Efectos adversos y complicaciones de la acupuntura: Resultados de un amplio estudio observacional comprendido en los proyectos piloto de la Seguridad Social alemana

Background and objective: Within a large research and reimbursement program by German social health insurance the eff ectiveness and safety of acupuncture for the treatment of patients suff ering 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 eff ects for all 503,397 treatment cycles documented between July 2001 and June 2003. Serious adverse eff ects 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 eff ects they had experienced. Results: Physicians documented at least one adverse eff ectin 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 eff ects, a quarter of these were considered as truly bothersome. The most frequent side eff ects reported by patients were pain, fatigue and circulatory disturbances. Conclusions: Serious adverse eff ects of acupuncture are very rare; however, minor side eff ects occur frequently. Overall, acupuncture provided by trained physicians is a comparably safe therapy.