SynthesisGastrointestinal endoscopy2017
Randomized sham-controlled trials in endoscopy: a systematic review and meta-analysis of adverse events.
Synthesis in Gastrointestinal endoscopy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis 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
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Endoscopic sphincterotomy for adults with biliary sphincter of Oddi dysfunction.The Cochrane database of systematic reviews · 2024Pooled it
- Diagnostic performance of the blood urea/creatinine ratio in the diagnosis of occult upper gastrointestinal hemorrhage in the ICU.Critical care (London, England) · 2025Article
- Endoscopic Ultrasound-Guided Vascular Procedures: A Review.Clinical endoscopy · 2020Article
Corrections and comments
- Commented on by
- Commented on byResponse.2018
Authors and funding
3 authors.
Funding
Abstract
BACKGROUND AND
aimsSham procedures in endoscopy are used with the intention of controlling for placebo response, potentially allowing more precise evaluation of treatment effect. Nevertheless, this type of study may impose significant risk without potential benefit for those in the sham group. The aim of the current study was to systematically review and analyze the endoscopic literature to assess the safety of sham controls.
methodsMEDLINE and Embase databases were searched for endoscopic sham procedures for all dates to July 2017. Only randomized controlled trials comparing an endoscopic therapy with a sham were included. Primary outcome was adverse events (AEs) categorized as mild, moderate, or severe. Results were combined using a random-effects model. Heterogeneity was assessed with the I
resultsData were extracted from 34 publications (1987-2017; 100% full text), with a total of 2492 procedures (1355 treatment/1137 sham). Sham procedures involved upper endoscopy (31 studies) and ERCP (3 studies). Treatment arms included procedures with the following indications: weight loss (38.2%), GI bleeding (26.5%), GERD (20.6%), sphincter of Oddi dysfunction (8.8%), and dysphagia (6.2%). Overall percentage of severe adverse events (SAEs) in the sham group was 1.7% (19/1137). Of these, the most common SAEs in the sham groups were need for surgery/intensive care unit stay (35.3%), post-ERCP pancreatitis (23.5%), and perforation (11.8%). There was no significant difference in the odds of developing an SAE between the treatment group and the sham group (odds ratio, 1.3; 95% confidence interval [CI], 0.7-2.3). The pooled additional risk incurred from being initially randomized to the sham arm and then receiving a cross-over intervention was significant (RR, 1.33; 95% CI, 1.14-1.56; P < .001), compared with patients initially randomized to the study intervention.
conclusionThe frequency of AEs in endoscopic sham procedures is substantial, and patients are subjected to considerable morbidity. These results raise a serious ethical dilemma regarding the use of sham-controlled trials.
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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.