Cohort studycited by the Tayebat archiveabstract only checked A-PPI-04 standard review

PPIs and dementia in German claims data

Association of Proton Pump Inhibitors With Risk of Dementia: A Pharmacoepidemiological Claims Data Analysis.

Overview

Gomm W et al.. JAMA Neurol 2016 · PMID 26882076 · DOI 10.1001/jamaneurol.2015.4791

Regular PPI users were diagnosed with dementia 1.44 times as often.

Does the study support the specific claim? Unclear · Methodological quality: low

Study explained simply

What did the researchers want to find out?: Dementia risk with PPIs.
How was the study done?: Insurance claims analysis.
How many people, animals or samples were studied?: 73,679 people ≥75 years.
What was actually found?: Association with dementia.
How large was the observed effect?: HR 1.44.
What do the results mean in everyday life?: Not proof of harm.
What are the study's limitations?: Claims data; confounding.
What does it say about Elawady's specific claim?: Not directly used by archive.
Do the results apply to Germany and Europe?: German data.
What can explicitly not be concluded from this study?: Causation.

Authors: Gomm W, von Holt K, Thomé F, Broich K, Maier W, Fink A, Doblhammer G, Haenisch B
Journal: JAMA Neurol
Year: 2016
Identifier: PMID 26882076 DOI 10.1001/jamaneurol.2015.4791
Verification: verified – PubMed E-utilities efetch, 2026-10-25
Retracted: no
Corrections: none
Extent checked: abstract only
Conflicts of interest and funding: not stated in abstract

Is regular PPI use associated with incident dementia in the elderly?

Study design: Cohort study – Prospective cohort analysis of German statutory health insurance claims data (AOK)
Population: Persons ≥75 years free of dementia
Country: Germany
Period: 2004–2011
Sample size: 73,679 (2,950 regular PPI users)
Inclusion and exclusion criteria: see abstract

Exposure / intervention: Regular prescription of omeprazole, pantoprazole, lansoprazole, esomeprazole or rabeprazole
Comparator: No PPI medication
Endpoints: Incident dementia (ICD-10-GM codes)
Statistical methods: Time-dependent Cox regression adjusted for age, sex, comorbidities, polypharmacy

Results: HR 1.44 (1.36–1.52) for regular PPI users vs non-users.
Absolute risks: not reported in abstract
Authors' conclusion: Avoidance of PPI medication may prevent dementia; RCTs needed.

Orienting tool: ROBINS-E
Type of assessment: simplified assessment (abstract only)
Full formal assessment: no
Overall risk of bias: high
Rationale: Strong potential for residual confounding; claims data lack key covariates.

Modest relative risks from observational data; see bias notes.

Background to C-PPI-09.

COMPASS RCT (I-PPI-01): no significant difference in dementia over 3 years.

High: European (Swedish, UK, Dutch, German) data show similar associations; PPIs are widely used in Germany.

Weak observational signal; later evidence inconsistent.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	low
Risk of bias	high
Precision of results	high
Directness	indirect
Reproducibility	not replicated
Consistency with the overall evidence	inconsistent
Regional transferability	high
Adequacy of the interpretation (by the archive)	not applicable

Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.

What the archive says about the study: Listed in the archive bibliography of the acid-blockers rule without its own interpretation; used implicitly to support the rule summary ('long-term suppression turns against the body: CKD, bacterial overgrowth, C. difficile, pneumonia, B12 and magnesium deficiency, hip fractures, microbiome change, excess mortality').
A. What was actually studied?: Is regular PPI use associated with incident dementia in the elderly?
B. What did the authors find?: HR 1.44 (1.36–1.52) for regular PPI users vs non-users.
C. What conclusions do the authors themselves draw?: Avoidance of PPI medication may prevent dementia; RCTs needed.
D. What does the archive derive from it?: Cited in the bibliography; dementia is not named in the archive summary.
E. Is this derivation scientifically justified?: Not used explicitly; association only, not confirmed in the COMPASS RCT.
Adequacy of the interpretation (by the archive): not applicable