Evidence map›Paper›PMID 22677718›Full record

Trial reportGut2013

A randomised controlled study of the effect of cholinesterase inhibition on colon function in patients with diabetes mellitus and constipation.

Adil E Bharucha, Phillip Low, Michael Camilleri, Erica Veil, Duane Burton, Yogish Kudva, Pankaj Shah, Tonette Gehrking, Alan R Zinsmeister

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00276406 (Pyridostigmine in Diabetics With Constipation), which is not on this map. Cited by 42 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00276406 phase1 / phase2completednot on this map

Pyridostigmine in Diabetics With Constipation: Randomized, Placebo-controlled, Double-blind Trial

TypeinterventionalSponsorMayo ClinicRan2006 to 2010Enrolled30ConditionsConstipation, Diabetes Mellitus, Colonic Transit, Gastric EmptyingArmsPyridostigmine, Placebo
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 3 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Randomised study: effects of the 5-HTAlimentary pharmacology & therapeutics · 2021
    Trial
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  9. Article
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  11. A molecular probe for detecting cholinesterase activity in MRI.Proceedings of the National Academy of Sciences of the United States of America · 2025
    Article
  12. Update on the Treatment of Autonomic Disorders.Current treatment options in neurology · 2025
    Article
  13. Article
  14. Review
  15. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Adil E BharuchaClinical and Enteric Neuroscience Translational and Epidemiological Research (CENTER) Program, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA. bharucha.adil@mayo.edu
Phillip Low
Michael Camilleri
Erica Veil
Duane Burton
Yogish Kudva
Pankaj Shah
Tonette Gehrking
Alan R Zinsmeister
Mayo Clinic · US

Funding

MAYO CLINIC CENTER FOR TRANSLATIONAL SCIENCE ACTIVITIESUL1RR024150 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 2006 to 2011
$66.4M
Physiological Characterization and Data Integration CoreP01DK068055 · NIDDK · MAYO CLINIC ROCHESTER · PI ORDOG, TAMAS · 2004 to 2019
$23.8M
Studies on Diagnosis, Pathophysiology, and Treatment of Autonomic Failure in MSAP01NS044233 · NINDS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LOW, PHILLIP A · 2003 to 2014
$12.4M
NCRR NIH HHS UL1 RR024150NCRR NIH HHS UL1 RR024150-01NIDDK NIH HHS P01 DK068055NINDS NIH HHS NS 44233NINDS NIH HHS P01 NS044233
6 · The paper itself

Abstract

objectivesChronic constipation in diabetes mellitus is associated with colonic motor dysfunction and is managed with laxatives. Cholinesterase inhibitors increase colonic motility. This study evaluated the effects of a cholinesterase inhibitor on gastrointestinal and colonic transit and bowel function in diabetic patients with constipation.

designAfter a 9-day baseline period, 30 patients (mean ± SEM age 50 ± 2 years) with diabetes mellitus (18 type 1, 12 type 2) and chronic constipation without defaecatory disorder were randomised to oral placebo or pyridostigmine, starting with 60 mg three times a day, increasing by 60 mg every third day up to the maximum tolerated dose or 120 mg three times a day; this dose was maintained for 7 days. Gastrointestinal and colonic transit (assessed by scintigraphy) and bowel function were evaluated at baseline and the final 3 and 7 days of treatment, respectively. Treatment effects were compared using analysis of covariance, with gender, body mass index and baseline colonic transit as covariates.

results19 patients (63%) had moderate or severe autonomic dysfunction; 16 (53%) had diabetic retinopathy. 14 of 16 patients randomised to pyridostigmine tolerated 360 mg daily; two patients took 180 mg daily. Compared with placebo (mean ± SEM 1.98 ± 0.17 (baseline), 1.84 ± 0.16 (treatment)), pyridostigmine accelerated (1.96 ± 0.18 (baseline), 2.45 ± 0.2 units (treatment), p<0.01) overall colonic transit at 24 h, but not gastric emptying or small-intestinal transit. Treatment effects on stool frequency, consistency and ease of passage were significant (p ≤ 0.04). Cholinergic side effects were somewhat more common with pyridostigmine (p=0.14) than with placebo.

conclusionsCholinesterase inhibition with oral pyridostigmine accelerates colonic transit and improves bowel function in diabetic patients with chronic constipation.

Indexed as

Administration, OralAdolescentAdultAgedAlgorithmsCholinesterase InhibitorsConstipationDefecationDiabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodFemaleGastrointestinal MotilityGastrointestinal TransitCholinesterase InhibitorsPyridostigmine Bromide

Identifiers

PMID22677718
PMCPMC3924965
OpenAlexW2100894191

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.