The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trial.
The issue of what constitutes an effective and realistic acupuncture placebo control has been a continuing problem for acupuncture research. In order to provide an effective placebo, the control procedure must be convincing, visible and should mimic, in all respects, apart from a physiological effect, the real active treatment. The 'Streitberger' needle might fulfil these criteria and this paper reports on a validation study. This was a single-blind, randomised, cross-over pilot study. Patients were drawn from the orthopaedic hip and knee, joint replacement waiting list. Intervention consisted of either 2 weeks of treatment with real acupuncture followed by 2 weeks on placebo, or vice versa. The prime outcome was a needle sensation questionnaire and there was a range of secondary outcomes. Thirty-seven patients were randomised and completed treatment. Groups were well balanced at baseline. No significant differences between groups or needle types were found for any of the sensations measured. Most patients were unable to discriminate between the needles by penetration; however, nearly 40% were able to detect a difference in treatment type between needles. No major differences in outcome between real and placebo needling could be found. The fact that nearly 40% of subjects did not find that the two interventions were similar, however, raises some concerns with regard to the wholesale adoption of this instrument as a standard acupuncture placebo. Further work on inter-tester reliability and standardisation of technique is highly recommended before we can be confident about using this needle in further studies.
White
Peter
P
Complementary Medicine Research Unit, Mail Point OPH, Royal South Hants Hospital, University of Southampton, Brintons Terrace, Southampton, UK Department of Mathematics, University of Southampton, Southampton, UK.
Lewith
George
G
Hopwood
Val
V
Prescott
Phil
P
D015670:Acupuncture Therapy / Q000295:instrumentation* / Q000379:methods*; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic / Q000379:methods; D016001:Confidence Intervals; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods*; D010865:Pilot Projects; D010919:Placebos; D016037:Single-Blind Method; D018709:Statistics, Nonparametric
D010919:Placebos