Background: The aim was to investigate the frequency of adverse effects due to acupuncture treatment, the need for treatment and the costs and to develop a new medical consent form for acupuncture.

Methods: The prospective observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhoea. After treatment, all patients documented adverse events associated with acupuncture (defined as adverse effects). Patients who reported a need for treatment due to an adverse effect completed an additional standardised questionnaire on the most important adverse effect. Based on this data and considering ethical and legal aspects a new consent form was developed. For patients with chronic low back pain and chronic neck pain costs for adverse effects were calculated from a societal perspective.

Results: A total of 229,230 patients received on average 10.2 +/- 3.0 acupuncture treatments. Altogether, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 (2.2%) reported one which required treatment. Common adverse effects were bleedings or haematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%) and vegetative symptoms (0.7%). Two patients experienced a pneumothorax (one needed hospital treatment, the other observation only). The longest duration of a side effect was 180 days (nerve lesion of the lower limb). The resulting medical consent form consists of five modules: Introduction to acupuncture and moxibustion, Risks of acupuncture treatment, Conditions which can increase the risk, Doctor's statement, and Consent.
From the 73,406 patients patients with chronic low back and chronic neck pain 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 12 months € 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).

Conclusion: Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent. When these effects needed treatment by a health professional additional expenses were the consequence.

Publications:

Witt CM, Pach D, Reinhold T, Wruck K, Brinkhaus B, Mank S, Willich SN. Treatment of the adverse effects from acupuncture and their economic impact: a prospective study in 73,406 patients with low back or neck pain. Eur J Pain. 2011 Feb;15(2):193-7.

Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7.

Principle investigator:
Willich, MD, MPH, MBA
Witt, MD, MBA

Research associate:
Brinkhaus, MD
Mank
Pach, MD
Reinhold, PhD

Coorperation:
Tag, PhD

Data management:
Icke

Study nurse:
Eden
Bartsch

Project duration:
2000-2012

Project status:
completed

Funding:
Techniker Krankenkasse (statutory health insurance)