Positive Health Online

Abstract

LINDE and DINCER, Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universitaet Muenchen, Munich, Germany, Klaus.Linde@lrz.tu-muenchen.de, have reviewed (32 references) the information given to participants in sham-needling controlled trials of acupuncture.

Background

The aim of the study was to investigate how information is given to participants in acupuncture trials who might receive sham acupuncture.

Methodology

47 published sham-controlled trials of acupuncture collected for a systematic review on sham techniques were screened to determine whether they reported on information given to patients about study interventions; any such information was extracted. Researchers and authors of published trials were contacted and asked to provide copies of original patient information leaflets. Information given to patients about true and sham interventions was extracted.

Results

10 (21%) of the 47 published studies included some information on how patients were informed. None of these studies appear to have used the term 'sham' or 'placebo' and most appear to have suggested that two types of acupuncture were compared. : 7 patient information leaflets explicitly included words such as 'sham', 'placebo', or 'dummy'. Others described the control intervention as not meeting all criteria of acupuncture. One group of studies simply suggested that different types of acupuncture were being compared.

Conclusion

Only a minority of trials report on information given to participants about true and sham interventions. Information strategies vary considerably and are often not fully explicit. This has ethical implications, and may influence results of such studies.

References

Linde K, Dincer F. How informed is consent in sham-controlled trials of acupuncture? Journal of Alternative and Complementary Medicine 10(2): 379-385, Apr 2004.