title: Immunotherapy with Mycobacterium vaccae and peripheral blood flow in long-treated leprosy patients, a randomised, placebo-controlled trial.
abstract: OBJECTIVE
  to evaluate immunotherapy as a means of improving peripheral blood flow in chronic leprosy patients.
  
  
  METHODS
  this was a double-blind, randomised, placebo-controlled, clinical trial.
  
  
  METHODS
  heat-killed Mycobacterium vaccae 1mg plus 0.02 microg Tuberculin protein per 0.1 ml dose in borate buffer, with saline as placebo. Those studied were 92 long-treated residents of a leprosy centre in Iran, 10 of their healthy children and 10 staff members. Evaluation employed the Perimed PF2, Laser-Doppler Flowmeter, a platinum skin thermistor, and a thermal sensibility tester.
  
  
  METHODS
  single intradermal injections of test or placebo were given to 103 patients 18 months before the blinded evaluation. Fingerpulp blood flux was measured in controlled conditions and vasomotor reflexes and skin sensation to touch, pain and heat were evaluated in 45 and 47 patients in the placebo and M. vaccae groups, respectively, and in 20 healthy control persons.
  
  
  RESULTS
  Laser-Doppler flux, skin temperature, vasomotor reflexes and sensation were impaired in leprosy patients. Immunotherapy improved (p < 0.05) Laser-Doppler flux, skin temperature and temperature sensation.
  
  
  CONCLUSIONS
  immunotherapy, given 18 months earlier, significantly improved blood flow and temperature sensation, in fully-treated, chronic, leprosy patients. The same principles might be employed in other conditions of reduced peripheral blood flow.
authors.affiliation: Department of Medicine, Ninewells Hospital and Medical School, University of Dundee, DD1 9SY, Scotland.
authors.forename: N C
authors.initials: NC
authors.lastname: Abbot
authors.forename: J S
authors.initials: JS
authors.lastname: Beck
authors.forename: F
authors.initials: F
authors.lastname: Feval
authors.forename: F
authors.initials: F
authors.lastname: Weiss
authors.forename: M H
authors.initials: MH
authors.lastname: Mobayen
authors.forename: K
authors.initials: K
authors.lastname: Ghazi-Saidi
authors.forename: Y
authors.initials: Y
authors.lastname: Dowlati
authors.forename: A A
authors.initials: AA
authors.lastname: Velayati
authors.forename: J L
authors.initials: JL
authors.lastname: Stanford
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D005385:Fingers / Q000098:blood supply* / Q000503:physiopathology*; D006801:Humans; D007167:Immunotherapy; D017078:Laser-Doppler Flowmetry; D007918:Leprosy / Q000276:immunology* / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D009161:Mycobacterium / Q000276:immunology* / Q000502:physiology*; D012039:Regional Blood Flow / Q000276:immunology / Q000502:physiology; D013997:Time Factors