Peter M Wayne1, Danielle L Berkowitz2, Daniel E Litrownik3, Julie E Buring4, Gloria Y Yeh5. 1. Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Harvard Medical School, Boston, MA; Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA. Electronic address: pwayne@partners.org. 2. Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA. 3. Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, MA. 4. Harvard Medical School, Boston, MA; Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA. 5. Harvard Medical School, Boston, MA; Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, MA.
Abstract
OBJECTIVE: To systematically review the frequency and quality of adverse event (AE) reports in randomized controlled trials (RCTs) of tai chi (TC). DATA SOURCES: Electronic searches of PubMed/MEDLINE and additional databases from inception through March 2013 of English-language RCTs. Search terms included tai chi, taiji, and tai chi chuan. Data were independently extracted by 2 investigators. STUDY SELECTION: We included all available RCTs that were published in English and used TC as an intervention. Inclusion and exclusion criteria of studies were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. DATA EXTRACTION: Eligible RCTs were categorized with respect to AE reporting: no mention of protocol for monitoring AEs or reports of AEs, and reports of AEs either with or without explicit protocol for monitoring AEs. DATA SYNTHESIS: There were 153 eligible RCTs identified; most targeted older adults. Only 50 eligible trials (33%) included reporting of AEs; of these, only 18 trials (12% overall) also reported an explicit AE monitoring protocol. Protocols varied with respect to the rigor of systematic monitoring in both the TC and comparison groups. Reported AEs were typically minor and expected and primarily musculoskeletal related (eg, knee and back pain); no intervention-related serious AEs were reported. CONCLUSIONS: TC is unlikely to result in serious AEs, but it may be associated with minor musculoskeletal aches and pains. However, poor and inconsistent reporting of AEs greatly limits the conclusions that can be drawn regarding the safety of TC.
OBJECTIVE: To systematically review the frequency and quality of adverse event (AE) reports in randomized controlled trials (RCTs) of tai chi (TC). DATA SOURCES: Electronic searches of PubMed/MEDLINE and additional databases from inception through March 2013 of English-language RCTs. Search terms included tai chi, taiji, and tai chi chuan. Data were independently extracted by 2 investigators. STUDY SELECTION: We included all available RCTs that were published in English and used TC as an intervention. Inclusion and exclusion criteria of studies were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. DATA EXTRACTION: Eligible RCTs were categorized with respect to AE reporting: no mention of protocol for monitoring AEs or reports of AEs, and reports of AEs either with or without explicit protocol for monitoring AEs. DATA SYNTHESIS: There were 153 eligible RCTs identified; most targeted older adults. Only 50 eligible trials (33%) included reporting of AEs; of these, only 18 trials (12% overall) also reported an explicit AE monitoring protocol. Protocols varied with respect to the rigor of systematic monitoring in both the TC and comparison groups. Reported AEs were typically minor and expected and primarily musculoskeletal related (eg, knee and back pain); no intervention-related serious AEs were reported. CONCLUSIONS:TC is unlikely to result in serious AEs, but it may be associated with minor musculoskeletal aches and pains. However, poor and inconsistent reporting of AEs greatly limits the conclusions that can be drawn regarding the safety of TC.
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