Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form.

BACKGROUND: To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, 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. 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. 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.

Breaking through the silence: illegality of performing resuscitation procedures on the "newly-dead".

Israeli author Daniel Sperling brings to a light a disturbing practice that is taking place in some teaching hospitals throughout the world--the practice of resuscitation procedures on newly dead patients without the consent of the next-of-kin. Mr. Sperling examines some of the policies and procedures in place to prevent such practice and also looks at the ethical principles that should guide such procedures. The paper also reviews the general issue of consent in the context of medical decision-making and discusses potential legal claims that might be available to persons who have not been consulted or informed before such procedures are performed. The evolving jurisprudence surrounding the treatment of the newly dead is analyzed and Mr. Sperling concludes by suggesting ways to improve upon the procedures currently in place at some teaching facilities.