Safety of Acupuncture: Results of a Prospective Observational Study with 229,230 Patients and Introduction of a Medical Information and Consent Form

Abstract

Background: To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, to develop a new medical consent form for acupuncture. Methods: The prospective observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhoea. After treatment, all patients documented adverse events associated with acupuncture (defined as adverse effects). Patients who reported a need for treatment due to an adverse effect completed an additional standardised questionnaire on the most important adverse effect. Based on this data and considering ethical and legal aspects a new consent form was developed. Results: A total of 229,230 patients received on average 10.2 ± 3.0 acupuncture treatments. Altogether, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 (2.2%) reported one which required treatment. Common adverse effects were bleedings or haematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%) and vegetative symptoms (0.7%). Two patients experienced a pneumothorax (one needed hospital treatment, the other observation only). The longest duration of a side effect was 180 days (nerve lesion of the lower limb). The resulting medical consent form consists of five modules: Introduction to acupuncture and moxibustion, Risks of acupuncture treatment, Conditions which can increase the risk, Doctor’s statement, and Consent. Conclusion: Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent.

Acupuncture-related adverse events: a systematic review of the Chinese literature

“…Similar events have been reported by other countries, [1][2][3][4][5][6][7][8][9] usually as a result of inappropriate technique. Acupuncture can be considered inherently safe in the hands of well trained practitioners.…”

“…5,6 This suggests that serious acupuncture-related adverse events are rare. Bleeding and pain during needling are reported less often in the Chinese-language than in the English-language literature, perhaps because practitioners in China consider such events too trivial to report.…”

“…Serious adverse events resulting from acupuncture, including pneumothorax, cardiac tamponade, spinal cord injury and viral hepatitis, have been identified in previous literature reviews. [1][2][3][4] Prospective surveys to determine the frequency of acupuncture-related adverse events have been conducted in Germany, 5,6 Norway 7 and the United Kingdom of Great Britain and Northern Ireland. 8,9 These studies have shown an incidence of mild, transient acupuncture-related adverse events that ranges from 6.71% to 15%.…”

“…5 Another large-scale observational study showed a rate of adverse events requiring specific treatment of 2.2% (4963 incidents among 229 230 subjects). 6 Studies such as these have shown that in extremely rare cases acupuncture can lead to serious, sometimes life-threatening complications, in addition to mild and transient adverse events.…”

Efficacy of Acupuncture for the Treatment of Sciatica: A Systematic Review and Meta-Analysis

“…Most of this cost is not generated by medical treatment but attributable to loss of productivity [28]. In TCM, it is classified into the category of Bi syndrome (Bi Zheng) [29].…”