Background and objective: Within a large research and reimbursement program by German social health insurance the effectiveness and safety of acupuncture for the treatment of patients suffering from chronic pain was investigated. We provide here the results regarding safety aspects from a large observational study.
Methods: Safety aspects were investigated in three ways: Physicians were asked to make a global assessment of safety and to report adverse effects for all 503,397 treatment cycles documented between July 2001 and June 2003. Serious adverse effects had to be reported directly to the research center and were collected up to December 2004. In addition, a sample of 6,140 patients was asked about the side effects they had experienced.
Results: Physicians documented at least one adverse effect in 7.8% of all patients, the most frequent being needling pain in 3.9%. Serious adverse events were reported in 17 cases, the most frequent event being pneumothorax (5 cases). 9.3% of patients reported side effects, a quarter of these were considered as truly bothersome. The most frequent side effects reported by patients were pain, fatigue and circulatory disturbances.
Conclusions: Serious adverse effects of acupuncture are very rare; however, minor side effects occur frequently. Overall, acupuncture provided by trained physicians is a comparably safe therapy.