SynthesisDigestive diseases and sciences2013
Pharmacodynamic and clinical endpoints for functional colonic disorders: statistical considerations.
Synthesis in Digestive diseases and sciences, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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
12 citing papers in PubMed, 25 citations in OpenAlex.
- Clinical Trial: Multi-Strain Probiotic Improves Bile Acid Profile, Microbiome, and Metabolomic Parameters in Patients With History of Bile Acid Malabsorption-A Randomized, Controlled Trial.Alimentary pharmacology & therapeutics · 2026Trial
- Randomised study: effects of the 5-HTAlimentary pharmacology & therapeutics · 2021Trial
- Effects of Alfuzosin, an αClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2019Trial
- Effects of naloxegol on whole gut transit in opioid-naïve healthy subjects receiving codeine: A randomized, controlled trial.Neurogastroenterology and motility · 2018Trial
- Article
- Genetics of irritable bowel syndrome: shifting gear via biobank-scale studies.Nature reviews. Gastroenterology & hepatology · 2022Review
- Targeting neurons in the gastrointestinal tract to treat Parkinson's disease.Clinical parkinsonism & related disorders · 2019Article
- Colonic Transit and Bile Acid Synthesis or Excretion in Patients With Irritable Bowel Syndrome-Diarrhea Without Bile Acid Malabsorption.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2017Observational
- Rectal Gas Volume Measured by Computerized Tomography Identifies Evacuation Disorders in Patients With Constipation.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2017Article
- Measurement of Gastrointestinal and Colonic Motor Functions in Humans and Animals.Cellular and molecular gastroenterology and hepatology · 2016Article
- Effect of increased bile acid synthesis or fecal excretion in irritable bowel syndrome-diarrhea.The American journal of gastroenterology · 2014Article
- Irritable bowel syndrome: a clinical review.World journal of gastroenterology · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundIntra- and inter-subject coefficients of variation (COV) of scintigraphic colonic transit (SCT) are well characterized. SCT response to therapy predicts clinical efficacy of experimental medications in lower functional gastrointestinal disorders (FGID).
aimTo compare COVs for bowel function with pharmacodynamic (PD) colonic transit geometric center (GC) as endpoints in lower FGID studies.
methodsWe evaluated data from placebo arm of 9 phase IIA, parallel-group, clinical trials of PD effects of linaclotide, dexloxiglumide, renzapride, elobixibat, ROSE 010, and chenodeoxycholate in lower FGID with constipation, and pexacerafont, VSL#3, and colesevelam in lower FGID with diarrhea. Patients completed daily diaries for at least 7 days of stool frequency, consistency (7-point Bristol Stool Form Scale), and ease of passage (7-point scale from manual disimpaction to incontinence). Seventeen patients received placebo in 2 separate studies allowing assessment of intra-patient COVs. We calculated sample sizes required to demonstrate a 30 % effect size for colonic transit, stool frequency, consistency and ease of passage for patients with lower FGID with constipation and, separately, diarrhea.
resultsCOV(inter) from 87 patients and COV(intra) from 17 patients are reported. Generally, COV(intra) is somewhat greater than COV(inter). The COVs for PD endpoints are lower than for clinical endpoints; however, clinically relevant effects can be identified with modest (~50 %) increases in the sample size using parallel-group design studies.
conclusionPhase IIA studies that incorporate clinical and PD endpoints are feasible in lower FGID associated with constipation or diarrhea. Crossover design would require lower sample size for most endpoints compared to parallel-group studies.
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Registered trials
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.