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Abstract
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 (I2 >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.
- adverse events
- risk management
- pain management
- complementary medicine
- general medicine (see internal medicine)
- quality in healthcare
Data availability statement
Data are available upon reasonable request. The full set of extracted data and the R-code underlying the meta-analyses are available from the corresponding and senior author (Petra.Baeumler@med.uni-muenchen.de, Dominik.Irnich@med.uni-muenchen.de).
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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- adverse events
- risk management
- pain management
- complementary medicine
- general medicine (see internal medicine)
- quality in healthcare
Data availability statement
Data are available upon reasonable request. The full set of extracted data and the R-code underlying the meta-analyses are available from the corresponding and senior author (Petra.Baeumler@med.uni-muenchen.de, Dominik.Irnich@med.uni-muenchen.de).
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Contributors DI, PB and WZ defined the research question as well as inclusion and exclusion criteria for this systematic review. WZ, TS and PB were responsible for article screening, data extraction and classifications of adverse events. TS and PB performed the quality assessment. Questions and discrepancies were discussed among all authors until consent was achieved. PB conducted the meta-analyses and designed the tables and figures. All authors contributed to drafting the manuscript and approved its final version for publication. PB, the corresponding author, attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. As the senior author, DI is the guarantor of the work presented in this article and accepts full responsibility for the finished article, has access to any data and controlled the decision to publish.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
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 Ärztegesellschaft für Akupunktur, DÄGfA, 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 DÄGfA. WZ and TS declare no other relationships or activities that could appear to have influenced the submitted work.
Provenance and peer review Not commissioned; externally peer reviewed.
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