PMID- 34489268 OWN - NLM STAT- MEDLINE DCOM- 20210915 LR - 20210923 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 11 IP - 9 DP - 2021 Sep 6 TI - Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. PG - e045961 LID - 10.1136/bmjopen-2020-045961 [doi] LID - e045961 AB - OBJECTIVE: Overview on risks of acupuncture-related adverse events (AEs). DESIGN: Systematic review and meta-analyses of prospective studies. DATA SOURCES: PubMed, Scopus and Embase from inception date to 15 September 2019. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Prospective studies assessing AEs caused by needle acupuncture in humans as primary outcome published in English or German. DATA EXTRACTION AND SYNTHESIS: Two independent researchers selected articles, extracted the data and assessed study quality. Overall risks and risks for different AE categories were obtained from random effects meta-analyses. MAIN OUTCOMES: Overall risk of minor AEs and serious adverse events (SAEs) per patients and per treatments. RESULTS: A total of 7679 publications were identified. Twenty-two articles reporting on 21 studies were included. Meta-analyses suggest at least one AE occurring in 9.31% (95% CI 5.10% to 14.62%, 11 studies) of patients undergoing an acupuncture series and in 7.57% (95% CI 1.43% to 17.95%, 5 studies) of treatments. Summary risk estimates for SAEs were 1.01 (95% CI 0.23 to 2.33, 11 studies) per 10 000 patients and 7.98 (95% CI 1.39 to 20.00, 14 studies) per one million treatments, for AEs requiring treatment 1.14 (95% CI 0.00 to 7.37, 8 studies) per 1000 patients. Heterogeneity was substantial (I(2) >80%). On average, 9.4 AEs occurred in 100 treatments. Half of the AEs were bleeding, pain or flare at the needle site that are argued to represent intended acupuncture reaction. AE definitions and assessments varied largely. CONCLUSION: Acupuncture can be considered among the safer treatments in medicine. SAEs are rare, and the most common minor AEs are very mild. AEs requiring medical management are uncommon but necessitate medical competence to assure patient safety. Clinical and methodological heterogeneity call for standardised AE assessments tools, clear criteria for differentiating acupuncture-related AEs from therapeutically desired reactions, and identification of patient-related risk factors for AEs. PROSPERO REGISTRATION NUMBER: CRD42020151930. CI - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Baumler, Petra AU - Baumler P AUID- ORCID: 0000-0002-3262-2993 AD - Multidisciplinary Pain Centre, Department of Anaesthesiology, University Hospital LMU Munich, Munich, Germany Petra.Baeumler@med.uni-muenchen.de. FAU - Zhang, Wenyue AU - Zhang W AD - School of Acupuncture, Moxibustion and Tuina, Beijing Rehabilitation Hospital, Beijing University of Chinese Medicine, Beijing, China. FAU - Stubinger, Theresa AU - Stubinger T AD - Multidisciplinary Pain Centre, Department of Anaesthesiology, University Hospital LMU Munich, Munich, Germany. FAU - Irnich, Dominik AU - Irnich D AD - Multidisciplinary Pain Centre, Department of Anaesthesiology, University Hospital LMU Munich, Munich, Germany. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20210906 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - *Acupuncture Therapy/adverse effects MH - Humans MH - Prospective Studies PMC - PMC8422480 OTO - NOTNLM OT - adverse events OT - complementary medicine OT - general medicine (see internal medicine) OT - pain management OT - quality in healthcare OT - risk management COIS- Competing interests: DI reports receiving honorarium and travel costs from non-profit academic organisations, physician chambers and universities for teaching and lecturing, and serving as president of the German Medical Acupuncture Association (Deutsche Arztegesellschaft fur Akupunktur, DAGfA, a non-profit medical association). PB declares receiving honorarium and travel costs from non-profit academic organisations and universities for teaching and lecturing and being a member of the scientific advisory board of the DAGfA. WZ and TS declare no other relationships or activities that could appear to have influenced the submitted work. EDAT- 2021/09/08 06:00 MHDA- 2021/09/16 06:00 PMCR- 2021/09/06 CRDT- 2021/09/07 07:00 PHST- 2021/09/07 07:00 [entrez] PHST- 2021/09/08 06:00 [pubmed] PHST- 2021/09/16 06:00 [medline] PHST- 2021/09/06 00:00 [pmc-release] AID - bmjopen-2020-045961 [pii] AID - 10.1136/bmjopen-2020-045961 [doi] PST - epublish SO - BMJ Open. 2021 Sep 6;11(9):e045961. doi: 10.1136/bmjopen-2020-045961.