title: Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease.
abstract: OBJECTIVE
  To evaluate the efficacy and tolerability of lubiprostone (Amitiza) for constipation in Parkinson disease (PD) in a double-blind, randomized, controlled study.
  
  
  METHODS
  Patients with PD and clinically meaningful constipation (constipation rating scale score > 10 [range: 0-28]) were recruited from 2 academic movement disorder centers to participate in the study. After enrollment, patients were initially followed for 2 weeks and then were randomly assigned 1:1 to lubiprostone, and the dose was titrated up to 48 μg/day. They returned 4 weeks later for a final assessment. Data included stool diaries and global impressions (co-primary endpoints), demographics, Unified Parkinson's Disease Rating Scale scores, constipation scale scores, visual analog scale (VAS) scores, a stool diary, and adverse events.
  
  
  RESULTS
  Fifty-four subjects (39 male, mean age 67.0 ± 10.1 years, and mean duration of PD 8.3 ± 5.4 years) were randomly assigned to lubiprostone or placebo. One patient in the drug group discontinued the study because of logistics, and one patient in the placebo group discontinued the study because of lack of efficacy. A marked or very marked clinical global improvement was reported by 16 of 25 (64.0%) subjects receiving drug vs 5 of 27 (18.5%) subjects receiving placebo (p = 0.001). The constipation rating scale (p < 0.05), VAS (p = 0.001), and stools per day in the diary (p < 0.001) all improved with drug compared with placebo. Adverse events with drug were mild, most commonly intermittent loose stools.
  
  
  CONCLUSIONS
  In this randomized controlled trial, lubiprostone seemed to be well tolerated and effective for the short-term treatment of constipation in PD.
authors.affiliation: Department of Neurology, University of Texas Health Science Center, Houston, TX, USA. William.Ondo@uth.tmc.edu
authors.forename: W G
authors.initials: WG
authors.lastname: Ondo
authors.forename: C
authors.initials: C
authors.lastname: Kenney
authors.forename: K
authors.initials: K
authors.lastname: Sullivan
authors.forename: A
authors.initials: A
authors.lastname: Davidson
authors.forename: C
authors.initials: C
authors.lastname: Hunter
authors.forename: I
authors.initials: I
authors.lastname: Jahan
authors.forename: A
authors.initials: A
authors.lastname: McCombs
authors.forename: A
authors.initials: A
authors.lastname: Miller
authors.forename: T A
authors.initials: TA
authors.lastname: Zesiewicz
mesh_terms: D000368:Aged; D000527:Alprostadil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D003248:Constipation / Q000188:drug therapy* / Q000209:etiology*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000068238:Lubiprostone; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000150:complications* / Q000188:drug therapy; D010919:Placebos; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage*
chemical_list: D010919:Placebos; D014665:Vasodilator Agents; D000068238:Lubiprostone; D000527:Alprostadil