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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.All trial participants who consented to take part in this qualitative study were interviewed twice by a researcher who was blind to all trial data. The acupuncture practitioner was interviewed once. Nineteen (19) semistructured interviews, 30-60 minutes long, were transcribed, coded, and analyzed both across and within cases.The 10 participants, 6 female, age 23-70 years had severe migraine and conventional treatment had been of limited benefit. They were satisfied with the organization of the trial and no acupuncture was perceived as obviously "sham." Most participants, and the practitioner, actively "played their part" in the trial, taking on research roles that differed from their usual roles of "patient" and "doctor." The resulting changes to their normal expectations and behavior influenced how the intervention was delivered and experienced. There was a reduction in talking, explanations, and participation, and treatment was focused on the migraine and usually excluded other conditions, even if the participants considered them to be a cause or a trigger of the 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.

Our understanding of acupuncture and Chinese medicine is limited by a lack of inquiry into the dynamics of the process. We used a longitudinal research design to investigate how the experience, and the effects, of a course of acupuncture evolved over time.This was a longitudinal qualitative study, using a constant comparative method, informed by grounded theory. Each person was interviewed three times over 6 months. Semistructured interviews explored people's experiences of illness and treatment. Across-case and within-case analysis resulted in themes and individual vignettes.Eight (8) professional acupuncturists in seven different settings informed their patients about the study. We interviewed a consecutive sample of 23 people with chronic illness, who were having acupuncture for the first time.People described their experience of acupuncture in terms of the acupuncturist's diagnostic and needling skills; the therapeutic relationship; and a new understanding of the body and self as a whole being. All three of these components were imbued with holistic ideology. Treatment effects were perceived as changes in symptoms, changes in energy, and changes in personal and social identity. The vignettes showed the complexity and the individuality of the experience of acupuncture treatment. The process and outcome components were distinct but not divisible, because they were linked by complex connections. The paper depicts these results as a diagrammatic model that illustrates the components and their interconnections and the cyclical reinforcement, both positive and negative, that can occur over time.The holistic model of acupuncture treatment, in which "the whole being greater than the sum of the parts," has implications for service provision and for research trial design. Research trials that evaluate the needling technique, isolated from other aspects of process, will interfere with treatment outcomes. The model requires testing in different service and research settings.