Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China

This important multicenter observational study analyzed the safety of acupuncture in 1,968 patients treated at 16 hospitals in five Chinese provinces between December 2007 and October 2009. The investigators monitored adverse events across three distinct randomized controlled clinical trials: one for migraine (475 patients), another for functional dyspepsia (593 patients), and a third for Bell's palsy (900 patients). All participants received acupuncture treatment for four weeks, totaling 20 sessions, followed by three months of follow-up. The acupuncturists involved had at least eight years of training in acupuncture and were physicians qualified in Traditional Chinese Medicine, or associate physicians with more than ten years of clinical experience.

Sterile single-use needles were used to avoid cross infections, and all practitioners underwent specific training on the study protocols before initiating treatments. The results demonstrated that acupuncture is a safe therapy, with a low risk of adverse events. Of the 1,968 patients monitored, only 74 (3.76%) experienced at least one adverse event throughout the treatment period. No serious adverse events were observed, such as organ injury or neurological damage.

The most common adverse events were bleeding at the puncture site (37.84%) and subcutaneous hematoma (25.68%), followed by skin ecchymosis and pain at the needle site. Notably, 73 of the 74 patients who experienced adverse events recovered fully within two weeks through effective treatment, including physical therapy, self-treatment, or other effective methods. Only three patients withdrew from the study due to adverse events. Logistic regression analysis revealed that age and sex were risk factors for acupuncture-related adverse events.

Older patients had a higher risk of adverse events, and male patients had a slightly higher risk than female patients. The investigators identified that the types of adverse events were related to the location and anatomical structure of the acupuncture points used. For example, in the treatment of Bell's palsy, which involves facial points where the skin is thin and rich in blood vessels, subcutaneous hematoma was more common. In migraine treatment, which uses points in the cranial region with abundant vascular supply, bleeding at the puncture site was more frequent.

The study also highlighted the importance of an appropriate medical setting, the high technical level of the acupuncturists, and the establishment of a strong mutual trust relationship between physician and patient in reducing the occurrence of adverse events. The clinical implications are significant, as they provide robust evidence that acupuncture, when performed by qualified professionals in an appropriate hospital setting, is a very safe therapy. The 3.76% adverse event rate found in this study falls within the range reported in international studies (0.67% to 11.4%) and all events were mild and temporary.