title: Credibility of a newly designed placebo needle for clinical trials in acupuncture research.
abstract: OBJECTIVE
  To test the credibility of a newly designed placebo needle for acupuncture research.
  
  
  METHODS
  Analysis of data on credibility of true and placebo interventions of a randomised, placebo-controlled, patient- and evaluator-blind clinical trial.
  
  
  METHODS
  The study was carried out at a university department for physical medicine and rehabilitation. 68 patients (age 48.1 +/- 14.1 years, mean +/- SD) fulfilling the criteria of the International Headache Society for tension-type headache were enrolled into the study.
  
  
  METHODS
  Group 1 (treatment) was assigned to traditional needle placement and manipulation, whereas in group 2 (control) a new placebo device was used.
  
  
  METHODS
  After the first treatment with real or placebo acupuncture, patients were asked to fill in a questionnaire on credibility. In addition, after 3 or 4 treatments, patients were asked for the feeling of needle insertion and deqi.
  
  
  RESULTS
  No difference between real and placebo acupuncture was detected with respect to the credibility of the treatment (p > 0.05). Needle insertion was recognised in all patients in the real acupuncture group and in all but 4 patients of the placebo group (p < 0.05). deqi was reported by 84% of patients in the real acupuncture group and by 34% of patients in the placebo group (p < 0.001).
  
  
  CONCLUSIONS
  Acupuncture with the placebo needle device described here is of high credibility, and does not differ from that of real acupuncture treatment. However, to achieve comparable prick sensations in both treatment conditions, careful training with the placebo needle is needed. Furthermore, from these results arise new questions with respect to the placebo response of placebo needles. Further investigations are warranted to test if placebo needles are active controls.
authors.affiliation: Department of Physical Medicine and Rehabilitation, Hannover Medical School. m.g.fink@gmx.de
authors.forename: M
authors.initials: M
authors.lastname: Fink
authors.forename: C
authors.initials: C
authors.lastname: Gutenbrunner
authors.forename: J
authors.initials: J
authors.lastname: Rollnik
authors.forename: M
authors.initials: M
authors.lastname: Karst
mesh_terms: D015670:Acupuncture Therapy / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009339:Needles / Q000592:standards; D010919:Placebos / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D018781:Tension-Type Headache / Q000628:therapy*
chemical_list: D010919:Placebos