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Cited by 53Gastrointestinal motility and disordersNausea and vomiting managementPharmaceutical Practices and Patient Outcomes

Efficacy and Safety of Drugs for Gastroparesis: Systematic Review and Network Meta-analysis

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Ingrosso, Maria Rosa, Camilleri, Michael, Tack, Jan, Ianiro, Gianluca, Black, Christopher J., Ford, Alexander C.·2023·Gastroenterology
DOI 10.1053/j.gastro.2022.12.014
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Abstract

BACKGROUND & AIMS: Although there have been multiple drugs tested in gastroparesis, their relative efficacy and safety are unknown. We evaluated this in a network meta-analysis of randomized controlled trials (RCTs). METHODS: We searched the literature to September 7, 2022. We judged the efficacy of drugs based on global symptoms of gastroparesis; individual symptoms, including nausea, vomiting, abdominal pain, bloating, or fullness; and safety according to total adverse events and adverse events leading to withdrawal. We extracted data as intention-to-treat analyses, assuming dropouts to be treatment failures and reporting pooled relative risks (RRs) of not improving with 95% confidence intervals (CIs), ranking drugs according to P-score. RESULTS: We identified 29 RCTs (3772 patients). Based on global symptoms, clebopride ranked first for efficacy (RR, 0.30; 95% CI, 0.16-0.57; P-score = .99) followed by domperidone (RR, 0.68; 95% CI, 0.48-0.98; P-score = .76). No other drug was superior to placebo. Only 2 drug classes were efficacious: in rank order, oral dopamine antagonists (RR, 0.58; 95% CI, 0.44-0.77; P-score = .96) and tachykinin-1 antagonists (RR, 0.69; 95% CI, 0.52-0.93; P-score = .83). For individual symptoms, oral metoclopramide ranked first for nausea (RR 0.46; 95% CI, 0.21-1.00; P-score = .95), fullness (RR 0.67; 95% CI, 0.35-1.28; P-score = .86), and bloating (RR 0.53; 95% CI, 0.30-0.93; P-score = .97), based on only 1 small trial. Only prucalopride was more likely to be associated with adverse events than placebo. CONCLUSIONS: In a network meta-analysis, oral dopamine antagonists and tachykinin-1 antagonists were more efficacious than placebo for gastroparesis, but confidence in the evidence was low to moderate for most comparisons. There is an unmet need for efficacious therapies for gastroparesis.

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  • The selective 5‐HT4 receptor agonist prucalopride may improve nausea, early satiety, bloating, and quality of life in selected patients, though it carries gastrointestinal side effects and requires individualization.

    “The selective 5‑HT4 receptor agonist prucalopride may improve nausea, early satiety, bloating, and quality of life in selected patients, though it carries gastrointestinal side effects and requires individualization [49, 124, 125].”

    From Diabetic gastroparesis: pathophysiology and impact on insulin timing choices (2026) · cites this paper as [124]

    The Discussion reports that prucalopride was superior to placebo in an included crossover trial, and that adverse events—mostly diarrhea—were significantly more likely with the drug. It also suggests prucalopride for patients with concomitant chronic idiopathic constipation. The paper does not establish the claimed improvements in each named symptom or in quality of life; its individual-symptom analysis finds no benefit over placebo for prucalopride on fullness or bloating. Page numbers are unavailable in our copy. (LLM, conf=0.86)

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Research works printed but not linked: 2

  1. Camilleri M, Chedid V, Ford AC, et al. Gastroparesis. Nat Rev Dis Primers. 2018;4:41.
  2. McCallum RW, Cynshi O. Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: A randomized, multi- center, placebo-controlled trial. Aliment Pharmacol Ther. 2007;26:107-116.

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Authors
Ingrosso, M. R., Camilleri, M., Tack, J., Ianiro, G., Black, C. J., & Ford, A. C.
Affiliations
  • Università Cattolica del Sacro Cuore (IT)
  • Mayo Clinic (US)
  • Universitair Ziekenhuis Leuven (BE)
  • St James's University Hospital (GB)
  • University of Leeds (GB)
Corresponding author
Ford, Alexander C.
ORCID
Venue
Gastroenterology
Publisher
Elsevier BV
Published
2023-04
Volume
164
Issue
4
Pages
642-654
ISSN
0016-5085 (ISSN-L)
DOI
10.1053/j.gastro.2022.12.014
OpenAlex
W4312220029
Cited by
53
References
64
Citations by year
2026: 11 · 2025: 16 · 2024: 11 · 2023: 15
FWCI
2.16
Type
journal article
Language
en
Open access
Licence
Locations
  • Gastroenterology (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (submittedVersion)
  • Lirias (submittedVersion, cc-by)
  • PubliCatt (Università Cattolica del Sacro Cuore) (submittedVersion, other-oa)
Funders
National Institutes of Health (R01-DK122280, R01-DK125680)
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Health Sciences › Medicine › Surgery › Nausea and vomiting management
  • Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
Keywords
gastroparesis, drug efficacy, drug safety, clebopride, domperidone, metoclopramide, prucalopride, dopamine antagonists, nausea, vomiting, abdominal pain, bloating, adverse events, drug withdrawal, placebo comparison
MeSH terms
Network Meta-Analysis, Humans, Nausea, Tachykinins, Dopamine Antagonists, Gastroparesis

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