title: α1-Antitrypsin in fibromyalgia: results of a randomized, placebo-controlled, double-blind and crossover pilot trial.
abstract: OBJECTIVE
  To assess clinical effect of a human plasma-derived alpha-1 antitrypsin (AAT) concentrate in reducing pain severity of patients with fibromyalgia (FM).
  
  
  METHODS
  Thirteen subjects with FM completed a randomized, double-blind, placebo-controlled, crossover study which consisted of 9 weeks trial of AAT or placebo with a washout period of 6 weeks. Primary efficacy endpoint was change on pain severity score, assessed by a daily visual analogue scale (VAS) for pain. Other outcome measures included a tender point score, the Fibromyalgia Impact Questionnaire, (FIQ), the Medical Outcomes Study Short Form 36 (SF-36), the Health Assessment Questionnaire Disability Index (HAQ-DI), the Hospital Anxiety and Depression Scale (HADS) and tiredness score evaluated by VAS.
  
  
  RESULTS
  No statistically significant differences were observed in either pain severity or other secondary outcome measures in either of the treatment groups, or between treatment groups in either of the treatment periods. No carryover or order of intervention effect was observed from one treatment to the other. Both investigational interventions were generally well tolerated, and vital signs during the drug infusions were within the respective normal ranges.
  
  
  CONCLUSIONS
  Treatment with a human plasma-derived AAT concentrate did not demonstrate significant improvement over placebo on reducing pain severity and other symptoms of FM. Further research should examine other FM subpopulations and drug doses.
authors.affiliation: Department of Rheumatology, Hospital Universitari Vall d'Hebron, Barcelona, Spain. calegre@vhebron.net
authors.forename: Cayetano
authors.initials: C
authors.lastname: Alegre
authors.forename: Mireia
authors.initials: M
authors.lastname: Barceló
authors.forename: Rosendo
authors.initials: R
authors.lastname: Jardí
authors.forename: Francisco
authors.initials: F
authors.lastname: Rodríguez-Frias
authors.forename: Sandra
authors.initials: S
authors.lastname: Camprubí
mesh_terms: D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D010919:Placebos; D011446:Prospective Studies; D015842:Serine Proteinase Inhibitors / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D000515:alpha 1-Antitrypsin / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D015842:Serine Proteinase Inhibitors; D000515:alpha 1-Antitrypsin