title: Getting inside acupuncture trials--exploring intervention theory and rationale.
abstract: BACKGROUND
  Acupuncture can be described as a complex intervention. In reports of clinical trials the mechanism of acupuncture (that is, the process by which change is effected) is often left unstated or not known. This is problematic in assisting understanding of how acupuncture might work and in drawing together evidence on the potential benefits of acupuncture. Our aim was to aid the identification of the assumed mechanisms underlying the acupuncture interventions in clinical trials by developing an analytical framework to differentiate two contrasting approaches to acupuncture (traditional acupuncture and Western medical acupuncture).
  
  
  METHODS
  Based on the principles of realist review, an analytical framework to differentiate these two contrasting approaches was developed. In order to see how useful the framework was in uncovering the theoretical rationale, it was applied to a set of trials of acupuncture for fatigue and vasomotor symptoms, identified from a wider literature review of acupuncture and early stage breast cancer.
  
  
  RESULTS
  When examined for the degree to which a study demonstrated adherence to a theoretical model, two of the fourteen selected studies could be considered TA, five MA, with the remaining seven not fitting into any recognisable model. When examined by symptom, five of the nine vasomotor studies, all from one group of researchers, are arguably in the MA category, and two a TA model; in contrast, none of the five fatigue studies could be classed as either MA or TA and all studies had a weak rationale for the chosen treatment for fatigue.
  
  
  CONCLUSIONS
  Our application of the framework to the selected studies suggests that it is a useful tool to help uncover the therapeutic rationale of acupuncture interventions in clinical trials, for distinguishing between TA and MA approaches and for exploring issues of model validity. English language acupuncture trials frequently fail to report enough detail relating to the intervention. We advocate using this framework to aid reporting, along with further testing and refinement of the framework.
authors.affiliation: School of Healthcare, University of Leeds, Baines Wing, Leeds, UK. s.price05@leeds.ac.uk
authors.forename: Sarah
authors.initials: S
authors.lastname: Price
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Long
authors.forename: Mary
authors.initials: M
authors.lastname: Godfrey
authors.forename: Kate J
authors.initials: KJ
authors.lastname: Thomas
mesh_terms: D026881:Acupuncture / Q000379:methods*; D015670:Acupuncture Therapy / Q000379:methods*; D001943:Breast Neoplasms / Q000150:complications; D002986:Clinical Trials as Topic; D019317:Evidence-Based Medicine; D005221:Fatigue / Q000209:etiology / Q000628:therapy*; D005260:Female; D006801:Humans; D008954:Models, Biological; D012107:Research Design; D014652:Vascular Diseases / Q000209:etiology / Q000628:therapy*; D014666:Vasomotor System