Trial reportAlimentary pharmacology & therapeutics2012
Randomised clinical trial: the efficacy and safety of pancreatin enteric-coated minimicrospheres (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis--a double-blind, placebo-controlled study.
Trial report in Alimentary pharmacology & therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 4 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
27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 68 citations in OpenAlex.
- European guidelines for the diagnosis and treatment of pancreatic exocrine insufficiency: UEG, EPC, EDS, ESPEN, ESPGHAN, ESDO, and ESPCG evidence-based recommendations.United European gastroenterology journal · 2025Guideline
- Clinical Efficacy and Safety of Treatments for Exocrine Pancreatic Insufficiency: A Systematic Literature Review.Digestion · 2025Pooled it
- Contribution of pancreatic enzyme replacement therapy to survival and quality of life in patients with pancreatic exocrine insufficiency.World journal of gastroenterology · 2019Pooled it
- Pooled it
- Randomised clinical trial: a 1-week, double-blind, placebo-controlled study of pancreatin 25 000 Ph. Eur. minimicrospheres (Creon 25000 MMS) for pancreatic exocrine insufficiency after pancreatic surgery, with a 1-year open-label extension.Alimentary pharmacology & therapeutics · 2013Trial
- Current Status of Pancreatic Exocrine Insufficiency Diagnosis and Pancreatic Enzyme Replacement Therapy Implementation in Patients With Chronic Pancreatitis.JGH open : an open access journal of gastroenterology and hepatology · 2026Article
- Pancrelipase Improves Symptoms of Exocrine Pancreatic Insufficiency and Health-Related Quality of Life in a Real-World Population of Patients with Chronic Pancreatitis.Digestive diseases and sciences · 2026Observational
- Pancreatic exocrine insufficiency beyond pancreatitis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026Review
- Clinical Practice Update on the Evaluation, Diagnosis, and Management of Pancreatic Exocrine Insufficiency: Expert Review.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2026Review
- Article
- Symptoms, burden, and unmet needs of patients living with exocrine pancreatic insufficiency: a narrative review of the patient experience.BMC gastroenterology · 2024Review
- Management of chronic pancreatitis: recent advances and future prospects.Therapeutic advances in gastroenterology · 2024Review
- The Hong Kong consensus recommendations on the diagnosis and management of pancreatic cystic lesions.Hepatobiliary surgery and nutrition · 2023Review
- Evidence-based clinical practice guidelines for chronic pancreatitis 2021.Journal of gastroenterology · 2022Review
- Pancreatic enzyme treatment in chronic pancreatitis: Quality of management and adherence to guidelines-A cross-sectional observational study.United European gastroenterology journal · 2022Observational
- Consensus for the management of pancreatic exocrine insufficiency: UK practical guidelines.BMJ open gastroenterology · 2021Review
- Turkish Gastroenterology Association, Pancreas Study Group, Chronic Pancreatitis Committee Consensus Report.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2020Article
- Differential Diagnosis and Management of Diarrhea in Patients with Neuroendocrine Tumors.Journal of clinical medicine · 2020Review
- The alterations of gut microbiota in mice with chronic pancreatitis.Annals of translational medicine · 2019Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPancreatic exocrine insufficiency (PEI) results in maldigestion, leading to abdominal pain, steatorrhoea, malnutrition and weight loss.
aimTo assess the efficacy and safety of pancreatin (Creon 40000 MMS) in treating PEI due to chronic pancreatitis (CP).
methodsThis was a 1-week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study in India. Men and women ≥18 years of age with proven CP and PEI [defined as a coefficient of fat absorption (CFA) ≤80% during run-in phase] were randomised 1:1 to pancreatin or placebo (two capsules orally per main meal, one with snacks). The primary outcome measure was change in CFA from baseline to end of double-blind treatment (analysis of covariance).
resultsOf 62 patients randomised (34 pancreatin, 28 placebo), 61 completed treatment; one patient in the placebo arm withdrew consent before completion. Patient characteristics were similar in both groups except for the proportion of men (pancreatin 82% vs. placebo 68%). Patients receiving pancreatin had a statistically significant greater improvement in fat absorption from baseline to the end of double-blind treatment compared with those receiving placebo, with a least squares mean change (95% CI) in CFA of 18.5% (15.8-21.2) vs. 4.1% (1.0-7.2), respectively. This resulted in a treatment difference of 14.4% (10.3-18.5); P = 0.001. Patients receiving pancreatin also had a statistically significant greater improvement in nitrogen absorption and greater reductions in mean stool fat, stool frequency and stool weight compared with those receiving placebo. Treatment-emergent adverse events occurred in 12 patients on pancreatin and in seven on placebo; none led to study discontinuation.
conclusionsThe results provide evidence for the efficacy of pancreatin (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis, and confirm that this formulation is well tolerated, with a good safety profile, at the dose administered.
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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.