The aim was to investigate the frequency of adverse effects due to acupuncture treatment, the need for treatment and the costs in patients with chronic low back or neck pain. This prospective observational study included patients who received acupuncture for chronic low back pain or chronic neck pain. After treatment all patients documented adverse events associated with acupuncture (defined as adverse effects) and provided details e.g. on treatment. Cost data was provided by the health insurance companies. We used a societal perspective including direct health care costs related to the acupuncture and the indirect costs caused through lost workdays. From 73,406 patients, 5440 patients (7.4% [95% CI 7.2%; 7.6%] reported experiencing at least one adverse effect and 1422 patients (1.9% [1.8%; 2.0%]) required treatment. The subsequent treatments reported were either self-treatment (1.2% [1.09%; 1.25%]), treatment with medication and/or by a physician (0.6% [0.57%; 0.68%]), or treatment in a hospital (0.03% [0.02%; 0.04%]). Patients reporting adverse effects that required treatment had higher costs compared to patients without adverse effects (at 3months €1265 [1179; 1351] vs. €1140 [1128; 1153] and at 12months € 3534 [3256; 3812] vs. € 3249 [3209; 3289]. The difference was caused through the expense of visiting physicians and higher indirect costs (difference at 3months: €125 [38; 211], p=0.005 and at 12months: €285 [4; 566], p=0.047). Adverse effects from acupuncture occur in about 7% of patients and were mainly treated by themselves. When these effects needed treatment by a health professional additional expenses were the consequence.
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