title: The nocebo effect during oral challenge in subjects with adverse drug reactions.
abstract: BACKGROUND
  Nocebo effect is the occurrence of troublesome symptoms after the administration of inert substances. It can be easily studied during blind oral challenges for drug reactions, which always involve the administration ofa placebo.
  
  
  METHODS
  We collected data about nocebo effect in outpatients undergoing oral drug challenge. Patients with previous documented adverse reactions to drugs underwent an oral challenge with alternative drugs to identify the compounds that can be safely used The challenges involved the administration of aplacebo before the active drugs and were performed under medical supervision.
  
  
  RESULTS
  Four hundred and thirty-five patients (18-68 yrs, 68% female) underwent the oral drug challenge. Most of them (52%) had a previous reaction with antibiotics and non-steroidal antinflammatory drugs. The reported reactions were urticaria (and/or angioedema), respiratory complaints, generalized itching and non-specific symptoms. A nocebo effect was seen in 13patients (3%), (10 female). The majority of the observed effects were subjective (malaise, itching, abdominal pain). No special demographic or clinical characteristic could be identified in the nocebo reactors. Ten/13 patients had an abnormal result at the hospital anxiety depression questionnaire.
  
  
  CONCLUSIONS
  Nocebo effect was not negligible in this procedure, although lessfrequent than previously reported.
authors.affiliation: Pneumoallergology Unit, Sant'Orsola FBF Hospital, Brescia.
authors.forename: C
authors.initials: C
authors.lastname: Lombardi
authors.forename: S
authors.initials: S
authors.lastname: Gargioni
authors.forename: G W
authors.initials: GW
authors.lastname: Canonica
authors.forename: G
authors.initials: G
authors.lastname: Passalacqua
mesh_terms: D015746:Abdominal Pain; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000485:Allergens / Q000008:administration & dosage / Q000009:adverse effects*; D000799:Angioedema; D001007:Anxiety / Q000523:psychology; D003863:Depression / Q000523:psychology; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D007114:Immunization / Q000009:adverse effects / Q000523:psychology; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011537:Pruritus; D012135:Respiratory Sounds; D012737:Sex Factors; D011795:Surveys and Questionnaires; D013627:Talc / Q000008:administration & dosage / Q000009:adverse effects*; D014581:Urticaria
chemical_list: D000485:Allergens; D013627:Talc