Trial reportArthritis research & therapy2017
Preliminary safety and efficacy profile of prucalopride in the treatment of systemic sclerosis (SSc)-related intestinal involvement: results from the open label cross-over PROGASS study.
Trial report in Arthritis research & therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- The role of prokinetics in managing gastrointestinal involvement in SSc: a systematic literature review.Rheumatology (Oxford, England) · 2025Pooled it
- 2023 Brazilian Society of Rheumatology guidelines for the treatment of systemic sclerosis.Advances in rheumatology (London, England) · 2024Guideline
- New horizons in systemic sclerosis treatment: advances and emerging therapies in 2025.RMD open · 2025Trial
- Gastrointestinal Disorders in Scleroderma.Gastroenterology · 2026Review
- Gastrointestinal involvement in systemic sclerosis: A spotlight on small bowel involvement, complications and management.Best practice & research. Clinical rheumatology · 2026Review
- Severe scleroderma colopathy at initial diagnosis of systemic sclerosis in a young man: a case report.Frontiers in medicine · 2026Article
- Expert recommendations for the management of refractory gastroesophageal reflux disease in systemic sclerosis: A report from the World Scleroderma Foundation (WSF) Gastrointestinal "Ad hoc committee".Journal of scleroderma and related disorders · 2026Article
- Expert recommendations for the management of fecal incontinence in systemic sclerosis: A report from the World Scleroderma Foundation (WSF) Gastrointestinal "Ad hoc committee".Journal of scleroderma and related disorders · 2026Article
- Eradication of Small Intestinal Bacterial Overgrowth in Systemic Sclerosis: Current Treatment and Perspectives-A Narrative Review.Biomedicines · 2025Review
- Prevalence, clinical characteristics, and hospital course of systemic sclerosis-associated pseudo-obstruction.Clinical rheumatology · 2025Article
- Chronic intestinal pseudo-obstruction in the course of systemic sclerosis successfully treated with intravenous immunoglobulins and rituximab.Reumatologia · 2025Article
- Does therapy with immunosuppressive drugs improve gastrointestinal symptoms in patients with systemic sclerosis?RMD open · 2024Article
- Managing gastrointestinal manifestations in systemic sclerosis, a mechanistic approach.Expert review of clinical immunology · 2024Review
- Treatable Traits in Systemic Sclerosis.Clinical reviews in allergy & immunology · 2023Review
- If Pills Don't Work, Try Staples: Surgery for Barrett's Esophagus Complicating Progressive Systemic Sclerosis.Digestive diseases and sciences · 2023Article
- Systemic sclerosis gastrointestinal dysmotility: risk factors, pathophysiology, diagnosis and management.Nature reviews. Rheumatology · 2023Review
- Fecal microbiome in systemic sclerosis, in search for the best candidate for microbiota-targeted therapy for small intestinal bacterial overgrowth control.Journal of scleroderma and related disorders · 2022Article
- Management of scleroderma gastrointestinal disease: Lights and shadows.Journal of scleroderma and related disorders · 2022Review
- Relationship Between Gastrointestinal Transit, Medsger Gastrointestinal Severity, and University of California-Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 Symptoms in Patients With Systemic Sclerosis.Arthritis care & research · 2022Article
- A practical approach to the evaluation and management of gastrointestinal symptoms in patients with systemic sclerosis.Best practice & research. Clinical rheumatology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProkinetics are used to treat enteric dismotility symptoms in systemic sclerosis (SSc) patients, but they often lack adequate efficacy. The most effective prokinetics belonging to the serotonin (5-HT
methodsForty patients with self-reported mild to moderately severe enteric symptoms were enrolled in a cross-over 2 × 2 study. Subjects were randomized 1:1 to prucalopride 2 mg/day or no treatment for one month and vice versa after a 2-week washout period. Before and after each sequence the patients compiled the University of California Los Angeles gastrointestinal tract (UCLA GIT) 2.0 questionnaire and the numbers of complete intestinal movements were recorded. Oro-cecal transit time (OCTT) was evaluated by lactulose breath test in a subgroup of patients. Data were evaluated by mixed linear models corrected for the number of laxatives used during the study periods.
resultsThere were 29 subjects who completed the study; 7 subjects withdrew due to side-effects and 4 subjects were not compliant with the study procedures. As compared to dummy treatment, prucalopride was associated with more intestinal evacuations (p < 0.001), improvement of UCLA GIT constipation (-0.672 ± 0.112 vs 0.086 ± 0.115; p < 0.001), reflux (-0.409 ± 0.094 vs 0.01 ± 0.096; p < 0.005) and bloating (-0.418 ± 0.088 vs -0.084 ± 0.09; p = 0.01) scores. Treatment was ranked moderately to more than moderately effective by 22 patients (72.4%). OCTT was significantly reduced during prucalopruide consumption (prucalopride: -20.1 ± 20.1 vs no treatment: 45.8 ± 21.3 minutes; treatment effect = -65.9 minutes; p = 0.035).
conclusionsThe safety profile of prucalopride in SSc is similar to what is known from the literature. In patients with mild to severe gastrointestinal problems, prucalopride may be effective in treating dismotility symptoms, increasing the number of complete bowel movements and improving bowel transit, reducing reflux disease and bloating.
trial registrationEU Clinical Trial Registry, EudraCT2012-005348-92 . Registered on 19 February 2013.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.