Evidence map›Paper›PMID 15164169›Full record

Trial reportDiabetologia2004

Acarbose for the prevention of Type 2 diabetes, hypertension and cardiovascular disease in subjects with impaired glucose tolerance: facts and interpretations concerning the critical analysis of the STOP-NIDDM Trial data.

J-L Chiasson, R G Josse, R Gomis, M Hanefeld, A Karasik, M Laakso, STOP-NIDDM Trial Research Group

Open access · bronzeAbstract readClinical TrialCommentRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Sex-Specific Regulation of Glycemic Homeostasis by Theabrownin from Pu-erh Tea.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
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  9. Prediabetes Deserves More Attention: A Review.Clinical diabetes : a publication of the American Diabetes Association · 2020
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  10. A novel series of mixed-ligand M(II) complexes containing 2,2'-bipyridyl as potent α-glucosidase inhibitor: synthesis, crystal structure, DFT calculations, and molecular docking.Journal of biological inorganic chemistry : JBIC : a publication of the Society of Biological Inorganic Chemistry · 2019
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 5 countries.

J-L ChiassonResearch Centre, Centre hospitalier de l'Université de Montréal-Hôtel-Dieu, Department of Medicine, University of Montreal, 3850 St. Urbain Street, Rm 8-202, Montreal, Quebec H2W 1T7, Canada. jean.louis.chiasson@umontreal.ca
R G Josse
R Gomis
M Hanefeld
A Karasik
M Laakso
STOP-NIDDM Trial Research Group
Sheba Medical Center · ILSt. Michael's Hospital · CATU Dresden · DEUniversitat de Barcelona · ESUniversité de Montréal · CAUniversity of Eastern Finland · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The STOP-NIDDM Trial has shown that acarbose treatment in subjects with impaired glucose tolerance is associated with a significant risk reduction in the development of diabetes, hypertension and cardiovascular complications. Kaiser and Sawicki have accused the investigators of the STOP-NIDDM Trial of major biases in the conduct of the study, of manipulating the data and of conflict of interest. The aim of this paper is to present data and explanations refuting these allegations. In the STOP-NIDDM Trial, 61 subjects were excluded from the efficacy analysis before unblinding for legitimate reasons: failure to satisfy major entry criteria (n=17) and lack of post-randomisation data (n=44). Blinding and randomisation were carried out by an independent biostatistician. Titration of placebo/acarbose is well described in the protocol and in the study design paper. Of the study population, 9.3% had a fasting plasma glucose of > or =7.0 mmol/l at screening and could have been diabetic according to the new diagnostic criteria. However, even if these subjects are excluded, patients having acarbose treatment still saw a significant risk reduction in the development of diabetes (p=0.0027). The changes in weight are consistent in different publications and are related to different times of follow-up and assessment. Weight change does have an effect on the development of diabetes, but acarbose treatment is still effective even after adjusting for this (p=0.0063). The cardiovascular endpoints were a clearly designated assessment in the original protocol, and only those defined in the protocol and ascertained by the independent Cardiovascular Event Adjudication Committee were used in the analysis. Hypertension was defined according to the most recent diagnostic criteria. The STOP-NIDDM Trial results are scientifically sound and credible. The investigators stand strongly behind these results demonstrating that acarbose treatment is associated with a delay in the development of diabetes, hypertension and cardiovascular complications in a high-risk population with IGT.

Indexed as

Reproducibility of ResultsAcarboseBlood GlucoseBody WeightCanadaCardiovascular DiseasesClinical ProtocolsData CollectionDiabetes Mellitus, Type 2Double-Blind MethodEatingEthics, ClinicalFastingFemaleFollow-Up StudiesGlucose IntoleranceAcarboseBlood Glucose

Identifiers

PMID15164169
OpenAlexW2087866400

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.