Objective: The objective of this study was to investigate the adverse events associated with acupuncture using a standard record form in order to identify the risks of acupuncture therapy and assess their causes.
Methods: Thirteen (13) Oriental medicine doctors volunteered to report the number of acupuncture treatment sessions administered and patients encountered every week. When adverse events occurred, these doctors reported it using a record form that we created. The record form contained six major items to be filled out: patient, acupuncture treatment, adverse event, causality, person reporting the incident, and acupuncturist.
Results: In 5 weeks, the 13 Oriental medicine doctors in our study conducted 3071 acupuncture treatment sessions on 2226 patients. A total of 99 adverse events were reported, which is a rate of 3.2 events per 100 treatments. Common adverse events were hemorrhage (32%), hematoma (28%), and needle site pain (13%). Of the 99 treatments during which an adverse events occurred, 64 treatments were ended, and 62 of the adverse events diminished or disappeared. Of the 35 remaining cases of adverse events in which treatment was continued, 28 patients had their adverse events diminish or disappear. Causality assessment suggested that 47% of adverse events were certainly caused by acupuncture, 45% were probably/likely caused by acupuncture, 7% were possibly caused by acupuncture, and only 1% of events were unassessable/unclassifiable.
Conclusions: Although acupuncture was associated with adverse events, there were no serious adverse events experienced by patients this study. If acupuncture treatment is administered by a practitioner with enough experience and is conducted in accordance with established guidelines, it is a safe treatment method.