title: Evaluation of the efficacy and safety of terguride in patients with fibromyalgia syndrome: results of a twelve-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.
abstract: OBJECTIVE
  To assess the efficacy and safety of terguride, a partial dopamine agonist, in patients with fibromyalgia syndrome (FMS).
  
  
  METHODS
  In a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, 99 patients were randomized at a ratio of 2 to 1 to receive terguride or placebo. Over 21 days, the dosage was titrated to a maximum daily dose of 3 mg of terguride or placebo, and this fixed dosage was continued over 9 weeks. The primary efficacy variable was the intensity of pain (100-mm visual analog scale). Secondary efficacy variables included the Fibromyalgia Impact Questionnaire (FIQ) score, the tender point score (TPS), and the Hamilton Depression Scale (HDS) score. During the study, patients were evaluated for the presence of cervical spine stenosis by magnetic resonance imaging (MRI).
  
  
  RESULTS
  No significant differences in the change in pain intensity, FIQ score, TPS, or HDS score between baseline and 12 weeks were observed in the terguride group as compared with the placebo group. Cervical spine stenosis was detected in 22% of the patients. Only patients with cervical spine stenosis responded to terguride treatment. FIQ scores improved significantly (per-protocol analysis), and pain intensity, the TPS score, and the HDS score showed a trend toward improvement in the terguride group as compared with the placebo group. Terguride treatment was safe. Only those adverse events already known to be side effects of terguride were observed. Premature termination of the study in patients receiving terguride (26%) occurred predominantly during up-titration and in the absence of comedication for treatment of nausea.
  
  
  CONCLUSIONS
  Terguride treatment did not improve pain, the FIQ score, the TPS, or the HDS score in the total study population. However, a subgroup of patients with cervical spine stenosis seemed to benefit from terguride treatment.
authors.affiliation: University Hospital Zurich, Zurich, Switzerland.
authors.forename: Oliver
authors.initials: O
authors.lastname: Distler
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Eich
authors.forename: Eva
authors.initials: E
authors.lastname: Dokoupilova
authors.forename: Zdenek
authors.initials: Z
authors.lastname: Dvorak
authors.forename: Martin
authors.initials: M
authors.lastname: Fleck
authors.forename: Markus
authors.initials: M
authors.lastname: Gaubitz
authors.forename: Manfred
authors.initials: M
authors.lastname: Hechler
authors.forename: Jan-Peter
authors.initials: JP
authors.lastname: Jansen
authors.forename: Andreas
authors.initials: A
authors.lastname: Krause
authors.forename: Martin
authors.initials: M
authors.lastname: Bendszus
authors.forename: Lothar
authors.initials: L
authors.lastname: Pache
authors.forename: Rudolf
authors.initials: R
authors.lastname: Reiter
authors.forename: Ulf
authors.initials: U
authors.lastname: Müller-Ladner
mesh_terms: D000328:Adult; D002574:Cervical Vertebrae; D003863:Depression / Q000188:drug therapy; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008090:Lisuride / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D010147:Pain Measurement; D011569:Psychiatric Status Rating Scales; D018434:Sickness Impact Profile; D013130:Spinal Stenosis / Q000188:drug therapy / Q000503:physiopathology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; C006208:dironyl; D008090:Lisuride