[Acupuncture--needle-pricking within a complex intervention].

The results of the large acupuncture studies initiated by the German Federal Committee of Physicians and Health Insurers raised several new questions concerning acupuncture effects. Based on the current evidence it is postulated that not yet entirely defined specific und unspecific factors contribute to outcome in acupuncture treatment. Consequently, acupuncture has to be regarded as a 'complex intervention' consisting of several components. A phased approach to evaluate 'complex intervention' is presented and transferred to acupuncture research. According to this phased approach unspecific factors contributing to acupuncture effects have to be identified and increasingly considered in future acupuncture research. Thus, several research methods to identify and evaluate unspecific acupuncture effects are suggested, e.g. qualitative methods. Therefore, the particular German situation of acupuncture, provided by physicians and state-licensed non-medical therapists ('Heilpraktiker'), is taken into account. Furthermore, it is discussed to what extent unspecific acupuncture effects can be assessed within randomized controlled trials.