in treating KOA. In terms of Lequesne index and Lysholm knee score scale score, the effectiveness of electroacupuncture was better than that of western medicine.LimitationsThere might be missing information. There may be duplicated clinical trials included by each SR that might have impact on the synthetic findings.ConclusionsAccording to the high-quality evidence, we concluded that acupuncture may have some advantages in treating KOA. However, there are some risk of bias and reporting deficiencies still needed to be improved.

Project description:BackgroundVirtual reality (VR) is an innovative neurorehabilitation modality that has been variously examined in systematic reviews. We assessed VR effectiveness and safety after cerebral stroke.MethodsIn this overview of systematic reviews, we searched eleven databases (Cochrane Database of Systematic Reviews, EMBASE, MEDLINE, SCOPUS, ISI Web of Science, CINAHL, PsycINFO, Pedro, Otseeker, Healthevidence.org, Epistemonikos) and grey literature from inception to January 17, 2023. Studies eligible for inclusion were systematic reviews published in English that included adult patients with a clinical diagnosis of stroke (acute to chronic phase) undergoing any kind of immersive, semi-immersive or non-immersive VR intervention with or without conventional therapy versus conventional therapy alone. The primary outcome was motor upper limb function and activity. The secondary outcomes were gait and balance, cognitive and mental function, limitation of activities, participation, and adverse events. We calculated the degree of overlap between reviews based on the corrected covered area (CCA). Methodological quality was assessed using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR 2) and the Certainty of Evidence (CoE) using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Discordances between results were examined using a conceptual framework based on the Jadad algorithm. This overview is registered with PROSPERO, CRD42022329263.FindingsOf the 58 reviews included (n = 345 unique primary studies), 42 (72.4%) had conducted meta-analysis. More than half of the reviews (58.6%) were published between 2020 and 2022 and many (77.6%) were judged critically low in quality by AMSTAR 2. Most reported the Fugl Meyer Assessment scale (FMA-UE) to measure upper limb function and activity. For the primary outcome, there was a moderate overlap of primary studies (CCA 9.0%) with discordant findings. Focusing on upper limb function (FMA-UE), VR with or without conventional therapy seems to be more effective than conventional therapy alone, with low to moderate CoE and probable to definite clinical relevance. For secondary outcomes there was uncertainty about the superiority or no difference between groups due to substantial heterogeneity of measurement scales (eg, methodological choices). A few reviews (n = 6) reported the occurrence of mild adverse events.InterpretationCurrent evidence suggests that multiple meta-analyses agreed on the superiority of VR with or without conventional therapy over conventional therapy on FME-UE for upper limb. Clinicians may consider embedding VR technologies into their practice as appropriate with patient's goals, abilities, and preferences. However, caution is needed given the poor methodological quality of reviews.FundingItalian Ministry of Health.

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Safety of Qigong: Protocol for an overview of systematic reviews.

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Safety of Qigong: Protocol for an overview of systematic reviews.

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