Designing an Acupuncture Study to Meet Evidence-based Medical Criteria - Methodological Considerations for Logistic Design and Development of Treatment Interventions Arising from the German Randomized Controlled Acupuncture Trial on Chronic Shoulder

摘要

The results from studies on potential treatment effects of acupuncture are often limited due to serious difficulties in methodology. Randomized controlled trials on acupuncture should test a widely accepted treatment strategy of verum and sham acupuncture. However, in clinical practice various patterns of acupuncture techniques are employed, and up to now no generally accepted guidelines on how to perform a reliable verum or sham treatment have been established. Another limitation is that in most studies the study populations are too small to obtain reliable data and to detect subtle differences between the unspecific needling of sham acupuncture and specific needling of verum acupuncture with sufficient statistical power. Moreover, only a multicenter trial in an outpatient setting would guarantee a naturalistic environment in which acupuncture is used in clinical practice. In the present report we discuss such methodological aspects in detail and summarize some practical considerations for planning anacupuncture trial that fulfills evidence-based medical criteria. The largest German study on the treatment effects of acupuncture in patients with chronic shoulder pain (recruited patients n = 452), might serve as an example for such a well-designed study. Before we could conduct our study, clear definitions and protocols for the verum and sham acupuncture treatments as well as adequate endpoints had to be developed. For this we used a combination of a comprehensive study of the literature and structured interviews with experienced physicians followed by an expert panel. A total of 41 physicians had to be trained to achieve a homogeneously high quality of acupuncture treatment. The latter represents a prerequisite for reproducibility, constituting a critical component of rigorous efficacy trials in scientific acupuncture research.