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Cited by 112Gastrointestinal motility and disordersParkinson's Disease Mechanisms and TreatmentsPelvic floor disorders treatments

Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease

Ondo, W.G., Kenney, C., Sullivan, K., Davidson, A., Hunter, C., Jahan, I., McCombs, A., Miller, A. +1 more·2012·Neurology
DOI 10.1212/wnl.0b013e3182574f28
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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 Conclusion In this randomized controlled trial, lubiprostone seemed to be well tolerated and effective for the short-term treatment of constipation in PD.

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Crossref · 10.1212/wnl.0b013e3182574f28

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  • Randomized controlled trials have demonstrated benefit of polyethylene glycol 3350 and lubiprostone in Parkinson disease-related constipation.

    “Randomized controlled trials have demonstrated benefit of polyethylene glycol 3350 (Zangaglia et al., 2007) and lubiprostone (Ondo et al., 2012) in PD-related constipation, and dopaminergic agents such as apomorphine can influence defecatory function (Edwards et al., 1993b).”

    From Autonomic nervous system and gastrointestinal manifestations with an emphasis on gastric dysfunction (2026) · cites this paper as Ondo et al., 2012

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Authors
Ondo, W. G., Kenney, C., Sullivan, K., Davidson, A., Hunter, C., Jahan, I., McCombs, A., Miller, A., & Zesiewicz, T. A.
Affiliations
Baylor College of Medicine (US)
ORCID
Venue
Neurology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2012-05-22
Volume
78
Issue
21
Pages
1650-1654
ISSN
  • 0028-3878 (ISSN-L)
  • 1526-632X
DOI
10.1212/wnl.0b013e3182574f28
OpenAlex
W2041741770
Cited by
112
References
34
Citations by year
2026: 3 · 2025: 13 · 2024: 6 · 2023: 8 · 2022: 8 · 2021: 8 · 2020: 11 · 2019: 12 · 2018: 4 · 2017: 4 · 2016: 12 · 2015: 8 · 2014: 3 · 2013: 9 · 2012: 2
FWCI
6.77
Type
journal article
Language
en
Open access
closed
Locations
  • Neurology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Health Sciences › Medicine › Neurology › Parkinson's Disease Mechanisms and Treatments
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
Keywords
lubiprostone, Parkinson's disease, constipation, gastrointestinal motility, prokinetic agents, drug efficacy, drug tolerability, stool frequency, adverse events
MeSH terms
Lubiprostone, Aged, Alprostadil, Constipation, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Parkinson Disease, Placebos, Severity of Illness Index, Vasodilator Agents, Treatment Outcome

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