title: A randomised double-blind comparability study of a placebo for Individualised Western Herbal Medicine.
abstract: OBJECTIVE
  To determine the non-inferiority of placebo Individualised Western Herbal Medicine (IWHM) tinctures compared with true IWHM tinctures.
  
  
  METHODS
  Randomised double blind comparability study.
  
  
  METHODS
  Pharmacy department of an NHS integrated medicine hospital.
  
  
  METHODS
  The IWHM intervention consisted of mixed tinctures of five herbs from a list of eleven herbs for which chronic knee pain is an established indication. Placebo IWHM tinctures contained food and colouring extracts, designed to mimic as closely as possible the taste, smell and appearance of true IWHM.
  
  
  METHODS
  The primary outcome of the study was the proportion of patients who indicated that they believed they were taking true IWHM. Secondary outcomes included the palatability of the true and placebo tinctures.
  
  
  RESULTS
  64% of the placebo group indicated that they believed they had consumed true IWHM, compared with 60% of the true IWHM group. The palatability of the placebo IWHM was also acceptable to participants, and similar to the palatability of true IWHM.
  
  
  CONCLUSIONS
  The findings from the present study indicate that the placebo tinctures were non-inferior to the true IWHM tinctures in terms of participants' ability to correctly identify them as herbal tinctures by their taste, smell and appearance. The placebo tinctures could be utilised in future double blind, placebo controlled randomised trials of IWHM.
authors: Royal London Hospital for Integrated Medicine, UCLH NHS Trust, United Kingdom. saul.berkovitz@uclh.nhs.uk
authors: S
authors: S
authors: Berkovitz
authors: P
authors: P
authors: Bassett
authors: J G
authors: JG
authors: Hughes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D029001:Herbal Medicine / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009812:Odorants; D008517:Phytotherapy; D010919:Placebos / Q000592:standards*; D010936:Plant Extracts; D010946:Plants, Medicinal; D057285:Precision Medicine; D021641:Recognition, Psychology; D012107:Research Design; D013649:Taste; D055815:Young Adult
chemical_list: D010919:Placebos; D010936:Plant Extracts