The journal of alternative and complementary medicine : research on paradigm, practice, and policy
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J Altern Complement Med · Mar 2008
Randomized Controlled Trial"Playing their parts": the experiences of participants in a randomized sham-controlled acupuncture trial.
Qualitative research has an important part to play in investigating how complex interventions are implemented within randomized controlled trials (RCTs) and what impact the RCT context has on participants, their behavior, and their outcomes. We explored these issues within a randomized sham-acupuncture controlled trial of traditional Chinese acupuncture for people with migraine. ⋯ We conclude that treatment in the trial differed from that described in studies of "real life" traditional acupuncture. These differences affected the needling-the characteristic or specific intervention-as well as contextual factors. This trial design limitation appears to be inevitable when a sham-controlled design is used to research an intervention that is based on a holistic and participative treatment strategy. These findings should be taken into account in the design and interpretation of RCTs of complex interventions such as acupuncture.